This article is more than 5 years old. Information may no longer be current.
Biochemotherapy may be attractive alternative to interferon in high-risk melanoma
CHICAGO — A biochemotherapy regimen was linked to improved relapse-free survival rates and comparable OS rates as high-dose interferon therapy among a cohort of patients with high-risk melanoma, according to findings presented here.
Lawrence E. Flaherty, MD, of the Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, said efforts to modify interferon dose or schedule for the treatment of patients with melanoma have not resulted in improved efficacy. He said data from Wheatley and colleagues showed that biochemotherapy was linked to superior response rates compared with chemotherapy in patients with stage IV melanoma.
In the current phase 3 trial, the researchers aimed to compare a short course of biochemotherapy with high-dose interferon as adjuvant therapy in a cohort of patients with high-risk melanoma.
Eligible participants had high-risk disease, which was defined as stage IIIA-N2a to stage IIIC-N3. Patients were randomly assigned in a 1:1 ratio to high-dose interferon or biochemotherapy, which consisted of dacarbazine, cisplatin, vinblastine, interleukin-2 and interferon with granulocyte colony–stimulating factor.
Biochemotherapy cycles were given every 21 days for three cycles, for 9 weeks of treatment.
Stratification was based on the number of involved nodes (1-3 vs. ≥4), micro vs. macro metastasis and ulceration of the primary.
Relapse-free survival and OS served as co-primary endpoints.
The median follow-up duration was 6.25 years.
Biochemotherapy was linked to an improvement in relapse-free survival (HR=0.77; 90% CI, 0.62-0.96). The median relapse-free survival linked to biochemotherapy was 4 years (90% CI, 1.9-5.9) vs. 1.9 years in the interferon group (90% CI, 1.4-2.5). Five-year relapse-free survival rates were 47% in the biochemotherapy group and 39% in the interferon group.
No difference was observed between the two groups regarding median OS (HR=1.0; 90% CI, 0.78-1.27). Median OS has not yet been reached for biochemotherapy and was 8.4 years (90% CI, 4.5-9.3) in the high-dose interferon arm. Five-year survival was 56% in both arms.
“Biochemotherapy was associated with significantly more grade 3-4 hematologic, gastrointestinal and metabolic toxicity, and less grade 3-4 hepatic and neuro/psych toxicity,” Flaherty said.
Grade-3 and grade-4 adverse events occurred in 57% and 7% of patients in the interferon group, respectively. Grade-3 events occurred 36% and grade-4 events occurred in 40% of patients receiving biochemotherapy.
Flaherty concluded that biochemotherapy does not replace interferon as a standard of care. “However, it may be an attractive alternative,” he said. “For patients with high-risk melanoma, this treatment regimen is shorter and more intense and delays time to treatment progression by about 25% compared with the usual high-dose interferon. Perhaps more important for our research community is the ability to modify all elements of biochemotherapy. This is a template that we can move forward with easily and effectively.”
For more information:
Flaherty LE. #8504. Presented at: the 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago.
Disclosure: Dr. Flaherty reports being a consultant or serving as an adviser for and receiving honoraria and research funding from Merck and Novartis.