Information from the OPTIMAL and ENSURE trials
| Publication(s) | OPTIMAL (CTONG-0802, NCT00874419) | ENSURE (NCT01342965) | ||
| Lancet Oncol 2011; Ann Oncol 2015 | Ann Oncol 2015 | |||
| Design | Multicentre, phase III, randomly assigned (1:1) First-line treatment | Multicentre, phase III, randomly assigned (1:1) First-line treatment | ||
| Experimental | Erlotinib 150 mg/day | Erlotinib 150 mg/day | ||
| Active comparator | Gemcitabine+carboplatin up to four cycles | Gemcitabine+cisplatin up to four cycles | ||
| Primary outcome | PFS | PFS | ||
| Response evaluation criteria | RECIST V.1.0 | RECIST V.1.1 | ||
| Criteria for AE record | NCI-CTCAE V.3.0 | NCI-CTCAE V.4.0 | ||
| Population | 22 centres in China, advanced NSCLC (stage IIIB or stage IV) ECOG PS: 0–2 | 30 centres across China, Malaysia and the Philippines, advanced NSCLC (stage IIIB or stage IV) ECOG PS: 0–2 | ||
| Age | Older than 18 years | Older than 18 years | ||
| EGFR mutation | Exon 19 deletion or exon 21 L858R point mutation | Exon 19 deletion or exon 21 L858R mutation | ||
| Time period | 24 August 2008–17 July 2009 | March 2011–June 2012 | ||
| Erlotinib | Chemotherapy | Erlotinib | Chemotherapy | |
| N | 83 | 82 | 110 | 107 |
| Evaluable Pts | 82 | 72 | 110 | 107 (safety 104) |
| mPFS (m), 95% CI | 13.1 (10·58 to 16·53) | 4.6 (4·21 to 5·42) | 11.0 | 5.5 |
| HR, 95% CI | 0.16 (0.10 to 0.26) | 0.34 (0.22 to 0.51) | ||
| P value | <0.0001 | <0.0001 | ||
| mOS(m) 95% CI | 22.8 | 27.2 | 26.3 | 25.5 |
| HR, 95% CI | 1.19 (0.83 to 1.71) | 0.91 (0.63 to 1.31) | ||
| P value | 0.2663 | 0.607 | ||
| AEs | Favours erlotinib | Favours erlotinib | ||
AEs, adverse events; ECOG PS, Eastern Cooperative Oncology Group Performance Status; EGFR, epidermoid growth factor receptor; m, median; N, number; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; Pts, patients.