Weekly docetaxel monotherapy for advanced gastric or esophagogastric junction cancer. Results of a phase II study in elderly patients or patients with impaired performance status

Background: Three-weekly docetaxel is active in patients with advanced esophagogastric cancer but myelosuppression may make this schedule unsuitable for some patient groups such as elderly, pretreated, or poor performance status patients. Patients and methods: Eligible patients were chemonaive with Karnofsky index ≤70% and/or had received prior platinum-based chemotherapy. Docetaxel 35 mg/m² was administered on days 1, 8, 15, 22, 29, and 36 of a 49-day cycle. The primary endpoint was disease stabilization rate. Results: Of 46 patients (median age, 68.5 years; 47% ≥70 years) included, 87% had Karnofsky index ≤70 and 50% had prior treatment. The safety profile was acceptable. Principal grade 3/4 toxicities were leukopenia (9%) and fatigue (14%). Fifteen patients experienced no progression for ≥100 days (disease stabilization rate: 36%). Overall response rate was 9%; median overall survival was 7.0 months. Conclusions: Weekly docetaxel was well tolerated and achieved disease stabilization in one-third of difficult-to-treat patients.