Table 4.
Selected Phase III Trials of Switch Maintenance Therapy With Cytotoxic Chemotherapy Agents
| Trial | Year | Induction Therapy |
Maintenance Therapy |
Therapy at Progression (% of patients) | PFS |
OS |
||||
|---|---|---|---|---|---|---|---|---|---|---|
| Regimen | No. of Patients | Regimen | No. of Patients | Median (months) | P | Median (months) | P | |||
| Westeel et al54 | 2005 | MIC × 4 cycles (wet IIIB or stage IV) or MIC × 2 cycles followed by RT to 55-60 Gy (stage IIIB) | 573 | Vinorelbine 25 mg/m2 weekly for up to 6 months | 91 | NR (cisplatin-etoposide advised) | 5 (from random assignment) | .11 | 12.3 | .65 |
| Observation | 90 | NR (cisplatin-etoposide advised; vinorelbine prohibited) | 3 (HR, 0.77) | 12.3 (HR, 1.08) | ||||||
| Sculier et al55 | 2007 | GIP × 3 cycles | 485 | GIP until progression | 140 | 61 (paclitaxel 225 mg/m2 every 3 weeks until progression in 49% [12% RR]; GIP in 6% [12% RR]) | 4.4 | .56 | 11.9 | .17 |
| Paclitaxel 225 mg/m2 every 3 weeks until progression | 141 | 47 (GIP until progression in 33% [17% RR]) | 4 | 9.7 | ||||||
| Fidias et al16 | 2009 | Carboplatin AUC 5 day 1 + gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks × 4 cycles | 566 | Docetaxel 75 mg/m2 every 3 weeks for up to 6 cycles | 153 | NR | 5.7 | < .001 | 12.3 | .09 |
| Observation | 156 | 63 (docetaxel 75 mg/m2 every 3 weeks up to 6 cycles) | 2.7 | 9.7 | ||||||
| JMEN (Ciuelanu et al17) | 2009 | Platinum-based doublet* × 4 cycles | 745 | Pemetrexed 500 mg/m2 every 3 weeks + BSC | 441 | 51 | 4.0 | < .001 | 13.4 | .01 |
| Placebo + BSC | 222 | 67 (19% pemetrexed) | 2.0 (HR, 0.6) | 10.6 (HR, 0.79) | ||||||
| ECOG 5508† | Ongoing | Carboplatin AUC 6 and paclitaxel 200 mg/m2 + bevacizumab 15 mg/kg | 1,282 | Bevacizumab 15 mg/kg every 3 weeks | ||||||
| Pemetrexed 500 mg/m2 every 3 weeks | ||||||||||
| Bevacizumab 15 mg/kg + pemetrexed 500 mg/m2 every 3 weeks | ||||||||||
Abbreviations: AUC, area under the curve; BSC, best supportive care; ECOG, Eastern Cooperative Oncology Group; GIP, gemcitabine 1,000 mg/m2 on days 1 and 8 plus ifosfamide 3 g/m2 on day 1 plus cisplatin 50 mg/m2 on day 1; HR, hazard ratio; MIC, mitomycin 6 mg/m2 on day 1 plus ifosfamide 1.5 g/m2 per day on days 1 to 3 plus cisplatin 30 mg/m2 per day on days 1 to 3; NR, not reported; OS, overall survival; PFS, progression-free survival; RR, response rate; RT, radiotherapy.
*
Cisplatin or carboplatin plus gemcitabine, docetaxel, or paclitaxel.
†
Nonsquamous non–small-cell lung cancer only.