Table 4. Comparison of PROFILE trials and real world experience.
| Clinical studies | PROFILE 1005 | PROFILE 1007 | PROFILE 1014 | PROFILE 1029 | Current case series |
|---|---|---|---|---|---|
| Study design | Phase 2, 2nd line | Phase 3, 2nd line | Phase 3, 1st line | Phase 3, 1st line, East Asian | Case series, 1st line, 2nd line & beyond |
| Treatment | Crizotinib | Crizotinib vs. pemetrexed or docetaxel | Crizotinib vs. pemetrexed with cisplatin or carboplatin | Crizotinib vs. pemetrexed-cisplatin/carboplatin | Crizotinib |
| ORR | 53% | 65% vs. 20% (P<0.001) | 74% vs. 45% (P<0.001) | 88% vs. 46% (P<0.0001) | 64% |
| Median DOR | 43 weeks | Not given | 11.3 vs. 5.3 months | 44 vs. 18 weeks (P<0.0001) | 34 weeks (8.5 months) |
| Median PFS | 8.5 months | 7.7 vs. 3.0 months (HR 0.49, P<0.001) | 10.9 vs. 7.0 months (HR 0.45, P<0.001) | 11.1 vs. 6.8 months (HR 0.40, P<0.0001) | 8 months, overall; 15 months, upfront crizotinib |
| Median OS | Not assessed | 20.3 vs. 22.8 months (HR 1.02, P=0.54, NS); median follow up 12 months | 45.8 to NR vs. 47.5 to NR months (HR 0.76, P=0.978); median follow up 46 months | 28.5 vs. 27.7 months (HR 0.09, P=0.33); median follow up 33 months | Not reached (for upfront crizotinib; median follow up 18 months |
ORR, higher objective response rates; DOR, duration of response; PFS, progression-free survival; OS, overall survival; NS, not significant; NR, not reached.