Objective To evaluate the efficacy of Gefitinib for patients with non-small-cell lung cancer (NSCLC). Methods We searched several databases, including MEDLINE (1991 to June 2008), The Cochrane Library (Issue 4, 2008) and CBMDisc (1978 to Feb. 2008). Randomized controlled trials (RCTs) were included in the meta-analyses, which were done using The Cochrane Collaboration’s RevMan 4.2 software. We also included retrospective case reports published in Chinese journals. Results Eight RCTs and 36 uncontrolled case reports were analyzed. The results of the RCTs showed that 250 mg/d Gefitinib had similar efficacy to 500 mg/d, but the side effect was significantly less for the lower dose. When used as a combined first-line treatment or a third-line treatment, Gefitinib was not superior to placebo on response rate, survival rate and life span. When used as second-line treatment, it did not prolong median survival, though it gave a higher response rate than placebo. Gefitinib caused many more side effects than placebo. Gefitinib exhibited similar efficacy to docetaxel in objective response rate [OR 1.18, 95%CI (0.84, 1.67), P=0.35], but was better for symptom and quality-of-life improvement [OR 1.58, 95%CI (1.33, 1.89), Plt;0.00001]. The overall uncontrolled clinical studies showed the following results: complete response rate was 2.2%, partial response rate was 25.8%, disease stable rate was 40.0% and progressive disease rate was 32.0%. The average median survival time was 8.9 months; the average time to progressive disease was 5.2 months, and the 1-year survival rate was 44.2%. The average median survival from EAP studies (6.9 months) was shorter than that for all the studies as well as the registered clinical trials (10.0 months). The average periods to progressive disease for registered clinical trials (3.2 months) and EAP studies (4.4 months) were somewhat shorter than that found for all studies combined, though response rate and 1-year survival rate were similar. Since there was no controlled clinical study, it was hard to conclude from the results whether Gefitinib brought any clinical benefit to NSCLC patients in China. Conclusion Gifitinib is not suitable as a combined first-line treatment or a third-line treatment for NSCLC. The clinical favor from gefitinib in the second-line treatment remains uncertain. There is not enough evidence to show whether Chinese people are more sensitive to Gefitinib, and its use in the second-line treatment of NSCLC needs to be tested further.
Objective To assess the efficacy, safety and dosage regimen of docetaxel in patients with non small cell lung cancer (NSCLC). Methods We searched The Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP and etc to collect controlled trials which involved docetaxel as the second-line treatment of NSCLC. Two reviewers evaluated the quality of included trials independently. The Cochrane Collaboration’s software RevMan 4.2 was used for meta-analyses. Results Eight randomized controlled trials were included, all of which didn’t mention the blinding methods. Compared with best supportive care (BSC), the docetaxel group showed longer time to progression (10.6 vs. 6.7 weeks, Plt;0.001) and longer median survival (7.0 vs. 4.6 months, P=0.047), as well as greater 1-year survival (37% vs. 11%, P=0.003). Patients treated with docetaxel showed higher incidence of hematologic toxicity than those treated with BSC. Meta-analyses of different docetaxel dosage regimens (1-week vs. 3-week) showed that there were no statistical differences in terms of disease control rate, response rate or 1-year survival; but the incidence of hematologic toxicity of 1-week regimen was lower than that of 3-week regimen, and no statistical difference was noted in the incidence of non-hematologic toxicity between the two regimens. Conclusion Docetaxel as the second-line chemotherapy for NSCLC significantly improved survival compared with BSC. Two dosage regimens of docetaxel had no difference in efficacy, but some differences in hematologic toxicity. Thus, if serious hematologic toxicity occurs, the 3-week treatment regimen of docetaxel could be replaced by 1-week treatment regimen.