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2. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Buck, M, Dean, A, Friedlander, M L, Goh, J C, Harnett, P, Kichenadasse, G, Scott, C L, Denys, H, Dirix, L, Vergote, I, Elit, L, Ghatage, P, Oza, A M, Plante, M, Provencher, D, Weberpals, J I, Welch, S, Floquet, A, Gladieff, L, Joly, F, Leary, A, Lortholary, A, Lotz, J, Medioni, J, Tredan, O, You, B, El-Balat, A, Hänle, C, Krabisch, P, Neunhöffer, T, Pölcher, M, Wimberger, P, Amit, A, Kovel, S, Leviov, M, Safra, T, Shapira-Frommer, R, Stemmer, S, Bologna, A, Colombo, N, Lorusso, D, Pignata, S, Sabbatini, R F, Scambia, G, Tamberi, S, Zamagni, C, Fong, P C, O'Donnell, A, Gancedo, M Amenedo, Herraez, A Casado, Garcia-Donas, J, Guerra, E M, Oaknin, A, Palacio, I, Romero, I, Sanchez, A, Banerjee, S N, Clamp, A, Drew, Y, Gabra, H G, Jackson, D, Ledermann, J A, McNeish, I A, Parkinson, C, Powell, M, Aghajanian, C, Armstrong, D K, Birrer, M J, Buss, M K, Chambers, S K, Chen, L-m, Coleman, R L, Holloway, R W, Konecny, G E, Ma, L, Morgan, M A, Morris, R T, Mutch, D G, O'Malley, D M, Slomovitz, B M, Swisher, E M, Vanderkwaak, T, Vulfovich, M, Coleman, Robert L, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Garcia-Donas, Jesus, Swisher, Elizabeth M, Floquet, Anne, Konecny, Gottfried E, McNeish, Iain A, Scott, Clare L, Cameron, Terri, Maloney, Lara, Isaacson, Jeff, Goble, Sandra, Grace, Caroline, Harding, Thomas C, Raponi, Mitch, Sun, James, Lin, Kevin K, Giordano, Heidi, and Ledermann, Jonathan A

Published
2017
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4. Consensus statements and treatment algorithm to guide clinicians in the selection of maintenance therapy for patients with newly diagnosed, advanced ovarian carcinoma: Results of a Delphi study

Author

Colombo, N, Gadducci, A, Landoni, F, Lorusso, D, Sabbatini, R, Artioli, G, Berardi, R, Ceccherini, R, Cecere, S, Cormio, G, De Angelis, C, Legge, F, Lissoni, A, Mammoliti, S, Mangili, G, Naglieri, E, Petrella, M, Ricciardi, G, Ronzino, G, Salutari, V, Sambataro, D, Savarese, A, Scandurra, G, Tasca, G, Tomao, F, Valabrega, G, Zavallone, L, Pignata, S, Colombo, Nicoletta, Gadducci, Angiolo, Landoni, Fabio, Lorusso, Domenica, Sabbatini, Roberto, Artioli, Grazia, Berardi, Rossana, Ceccherini, Rita, Cecere, Sabrina Chiara, Cormio, Gennaro, De Angelis, Carmine, Legge, Francesco, Lissoni, Andrea, Mammoliti, Serafina, Mangili, Giorgia, Naglieri, Emanuele, Petrella, Maria Cristina, Ricciardi, Giuseppina Rosaria Rita, Ronzino, Graziana, Salutari, Vanda, Sambataro, Daniela, Savarese, Antonella, Scandurra, Giuseppa, Tasca, Giulia, Tomao, Federica, Valabrega, Giorgio, Zavallone, Laura, Pignata, Sandro, Colombo, N, Gadducci, A, Landoni, F, Lorusso, D, Sabbatini, R, Artioli, G, Berardi, R, Ceccherini, R, Cecere, S, Cormio, G, De Angelis, C, Legge, F, Lissoni, A, Mammoliti, S, Mangili, G, Naglieri, E, Petrella, M, Ricciardi, G, Ronzino, G, Salutari, V, Sambataro, D, Savarese, A, Scandurra, G, Tasca, G, Tomao, F, Valabrega, G, Zavallone, L, Pignata, S, Colombo, Nicoletta, Gadducci, Angiolo, Landoni, Fabio, Lorusso, Domenica, Sabbatini, Roberto, Artioli, Grazia, Berardi, Rossana, Ceccherini, Rita, Cecere, Sabrina Chiara, Cormio, Gennaro, De Angelis, Carmine, Legge, Francesco, Lissoni, Andrea, Mammoliti, Serafina, Mangili, Giorgia, Naglieri, Emanuele, Petrella, Maria Cristina, Ricciardi, Giuseppina Rosaria Rita, Ronzino, Graziana, Salutari, Vanda, Sambataro, Daniela, Savarese, Antonella, Scandurra, Giuseppa, Tasca, Giulia, Tomao, Federica, Valabrega, Giorgio, Zavallone, Laura, and Pignata, Sandro

Abstract

Introduction: Standard treatment of newly diagnosed, advanced ovarian carcinoma (OC) consists of cytoreductive surgery followed by platinum-based chemotherapy with or without bevacizumab. Maintenance therapy with PARP inhibitors and olaparib-bevacizumab has recently shown to significantly improve progression-free survival in the first-line setting. Some practical aspects of maintenance therapy, however, are still poorly defined. Aim of the study: To provide guidance to clinicians in the selection of maintenance therapy for newly diagnosed, advanced ovarian carcinoma. Methods: A board of six gynecologic oncologists with expertise in the treatment of OC in Italy convened to address issues related to the new options for maintenance treatment. Based on scientific evidences, the board produced practice-oriented statements. Consensus was reached via a modified Delphi study that involved a panel of 22 experts from across Italy. Results: Twenty-seven evidence- and consensus-based statements are presented, covering the following areas of interest: use of biomarkers (BRCA mutations and presence of homologous recombination deficiency); timing and outcomes of surgery; selection of patients eligible for bevacizumab; definition of response to treatment; toxicity and contraindications; evidence of synergy of bevacizumab plus PARP inhibitor. Two treatment algorithms are also included, for selecting maintenance therapy based on timing and outcomes of surgery, response to platinum-based chemotherapy and biomarker status. A score for the assessment of response to chemotherapy is proposed, but its validation is ongoing. Conclusions: We provide here consensus statements and treatment algorithms to guide clinicians in the selection of appropriate and personalized maintenance therapy in the first-line setting of advanced OC management.

