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A single-centre experience of patients with metastatic melanoma enrolled in a dabrafenib named patient programme

Lau, David K.a; Andrews, Miles C.a; Turner, Nataliea; Azad, Arun A.a; Davis, Ian D.a,b; Cebon, Jonathan S.a

doi: 10.1097/CMR.0000000000000036
ORIGINAL ARTICLES: Clinical research

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

Correspondence to Jonathan S. Cebon, Ludwig Institute for Cancer Research – Austin Branch, Level 5, Joint Ludwig-Austin Medical Oncology Unit, Olivia Newton John Cancer and Wellness Centre, 145-163 Studley Road, Heidelberg, Victoria 3084, Australia Tel: +61 3 9496 5763; fax: +61 3 9457 6698; e-mail:

Received August 29, 2013

Accepted October 18, 2013

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins