Four-month course of adjuvant dabrafenib in patients with surgically resected stage IIIC melanoma characterized by a BRAFV600E/K mutation Journal Article
| Authors: | Momtaz, P.; Harding, J. J.; Ariyan, C.; Coit, D. G.; Merghoub, T.; Gasmi, B.; You, D.; Viale, A.; Panageas, K. S.; Samoila, A.; Postow, M. A.; Wolchok, J. D.; Chapman, P. B. |
| Article Title: | Four-month course of adjuvant dabrafenib in patients with surgically resected stage IIIC melanoma characterized by a BRAFV600E/K mutation |
| 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 leadtime 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. © Momtaz et al. |
| Keywords: | adult; cancer survival; clinical article; controlled study; human tissue; treatment response; aged; middle aged; young adult; gene mutation; overall survival; fatigue; diarrhea; drug efficacy; drug safety; hypophosphatemia; treatment duration; cancer adjuvant therapy; cancer staging; outcome assessment; sensitivity and specificity; anorexia; melanoma; phase 2 clinical trial; anemia; leukopenia; nausea; neuropathy; vomiting; myalgia; arthralgia; chill; fever; pruritus; rash; drug cost; insomnia; dna; headache; hot flush; cancer epidemiology; dyspepsia; hand foot syndrome; dry skin; alopecia; dna determination; photophobia; blurred vision; dysgeusia; sore throat; recurrence free survival; hypertransaminasemia; photosensitivity disorder; relapse-free survival; dabrafenib; faintness; human; male; female; article; digital pcr; x-ray computed tomography; cfdna; abducens nerve disease |
| Journal Title: | Oncotarget |
| Volume: | 8 |
| Issue: | 62 |
| ISSN: | 1949-2553 |
| Publisher: | Impact Journals |
| Date Published: | 2017-12-01 |
| Start Page: | 105000 |
| End Page: | 105010 |
| Language: | English |
| DOI: | 10.18632/oncotarget.21072 |
| PROVIDER: | scopus |
| PMCID: | PMC5739615 |
| PUBMED: | 29285228 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 January 2018 -- Source: Scopus |
