Table 5.
Selected Phase III Trials of Maintenance Therapy With Molecularly Targeted Agents
| Trial | Year | Induction Therapy |
Maintenance Therapy |
Therapy at Progression (% of patients) | PFS |
OS |
||||
|---|---|---|---|---|---|---|---|---|---|---|
| Regimen | No. of Patients | Regimen | No. of Patients | Median | P | Median (months) | P | |||
| SATURN58 | 2010 | Platinum-based doublet × 4 cycles | 1,949 | Erlotinib 150 mg PO daily | 438 | 55 | 12.3 weeks | < .001 | 12.0 | .01 |
| Placebo | 451 | 64 (16% EGFR TKI [67% of patients with EGFR mutations received EGFR TKI]) | 11.1 weeks (HR, 0.71) | 11.0 (HR, 0.81) | ||||||
| ATLAS59,60 | 2009 | Platinum-based doublet plus bevacizumab 15 mg/kg × 4 cycles | 1,160 | Bevacizumab 15 mg/kg every 3 weeks plus erlotinib 150 mg PO daily | 743 randomly assigned | NR | 4.8 months | .001 | 15.9 | .27 (or .56?) |
| Bevacizumab 15 mg/kg every 3 weeks plus placebo | 56 (40% EGFR TKI) | 3.7 months (HR, 0.72) | 13.9 (HR, 0.9) | |||||||
| IFCT-GFPC 050233* | 2010 | Cisplatin 80 mg/m2 on day 1 plus gemcitabine 1,250 mg/m2 on days 1 and 8 every 3 weeks × 4 cycles | 834 | Erlotinib 150 mg PO daily | 155 | 63 (pemetrexed) | 2.9 months | .002 | 11.8 | |
| Observation | 155 | 82 (76% pemetrexed [15% RR]) | 1.9 months (HR, 0.82) | 10.7 (HR, 0.91) | ||||||
| WJTOG 020361 | 2010 | Platinum-based doublet chemotherapy × 3 cycles | 302 | Gefitinib | 172 | 65 | 4.6 months | < .001 | 13.7 | .11 |
| Platinum-based doublet chemotherapy for up to 6 cycles | 301 | Observation | 73 (54% EGFR TKI) | 4.3 months (HR, 0.68) | 12.9 (HR, 0.86) | |||||
| EORTC 08021– ILCP 01/0362 | 2010 | Platinum-based doublet × 4 cycles | 173 | Gefitinib 250 mg PO daily | 86 | NR | 4.1 months | .002 | 10.9 | .20 |
| Placebo | 87 | NR | 2.9 months (HR, 0.61) | 9.4 (HR, 0.81) | ||||||
| INFORM (C-TONG 0804)63 | 2011 | Platinum-based doublet × 4 cycles | 298 | Gefitinib 250 mg PO daily | 148 | NR | 4.8 months | < .001 | 18.7 | .26 |
| Placebo | 148 | 32 (EGFR TKI) | 2.6 months (HR, 0.42) | 16.9 (HR, 0.84) | ||||||
| CALGB 30607 | Ongoing | Platinum-based chemotherapy × 4 cycles | 244 | Sunitinib 37.5 mg PO daily | ||||||
| Placebo | ||||||||||
Abbreviations: CALGB, Cancer and Leukemia Group B; C-TONG, Chinese Thoracic Oncology Group; EGFR, epidermal growth factor receptor; EORTC, European Organisation for Research and Treatment of Cancer; HR, hazard ratio; IFCT-GFPC, Intergroupe Francophone de Cancerologie Thoracique–Groupe Francais de Pneumo-Cancerologie; ILCP, Italian Lung Cancer Project; NR, not reported; OS, overall survival; PFS, progression-free survival; PO, oral; RR, response rate; TKI, tyrosine kinase inhibitor; SATURN, Sequential Tarceva in Unresectable Non–Small-Cell Lung Cancer; WJTOG, West Japan Thoracic Oncology Group.
IFCT-GFPC 0502 was a three-arm trial randomly assigning patients to maintenance gemcitabine, maintenance erlotinib, or observation. The active maintenance therapy arms were individually compared with observation. Results from the maintenance gemcitabine arm are listed in Table 3.