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.