A phase II study of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
Background
Both docetaxel and paclitaxel are a class of microtubule-stabilizing anticancer agents. Partial cross-resistance between docetaxel and paclitaxel was indicated in breast and ovary cancers. In advanced gastric cancer, retrospective study showed comparable efficacy of subsequent weekly paclitaxel with or without prior docetaxel-based chemotherapy. Therefore, we evaluated the efficacy and safety of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy.
Methods
This study was a multi-center, single-arm phase II study in patients with advanced or recurrent esophageal cancer. Eligible criteria included histologically confirmed esophageal squamous cell carcinoma or adenosquamous carcinoma with measurable lesions, refractory to prior docetaxel-containing chemotherapy, aged 20 years and older, and an ECOG performance status (PS) of 0-1. Paclitaxel at 100 mg/m2 was administered by intravenous infusion, and this was repeated weekly for 6 weeks followed by a 1-week rest. The primary end point was confirmed objective response rate (ORR), as assessed according to the RECIST version 1.1 criteria. The secondary end points included progression-free survival (PFS), overall survival (OS) and safety.
Results
Between January 2016 and November 2019, 25 patients were enrolled from 6 institutions in Japan. Two patients with ineligible (n=1) and refusal of treatment (n=1) were excluded. Therefore, 23 patients were included in this analysis. In prior treatment, all patients received fluoropyrimidine, platinum and docetaxel. The median number of treatment cycles was 2 (range 1–4). The ORR was 9% (2/23), however, the confirmed ORR was 0%. The disease control rates (DCR) was 52% (12 /23). The median PFS and median OS were 81 days (95% confidence intervals (CI), 47 to 91), and 211 days (95% CI, 162 to 262), respectively. The common grade 3 or 4 treatment-related adverse events were neutropenia (34%), leukocytopenia (26%) and anemia (22%). There were no treatment-related deaths.
Conclusions
Although this phase II study did not meet the primary endpoint, it showed modest efficacy with an acceptable safety profile.
Clinical trial identification
UMIN000019230.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosures
A. Hosokawa: Honoraria (self): Yakult Honsha, Taiho Pharmaceutical, Daiichi Sankyo, Chugai Pharma, Ono Pharmaceutical, Eisai, Lilly; Research grant / Funding (institution): Chugai Pharma, Taiho Pharmaceutical, Ono Pharmaceutical. All other authors have declared no conflicts of interest.
