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1. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group

Author

Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., and Vermorken, J. B.

Published
2003

4. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group

Author

Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., Vermorken, J. B., Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., and Vermorken, J. B.

Abstract

Background: Combination chemotherapy yields better response rates which do not always lead to a survival advantage. The aim of this study was to investigate whether the reported differences in the efficacy and toxicity of monotherapy with doxorubicin (DOX) versus combination therapy with cisplatin (CDDP) in endometrial adenocarcinoma lead to significant advantage in favour of the combination. Patients and methods: Eligible patients had histologically-proven advanced and/or recurrent endometrial adenocarcinoma and were chemo-naïve. Treatment consisted of either DOX 60 mg/m2 alone or CDDP 50 mg/m2 added to DOX 60 mg/m2, every 4 weeks. Results: A total of 177 patients were entered and median follow-up is 7.1 years. The combination DOX-CDDP was more toxic than DOX alone. Haematological toxicity consisted mainly of white blood cell toxicity grade 3 and 4 (55% versus 30%). Non-haematological toxicity consisted mainly of grade 3 and 4 alopecia (72% versus 65%) and nausea/vomiting (36 % versus 12%). The combination DOX-CDDP provided a significantly higher response rate than single agent DOX (P <0.001). Thirty-nine patients (43%) responded on DOX-CDDP [13 complete responses (CRs) and 26 partial responses (PRs)], versus 15 patients (17%) on DOX alone (8 CR and 7 PR). The median overall survival (OS) was 9 months in the DOX-CDDP arm versus 7 months in the DOX alone arm (Wilcoxon P = 0.0654). Regression analysis showed that WHO performance status was statistically significant as a prognostic factor for survival, and stratifying for this factor, treatment effect reaches significance (hazard ratio = 1.46, 95% confidence interval 1.05-2.03, P = 0.024). Conclusions: In comparison to single agent DOX, the combination of DOX-CDDP results in higher but acceptable toxicity. The response rate produced is significantly higher, and a modest survival benefit is achieved with this combination regimen, especially in patients with a good performance status

Published
2017

5. ICON2: randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer. ICON Collaborators. International Collaborative Ovarian Neoplasm Study

Author

Parmar, MKB, Torri, V, Bonaventura, A, Bonazzi, C, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, McCormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, McIllmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, Omura, G., COLOMBO, NICOLETTA, Parmar, M, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, Mcillmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, and Omura, G

Subjects
Antineoplastic Combined Chemotherapy Protocol, Ovarian Neoplasm, Alopecia, Leukopenia, Middle Aged, Thrombocytopenia, Carboplatin, Antineoplastic Agent, Doxorubicin, Proportional Hazards Model, Female, Survival Analysi, Cisplatin, Cyclophosphamide, Aged, Human
Abstract

A series of meta-analyses of randomised controlled trials raised the question of whether the three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) was more or less effective than optimal-dose single-agent carboplatin for women with advanced ovarian cancer.

Published
1998

6. Linee guida sul Taglio Cesareo (revisione Linee guida del 1999)

Author

Castellano, A, Dell'Aquila, C, Di Lallo, D, Ferrazzani, Sergio, Proietti, P, Scotto Di Palumbo, V, Spinelli, A, Torcia, F, and Tempesta, F.

Subjects
Settore MED/40 - GINECOLOGIA E OSTETRICIA, distocia, monitoraggio fetale, cesarean section, gravidanza, parto cesareo, pregnancy
Published
2006

7. Linee guida sul Taglio Cesareo (revisione Linee guida del 1999)

Author

Laziosanità - Agenzia di Sanità Pubblica, Castellano, A, Dell'Aquila, C, Di Lallo, D, Ferrazzani, Sergio, Proietti, P, Scotto Di Palumbo, V, Spinelli, A, Torcia, F, Tempesta, F., Ferrazzani, Sergio (ORCID:0000-0001-7382-2951), Laziosanità - Agenzia di Sanità Pubblica, Castellano, A, Dell'Aquila, C, Di Lallo, D, Ferrazzani, Sergio, Proietti, P, Scotto Di Palumbo, V, Spinelli, A, Torcia, F, Tempesta, F., and Ferrazzani, Sergio (ORCID:0000-0001-7382-2951)

