71 results on '"Collovà, E"'
Search Results
2. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study
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Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E, Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Abstract
Background: The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE). Methods: Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2–3 (DEX3), or 3) DEX (4 mg twice daily) on days 2–4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis. Results: In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [±1.8; SE] vs. 53.7 [±1.5]), vomiting score (56.6 [±1.4] vs. 58.7 [±0.8]) and overall score (105.6 [±2.8] vs.112.4 [±1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [±1.7]), vomiting score (58.2 [±1]) and overall score (107.8 [±2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL. Conclusion: Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin. Trial registration: ClinicalTrials.govNCT04201769. Registration date: 17/12/2019 - Retrospectively registered.
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- 2022
3. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study
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Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E, Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Abstract
Background: To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin-based chemotherapy, we evaluated the noninferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with an oral fixed-dose combination of netupitant and palonosetron (NEPA), compared with the guideline-consistent use of 4-day DEX. Patients and Methods: In this open-label, multicenter study, chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either (a) no further DEX (DEX1), (b) oral DEX (4 mg daily) on days 2–3 (DEX3), or (c) DEX (4 mg twice daily) on days 2–4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5-day overall phase. The noninferiority margin was set at −15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea). Results: Two-hundred twenty-eight patients, 76 in each arm, were assessable. Noninferiority was met for both DEX-sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% confidence interval, −12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups. Conclusion: A simplified regimen of NEPA plus single-dose DEX offers comparable chemotherapy-induced nausea and vomiting prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high–emetic-risk setting of cisplatin-based chemotherapy. Implications for Practice: Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy-induced emesis. Although generally considered safe, even short-term DEX use is associated with various side effects, and some evidence suggests that concurrent steroids may reduce the efficacy of immunotherapi
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- 2021
4. C14 - From the CLEOPATRA study to real life: preliminary results from the G.O.N.O. SUPER trial
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Garrone, O., Cursano, M.C., De Angelis, C., Giarratano, T., Saggia, C., Beano, A., Cazzaniga, M., La Verde, N., Milani, A., Collovà, E., Coltelli, L., de Conciliis, E., Vandone, A.M., Airoldi, M., D'Onofrio, L., Bertolini, I., Guarneri, V., Donadio, M., Riva, F., and Merlano, M.C.
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- 2017
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5. Efficacy and Safety of Pertuzumab in Metastatic Breast Cancer Patients in a Real-World Setting: Results from the SUPER-GONO (Gruppo Oncologico Del Nord Ovest) Study
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Garrone O, Giarratano T, Blondeaux E, Mastro LD, Santini D, D’Onofrio L, Michelotti A, Landucci E, Beano A, Aprile G, Guarneri V, Paccagnella M, Vanella P, Ruatta F, Denaro N, Saggia C, Coltelli L, Allegrini G, Cazzaniga ME, LaVerde N, Collovà E, Montemurro F, Blasi L, Ardito R, DeConciliis E, Airoldi M, and Merlano MC
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- 2021
6. 216MO A randomized phase II trial of metronomic oral vinorelbine plus cyclophosphamide and capecitabine (VEX) vs weekly paclitaxel (P) as first- or second-line treatment in patients (pts) with ER+/HER2- metastatic breast cancer (MBC): The METEORA-II trial (IBCSG 54-16)
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Munzone, E., Regan, M.M., Cinieri, S., Montagna, E., Orlando, L., Shi, R., Campadelli, E., Gianni, L., De Giorgi, U.F.F., Bengala, C., Generali, D., Collova, E., Puglisi, F., Cretella, E., Zamagni, C., Chini, C., Goldhirsch, A., and Colleoni, M.A.
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- 2022
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7. Metronomic oral vinorelbine in advanced breast cancer and non-small-cell lung cancer: Current status and future development
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Cazzaniga, M, Camerini, A, Addeo, R, Nolè, F, Munzone, E, Collovà, E, Del Conte, A, Mencoboni, M, Papaldo, P, Pasini, F, Saracchini, S, Bocci, G, Cazzaniga M, Camerini A, Addeo R, Nolè F, Munzone E, Collovà E, Del Conte A, Mencoboni M, Papaldo P, Pasini F, Saracchini S, Bocci G, Cazzaniga, M, Camerini, A, Addeo, R, Nolè, F, Munzone, E, Collovà, E, Del Conte, A, Mencoboni, M, Papaldo, P, Pasini, F, Saracchini, S, Bocci, G, Cazzaniga M, Camerini A, Addeo R, Nolè F, Munzone E, Collovà E, Del Conte A, Mencoboni M, Papaldo P, Pasini F, Saracchini S, and Bocci G
- Abstract
Metronomic chemotherapy (mCT), a frequent administration of low-dose chemotherapy, allows prolonged treatment duration and minimizes the toxicity of standard-dose chemotherapy. mCT has multiple actions against cancer cells including inhibition of angiogenesis and modulation of the immune system. A number of studies lend support to the clinical efficacy of mCT in advanced breast cancer and non-small-cell lung cancer. However, further evidence is necessary to describe the optimal use of mCT and to identify suitable patients. Oral vinorelbine has emerged as a promising metronomic treatment in patients with metastatic breast cancer and non-small-cell lung cancer and is the only orally available microtubule-targeting agent. This paper reviews current evidence on metronomic oral vinorelbine, discusses its management and defines a suitable patient profile on the basis of a workshop of Italian experts.
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- 2016
8. SIOG2021-0013* - Evaluation of dexamethasone (DEX)-sparing regimens, administered with NEPA, a fixed combination of netupitant and palonosetron, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in older patients receiving high-dose cisplatin
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Celio, L., Cortinovis, D., Cogoni, A.A., Cavanna, L., Martelli, O., Carnio, S., Collovà, E., Bertolini, F., Petrelli, F., Cassano, A., Chiari, R., Zanelli, F., Pisconti, S., Vittimberga, I., Letizia, A., Misino, A., Gernone, A., Bonizzoni, E., Pilotto, S., De Placido, S., and Bria, E.
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- 2021
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9. 1815MO Two simplified dexamethasone (DEX)-sparing regimens with NEPA for the prevention of emesis caused by cisplatin (DDP): A phase III, controlled, non-inferiority trial
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Celio, L., Cortinovis, D., Cogoni, A., Cavanna, L., Martelli, O., Carnio, S., Collovà, E., Bertolini, F., Petrelli, F., Cassano, A., Chiari, R., Zanelli, F., Vittimberga, I., Letizia, A., Misino, A., Silvestris, F., Bonizzoni, E., Pilotto, S., De Placido, S., and Bria, E.
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- 2020
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10. 290P From the CLEOPATRA study to real life: Final results from the G.O.N.O. SUPER trial
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Garrone, O., Giarratano, T., Michelotti, A., Saggia, C., D'Onofrio, L., Merlini, L., Blondeaux, E., Beano, A., Coltelli, L., Cazzaniga, M.E., Montemurro, F., Farnesi, A., La Verde, N.M., Vandone, A.M., Collovà, E., Blasi, L., Ardito, R., DeConciliis, E., Airoldi, M., and Merlano, M.C.
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- 2020
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11. Use of metronomic chemotherapy in oncology: Results from a national Italian survey
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Collovà, E., Sebastiani, F., Matteis, E., DANIELE GENERALI, Aurilio, G., Boccardo, F., Crispino, S., Cruciani, G., Collovà, Elena, Sebastiani, Federica, De Matteis, Elisabetta, Generali, Daniele, Aurilio, Gaetano, Boccardo, Francesco, Crispino, Sergio, and Cruciani, Giorgio
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Adult ,Male ,Vascular Endothelial Growth Factor A ,Cancer Research ,Administration, Oral ,Antineoplastic Agents ,Medical Oncology ,Vinblastine ,Deoxycytidine ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Neoplasms ,Surveys and Questionnaires ,Antineoplastic Combined Chemotherapy Protocols ,Capecitabine ,Cyclophosphamide ,Methotrexate ,Metronomic chemotherapy ,Survey ,Vinorelbine ,Medicine (all) ,Oncology ,Humans ,Practice Patterns, Physicians' ,Etoposide ,Neovascularization, Pathologic ,General Medicine ,Middle Aged ,Italy ,030220 oncology & carcinogenesis ,Administration, Metronomic ,Workforce ,Female ,Fluorouracil - Abstract
Aims and background Metronomic chemotherapy refers to the administration of low doses of cytotoxic agents over a prolonged period of time with no or only short drug-free intervals. It is designed to overcome acquired tumor resistance to chemotherapy and reduce neo-angiogenesis despite a lower toxicity than with standard chemotherapy. The role of metronomic chemotherapy remains controversial, and its optimal therapeutic use has not yet been defined. Methods and study design The present survey was designed as a short questionnaire and was sent to the medical oncologists registered with Medikey, a national database listing all the Italian oncology specialists linked with the Italian Council of Medical Oncology Hospital Consultants (Collegio Italiano Primari Oncologi Medici Ospedalieri, CIPOMO) and the Italian Association of Medical Oncology (Associazione Italiana di Oncologia Medica, AIOM). The questionnaire was completed on a voluntary basis and it was totally anonymous. Results The questionnaire was sent to 3,289 oncologists, and 191 (5.8%) actively participated in the survey. Seventy-two percent of responders declared that they had administered a regimen of metronomic chemotherapy at least once. Metronomic chemotherapy is commonly used in advanced breast cancer patients, and inmost cases it was prescribed after failure of at least two lines of treatment. Oral agents such as cyclophosphamide, capecitabine, methotrexate and vinorelbine were the most commonly prescribed drugs. Nearly 60% of responders was believed to have significantly less toxicity with metronomic chemotherapy than with standard chemotherapy. Conclusions The sample of oncologists who participated in the survey is small but it appears to be representative of the Italian medical oncology community. The answers to the questionnaire indicate a significant interest in metronomic chemotherapy, which is apparently widely prescribed. This is the first large national survey on the use of metronomic chemotherapy. Considering the results, larger research on metronomic chemotherapy is strongly warranted.
