Abstract 1387P
Background
The standard first-line systemic therapy for advanced or metastatic esophageal squamous cell carcinoma (ESCC) consists of a fluoropyrimidine- and platinum-based chemotherapy. In the second-line setting, treatment options are limited. We performed a randomized, phase II trial to compare docetaxel (DTX) and paclitaxel (PTX) in this setting.
Methods
Eligible patients (pts) were randomly assigned to receive either DTX (70 mg/m2 on day 1 of each 21-day cycle) or PTX (100 mg/m2 on days 1, 8, 15, 22, 29, and 36 of each 49-day cycle). The primary end point of the study was overall survival (OS), and secondary end points included progression-free survival (PFS), time to treatment failure (TTF), response rate (RR), and safety.
Results
Although 80 pts were randomized to receive DTX (N = 41) or PTX (N = 39), 78 eligible pts (N = 39 in each group) were included for efficacy analysis. The median OS was significantly longer in the PTX group than in the DTX group (8.8 vs. 7.3 months; hazard ratio [HR], 0.62; P = 0.047). A significant benefit of PTX over DTX was also apparent in the median PFS (4.4 vs. 2.1 months; HR, 0.49; P = 0.002) and median TTF (3.8 vs. 2.1 months; HR, 0.45; P < 0.001). RR (25.6% vs. 7.7%, P = 0.065) as well as disease control rate (74.4% vs. 35.9%, P = 0.0013) were higher in the PTX group than in the DTX group. Neutropenia (80% vs. 28%) and leukopenia (76% vs. 28%) of grade ≧3 as well as febrile neutropenia (46% vs. 0%, P < 0.0001) occurred more frequently in the DTX group than in the PTX group. Among the 78 pts analyzed, 44 individuals received subsequent therapy. Of note, 24 pts, comprising 14 in the DTX group and 10 in the PTX group, received subsequent crossover treatment. Pts who received such crossover therapy showed a significantly longer OS compared with those who received other poststudy treatment (HR of 0.40 [95% CI, 0.23–0.71], P = 0.002), with the survival benefit of such treatment being apparent in the DTX group (HR of 0.30 [95% CI, 0.14–0.65], P = 0.002) but not in the PTX group (HR of 0.58 [95% CI, 0.26–1.28], P = 0.171).
Conclusions
PTX showed a significantly better efficacy as well as a more manageable toxicity compared with DTX.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Osaka Gastrointestinal cancer chemotherapy Study Group.
Funding
Has not received any funding.
Disclosure
H. Hara: Financial Interests, Personal and Institutional, Speaker’s Bureau: BMS; Financial Interests, Personal and Institutional, Speaker’s Bureau: Yakult; Financial Interests, Personal and Institutional, Speaker’s Bureau: Sanof; Financial Interests, Personal and Institutional, Speaker’s Bureau: Takeda; Financial Interests, Institutional, Research Grant: Pfizer. H. Kawakami: Financial Interests, Personal and Institutional, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Takeda. Y. Kurokawa: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Yakult; Financial Interests, Personal, Invited Speaker: Nippon Kayaku; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Takeda. T. Satoh: Financial Interests, Personal and Institutional, Invited Speaker: Yakult; Financial Interests, Personal and Institutional, Invited Speaker: BMS. All other authors have declared no conflicts of interest.