Abstract

In molti paesi europei ed extra-europei si osserva un aumento dei parti che vengono assistiti con il taglio cesareo (TC), con frequenze che si collocano intorno al 25-30%. Anche nel Lazio si osserva un andamento simile: in un periodo di vent’anni, dal 1985 al 2005, i TC sono aumentati dal 23% al 42,7% con un incremento pari all’85,7%. Confrontando questi valori con quelli di altre regioni italiane, il Lazio insieme alla Campania, Basilicata, Sicilia, Puglia, Molise e Calabria si colloca ai primi posti, mentre altre regioni come la Lombardia, il Veneto e la Toscana presentano una frequenza di TC notevolmente inferiore (al di sotto del 30%); il Friuli Venezia Giulia ha la frequenza di TC più bassa (22%). Valori così elevati non sembrano giustificati da una maggiore frequenza di quelle condizioni cliniche (ad esempio ritardo di crescita intrauterino o patologie della placenta) che, correttamente, possono rappresentare un’indicazione ad assistere il parto con taglio cesareo. Anche escludendo dalla valutazione del fenomeno i cesarei ripetuti, che nel 2005 rappresentavano nella regione il 27,2% del totale dei cesarei, il tasso osservato di primi cesarei (35,3%) risulta ancora molto più elevato di quello di altri paesi e regioni italiane. C’è inoltre da sottolineare che sia il Piano Sanitario Nazionale del 2006-2008 che quello precedente hanno indicato tra gli obiettivi da raggiungere la riduzione del ricorso al taglio cesareo. E’ quindi opportuno valutare anche il contributo svolto da fattori “non clinici”. Un’analisi delle schede di nascita di tutti i parti effettuati nella regione ha evidenziato che, a parità di condizioni cliniche della donna e del feto, la probabilità di ricorso al TC è più alta del 35% nelle maternità private convenzionate e del 64% in quelle completamente private rispetto a quella osservata nelle maternità pubbliche. L’effetto del punto nascita, che a sua volta è determinato da fattori organizzativi della struttura ed individuali dei sing

Published
2006

8. Doxurubicin versus doxorubicin and cisplatin in endometrial carcinoma: Definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group

Author

Aapro, Matti, van Wijk, F H, Bolis, G, Chevallier, Bernard, van der Burg, Maria, Poveda, Andrés, de Oliveira, Carlos Freire, Tumolo, Salvatore, Scotto di Palumbo, V, Piccart-Gebhart, Martine, Franchi, M, Zanaboni, Flavia, Lacave, Ángel Jiménez, Fontanelli, Rosanna, Favalli, Giuseppe, Zola, Paolo, Guastalla, Jean Paul, Rosso, Riccardo, Marth, C, Nooij, Marianne, Presti, Mauro, Scarabelli, Claudio, Splinter, Ted, Plöchl, Elzbieta, Beex, Louk, ten Bokkel Huinink, Wim, Forni, Mario, Melpignano, Mauro, Blake, Peter, Kerbrat, Pierre, Mendiola, César, Cervantes, Andrés, Goupil, A, Harper, Peter, Madronal, Catherina, Namer, Moïse, Scarfone, G, Stoot, J. E G M, Teodorovic, Ivana, Coens, Corneel, Vergote, Ignace, Vermorken, Jan Baptist, Aapro, Matti, van Wijk, F H, Bolis, G, Chevallier, Bernard, van der Burg, Maria, Poveda, Andrés, de Oliveira, Carlos Freire, Tumolo, Salvatore, Scotto di Palumbo, V, Piccart-Gebhart, Martine, Franchi, M, Zanaboni, Flavia, Lacave, Ángel Jiménez, Fontanelli, Rosanna, Favalli, Giuseppe, Zola, Paolo, Guastalla, Jean Paul, Rosso, Riccardo, Marth, C, Nooij, Marianne, Presti, Mauro, Scarabelli, Claudio, Splinter, Ted, Plöchl, Elzbieta, Beex, Louk, ten Bokkel Huinink, Wim, Forni, Mario, Melpignano, Mauro, Blake, Peter, Kerbrat, Pierre, Mendiola, César, Cervantes, Andrés, Goupil, A, Harper, Peter, Madronal, Catherina, Namer, Moïse, Scarfone, G, Stoot, J. E G M, Teodorovic, Ivana, Coens, Corneel, Vergote, Ignace, and Vermorken, Jan Baptist

