Feasibility of adjuvant chemotherapy with S-1 consisting of a 4-week administration and a two-week rest period in patients with completely resected non-small cell lung cancer
Feasibility of adjuvant chemotherapy with S-1 consisting of a 4-week administration and a two-week rest period in patients with completely resected non-small cell lung cancer
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DOI：
10.3892/mco.2012.6
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发表时间：
2013-01-01
影响因子：
1.2
通讯作者：
Ohsaki, Yoshinobu
中科院分区：
文献类型：
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作者：
Okumura, Shunsuke;Sasaki, Takaaki;Ohsaki, Yoshinobu
S-1辅助化疗对完全切除的非小细胞肺癌的疗效尚不清楚，S-1辅助化疗的合适方案尚不清楚。为评价S-1辅助化疗的可行性和疗效，进行了II期研究。纳入本研究的患者年龄20-75岁，病理分期IB-IIIA非小细胞肺癌，并接受了非小细胞肺癌完全切除。患者口服S-1(80 mg/m(2))4周，然后休息2周(常规方案)，最多8个周期。主要终点是相对剂量强度(RDI)，次要终点是安全和1年无病生存(1Y-DFS)。2007年5月至2009年10月，共有28名患者入选。RDI为63.1%(95%CI，48.6~77.7)。未观察到3级或更严重的血液学毒性。4例患者出现3级非血液学毒性反应。未检测到4级或更严重的血液毒性。1Y-DFS的概率为85.7%(95%CI，72.8-98.6)。在亚组分析中，65岁以上患者的中位数RDI值低于其他患者(44.8vs.100%；P=0.013；Mann-Whitney U检验)。老年组Ccr较低，有较多的2级或3级非血液学毒性。这些结果表明，在完全切除的老年非小细胞肺癌患者中，常规的S-1辅助化疗方案不太可能可行。
The efficacy of adjuvant chemotherapy with S-1 in patients with completely resected non-small cell lung cancer (NSCLC) has yet to be clarified, and the appropriate schedule for the adjuvant chemotherapy with S-1 remains unknown. A phase II study was conducted to evaluate the feasibility and efficacy of adjuvant chemotherapy with S-1. Patients enrolled in this study were 20-75 years old, had pathological stage IB-IIIA NSCLC, and had received complete resection of NSCLC. S-1 (80 mg/m(2)) was administered orally to the patients for four weeks followed by a two-week rest period (conventional schedule), for a maximum of eight cycles. The primary endpoint was relative dose intensity (RDI), while the secondary endpoints were safety and 1 year of disease-free survival (1y-DFS). Between May 2007 and October 2009, 28 patients were enrolled. The RDI was 63.1% (95% CI, 48.6-77.7). No grade 3 or worse hematological toxicity was observed. Grade 3 non-hematological toxicities were observed in four patients. No grade 4 or worse hematological toxicity was detected. The probability of 1y-DFS was 85.7% (95% CI, 72.8-98.6). In the subgroup analysis, the median RDI of patients over 65 years old was lower compared to the other patients (44.8 vs. 100%; P = 0.013; Mann-Whitney U test). Creatinine clearance (CCr) was lower in the older group, with more grade 2 or 3 non-hematological toxicities in the elderly patients. These results suggest that the conventional schedule of adjuvant chemotherapy with S-1 is not likely to be feasible in older patients with completely resected NSCLC.