Patients are randomized within 16 weeks of completing chemoradiation therapy with or without subsequent neck dissection to receive afatinib (40mg, orally, every week) or placebo. This treatment regimen continues for 18 months in the absence of disease recurrence, second primary tumors, or intolerance to the study medication. “Dose escalation to 50mg every day is undertaken in patients with no side effects, and stepwise dose reduction to 30 or 20mg orally every day for diarrhea, skin toxicity or other adverse events is permitted, until patients have reached a primary end point of disease-free survival (DFS),” the investigators wrote.

“We know the EGFR and its family members to be good targets in head and neck cancers, and the hypothesis here is that prolonged exposure to EGFR/HER2 inhibitor may reduce the risk of recurrence,” said Dr. Burtness. “This is an idea that people had in the past with cetuximab, but we had data from ECOG that patients did not show up for prolonged cetuximab after chemoradiation therapy. So the availability of an oral EGFR inhibitor really seems to be a marvelous new opportunity for us.”   


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References

1. National Cancer Institute. A Snapshot of Head and Neck Cancer. http://www.cancer.gov/aboutnci/servingpeople/snapshots/head-neck.pdf. Updated October 2011. Accessed July 19, 2012.

2. National Cancer Institute. SEER Stat Fact Sheets: Esophagus. http://seer.cancer.gov/statfacts/html/esoph.html. Accessed July 19, 2012.

3. Waddell TS, Chau I, Barbachano Y, et al. A randomized multicenter trial of epirubicin, oxaliplatin, and capecitabine (EOC) plus panitumumab in advanced esophagogastric cancer (REAL3). Paper presented at: 2012 American Society for Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago, IL. http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=94595. Accessed July 19, 2012.

4. Ueda S, Hironaka S, Yasui H, et al. Randomized phase III study of irinotecan (CPT-11) versus weekly paclitaxel (wPTX) for advanced gastric cancer (AGC) refractory to combination chemotherapy (CT) of fluoropyrimidine plus platinum (FP): WJOG4007 trial. Paper presented at: 2012 American Society for Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago, IL. http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=92145. Accessed July 19, 2012.

5. Burtness B, Bourhis J, Vermorken IB, et al. LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients. Paper presented at: 2012 American Society for Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago, IL. http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=91801. Accessed July 19, 2012.