Adjuvant chemoradiation for gastric cancer with infusional 5-fluorouracil and cisplatin: a phase I study

Z. Kassam, H. Mackay, C.A. Buckley, S. Fung, M. Pintile, A. Oza, J. Brierley, C. Swallow, B. Cummings, J.J. Knox, J. Kim, R. Wong, L. Siu, R. Feld, J. Ringash

Abstract


Objective

This phase I study aimed to determine the maximal tolerated dose of cisplatin administered every 2 weeks with infusional 5-fluorouracil (5FU) and concurrent radiation therapy (RT) in patients after complete resec­tion of gastric adenocarcinoma.

Methods

Patients with resected stage IB to IV (M0) gastric adenocarcinoma were treated with 12 weeks of in­fusional 5FU (200 mg/m2 daily) and with RT (45 Gy in 25 fractions starting on day 16). Cisplatin was administered in escalating doses (0, 20, 30, and 40 mg/m2) in weeks 1, 3, 5, and 7. In the final co­hort, patients received an additional dose of cisplatin (40 mg/m2) in week 9.

Results

Among the 34 patients [median age: 56 years (range: 31-77 years)] who were assessable for toxicity, 5 ex­perienced dose-limiting toxicities: 1 sepsis (cohort 1), 1 fatigue (cohort 2), 3 upper gastrointestinal toxicity (1 in cohort 2, 2 in cohort 5). Cohort 5 exceeded the maximal tolerated dose. Median follow-up was 2.5 years (range: 0.3-5 years). The 3-year overall and relapse-free survival rates were 86% and 71% respectively; median survival was not reached.

Conclusions

Cisplatin was well tolerated in combination with in­fusional 5FU and RT, showing promising activity in the adjuvant treatment of gastric cancer. Infusional 5FU 200 mg/m2 daily for 12 weeks with cisplatin 40 mg/m2 in weeks 1, 3, 5, and 7 and with concurrent RT 45 Gy in 25 fractions, starting at day 16, is being explored in a phase II study at our institution.


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DOI: http://dx.doi.org/10.3747/co.v17i4.521






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ISSN: 1198-0052 (Print) ISSN: 1718-7729 (Online)