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. 2016 Nov 3;5(3):123–130. doi: 10.2217/lmt-2016-0011

Table 3. . Comparison between registration trials, large randomized controlled trials using cisplatin/gemcitabine as control arm and our retrospective study.

Trial data Cardenal et al. (all NSCLC) [8] Sandler et al. (all NSCLC) [9] Schiller et al. (all NSCLC) [17] Scagliotti et al. (nonsquamous subgroup) [10] Reck et al. (nonsquamous) [12,13] Kohutek et al. (nonsquamous)
Number of patients 69 260 288 634 347 56

Treatment used GEM 1250 mg/m2 D1, D8 + cisplatin 100 mg/m2 D1 3-week cycle (up to 6 cycles) GEM 1000 mg/m2 D1, D8, D15 + cisplatin 100 mg/m2 D1 4-week cycle (up to 5 cycles) GEM 1250 mg/m2 D1, D8 + cisplatin 75 mg/m2 D1 3-week cycle (up to 6 cycles) GEM 1250 mg/m2 D1, D8 + cisplatin 80 mg/m2 D1 3-week cycle (up to 6 cycles) GEM 1250 mg/m2 D1 and D8 ± cisplatin 75 mg/m2 or carboplatin AUC5 D1 3-week cycle (1–6 cycles)

Median PFS (months) 6.9 (TTP) 5.6 (TTP) 4.2 (TTP) 4.7 6.1 6.48

Median OS (months) 8.7 9.1 8.1 10.4 13.1 10.8

D: Day; GEM: Gemcitabine; OS: Overall survival; PFS: Progression-free survival; PS: Performance status; TTP: Time to progression.