Abstract
Background
The purpose of this multistage, adaptively, designed randomized phase II study was to evaluate the role of intraperitoneal (IP) chemotherapy following neoadjuvant chemotherapy (NACT) and optimal debulking surgery in women with epithelial ovarian cancer (EOC). Patients and Methods
We performed a multicentre, 2 stage, phase II trial. Eligible patients with stage IIB-IVA EOC treated with platinum-based intravenous (IV) NACT followed by optimal (<1cm) debulking surgery were randomized to one of 3 treatment arms: 1) IV carboplatin/paclitaxel; 2) IP cisplatin plus IV/IP paclitaxel, or 3) IP carboplatin plus IV/IP paclitaxel. The primary endpoint was 9 month progressive disease rate (PD9). Secondary endpoints included progression free survival (PFS), overall survival (OS), toxicity and quality of life (QOL). Results
Between 2009 and 2015, 275 patients were randomized. IP 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 IV carboplatin/paclitaxel (n = 101) to IP carboplatin, IV/IP paclitaxel (n = 102). The intention to treat PD9 was lower in the IP carboplatin arm compared to the IV carboplatin arm: 24.5% (95% CI 16.2%-32.9%) vs. 38.6% (95% CI 29.1%- 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) p = 0.40. The IP carboplatin based regimen was well tolerated with no reduction in QOL or increase in toxicity compared to IV administration alone. Conclusion
In women with stage IIIC or IVA EOC treated with NACT and optimal debulking surgery, IP carboplatin based chemotherapy is well tolerated and associated with an improved PD9 compared to IV carboplatin based chemotherapy.clinicaltrials.gov, NCT01622543http://ift.tt/2hYkT1t
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