Phase II randomized trial of neoadjuvant (NA) chemotherapy (CT) with or without bevacizumab (Bev) in advanced epithelial ovarian cancer (EOC) (GEICO 1205/NOVA TRIAL).
2015; Lippincott Williams & Wilkins; Volume: 33; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2015.33.15_suppl.5531
ISSN1527-7755
AutoresYolanda García García, Ana De Juan, César Mendiola, Pilar Barretina-Ginesta, Laura Vidal, Ana Santaballa, Isabel Bover, Marta Gil-Martín, Aránzazu Manzano, María Jesús Rubio, Margarita Romeo, Alfonso Gómez De Liaño Lista, Elena García-Martínez, Antonio González‐Martín,
Tópico(s)Renal cell carcinoma treatment
Resumo5531 Background: First-line carboplatin(C)-paclitaxel(P) and Bev has proved to be an active combination after primary debulking surgery and improved overall survival in suboptimal resected advanced EOC patients (pts). However, the role of Bev in the NA setting has not been well defined yet. Methods: We performed a phase II randomized open label multicentric study in 66 pts with high grade serous or endometroid EOC, FIGO stage III-IV, ECOG 0-2, considered unresectable in whom NA CT and interval debulking surgery (IDS) were planned. Main exclusion criteria were intestinal occlusion and contraindication for Bev therapy. Pts were randomized to four courses of triweekly C AUC 6 and P 175 mg/m2 iv alone or with at least 3 courses of bev 15 mg/kg i.v. every 3 w. in experimental arm. The primary endpoint was the complete macroscopic response rate at the time of IDS. Secondary objectives were safety, surgical feasibility, optimal surgery rate, RECIST 1.1 and GCIG response rate. Biomarker analysis were performed in pre and post biopsies. All pts received 3 additional courses of CT and Bev after IDS followed by maintenance Bev up to complete 15 month. Results: We report the preliminary data of 64 pts. Clinical pts characteristics were well balanced with median age 59.9 y.o and a 34.4% stage IV. No differences in the primary endpoint were found (1/32 Control Arm and 0/32 Bev Arm) but there was a higher rate of surgical feasibility in the Bev Arm (64 vs 88%). Optimal surgery rate also favored the Bev arm (77.7 vs 86.4%) and there wasn't any patient deemed unresectable at the time of surgery in the Bev arm (2 vs 0). None of these figures were statistically significant difference. There were lower rates of serious adverse events (grade 3-4) in bev arm (40.6 vs 18.8%, p = 0.055). Three Bev related adverse events of special interest were observed in 3 pts (1 G3 entero-vaginal fistulae, 1 surgical dehiscence, 1 deep venous thrombosis). Conclusions: Our preliminary data have shown that NA bev seems feasible and could improve the surgical outcomes in advanced EOC considered initially unresectable. Updated clinical and translational data will be provided. Clinical trial information: NCT01847677.
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