Table 4.
Polychemotherapy regimens
| Chemotherapy regimens | Dosage | References | Age, median and range (years) | Study design and population | Line | Efficacy | Toxicity |
|---|---|---|---|---|---|---|---|
| Gemcitabine and vinorelbine | Vinorelbine 25 mg/m2 IV and gemcitabine 1,000 mg/m2 IV on days 1 and 8 every 3 weeks | Dinota et al209 | 69 (65–87) | Phase II, 34 patients | First line | ORR 53% | Grade 3/4 neutropenia 20% |
| Vinorelbine 25 mg/m2 plus gemcitabine 1,000 mg/m2 on days 1 and 8, every 3 weeks | Basso et al210 | 74 (70–82) | Phase II prematurely terminated for poor RR, 12 patients | First line | ORR 11.1% TTP 3 months |
Grade 3 neutropenia 25% Grade 3 anemia and grade 3 GI toxicity 25% |
|
| Gemcitabine 1,000 mg/m2 and vinorelbine 25 mg/m2 on days 1 and 8 every 3 weeks for a maximum of 6 cycles | Dong et al172 | 73 (65–84) | Phase II, 51 patients | First line (54.9%) | RR 33.3% PFS 6.2 months OS 17 months |
Febrile neutropenia 4% One toxic death because of GI hemorrhage | |
| PLD plus vinorelbine | PLD 40 mg/m2 plus vinorelbine 25 mg/m2 IV on day 1 and oral vinorelbine 60 mg/m2 on day 15 | Addeo et al211 | 71 (65–82) | Phase II, 34 patients | First line | ORR 50% OS 13 months TTP 8 months |
Neutropenia grade 3/4 26% Febrile neutropenia 8.8% |
| PLD 40 mg/m2 IV on day 1 and vinorelbine 30 mg/m2 IV on days 1 and 15 every 4 weeks | Mlineritsch et al212 | 68 (60–82) | Multicenter, Phase II, 42 patients | First line | ORR 36% TTP 4 months OS 24 months |
||
| Oral capecitabine and vinorelbine | 6 cycles: capecitabine 750 mg/m2 bid, days 1–14 every 21 days Vinorelbine 45 mg/m2, days 1 and 8 Dose escalation after 3 cycles depending on tolerance (capecitabine 1,000 mg/m2 bid, days 1–14 and vinorelbine 60 mg/m2, days 1 and 8) |
Rousseau et al173 | 75.5 (69–86) | Multicenter, Phase II trial, 80 patients | First line | ORR 8.6% 1-year PFS 9.8% 1-year OS 54.9% |
Febrile neutropenia 1.3% grade 3/4 hematological toxicity: 17.9% Grade 3/4 GI toxicity 7.7% |
Abbreviations: ORR, objective response rate; PFS, progression-free survival; OS, overall survival; TTP, time to progression; PLD, pegylated liposomal doxorubicin; RR, response rate; GI, gastrointestinal; IV, intravenous; bid, twice daily.