Table 3.
Second- and Third-Line Efficacy Outcomes
| Reference | Study | Treatment Line | Intervention | Primary Outcome | No. of Patients Analyzed | OS | PFS | Response Rate (CR + PR) |
|
|---|---|---|---|---|---|---|---|---|---|
| No. | % | ||||||||
| Garassino et al41 | TAILOR | Second | Erlotinib | OS | 109 | Median, 5.4 months (95% CI, 4.5 to 6.8) | Median, 2.4 months (95% CI, 2.1 to 2.6) | 3a | 3.0 |
| Docetaxel | 110 | Median, 8.2 months (95% CI, 5.8 to 10.9) | Median, 2.9 months (95% CI, 2.4 to 3.8) | 15 | 15.5 | ||||
| Statistics and significance | HR, 0.78 (95% CI, 0.51 to 1.05; P = .10) | HR, 0.7 (95% CI, 0.55 to 0.94; P = .01) | P = .003 | ||||||
| Shaw et al56 | Second | Crizotinib | PFS | 173 | Median, 20.3 months (95% CI, 18.1 to not reached) | Median, 7.7 months (95% CI, 6.0 to 8.8) | 112 | 65.0 | |
| Chemotherapy (pemetrexed or docetaxel) | 174 | Median, 22.8 months (95% CI, 18.6 to not reached) | Median, 3.0 months (95% CI, 2.6 to 4.3) | 34 | 20.0 | ||||
| Statistics and significance | HR, 1.02 (95% CI, 0.68 to 1.54; P = .54)b | HR, 0.49 (95% CI, 0.37 to 0.64; P < .001) | P < .001c | ||||||
| Miller et al15 | Lux-Lung 1 | Second, third, and beyond | Afatinib | OS | 390 | Median, 10.8 months (95% CI, 10.0 to 12.0) | Median, 3.3 months (95% CI, 2.79 to 4.40) | 29d | 7.0 |
| Placebo | 195 | Median, 12.0 months (95% CI, 10.2 to 14.3) | Median, 1.1 months (95% CI, 0.95 to 1.68) | 1d | 0.5 | ||||
| Statistics and significance | HR, 1.08 (95% CI, 0.86 to 1.35; P = .74) | HR, 0.38 (95% CI, 0.31 to 0.48; P < .001) | P = .0071e | ||||||
| Quoix et al53 | IFCT-0501 | First and second | Carboplatin plus taxol | OSf | 226 (144 received second line) | Median, 10.3 months (95% CI, 8.3 to 12.6) | Median, 6.0 months (95% CI, 5.5 to 6.8) | NR | 27.1 |
| Vinorelbine or gemcitabine | 225 (145 received second line) | Median, 6.2 months (95% CI, 5.3 to 7.3) | Median, 2.8 months (95% CI, 2.6 to 3.7) | NR | 10.2 | ||||
| Statistics and significance | HR, 0.64 (95% CI, 0.52 to 0.78; P < .001) | P < .001 | P < .001g | ||||||
| Garon et al57 | REVEL | Second | Ramucirumab plus docetaxel | OS | 628 | Median, 10.5 months (IQR, 5.1 to 21.2) | Median, 4.5 months (IQR, 2.3 to 8.3)h | 144 | 23.0 |
| Placebo plus docetaxel | 625 | Median, 9.1 months (IQR, 4.2 to 18) | Median, 3 months (IQR, 1.4 to 6.9)i | 85 | 14.0 | ||||
| Statistics and significance | HR, 0.86 (95% CI, 0.75 to 0.98; P = .023) | HR, 0.76 (95% CI, 0.68 to 0.86; P < .001) | P < .001 | ||||||
Abbreviations: CR, complete response; HR, hazard ratio; IFCT, Intergroupe Francophone de Cancérologie Thoracique; IQR, interquartile range; NR, not reported; OS, overall survival; PFS, progression-free survival; PR, partial response.
a
Disease control rate.
b
Interim analysis.
c
Intention to treat.
d
PR.
e
Confirmation of response rate was reported separately by independent review and investigator assessment.
f
Survival was censored at last follow-up or at final analysis.
g
Response was assessable in 418 patients: 215 in monotherapy group and 203 in doublet group.
h
Censoring, 11.1%.
i
Censoring, 6.7%.