Published
2023

6. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Poveda, A, Floquet, A, Ledermann, J, Asher, R, Penson, R, Oza, A, Korach, J, Huzarski, T, Pignata, S, Friedlander, M, Baldoni, A, Park-Simon, T, Tamura, K, Sonke, G, Lisyanskaya, A, Kim, J, Filho, E, Milenkova, T, Lowe, E, Rowe, P, Vergote, I, Pujade-Lauraine, E, Byrski, T, Pautier, P, Harter, P, Colombo, N, Scambia, G, Nicoletto, M, Nussey, F, Clamp, A, Poveda Velasco, A, Rodrigues, M, Lotz, J, Selle, F, Ray-Coquard, I, Provencher, D, Prat Aparicio, A, Vidal Boixader, L, Scott, C, Yunokawa, M, Medioni, J, Pecuchet, N, Dubot, C, De La Motte Rouge, T, Kaminsky, M, Weber, B, Lortholary, A, Parkinson, C, Williams, S, Banerjee, S, Cosin, J, Hoffman, J, Plante, M, Covens, A, Joly, F, Hirte, H, Amit, A, Matsumoto, K, Tjulandin, S, Hoon Kim, J, Gladieff, L, Sabbatini, R, O'Malley, D, Timmins, P, Kredentser, D, Lainez Milagro, N, Barretina Ginesta, M, Tibau Martorell, A, Gomez De Liano Lista, A, Ojeda Gonzalez, B, Mileshkin, L, Mandai, M, Boere, I, Ottevanger, P, Nam, J, Hamizi, S, Cognetti, F, Warshal, D, Dickson-Michelson, E, Kamelle, S, Mckenzie, N, Rodriguez, G, Armstrong, D, Chalas, E, Celano, P, Behbakht, K, Davidson, S, Welch, S, Helpman, L, Fishman, A, Bruchim, I, Sikorska, M, Slowinska, A, Rogowski, W, Bidzinski, M, Spiewankiewicz, B, Casado Herraez, A, Mendiola Fernandez, C, Gropp-Meier, M, Saito, T, Takehara, K, Enomoto, T, Watari, H, Choi, C, Kim, B, Weon Kim, J, Hegg, R, Poveda A., Floquet A., Ledermann J. A., Asher R., Penson R. T., Oza A. M., Korach J., Huzarski T., Pignata S., Friedlander M., Baldoni A., Park-Simon T. -W., Tamura K., Sonke G. S., Lisyanskaya A., Kim J. -H., Filho E. A., Milenkova T., Lowe E. S., Rowe P., Vergote I., Pujade-Lauraine E., Byrski T., Pautier P., Harter P., Colombo N., Scambia G., Nicoletto M., Nussey F., Clamp A., Penson R., Poveda Velasco A., Rodrigues M., Lotz J. -P., Selle F., Ray-Coquard I., Provencher D., Prat Aparicio A., Vidal Boixader L., Scott C., Yunokawa M., Medioni J., Pecuchet N., Dubot C., De La Motte Rouge T., Kaminsky M. -C., Weber B., Lortholary A., Parkinson C., Ledermann J., Williams S., Banerjee S., Cosin J., Hoffman J., Plante M., Covens A., Sonke G., Joly F., Hirte H., Amit A., Matsumoto K., Tjulandin S., Hoon Kim J., Gladieff L., Sabbatini R., O'Malley D., Timmins P., Kredentser D., Lainez Milagro N., Barretina Ginesta M. P., Tibau Martorell A., Gomez De Liano Lista A., Ojeda Gonzalez B., Mileshkin L., Mandai M., Boere I., Ottevanger P., Nam J. -H., Filho E., Hamizi S., Cognetti F., Warshal D., Dickson-Michelson E., Kamelle S., McKenzie N., Rodriguez G., Armstrong D., Chalas E., Celano P., Behbakht K., Davidson S., Welch S., Helpman L., Fishman A., Bruchim I., Sikorska M., Slowinska A., Rogowski W., Bidzinski M., Spiewankiewicz B., Casado Herraez A., Mendiola Fernandez C., Gropp-Meier M., Saito T., Takehara K., Enomoto T., Watari H., Choi C. H., Kim B. -G., Weon Kim J., Hegg R., Poveda, A, Floquet, A, Ledermann, J, Asher, R, Penson, R, Oza, A, Korach, J, Huzarski, T, Pignata, S, Friedlander, M, Baldoni, A, Park-Simon, T, Tamura, K, Sonke, G, Lisyanskaya, A, Kim, J, Filho, E, Milenkova, T, Lowe, E, Rowe, P, Vergote, I, Pujade-Lauraine, E, Byrski, T, Pautier, P, Harter, P, Colombo, N, Scambia, G, Nicoletto, M, Nussey, F, Clamp, A, Poveda Velasco, A, Rodrigues, M, Lotz, J, Selle, F, Ray-Coquard, I, Provencher, D, Prat Aparicio, A, Vidal Boixader, L, Scott, C, Yunokawa, M, Medioni, J, Pecuchet, N, Dubot, C, De La Motte Rouge, T, Kaminsky, M, Weber, B, Lortholary, A, Parkinson, C, Williams, S, Banerjee, S, Cosin, J, Hoffman, J, Plante, M, Covens, A, Joly, F, Hirte, H, Amit, A, Matsumoto, K, Tjulandin, S, Hoon Kim, J, Gladieff, L, Sabbatini, R, O'Malley, D, Timmins, P, Kredentser, D, Lainez Milagro, N, Barretina Ginesta, M, Tibau Martorell, A, Gomez De Liano Lista, A, Ojeda Gonzalez, B, Mileshkin, L, Mandai, M, Boere, I, Ottevanger, P, Nam, J, Hamizi, S, Cognetti, F, Warshal, D, Dickson-Michelson, E, Kamelle, S, Mckenzie, N, Rodriguez, G, Armstrong, D, Chalas, E, Celano, P, Behbakht, K, Davidson, S, Welch, S, Helpman, L, Fishman, A, Bruchim, I, Sikorska, M, Slowinska, A, Rogowski, W, Bidzinski, M, Spiewankiewicz, B, Casado Herraez, A, Mendiola Fernandez, C, Gropp-Meier, M, Saito, T, Takehara, K, Enomoto, T, Watari, H, Choi, C, Kim, B, Weon Kim, J, Hegg, R, Poveda A., Floquet A., Ledermann J. A., Asher R., Penson R. T., Oza A. M., Korach J., Huzarski T., Pignata S., Friedlander M., Baldoni A., Park-Simon T. -W., Tamura K., Sonke G. S., Lisyanskaya A., Kim J. -H., Filho E. A., Milenkova T., Lowe E. S., Rowe P., Vergote I., Pujade-Lauraine E., Byrski T., Pautier P., Harter P., Colombo N., Scambia G., Nicoletto M., Nussey F., Clamp A., Penson R., Poveda Velasco A., Rodrigues M., Lotz J. -P., Selle F., Ray-Coquard I., Provencher D., Prat Aparicio A., Vidal Boixader L., Scott C., Yunokawa M., Medioni J., Pecuchet N., Dubot C., De La Motte Rouge T., Kaminsky M. -C., Weber B., Lortholary A., Parkinson C., Ledermann J., Williams S., Banerjee S., Cosin J., Hoffman J., Plante M., Covens A., Sonke G., Joly F., Hirte H., Amit A., Matsumoto K., Tjulandin S., Hoon Kim J., Gladieff L., Sabbatini R., O'Malley D., Timmins P., Kredentser D., Lainez Milagro N., Barretina Ginesta M. P., Tibau Martorell A., Gomez De Liano Lista A., Ojeda Gonzalez B., Mileshkin L., Mandai M., Boere I., Ottevanger P., Nam J. -H., Filho E., Hamizi S., Cognetti F., Warshal D., Dickson-Michelson E., Kamelle S., McKenzie N., Rodriguez G., Armstrong D., Chalas E., Celano P., Behbakht K., Davidson S., Welch S., Helpman L., Fishman A., Bruchim I., Sikorska M., Slowinska A., Rogowski W., Bidzinski M., Spiewankiewicz B., Casado Herraez A., Mendiola Fernandez C., Gropp-Meier M., Saito T., Takehara K., Enomoto T., Watari H., Choi C. H., Kim B. -G., Weon Kim J., and Hegg R.