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- 2011
12. Male breast cancer: clinical features and multimodal treatment in a retrospective survey analysis at Italian centers
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La Verde, N, Collovà, E, Lonardi, S, Generali, D, Moretti, A, Atzori, F, Cazzaniga, M, Saggia, C, Tondulli, L, Marcon, I, Gentile, A, Rossello, R, Martelli, O, Aglione, S, Farina, G, Cinquini, M, Garassino, M, La Verde N, Collovà E, Lonardi S, Generali D, Moretti A, Atzori F, Cazzaniga M, Saggia C, Tondulli L, Marcon I, Gentile AL, Rossello R, Martelli O, Aglione S, Farina G, Cinquini M, Garassino M, La Verde, N, Collovà, E, Lonardi, S, Generali, D, Moretti, A, Atzori, F, Cazzaniga, M, Saggia, C, Tondulli, L, Marcon, I, Gentile, A, Rossello, R, Martelli, O, Aglione, S, Farina, G, Cinquini, M, Garassino, M, La Verde N, Collovà E, Lonardi S, Generali D, Moretti A, Atzori F, Cazzaniga M, Saggia C, Tondulli L, Marcon I, Gentile AL, Rossello R, Martelli O, Aglione S, Farina G, Cinquini M, and Garassino M
- Abstract
Aims and background. We report a collection of data about early breast cancer in male patients from 13 Italian institutions. Methods and study design. We obtained data from patient charts and performed statistical analysis. The primary end points were overall survival and disease-free survival. Results. A total of 205 men with invasive breast cancer was identified, with a median age of 66 years. Pathological characteristics were heterogeneous for T stage, N stage and HER2 status. Histological subtype was predominantly ductal infiltrating carcinoma. Most of them were hormone receptor positive. Mastectomy was the most common strategy. Postsurgical treatment was not standardized. Patients with large tumors were more likely to be treated with chemotherapy. Disease recurrence was associated with an ER+ and PR+ status. Conclusions. We identified a correlation between relapse and hormone receptor expression, as is the case in female breast cancer.
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- 2013
13. Male breast cancer: clinical features and multimodal treatment in a retrospective survey analysis at Italian centers
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La Verde N, Collovà E, Lonardi S, Generali D, Moretti A, Atzori F, Cazzaniga M, Saggia C, Tondulli L, Marcon I, Gentile AL, Rossello R, Martelli O, Aglione S, Farina G, Cinquini M, Garassino M, La Verde, N, Collovà, E, Lonardi, S, Generali, D, Moretti, A, Atzori, F, Cazzaniga, M, Saggia, C, Tondulli, L, Marcon, I, Gentile, A, Rossello, R, Martelli, O, Aglione, S, Farina, G, Cinquini, M, and Garassino, M
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breast cancer - Abstract
Aims and background. We report a collection of data about early breast cancer in male patients from 13 Italian institutions. Methods and study design. We obtained data from patient charts and performed statistical analysis. The primary end points were overall survival and disease-free survival. Results. A total of 205 men with invasive breast cancer was identified, with a median age of 66 years. Pathological characteristics were heterogeneous for T stage, N stage and HER2 status. Histological subtype was predominantly ductal infiltrating carcinoma. Most of them were hormone receptor positive. Mastectomy was the most common strategy. Postsurgical treatment was not standardized. Patients with large tumors were more likely to be treated with chemotherapy. Disease recurrence was associated with an ER+ and PR+ status. Conclusions. We identified a correlation between relapse and hormone receptor expression, as is the case in female breast cancer.
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- 2013
14. Italian Survey on adjuvant treatment of non-small cell lung cancer (ISA)
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Banna, G, Di Maio, M, Follador, A, Collovà, E, Menis, J, Novello, S, Bria, E, Airoldi, M, Amoroso, D, Ardizzoia, A, Aurilio, G, Bajetta, E, Ballardini, P, Barbieri, F, Barletta, E, Balzelloni, M, Basso, U, Bernardini, I, Boni, C, Bordin, V, Bretti, S, Bronte, G, Brunetti, C, Buti, S, Capanna, L, Colombo, A, Condemi, G, Cortinovis, D, Dambrosio, M, Di Fonzo, C, Di Lucca, G, Dima, G, Falzetta, A, Favaretto, A, Ferraù, F, Garetto, L, Gebbia, V, Genestreti, G, Gentile, A, Giovanardi, F, Labianca, R, Lorusso, V, Mantovani, G, Martelli, O, Massari, F, Mazzoli, M, Michetti, G, Mordenti, P, Mucciarini, C, Munao, S, Nacci, A, Pogliani, C, Procopio, G, Riccardi, F, Rizzato, S, Rossi, A, Rosti, G, Russo, P, Saladino, T, Salesi, N, Santangelo, D, Sava, T, Savarino, A, Spinnato, F, Tiseo, M, Tomassi, O, Tondulli, L, Tonini, G, Turano, S, Valerio, M, Verderame, F, Zanelli, F, Zanon, E, Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, Zanon E., Banna, G, Di Maio, M, Follador, A, Collovà, E, Menis, J, Novello, S, Bria, E, Airoldi, M, Amoroso, D, Ardizzoia, A, Aurilio, G, Bajetta, E, Ballardini, P, Barbieri, F, Barletta, E, Balzelloni, M, Basso, U, Bernardini, I, Boni, C, Bordin, V, Bretti, S, Bronte, G, Brunetti, C, Buti, S, Capanna, L, Colombo, A, Condemi, G, Cortinovis, D, Dambrosio, M, Di Fonzo, C, Di Lucca, G, Dima, G, Falzetta, A, Favaretto, A, Ferraù, F, Garetto, L, Gebbia, V, Genestreti, G, Gentile, A, Giovanardi, F, Labianca, R, Lorusso, V, Mantovani, G, Martelli, O, Massari, F, Mazzoli, M, Michetti, G, Mordenti, P, Mucciarini, C, Munao, S, Nacci, A, Pogliani, C, Procopio, G, Riccardi, F, Rizzato, S, Rossi, A, Rosti, G, Russo, P, Saladino, T, Salesi, N, Santangelo, D, Sava, T, Savarino, A, Spinnato, F, Tiseo, M, Tomassi, O, Tondulli, L, Tonini, G, Turano, S, Valerio, M, Verderame, F, Zanelli, F, Zanon, E, Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, and Zanon E.
- Abstract
Background: A recent pooled analysis of randomized trials indicated significant improvement in overall survival from cisplatin-based adjuvant chemotherapy for non-small cell lung cancer (NSCLC), depending on disease stage (only in stages II and III) and PS (≤1). Post-operative radiotherapy (RT) is optional for pN2 tumours. Patients and methods: To evaluate opinions and daily clinical practice of Italian Oncologists about adjuvant treatment of NSCLC, a 46-item questionnaire was delivered via e-mail. Results: Seventy-eight physicians from 68 Centers (out of 98 contacted) returned their questionnaire. Seventy-four, 86, 94, and 78% of them give the indication for adjuvant chemotherapy for stage IIA, IIB, IIIA, and IIIB disease, respectively and 14% in stage IB disease. Stage, PS, and age are taken into consideration evaluating adjuvant approach by 97, 95 and 73%, respectively. Cisplatin-vinorelbine (64%) and cisplatin-gemcitabine (33%), for 4 cycles (81%), are the preferred regimens, while 32% use different regimens. Ninety-two percent indicate RT in pN2 disease and/or positive resection margins. Real Number of patients Needed to Treat (NNT) is probably not completely known/understood and/or used by physicians. Conclusions: A substantial adherence between clinical daily practice in Italy and scientific progresses is described in this paper, even with some discordances regarding the most appropriate adjuvant chemotherapy regimen.
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- 2011
15. L’attualità nella pratica clinica del trattamento del carcinoma della mammella avanzato
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Collovà, E, Ciccarese, M, Di Maio, M, Fabi, A, Generali, D, Guarneri, Valentina, La Verde, N, Moscettti, L, Salesi, N, and Scandurra, G.
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- 2013
16. Anticancer oral therapy: emerging related issues
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Banna GL, Collovà E, Gebbia V, Lipari H, Giuffrida P, Cavallaro S, Condorelli R, Buscarino C, Tralongo P, and Ferraù F
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- 2010
17. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study
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Agnelli, G, Gussoni, G, Bianchini, C, Verso, M, Mandalà, M, Cavanna, L, Barni, S, Labianca, R, Buzzi, F, Scambia, G, Passalacqua, R, Ricci, S, Gasparini, G, Lorusso, V, Bonizzoni, E, Tonato, M, PROTECHT Investigators Agnelli, G, Amadori, D, Barbui, T, Cognetti, F, Crinò, L, Mannucci, Pm, Moia, M, Gianni, L, Prandoni, P, Cesana, B, de Braud, F, Del Favero, A, Lazzaro, A, Anselmi, E, Mordenti, P, Cabiddu, M, Petrelli, F, Ghilardi, M, Poletti, P, Marelli, B, Fumagalli, D, Sabatini, S, Fumi, G, Masi, C, Salutari, V, Malaggese, M, Brighenti, M, Lazzarelli, S, Donati, G, Di Donato, S, Arrighi, G, Orlandini, C, Amici, S, Verì, A, Sarmento, R, Pollera, C, Capomolla, E, Moschetti, L, Garufi, C, Campanella, C, Torsello, A, Misino, A, Ciuffreda, L, Dongiovanni, V, Addeo, A, Vitale, Fv, Ferraù, F, Priolo, D, Muggiano, A, Mulas, C, Tedde, A, Pogliani, Ea, Ardizzoia, A, Villa, F, Montedoro, M, Bravi, S, Biagioni, F, Palazzo, S, Filice, A, Gori, S, Porrozzi, S, Ciccarese, M, Petrucelli, L, Chiuri, Ve, Passardi, A, Ravaioli, E, Ceravolo, R, Crivellari, G, Nicoletto, Mo, Brandes, A, Bertolini, S, Benedetti, G, Bernardo, G, Teragni, C, Jirillo, A, Falci, C, Santoro, A, Masci, G, Monti, M, Casanova, C, Intrivici, C, Rinaldi, G, Massidda, B, Ionta, Mt, Dogliotti, Luigi, Russo, L, Collovà, E, Luoni, M, Maiello, E, Romano, Mp, Molica, S, Battaglia, C, Doni, L, Di Costanzo, F, Giuliodori, L, Silva, Rr, Sarobba, Mg, Pinna, A, Sorarù, M, Gaion, F, Ferrandina, G, Gilli, G, Locatelli, Mc, Zanaboni, F, Bologna, A, Ferretti, G, Chini, C, Farina, G, Bronner, L, Biscottini, B, Tomirotti, M, and Sciacca, V.
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- 2009
18. Tumor Characteristics and Adjuvant treatment in Very Young Women
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Ghidini, A, Cazzaniga, M. E., Adamo, Barbara, Mancuso, A, Bettini, A. C., Martelli, O, GARASSINO M, CARTA A. M., Collovà, E, Aglione, S, and Saggese, M.
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- 2006
19. 372P - Targeted Chemotherapy with Albumin-Bound Paclitaxel (Nab-Paclitaxel) for Metastatic Breast Cancer (Mbc): Which Benefit for Which Patients? a Real World Multicenter Italian Experience on 150 Women
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Palumbo, R., Cazzaniga, M.E., Piazza, E., Ferzi, A., Grasso, D., Tondini, C., Danova, M., Tarenzi, E., Sottotetti, F., Villa, F., Gambaro, A., Tosi, F., Fasola, C., Collova, E., Caremoli, E. Rota, Poletti, P., Cavalli, C., Torchio, M., and Bernardo, A.
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- 2014
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20. 9129 Outcomes of malignant pleural mesothelioma patients treated with second-line chemotherapy (SL): a retrospective analysis of 161 patients
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Garassino, M., Moretti, A., Cinquini, M., Tiseo, M., Michetti, G., Collova, E., Follador, A., Verde, N. La, Farina, G., and Zucali, P.
