Abstract:
ObjectiveTo define the maximum-tolerated dose (MTD) of capecitabine with fixed docetaxel for Chinese patients with previously treated NSCLC. Methods Escalating doses of capecitabine with fixed docetaxel were administered in a modified Fibonacci sequence.Eighteen patients received 67 cycles at capecitabine of level I (1 250 mg/m
2,divided into 625 mg/m
2,bid) and level Ⅱ (1 500 mg/m
2 750 mg/m
2,bid).The initial doses were capecitabine 625 mg/m
2,bid,on day d5-d18,and docetaxel 30 mg/m
2 on days 1,8,respectively.The regimen was repeated every 21 days.If no dose-limiting toxicity (DLT) was observed,the next dose level was applied.The procedures were repeated until DLT appeared.The MTD was declared to be one dose level below the level without DLT. Results The most common toxicities were neutropenia,hand and feet syndrome,fatigue and nausea.Eight DLTs occurred in 5 patients in the whole group,including 1 DLT in 1 patient at dose level I and 7 DLTs in 4 patients at dose level 2.Since 4 of 6 patients in level II experienced DLTs,we declared that level I was MTD. Conclusion MTD of our escalation trial was capecitabine of 1 250 mg/(m
2·d) (625 mg/m2,bid) combined with docetaxel of 30mg/m
2,d1,d8,repeated every 21 days.This combination regimen was well tolerated for previously treated patients with NSCLC.