Four-month course of adjuvant dabrafenib in patients with surgically resected stage IIIC melanoma characterized by a BRAFV600E/K mutation
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Parisa Momtaz1, James J. Harding1,2, Charlotte Ariyan1,2, Daniel G. Coit1,2, Taha Merghoub1, Billel Gasmi1, Daoqi You1, Agnes Viale1, Katherine S. Panageas1, Aliaksandra Samoila1, Michael A. Postow1,2, Jedd D. Wolchok1,2 and Paul B. Chapman1,2
1Memorial Sloan Kettering Cancer Center, New York, New York, USA
2Weill Cornell Medical College, New York, New York, USA
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
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.
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