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- 2009
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21. Second-line chemotherapy in malignant pleural mesothelioma: Results of a retrospective multicenter survey
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Zucali, P.A., Simonelli, M., Michetti, G., Tiseo, M., Ceresoli, G.L., Collovà, E., Follador, A., Lo Dico, M., Moretti, A., De Vincenzo, F., Lorenzi, E., Perrino, M., Giordano, L., Farina, G., Santoro, A., and Garassino, M.
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- *
CANCER chemotherapy , *MESOTHELIOMA , *RETROSPECTIVE studies , *MEDICAL care surveys , *CANCER patients , *CISPLATIN , *HEALTH outcome assessment , *CANCER invasiveness , *THERAPEUTICS - Abstract
Abstract: The pemetrexed-cisplatin chemotherapy is standard of care in first-line (FL) treatment of malignant pleural mesothelioma (MPM). The second-line (SL) chemotherapy is considered, but the optimal treatment has not been defined yet. The aim of this study was to evaluate the clinical outcomes of SL-therapy in a series of MPM-patients included in a retrospective multicenter database. Clinical records of MPM-patients who received SL-treatment from 1996 to 2008 were reviewed. Study endpoints were response, overall-survival (OS), and progression-free-survival (PFS) for SL, stratified for patient characteristics, FL-outcomes, and type of SL. Out of 423 patients, 181 with full clinical data were identified. Patients’ characteristics: median-age 64 years (range: 36–85); male gender 115 (63.5%); good EORTC-score 109 (60.2%); epithelial histology 135 (74.6%). After FL, 147 (81.2%) patients achieved disease-control (DC) and 45 had a time-to-progression≥12months (TTP≥12). After SL, 95 patients (52.6%) achieved DC (21 response; 74 stable-disease); median PFS and OS were 4.3 and 8.7months, respectively. According to multivariate analysis, DC after SL-therapy was significantly related to pemetrexed-based treatment (OR: 2.46; p =0.017) and FL-TTP≥12 (OR: 3.50; p =0.006). PFS was related to younger age (<65years) (HR: 0.70; p =0.045), ECOG-PS0 (HR: 0.67; p =0.022), and FL-TTP≥12 (HR: 0.45; p <0.001). OS was significantly related to ECOG-PS0 (HR: 0.43; p <0.001) and to FL-TTP≥12 (HR: 0.54; p =0.005). In pemetrexed pre-treated patients, re-treatment with a pemetrexed/platinum combination significantly reduced the risk-of-death than pemetrexed alone (HR: 0.11; p <0.001). In conclusion, SL-chemotherapy seems to be active in MPM-patients, particularly in younger patients with ECOG-PS0 and prolonged TTP after FL-pemetrexed-based chemotherapy. In selected patients, re-challenge with pemetrexed-based regimens, preferentially associated with platinum-compound, appears to be an option for SL-setting. Considering the important limitations of this study, due to retrospective nature and the possible selection bias, prospective clinical trials are warranted to clarify these issues. [Copyright &y& Elsevier]
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- 2012
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22. Metronomic oral vinorelbine in advanced breast cancer and non-small-cell lung cancer: Current status and future development
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Paola Papaldo, Marina Cazzaniga, Franco Nolè, Guido Bocci, Silvana Saracchini, Alessandro Del Conte, Andrea Camerini, Felice Pasini, Manlio Mencoboni, Elena Collovà, Elisabetta Munzone, Raffaele Addeo, Cazzaniga, M, Camerini, A, Addeo, R, Nolè, F, Munzone, E, Collovà, E, Del Conte, A, Mencoboni, M, Papaldo, P, Pasini, F, Saracchini, S, and Bocci, G
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0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,medicine.medical_treatment ,Administration, Oral ,NSCLC ,breast cancer ,metronomic chemotherapy ,vinorelbine ,Breast Neoplasms ,Pharmacology ,Vinblastine ,Vinorelbine ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Carcinoma, Non-Small-Cell Lung ,Internal medicine ,medicine ,Humans ,Lung cancer ,Neoplasm Staging ,Chemotherapy ,Metronomic oral vinorelbine, advanced breast cancer ,business.industry ,Cancer ,General Medicine ,medicine.disease ,Antineoplastic Agents, Phytogenic ,Metastatic breast cancer ,Metronomic Chemotherapy ,030104 developmental biology ,030220 oncology & carcinogenesis ,Administration, Metronomic ,Cancer cell ,business ,medicine.drug - Abstract
Metronomic chemotherapy (mCT), a frequent administration of low-dose chemotherapy, allows prolonged treatment duration and minimizes the toxicity of standard-dose chemotherapy. mCT has multiple actions against cancer cells including inhibition of angiogenesis and modulation of the immune system. A number of studies lend support to the clinical efficacy of mCT in advanced breast cancer and non-small-cell lung cancer. However, further evidence is necessary to describe the optimal use of mCT and to identify suitable patients. Oral vinorelbine has emerged as a promising metronomic treatment in patients with metastatic breast cancer and non-small-cell lung cancer and is the only orally available microtubule-targeting agent. This paper reviews current evidence on metronomic oral vinorelbine, discusses its management and defines a suitable patient profile on the basis of a workshop of Italian experts.
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- 2016
23. Natural History of Non-Small-Cell Lung Cancer with Bone Metastases
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Michelle Sterpi, Maria Antonietta Satolli, Salvatore Intagliata, Toni Ibrahim, L. Ginocchi, Bruno Vincenzi, Vincenzo Adamo, Raffaele Addeo, Alfredo Falcone, Filippo de Marinis, Giuseppe Badalamenti, Cinzia Ortega, Antonio Russo, Nicla La Verde, Flavia Longo, Daniele Santini, Gaetano Lanzetta, Davide Ottaviani, Giovanni Mansueto, Enrico Vasile, Flavia Cantile, Francesco Ferraù, Fausto Petrelli, Giuseppe Tonini, Elena Collovà, Francesca Maria Tanca, Sandro Barni, Luca Moscetti, Francesco Pantano, Andrea Mancuso, Domenico Galetta, Marco Russano, Santini D, Barni S, Intagliata S, Falcone A, Ferraù F, Galetta D, Moscetti L, La Verde N, Ibrahim T, Petrelli F, Vasile E, Ginocchi L, Ottaviani D, Longo F, Ortega C, Russo A, Badalamenti G, Collovà E, Lanzetta G, Mansueto G, Adamo V, De Marinis F, Satolli MA, Cantile F, Mancuso A, Tanca FM, Addeo R, Russano M, Sterpi M, Pantano F, Vincenzi B, and Tonini G.
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Oncology ,Adult ,Male ,medicine.medical_specialty ,Lung Neoplasms ,medicine.medical_treatment ,ECOG Performance Status ,Bone Neoplasms ,Young Adult ,Internal medicine ,Carcinoma ,medicine ,80 and over ,Humans ,Young adult ,Lung cancer ,Non-Small-Cell Lung ,Aged ,Lung ,Multidisciplinary ,business.industry ,Adult, Aged, Aged, 80 and over, Bone Neoplasms, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Young Adult, Disease Progression, Multidisciplinary ,Bone metastasis ,Middle Aged ,medicine.disease ,Radiation therapy ,medicine.anatomical_structure ,Concomitant ,Disease Progression ,Female ,Aged, 80 and over ,Carcinoma, Non-Small-Cell Lung ,business - Abstract
We conducted a large, multicenter, retrospective survey aimed to explore the impact of tumor bone involvement in Non-Small Cell Lung Cancer.Data on clinical-pathology, skeletal outcomes and bone-directed therapies for 661 deceased patients with evidence of bone metastasis were collected and statistically analyzed. Bone metastases were evident at diagnosis in 57.5% of patients. In the remaining cases median time to bone metastases appearance was 9 months. Biphosphonates were administered in 59.6% of patients. Skeletal-related events were experienced by 57.7% of patients; the most common was the need for radiotherapy. Median time to first skeletal-related event was 6 months. Median survival after bone metastases diagnosis was 9.5 months and after the first skeletal-related event was 7 months. We created a score based on four factors used to predict the overall survival from the diagnosis of bone metastases: age >65 years, non-adenocarcinoma histology, ECOG Performance Status >2, concomitant presence of visceral metastases at the bone metastases diagnosis. The presence of more than two of these factors is associated with a worse prognosis.This study demonstrates that patients affected by Non-Small Cell Lung Cancer with bone metastases represent a heterogeneous population in terms of risk of skeletal events and survival.
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- 2015
24. Natural history of malignant bone disease in renal cancer: final results of an Italian bone metastasis survey
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Williams, Bart O., Daniele, Santini, Giuseppe, Procopio, Camillo, Porta, Toni, Ibrahim, Sandro, Barni, Calogero, Mazzara, Andrea, Fontana, Berruti, Alfredo, Rossana, Berardi, Bruno, Vincenzi, Cinzia, Ortega, Davide, Ottaviani, Giacomo, Carteni, Gaetano, Lanzetta, Vladimir, Virzì, Matteo, Santoni, Nicola, Silvestris, Maria Antonietta Satolli, Elena, Collovà, Antonio, Russo, Giuseppe, Badalamenti, Stefano Luzi Fedeli, Francesca Maria Tanca, Vincenzo, Adamo, Evaristo, Maiello, Roberto, Sabbatini, Alessandra, Felici, Saverio, Cinieri, Giuseppe, Tonini, Sergio, Bracarda, Santini, D, Procopio, G, Porta, C, Ibrahim, T, Barni, S, Mazzara, C, Fontana, A, Berruti, A, Berardi, R, Vincenzi, B, Ortega, C, Ottaviani, D, Carteni, G, Lanzetta, G, Virzì, V, Santoni, M, Silvestris, N, Satolli, MA, Collovà, E, Russo, A, Badalamenti, G, Fedeli, SL, Tanca, FM, Adamo, V, Maiello, E, Sabbatini, R, Felici, A, Cinieri, S, Tonini, G, and Bracarda, S
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Oncology ,Male ,Anatomy and Physiology ,Bone disease ,Epidemiology ,Settore MED/06 - Oncologia Medica ,medicine.medical_treatment ,Metastasis ,bone metastases ,Renal cell carcinoma ,Basic Cancer Research ,Medicine ,Musculoskeletal System ,Multidisciplinary ,Diphosphonates ,renal cell carcinoma, bone metastasis, zoledronic acid ,Bone metastasis ,Kidney Neoplasms ,Italy ,Observational Studies ,Disease Progression ,Female ,Cancer Epidemiology ,medicine.drug ,Research Article ,medicine.medical_specialty ,Clinical Research Design ,Science ,renal cancer ,Bone Neoplasms ,Internal medicine ,Humans ,Bone ,Retrospective Studies ,business.industry ,Renal Cell Carcinoma ,Cancer ,Cancers and Neoplasms ,Bone fracture ,medicine.disease ,Surgery ,Radiation therapy ,Genitourinary Tract Tumors ,Zoledronic acid ,business - Abstract
BackgroundBone metastasis represents an increasing clinical problem in advanced renal cell carcinoma (RCC) as disease-related survival improves. There are few data on the natural history of bone disease in RCC.Patients and methodsData on clinicopathology, survival, skeletal-related events (SREs), and bone-directed therapies for 398 deceased RCC patients (286 male, 112 female) with evidence of bone metastasis were statistically analyzed.ResultsMedian time to bone metastasis was 25 months for patients without bone metastasis at diagnosis. Median time to diagnosis of bone metastasis by MSKCC risk was 24 months for good, 5 months for intermediate, and 0 months for poor risk. Median number of SREs/patient was one, and 71% of patients experienced at least one SRE. Median times to first, second, and third SRE were 2, 5, and 12 months, respectively. Median survival was 12 months after bone metastasis diagnosis and 10 months after first SRE. Among 181 patients who received zoledronic acid (ZOL), median time to first SRE was significantly prolonged versus control (n = 186) (3 months vs 1 month for control; PConclusionsRCC patients with bone metastasis are at continuous risk of SREs, and in this survey ZOL effectively reduced this risk.
