Table V.
Previous phase II–III studies of platinum doublet and COX-2 inhibitor in NSCLC.
| Design | Author (year) | No. of patients | COX-2 inhibitor | Chemotherapy | Response rate (%) | Median PFS (months) | Median OS (months) | (Refs.) |
|---|---|---|---|---|---|---|---|---|
| Phase II | Edelman et al (2008) | 45 | Celecoxib | CBDCA+GEM | NA | 4.3a | 11.8 | (23) |
| Wang et al (2008) | 44 | Celecoxib | CDDP+GEM CDDP+VNR CDDP+DOC |
45.0 | 6.0 | 18.0 | (24) | |
| Suzuki et al (2009) | 44 | Meloxicam | CBDCA+PTX | 43.0 | 5.4b | 15.9 | (35) | |
| This study | 50 | Meloxicam | CBDCA+DOC | 36.0 | 5.7b | 13.7 | ||
| Phase III | Groen et al (2011) | 281 | Celecoxib | CBDCA+DOC | 38.0 | 4.5 | 8.2 | (21) |
| 280 | Placebo | 30.0 | 4.0 | 8.2 | ||||
| HR | 0.8 | 0.9 | ||||||
| 95% CI | 0.6–1.1 | 0.6–1.2 | ||||||
| P-value | 0.25 | 0.32 | ||||||
| Koch et al (2011) | 158 | Celecoxib | 3rd generation | 36.0 | 6.1 | 8.9 | (22) | |
| 158 | Placebo | Drug + platinum | 31.0 | 6.5 | 7.9 | |||
| HR | 1.01 | 1.0 | ||||||
| 95% CI | 0.77–1.33 | 0.79–1.26 | ||||||
| P-value | 0.94 | 0.97 |
a
Failure-free survival.
b
Time-to-progression.
COX-2, cyclooxygenase-2; NSCLC, non-small-cell lung cancer; PFS, progression-free survival; OS, overall survival; CBDCA, carboplatin; GEM, gemcitabine; NA, not available; CDDP, cisplatin; VNR, vinorelbine; DOC, docetaxel; PTX, paclitaxel; HR, hazard ratio to placebo; CI, confidence interval.