Table 2.
Study | Treatment arm | Control arm | Dose of regimens (mg/m2) | No. of planned cycles | Median OS, months (treatment/control) (p-value) | HR for OS (95% CI) | Grade 3–4 Toxicity, % (treatment/control) |
---|---|---|---|---|---|---|---|
Albers et al. (12) | Short-term GP | Prolonged GP | Gemcitabine: 1,000 Paclitaxel: 175 |
6 | 7.8/8.0 (0.772) | NA | 6.6/26.6 |
Bellmunt et al. (13) (NCT00315237) | Vinflunine | BSC alone | 320 or 280 | NA | 6.9/4.3 (0.040) | 0.77 (0.61–0.98) | 19.3/17.9 |
Bellmunt et al. (14) | Vinflunine | BSC alone | 320 or 280 | NA | 6.9/4.3 (0.023) | 0.78 (0.61–0.96) | NA |
Harshman et al. (15) | Vinflunine | BSC alone | 320 or 280 | NA | 6.9/4.7 (0.043) | 0.76 (0.58–0.99) | NA |
Powles et al. (16) (NCT00949455) | Lapatinib | Placebo | 1,500 (fixed dose) | NA | 12.6/12.0 (0.80) | 0.96 (0.70–1.31) | 8.6/8.1 |
Bellmunt et al. (18) (NCT02256436, KEYNOTE-045) | Pembrolizumab | Investigator's choice of chemotherapy (paclitaxel, docetaxel, or vinflunine) | Pembrolizumab: 200 (fixed dose) Paclitaxel: 175 Docetaxel: 75 Vinflunine: 320 |
NA | 10.4/7.4 (0.002) | 0.73 (0.59–0.91) | 15.0/49.4 |
Powles et al. (19) (NCT02302807, IMvigor211) | Atezolizumab | Investigator's choice of chemotherapy (paclitaxel, docetaxel, or vinflunine) | Atezolizumab: 1,200 (fixed dose) Paclitaxel: 175 Docetaxel: 75 Vinflunine: 320 |
NA | 11.1/10.6 (0.41) | 0.87 (0.63–1.21) | 20/43 |
BSC, best supportive care; GP, gemcitabine and paclitaxel; NA, non-available; OS, overall survival; HR, hazard ratio; CI, confidence interval.