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- 2013
25. Bone metastases in patients with metastatic renal cell carcinoma: are they always associated with poor prognosis?
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Alfredo Berruti, Delia De Lisi, Gaetano Lanzetta, Vincenzo Adamo, Giacomo Cartenì, Cinzia Ortega, Maria Antonietta Satolli, Roberto Sabbatini, Rodolfo Montironi, Stefano Cascinu, Giuseppe Badalamenti, Stefano Luzi Fedeli, Rossana Berardi, Bruno Vincenzi, Nicola Silvestris, Giuseppe Tonini, Alessandro Conti, Camillo Porta, Daniele Santini, Matteo Santoni, Evaristo Maiello, Francesca Maria Tanca, Davide Ottaviani, Saverio Cinieri, Alessandra Felici, Giuseppe Procopio, Sergio Bracarda, Antonio Russo, Andrea Fontana, Elena Collovà, Toni Ibrahim, Francesco Maria Guida, Francesco Massari, Sandro Barni, Santoni, M., Conti, A., Procopio, G., Porta, C., Ibrahim, T., Barni, S., Guida, F. M., Fontana, A., Berruti, A., Berardi, R., Massari, F., Vincenzi, B., Ortega, C., Ottaviani, D., Carteni, G., Lanzetta, G., De Lisi, D., Silvestris, N., Satolli, M. A., Collova, E., Russo, A., Badalamenti, G., Fedeli, S. L., Tanca, F. M., Adamo, V., Maiello, E., Sabbatini, R., Felici, A., Cinieri, S., Montironi, R., Bracarda, S., Tonini, G., Cascinu, S., Santini, D., Guida, F., Satolli, M., Collovà, E., Fedeli, S., and Tanca, F.
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Oncology ,Adult ,Male ,medicine.medical_specialty ,Cancer Research ,Prognosi ,medicine.medical_treatment ,Bone Neoplasms ,Bone Neoplasm ,Prognostic factors ,Metastasis ,Renal cell carcinoma ,Retrospective Studie ,Bone metastasis ,Time to distant metastasis ,Internal medicine ,Bone metastasis, Prognostic factors, Renal cell carcinoma, Time to distant metastasis ,Carcinoma ,Medicine ,Humans ,Lymph node ,Carcinoma, Renal Cell ,Survival analysis ,Aged ,Retrospective Studies ,Aged, 80 and over ,Female ,Kidney Neoplasms ,Middle Aged ,Prognosis ,Survival Analysis ,Prognostic factor ,Time to distant metastasi ,business.industry ,Research ,Kidney Neoplasm ,medicine.disease ,Nephrectomy ,medicine.anatomical_structure ,Concomitant ,Bone metastasi ,Survival Analysi ,business ,Human - Abstract
Purpose: Aim of this study was to investigate for the presence of existing prognostic factors in patients with bone metastases (BMs) from RCC since bone represents an unfavorable site of metastasis for renal cell carcinoma (mRCC). Materials and methods: Data of patients with BMs from RCC were retrospectively collected. Age, sex, ECOG-Performance Status (PS), MSKCC group, tumor histology, presence of concomitant metastases to other sites, time from nephrectomy to bone metastases (TTBM, classified into three groups: 5 years) and time from BMs to skeletal-related event (SRE) were included in the Cox analysis to investigate their prognostic relevance. Results: 470 patients were enrolled in this analysis. In 19 patients (4%),bone was the only metastatic site; 277 patients had concomitant metastases in other sites. Median time to BMs was 16 months (range 0 - 44y) with Median OS of 17 months. Number of metastatic sites (including bone, p = 0.01), concomitant metastases, high Fuhrman grade (p < 0.001) and non-clear cell histology (p = 0.013) were significantly associated with poor prognosis. Patients with TTBM >5 years had longer OS (22 months) compared to patients with TTBM
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26. Efficacy of Metronomic Oral Vinorelbine, Cyclophosphamide, and Capecitabine vs Weekly Intravenous Paclitaxel in Patients With Estrogen Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: Final Results From the Phase 2 METEORA-II Randomized Clinical Trial.
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Munzone E, Regan MM, Cinieri S, Montagna E, Orlando L, Shi R, Campadelli E, Gianni L, Palleschi M, Petrelli F, Bengala C, Generali D, Collovà E, Puglisi F, Cretella E, Zamagni C, Chini C, Ruepp B, Loi S, and Colleoni M
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- Female, Humans, Middle Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Capecitabine, Cyclophosphamide, Paclitaxel, Receptor, ErbB-2, Receptors, Estrogen, Vinorelbine adverse effects, Adult, Aged, Aged, 80 and over, Breast Neoplasms pathology
- Abstract
Importance: In spite of the effectiveness of endocrine therapy plus cyclin-dependent kinase (CDK) 4/6 inhibitors as the first-line treatment for estrogen receptor (ER)-positive, erb-b2 receptor tyrosine kinase 2 (ERBB2 [formerly HER2/neu])-negative (ER+/ERBB2-) metastatic breast cancer (MBC), patients eventually develop resistance, and eventually most will receive chemotherapy. The METEORA-II trial compared a metronomic all-oral treatment with intravenous (IV) chemotherapy., Objective: To compare the efficacy of the oral vinorelbine plus cyclophosphamide plus capecitabine (VEX) regimen vs weekly IV paclitaxel among patients with ER+/ERBB2- MBC who are candidates for chemotherapy., Design, Setting, and Participants: This phase 2 randomized clinical trial including 140 women 18 years and older (randomized 1:1) with ER+/ERBB2- MBC was carried out from September 13, 2017, to January 14, 2021 at 15 centers in Italy. Eligible patients could have received 1 prior line of chemotherapy for MBC and/or 2 lines of endocrine therapy (including CDK4/6 inhibitors)., Interventions: In 4-week cycles, patients received either metronomic oral VEX or weekly IV paclitaxel., Main Outcomes and Measures: The primary end point was investigator-assessed time to treatment failure (TTF) defined as the interval between the date of randomization to the end of treatment (because of disease progression or lack of tolerability or because further trial treatment was declined). Secondary end points included progression-free survival (PFS), overall survival (OS), and disease control rate (complete or partial response or stable disease lasting for at least 24 weeks)., Results: In total, 133 patients received either VEX (n = 70) or paclitaxel (n = 63) in 4-weekly cycles. The median age was 61 (range, 30-80) years. The VEX treatment significantly prolonged TTF vs paclitaxel (hazard ratio [HR], 0.61; 95% CI, 0.42-0.88; P = .008), median TTF was 8.3 (95% CI, 5.6-11.1) months for VEX vs 5.7 (95% CI, 4.1-6.1) months for paclitaxel, and the 12-month TTF was 34.3% for VEX vs 8.6% for paclitaxel. The median PFS was 11.1 (95% CI, 8.3-13.8) months vs 6.9 (95% CI, 5.4-10.1) months favoring VEX (HR, 0.67; 95% CI, 0.46-0.96, P = .03). The 12-month PFS was 43.5% for VEX vs 21.9% for paclitaxel. No difference in OS was found. The TF event for 55.6% of patients was progression of disease; for 23% it was AEs. More patients assigned to VEX had at least 1 grade 3 or 4 targeted adverse event (VEX, 42.9%; 95% CI, 31.1%-55.3% vs paclitaxel, 28.6%; 95% CI, 17.9%-41.3%), but essentially no alopecia., Conclusion and Relevance: This randomized clinical trial found significantly prolonged TTF and PFS for oral VEX but no improvement in OS compared with intravenous paclitaxel, despite increased but still manageable toxic effects. The VEX regimen may provide more prolonged disease control than weekly paclitaxel for ER+/ERBB2- MBC., Trial Registration: ClinicalTrials.gov Identifier: NCT02954055.
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- 2023
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27. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study).
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Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
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- Humans, Cisplatin therapeutic use, Palonosetron, Vomiting chemically induced, Nausea chemically induced, Dexamethasone therapeutic use, Eating, Lung, Antiemetics, Antineoplastic Agents therapeutic use
- Abstract
We demonstrated the non-inferiority of a dexamethasone (DEX)-sparing (single-dose) regimen with NEPA, a netupitant/palonosetron fixed combination, for preventing chemotherapy-induced nausea and vomiting (CINV) caused by cisplatin. This pre-planned exploratory analysis assessed the effect of the DEX-sparing regimen on a patient's food intake. Chemotherapy-naïve patients undergoing cisplatin (≥ 70 mg/m
2 ) were given NEPA and DEX (12 mg) on day 1 and randomized to receive either no further DEX (DEX1), or oral DEX (4 mg BID) on days 2-4 (DEX4). Patient-reported endpoint maintenance of usual daily food intake was assessed during the 5-days post-chemotherapy. The relationship between usual daily food intake and CINV control, pre-chemotherapy self-rated food intake and BMI-adjusted weight loss (WL) were evaluated. One-hundred fifty-two patients (76/group) were assessable. The proportion of patients reporting maintenance of usual daily food intake was similar in both groups: 69.7% (95% CI, 58.6-78.9) for DEX1 vs. 72.4% (95% CI, 61.4-81.2) for DEX4. Only CINV control was significantly associated with maintenance of usual daily food intake (P ≤ 0.001) during the overall phase. The DEX-sparing regimen does not adversely affect patient-reported daily food intake post-chemotherapy. The current analysis adds further insights into antiemetic efficacy of DEX sparing beyond day 1 in the challenging setting of cisplatin.Trial registration: The parent study was registered on ClinicalTrials.gov (NCT04201769)., (© 2023. The Author(s).)- Published
- 2023
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28. Tolerability of Eribulin and correlation between polymorphisms and neuropathy in an unselected population of female patients with metastatic breast cancer: results of the multicenter, single arm, phase IV PAINTER study.
