S-1 Combined with Bi-Weekly Docetaxel for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy: A Phase II Study of North Japan Lung Cancer Group (NJLCG0701)

OSAMU ISHIMOTO, Tomohiro Sakakibara, Makoto Maemondo, Akira Inoue, Nobumichi Matsubara, Naoto Morikawa, Koichi Okudera, Kazuhiro Usui, Toshiro Suzuki, Toshihiro Nukiwa, Shunichi Sugawara


Objectives: We conducted a phase II study to evaluate the combination of bi-weekly docetaxel and S-1, a novel oral fluorouracil derivative, for patients with previously treated non-small cell lung cancer. Methods: Patients received S-1 on days 1-14 and docetaxel on days 1 and 15 of each 28-day cycle. The primary endpoint was overall response rate (ORR). Results: We enrolled 35 pts from 7 institutions (Feb. 2007-Sep. 2008). Patient characteristics: male/female, 23/12; median age, 64 years; and PS, 0/1 (17/18). The ORR was 26% (95% confidence interval, 11-40). The median progression-free survival was 4.1 months and the median overall survival was 16.3 months. Hematologic grade 3/4 toxicity included neutropenia (31%) and anemia (11%). Major non-hematologic grade 3 toxicity included diarrhea (17%). Conclusions: The combination of S-1 and bi-weekly docetaxel is an active regimen with a tolerable toxicity for previously treated NSCLC. Further evaluation of this regimen is warranted.

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DOI: http://dx.doi.org/10.5539/cco.v1n1p108

Cancer and Clinical Oncology ISSN 1927-4858(Print) ISSN 1927-4866(Online)

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