Gennaro Daniele1, Domenica Lorusso2, Giovanni Scambia3, Sabrina C Cecere4, Maria Ornella Nicoletto5, Enrico Breda6, Nicoletta Colombo7, Grazia Artioli8, Lucia Cannella9, Giovanni Lo Re10, Francesco Raspagliesi2, Giuseppa Maltese2, Vanda Salutari3, Gabriella Ferrandina3, Stefano Greggi4, Alessandra Baldoni5, Alice Bergamini11, Maria Carmela Piccirillo1, Germana Tognon12, Irene Floriani13, Simona Signoriello14, Francesco Perrone1, Sandro Pignata15. 1. Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- IRCCS, Naples, Italy. 2. Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. 3. Division of Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Catholic University of the Sacred Heart, Rome, Italy. 4. Division of Medical Oncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS, Naples, Italy. 5. Medical Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy. 6. Medical Oncology Department, San Giovanni Calibita-Fatebenefratelli Hospital, Isola Tiberina, Rome, Italy. 7. Gynecology Department, European Institute of Oncology (IEO), Milan, Italy. 8. Department of Oncology, AO U.L.S.S., 13, Mirano, Italy. 9. Department of Medical Oncology, G Rummo Hospital, Benevento, Italy. 10. Medical Oncology Department, Santa Maria degli Angeli Hospital, Pordenone, Italy. 11. Obstetrics and Gynecology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. 12. Obstetric and Gynaecology Azienda Ospedaliera "Spedali Civili", Brescia, Italy. 13. Dipartimento di Oncologia, IRCCS Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy. 14. Medical Statistics, Second University of Naples, Naples, Italy. 15. Division of Medical Oncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori "Fondazione G. Pascale" - IRCCS, Naples, Italy. Electronic address: s.pignata@istitutotumori.na.it.
Abstract
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 chemonaïve epithelial ovarian cancer patients, age≥18, ECOG PS 0-2 were eligible to receive C (AUC 5 d1, q21) plus P (175mg/m2 d1, q21) and B (15mg/kg d1 q21) for 6cycles 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 ≤1cm 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 MITO16A-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.
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 chemonaïve epithelial ovarian cancerpatients, age≥18, ECOG PS 0-2 were eligible to receive C (AUC 5 d1, q21) plus P (175mg/m2 d1, q21) and B (15mg/kg d1 q21) for 6cycles 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 ≤1cm 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 MITO16A-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.
Authors: Sarah L Coleridge; Andrew Bryant; Thomas J Lyons; Richard J Goodall; Sean Kehoe; Jo Morrison Journal: Cochrane Database Syst Rev Date: 2019-10-31
Authors: Luigi Carlo Turco; Gabriella Ferrandina; Virginia Vargiu; Serena Cappuccio; Anna Fagotti; Giuseppina Sallustio; Giovanni Scambia; Francesco Cosentino Journal: Ann Transl Med Date: 2020-12
Authors: Junsik Park; Kyung Jin Eoh; Eun Ji Nam; Sunghoon Kim; Sang Wun Kim; Young Tae Kim; Jung Yun Lee Journal: Yonsei Med J Date: 2020-04 Impact factor: 2.759