HOUSTON-Combining erlotinib (Tarceva) with chemotherapy for advanced head and neck cancer appears to boost response rates, according to early findings from a small phase II study. After two cycles of therapy with cisplatin(Drug information on cisplatin) , docetaxel(Drug information on docetaxel) (Taxotere), and erlotinib, 96% of patients in this trial had tumor shrinkage or stable disease, said Edward Kim, MD, and colleagues at The University of Texas M.D. Anderson Cancer Center in Houston. Dr. Kim, an assistant professor in the division of thoracic/head & neck medical oncology, presented the results (abstract 5546). By comparison, in other trials in small cell carcinoma of the head and neck (SCCHN), patients treated with cisplatin and docetaxel have had a response rate of 40% and erlotinib as a single agent has yielded a response rate of 4.3%. This ongoing study includes patients with metastatic or recurrent SCCHN who have had no prior EGFRtargeted therapy. Participants may have had one prior chemotherapy regimen but not for metastatic or recurrent disease. They receive cisplatin and docetaxel every 3 weeks and erlotinib daily. Interim Results With 27 of a planned 50 patients enrolled, the investigators were able to report on 22 evaluable patients who had completed two cycles of therapy. Three patients had a complete response, 14 had a partial response, and four had stable disease, for an "overall disease control rate" of 96%. Other toxicities associated with the chemotherapy/erlotinib combination have been manageable, the investigators reported; six patients had grade 3 neutropenia and one had grade 4 fe-brile neutropenia. The most common grade 1 and 2 toxicities have been diarrhea, nausea, and rash. EGFR is overexpressed in 80% to 90% of HNSCC tumors. The investigators plan to look for biomarkers in the EGFR signaling pathway, such as phosphorylated Akt, MEK, and K-ras, that may correlate with response tothis regimen. EGRF mutations have not been found in head and neck cancers, Dr. Kim said, but the investigators will look for other EGFR-related biomarkers, such as gene copy number. If the response data continue to hold up, he said, the next step could bea phase III trial with patients randomized to receive either cisplatin and docetaxel alone or cisplatin and docetaxel with erlotinib. A neoadjuvant regimen could also be considered, Dr. Kim said. Testing a Treatment Algorithm for Rash In this trial, Dr. Kim and colleagues are also testing a prospective treatment algorithm for rash, a common and sometimes serious adverse event associated with erlotinib and other tyrosine kinase inhibitors. The algorithm includes topical and oral antibiotics and steroids in different combinations and at different levels, depending on the type and severity of the rash. Of the 16 patients who had received treatment for rash at the time of Dr. Kim's presentation, most had responded either completely or partially.