ATTAX: Randomised phase II study evaluating weekly docetaxel-based chemotherapy combinations in advanced esophago- gastric cancer, final results of an AGITG trial

Abstract

4528 Background: Docetaxel (T), cisplatin (C) and 5FU(F) are active agents in esophago-gastric cancer. A recent phase III study evaluating 3-weekly TCF demonstrated a survival advantage over standard therapy, but TCF was associated with high rates of hematological toxicity (30% incidence of febrile neutropenia/neutropenic infection) as well as non-hematological side effects (Van Cutsem et al, J. Clin Oncol. 24 4991–4997 2006). Weekly docetaxel is associated with a lower incidence of hematological toxicity. This randomized phase II study aimed to test weekly docetaxel based combination chemotherapy regimens with the aim of maintaining the activity of such regimens but reducing toxicity. Methods: Eligibility included; histologically confirmed, metastatic esophageal or gastric (OG) carcinoma, measurable disease, PS0–2, adequate organ function, no prior treatment, informed consent. Patients (Pts) were randomized to receive weekly (w) T 30mg/m2 d1,8 C 60 mg/m2 d1 F 200 mg/m2/d continuously q 3w or wT 30 mg/m2 d1,d8 and capecitabine (X)1,600 mg/m2/d d1–14 q3w. The primary endpoint is confirmed response rate (RR), with each arm analyzed independently. Simon’s 2-stage design was used, with 5/21 responses required in the first stage to allow continuation to 50 pts per arm. Results: Response rates in each arm satisfied the first stage, and complete accrual of 106 pts was completed in May 2006. Demographics, toxicity and response rates are shown in the table . With a median follow-up of 14.6 months, progression free and overall survival times are 5.9 m and 12.8 m, and 4.2m and 10.1 m for wTCF and wTX, respectively. Conclusions: wTCF and wTX have encouraging activity and a far more favorable toxicity profile than TCF administered 3-weekly. Weekly docetaxel-based combination regimens should be evaluated further in this disease. [Table: see text] [Table: see text]