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INTERLEUKIN-2/LAK THERAPY ADJUVANT USE IN ADVANCED CANCERS

Executive Summary

INTERLEUKIN-2/LAK THERAPY ADJUVANT USE IN ADVANCED CANCERS is being considered by the National Cancer Institute's Division of Caner Treatment as part of a continued expansion of the applications of the interleukin-2 (IL-2)/lymphokine activated killer (LAK) cell therapy. Robert Wittes, Division of Cancer Treatment associate director for cancer therapy evaluation, outlined proposed adjuvant studies at the June 2 meeting of the division's board of scientific counselors. According to Wittes, "it seems appropriate now to consider whether the [IL-2/LAK] regimen should be put into large-scale adjuvant studies." Melanoma and colorectal metastases would be likely candidate diseases for using IL-2/LAK post-surgically, "when all gross disease has been cleared," Wittes told the board. NCI clinical investigator Steven Rosenberg, who pioneered the therapy, currently is conducting small-scale adjuvant studies in patients with these tumors at NIH, Wittes said. The adjuvant use of IL-2/LAK is one of several experimental options for the therapy being considered by NCI. IL-2/LAK also is being offered for use in NCI-designated cancer centers under a modified Group C distribution mechanism recently approved by FDA ("The Pink Sheet" April 27, p. 3). Although Wittes supported the concept of using IL-2/LAK in an adjuvant setting, he said questions remained about its efficacy. "I think that one could legitimately question whether regimens that produce response rates in the ranges that we're talking about are likely to be highly effective adjuvants." Response rates in NCI intramural and extramural trials of IL-2/LAK in renal cell cancer and melanoma have ranged between 15% and 30%. John Niederhuber, Johns Hopkins University Medical School, summarized the concerns expressed by several board members: "I have real problems with taking this to an adjuvant setting. . . I think there are so many negative that we would be better off to concentrate on looking at the broader spectrum of [IL-2/LAK] activity." Division of Cancer Treatment Director Bruce Chabner echoed the board's reservations, commenting that the therapy "is extremely toxic and costly, and I think probably . . . we need to wait and reassess" plans to expand the experimental use of IL-2/LAK. According to Wittes, developmental studies currently are underway in the division to find better-tolerated regimens for the therapy. Wittes also described NCI plans to fund Phase II trials of IL-2/LAK in patients with other tumors. The clinicals, which are slated to be conducted under contract by six or seven NCI-funded institutions, will test cohorts of six to eight patients across 20 to 25 different tumor types. The estimated NCI budget for IL-2/LAK activities is approximately $14.1 mil. in fiscal 1987 and is expected to increase to about $16.1 mil. in FY 1988, Wittes said.
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