Abstract

Background: Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, has previously been shown to extend progression-free survival versus placebo when given to patients with relapsed high-grade serous or endometrioid ovarian cancer who were platinum sensitive and who had a BRCA1 or BRCA2 (BRCA1/2) mutation, as part of the SOLO2/ENGOT-Ov21 trial. The aim of this final analysis is to investigate the effect of olaparib on overall survival. Methods: This double-blind, randomised, placebo-controlled, phase 3 trial was done across 123 medical centres in 16 countries. Eligible patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status at baseline of 0–1, had histologically confirmed, relapsed, high-grade serous or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer, and had received two or more previous platinum regimens. Patients were randomly assigned (2:1) to receive olaparib tablets (300 mg in two 150 mg tablets twice daily) or matching placebo tablets using an interactive web or voice-response system. Stratification was by response to previous chemotherapy and length of platinum-free interval. Treatment assignment was masked to patients, treatment providers, and data assessors. The primary endpoint of progression-free survival has been reported previously. Overall survival was a key secondary endpoint and was analysed in all patients as randomly allocated. Safety was assessed in all patients who received at least one treatment dose. This trial is registered with ClinicalTrials.gov, NCT01874353, and is no longer recruiting patients. Findings: Between Sept 3, 2013 and Nov 21, 2014, 295 patients were enrolled. Patients were randomly assigned to receive either olaparib (n=196 [66%]) or placebo (n=99 [34%]). One patient, randomised in error, did not receive olaparib. Median follow-up was 65·7 months (IQR 63·6–69·3) with olaparib and 64·5 months (63·4–68·7) with placebo. Median overall survi

Published
2021

7. Management of ovarian cancer: guidelines of the Italian Medical Oncology Association (AIOM)

Author

Gadducci, A, Aletti, G, Landoni, F, Lazzari, R, Mangili, G, Olivas, P, Pignata, S, Salutari, V, Sartori, E, Scambia, G, Zannoni, G, Sabbatini, R, Lorusso, D, Gadducci A., Aletti G. D., Landoni F., Lazzari R., Mangili G., Olivas P., Pignata S., Salutari V., Sartori E., Scambia G., Zannoni G. F., Sabbatini R., Lorusso D., Gadducci, A, Aletti, G, Landoni, F, Lazzari, R, Mangili, G, Olivas, P, Pignata, S, Salutari, V, Sartori, E, Scambia, G, Zannoni, G, Sabbatini, R, Lorusso, D, Gadducci A., Aletti G. D., Landoni F., Lazzari R., Mangili G., Olivas P., Pignata S., Salutari V., Sartori E., Scambia G., Zannoni G. F., Sabbatini R., and Lorusso D.

Abstract

Introduction: Ovarian cancer is the most lethal gynecologic malignancy. Over 5200 new cases of this tumor are diagnosed yearly in Italy, resulting in more than 3600 deaths. In terms of molecular biology, five different ovarian cancer subtypes should be distinguished. Method: This article summarizes the evidence-based guidelines that the Italian Medical Oncology Association (AIOM) has developed with a multidisciplinary panel of experts, including pathologists, gynecologic oncologists, medical oncologists, and radiotherapists, with the support of methodologists, to help clinicians involved in the management of patients with ovarian cancer in their daily clinical practice. Results: The most relevant randomized clinical trials regarding surgery, chemotherapy, and molecularly targeted agents (bevacizumab and PARP inhibitors) in early, advanced, and recurrent disease have been critically analyzed. The levels of evidence and strength of recommendation have been reported for any issue. Conclusion: Women with a clinical suspicion of ovarian cancer should be centralized in referral centers. The BRCA test should be requested for all women with nonmucinous and nonborderline tumors, regardless of age and family history. BRCA testing could be preferentially performed on neoplastic tissue. In the presence of a positive tumor test, a genetic test should always be performed on a blood sample to differentiate between germline mutations, which require counseling and genetic testing of family members, and somatic mutations.

Published
2021

8. No improvement of survival with reduced- versus high-intensity conditioning for allogeneic stem cell transplants in Ewing tumor patients

Author

Thiel, U., Wawer, A., Wolf, P., Badoglio, M., Santucci, A., Klingebiel, T., Basu, O., Borkhardt, A., Laws, H.-J., Kodera, Y., Yoshimi, A., Peters, C., Ladenstein, R., Pession, A., Prete, A., Urban, E.-C., Schwinger, W., Bordigoni, P., Salmon, A., Diaz, M.A., Afanasyev, B., Lisukov, I., Morozova, E., Toren, A., Bielorai, B., Korsakas, J., Fagioli, F., Caselli, D., Ehninger, G., Gruhn, B., Dirksen, U., Abdel-Rahman, F., Aglietta, M., Mastrodicasa, E., Torrent, M., Corradini, P., Demeocq, F., Dini, G., Dreger, P., Eyrich, M., Gozdzik, J., Guilhot, F., Holler, E., Koscielniak, E., Messina, C., Nachbaur, D., Sabbatini, R., Oldani, E., Ottinger, H., Ozsahin, H., Schots, R., Siena, S., Stein, J., Sufliarska, S., Unal, A., Ussowicz, M., Schneider, P., Woessmann, W., Jürgens, H., Bregni, M., and Burdach, S.

Published
2011
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9. Association of systemic inflammation index and body mass index with survival in patients with renal cell cancer treated with nivolumab

Author

De Giorgi, U, Procopio, G, Giannarelli, D, Sabbatini, R, Bearz, A, Buti, S, Basso, U, Mitterer, M, Ortega, C, Bidoli, P, Ferraù, F, Crinò, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Fornarini, G, Cartenì, G, Caserta, C, Sternberg, C, De Giorgi U, Procopio G, Giannarelli D, Sabbatini R, Bearz A, Buti S, Basso U, Mitterer M, Ortega C, Bidoli P, Ferraù F, Crinò L, Frassoldati A, Marchetti P, Mini E, Scoppola A, Verusio C, Fornarini G, Cartenì G, Caserta C, Sternberg CN., De Giorgi, U, Procopio, G, Giannarelli, D, Sabbatini, R, Bearz, A, Buti, S, Basso, U, Mitterer, M, Ortega, C, Bidoli, P, Ferraù, F, Crinò, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Fornarini, G, Cartenì, G, Caserta, C, Sternberg, C, De Giorgi U, Procopio G, Giannarelli D, Sabbatini R, Bearz A, Buti S, Basso U, Mitterer M, Ortega C, Bidoli P, Ferraù F, Crinò L, Frassoldati A, Marchetti P, Mini E, Scoppola A, Verusio C, Fornarini G, Cartenì G, Caserta C, and Sternberg CN.

Abstract

Purpose: Inflammation indexes and body mass index (BMI) are easily evaluated, predict survival, and are potentially modifiable. We evaluated the potential association of inflammatory indexes and BMI with the clinical outcome of patients with renal cell carcinoma (RCC) undergoing immune checkpoint inhibitor therapy. Experimental Design: A prospective cohort of patients with metastatic RCC treated with nivolumab enrolled in the Italian Expanded Access Program from July 2015 through April 2016 was examined. Reference measures of inflammation were identified for neutrophil-to-lymphocyte ratio (NLR)

Published
2019

10. Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial

Author

Lorusso, D, Ferrandina, G, Colombo, N, Pignata, S, Pietragalla, A, Sonetto, C, Pisano, C, Lapresa, M, Savarese, A, Tagliaferri, P, Lombardi, D, Cinieri, S, Breda, E, Sabatucci, I, Sabbatini, R, Conte, C, Cecere, S, Maltese, G, Scambia, G, Lorusso D., Ferrandina G., Colombo N., Pignata S., Pietragalla A., Sonetto C., Pisano C., Lapresa M. T., Savarese A., Tagliaferri P., Lombardi D., Cinieri S., Breda E., Sabatucci I., Sabbatini R., Conte C., Cecere S. C., Maltese G., Scambia G., Lorusso, D, Ferrandina, G, Colombo, N, Pignata, S, Pietragalla, A, Sonetto, C, Pisano, C, Lapresa, M, Savarese, A, Tagliaferri, P, Lombardi, D, Cinieri, S, Breda, E, Sabatucci, I, Sabbatini, R, Conte, C, Cecere, S, Maltese, G, Scambia, G, Lorusso D., Ferrandina G., Colombo N., Pignata S., Pietragalla A., Sonetto C., Pisano C., Lapresa M. T., Savarese A., Tagliaferri P., Lombardi D., Cinieri S., Breda E., Sabatucci I., Sabbatini R., Conte C., Cecere S. C., Maltese G., and Scambia G.

