Journal of Clinical Oncology, Vol 10, 1919-1926, Copyright © 1992 by American Society of Clinical Oncology
A promising interferon plus four-drug chemotherapy regimen for metastatic melanoma
S Pyrhonen, M Hahka-Kemppinen and T Muhonen
Department of Radiotherapy and Oncology, Helsinki University Central Hospital, Finland.
PURPOSE: The goal of this study was to determine the therapeutic efficacy
and toxicity of a four-drug chemotherapy regimen combined with natural
leukocyte interferon alfa (IFN-alpha) for metastatic melanoma. PATIENTS AND
METHODS: Between December 1988 and December 1991, 48 consecutive unselected
patients with metastatic melanoma were entered onto this phase II study.
Forty-five of these patients were assessable for response and 46 for
toxicity. The four-drug chemotherapy regimen was as follows: dacarbazine
(DTIC) 200 mg/m2 days 1 to 5, vincristine 1 mg/m2 days 1 and 4, bleomycin
15 mg days 2 and 5 intravenously (IV), and lomustine (CCNU) 80 mg day 1
orally. IFN-alpha, initiated day 8, was administered 3 x 10(6) IU/d,
subcutaneously (SC) for 6 weeks, followed by 6 x 10(6) IU three times per
week. A small protocol modification was adopted from the 21st patient
onwards whenever there was more than 2 months' stabilization or progression
with the original protocol: IFN therapy was split into 2-week treatment
periods interrupted by a 2-week rest period. RESULTS: Among the 45
assessable patients, the objective response rate was 62% (95% confidence
limit, 48 to 77); six patients (13%) achieved a complete response (CR) and
22 (49%) a partial response (PR). Metastases in such sites as liver also
responded favorably (one CR, six PR, one stable disease [SD], two
progressive disease [PD]). After splitting IFN therapy for nonresponders,
in two patients PD and in another two patients SD changed into regression.
Three of the six patients with a CR have suffered a relapse, but the other
three have been off treatment for 7, 18, and 31 months without recurrence.
Most of the symptomatic patients also experienced rapid relief of symptoms.
Overall toxicity of this mainly outpatient regimen seemed to be acceptable.
One patient died of a septic fever with grade 4 leukopenia and
thrombocytopenia. The most frequent side effects were transient fever,
nausea/vomiting, fatigue, and grade I/II hematologic toxicity. CONCLUSION:
Results demonstrate a remarkably high response rate in combining IFN-alpha
and four chemotherapeutic agents. The apparent schedule-dependency of
responses must be further explored in a controlled phase III study.
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