March 28, 2013
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Maintenance IL-2, GM-CSF may improve response in metastatic melanoma

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NEW YORK — Maintenance therapy with interleukin-2 and sargramostim may help extend positive outcomes in patients with metastatic melanoma who achieve partial response to high-dose interleukin-2 therapy, according to study results presented at the HemOnc Today Melanoma and Cutaneous Malignancies meeting.

Patients with metastatic melanoma who are treated at Saint Louis University Cancer Center and achieve partial response to high-dose interleukin-2 (HD IL-2) undergo monthly maintenance treatment in hopes the regimen will continue to stimulate the immune system and improve response.

To evaluate outcomes in these patients, researchers from the department of dermatology at Saint Louis University — under the direction of principal investigator John M. Richart, MD — performed a retrospective chart review of five patients treated at the center from January 1999 to June 2011.

All patients achieved partial response to HD IL-2 as defined by RECIST criteria, and then underwent maintenance treatment every 4 weeks for 13 cycles or until disease progression.

The IL-2 component of the regimen consisted of a continuous 42-hour infusion of three consecutive doses of 18 million IU/m2 over 6, 12 and then 24 hours. The sargramostim (granulocyte-macrophage colony–stimulating factor; Leukine, Berlex Laboratories) component included daily subcutaneous injection of 125 mcg/m2 for 3 days.

The median duration of response was 9 months (range, 3.9 to 53.4 months). An evaluation of a comparable cohort of patients who achieved partial response to HD IL-2 but did not undergo maintenance therapy showed a median response of 5.9 months (P=.068), according to the package insert HD IL-2.

Melinda Chu, MD 

Melinda B. Chu

“The difference was trending toward statistical significance,” researcher Melinda B. Chu, MD, told HemOnc Today.

Median OS among the maintenance therapy cohort evaluated by Chu and colleagues was 20.6 months (range, 15 to 53.4 months).

One patient who achieved partial response to HD IL-2 converted to complete response during the maintenance regimen and remains free of disease at 53.4 months, Chu said.

“Maintenance with IL-2 and GM-CSF should be considered,” Chu said. “Patients may convert to complete response, and this is an area worthy of additional study.”

For more information:

Chu MB. Abstract #6. Presented at: HemOnc Today Melanoma and Cutaneous Malignancies; March 22-23, 2013; New York.

 

Disclosure: Chu reports no relevant financial disclosures.