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La Verde N, Damia G, Garrone O, Santini D, Fabi A, Ciccarese M, Generali DG, Nunzi M, Poletto E, Ferraris E, Cretella E, Scandurra G, Meattini I, Bertolini AS, Cavanna L, Collovà E, Romagnoli E, Rulli E, Legramandi L, Guffanti F, Bramati A, Moretti A, Cassano A, Vici P, Torri V, and Farina G
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- Humans, Female, Middle Aged, Quality of Life, Treatment Outcome, Polymorphism, Genetic, Neoplasm Metastasis, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Peripheral Nervous System Diseases chemically induced, Peripheral Nervous System Diseases genetics, Neutropenia chemically induced, Neutropenia epidemiology
- Abstract
Background: Metastatic breast cancer (MBC) is an incurable disease and its treatment focuses on prolonging patients' (pts) overall survival (OS) and improving their quality of life. Eribulin is a microtubule inhibitor that increases OS in pre-treated MBC pts. The most common adverse events (AEs) are asthenia, neutropenia and peripheral neuropathy (PN)., Methods: PAINTER is a single arm, phase IV study, aimed at evaluating the tolerability of eribulin in MBC pts. Secondary objectives were the description of treatment efficacy and safety, the assessment of the incidence and severity of PN and its association with genetic polymorphisms. Genomic DNA was isolated from blood samples and 15 Single Nucleotide Polymorphisms (SNPs) were genotyped by Taqman specific assays. The association between PN and SNPs were evaluated by Fisher exact test., Results: Starting from May 2014 until June 2018 180 pts were enrolled in this study by 20 Italian centers. 170 of these pts could be evaluated for efficacy and toxicity and 159 for polymorphisms analysis. The median age of pts was 60 years old and the biological subtypes were luminal type (64.7%), Her2 positive (18.3%) and triple negative (17%). Pts were pretreated with a median of 5 lines for MBC. The median follow up of this study was 15.4 months with a median number of 4.5 cycles administered (minimum-maximum 1-23). The median overall survival was 12 months. 48.8% of pts experienced a dose reduction, mainly for neutropenia (23.9%) and liver toxicity (12%). 65 pts (38.2%) reported at least one severe toxicity. Neutropenia and neurotoxicity were the most frequent severe AEs (15.3% and 14.7%, respectively); other reported toxicities were osteo-muscular, abdominal or tumor site pain (19.4%), liver toxicity (6.6%), pulmonary toxicity (6.5%) and dermatological toxicity (3.6%). Among the 15 evaluated SNPs, an association with PN was found for rs2233335 and rs7214723., Conclusions: Eribulin is a well-tolerated treatment option in MBC. Schedule and dosage modifications were common, but toxicity rarely led to treatment discontinuation. SNPs rs2233335 (G/T and T/T) in the NDRG1 gene and rs7214723 (CC and CT) in the CAMKK1 gene were associated with PN. These findings, if validated, could allow a tailored treatment with eribulin in cancer patients., Trial Registration: ClinicalTrials.gov ID: NCT02864030., (© 2022. The Author(s).)
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- 2022
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29. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study.
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Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
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- Benzeneacetamides, Cisplatin adverse effects, Dexamethasone, Humans, Nausea chemically induced, Palonosetron therapeutic use, Piperazines, Pyridines, Quinuclidines, Vomiting chemically induced, Vomiting drug therapy, Antiemetics, Antineoplastic Agents adverse effects
- Abstract
Background: The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE)., Methods: Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m
2 ), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2-3 (DEX3), or 3) DEX (4 mg twice daily) on days 2-4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis., Results: In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [±1.8; SE] vs. 53.7 [±1.5]), vomiting score (56.6 [±1.4] vs. 58.7 [±0.8]) and overall score (105.6 [±2.8] vs.112.4 [±1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [±1.7]), vomiting score (58.2 [±1]) and overall score (107.8 [±2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL., Conclusion: Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin., Trial Registration: ClinicalTrials.gov NCT04201769 . Registration date: 17/12/2019 - Retrospectively registered., (© 2022. The Author(s).)- Published
- 2022
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30. Overall Survival in Metastatic Breast Cancer Patients in the Third Millennium: Results of the COSMO Study.
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La Verde N, Collovà E, Blasi L, Pinotti G, Palumbo R, Bonotto M, Garrone O, Brunello A, Rimanti A, Bareggi C, Zaniboni A, Frassoldati A, Foglietta J, Berardi R, Moretti A, Farina G, Porcu L, and Barni S
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- Aged, Breast Neoplasms pathology, Disease-Free Survival, Female, Humans, Middle Aged, Neoplasm Metastasis, Neoplasms, Second Primary mortality, Neoplasms, Second Primary pathology, Prognosis, Retrospective Studies, Survival Rate, Breast Neoplasms mortality, Cancer Survivors statistics & numerical data
- Abstract
Introduction: Metastatic breast cancer (MBC) is a life-threatening disease, and although some data suggest a trend in survival improvement, it has not yet been unequivocally demonstrated. This study aimed to evaluate the overall survival (OS) of MBC patients, assessing its correlation with prognostic factors., Patients and Methods: COSMO (Checking Overall Survival in a MBC Observational study) is an Italian longitudinal retrospective multicenter study that enrolled patients with MBC diagnosed between 2000 and 2008. The primary objective was to detect a temporal difference in OS; the secondary objective was to identify prognostic factors as causal factors of the temporal variation in OS., Results: A total of 3721 of 3930 patients from 31 centers were distributed in 3 periods: 886 (23.8%), 1302 (35.0%), and 1533 (41.2%) in 2000-2002, 2003-2005, and 2006-2008, respectively. With a median follow-up of 9.3 years, median OS was 2.8 years (95% confidence interval, 2.6-2.9). No difference in OS was found in the 3 cohorts (P for trend = .563). The worst prognosis was observed for patients with triple-negative MBC (OS, 1.5 years) and for those with central nervous system metastases (1.7 years); the best prognosis was observed in those with bone metastases or nonvisceral disease (3.4 and 3.2 years, respectively) and in patients with a disease-free interval, defined as the time between resection of the primary malignancy and diagnosis of MBC, of > 2 years (3 years)., Conclusions: The COSMO study found improvement in OS between 2000 and 2008. Molecular subtype remained the strongest prognostic factor, and the role of other prognostic factors was confirmed, in particular disease-free interval, site of metastasis, and age., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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31. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study.
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Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Subjects
- Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone, Humans, Palonosetron therapeutic use, Pyridines, Quinuclidines, Vomiting chemically induced, Vomiting drug therapy, Vomiting prevention & control, Antiemetics therapeutic use, Cisplatin adverse effects
- Abstract
Background: To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin-based chemotherapy, we evaluated the noninferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with an oral fixed-dose combination of netupitant and palonosetron (NEPA), compared with the guideline-consistent use of 4-day DEX., Patients and Methods: In this open-label, multicenter study, chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m
2 ), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either (a) no further DEX (DEX1), (b) oral DEX (4 mg daily) on days 2-3 (DEX3), or (c) DEX (4 mg twice daily) on days 2-4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5-day overall phase. The noninferiority margin was set at -15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea)., Results: Two-hundred twenty-eight patients, 76 in each arm, were assessable. Noninferiority was met for both DEX-sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% confidence interval, -12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups., Conclusion: A simplified regimen of NEPA plus single-dose DEX offers comparable chemotherapy-induced nausea and vomiting prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high-emetic-risk setting of cisplatin-based chemotherapy., Implications for Practice: Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy-induced emesis. Although generally considered safe, even short-term DEX use is associated with various side effects, and some evidence suggests that concurrent steroids may reduce the efficacy of immunotherapies. This study demonstrates comparable antiemetic control during the 5 days post-chemotherapy with a simplified regimen of netupitant/palonosetron plus single-dose DEX versus the standard 4-day DEX reference treatment in high-dose cisplatin. This represents a clinically relevant achievement as it not only simplifies antiemetic prophylaxis but also offers an opportunity to appropriately use in patients where caution with corticosteroid use is advised., (© 2021 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press.)- Published
- 2021
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32. Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study.
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Palumbo R, Torrisi R, Sottotetti F, Presti D, Rita Gambaro A, Collovà E, Ferzi A, Agostinetto E, Maria Teragni C, Saltalamacchia G, Tagliaferri B, Balletti E, Bernardo A, and Quaquarini E
- Abstract
Background: The CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials., Patients and Methods: This is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B)., Results: In total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47-79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6-32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively., Conclusions: Our data indicate that palbociclib plus ET is active and safe in HR+/HER2- MBC, also suggesting a better performance of the combinations in earlier treatment lines., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest., (© The Author(s), 2021.)
- Published
- 2021
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33. Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study.
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Caputo R, Cazzaniga ME, Sbrana A, Torrisi R, Paris I, Giordano M, Montesarchio V, Guarneri V, Amaducci L, Bilancia D, Cilenti G, Fabi A, Collovà E, Schirone A, Bonizzoni E, Celio L, De Placido S, and De Laurentiis M
- Subjects
- Adult, Aged, Anthracyclines therapeutic use, Antiemetics administration & dosage, Antineoplastic Agents, Alkylating therapeutic use, Chemotherapy, Adjuvant, Cyclophosphamide therapeutic use, Dexamethasone administration & dosage, Drug Combinations, Female, Humans, Middle Aged, Neurokinin-1 Receptor Antagonists administration & dosage, Palonosetron administration & dosage, Pyridines administration & dosage, Anthracyclines adverse effects, Antiemetics therapeutic use, Antineoplastic Agents, Alkylating adverse effects, Breast Neoplasms drug therapy, Cyclophosphamide adverse effects, Dexamethasone therapeutic use, Neurokinin-1 Receptor Antagonists therapeutic use, Palonosetron therapeutic use, Pyridines therapeutic use, Vomiting chemically induced, Vomiting prevention & control
- Abstract
Background: NEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle., Methods: In this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2-4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined., Results: Of the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65-0.50 for no CINV events on cycles 3 and 4)., Conclusion: The high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle., Trial Registration: This trial was retrospectively registered at Clinicaltrials.gov identifier (NCT03862144) on 05/Mar/2019.
- Published
- 2020
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34. A New Genetic Risk Score to Predict the Outcome of Locally Advanced or Metastatic Breast Cancer Patients Treated With First-Line Exemestane: Results From a Prospective Study.
