Final results of a randomized controlled phase III trial (TAX 325) comparing docetaxel (T) combined with cisplatin (C) and 5-fluorouracil (F) to CF in patients (pts) with metastatic gastric adenocarcinoma (MGC)

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Abstract
4002 Background: Locally advanced or MGC has a poor prognosis (2-year survival 11.5%). Different treatments are used with no evidence of survival benefit. Methods: Pts with chemotherapy-naive MGC were randomized to either TCF: T 75 mg/m2 day (d) 1, C 75 mg/m2 d 1, and F 750 mg/m2/d continuous infusion (c.i.) d 1–5 every (q) 3 weeks (w) or CF: C 100 mg/m2 d 1 and F 1000 mg/m2/d c.i. d 1–5 q 4 w. Pts with locally recurrent or metastatic gastric adenocarcinoma (including gastroesophageal junction in 22% pts) and measurable/evaluable disease were eligible. Biased-coin randomization was stratified for center, liver metastases, prior gastrectomy, 5% weight loss, and measurability. Tumor assessments were performed q 8 w and externally reviewed. Time to progression (TTP) was the primary endpoint; the trial was equally powered for overall survival (OS). Results: 457 pts (227/230 TCF/CF) were randomized between Nov 99-Jan 03. Median age was 55 yrs and 97% pts had metastatic cancer. Weight loss in prior 3 months [mo] was >5–10%: 29% pts and >10%: 27% pts. TTP was longer with TCF (5.6 mo) compared to CF (3.7 mo; risk reduction 32%; log-rank p=0.0004). With median follow-up of 23 mo, OS was longer with TCF (risk reduction 23%, log-rank p=0.0201). 2-year survival was 18% with TCF vs 9% with CF. Response rate to TCF (37%) was superior to CF (25%; chi-square p=0.0106); 17%/31% pts had disease progression as best response to TCF/CF. Grade 3–4 treatment-emergent adverse events occurred in 81% and 75% of TCF and CF pts, the most common of which included diarrhea and stomatitis (20%/8% and 21%/27% TCF/CF pts); neutropenia was more frequent with TCF while anemia was less. With TCF/CF, 60-day all-cause mortality was 7%/9%. The TCF benefit/risk ratio tended to be less in pts ≥65 years. Conclusions: Docetaxel is the first drug with a proven survival benefit in MGC. Tolerance of TCF and CF was limited in this sick patient population. Docetaxel combined with CF and appropriate risk management represents a new option for MGC.

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