Safety and effectiveness of bevacizumab plus chemotherapy in patients with advanced cervical cancer in real world practice in Argentina.

Abstract

e17500 Background: In Argentina, 5000 women are diagnosed every year with cervical cancer and half of them die from the disease. Cisplatin-Paclitaxel + Bevacizumab (TP-B) had improved the survival of these patients (GOG 240). We aimed to evaluate Carboplatin-Paclitaxel + Bevacizumab (TC-B) that is the standard of care in our country. Methods: This retrospective cohort included 84 patients with metastatic, recurrent or persistent CC treated with TC-B (86%) or TP-B (14%) during 2015 in Argentina (Avastin was used in all patients). Main objective: evaluate the effectiveness and safety (incidence of grade 3 or more treatment related adverse events) in the total population and in both treatment subgroups (TC-B and TP-B). Results: Patients had predominant recurrent (48%) or persistent (36%) disease over metastatic (17%), with high proportion of pelvic involvement (69%) and prior platinum radiosensitizer (82%). According Moore Criteria, patients were categorized as Low (12%), Mid (58%) and High Risk (30%). Median follow up was 14 months (1,4 – 32,3). ORR, mPFS and mOS were, considering Moore criteria: Low: 70%; 15,4; NR, Mid: 59%; 10,2; 25,4 and High Risk: 20,5; 4,8; 19, 2 months. High risk Moore score was associated with an increased hazard rate of progression or death of 2.16 (95% CI: 1.22-3.81; p = 0,007). Most frequent grade 3 or more adverse events were fistulas 15% (CI 9-25%); Thromboembolic events 7% (CI: 3-15%); Bleeding 5% (95% CI: 2-12%) and isolated gastrointestinal perforations 4% (CI: 0.9-11%). Time from diagnosis to first recurrence of one year or less was more frequent in patients with fistula and/or gastrointestinal perforations (76% versus 55%, p: 0,11). There was a borderline statistical trend (p: 0,066) towards higher pelvic involvement in patients with persistent disease (83%) compared with stage IVB (71%) or recurrent disease (58%). Conclusions: In this real world patients’ cohort, the combination of TC-B has shown to be safe and effective. Moore criteria have shown real world clinical applicability and High Risk score was an independent predictor of increased hazard rate of progression or death.