Efficacy and safety study of docetaxel as salvage chemotherapy in metastatic gastric cancer failing fluoropyrimidine and platinum combination chemotherapy

Abstract

4220 Background: Fluoropyrimidine (F) and platinum (P) combination chemotherapy has been widely used for the 1st line treatment of advanced gastric cancer (AGC). Docetaxel (D) has shown promising activity in this disease; overall response rates (RR) were 17∼25% when used as single agent in the 1st line setting. The action mechanism of D is also different from F or P. We investigated the efficacy of D monotherapy as salvage treatment in AGC failing F and P combination chemotherapy. Methods: Twenty-eight patients with measurable and documented progression within 4 months after F and P containing regimens were included in this study. D was given at a dose of 75 mg/m2 IV every 3 weeks. Patients characteristics are as follows; Male/female 24/4, median age 53(31∼70), median ECOG PS 1(1∼2), peritoneal seeding 36%, liver metastases 54%, elevated ALP level 45%, prior exposure to capecitabine + CDDP 13, 5-FU+CDDP 10, doxifluridine+CDDP 3, S1+CDDP 1, and 5-FU+heptaplatin 1. Median treatment free interval was 42 days (21∼158), and 75% of patients had had progression while receiving F+P and 25% had had progression within 4 months after withdrawal of F+P chemotherapy. Results: At the time of analysis, 24 patients were evaluable for response (refusal after 1st cycle 1, docetaxel anaphylaxis 1, too early to evaluate 2) and 26 patients for safety with 8 patients continuing D treatment. A total of 95 cycles of D were administered with a median of 3 (1∼8) cycles. We observed 5 partial responses (PR) without any complete response for an overall RR of 21% (95% CI, 5∼37). Nine patients showed stable disease and 10 patients progressed. The median time to progression was 2.6 months (95% CI, 1.9∼3.3). The duration of objective PRs were 1.8+, 2.5, 2.3+, 3.2+, and 4.0+ months, respectively. Grade 3/4 febrile neutropenia occurred in 11%. The incidence of grade 2 or worse nonhematologic toxicities are as follows; Mucositis 19%, asthenia 33%, neuropathy 10%, and nail change 14%. Conclusions: Docetaxel monotherapy is active for 2nd line salvage chemotherapy after prior exposure to F and P combination chemotherapy in AGC; The RR is comparable to that achieved in previously untreated patients. No significant financial relationships to disclose.