Abstract

Objective: Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. Methods: In a phase II trial, patients with advanced (FIGO stage III-IV) or recurrent EC were randomized to receive Carboplatin-Paclitaxel standard dose for 6–8 cycles vs Carboplatin-Paclitaxel and Bevacizumab 15 mg/kg in combination with chemotherapy and maintenance until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). Results: 108 patients were randomized; PFS (10.5 vs 13.7 months, HR 0.84 p = 0.43), overall response rate (ORR 53.1% vs 74.4%) and overall survival (OS) (29.7 vs 40.0 months, HR 0.71 p = 0.24) resulted in a non-significant increase in Bevacizumab treated patients. The PFS increase became significant when an exploratory analysis with the Breslow test was used. Moreover, patients treated with Bevacizumab experienced a significant increase in 6-month disease control rate (70.4% vs 90.7%). Cardiovascular events were more frequent in the experimental arm (“de novo” grade ≥2 hypertension 21% vs 0% and grade ≥2 thromboembolic events 11% vs 2% in the Bevacizumab vs standard treatment arm, respectively). Conclusions: Bevacizumab combined with chemotherapy in the treatment of advanced/recurrent EC failed to demonstrate a significant increase in PFS in the MITO END-2 trial. Nevertheless, these preliminary data suggests some effectiveness of the antiangiogenic agent which merits further exploration in a larger population with a better molecular characterization.

Published
2019

11. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, Bidoli, P, De Giorgi U, Cartenì G, Giannarelli D, Basso U, Galli L, Cortesi E, Caserta C, Pignata S, Sabbatini R, Bearz A, Buti S, Lo Re G, Berruti A, Bracarda S, Cognetti F, Rastelli F, Fornarini G, Porta C, Turci D, Sternberg CN, Procopio G, Bidoli P, De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, Bidoli, P, De Giorgi U, Cartenì G, Giannarelli D, Basso U, Galli L, Cortesi E, Caserta C, Pignata S, Sabbatini R, Bearz A, Buti S, Lo Re G, Berruti A, Bracarda S, Cognetti F, Rastelli F, Fornarini G, Porta C, Turci D, Sternberg CN, Procopio G, and Bidoli P

Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

12. Prostate cancer awareness among Italian adult males: a national web-based survey

Author

Sighinolfi, M.C., primary, Battaglia, M., additional, Bellardita, L., additional, Castiglioni, S., additional, Dal Moro, F., additional, De Giorgi, U., additional, De Monte, A., additional, Di Maio, M., additional, Gaboardi, F., additional, Gontero, P., additional, Jereczek, B.A., additional, Leonardi, R., additional, Lombardi, E., additional, Madonia, M., additional, Mangiagalli, A., additional, Marenghi, C., additional, Marrocco, W., additional, Masini, C., additional, Miano, R., additional, Polloni, G., additional, Prezioso, D., additional, Ruffini, L., additional, Sabbatini, R., additional, Schips, L., additional, Selli, C., additional, Valdagni, R., additional, Varca, V., additional, Veneziano, P., additional, Calcagnile, T., additional, and Rocco, B., additional

Published
2021
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13. Circulating mucosal-associated invariant T cells identify patients responding to anti-PD-1 therapy

Author

Biasi, S. De, Gibellini, L., Tartaro, D. Lo, Puccio, S., Rabacchi, C., Mazza, E.M.C., Brummelman, J., Williams, B., Kaihara, K., Forcato, M., Bicciato, S., Pinti, M., Depenni, R., Sabbatini, R., Longo, C., Dominici, M., Pellacani, G., Lugli, E., and Cossarizza, A.

Subjects
Aged, 80 and over, Male, Receptors, CXCR4, Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], Science, Programmed Cell Death 1 Receptor, T cells, Translational immunology, CD8-Positive T-Lymphocytes, Middle Aged, Antibodies, Monoclonal, Humanized, Granzymes, Mucosal-Associated Invariant T Cells, Article, Prognostic markers, Humans, Female, Immunotherapy, Biomarkers, Aged
Abstract

Immune checkpoint inhibitors are used for treating patients with metastatic melanoma. Since the response to treatment is variable, biomarkers are urgently needed to identify patients who may benefit from such therapy. Here, we combine single-cell RNA-sequencing and multiparameter flow cytometry to assess changes in circulating CD8+ T cells in 28 patients with metastatic melanoma starting anti-PD-1 therapy, followed for 6 months: 17 responded to therapy, whilst 11 did not. Proportions of activated and proliferating CD8+ T cells and of mucosal-associated invariant T (MAIT) cells are significantly higher in responders, prior to and throughout therapy duration. MAIT cells from responders express higher level of CXCR4 and produce more granzyme B. In silico analysis support MAIT presence in the tumor microenvironment. Finally, patients with >1.7% of MAIT among peripheral CD8+ population show a better response to treatment. Our results thus suggest that MAIT cells may be considered a biomarker for patients responding to anti-PD-1 therapy., Immune checkpoint inhibition (ICI) shows potential for cancer therapies, but response rates vary. Here, the authors use single-cell analyses to show that, in a 28 patient cohort, patients stratified by mucosal-associated invariant T (MAIT) percentages show different response rates, and ICI responders have more MAIT cells expressing CXCR4 and granzyme B.

Published
2021

14. «Un’amicizia sincera e di buona fede». La Spagna nelle relazioni degli ambasciatori lucchesi a Madrid (1700-1750)

Author

Sabbatini, R.

Subjects
Republic of Lucca, Diplomazia, lcsh:D204-475, Diplomazia, Spagna, Repubblica di Lucca, War of Spanish Succession, Grand Duchy of Tuscany, Repubblica di Lucca, Spagna, Diplomacy, lcsh:Modern history, 1453
Abstract

This paper, a preview of a more extensive work across a wider time frame, contributes to the understanding of the European balance of power, the cultural exchanges, and the image of Spain during the complicated phase of the War of the Spanish Succession and the following ‘Spanish resurgence’. The reports of successive ambassadors to Madrid (Giovanni Lando Diversi, Pierfrancesco Boccella, Carlo Orsucci, Giovan Battista Domenico Sardini, Andrea Sbarra) allow the reader to appreciate little-known details, to examine the change in court ritual and taste (with typically Spanish traits such as bullfighting taking a back seat), to witness the machinations of princess Orsini and the backrooms of foreign policy, and to enjoy the portraits – warts and all – of prominent ministers and of the sovereigns themselves: Philip V, Elisabeth Farnese, and Ferdinand VI., Diciottesimo Secolo, Vol. 5 (2020)

Published
2020

16. Does the number of nodes removed at the pelvic lymphadenectomy impact on cancer specific survival of pca patients with adverse pathological outcomes at radical prostatectomy? A retrospective 5- and 10-years analysis on 1274 series

Author

Morini, E., primary, Eissa, A., additional, Sighinolfi, M.C., additional, Bonfante, G., additional, Vitale, M.G., additional, Sandri, M., additional, Sabbatini, R., additional, Bruni, A., additional, Romano, A., additional, Peracchia, G., additional, Grisanti, R., additional, Reggiani Bonetti, L., additional, Bagni, I., additional, Micali, S., additional, and Rocco, B., additional

Published
2020
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17. 5- and 10-years follow up of radical prostatectomy with pelvic lymphadenectomy: A cancer-specific survival analysis on a 1274 prostate cancer series

Author

Bonfante, G., primary, Sighinolfi, M.C., additional, Morini, E., additional, Sandri, M., additional, Sabbatini, R., additional, Vitale, M.G., additional, Bruni, A., additional, Romano, A., additional, Peracchia, G., additional, Grisanti, R., additional, Reggiani Bonetti, L., additional, Bgni, I., additional, Micali, S., additional, Bianchi, G., additional, and Rocco, B., additional

Published
2020
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20. Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

