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Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 4074
© 2004 American Society of Clinical Oncology
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Abstract

Epirubicin (E), cisplatin (C) and capecitabine (X) in first-line chemotherapy for patients with advanced gastric cancer

E. K. Cho, W. K. Lee, S. A. Im, S. N. Lee, S. H. Park, S. M. Bang, D. B. Shin and J. H. Lee

Gachon Medical School, Inchon, Republic of Korea; Ewha Womens' University, Seoul, Republic of Korea

4074

Background: ECF has been regarded as a highly active regimen for the advanced gastric cancer. Capecitabine (X) is an oral fluoropyrimidine carbamate and may be less toxic and more active than infusional 5-FU. We evaluated the antitumor activity and toxicity of ECX combination for untreated patients (pts) with advanced gastric cancer. Methods: Eligibility included (a) histologically proven gastric adenocarcinoma, (b) locally unresectable, metastatic or relapsed disease after resection, (c) measurable disease, (d) no previous chemotherapy or radiation therapy, (e) PS ECOG 0–2, (f) aged 18 years or older, and (g) no contraindication to chemotherapy. Pts received E (50 mg/m2 IV on D1), C (60 mg/m2 IV on D1) and X (2,000 mg/m2/day PO on D1–14) every 3 weeks. Results: Between May 2001 and January 2003, 54 pts were enrolled in this study; median age was 56 years (range, 32 to 73) with 41 male and 13 female pts; 32 metastatic diseases, 20 relapsed diseases after surgery and 2 locally advanced diseases. A total of 250 cycles were administered with a median of 4 cycles per patient (range, 1–12). Fifty-three pts were assessable for toxicity and 50 for responses. The most common grade 3/4 hematological adverse event was neutropenia in 76 cycles (31%). Grade 3/4 leukopenia and febrile neutropenia occurred in 27 cycles (11%) and 11 cycles (4.8%), respectively. Non-hematological toxicity was generally mild and reversible. Grade 3/4 nausea, vomiting and stomatitis occurred in 8%, 9%, and 8% of the patients, respectively. Hand-foot skin reaction developed in 51% of patients, but grade 3 occurred only in 4%. One patient died of neutropenic sepsis. The overall best response rate by intent-to-treat analysis was 59% (95%CI, 46–72%) including 52% of PR and 7% of CR. Median follow-up was 16 months (range 8 to 28 months). Median response duration and time to progression was 5.8 months (95%CI, 4.7–6.9) and 6 months (95% CI, 3.8–8.2), respectively. Median survival for all patients was 9.6 months (95% CI, 8.7–10.5). Conclusions: ECX combination regimen showed high anti-tumor activity with a tolerable toxicity as a front line chemotherapy for pts with advanced gastric cancer.

No significant financial relationships to disclose.

Abstract presentation from the 2004 ASCO Annual Meeting




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