Detalle Publicación

OV21/PETROC: a randomized Gynecologic Cancer Intergroup phase II study of intraperitoneal versus intravenous chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer

Autores: Provencher, DM.; Gallagher, CJ.; Parulekar, WR.; Ledermann, JA.; Armstrong, DK.; Brundage, M.; Gourley, C.; Romero, I.; González Martín, Antonio; Bessette, P.; Hall, M.; Weberpals, JI.; Hall, G.; Lau, SK.; MacKay, HJ.; Feeney, M.; Gauthier, P.; Fung-Kee-Fung, M.; Eisenhauer, EA.; Winch, C.; Tu, D.; MacKay ,HJ.
Título de la revista: ANNALS OF ONCOLOGY
ISSN: 0923-7534
Volumen: 29
Número: 2
Páginas: 431-438
Fecha de publicación: 2018
BACKGROUND: The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (i.p.) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC). PATIENTS AND METHODS: We carried out a multicenter, two-stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (i.v.) NACT followed by optimal (<1¿cm) debulking surgery were randomized to one of the three treatment arms: (i) i.v. carboplatin/paclitaxel, (ii) i.p. cisplatin plus i.v./i.p. paclitaxel, or (iii) i.p. carboplatin plus i.v./i.p. paclitaxel. The primary end point was 9-month progressive disease rate (PD9). Secondary end points included progression-free survival (PFS), overall survival (OS), toxicity, and quality of life (QOL). RESULTS: Between 2009 and 2015, 275 patients were randomized; i.p. cisplatin containing arm did not progress beyond the first stage of the study after failing to meet the pre-set superiority rule. The final analysis compared i.v. carboplatin/paclitaxel (n¿=¿101) with i.p. carboplatin, i.v./i.p. paclitaxel (n¿=¿102). The intention to treat PD9 was lower in the i.p. carboplatin arm compared with the i.v. carboplatin arm: 24.5% (95% CI 16.2% to 32.9%) versus 38.6% (95% CI 29.1% to 48.1%) P¿=¿0.065. The study was underpowered to detect differences in PFS: HR PFS 0.82 (95% CI 0.57-1.17); P¿=¿0.27 and OS HR 0.80 (95% CI 0.47-1.35)