A single-centre experience of patients with metastatic melanoma enrolled in a dabrafenib named patient programme.
We studied the efficacy, tolerability and clinical courses of dabrafenib in patients with metastatic melanoma who were ineligible for enrolment into a clinical trial. Between July 2011 and May 2013, patients with unresectable stage III or stage IV, V600-mutated metastatic melanoma who were not eligible for inclusion into clinical trials were offered treatment with dabrafenib through a named patient programme. Routine efficacy and toxicity data were collected throughout treatment and studied retrospectively. The endpoints were progression-free survival (PFS), overall survival and best overall response. Thirty-one patients commenced dabrafenib therapy including six individuals who had progressed on a prior BRAF-inhibitor treatment. The majority of patients had cerebral metastases (n=17) and/or a poor performance status [Eastern Cooperative Oncology Group (ECOG)≥2, n=11]. Median overall survival was 5.6 months (range 0.1-22 months). Median PFS was 3.3 months (range 0.1-21) and was similar despite performance status. One patient had a complete response and eight showed partial responses to treatment. Patients with cerebral metastases (n=17) had a median PFS of 4.6 months. Five patients (16%) had dose-limiting toxicities. Despite several poor prognostic features, dabrafenib is a safe and effective treatment in the community setting, with occasional impressive outcomes.
aLudwig Institute for Cancer Research - Austin Branch, Joint Ludwig-Austin Medical Oncology Unit, Olivia Newton John Cancer and Wellness Centre, Austin Health bEastern Health Clinical School, Monash University, Victoria, Australia.
David K
DK
Lau
Miles C
MC
Andrews
Natalie
N
Turner
Arun A
AA
Azad
Ian D
ID
Davis
Jonathan S
JS
Cebon
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D010091:Oximes / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D007093:Imidazoles; D010091:Oximes; C561627:dabrafenib