PMID- 24999899 OWN - NLM STAT- MEDLINE DCOM- 20140904 LR - 20220317 IS - 1326-5377 (Electronic) IS - 0025-729X (Linking) VI - 201 IP - 1 DP - 2014 Jul 7 TI - Ipilimumab in pretreated patients with unresectable or metastatic cutaneous, uveal and mucosal melanoma. PG - 49-53 AB - OBJECTIVES: To evaluate the efficacy and tolerability of ipilimumab in an Australian clinical setting, and to assess the association of response with melanoma subtype, BRAF mutation status, absolute lymphocyte count and incidence of serious immune-related adverse events (AEs). DESIGN, SETTING AND PARTICIPANTS: Retrospective review of patients with unresectable or metastatic melanoma treated with ipilimumab at an Australian oncology centre between July 2010 and April 2012. MAIN OUTCOME MEASURES: Overall survival (OS), progression-free survival (PFS), incidence and severity of AEs. RESULTS: 104 patients were retrospectively followed for a median of 7 months (range 0-30 months). Median OS was 9.6 months (95% CI, 6.6-12.4), and median PFS was 3.0 months (95% CI, 2.7-3.4). The 1- and 2-year survival rates were 42% (95% CI, 32%-52%) and 18% (95% CI, 9%-30%), respectively. Median OS for patients with non-cutaneous (mucosal and uveal) melanomas was almost half that of patients with cutaneous melanoma: 5.8 months (95% CI, 2.8-12.4) v 11.7 months (95% CI, 7.1-13.8); P = 0.11. Raised absolute lymphocyte count was associated with increased PFS (P 0.15). Sex, age, brain metastases, BRAF mutation status, incidence of severe immune-related AEs and baseline lactate dehydrogenase levels did not affect OS or PFS (P > 0.05). Eighteen of 104 patients experienced serious AEs (>/= grade 3), including two treatment-related deaths. CONCLUSION: In an Australian clinical practice setting, ipilimumab achieved efficacy and tolerability measures similar to those reported in clinical trials. The frequency and severity of ipilimumab-related AEs (including death) are notable, and treatment should occur under the supervision of an experienced clinical team. FAU - Alexander, Marliese AU - Alexander M AD - Peter MacCallum Cancer Centre, Melbourne, VIC, Australia. Marliese.Alexander@petermac.org. FAU - Mellor, James D AU - Mellor JD AD - Peter MacCallum Cancer Centre, Melbourne, VIC, Australia. FAU - McArthur, Grant AU - McArthur G AD - Peter MacCallum Cancer Centre, Melbourne, VIC, Australia. FAU - Kee, Damien AU - Kee D AD - Peter MacCallum Cancer Centre, Melbourne, VIC, Australia. LA - eng PT - Journal Article PL - Australia TA - Med J Aust JT - The Medical journal of Australia JID - 0400714 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 0 (Ipilimumab) RN - EC 2.7.11.1 (BRAF protein, human) RN - EC 2.7.11.1 (Proto-Oncogene Proteins B-raf) SB - IM MH - Antibodies, Monoclonal/adverse effects/*therapeutic use MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - DNA Mutational Analysis MH - Disease Progression MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Humans MH - Ipilimumab MH - Lymphocyte Count MH - Melanoma/*drug therapy/genetics/mortality/pathology MH - *Mucous Membrane MH - Neoplasm Staging MH - Proto-Oncogene Proteins B-raf/genetics MH - Retrospective Studies MH - Skin Neoplasms/*drug therapy/genetics/mortality/pathology MH - Uveal Neoplasms/*drug therapy/genetics/mortality/pathology EDAT- 2014/07/08 06:00 MHDA- 2014/09/05 06:00 CRDT- 2014/07/08 06:00 PHST- 2013/04/08 00:00 [received] PHST- 2013/11/06 00:00 [accepted] PHST- 2014/07/08 06:00 [entrez] PHST- 2014/07/08 06:00 [pubmed] PHST- 2014/09/05 06:00 [medline] AID - 10.5694/mja13.10448 [pii] AID - 10.5694/mja13.10448 [doi] PST - ppublish SO - Med J Aust. 2014 Jul 7;201(1):49-53. doi: 10.5694/mja13.10448.