Randomized Phase II Study of Palifermin for Reducing Dysphagia in Patients Receiving Concurrent Chemoradiotherapy for Locally Advanced Unresectable Non-small Cell Lung Cancer
Cet essai randomisé de phase II (49 cas et 46 témoins) évalue la toxicité et l'efficacité de la palifermine dans le traitement d'une dysphagie chez les patients atteints d'un cancer du poumon non à petites cellules de stade III et recevant une chimioradiothérapie concomittante
Introduction: Dysphagia is a common, dose-limiting toxicity of combined chemoradiotherapy (CT/RT) in patients with locally advanced non-small cell lung cancer (NSCLC). This study assessed the efficacy and safety of palifermin in reducing dysphagia from CT/RT followed by consolidation chemotherapy (CT). Methods: This randomized, double-blind, phase II trial enrolled adults with unresectable stage III NSCLC. Subjects received weekly paclitaxel (50 mg/m2) and carboplatin (AUC 2.0) with concurrent daily radiation (RT) of 6000 to 6600 cGy, followed by consolidation CT. Palifermin (n = 49) or placebo (n = 46) was administered before starting concurrent CT/RT and once weekly for 6 weeks. The primary end points were the incidence of grade >=2 dysphagia and safety. Results: The incidence of grade >=2 and >=3 dysphagia was numerically lower in palifermin subjects versus placebo subjects (61% versus 70%; p = 0.36; 22% versus 28%, p = 0.50, respectively). Mean duration of dysphagia (grade >=2) was 25 days for palifermin subjects and 32 days for placebo subjects (p = 0.32). The incidence of adverse events was similar in the two treatment groups, and median overall survival and progression-free survival were not adversely affected by palifermin treatment (overall survival: 513 versus 319 days; progression-free survival: 262 versus 235 days for palifermin versus placebo arms, respectively). The palifermin arm received more doses of CT per study design and significantly more patients received RT doses >=6000 cGy (84% versus 61%, p = 0.01). Conclusions: The results of this exploratory trial suggest that additional larger studies may be warranted to further evaluate the effect of palifermin on dysphagia, exposure to CT/RT, and long-term survival. (C) 2011International Association for the Study of Lung Cancer