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 ≤ 0.005 at all measured time points) but not with OS (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.
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 ≤ 0.005 at all measured time points) but not with OS (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.
Authors: Sandra P D'Angelo; James Larkin; Jeffrey A Sosman; Celeste Lebbé; Benjamin Brady; Bart Neyns; Henrik Schmidt; Jessica C Hassel; F Stephen Hodi; Paul Lorigan; Kerry J Savage; Wilson H Miller; Peter Mohr; Ivan Marquez-Rodas; Julie Charles; Martin Kaatz; Mario Sznol; Jeffrey S Weber; Alexander N Shoushtari; Mary Ruisi; Joel Jiang; Jedd D Wolchok Journal: J Clin Oncol Date: 2016-11-07 Impact factor: 44.544
Authors: Shengwen Calvin Li; Lisa May Ling Tachiki; Mustafa H Kabeer; Brent A Dethlefs; Michael J Anthony; William G Loudon Journal: Cancer Cell Int Date: 2014-11-12 Impact factor: 5.722
Authors: Saif S Ahmad; Wendi Qian; Sarah Ellis; Elaine Mason; Muhammad A Khattak; Avinash Gupta; Heather Shaw; Amy Quinton; Jarmila Kovarikova; Kiruthikah Thillai; Ankit Rao; Ruth Board; Jenny Nobes; Angus Dalgleish; Simon Grumett; Anthony Maraveyas; Sarah Danson; Toby Talbot; Mark Harries; Maria Marples; Ruth Plummer; Satish Kumar; Paul Nathan; Mark R Middleton; James Larkin; Paul Lorigan; Matthew Wheater; Christian H Ottensmeier; Pippa G Corrie Journal: Melanoma Res Date: 2015-10 Impact factor: 3.599
Authors: Lisa Zimmer; Thomas K Eigentler; Felix Kiecker; Jan Simon; Jochen Utikal; Peter Mohr; Carola Berking; Eckhart Kämpgen; Edgar Dippel; Rudolf Stadler; Axel Hauschild; Michael Fluck; Patrick Terheyden; Rainer Rompel; Carmen Loquai; Zeinab Assi; Claus Garbe; Dirk Schadendorf Journal: J Transl Med Date: 2015-11-06 Impact factor: 5.531