Abstract

SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2003

10. Bleomycin, methotrexate, and CCNU in locally advanced or recurrent, inoperable, squamous-cell carcinoma of the vulva: an EORTC Gynaecological Cancer Cooperative Group Study. European Organization for Research and Treatment of Cancer.

Author

Wagenaar, H.C., Colombo, N., Vergote, I., Hoctin-Boes, G., Zanetta, G., Pecorelli, S., Lacave, A.J., Hoesel, Q.G.C.M. van, Cervantes, A., Bolis, G., Namer, M., Lhomme, C., Guastalla, J.P., Nooij, M.A., Poveda, A., Scotto di Palumbo, V., Vermorken, J.B., Wagenaar, H.C., Colombo, N., Vergote, I., Hoctin-Boes, G., Zanetta, G., Pecorelli, S., Lacave, A.J., Hoesel, Q.G.C.M. van, Cervantes, A., Bolis, G., Namer, M., Lhomme, C., Guastalla, J.P., Nooij, M.A., Poveda, A., Scotto di Palumbo, V., and Vermorken, J.B.

Abstract

Item does not contain fulltext, OBJECTIVE: To investigate tumor response rate and treatment toxicity of a modified combination chemotherapy consisting of bleomycin (B), methotrexate (M), and CCNU (C) for patients with locally advanced, squamous-cell carcinoma of the vulva (not amenable to resection by standard radical vulvectomy) or recurrent disease (after incomplete resection). Tumor resectability was reassessed in patients who had responded to chemotherapy. METHODS: The regimen consisted of bleomycin 5 mg intramuscular (im) days 1-5, CCNU 40 mg per os (po) days 5-7, and methotrexate 15 mg po days 1 and 4 during the first week. During weeks 2-6 the patient was administered bleomycin 5 mg im days 1 and 4, and methotrexate 15 mg po on day 1 of the week. This 6-week cycle was repeated at 49-day intervals. RESULTS: Twenty-five eligible patients with a median age of 66 years (range, 39-82 years) were entered in this phase II trial. Twelve patients had primary locally advanced disease, 13 patients had a locoregional recurrence, and all received up to three BMC cycles. Two complete and twelve partial responses were observed (response rate, 56%; 95% confidence limits, 35-76%). The BMC regimen was associated with major hematological side effects and mild signs of bleomycin-related pulmonary toxicity. At a median follow-up of 8 months, 3 patients were alive, 18 had died due to malignant disease, 2 had died due to toxicity, and 2 had died due to intercurrent disease and unknown cause. The median progression-free survival was 4.8 months and the median survival was 7.8 months. The 1-year survival was 32% (95% confidence limits, 13-51%). CONCLUSION: The present data confirm the therapeutic activity of the BMC regimen in locoregionally advanced or recurrent squamous-cell carcinoma of the vulva. Following neoadjuvant chemotherapy, the overall response rate was 56%. BMC is an outpatient treatment that may play a role in the palliative therapy of advanced or recurrent vulva cancer.

