Feasibility trial for adjuvant chemotherapy with docetaxel plus cisplatin followed by single agent long-term administration of S-1 chemotherapy in patients with completely resected non-small cell lung cancer: Thoracic Oncology Research Group Study 0809.

Abstract:

BACKGROUND:We conducted a multicentre feasibility study for single agent long-term S-1 chemotherapy following docetaxel plus cisplatin in patients with curatively resected stage II-IIIA non-small cell lung cancer. METHODS:Patients received three cycles of docetaxel (60 mg m(-2)) plus cisplatin (80 mg m(-2)) and then received S-1 (40 mg m(-2) twice daily) for 14 consecutive days with a 1-week rest for >6 months (maximum, 1 year). The primary end point was feasibility, which was defined as the proportion of patients who completed eight or more cycles of S-1 chemotherapy. If the lower 95% confidence interval (CI) of this proportion was 50% or more, then the treatment was considered as feasible. The sample size was set at 125 patients. RESULTS:One hundred and thirty-one patients were enrolled, of whom 129 patients were eligible and assessable. In all, 109 patients (84.5%) completed 3 cycles of docetaxel plus cisplatin and 66 patients (51.2%, 95% CI: 42.5-59.8) completed 8 or more cycles of S-1 treatment. Grade 3/4 toxicities during the S-1 chemotherapy included anaemia (7.3%), neutropaenia (3.7%), and anorexia (3.7%). CONCLUSION:The toxicity level was acceptable, although the results did not meet our criterion for feasibility. Modification of the treatment schedule for S-1 chemotherapy might improve the treatment compliance.

journal_name

Br J Cancer

authors

Niho S,Ikeda N,Michimae H,Suzuki K,Sakai H,Kaburagi T,Minato K,Kato T,Okamoto H,Seto T,Hosomi Y,Shimizu K,Oshita F,Kunitoh H,Tsuboi M,Takeuchi M,Watanabe K

doi

10.1038/bjc.2013.378

subject

Has Abstract

pub_date

2013-08-06 00:00:00

pages

545-51

issue

3

eissn

0007-0920

issn

1532-1827

pii

bjc2013378

journal_volume

109

pub_type

临床试验,杂志文章,多中心研究
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