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Multicenter, randomized trial comparing a combined gemcitabine and cisplatin 3-week regimen with a 4-week regimen in non-small cell lung cancer (NSCLC) patients

, : Multicenter, randomized trial comparing a combined gemcitabine and cisplatin 3-week regimen with a 4-week regimen in non-small cell lung cancer (NSCLC) patients. Journal of Clinical Oncology 24(18_suppl): 17062-17062

NlmCategory="UNASSIGNED">17062 Background: This multicenter, randomized Phase II study (B9E-GH-JHSE) was aimed to compare the efficacy and safety of a gemcitabine-cisplatin combination over a 3-week schedule versus a 4-week schedule as first line treatment for Chinese patients with advanced NSCLC. Patients (pts) with pathologically or histologically confirmed stage IIIB/IV NSCLC not amenable to curative surgery, and presenting at least one measurable lesion were eligible for this study. Pts were randomized to receive cisplatin (cis) 75 mg/m2 on Day 1 plus either gemcitabine (gem) 1250 mg/m2 on Day 1 and 8 of a 21-day cycle (3-week arm) or gem 1000 mg/m2 on Day 1, 8, and 15 of a 28-day cycle (4-week arm). Patients received up to 6 cycles of treatment during this study. The primary endpoint was WHO objective response rate (ORR) and secondary endpoints included time to progression (TTP), CTC toxicity, and overall survival. Of the 100 pts who were randomized to treatment, there were 51 pts in the 3-week arm: 14 females; mean age 59±8 yrs; 37% stage IIIB, 63% stage IV. In the 4-week arm, there were 49 pts: 24 females; mean age 56 ± 13 yrs; 33% stage IIIB, 67% stage IV. In the 3-week arm the overall response rate (complete response or partial response) was 24%, compared to 27% in the 4-week arm (Odds ratio: 1.17, 95% CI 0.47- 2.9, p = .819). There were no statistically significant differences between the two treatment arms in median overall survival time (3-week: 12.1 mths, 4-week: 13.8 mths; Hazard ratio (HR): 1.19, 95% CI 0.68-2.1, p = .54) and TTP (3-week: 4.9 mths, 4-week: 6.9 mths; HR: 1.33, 95% CI 0.85-2.1, p = .21). The difference in grade 3/4 hematological toxicities did not reach statistical significance (3-week: 37%, 4-week: 57%, p = .07), while grade 3/4 non-hematological toxicities were statistically significantly reduced in the 3-week arm (33% vs. 63%, p = .005). Grade 3/4 study drug related neutropenia (3-week: 27%, 4-week: 51%, p = .02) and thrombocytopenia (3-week: 8%, 4-week: 31%, p = .005) were reduced in the 3-week arm. While all efficacy endpoints were numerically superior in the 4-week arm, the difference was not statistically significant. However, grade 3/4 toxicities were reduced in the 3-week arm. [Table: see text].


PMID: 27953433

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