Published
2001

11. Bleomycin, methotrexate, and CCNU in locally advanced or recurrent, inoperable, squamous-cell carcinoma of the vulva: An EORTC gynaecological cancer cooperative group study

Author

Wagenaar, H, Colombo, N, Vergote, I, Hoctin Boes, G, Zanetta, G, Pecorelli, S, Lacave, A, van Hoesel, Q, Cervantes, A, Bolis, G, Namer, M, Lhommé, C, Guastalla, J, Nooij, M, Poveda, A, Scotto di Palumbo, V, Vermorken, J, Wagenaar, HC, Lacave, AJ, Guastalla, JP, Nooij, MA, Vermorken, JB, COLOMBO, NICOLETTA, Wagenaar, H, Colombo, N, Vergote, I, Hoctin Boes, G, Zanetta, G, Pecorelli, S, Lacave, A, van Hoesel, Q, Cervantes, A, Bolis, G, Namer, M, Lhommé, C, Guastalla, J, Nooij, M, Poveda, A, Scotto di Palumbo, V, Vermorken, J, Wagenaar, HC, Lacave, AJ, Guastalla, JP, Nooij, MA, Vermorken, JB, and COLOMBO, NICOLETTA

Abstract

To investigate tumor response rate and treatment toxicity of a modified combination chemotherapy consisting of bleomycin (B), methotrexate (M), and CCNU (C) for patients with locally advanced, squamous-cell carcinoma of the vulva (not amenable to resection by standard radical vulvectomy) or recurrent disease (after incomplete resection). Tumor resectability was reassessed in patients who had responded to chemotherapy.

Published
2001

12. ICON2: Randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer

Author

Parmar, M, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, Mcillmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, Omura, G, Parmar, MKB, McCormack, T, McIllmurray, M, Omura, G., COLOMBO, NICOLETTA, Parmar, M, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, Mcillmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, Omura, G, Parmar, MKB, McCormack, T, McIllmurray, M, Omura, G., and COLOMBO, NICOLETTA

Abstract

A series of meta-analyses of randomised controlled trials raised the question of whether the three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) was more or less effective than optimal-dose single-agent carboplatin for women with advanced ovarian cancer.

Published
1998

13. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group

Author

Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., Vermorken, J. B., Aapro, M. S., van Wijk, F. H., Bolis, G., Chevallier, B., van der Burg, M. E. L., Poveda, A., de Oliveira, C. F., Tumolo, S., Scotto di Palumbo, V., Piccart, M., Franchi, M., Zanaboni, F., Lacave, A. J., Fontanelli, R., Favalli, G., Zola, P., Guastalla, J. P., Rosso, R., Marth, C., Nooij, M., Presti, M., Scarabelli, C., Splinter, T. A. W., Ploch, E., Beex, L. V. A., ten Bokkel Huinink, W., Forni, M., Melpignano, M., Blake, P., Kerbrat, P., Mendiola, C., Cervantes, A., Goupil, A., Harper, P. G., Madronal, C., Namer, M., Scarfone, G., Stoot, J. E. G. M., Teodorovic, I., Coens, C., Vergote, I., and Vermorken, J. B.

Abstract

Background: Combination chemotherapy yields better response rates which do not always lead to a survival advantage. The aim of this study was to investigate whether the reported differences in the efficacy and toxicity of monotherapy with doxorubicin (DOX) versus combination therapy with cisplatin (CDDP) in endometrial adenocarcinoma lead to significant advantage in favour of the combination. Patients and methods: Eligible patients had histologically-proven advanced and/or recurrent endometrial adenocarcinoma and were chemo-naïve. Treatment consisted of either DOX 60 mg/m2 alone or CDDP 50 mg/m2 added to DOX 60 mg/m2, every 4 weeks. Results: A total of 177 patients were entered and median follow-up is 7.1 years. The combination DOX-CDDP was more toxic than DOX alone. Haematological toxicity consisted mainly of white blood cell toxicity grade 3 and 4 (55% versus 30%). Non-haematological toxicity consisted mainly of grade 3 and 4 alopecia (72% versus 65%) and nausea/vomiting (36 % versus 12%). The combination DOX-CDDP provided a significantly higher response rate than single agent DOX (P <0.001). Thirty-nine patients (43%) responded on DOX-CDDP [13 complete responses (CRs) and 26 partial responses (PRs)], versus 15 patients (17%) on DOX alone (8 CR and 7 PR). The median overall survival (OS) was 9 months in the DOX-CDDP arm versus 7 months in the DOX alone arm (Wilcoxon P = 0.0654). Regression analysis showed that WHO performance status was statistically significant as a prognostic factor for survival, and stratifying for this factor, treatment effect reaches significance (hazard ratio = 1.46, 95% confidence interval 1.05-2.03, P = 0.024). Conclusions: In comparison to single agent DOX, the combination of DOX-CDDP results in higher but acceptable toxicity. The response rate produced is significantly higher, and a modest survival benefit is achieved with this combination regimen, especially in patients with a good performance status

