Feasibility and outcome of interval debulking surgery (IDS) after carboplatin-paclitaxel-bevacizumab (CPB): A subgroup analysis of the MITO-16A-MaNGO OV2A phase 4 trial

被引:32
作者
Daniele, Gennaro [1 ]
Lorusso, Domenica [2 ]
Scambia, Giovanni [3 ]
Cecere, Sabrina C. [4 ]
Nicoletto, Maria Ornella [5 ]
Breda, Enrico [6 ]
Colombo, Nicoletta [7 ]
Artioli, Grazia [8 ]
Cannella, Lucia [9 ]
Lo Re, Giovanni [10 ]
Raspagliesi, Francesco [2 ]
Maltese, Giuseppa [2 ]
Salutari, Vanda
Ferrandina, Gabriella [3 ]
Greggi, Stefano [4 ]
Baldoni, Alessandra [5 ]
Bergamini, Alice [11 ]
Piccirillo, Maria Carmela [1 ]
Tognon, Germana [12 ]
Floriani, Irene [13 ]
Signoriello, Simona [14 ]
Perrone, Francesco [1 ]
Pignata, Sandro [4 ]
机构
[1] Ist Nazl Studio & Cura Tumori, Fdn Giovanni Pascale IRCCS, Clin Trials Unit, Naples, Italy
[2] IRCCS Natl Canc Inst, Dept Gynecol Oncol, Milan, Italy
[3] Univ Cattolica Sacro Cuore, Dept Obstet & Gynaecol, Div Gynaecol Oncol, Rome, Italy
[4] Ist Nazl Tumori Fdn G Pascale IRCCS, Dept Urogynaecol Oncol, Div Med Oncol, Naples, Italy
[5] Ist Oncol Veneto IOV IRCCS, Med Oncol Unit, Padua, Italy
[6] San Giovanni Calibita Fatebenefratelli Hosp, Dept Med Oncol, Rome, Italy
[7] European Inst Oncol IEO, Dept Gynecol, Milan, Italy
[8] AO ULSS, Dept Oncol, Mirano 13, Italy
[9] G Rummo Hosp, Dept Med Oncol, Benevento, Italy
[10] Santa Maria Angeli Hosp, Dept Med Oncol, Pordenone, Italy
[11] IRCCS San Raffaele Sci Inst, Obstet & Gynecol Unit, Milan, Italy
[12] Azienda Osped Spedali Civili, Obstet & Gynaecol, Brescia, Italy
[13] IRCCS Ist Ric Farmacol Mario Negri, Dipartimento Oncol, Milan, Italy
[14] Univ Naples 2, Med Stat, Naples, Italy
关键词
Ovarian cancer; Bevacizumab; Neoadjuvant; Interval debulking; Surgery; RECURRENT EPITHELIAL OVARIAN; NEOADJUVANT CHEMOTHERAPY; CANCER;
D O I
10.1016/j.ygyno.2016.12.011
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background. Few data are available on the outcome of surgery after a bevacizumab-containing regimen. The MITO 16A- MaNGO OV2A phase 4 trial evaluates the outcomes of first-line CPB in a clinical-practice-like setting. Here we present the results of the subgroup of patients undergoing IDS after neoadjuvant treatment or suboptimal primary surgery. Methods. 400 chemonaive epithelial ovarian cancer patients, age >= 18, ECOG PS 0-2 were eligible to receive C(AUC 5 d1, q21) plus P (175 mg/m(2) d1, q21) and B (15 mg/kg d1 q21) for 6 cycles followed by B maintenance until cycle 22nd. Results. 79 patients (20%) underwent IDS. Overall, 74 patients received at least one administration of B before IDS. Median age was 61.2, 70% of the patients had FIGO IIIC disease. The median number of cycles before IDS was 3 both for chemotherapy and bevacizumab respectively. A residual disease <= 1 cm was achieved in 64 patients (86.5%). Four percent of the patients experienced fever and 4% required blood transfusion after surgery. Surgical wound infection and/or dehiscence, pelvic abscess, intestinal sub-occlusion and fistula were experienced by one patient each. Conclusions. In the MIT016A-MaNGO OV2A phase 4 trial, combined chemotherapy and bevacizumab did not hamper IDS and the rate of perioperative complications was similar to what expected without bevacizumab. These data support the hypothesis that adding bevacizumab to first line chemotherapy for ovarian cancer might not be denied to patients for whom IDS is planned. (C) 2016 Elsevier Inc. All rights reserved.
