A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1^st line or 2^nd line chemotherapy. A National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trial

Which biomarker predicts benefit from EGFR-TKI treatment for patients with lung cancer?

“…In a recent phase II trial of erlotinib conducted in Japan, possible ILD-like events were reported in four of 60 evaluable patients (6.7%) (Tamura et al, 2006), whereas ILD was reported in three of 485 in BR. 21 (Shepherd et al, 2004).…”

Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer

“…In 2004, Sheppard et al [85] presented data from a randomized placebo controlled trial of the EGFR inhibitor, Tarceva (erlotinib, OSI-774; Genentech) in patients with advanced non-small-cell lung cancer following failure of first-line or second-line chemotherapy and documented statistically significant and clinically relevant differences for overall and progression-free survival. Schilder (study chair for GOG-227D) is currently evaluating OSI-774, an orally active, potent, selective inhibitor of the EGFR tyrosine kinase, in patients with persistent or recurrent squamous cell cervical cancer.…”

HER1/EGFR Inhibitor-Associated Rash: Future Directions for Management and Investigation Outcomes from the HER1/EGFR Inhibitor Rash Management Forum

“…These considerations are summarized in Table 4. Clinical experience also shows that rash commonly occurs within the first 2 weeks of treatment [4,6,11,17,20,21], although time to first rash appearance may be related to the agent and dose [22]. There are frequent anecdotal reports of rash improving or resolving spontaneously, generally quite gradually, in spite of continued treatment [5,6,23].…”

“…In this trial, 6% of erlotinib-treated patients had dose reductions because of grade 3/4 rash, and only 1% of patients withdrew as a result of grade 3/4 rash or diarrhea. The findings from this large phase III trial suggest that adjusting the dose of erlotinib is a useful approach for managing severe rash with this agent [21,49].…”

“…The FDA approved gefitinib as third-line monotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of both platinum-based and docetaxel chemotherapies, and cetuximab for patients with irinotecan-refractory or intolerant metastatic colorectal cancer (CRC). Recent data from a phase III study of erlotinib HCl, a HER1/EGFR tyrosine kinase inhibitor, show it is the only HER1/EGFR-targeted agent to improve survival compared with placebo in patients with advanced/refractory NSCLC [1].…”