14. ICON2: randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer

Author

Parmar MKB, Torri V, Bonaventura A, Bonazzi C, Colombo N, Delaloye JF, Marsoni S, Mangioni C, Sandercock J, Sessa C, Williams C, Tinazzi A, Flann M, Geiser K, Scorpiglione N, Stewart JF, Chaves J, Palmeiro E, Curtain A, McCormack T, Gennatas C, Marras F, Oppo TG, Balestrino M, Malzoni C, Malzoni M, Belli M, Geminiani ML, Crestani G, Monaco A, Vavala V, Piatto E, Barattini G, Fornara PG, Chetri MC, Santeufemia G, Artioli F, Carone D, Fanizza G, Trentadue R, Priolo D, Scollo P, Nigro SC, Petrina M, Mastrantonio P, Spanna GD, Zagni R, Belloni C, Colleoni R, Redaelli L, Cavagnini A, Di Costanzo G, Perroni D, Arienti S, Orfanotti G, Cantoni FM, Secli R, Bianchi A, Martinello R, Mollica G, Maizzi D, Picchiarelli ME, Fiorini G, Borsani M, Colombo E, Garsia S, Melgrati L, Paggi G, Brunenghi GM, Casini M, Isa L, Algeri R, Prozio G, Belfiore G, Angelini F, D'Aprile M, Moreschi M, Mauri ML, Natale N, Senzani FM, Pavanato G, Poggi G, Garuti G, Luerti M, Cruciani G, Pagano F, Baccolo M, Poddi ER, Bocciolone L, Sabelli MA, Maggi R, Restelli C, D'Antona A, Locatelli MC, Pessi A, Raina A, Chiari S, Gabriele A, Pittelli MR, Iacobelli P, Dogliotti L, Gorzegno G, Musso P, Vegna G, Coco G, Alletti DG, Picciotto F, Lucchese V, Epis A, di Palumbo VS, Drudi G, Ravaioli A, Zampella D, Morandi MG, Gorga G, Zucchelli C, Cariello S, Galletto L, Sussio M, Massacesi L, Massacesi M, Carli A, Tucci E, Tajani E, Corrado G, Bumma S, Durando A, Massobrio M, Sberveglieri M, Biasio M, Guercio E, Jura R, Danese S, Wierdis T, Farnelli C, Tarantino G, Grassi R, Repetti F, Rocchi B, Grampa M, Ercoli A, Griso C, Signori E, Zanini L, Presti M, Klimek M, Urbanski K, Biswas A, Viegas O, Kochli O, Dreher E, Fey M, Beck G, Ludin J, Bonnefoi H, Krauer F, Bauer J, Delmore G, Furrer C, Lorenz U, Thurlimann B, Bronz L, Sanna P, Wyss D, Goldhirsch A, Gyr T, Leidi L, Pastorelli G, Pagani O, Rey P, Hailer U, Benz J, Kaye SB, Reed NS, Symonds RP, Atkinson RJ, Axford AT, Rustin G, Seckl MJ, Green JA, Scott IV, Guthrie D, Harper PG, Calman F, Dobbs HJ, Weir P, Cassoni A, Lederman JA, Souhami RL, Bozzino J, Adab F, Redman CWE, Scoble JE, Paterson M, Daniel F, Cowley N, Williams CJ, Spooner D, Hong A, McIllmurray M, Hendy-Ibbs P, Hall V, Iveson TJ, Whitehouse JMA, Garry R, Lamont A, Robinson A, Trask CW, Clubb AW, Murrell D, Newman G, Wilkins M, Goldthorp WO, Roberts JK, Radstone DJ, Whipp MJ, Ledermann JA, Pater J, Buyse M, Omura G, Parmar, Mkb, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, Jf, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, Jf, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, Tg, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, Ml, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, Pg, Chetri, Mc, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, Sc, Petrina, M, Mastrantonio, P, Spanna, Gd, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, Fm, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, Me, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, Gm, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, Ml, Natale, N, Senzani, Fm, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, Er, Bocciolone, L, Sabelli, Ma, Maggi, R, Restelli, C, D'Antona, A, Locatelli, Mc, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, Mr, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, Dg, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, Mg, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, Sb, Reed, N, Symonds, Rp, Atkinson, Rj, Axford, At, Rustin, G, Seckl, Mj, Green, Ja, Scott, Iv, Guthrie, D, Harper, Pg, Calman, F, Dobbs, Hj, Weir, P, Cassoni, A, Lederman, Ja, Souhami, Rl, Bozzino, J, Adab, F, Redman, Cwe, Scoble, Je, Paterson, M, Daniel, F, Cowley, N, Williams, Cj, Spooner, D, Hong, A, Mcillmurray, M, Hendy-Ibbs, P, Hall, V, Iveson, Tj, Whitehouse, Jma, Garry, R, Lamont, A, Robinson, A, Trask, Cw, Clubb, Aw, Murrell, D, Newman, G, Wilkins, M, Goldthorp, Wo, Roberts, Jk, Radstone, Dj, Whipp, Mj, Ledermann, Ja, Pater, J, Buyse, M, and Omura, G

