Premium
A multicenter phase II clinical trial using dacarbazine and continuous infusion lnterleukin‐2 for metastatic melanoma. Clinical data and immunomonitoring
Author(s) -
Dummer Reinhard,
Burg Günter,
Gore Martin E.,
Hancock Barry W.,
Guillou Pierre J.,
Grobben Heleen C.,
Oskam Ralph,
Dieleman Jeanne P.,
Becker Jürgen C.
Publication year - 1995
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19950215)75:4<1038::aid-cncr2820750421>3.0.co;2-f
Subject(s) - medicine , dacarbazine , nausea , vomiting , chemoimmunotherapy , gastroenterology , leukopenia , phases of clinical research , anemia , melanoma , surgery , clinical trial , cancer , chemotherapy , immunotherapy , cancer research
Background . Treatment of patients with metastatic melanoma with either dacarbazine or recombinant interleukin‐2 (rIL‐2) resulted in a response rate of approximately 15%. This study investigates the possible synergism of this chemoimmunotherapy combination. Methods . Fifty‐seven patients with metastatic malignant melanoma received 135 treatment cycles. Treatment consisted of dacarbazine (Days 1‐5) at 250 mg/m 2 by a 30‐minute slow infusion, and interleukin‐2 by constant intravenous infusion (Days 21‐25 and 28‐32) at 18 × 10 6 IU/m 2 /24 hours. After this treatment cycle, a 1‐week rest was scheduled, and in the absence of undue toxicity or tumor progression, patients received a second cycle as described. Maximum treatment consisted of two induction and four maintenance cycles. In a subgroup of patients, immunoparameters were analyzed to identify prognostic factors. Standard supportive care was given. Results . Common toxicities included fever, hypotension, nausea/vomiting, anemia, leukopenia, thrombocytopenia, an increase in serum lactic dehydrogenase levels and diarrhea. The objective response rate was 15.8% (one complete response and eight partial responses). In 14 patients, the disease stabilized. For patients who had an objective response, median response duration was 13.9 months (6.3‐39.0 + ), and median survival was 19.0 months (6.3‐39.0 + ); overall survival was 9.3 months (0.8‐39.0 + ). Immunomonitoring did not reveal any relevant prognostic factors for overall response. Conclusions . Sequential treatment with dacarbazine and rIL‐2 is feasible and produces long‐lasting responses 4 in a minority of patients. Cancer 1995;75:1038‐44.