- Phase III study (N = 173) of 1st-line erlotinib vs physician-choice standard chemotherapy in EGFR-mutant, advanced NSCLC
- Median PFS 9.7 vs 5.2 mo, ORR 58% vs 15%. No difference in OS, possibly due to crossover
- With the exceptions of rash and diarrhea, the toxicity profile favored erlotinib over chemotherapy
Like other studies for patients with EGFR mutations, this trial demonstrated in yet another population (European) that short-term outcomes such as response rate and PFS are better with a TKI than with chemotherapy as first-line treatment for metastatic disease. In this regard, most clinical investigators will opt for the TKI for patients with mutations even when rapid tumor response is needed (such as in rapidly progressive visceral disease), not only because of the efficacy advantage but also because of the oral administration and the low incidence of life-threatening toxicity. These and other data sets are rapidly pushing clinicians caring for patients with NSCLC to consider a breast cancer-like paradigm in which key potential treatment targets are measured in all tissue specimens and then the findings are used to guide every systemic decision made.