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Gagno S, D'Andrea MR, Mansutti M, Zanusso C, Puglisi F, Dreussi E, Montico M, Biason P, Cecchin E, Iacono D, Russo S, Cinausero M, Saracchini S, Gasparini G, Sartori D, Bari M, Collovà E, Meo R, Merkabaoui G, Spagnoletti I, Pellegrino A, Gianni L, Sandri P, Cretella E, Vattemi E, Rocca A, Serra P, Fabbri MA, Benedetti G, Foghini L, Medici M, Basso U, Amoroso V, Riccardi F, Baldelli AM, Clerico M, Bonura S, Saggia C, Innocenti F, and Toffoli G
- Subjects
- Adult, Aged, Aged, 80 and over, Aromatase Inhibitors metabolism, Breast Neoplasms genetics, Breast Neoplasms pathology, DNA Repair genetics, Female, Humans, Middle Aged, Polymorphism, Genetic, Prospective Studies, Receptors, Estrogen metabolism, Reproducibility of Results, Risk, Signal Transduction genetics, Survival Analysis, Androstadienes therapeutic use, Antineoplastic Agents, Hormonal therapeutic use, Aromatase Inhibitors therapeutic use, Biomarkers, Tumor genetics, Breast Neoplasms drug therapy
- Abstract
Introduction: Approximately 50% of locally advanced or metastatic breast cancer (MBC) patients treated with first-line exemestane do not show objective response and currently there are no reliable biomarkers to predict the outcome of patients using this therapy. The constitutive genetic background might be responsible for differences in the outcome of exemestane-treated patients. We designed a prospective study to investigate the role of germ line polymorphisms as biomarkers of survival., Patients and Methods: Three hundred two locally advanced or MBC patients treated with first-line exemestane were genotyped for 74 germ line polymorphisms in 39 candidate genes involved in drug activity, hormone balance, DNA replication and repair, and cell signaling pathways. Associations with progression-free survival (PFS) and overall survival (OS) were tested with multivariate Cox regression. Bootstrap resampling was used as an internal assessment of results reproducibility., Results: Cytochrome P450 19A1-rs10046TC/CC, solute carrier organic anion transporter 1B1-rs4149056TT, adenosine triphosphate binding cassette subfamily G member 2-rs2046134GG, fibroblast growth factor receptor-4-rs351855TT, and X-ray repair cross complementing 3-rs861539TT were significantly associated with PFS and then combined into a risk score (0-1, 2, 3, or 4-6 risk points). Patients with the highest risk score (4-6 risk points) compared with ones with the lowest score (0-1 risk points) had a median PFS of 10 months versus 26.3 months (adjusted hazard ratio [AdjHR], 3.12 [95% confidence interval (CI), 2.18-4.48]; P < .001) and a median OS of 38.9 months versus 63.0 months (AdjHR, 2.41 [95% CI, 1.22-4.79], P = .012), respectively., Conclusion: In this study we defined a score including 5 polymorphisms to stratify patients for PFS and OS. This score, if validated, might be translated to personalize locally advanced or MBC patient treatment and management., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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35. Corrigendum: Natural History of Non-Small-Cell Lung Cancer with Bone Metastases.
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Santini D, Barni S, Intagliata S, Falcone A, Ferraù F, Galetta D, Moscetti L, La Verde N, Ibrahim T, Petrelli F, Vasile E, Ginocchi L, Ottaviani D, Longo F, Ortega C, Russo A, Badalamenti G, Collovà E, Lanzetta G, Mansueto G, Adamo V, De Marinis F, Satolli MA, Cantile F, Mancuso A, Tanca FM, Addeo R, Russano M, Sterpi M, Pantano F, Vincenzi B, and Tonini G
- Published
- 2016
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36. Metronomic oral vinorelbine in advanced breast cancer and non-small-cell lung cancer: current status and future development.
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Cazzaniga ME, Camerini A, Addeo R, Nolè F, Munzone E, Collovà E, Del Conte A, Mencoboni M, Papaldo P, Pasini F, Saracchini S, and Bocci G
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- Administration, Metronomic, Administration, Oral, Breast Neoplasms pathology, Humans, Neoplasm Staging, Vinblastine administration & dosage, Vinorelbine, Antineoplastic Agents, Phytogenic administration & dosage, Breast Neoplasms drug therapy, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Vinblastine analogs & derivatives
- Abstract
Metronomic chemotherapy (mCT), a frequent administration of low-dose chemotherapy, allows prolonged treatment duration and minimizes the toxicity of standard-dose chemotherapy. mCT has multiple actions against cancer cells including inhibition of angiogenesis and modulation of the immune system. A number of studies lend support to the clinical efficacy of mCT in advanced breast cancer and non-small-cell lung cancer. However, further evidence is necessary to describe the optimal use of mCT and to identify suitable patients. Oral vinorelbine has emerged as a promising metronomic treatment in patients with metastatic breast cancer and non-small-cell lung cancer and is the only orally available microtubule-targeting agent. This paper reviews current evidence on metronomic oral vinorelbine, discusses its management and defines a suitable patient profile on the basis of a workshop of Italian experts.
- Published
- 2016
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37. Oral chemotherapy and patient perspective in solid tumors: a national survey by the Italian association of medical oncology.
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Aurilio G, Gori S, Nolè F, Pruneri G, Coati F, Torri V, Lunardi G, Atzori F, La Verde N, Banna GL, Rossi A, Del Mastro L, Di Fabio F, Marcon I, Gebbia V, Loupakis F, Orlando L, Ciuffreda L, Amadio P, Luppi G, Redana S, Filippelli G, Gentile A, and Collovà E
- Subjects
- Administration, Oral, Adult, Aged, Female, Humans, Infusions, Intravenous, Italy, Male, Middle Aged, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Neoplasms drug therapy, Quality of Life
- Abstract
Aim: To assess patient perception toward oral chemotherapy for solid tumors, the Italian Association of Medical Oncology performed a large multi-institutional national survey., Methods: A 17-item anonymous questionnaire including 7 general and 10 investigational questions with free-text, single-choice, or multiple-choice answers was administered. Analysis of response distribution according to predefined factors was described by summary measures and conducted by χ2 test and other nonparametric tests., Results: From January to June 2010, 581 patients completed the questionnaire; data of 404 patients constituted the final study sample. Three groups could be distinguished according to treatment: IV chemotherapy (IV group, n = 313), oral chemotherapy (oral group, n = 48), or combined therapy (combined group, n = 43). Thirty-one (72%) patients in the combined group and 187 (60%) in the IV group expressed preference for oral therapy (p = 0.028). Limitations in family and work commitment were more frequently perceived by patients on IV than oral chemotherapy (147 (47%) vs 14 (29%) patients, p<0.05, and 134 (43%) vs 11 (23%) patients, p<0.05). A total of 134 (43%) patients on IV chemotherapy versus 15 (31%) patients in the oral group did not point out any limitation for number of tablets per day (p = 0.004)., Conclusions: We observed a propensity from the patient perspective in favor of oral chemotherapy that was considered to have a lower impact on family and work commitments than IV chemotherapy. The treatment that patients were taking when the questionnaire was administered likely influenced their perception and related results.
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- 2016
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38. Natural History of Non-Small-Cell Lung Cancer with Bone Metastases.
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Santini D, Barni S, Intagliata S, Falcone A, Ferraù F, Galetta D, Moscetti L, La Verde N, Ibrahim T, Petrelli F, Vasile E, Ginocchi L, Ottaviani D, Longo F, Ortega C, Russo A, Badalamenti G, Collovà E, Lanzetta G, Mansueto G, Adamo V, De Marinis F, Satolli MA, Cantile F, Mancuso A, Tanca FM, Addeo R, Russano M, Sterpi M, Pantano F, Vincenzi B, and Tonini G
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Young Adult, Bone Neoplasms secondary, Carcinoma, Non-Small-Cell Lung pathology, Disease Progression, Lung Neoplasms pathology
- Abstract
We conducted a large, multicenter, retrospective survey aimed to explore the impact of tumor bone involvement in Non-Small Cell Lung Cancer.Data on clinical-pathology, skeletal outcomes and bone-directed therapies for 661 deceased patients with evidence of bone metastasis were collected and statistically analyzed. Bone metastases were evident at diagnosis in 57.5% of patients. In the remaining cases median time to bone metastases appearance was 9 months. Biphosphonates were administered in 59.6% of patients. Skeletal-related events were experienced by 57.7% of patients; the most common was the need for radiotherapy. Median time to first skeletal-related event was 6 months. Median survival after bone metastases diagnosis was 9.5 months and after the first skeletal-related event was 7 months. We created a score based on four factors used to predict the overall survival from the diagnosis of bone metastases: age >65 years, non-adenocarcinoma histology, ECOG Performance Status >2, concomitant presence of visceral metastases at the bone metastases diagnosis. The presence of more than two of these factors is associated with a worse prognosis.This study demonstrates that patients affected by Non-Small Cell Lung Cancer with bone metastases represent a heterogeneous population in terms of risk of skeletal events and survival.
- Published
- 2015
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39. Bone metastases in patients with metastatic renal cell carcinoma: are they always associated with poor prognosis?
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Santoni M, Conti A, Procopio G, Porta C, Ibrahim T, Barni S, Guida FM, Fontana A, Berruti A, Berardi R, Massari F, Vincenzi B, Ortega C, Ottaviani D, Carteni G, Lanzetta G, De Lisi D, Silvestris N, Satolli MA, Collovà E, Russo A, Badalamenti G, Luzi Fedeli S, Tanca FM, Adamo V, Maiello E, Sabbatini R, Felici A, Cinieri S, Montironi R, Bracarda S, Tonini G, Cascinu S, and Santini D
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Prognosis, Retrospective Studies, Survival Analysis, Bone Neoplasms mortality, Bone Neoplasms secondary, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell pathology, Kidney Neoplasms mortality, Kidney Neoplasms pathology
- Abstract
Purpose: Aim of this study was to investigate for the presence of existing prognostic factors in patients with bone metastases (BMs) from RCC since bone represents an unfavorable site of metastasis for renal cell carcinoma (mRCC)., Materials and Methods: Data of patients with BMs from RCC were retrospectively collected. Age, sex, ECOG-Performance Status (PS), MSKCC group, tumor histology, presence of concomitant metastases to other sites, time from nephrectomy to bone metastases (TTBM, classified into three groups: <1 year, between 1 and 5 years and >5 years) and time from BMs to skeletal-related event (SRE) were included in the Cox analysis to investigate their prognostic relevance., Results: 470 patients were enrolled in this analysis. In 19 patients (4%),bone was the only metastatic site; 277 patients had concomitant metastases in other sites. Median time to BMs was 16 months (range 0 - 44y) with Median OS of 17 months. Number of metastatic sites (including bone, p = 0.01), concomitant metastases, high Fuhrman grade (p < 0.001) and non-clear cell histology (p = 0.013) were significantly associated with poor prognosis. Patients with TTBM >5 years had longer OS (22 months) compared to patients with TTBM <1 year (13 months) or between 1 and 5 years (19 months) from nephrectomy (p < 0.001), no difference was found between these two last groups (p = 0.18). At multivariate analysis, ECOG-PS, MSKCC group and concomitant lung or lymph node metastases were independent predictors of OS in patients with BMs., Conclusions: Our study suggest that age, ECOG-PS, histology, MSKCC score, TTBM and the presence of concomitant metastases should be considered in order to optimize the management of RCC patients with BMs.