Author

Schmidinger, M. Bamias, A. Procopio, G. Hawkins, R. Sanchez, A.R. Vázquez, S. Srihari, N. Kalofonos, H. Bono, P. Pisal, C.B. Hirschberg, Y. Dezzani, L. Ahmad, Q. Jonasch, E. Gimeno, R.A. Herranz, U.A. Ardavanis, A. Ashraf, S.A. Bamias, A. Barone, C. Bella, S.R. Belz, H. Companario, E.B. Bolling, C. Bono, P. Bothe, K. Carteni, G. Espinosa, J.C. Clausse, M. Confente, C. Coskun, H. Herrero, G.C. Demey, W. D'hondt, R. Santasusana, M.D. Doshi, G. Elkiran, E. Facchini, G. Fein, L. Calvo, O.F. Flaherty, A. Fountzilas, G. Fruehauf, J. Díaz, E.G. Garcia, R. Domínguez, R.G. Ghosn, M. Glorieux, P. Goebell, P.J. Gutierrez, L.G.-A. Gonzalez, M. Green, N.B. Arnau, M.G. Harich, H.-D. Hawkins, R. Hegele, A. Pérez, C.H. Herrmann, E. Horniniger, W.J. Hutson, T.E. Janetschek, G. Kalantari, H. Kalofonos, H. Klausmann, M. Kolin, M. Krause, S. Kroening, H. Sorrosal, J.J.L. Lázaro, M. Lema, M. Lema, M.L. Lin, J. Lueck, A. Lybaert, W. Magi, A. Marina, V.A. Rey, J.P.M. Matus, G. Melear, J. Gonzalez, B.M. Milella, M. Montalar, J. Ferrandis, J.M. Nathan, P. Nechushtan, H. Nusch, A. Ojamaa, K. Oksuzoglu, B. Ozkan, M. Papazisis, K. Passalacqua, R. Pe'er, A. Gracia, J.L.P. Pichler, A. Pokker, H. Porta, C. Rauchenwald, M. Richardet, M.E. Richey, S.L. Garcia, J.M.R. Sánchez, A.R. Rudolph, R. Sabbatini, R. Salmon, J.-P. Lobera, C.S. Sarid, D.L. Saylors, G.B. Schmidinger, M. Schrijvers, D. Schulze, M. Sevilay, A. Shumaker, G.G. Siemer, S. de Prado y Otero, D.S. Srihari, N. Stoiber, F. Rodriguez, C.S. Varela, M.S. Vasanthan, S. Estevez, S.V. Vehling-Kaiser, U. Vogelzang, N. Weiss, H. Whenham, N. Wyendaele, W. Yildiz, R. Yucel, I. Zarba, J.J. Zarkar, A. Zhong, W. Ziem, P. the PRINCIPAL Study Group

Abstract

Background: Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC). Subjects, Materials, and Methods: Patients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups. Results: Six hundred fifty-seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2–12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups. Conclusion: PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting. Implications for Practice: PRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced/metastatic renal cell carcinoma, to the authors’ knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real-world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first-line pazopanib generally do not show disease progression for approximately 10 months and generally survive for nearly 30 months. © AlphaMed Press 2019

Published
2019

21. Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial

Author

Lorusso, Domenica, Ferrandina, Maria Gabriella, Colombo, N., Pignata, S., Pietragalla, A., Sonetto, C., Pisano, C., Lapresa, M. T., Savarese, A., Tagliaferri, P., Lombardi, Debora Benedetta, Cinieri, S., Breda, E., Sabatucci, I., Sabbatini, R., Conte, C., Cecere, S. C., Maltese, G., Scambia, Giovanni, Lorusso D., Ferrandina G. (ORCID:0000-0003-4672-4197), Lombardi D., Scambia G. (ORCID:0000-0003-2758-1063), Lorusso, Domenica, Ferrandina, Maria Gabriella, Colombo, N., Pignata, S., Pietragalla, A., Sonetto, C., Pisano, C., Lapresa, M. T., Savarese, A., Tagliaferri, P., Lombardi, Debora Benedetta, Cinieri, S., Breda, E., Sabatucci, I., Sabbatini, R., Conte, C., Cecere, S. C., Maltese, G., Scambia, Giovanni, Lorusso D., Ferrandina G. (ORCID:0000-0003-4672-4197), Lombardi D., and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Objective: Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. Methods: In a phase II trial, patients with advanced (FIGO stage III-IV) or recurrent EC were randomized to receive Carboplatin-Paclitaxel standard dose for 6–8 cycles vs Carboplatin-Paclitaxel and Bevacizumab 15 mg/kg in combination with chemotherapy and maintenance until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). Results: 108 patients were randomized; PFS (10.5 vs 13.7 months, HR 0.84 p = 0.43), overall response rate (ORR 53.1% vs 74.4%) and overall survival (OS) (29.7 vs 40.0 months, HR 0.71 p = 0.24) resulted in a non-significant increase in Bevacizumab treated patients. The PFS increase became significant when an exploratory analysis with the Breslow test was used. Moreover, patients treated with Bevacizumab experienced a significant increase in 6-month disease control rate (70.4% vs 90.7%). Cardiovascular events were more frequent in the experimental arm (“de novo” grade ≥2 hypertension 21% vs 0% and grade ≥2 thromboembolic events 11% vs 2% in the Bevacizumab vs standard treatment arm, respectively). Conclusions: Bevacizumab combined with chemotherapy in the treatment of advanced/recurrent EC failed to demonstrate a significant increase in PFS in the MITO END-2 trial. Nevertheless, these preliminary data suggests some effectiveness of the antiangiogenic agent which merits further exploration in a larger population with a better molecular characterization.

Published
2019

31. Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)

Author

Hoffman-Censits, J., primary, Rosenberg, J.E., additional, van Der Heijden, M., additional, Dreicer, R., additional, Perez Gracia, J.L., additional, Petrylak, D.P., additional, Retz, M.M., additional, Sabbatini, R., additional, Naglieri, E., additional, Caserta, C., additional, Maruzzo, M., additional, Iacovelli, R., additional, Galli, L., additional, McDermott, R., additional, Morales Barrera, R., additional, Bonfill, T., additional, De Ducla, S., additional, Ding, B., additional, Linsenmeier, J., additional, and Sternberg, C.N., additional

Published
2019
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32. Does the number of nodes removed at the pelvic lymphadenectomy impact on cancer specific survival of PCa patients with adverse pathological outcomes at radical prostatectomy? A retrospective 5 - and 10- years analysis on 1274 series

Author

Eissa, A., primary, Sighinolfi, M., additional, Sandri, M., additional, Morini, E., additional, Sabbatini, R., additional, Vitale, M., additional, Bruni, A., additional, Romano, A., additional, Peracchia, G., additional, Grisanti, R., additional, Bonetti, L. Reggiani, additional, Bagni, I., additional, Zoeir, A., additional, Micali, S., additional, Bianchi, G., additional, and Rocco, B., additional

Published
2019
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34. INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors: a transversal challenge. The INVIDIa study.

Author

Bersanelli, M, Giannarelli, D, Castrignanò, P, Fornarini, G, Panni, S, Mazzoni, F, Tiseo, M, Rossetti, S, Gambale, E, Rossi, Ernesto, Papa, A, Cortellini, A, Lolli, C, Ratta, R, Michiara, M, Milella, M, De Luca, E, Sorarù, M, Mucciarini, C, Atzori, F, Banna, Gl, La Torre, L, Vitale, Mg, Massari, F, Rebuzzi, Se, Facchini, G, Schinzari, Giovanni, Tomao, S, Bui, S, Vaccaro, V, Procopio, G, De Giorgi, U, Santoni, M, Ficorella, C, Sabbatini, R, Maestri, A, Natoli, C, De Tursi, M, Di Maio, M, Rapacchi, E, Pireddu, A, Sava, T, Lipari, H, Comito, F, Verzoni, E, Leonardi, F, Buti, S1, Rossi Ernesto, Schinzari Giovanni (ORCID:0000-0001-6105-7252), Bersanelli, M, Giannarelli, D, Castrignanò, P, Fornarini, G, Panni, S, Mazzoni, F, Tiseo, M, Rossetti, S, Gambale, E, Rossi, Ernesto, Papa, A, Cortellini, A, Lolli, C, Ratta, R, Michiara, M, Milella, M, De Luca, E, Sorarù, M, Mucciarini, C, Atzori, F, Banna, Gl, La Torre, L, Vitale, Mg, Massari, F, Rebuzzi, Se, Facchini, G, Schinzari, Giovanni, Tomao, S, Bui, S, Vaccaro, V, Procopio, G, De Giorgi, U, Santoni, M, Ficorella, C, Sabbatini, R, Maestri, A, Natoli, C, De Tursi, M, Di Maio, M, Rapacchi, E, Pireddu, A, Sava, T, Lipari, H, Comito, F, Verzoni, E, Leonardi, F, Buti, S1, Rossi Ernesto, and Schinzari Giovanni (ORCID:0000-0001-6105-7252)