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收藏
页码:256 / 259
页数:4
相关论文
共 17 条
[1]   OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer [J].
Aghajanian, Carol ;
Blank, Stephanie V. ;
Goff, Barbara A. ;
Judson, Patricia L. ;
Teneriello, Michael G. ;
Husain, Amreen ;
Sovak, Mika A. ;
Yi, Jing ;
Nycum, Lawrence R. .
JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (17) :2039-2045
[2]   Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer [J].
Burger, Robert A. ;
Brady, Mark F. ;
Bookman, Michael A. ;
Fleming, Gini F. ;
Monk, Bradley J. ;
Huang, Helen ;
Mannel, Robert S. ;
Homesley, Howard D. ;
Fowler, Jeffrey ;
Greer, Benjamin E. ;
Boente, Matthew ;
Birrer, Michael J. ;
Liang, Sharon X. .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (26) :2473-2483
[3]   Morbidity of Surgery After Neoadjuvant Chemotherapy Including Bevacizumab for Advanced Ovarian Cancer [J].
Chereau, Elisabeth ;
Lambaudie, Eric ;
Houvenaeghel, Gilles .
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 2013, 23 (07) :1326-1330
[4]  
Coleman R., 2016, J CLIN ONCOL
[5]   New biological treatments for gynecological tumors: focus on angiogenesis [J].
Daniele, Gennaro ;
Di Maio, Massimo ;
Piccirillo, Maria Carmela ;
Giordano, Pasqualina ;
Capuano, Ida ;
Cecere, Sabrina Chiara ;
Bryce, Jane Claire ;
Pignata, Sandro ;
Perrone, Francesco .
EXPERT OPINION ON BIOLOGICAL THERAPY, 2014, 14 (03) :337-346
[6]  
Ferlay J., 2013, GLOBOCAN 2012 CANC I
[7]  
Hurwitz H, 2006, SEMIN ONCOL, V33, pS26, DOI 10.1053/j.seminoncol.2006.08.001
[8]   Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): an open-label, randomised, controlled, non-inferiority trial [J].
Kehoe, Sean ;
Hook, Jane ;
Nankivell, Matthew ;
Jayson, Gordon C. ;
Kitchener, Henry ;
Lopes, Tito ;
Luesley, David ;
Perren, Timothy ;
Bannoo, Selina ;
Mascarenhas, Monica ;
Dobbs, Stephen ;
Essapen, Sharadah ;
Twigg, Jeremy ;
Herod, Jonathan ;
McCluggage, Glenn ;
Parmar, Mahesh ;
Swart, Ann-Marie .
LANCET, 2015, 386 (9990) :249-257
[9]   Can advanced-stage ovarian cancer be cured? [J].
Narod, Steven .
NATURE REVIEWS CLINICAL ONCOLOGY, 2016, 13 (04) :255-261
[10]   A Phase 3 Trial of Bevacizumab in Ovarian Cancer [J].
Perren, Timothy J. ;
Swart, Ann Marie ;
Pfisterer, Jacobus ;
Ledermann, Jonathan A. ;
Pujade-Lauraine, Eric ;
Kristensen, Gunnar ;
Carey, Mark S. ;
Beale, Philip ;
Cervantes, Andres ;
Kurzeder, Christian ;
du Bois, Andreas ;
Sehouli, Jalid ;
Kimmig, Rainer ;
Staehle, Anne ;
Collinson, Fiona ;
Essapen, Sharadah ;
Gourley, Charlie ;
Lortholary, Alain ;
Selle, Frederic ;
Mirza, Mansoor R. ;
Leminen, Arto ;
Plante, Marie ;
Stark, Dan ;
Qian, Wendi ;
Parmar, Mahesh K. B. ;
Oza, Amit M. .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (26) :2484-2496