S-1 chemotherapy and intensity-modulated radiotherapy after D1/D2 lymph node dissection in patients with node-positive gastric cancer: a phase I/II study.

Autor: Wang, X, Zhao, D B, Yang, L, Chi, Y, Tang, Y, Li, N, Wang, S L, Song, Y W, Liu, Y P, Liu, W Y, Ren, H, Zhang, T, Wang, J Y, Chen, X S, Fang, H, Wang, W H, Li, Y X, Jin, J
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Zdroj: British Journal of Cancer; 2/6/2018, Vol. 118 Issue 3, p338-343, 6p, 4 Charts
Abstrakt: Background: This phase I/II clinical trial investigated S-1 administered with intensity-modulated radiotherapy (IMRT) as adjuvant therapy for node-positive gastric cancer. Patients had undergone radical resection and D1/D2 lymph node dissection.Methods: In phase I, patients received adjuvant chemoradiotherapy of IMRT (45 Gy in 25 fractions) with concurrent S-1 administered on a dose-escalation schedule to determine the recommended dose (RD). In phase II, the safety and efficacy of the RD of S-1 combined with IMRT were assessed.Results: We consecutively enrolled 73 patients (56 men; median age, 53 years; range, 29-73 years) and the phase I portion of the study included 27 patients. The RD of S-1 administered concomitantly with IMRT was 80 mg m-2 day-1 orally, twice daily. The phase II analysis included 52 patients (46 new patients plus 6 from phase I). 8 patients (15.4%) developed grade 3 or 4 toxicities. There were 21 recurrence events and 15 deaths (1 bowel obstruction, 14 gastric cancer). Three-year disease-free survival and overall survival were 62.2% (95% confidence interval (CI), 48.5-75.9) and 70.0% (95% CI, 56.3-83.7), respectively. The median time to recurrence was 17.5 months (range, 3.8-42.0). The median time from recurrence to death was 7.0 months (range, 1.5-28.7).Conclusions: S-1 combined with IMRT adjuvant chemoradiotherapy is safe and efficacious for advanced gastric cancer. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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