Abstract

AIM: Considering the unmet need for the counseling of cancer patients treated with immune checkpoint inhibitors (CKI) about influenza vaccination, an explorative study was planned to assess flu vaccine efficacy in this population. METHODS: INVIDIa was a retrospective, multicenter study, enrolling consecutive advanced cancer outpatients receiving CKI during the influenza season 2016-2017. RESULTS: Of 300 patients, 79 received flu vaccine. The incidence of influenza syndrome was 24.1% among vaccinated, versus 11.8% of controls; odds ratio: 2.4; 95% CI: 1.23-4.59; p = 0.009. The clinical ineffectiveness of vaccine was more pronounced among elderly: 37.8% among vaccinated patients, versus 6.1% of unvaccinated, odds ratio: 9.28; 95% CI: 2.77-31.14; p < 0.0001. CONCLUSION: Although influenza vaccine may be clinically ineffective in advanced cancer patients receiving CKI, it seems not to negatively impact the efficacy of anticancer therapy.

Published
2018

35. SC98 - Prostate cancer awareness among Italian adult males: a national web-based survey

Author

Sighinolfi, M.C., Battaglia, M., Bellardita, L., Castiglioni, S., Dal Moro, F., De Giorgi, U., De Monte, A., Di Maio, M., Gaboardi, F., Gontero, P., Jereczek, B.A., Leonardi, R., Lombardi, E., Madonia, M., Mangiagalli, A., Marenghi, C., Marrocco, W., Masini, C., Miano, R., Polloni, G., Prezioso, D., Ruffini, L., Sabbatini, R., Schips, L., Selli, C., Valdagni, R., Varca, V., Veneziano, P., Calcagnile, T., and Rocco, B.

Published
2021
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39. “Corrections to Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC”

Author

Knox, J.J., primary, Barrios, C.H., additional, Kim, T.M., additional, Cosgriff, T., additional, Srimuninnimit, V., additional, Pittman, K., additional, Sabbatini, R., additional, Rha, S.Y., additional, Flaig, T.W., additional, Page, R.D., additional, Beck, J.T., additional, Cheung, F., additional, Yadav, S., additional, Patel, P., additional, Geoffrois, L., additional, Niolat, J., additional, Berkowitz, N., additional, Marker, M., additional, Chen, D., additional, and Motzer, R.J., additional

Published
2018
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40. Correlation between immuno-related adverse events (IRAEs) occurrence and clinical outcome in metastatic renal cell carcinoma (mRCC) patients treated with nivolumab: IRAENE trial, an Italian multi-institutional retrospective study

Author

Vitale, M.G., primary, Pipitone, S., additional, Scagliarini, S., additional, Zucali, P.A., additional, Galli, L., additional, Rossetti, S., additional, Caserta, C., additional, Iacovelli, R., additional, Masini, C., additional, Ficorella, C., additional, Di Girolamo, S., additional, Buti, S., additional, Benedetti, B., additional, Santoni, M., additional, Porta, C., additional, Bracarda, S., additional, Baldessari, C., additional, Giaquinta, S., additional, Cascinu, S., additional, and Sabbatini, R., additional

Published
2018
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41. No improvement of survival with reduced- versus high-intensity conditioning for allogeneic stem cell transplants in Ewing tumor patients

Author

Thiel, U., Wawer, A., Wolf, P., Badoglio, M., Santucci, A., Klingebiel, T., Basu, O., Borkhardt, A., Laws, H.-J, Kodera, Y., Yoshimi, A., Peters, C., Ladenstein, R., Pession, A., Prete, A., Urban, E.-C, Schwinger, W., Bordigoni, P., Salmon, A., Diaz, M. A., Afanasyev, B., Lisukov, I., Morozova, E., Toren, A., Bielorai, B., Korsakas, J., Fagioli, F., Caselli, D., Ehninger, G., Gruhn, B., Dirksen, U., Abdel-Rahman, F., Aglietta, M., Mastrodicasa, E., Torrent, M., Corradini, P., Demeocq, F., Dini, G., Dreger, P., Eyrich, M., Gozdzik, J., Guilhot, F., Holler, E., Koscielniak, E., Messina, C., Nachbaur, D., Sabbatini, R., Oldani, E., Ottinger, H., Ozsahin, H., Schots, R., Siena, S., Stein, J., Sufliarska, S., Unal, A., Ussowicz, M., Schneider, P., Woessmann, W., Jürgens, H., Bregni, M., Burdach, S., Thiel, U., Wawer, A., Wolf, P., Badoglio, M., Santucci, A., Klingebiel, T., Basu, O., Borkhardt, A., Laws, H.-J, Kodera, Y., Yoshimi, A., Peters, C., Ladenstein, R., Pession, A., Prete, A., Urban, E.-C, Schwinger, W., Bordigoni, P., Salmon, A., Diaz, M. A., Afanasyev, B., Lisukov, I., Morozova, E., Toren, A., Bielorai, B., Korsakas, J., Fagioli, F., Caselli, D., Ehninger, G., Gruhn, B., Dirksen, U., Abdel-Rahman, F., Aglietta, M., Mastrodicasa, E., Torrent, M., Corradini, P., Demeocq, F., Dini, G., Dreger, P., Eyrich, M., Gozdzik, J., Guilhot, F., Holler, E., Koscielniak, E., Messina, C., Nachbaur, D., Sabbatini, R., Oldani, E., Ottinger, H., Ozsahin, H., Schots, R., Siena, S., Stein, J., Sufliarska, S., Unal, A., Ussowicz, M., Schneider, P., Woessmann, W., Jürgens, H., Bregni, M., and Burdach, S.

Abstract

Background: Outcomes of Ewing tumor (ET) patients treated with allogeneic stem cell transplantation (allo-SCT) were compared regarding the use of reduced-intensity conditioning (RIC) and high-intensity conditioning (HIC) regimens as well as human leukocyte antigen (HLA)-matched and HLA-mismatched grafts. Patients and methods: We retrospectively analyzed data of 87 ET patients from the European Group for Blood and Marrow Transplantation, Pediatric Registry for Stem Cell Transplantations, Asia Pacific Blood and Marrow Transplantation and MetaEICESS registries treated with allo-SCT. Fifty patients received RIC (group A) and 37 patients received HIC (group B). Twenty-four patients received HLA-mismatched grafts and 63 received HLA-matched grafts. Results: Median overall survival was 7.9 months [±1.24, 95% confidence interval (CI) 5.44-10.31] for group A and 4.4 months (±1.06, 95% CI 2.29-6.43) for group B patients (P = 1.3). Death of complications (DOC) occurred in 4 of 50 (0.08) and death of disease (DOD) in 33 of 50 (0.66) group A and in 16 of 37 (0.43) and 17 of 37 (0.46) group B patients, respectively. DOC incidence was decreased (P < 0.01) and DOD/relapse increased (P < 0.01) in group A compared with group B. HLA mismatch was not generally associated with graft-versus-Ewing tumor effect (GvETE). Conclusions: There was no improvement of survival with RIC compared with HIC due to increased DOD/relapse incidence after RIC despite less DOC incidence. This implicates general absence of a clinically relevant GvETE with current protocols

