Work

Four-month course of adjuvant dabrafenib in patients with surgically resected stage IIIC melanoma characterized by a BRAFV600E/K mutation

Year: 2017

Type: article

Abstract: // Parisa Momtaz 1 , James J. Harding 1, 2 , Charlotte Ariyan 1, 2 , Daniel G. Coit 1, 2 , Taha Merghoub 1 , Billel Gasmi 1 , Daoqi You 1 , Agnes Viale 1 , Katherine S. Panageas 1 , Aliaksandra Samoila 1 , Michael A. Postow 1, 2 , Jedd D. Wolchok 1, 2 and Paul B. Chapman 1, 2 1 Memorial Sloan Kettering Cancer Center, New York, New York, USA 2 Weill Cornell Medical College, New York, New York, USA Correspondence to: Paul B. Chapman, email: [email protected] Keywords: cfDNA, digital PCR, drug cost, relapse-free survival Received: June 07, 2017 Accepted: July 25, 2017 Published: September 16, 2017 ABSTRACT Background: We tested the hypothesis that a 4-month course of adjuvant dabrafenib in stage IIIC BRAF-mutated melanoma would improve 2 year RFS from 24% to 51%, and that tumor-derived cell free DNA (cfDNA) in plasma would correlate with and predict recurrence. Methods: Patients with stage IIIC BRAF V600E/K mutated melanoma who were free of disease after surgical resection received 4 months of adjuvant dabrafenib. Patients were evaluated with imaging at baseline, at the end of cycles 2, 4, 6, then every 3 months until disease relapse or 2 years, whichever came first. Serial blood samples were collected for evaluation of cfDNA at the same time. Results: 21/23 patients enrolled were evaluable; 2 patients withdrew consent during the first week of treatment. The 2 year RFS was 28.6% (95% CI 12-48%). The estimated overall survival at 2 years was 78% (95% CI 51-91%). cfDNA detection had a 53% sensitivity in relapsing patients but cfDNA detection did not provide lead-time advantage over CT scanning. Conclusion: A 4-month course of adjuvant dabrafenib did not result in a detectable improvement in 2-year RFS. cfDNA was less sensitive than standard CT imaging and did not provide a lead-time advantage in detecting relapse.

Source: Oncotarget

DOI: 10.18632/oncotarget.21072