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- 2015
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40. Adjuvant hormonal therapy and fertility preservation in premenopausal breast cancer: a survey among Italian oncologists.
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Barni S, Collovà E, Frassoldati A, and Amoroso D
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- Adult, Aged, Aromatase Inhibitors administration & dosage, Attitude of Health Personnel, Chemotherapy, Adjuvant, Female, Humans, Italy, Male, Middle Aged, Practice Patterns, Physicians', Pregnancy Tests, Premenopause, Surveys and Questionnaires, Tamoxifen administration & dosage, Antineoplastic Agents, Hormonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms therapy, Fertility Preservation, Gonadotropin-Releasing Hormone agonists, Medical Oncology
- Abstract
Background: Increasing age of first pregnancy among Italian women with premenopausal breast cancer makes adjuvant hormonal therapy a hot topic, justifying a survey on the therapeutic approach of Italian oncologists., Materials & Methods: From April to July 2012, an 11-item electronic questionnaire was submitted to Italian oncologists and 611 out of 974 invited filled questionnaires were collected from all over Italy., Results: In total, 97.7% of patients aged <40 years needing only hormonal therapy would receive both tamoxifen and luteinizing hormone-releasing hormone agonists (LHRHa); 2.3% tamoxifen or LHRHa alone. For the majority of oncologists LHRHa was also the preferred choice to preserving fertility., Conclusion: Results are rather consistent with major guidelines but with a greater use of LHRHa and aromatase inhibitor.
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- 2015
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41. Efficacy of trastuzumab in unselected patients with HER2-positive metastatic breast cancer: a retrospective analysis.
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Collovà E, Ferzi A, Scandurra G, Aurilio G, Torri V, Porcu L, Sanò MV, Taibi E, Foglietta J, Generali D, Andreis D, Dazzani MC, Bramati A, Marcon I, Atzori F, Cinieri S, Tondulli L, Grasso D, Nolè F, Petrella MC, Gori S, and La Verde N
- Subjects
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Agents adverse effects, Breast Neoplasms pathology, Cardiotoxicity etiology, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Grading, Neoplasm Staging, Retrospective Studies, Trastuzumab, Treatment Outcome, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Agents therapeutic use, Biomarkers, Tumor analysis, Breast Neoplasms chemistry, Breast Neoplasms drug therapy, Molecular Targeted Therapy methods, Receptor, ErbB-2 analysis
- Abstract
Aims and Background: The addition of trastuzumab to chemotherapy for HER2-positive metastatic breast cancer has significantly improved progression-free survival and overall survival, although most patients develop resistance or have a primarily resistant disease. The aim of the study was to describe the efficacy and safety of a first-line treatment in unselected metastatic HER2-positive breast cancer patients, treated according to clinical practice., Methods: From 2000 to 2009, we conducted a retrospective multi-institutional analysis of 182 consecutive patients with HER2-positive metastatic breast cancer who underwent first-line treatment with trastuzumab. The primary end points were progression-free survival and overall survival; the secondary end points were survival after progression in patients treated with second-line chemotherapy with or without trastuzumab and safety. A total of 172 patients were analyzed., Results: Median progression-free survival and overall survival were 1.2 (95% CI, 1.1-1.4) and 4.4 years (95% CI, 3.6-5.4), respectively. For 100 patients who received second-line chemotherapy, median survival after progression was significantly longer in those who also received trastuzumab: 2.8 (95% CI, 2.1-4.0) versus 1.2 years (95% CI, 0.6-1.9)., Conclusions: Although based on retrospective data, the study confirms the role of trastuzumab as first-line treatment in metastatic breast cancer outside of a controlled trial. Moreover, information obtained on the use of trastuzumab beyond disease progression supports its use in this setting.
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- 2014
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42. Natural history of malignant bone disease in renal cancer: final results of an Italian bone metastasis survey.
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Santini D, Procopio G, Porta C, Ibrahim T, Barni S, Mazzara C, Fontana A, Berruti A, Berardi R, Vincenzi B, Ortega C, Ottaviani D, Carteni G, Lanzetta G, Virzì V, Santoni M, Silvestris N, Satolli MA, Collovà E, Russo A, Badalamenti G, Fedeli SL, Tanca FM, Adamo V, Maiello E, Sabbatini R, Felici A, Cinieri S, Tonini G, and Bracarda S
- Subjects
- Bone Neoplasms epidemiology, Diphosphonates therapeutic use, Disease Progression, Female, Humans, Italy epidemiology, Kidney Neoplasms epidemiology, Male, Retrospective Studies, Bone Neoplasms secondary, Kidney Neoplasms pathology
- Abstract
Background: Bone metastasis represents an increasing clinical problem in advanced renal cell carcinoma (RCC) as disease-related survival improves. There are few data on the natural history of bone disease in RCC., Patients and Methods: Data on clinicopathology, survival, skeletal-related events (SREs), and bone-directed therapies for 398 deceased RCC patients (286 male, 112 female) with evidence of bone metastasis were statistically analyzed., Results: Median time to bone metastasis was 25 months for patients without bone metastasis at diagnosis. Median time to diagnosis of bone metastasis by MSKCC risk was 24 months for good, 5 months for intermediate, and 0 months for poor risk. Median number of SREs/patient was one, and 71% of patients experienced at least one SRE. Median times to first, second, and third SRE were 2, 5, and 12 months, respectively. Median survival was 12 months after bone metastasis diagnosis and 10 months after first SRE. Among 181 patients who received zoledronic acid (ZOL), median time to first SRE was significantly prolonged versus control (n = 186) (3 months vs 1 month for control; P<0.05)., Conclusions: RCC patients with bone metastasis are at continuous risk of SREs, and in this survey ZOL effectively reduced this risk.
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- 2013
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43. Italian Survey on adjuvant treatment of non-small cell lung cancer (ISA).
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Banna GL, Di Maio M, Follador A, Collovà E, Menis J, Novello S, Bria E, Airoldi M, Amoroso D, Ardizzoia A, Aurilio G, Bajetta E, Ballardini P, Barbieri F, Barletta E, Balzelloni ML, Basso U, Bernardini I, Boni C, Bordin V, Bretti S, Bronte G, Brunetti C, Buti S, Capanna L, Colombo A, Condemi G, Cortinovis D, Dambrosio M, Di Fonzo C, Di Lucca G, Dima G, Falzetta A, Favaretto A, Ferraù F, Garetto L, Gebbia V, Genestreti G, Gentile AL, Giovanardi F, Labianca R, Lorusso V, Mantovani G, Martelli O, Massari F, Mazzoli M, Michetti G, Mordenti P, Mucciarini C, Munao S, Nacci A, Pogliani C, Procopio G, Riccardi F, Rizzato S, Rossi A, Rosti G, Russo P, Saladino T, Salesi N, Santangelo D, Sava T, Savarino A, Spinnato F, Tiseo M, Tomassi O, Tondulli L, Tonini G, Turano S, Valerio MR, Verderame F, Zanelli F, and Zanon E
- Subjects
- Carboplatin administration & dosage, Cisplatin administration & dosage, Deoxycytidine administration & dosage, Deoxycytidine analogs & derivatives, Humans, Neoplasm Staging, Paclitaxel administration & dosage, Radiotherapy, Adjuvant statistics & numerical data, Vinblastine administration & dosage, Vinblastine analogs & derivatives, Vinorelbine, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung therapy, Chemotherapy, Adjuvant statistics & numerical data, Health Care Surveys, Lung Neoplasms therapy
- Abstract
Background: A recent pooled analysis of randomized trials indicated significant improvement in overall survival from cisplatin-based adjuvant chemotherapy for non-small cell lung cancer (NSCLC), depending on disease stage (only in stages II and III) and PS (≤ 1). Post-operative radiotherapy (RT) is optional for pN2 tumours., Patients and Methods: To evaluate opinions and daily clinical practice of Italian Oncologists about adjuvant treatment of NSCLC, a 46-item questionnaire was delivered via e-mail., Results: Seventy-eight physicians from 68 Centers (out of 98 contacted) returned their questionnaire. Seventy-four, 86, 94, and 78% of them give the indication for adjuvant chemotherapy for stage IIA, IIB, IIIA, and IIIB disease, respectively and 14% in stage IB disease. Stage, PS, and age are taken into consideration evaluating adjuvant approach by 97, 95 and 73%, respectively. Cisplatin-vinorelbine (64%) and cisplatin-gemcitabine (33%), for 4 cycles (81%), are the preferred regimens, while 32% use different regimens. Ninety-two percent indicate RT in pN2 disease and/or positive resection margins. Real Number of patients Needed to Treat (NNT) is probably not completely known/understood and/or used by physicians., Conclusions: A substantial adherence between clinical daily practice in Italy and scientific progresses is described in this paper, even with some discordances regarding the most appropriate adjuvant chemotherapy regimen., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)
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- 2011
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44. Outcomes of small-cell lung cancer patients treated with second-line chemotherapy: a multi-institutional retrospective analysis.
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Garassino MC, Torri V, Michetti G, Lo Dico M, La Verde N, Aglione S, Mancuso A, Gallerani E, Galetta D, Martelli O, Collovà E, Fatigoni S, Ghidini A, Saggia C, Bareggi C, Rossi A, Farina G, Thatcher N, Blackhall F, Lorigan P, and Califano R
- Subjects
- Aged, Etoposide adverse effects, Female, Humans, Lung Neoplasms mortality, Lung Neoplasms pathology, Lung Neoplasms physiopathology, Male, Middle Aged, Platinum administration & dosage, Platinum adverse effects, Retrospective Studies, Small Cell Lung Carcinoma mortality, Small Cell Lung Carcinoma pathology, Small Cell Lung Carcinoma physiopathology, Survival Analysis, Topotecan administration & dosage, Topotecan adverse effects, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Etoposide administration & dosage, Lung Neoplasms drug therapy, Small Cell Lung Carcinoma drug therapy
- Abstract
Background: Patients with small-cell lung cancer (SCLC) that progress after first-line chemotherapy have a poor prognosis and the evidence of a benefit from second-line (SL) chemotherapy is limited. Patients relapsing or progressing more than 90 days after completion of first-line treatment are considered platinum sensitive and may be rechallenged with platinum-based chemotherapy. Topotecan is approved as SL treatment independent of time to progression. This retrospective analysis evaluates the clinical outcomes of SCLC patients who received SL chemotherapy after platinum-etoposide chemotherapy., Patients and Methods: We retrospectively reviewed 161 patients who received SL chemotherapy for SCLC. Patients were divided into four subgroups by type of SL treatment: (1) platinum-based rechallenge; (2) anthracycline-based regimens; (3) topotecan; (4) other single agents. The endpoints were overall survival (OS), progression-free survival (PFS) and response rate (RR). Survival curves were plotted using the Kaplan-Meier method. The Cox proportional hazard model was used for multivariate analysis to investigate factors influencing survival., Results: The median age was 63. There were 125 males and 36 females. Eastern Cooperative Oncology Group performance status (ECOG-PS) was 0, 1 and 2 in 12.5%, 62.5% and 25% of patients, respectively. Platinum sensitive/platinum resistant/platinum refractory/unknown=121/29/3/8 patients. Median time to SL chemotherapy was 6.9 months. The median PFS from starting second-line treatment was 4.3 months and median OS was 5.8 months. The overall RR was 22.9%. There was a trend toward higher RR (34.5% vs 17.5%, p for trend: 0.06) and OS (9.2 months vs 5.8 months, p=0.08) for patients with sensitive disease who were rechallenged with platinum-based chemotherapy. A multivariate analysis that adjusted for the time to SL treatment showed that a platinum-containing regimen achieves better RR, PFS and OS independently of the time to SL chemotherapy and that response to first-line treatment and PS at SL are the only independent prognostic factors., Conclusions: The outcome for second-line therapy for SCLC was poor and benefit appeared to be limited to those patients with good PS and rechallenged with platinum-based chemotherapy. Platinum-based rechallenge should be considered as a standard comparator in future randomized controlled trials of SL chemotherapy., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)
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- 2011
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45. Effect of peg-filgrastim-supported dose-dense adjuvant chemotherapy on the peripheral blood leukocyte phenotype in breast cancer patients.