Published
2017

42. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Coleman, Robert L, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Garcia-Donas, Jesu, Swisher, Elizabeth M, Floquet, Anne, Konecny, Gottfried E, Mcneish, Iain A, Scott, Clare L, Cameron, Terri, Maloney, Lara, Isaacson, Jeff, Goble, Sandra, Grace, Caroline, Harding, Thomas C, Raponi, Mitch, Sun, Jame, Lin, Kevin K, Giordano, Heidi, Ledermann, Jonathan A, Buck, M., Willis, Dean Alistair Tobia, Friedlander, M. L., Goh, J. C., Harnett, P., Kichenadasse, G., Scott, C. L., Denys, H., Dirix, L., Vergote, I., Elit, L., Ghatage, P., Oza, A. M., Plante, M., Provencher, D., Weberpals, J. I., Welch, S., Floquet, A., Gladieff, L., Joly, F., Leary, A., Lortholary, A., Lotz, J., Medioni, J., Tredan, O., You, B., El-Balat, A., Hänle, C., Krabisch, P., Neunhöffer, T., Pölcher, M., Wimberger, P., Amit, A., Kovel, S., Leviov, M., Safra, T., Shapira-Frommer, R., Stemmer, S., Bologna, Alessio, Colombo, N., Pignata, S., Sabbatini, R. F., Tamberi, S., Zamagni, C., Fong, P. C., O'Donnell, A., Gancedo, M Amenedo, Herraez, A Casado, Garcia-Donas, J., Guerra, E. M., Oaknin, A., Palacio, I., Romero, I., Sanchez, A., Banerjee, S. N., Clamp, A., Drew, Y., Gabra, H. G., Jackson, D., Ledermann, J. A., Mcneish, I. A., Parkinson, C., Powell, M., Aghajanian, C., Armstrong, D. K., Birrer, M. J., Buss, M. K., Chambers, S. K., Chen, L. -M., Coleman, R. L., Holloway, R. W., Konecny, G. E., Ma, L., Morgan, M. A., Morris, R. T., Mutch, D. G., O'Malley, D. M., Slomovitz, B. M., Swisher, E. M., Vanderkwaak, T., Vulfovich, M., Scambia, Giovanni (ORCID:0000-0003-2758-1063), Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), Coleman, Robert L, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Garcia-Donas, Jesu, Swisher, Elizabeth M, Floquet, Anne, Konecny, Gottfried E, Mcneish, Iain A, Scott, Clare L, Cameron, Terri, Maloney, Lara, Isaacson, Jeff, Goble, Sandra, Grace, Caroline, Harding, Thomas C, Raponi, Mitch, Sun, Jame, Lin, Kevin K, Giordano, Heidi, Ledermann, Jonathan A, Buck, M., Willis, Dean Alistair Tobia, Friedlander, M. L., Goh, J. C., Harnett, P., Kichenadasse, G., Scott, C. L., Denys, H., Dirix, L., Vergote, I., Elit, L., Ghatage, P., Oza, A. M., Plante, M., Provencher, D., Weberpals, J. I., Welch, S., Floquet, A., Gladieff, L., Joly, F., Leary, A., Lortholary, A., Lotz, J., Medioni, J., Tredan, O., You, B., El-Balat, A., Hänle, C., Krabisch, P., Neunhöffer, T., Pölcher, M., Wimberger, P., Amit, A., Kovel, S., Leviov, M., Safra, T., Shapira-Frommer, R., Stemmer, S., Bologna, Alessio, Colombo, N., Pignata, S., Sabbatini, R. F., Tamberi, S., Zamagni, C., Fong, P. C., O'Donnell, A., Gancedo, M Amenedo, Herraez, A Casado, Garcia-Donas, J., Guerra, E. M., Oaknin, A., Palacio, I., Romero, I., Sanchez, A., Banerjee, S. N., Clamp, A., Drew, Y., Gabra, H. G., Jackson, D., Ledermann, J. A., Mcneish, I. A., Parkinson, C., Powell, M., Aghajanian, C., Armstrong, D. K., Birrer, M. J., Buss, M. K., Chambers, S. K., Chen, L. -M., Coleman, R. L., Holloway, R. W., Konecny, G. E., Ma, L., Morgan, M. A., Morris, R. T., Mutch, D. G., O'Malley, D. M., Slomovitz, B. M., Swisher, E. M., Vanderkwaak, T., Vulfovich, M., Scambia, Giovanni (ORCID:0000-0003-2758-1063), Lorusso, D., and Scambia, G. (ORCID:0000-0003-2758-1063)

Abstract

Background Rucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma. Methods In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals and cancer centres across 11 countries. Eligible patients were aged 18 years or older, had a platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma, had received at least two previous platinum-based chemotherapy regimens, had achieved complete or partial response to their last platinum-based regimen, had a cancer antigen 125 concentration of less than the upper limit of normal, had a performance status of 0–1, and had adequate organ function. Patients were ineligible if they had symptomatic or untreated central nervous system metastases, had received anticancer therapy 14 days or fewer before starting the study, or had received previous treatment with a poly(ADP-ribose) polymerase inhibitor. We randomly allocated patients 2:1 to receive oral rucaparib 600 mg twice daily or placebo in 28 day cycles using a computer-generated sequence (block size of six, stratified by homologous recombination repair gene mutation status, progression-free interval after the penultimate platinum-based regimen, and best response to the most recent platinum-based regimen). Patients, investigators, site staff, assessors, and the funder were masked to assignments. The primary outcome was investigator-assessed progression-free survival evaluated with use of an ordered step-down procedure for three nested cohorts: patients with BRCA mutations (carcinoma associated with deleterious germline or somatic BRCA mutations), patients wi

Published
2017

44. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Coleman, Robert L, primary, Oza, Amit M, additional, Lorusso, Domenica, additional, Aghajanian, Carol, additional, Oaknin, Ana, additional, Dean, Andrew, additional, Colombo, Nicoletta, additional, Weberpals, Johanne I, additional, Clamp, Andrew, additional, Scambia, Giovanni, additional, Leary, Alexandra, additional, Holloway, Robert W, additional, Gancedo, Margarita Amenedo, additional, Fong, Peter C, additional, Goh, Jeffrey C, additional, O'Malley, David M, additional, Armstrong, Deborah K, additional, Garcia-Donas, Jesus, additional, Swisher, Elizabeth M, additional, Floquet, Anne, additional, Konecny, Gottfried E, additional, McNeish, Iain A, additional, Scott, Clare L, additional, Cameron, Terri, additional, Maloney, Lara, additional, Isaacson, Jeff, additional, Goble, Sandra, additional, Grace, Caroline, additional, Harding, Thomas C, additional, Raponi, Mitch, additional, Sun, James, additional, Lin, Kevin K, additional, Giordano, Heidi, additional, Ledermann, Jonathan A, additional, Buck, M, additional, Dean, A, additional, Friedlander, M L, additional, Goh, J C, additional, Harnett, P, additional, Kichenadasse, G, additional, Scott, C L, additional, Denys, H, additional, Dirix, L, additional, Vergote, I, additional, Elit, L, additional, Ghatage, P, additional, Oza, A M, additional, Plante, M, additional, Provencher, D, additional, Weberpals, J I, additional, Welch, S, additional, Floquet, A, additional, Gladieff, L, additional, Joly, F, additional, Leary, A, additional, Lortholary, A, additional, Lotz, J, additional, Medioni, J, additional, Tredan, O, additional, You, B, additional, El-Balat, A, additional, Hänle, C, additional, Krabisch, P, additional, Neunhöffer, T, additional, Pölcher, M, additional, Wimberger, P, additional, Amit, A, additional, Kovel, S, additional, Leviov, M, additional, Safra, T, additional, Shapira-Frommer, R, additional, Stemmer, S, additional, Bologna, A, additional, Colombo, N, additional, Lorusso, D, additional, Pignata, S, additional, Sabbatini, R F, additional, Scambia, G, additional, Tamberi, S, additional, Zamagni, C, additional, Fong, P C, additional, O'Donnell, A, additional, Gancedo, M Amenedo, additional, Herraez, A Casado, additional, Garcia-Donas, J, additional, Guerra, E M, additional, Oaknin, A, additional, Palacio, I, additional, Romero, I, additional, Sanchez, A, additional, Banerjee, S N, additional, Clamp, A, additional, Drew, Y, additional, Gabra, H G, additional, Jackson, D, additional, Ledermann, J A, additional, McNeish, I A, additional, Parkinson, C, additional, Powell, M, additional, Aghajanian, C, additional, Armstrong, D K, additional, Birrer, M J, additional, Buss, M K, additional, Chambers, S K, additional, Chen, L-m, additional, Coleman, R L, additional, Holloway, R W, additional, Konecny, G E, additional, Ma, L, additional, Morgan, M A, additional, Morris, R T, additional, Mutch, D G, additional, O'Malley, D M, additional, Slomovitz, B M, additional, Swisher, E M, additional, Vanderkwaak, T, additional, and Vulfovich, M, additional

