By Anthony J. Brown, MD
WESTPORT, CT (Reuters Health) – A once-daily outpatient regimen of IV interleukin-2 (IL-2) is a promising treatment for metastatic malignant melanoma, according to the results of a phase II trial reported in the July 1st issue of the Journal of Clinical Oncology.
Dr. Lawrence E. Flaherty, from Harper Hospital in Detroit, and colleagues assessed the treatment-related outcomes of 81 melanoma patients who were randomized to receive IV or SC interleukin-2.
Patients in both groups received once-daily IL-2 therapy on days 6 to 10 and 13 to 15 of the treatment cycle. The IV group received 18 MU/m² daily of IL-2 and the SC group received 5 MU/m² daily. All subjects also received dacarbazine, cisplatin, and interferon.
The objective response rate (ORR, meaning complete response or partial response) was 36% in the IV group and 17% in the SC group, the authors note. The median survival was 10.7 and 7.3 months, respectively. The incidence of toxicities was similar in the two groups.
"Although biochemotherapy regimens have shown good activity in patients with melanoma, we've been encumbered by the fact that all of the previous studies have involved inpatient regimens," Dr. Flaherty told Reuters Health. "An alternative to the inpatient IL-2 regimens is outpatient subcutaneous therapy, but we've never been convinced that this is the best approach," he said.
In the current study, Dr. Flaherty noted, "an IV dose of IL-2 was used that is very similar to the IV dose currently approved by the US Food and Drug Administration." However, "instead of giving it three times a day, which would require inpatient administration, we simply gave it once a day," he explained.
"This trial is not a phase III trial," Dr. Flaherty emphasized. "People often confuse a randomized phase II trial with a randomized phase III trial." The purpose of this trial was not to conclusively determine if one regimen was superior to the other, but rather to assist in selecting a regimen that warrants a phase III trial, he said.
"If the current ongoing trials establish inpatient biochemotherapy as a standard treatment for melanoma patients, then a logical next step would be to compare inpatient with outpatient regimens," Dr. Flaherty noted. Based on the current findings, an IV outpatient IL-2 regimen would be a likely phase III trial candidate, he said.
J Clin Oncol 2001;19:3194-3202.
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