Randomized phase II study comparing docetaxel versus paclitaxel in patients with esophageal squamous cell carcinoma who are refractory to fluoropyrimidine and platinum-based chemotherapy: OGSG1201.

4037 Background: Fluoropyrimidine and platinum-based chemotherapy are considered first-line therapy options for patients with unresectable advanced or recurrent metastatic esophageal squamous cell carcinoma(ESCC). After fluoropyrimidine and platinum-based chemotherapy is failed, taxanes (docetaxel(DTX) and paclitaxel(PTX)) was mainly used as a second-line treatment for ESCC. Therefore, we conducted a trial to compare DTX and PTX in patients with unresectable advanced or recurrent ESCC who were failed to previous fluoropyrimidine and platinum-based chemotherapy. Methods: We did a randomized, an open-labeled and multicentre phase 2 study. Inclusion criteria included age 20 to 80 years with unresectable advanced or recurrent ESCC, Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Patients who were refractory to fluoropyrimidine and platinum-based chemotherapy. Treatment consisted of DTX 70 mg/m2 repeated every 21 days or PTX 100 mg/m2 once weekly on days 1, 8, 15, 22, 29, and 36 of a 49-day cycle. Results: 80 patients were enrolled between May 2012 and April 2019. 41 patients received DTX and 39 patients received PTX. After assessment of eligibility, two patients proved uneligible (one for double cancer, one for contraindication to DTX) and were excluded from the analysis. But, 80 patients were evaluable for the toxicity analyses. A median follow-up time was 32 months. Overall survival was significantly longer in the PTX group than in the DTX group (median, 8.8 months vs. 7.3 months; hazard ratio, 0.62; 95% CI, 0.38 to 0.9998; P = 0.047). The median progression-free survival was significantly longer in the PTX group than in the DTX group (median, 4.4 months vs. 2.1 months; hazard ratio, 0.49; 95% CI, 0.30 to 0.78; P = 0.002). The median time to treatment failure was significantly longer in the PTX group than in the DTX group (median, 3.8 months vs. 2.1 months; hazard ratio, 0.45; 95% CI, 0.28 to 0.73; P＜0.001). The most common adverse events of grade 3 or higher were a decreased neutrophil count (in 28% of the PTX group and in 80% of the DTX group). Febrile neutropenia was also more frequent in the DTX group than the PTX group (46％ vs. 0%). There was one death from sudden death in which treatment-related mortality could not be ruled out. Conclusions: Secound-line treatment with PTX, as compared with DTX, reduced the risk of ESCC. Clinical trial information: UMIN000007940.