Medline ® Abstract for Reference 1
of 'Medical treatment for relapsed epithelial ovarian, fallopian tubal, or peritoneal cancer: Platinum-sensitive disease'
Randomized Controlled Trial Testing the Efficacy of Platinum-Free Interval Prolongation in Advanced Ovarian Cancer: The MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG Study.
Pignata S, Scambia G, Bologna A, Signoriello S, Vergote IB, Wagner U, Lorusso D, Murgia V, Sorio R, Ferrandina G, Sacco C, Cormio G, Breda E, Cinieri S, Natale D, Mangili G, Pisano C, Cecere SC, Di Napoli M, Salutari V, Raspagliesi F, Arenare L, Bergamini A, Bryce J, Daniele G, Piccirillo MC, Gallo C, Perrone F
J Clin Oncol. 2017;35(29):3347. Epub 2017 Aug 21.
Purpose Platinum-based chemotherapy (PBC) for patients with progressing ovarian cancer (OC) is more effective with a longer time intervalfrom previous platinum treatment (platinum-free interval [PFI]). In 1999, it was hypothesized that prolonging PFI with single-agent non-PBC (NPBC) may offer a strategy to improve overall outcome. MITO-8 aimed to verify this hypothesis commonly used in clinical practice although it has not been prospectively tested. Methods MITO-8 is an open-label, prospective, randomized, superiority trial. Patients with OC who experienced disease progression 6 to 12 months after their last platinum treatment were randomly assigned 1:1 to the experimental sequence of NPBC followed by PBC at subsequent relapse or the standard reverse treatment sequence. Overall survival (OS) was the primary end point. Results Two hundred fifteen patients were enrolled (standard arm [n = 108]; experimental arm [n = 107]). The trial ended before planned because of slow enrollment. PFI was prolonged in the experimental arm (median, 7.8 v 0.01 months). There was no OS benefit in the experimental arm (median, 21.8 v 24.5 months; hazard ratio, 1.38; 95% CI, 0.99 to 1.94; P = .06). Progression-free survival after the sequence was significantly shorter in the experimental arm (median, 12.8 v 16.4 months; hazard ratio, 1.41; 95% CI, 1.04 to 1.92; P = .025). Global quality-of-life change after three cycles was worse in the experimental arm. Slight differences were observed in the incidence of adverse effects. Conclusion MITO-8 supports the recommendation that PBC not be delayed in favor of an NPBC in patients with partially platinum-sensitive OC. PBC should be used as a control arm in future trials of new drugs in this setting.
Sandro Pignata, Carmela Pisano, Sabrina Chiara Cecere, Marilena Di Napoli, Laura Arenare, Alice Bergamini, Jane Bryce, Gennaro Daniele, Maria Carmela Piccirillo, and Francesco Perrone, Istituto Nazionale per lo Studio e la Cura dei Tumori-Fondazione G. Pascale, IRCCS; Simona Signoriello and Ciro Gallo, Universitàdegli Studi della Campania Luigi Vanvitelli, Naples; Giovanni Scambia, Domenica Lorusso, Gabriella Ferrandina, and Vanda Salutari, UniversitàCattolica del Sacro Cuore; Enrico Breda, Ospedale San Giovanni Calibita Fatebenefratelli, Rome; Alessandra Bologna, Azienda Ospedaliea Santa Maria Nuova, IRCCS, Reggio Emilia; Domenica Lorusso and Francesco Raspagliesi, Fondazione IRCCS Istituto Nazionale dei Tumori; Giorgia Mangili and Alice Bergamini, Ospedale San Raffaele, Milan; Viviana Murgia, Ospedale Santa Chiara, Trento; Roberto Sorio, Centro di Riferimento Oncologico, Aviano; Gabriella Ferrandina, Centro di Ricerca e Formazione Ad Alta Tecnologia nelle Scienze Biomediche, Univer