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Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin for gastric cancer

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Abstract

Purpose

To evaluate the feasibility of S-1 plus cisplatin as adjuvant chemotherapy for stage III gastric cancer after curative resection.

Methods

Japanese patients with stage III gastric cancer who underwent gastrectomy with D2 lymph node resection were enrolled. Treatment consisted of 3 cycles of S-1 (80 mg/m2/day, b.i.d.) for 21 days followed by a 14-day rest, and cisplatin (60 mg/m2 iv) on day 8. After that, S-1 monotherapy was given on days 1–28 every 6 weeks until 1-year postsurgery. After protocol amendment, the first chemotherapy cycle consisted of S-1 monotherapy; cisplatin was added to cycles 2, 3, and 4, followed by S-1 monotherapy up to 1-year postsurgery. The primary endpoint was the completion rate of three cycles of S-1 plus cisplatin.

Results

A total of 63 enrolled patients have been evaluated. Grade 3/4 toxicities included neutropenia (40%), anorexia (28%), and febrile neutropenia (4%) before protocol amendment (n = 25), and neutropenia (37%), anorexia (8%), and febrile neutropenia (3%) after amendment implementation (n = 38). Excluding ineligible cases, treatment completion rates were 57% (12/21) before and 81% (30/37) after the protocol amendment.

Conclusions

The amended S-1 plus cisplatin is more feasible than the original protocol because of early dose reduction of S-1 prior to cisplatin addition and greater recovery time from surgery prior to cisplatin. This treatment should be considered as a feasible experimental arm for the next postoperative adjuvant phase III trial.

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Acknowledgments

We thank Mr. Yushi Nagai and Ms. Michiyo Tada for help in collecting and organizing the database. We received no financial support.

Conflicts of interest

T. Sano has received lecture fees from Taiho Pharmaceutial (Tokyo, Japan). All other authors declared no conflicts of interest.

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Correspondence to D. Takahari.

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Takahari, D., Hamaguchi, T., Yoshimura, K. et al. Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin for gastric cancer. Cancer Chemother Pharmacol 67, 1423–1428 (2011). https://doi.org/10.1007/s00280-010-1432-8

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  • DOI: https://doi.org/10.1007/s00280-010-1432-8

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