GO01 : Genexol-PM/carboplatin versus paclitaxel/carboplatin with or without bevacizumab in advanced high-grade serous ovarian cancer: interim analysis of a prospective cohort study with historical control

Objective: Cremophor-free polymeric micelle formulation of paclitaxel (Genexol-PM) plus carboplatin (PM/C) has been reported to have a non-inferior effect with tolerable toxicities when compared to the standard paclitaxel plus carboplatin (P/C) in ovarian cancer. However, there is still a lack of evidence on the effect of an increased dose of paclitaxel in PM/C, especially, when compared to P/C and paclitaxel plus carboplatin with bevacizumab (P/C/B) in advanced high-grade serous ovarian cancer (HGSO). Thus, we performed a prospective cohort study on PM/C and compared the effect of PM/C with historical control of P/C and P/C/B in HGSO. Methods: We performed a prospective cohort study between October 2015 and June 2019. Patients aged 20 or more years with FIGO stage III-IV HGSO who received PM (260 mg/m2)/C (AUC 5) after primary debulking surgery (PDS) were enrolled. We collected clinico-pathologic data from a retrospective cohort when P (175 mg/m2)/C (AUC 5) or P (175 mg/m2)/C (AUC 5)/B (15 mg/kg) were used as adjuvant treatment after PDS during the same period. Results: A total of 104 patients were enrolled, and 17, 28, and 59 received P/C, P/C/B and, PM/C respectively (Table 1). Complete response was significantly highest in PM/C (29.4 vs. 39.3 vs. 61%, P=0.030; Table 1). Progression-free survival was longest in PM/C (Figure 1) and multivariate analysis showed that gross residual tumor after PDS and P/C were poor prognostic factors (adjusted hazard ratios, 2.415 and 2.751; 95% confidence intervals, 1.172-4.976 and 1.214-6.236; Table 2). Even after adjustment of the patient pool to those with no gross residual tumor after PDS, multivariate analysis still showed that P/C lowered the survival curve (adjusted hazard ratio, 3.342; 95% confidence interval, 1.143-9.777; Table 2). Conclusion: This interim analysis showed that PM/C had a comparable effect to P/C/B for stage III-IV HGSO patients who received optimal cytoreduction during PDS.