Published
1998

16. [Extremely prolonged premature rupture of membranes].

Author

Amici B, Rosica G, Bucari D, and Scotto di Palumbo V

Subjects
Adult, Breech Presentation, Cesarean Section, Female, Humans, Pregnancy, Time Factors, Fetal Membranes, Premature Rupture
Abstract

The amniochorial membrane is composed of two layers deriving from amnios and chorion and they are sealed at the 12th week of pregnancy; they have to contain the amniotic fluid. Very prolonged premature rupture of the membranes (VPPROM) is considered if it occurs more than five days before delivery. The case of a patient 29 years old, (GRAV 2 PARA 1) with rupture of membranes at the 17th week of pregnancy is presented. Obstetric management and the treatment of amnios and vaginal infections is reported. Amnioinfusions were repeatedly performed. The delivery occurred by cesarean section at 34th week for breech presentation. No somatic or neurologic defects were evident at the birth.

Published
1997

17. A randomized study comparing retroperitoneal drainage with no drainage after lymphadenectomy in gynecologic malignancies.

Author

Benedetti-Panici P, Maneschi F, Cutillo G, D'Andrea G, di Palumbo VS, Conte M, Scambia G, and Mancuso S

Subjects
Adolescent, Adult, Aged, Female, Humans, Middle Aged, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Retroperitoneal Space, Drainage methods, Lymph Node Excision adverse effects, Ovarian Neoplasms surgery, Postoperative Care, Uterine Neoplasms surgery
Abstract

Objective: To evaluate the clinical effectiveness of retroperitoneal drainage following lymphadenectomy in gynecologic surgery., Methods: One hundred thirty-seven consecutive patients undergoing systematic lymphadenectomy for gynecologic malignancies were randomized to receive (Group A, 68) or not (Group B, 69) retroperitoneal drainage. The pelvic peritoneum and the paracolic gutters were not sutured after node dissection. Perioperative data and complications were recorded., Results: Clinical and surgical parameters were comparable in the two groups. Postoperative hospital stay was significantly shorter in Group B (P < 0.001), whereas the complication rate was significantly higher in Group A (P = 0.01). This was mainly due to a significant increase in lymphocyst and lymphocyst-related morbidity. Sonographic monitoring for lymphocyst showed free abdominal fluid in 18% of drained and 36% of not-drained patients (P = 0.03). Symptomatic ascites developed in 2 drained (3%) and 3 not-drained (4%) patients (NS), respectively., Conclusions: Prophylactic drainage of the retroperitoneum seems to increase lymphadenectomy-related morbidity and postoperative stay. Therefore, routine drainage following lymphadenectomy seems to be no longer indicated when the retroperitoneum is left open.

Published
1997
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