Published
2017
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45. Efficacy and safety data in elderly patients (pts) with metastatic renal cell carcinoma (mRCC) included in the nivolumab expanded access program (EAP) in Italy

Author

Sabbatini, R., primary, Galli, L., additional, Pignata, S., additional, Lo Re, G., additional, Valcamonico, F., additional, Defferrari, C., additional, Spada, M., additional, Santini, D., additional, Masini, C., additional, Ciuffreda, L., additional, Ruggeri, E.M., additional, Chioni, A., additional, Livi, L., additional, Fagnani, D., additional, Bonetti, A., additional, Giustini, L., additional, Duranti, S., additional, Procopio, G., additional, Caserta, C., additional, and Cartenì, G., additional

Published
2017
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46. Prospective phase II trial of trabectedin in BRCA-mutated and/or BRCAness phenotype recurrent ovarian cancer patients: the MITO 15 trial

Author

Lorusso, D, Scambia, Giovanni, Pignata, S, Sorio, R, Amadio, Giulia, Lepori, S, Mosconi, A, Pisano, C, Mangili, G, Maltese, Giustina, Sabbatini, R, Artioli, G, Gamucci, T, Di Napoli, M, Capoluongo, Ettore Domenico, Ludovini, V, Raspagliesi, F, Ferrandina, Maria Gabriella, Scambia, Giovanni (ORCID:0000-0003-2758-1063), Capoluongo, Ettore Domenico (ORCID:0000-0001-9872-0572), Ferrandina, Maria Gabriella (ORCID:0000-0003-4672-4197), Lorusso, D, Scambia, Giovanni, Pignata, S, Sorio, R, Amadio, Giulia, Lepori, S, Mosconi, A, Pisano, C, Mangili, G, Maltese, Giustina, Sabbatini, R, Artioli, G, Gamucci, T, Di Napoli, M, Capoluongo, Ettore Domenico, Ludovini, V, Raspagliesi, F, Ferrandina, Maria Gabriella, Scambia, Giovanni (ORCID:0000-0003-2758-1063), Capoluongo, Ettore Domenico (ORCID:0000-0001-9872-0572), and Ferrandina, Maria Gabriella (ORCID:0000-0003-4672-4197)

Abstract

BACKGROUND: Current evidence suggest that trabectedin is particularly effective in cells lacking functional homologous recombination repair mechanisms. A prospective phase II trial was designed to evaluate the activity of trabectedin in the treatment of recurrent ovarian cancer patients presenting BRCA mutation and/or BRCAness phenotype. PATIENTS AND METHODS: A total of 100 patients with recurrent BRCA-mutated ovarian cancer and/or BRCAness phenotype (≥2 previous responses to platinum) were treated with trabectedin 1.3 mg/mq i.v. q 3 weeks. The activity of the drug with respect to BRCA mutational status and to a series of polymorphisms [single-nucleotide polymorphisms (SNPs)] involved in DNA gene repair was analyzed. RESULTS: Ninety-four were evaluable for response; in the whole population, 4 complete and 33 partial responses were registered for an overall response rate (ORR) of 39.4. In the platinum-resistant (PR) and -sensitive (PS) population, an ORR of 31.2% and 47.8%, and an overall clinical benefit of 54.2% and 73.9%, respectively, were registered. In the whole series, the median progression-free survival (PFS) was 18 weeks and the median overall survival (OS) was 72 weeks; PS patients showed a more favorable PFS and OS compared with PR patients. BRCA gene mutational status was available in 69 patients. There was no difference in ORR, PFS and OS according to BRCA 1-2 status nor any association between SNPs of genes involved in DNA repair and NER machinery and response to trabectedin was reported. CONCLUSIONS: Our data prospectively confirmed that the signature of 'repeated platinum sensitivity' identifies patients highly responsive to trabectedin. In this setting, the activity of trabectedin seems comparable to what could be obtained using platinum compounds and the drug may represent a valuable alternative option in patients who present contraindication to receive platinum.

Published
2016

47. 927P - Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)

Author

Hoffman-Censits, J., Rosenberg, J.E., van Der Heijden, M., Dreicer, R., Perez Gracia, J.L., Petrylak, D.P., Retz, M.M., Sabbatini, R., Naglieri, E., Caserta, C., Maruzzo, M., Iacovelli, R., Galli, L., McDermott, R., Morales Barrera, R., Bonfill, T., De Ducla, S., Ding, B., Linsenmeier, J., and Sternberg, C.N.

Published
2019
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48. SC167 - Does the number of nodes removed at the pelvic lymphadenectomy impact on cancer specific survival of PCa patients with adverse pathological outcomes at radical prostatectomy? A retrospective 5 - and 10- years analysis on 1274 series

Author

Eissa, A., Sighinolfi, M., Sandri, M., Morini, E., Sabbatini, R., Vitale, M., Bruni, A., Romano, A., Peracchia, G., Grisanti, R., Bonetti, L. Reggiani, Bagni, I., Zoeir, A., Micali, S., Bianchi, G., and Rocco, B.

Published
2019
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49. EFFICACY OF ZOLEDRONIC ACID IN PATIENTS WITH COLORECTAL CANCER METASTATIC TO BONE

Author

Tonini, G, Loupakis, F, Berardi, R, Addeo, L, Ortega, C, Sabbatini, R, Venditti, O, Virzì, V. Santini D., BADALAMENTI, Giuseppe, Tonini, G, Loupakis, F, Berardi, R, Badalamenti, G, Addeo, L, Ortega, C, Sabbatini, R, Venditti, O, and Virzì, V Santini D

Subjects
bone metastasis, metastatic colon cancer, Settore MED/06 - Oncologia Medica
Abstract

Introduction. Bone metastases are an emerging clinical problem in colorectal cancer patients probably related to survival increase. There are no data in literature about the role of BPs in the treatment of bone disease from colorectal cancer. We present the final data of a large Italian multicenter retrospective analysis. Methods. 264 colorectal cancer patients with occurrence of bone metastases have been included in the study. All patients were dead due to cancer at the moment of the study inclusion. Patients characteristics, Skeletal Related Events (SRE) data and median survival after bone metastases appearance have been collected in a master data base and statistically analyzed. The primary efficacy endpoint was time to first SRE; secondary endpoint was median survival. 31 patients have been analysed as control group. Results. In 107 patients bisphosphonates data were not available. A total of 157 patients have been included for zoledronic efficacy analysis. A total of 126 patients received zoledronic acid (4 mg) via a 15-minute infusion every 4 weeks until performance status worsening or death. The median time to first SRE in the whole population was 2 mths (1.04-3.45). The median time to first SRE in the zoledronic treated patients was 3.168 mths (0.49- 2.19) compared with 1.71 mths (0.41-0.90) in the control group (p = 0.009). The median survival after skeletal progression was 7 mths (5.75-8.704). The median survival in the zoledronic treated group was 10 mths (8.08-11.91) compared with 6 mths (4.45- 7.54) (p = 0.161). Conclusions. Complete results of statistical analysis will be presented during the meeting. The present analysis represent the efficacy demonstration of a bisphosphonate in bone metastases from colorectal cancer patients. B13 LENOGRASTIM IN PREVENTING

Published
2010

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