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Collovà E, Rovati B, Grasso D, Bencardino K, Manzoni M, and Danova M
- Abstract
The aim of this study was to evaluate the effect of dose-dense adjuvant chemotherapy regimens with peg-filgrastim support on the phenotype of peripheral blood leukocytes in breast cancer patients. We evaluated the leukocyte phenotype of 14 patients aged 46-67 years undergoing 4 courses of chemotherapy with either epirubucin/cyclophosphamide (n=7) or 5-fluorouracil/epirubucin/cyclophosphamide (n=7) followed by 4 courses of taxol supported by peg-filgrastim (6 mg) administered 72 h after each chemotherapy course. The overall leukocyte number significantly increased from the first treatment course, while total lymphocytes tended to decrease with a negative peak following the 6th course (p=0.03). B (CD19+, CD20+) and early B lymphocyte subsets (CD20+/CD38+) significantly decreased during treatment (p<0.05), while T lymphocyte subsets did not show significant changes, except a decrease in T helper (CD4+) cells. Immature T lymphocytes (CD4+/CD8+ subset), dendritic cells (CD11c+) and NK cells (CD56+) increased with respect to the baseline. Our results suggest that dose-dense chemotherapy programs with the support of peg-filgrastim did not significantly impair the immune system of breast cancer patients and allowed for a rapid restoration of most immune competent cells. These observations may have important clinical implications with a view to vaccination or other immunotherapeutic approaches to solid tumours.
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- 2009
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46. Biological effects of pegfilgrastim on circulating neutrophils in breast cancer patients undergoing dose-dense chemotherapy.
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Invernizzi R, Grasso D, Travaglino E, Benatti C, Collovà E, Manzoni M, Livraghi L, Danova M, and Riccardi A
- Subjects
- Actins metabolism, Aged, Alkaline Phosphatase metabolism, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast pathology, Breast Neoplasms blood, Breast Neoplasms pathology, Female, Filgrastim, Humans, In Situ Nick-End Labeling, Leukocyte Count, Middle Aged, Neutrophils pathology, Polyethylene Glycols, Recombinant Proteins, Apoptosis drug effects, Breast Neoplasms drug therapy, Cell Proliferation drug effects, Granulocyte Colony-Stimulating Factor pharmacology, Neutrophils drug effects
- Abstract
Pegfilgrastim is a covalent conjugate of filgrastim and polyethylene glycol that has proved to be effective in supporting myelopoiesis during chemotherapy. Since very limited information is available on the biological effects of pegfilgrastim on neutrophils exposed to chemotherapy, we analyzed the following parameters in neutrophils of patients undergoing dose-dense chemotherapy for breast cancer: apoptosis, by a TUNEL technique; actin polymerization, using FITC-labeled phalloidin, and alkaline phosphatase activity by cytochemistry. Peripheral blood buffy coat smears were obtained before starting treatment and immediately before each chemotherapy course. After pegfilgrastim stimulation we observed the following: (1) stability of the absolute neutrophil count for the whole duration of treatment and no infectious events; (2) a reduction in the neutrophil constitutive apoptosis rate in comparison with that observed in control patients treated with standard chemotherapy courses with no growth factor support; (3) persistent abnormalities of actin assembly in neutrophils, indicative of changes in cytoskeletal organization, and (4) a significant increase in the activity of leukocyte alkaline phosphatase, a sensitive marker of the later stages of neutrophil maturation. In conclusion, these results suggest that pegfilgrastim improves the neutrophil functions in patients exposed to chemotherapy by inhibition of constitutive apoptosis, thereby prolonging the survival of these cells., (Copyright 2008 S. Karger AG, Basel.)
- Published
- 2008
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47. Lack of dendritic cell mobilization into the peripheral blood of cancer patients following standard- or high-dose chemotherapy plus granulocyte-colony stimulating factor.
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Ferrari S, Rovati B, Porta C, Alessandrino PE, Bertolini A, Collovà E, Riccardi A, and Danova M
- Subjects
- Adult, Aged, Antibiotics, Antineoplastic therapeutic use, Antigens, CD34 biosynthesis, Antineoplastic Agents, Alkylating therapeutic use, Antineoplastic Agents, Phytogenic therapeutic use, Breast Neoplasms therapy, Cell Lineage, Combined Modality Therapy methods, Cyclophosphamide therapeutic use, Dendritic Cells drug effects, Epirubicin therapeutic use, Female, Flow Cytometry, Humans, Immunotherapy methods, Leukocytes, Mononuclear metabolism, Lymphoma, Non-Hodgkin therapy, Male, Middle Aged, Paclitaxel therapeutic use, Th2 Cells metabolism, Dendritic Cells cytology, Dendritic Cells immunology, Granulocyte-Macrophage Colony-Stimulating Factor therapeutic use, Neoplasms blood, Neoplasms therapy
- Abstract
Background: Dendritic cells (DC), the most specialized antigen-presenting cells, can be detected in the peripheral blood (PB) and divided into two subsets of populations, DC1 and DC2, endowed with different functions. The aim of this study was to evaluate the effect on DC release and on their subsets of three regimens utilized to mobilize CD34+ cells into the PB in cancer patients and in normal CD34+ cell donors., Patients and Methods: The mobilizing sequences were: standard-dose epirubicin+taxol+granulocyte-colony-stimulating factor (G-CSF; 15 patients with advanced breast cancer), high-dose cyclophosphamide (CTX)+G-CSF (10 patients with breast cancer patients and 7 with non-Hodgkin's lymphoma, NHL), and G-CSF alone (5 normal donors of CD34+ cells for allogeneic transplantation). Comparative data were obtained from the steady-state PB of 20 healthy volunteers. For flow cytometric analysis, DC were gated as negative for specific lineage markers (CD3, CD11b, CD14, CD16, CD56, CD19, CD20, CD34) and positive for HLA-DR. The DC1 and DC2 subsets were defined as CD11c and CDw123 positive, respectively., Results: The percentages of DC at baseline and the time of CD34+ cell peak were: 0.48 and 0.51 for standard-dose chemotherapy (CT); 0.55 and 0.63 for breast cancer after high-dose CTX+G-CSF; 0.53 and 0.71 for NHL after high-dose CTX+G-CSF; and 0.51 and 0.54 for normal donors of CD34+ cells after G-CSF alone (all p=n.s.). Mean DC1/DC2 ratios in each study group at the time of CD34+ cell peak were 0.10, 0.12, and 0.18, respectively. Finally, in the group of healthy volunteers, the percentage of circulating DC was 0.95 and the mean DC1/DC2 ratio was 1.28., Conclusion: To our knowledge, this is the first report that demonstrates that both standard-dose or high-dose CT, when utilized together with G-CSF, do not induce DC mobilization into the PB, whereas a reversed DC1/DC2 ratio is observed. Furthermore, a lack of significant DC mobilization after G-CSF alone was also seen, in contrast to what was previously observed by others. These data should be taken in account when evaluating clinical correlations between DC number and CPC engraftment in both the transplantation setting, when monitoring the effects on the immune system of combinations of new drugs and/or cytokines, and when high numbers of DC are required for both experimental and clinical applications.
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- 2003
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48. Impact of topotecan-based chemotherapy on the immune system of advanced ovarian cancer patients: an immunophenotypic study.
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Ferrari S, Rovati B, Cucca L, Scarabelli C, Presti M, Beccaria C, Collovà E, Porta C, and Danova M
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- Adult, Aged, Female, Humans, Immune System drug effects, Immunologic Memory, Middle Aged, Phenotype, Recurrence, Time Factors, Antineoplastic Agents therapeutic use, Immunophenotyping methods, Lymphocyte Subsets drug effects, Ovarian Neoplasms drug therapy, Ovarian Neoplasms immunology, Topotecan therapeutic use
- Abstract
The effects of topotecan-based chemotherapy (CT) on peripheral blood lymphocyte (PBL) subsets were evaluated in ovarian cancer patients. Fourteen patients with epithelial ovarian cancer, at the diagnosis or relapsed after platinum-based CT, were treated with: a) topotecan in association with carboplatin and taxanes as first line CT; b) topotecan alone or c) topotecan in association with carboplatin both as second line of treatment after platinum. The phenotype of PBL was determined before starting treatment and immediately before each CT course by flow cytometric analysis. Before starting CT, the absolute number of lymphocytes and the CD2+, CD3+, CD4+ subsets were significantly lower in pre-treated patients and not significantly altered in CT-naive patients with respect to a cohort of 20 healthy donors utilized as control. Lymphocytes co-expressing CD4+/CD8+ were significantly higher in both subgroups of patients than in normal donors. CD4+/CD45RA+ and CD4+/CD45RO+ subsets were significantly decreased in pre-treated patients and normal in CT-naive patients. CD3+/HLA-DR+ T cell population significantly increased in CT-naive patients at baseline. During CT and after its discontinuation, no relevant changes were recorded for both subgroups of patients with respect to the baseline in lymphocyte absolute count, CD2+, CD3+, CD4+, CD4+/CD45RO+ subsets, while CD4+/CD45RA+ subpopulation was significantly decreased in CT-naive patients. CD8+, CD19+, CD20+, CD16+, CD56+, CD2+/CD25+ subsets did not differ statistically comparing to normal donors both at baseline and during CT. The treatment was well tolerated and no patient developed non-neutropenic infection. Topotecan-based therapy does not have a negative impact on PBL in either CT-naive or in pretreated ovarian cancer patients. This information should be considered when utilizing topotecan with other anticancer drugs in the adjuvant setting as well as when dose-intensification of topotecan with stem cell support is planned.
- Published
- 2002
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