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AP treatment of proliferation of small cell lung cancer compared with IP is nothing more than inferior effectiveness

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<A name=OLE_LINK5>Background: The IP is the standard therapy for treatment of

IVL proliferation of small cell lung cancer, but a common cause of severe diarrhea. AP treatment of small cell lung cancer potentially active, rarely diarrhea. Conducted a phase III clinical trials for efficacy comparison of AP and IP.Methods: Inclusion criteria: the proliferation of small cell lung cancer patients after chemotherapy alone, age 20-70, ECOG performance score of 0-1. Patients were randomized to take IP or AP, in order to balance the Jag1 patient's lesion location, sex and score. IP group program: every four weeks, the first 1,8, and 15 days of intravenous irinotecan (60mg/m2 Â) and one day of intravenous cisplatin (60mg/m2 Â); the AP group program: every three weeks - 3 days of intravenous ammonia doxorubicin (40mg/m2) and 1 day intravenous cisplatin (60mg/m2 Â). Each group planned sample size of 141 patients with JAK1 unilateral a = 5%, the test performance of 70%, risk ratio of non-inferiority test limit value of 1.31. The primary endpoint was overall survival, secondary endpoints were response rate, progression-free survival, side effects, quality of life. Two evaluations of the quality of life: into the group before and after the second JAK2 stage.

Results: 284 patients were randomly assigned to the IP group (n = 142) and AP (n = 142). The average age was 63 years old, 84% were male, 56% of patients with ECOG performance status of 0. To recruit 191 patients and found the cells to reduce febrile neutropenia in the AP group than expected, ammonia JAK3 supple than the star of the initial dose reduced to 35 mg/m2 by 40mg/m2. After the completion of patient recruitment for the second interim analysis, the AP group, the average overall survival (15 months) than the IP group (18.3) Poor risk (1.41; 96.3% confidence interval ,1.03-1.93) and even beyond the non-inferiority test The threshold values, so that the data safety monitoring committee recommended the publication of the results as soon as possible. The average progression-free survival of 5.7 months (IP group), 5.2 (APs) (hazard ratio 1.43,95% confidence interval ,1.13-1 .82). The remission rate was 69.5% (IP) 77.9% (AP) (p = 0.14). Side effects in the IP group and AP group 4 neutropenia (22.5% vs. 78.6%), 3 - 4 neutropenia (10.7% vs. 32.1%), 3-4 diarrhea (7.1% 1.4%). The physical state of the quality of life to enhance the ratio is 37.1% (IP) 31.7% (AP) (odds ratio 0.72; 95% confidence interval ,0.43-1 .22; P = 0.227)Conclusion: Although the AP rarely cause diarrhea, but there is a strong bone marrow suppression. To prove non-inferiority AP IP, IP is still the standard therapy on the proliferation of small cell lung cancer.

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