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Health-Related Outcomes Reported for Afatinib in Advanced NSCLC

Drug’s effect on cough, dyspnea, and pain presented at ESMO congress (Sept. 28)

On September 28, Boehringer Ingelheim, based in Ridgefield, Conn., announced new patient-reported health-related outcomes, including lung cancer-related symptoms and quality of life (QOL), for its investigational oncology compound afatinib. These data are secondary endpoints of the phase III LUX-Lung 3 trial of afatinib (n = 230) compared with chemotherapy (pemetrexed/cisplatin; n = 115) in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non–small-cell lung cancer (NSCLC).

The new data will be featured as a poster presentation at the European Society for Medical Oncology (ESMO) 2012 Congress on Sunday, September 30.

According to the study abstract, three lung cancer symptoms — cough, dyspnea (shortness of breath), and pain — were analyzed using the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire for lung cancer (QLQ-LC13). The results showed that a higher proportion of afatinib-treated patients had 10-point or greater improvements in cough (67% vs. 60%; P = 0.2444), dyspnea (64% vs. 50%; P = 0.0103), and pain (59% vs. 48%; P = 0.0513) compared with those treated with chemotherapy.

Patients treated with afatinib also reported a delay in the worsening (time to deterioration) of their cancer-related symptoms — cough (hazard ratio [HR], 0.60; P = 0.0072) and dyspnea (HR, 0.68; P = 0.0145) — compared with those treated with chemotherapy. The time to deterioration of pain was not significant between the two treatment arms (HR, 0.82; P = 0.1913). Mean symptom scores over time significantly favored afatinib over chemotherapy for cough and dyspnea.

Health-related QOL was measured using the EORTC QLQ-C30 questionnaire, which evaluates global health status/QOL (overall well-being) in addition to physical, cognitive, role, social, and emotional functioning. Of these six measures, patients treated with afatinib experienced improvements in their global health-related QOL and physical, cognitive, and role functioning compared with chemotherapy (P < 0.05).

Consistent with the safety profiles of afatinib and cisplatin/pemetrexed, afatinib-treated patients reported worse scores for diarrhea, sore mouth, and dysphagia, whereas patients treated with cisplatin/pemetrexed reported worse scores for fatigue, nausea, and vomiting.

Afatinib is an investigational, oral, once-daily irreversible ErbB-family blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2), and ErbB4. The drug is currently in phase III clinical development in advanced NSCLC, head-and-neck cancer, and breast cancer. Afatinib is not approved by the FDA, and its safety and efficacy have not been established. The company is working on a new drug application (NDA).

For more information, visit the Boehringer Ingelheim Web site.

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