Personalized Vaccines May Protect Patients With High-Risk Melanoma

Excerpt:

“The field of cancer vaccines may be reinvigorated by a new understanding, and the therapeutic leveraging, of neoantigens. Researchers from Dana-Farber Cancer Institute in Boston are exploring this novel approach as a means of protecting patients with high-risk melanoma from recurrence. Early results from a phase I study were reported at the 2nd International Cancer Immunotherapy Conference by Patrick A. Ott, MD, PhD, Clinical Director of the Melanoma Center and the Center for Immuno-Oncology.”

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Adjuvant Ipilimumab Improves Survival in High-Risk Melanoma

Excerpt:

“Patients with stage III melanoma who were considered to be at high risk for recurrence derived an overall survival benefit from adjuvant treatment with ipilimumab (Yervoy), although it came at the price of considerable toxicity, according to updated survival results from the phase III European Organisation for Research and Treatment (EORTC) 18071 trial. The results were presented at the 2016 European Society for Medical Oncology (ESMO) Congress by Alexander Eggermont, MD, Director General of the Institut Gustave Roussy in Villejuif, France, and simultaneously published in The New England Journal of Medicine.

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Ipilimumab Improves Survival in High-Risk Stage III Melanoma After Surgery

“Results of an EORTC trial appearing in The Lancet Oncology show that adjuvant Ipilimumab significantly improves recurrence-free survival in patients with completely resected stage III melanoma at high risk of disease recurrence, but that this treatment was also associated with a high rate of immune-related adverse events.

“Prof Alexander M M Eggermont of the Gustave Roussy Cancer Campus and lead author of this study says, ‘Ipilimumab has already been approved as a treatment for patients with advanced melanoma. Our intention with this study was to assess Ipilimumab as an adjuvant treatment for patients with completely resected stage III melanoma at high risk of recurrence. In my experience, this marks both the first clinical trial of an approved drug with an effect on survival in advanced melanoma in the adjuvant setting, and, in this same setting, the first to study an immune checkpoint inhibitor in the adjuvant setting. Our results show that Ipilimumab is active in the adjuvant setting, but the side-effects are considerable.’

“Between 2008 and 2011, the double-blind, phase III EORTC trial 18071 accrued 951 patients who were randomly assigned to receive either Ipilimumab (475 patients) or placebo (476 patients). All patients were included in the intention-to-treat analyses. At a median follow-up of 2.74 years, the median recurrence-free survival was 26.1 months (95% confidence interval (CI) 19.3 – 39.3) in the Ipilimumab group and 17.1 months (95% CI 13.4 – 21.6) in the placebo group (hazard ratio 0.75; 95% CI 0.64 – 0.90; p = 0.0013). The 3-year recurrence-free survival rate was 46.5% (95% CI 41.5 – 51.3) in the Ipilimumab group and 34.8% (30.1 – 39.5) in the placebo group.”


Briefer Biochemotherapy Yields Better Relapse-Free Survival but Greater Toxicity vs 1-Year High-Dose Interferon in High-Risk Melanoma

The gist: Compared to a standard treatment, an alternative, shorter treatment for stage III melanoma may lengthen the amount of time patients go without their cancer returning. However, it has more toxic side effects. And compared to the standard, it doesn’t lengthen life. The alternative treatment uses the drugs cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b. In a clinical trial with volunteer patients, it was compared to longer (1-year), high-dose treatment with the drug interferon alfa-2b. The trial involved people aged 10 years and older with stage IIIA-N2a through IIIC-N3 melanoma.

“In a phase III trial (Southwest Oncology Group Intergroup S0008) reported in the Journal of Clinical Oncology, Flaherty et al found that a shorter course of biochemotherapy consisting of cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b produced better relapse-free survival, but not overall survival, and was associated with greater toxicity compared with a 1-year high-dose interferon alfa-2b regimen in patients with high-risk melanoma. The trial is a Cancer and Leukemia Group B, Children’s Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group Intergroup study…

“In the trial, 402 patients aged ≥ 10 years with stage IIIA-N2a through IIIC-N3 melanoma were randomly assigned between September 2000 and November 2007 to receive biochemotherapy plus granulocyte colony-stimulating factor given every 21 days for three cycles (n = 199) or high-dose interferon alfa-2b intravenously 5 days per week for 4 weeks and subcutaneously three times per week for 48 weeks (n = 203). The coprimary endpoints were relapse-free survival and overall survival.

“The high-dose interferon and biochemotherapy groups were generally balanced for age (median, 48 and 46 years), sex (69% and 71% male), race/ethnicity (96% and 95% white), number of involved nodes (1–3 or satellite/in-transit only in 76% in both), nodal involvement (micrometasteses only in 43% and 44%), and ulceration (41% in both)…

“The investigators concluded: ‘Biochemotherapy is a shorter, alternative adjuvant treatment for patients with high-risk melanoma that provides statistically significant improvement in [relapse-free survival] but no difference in [overall survival] and more toxicity compared with [high-dose interferon].’ ”