Biochemotherapy with low doses of subcutaneous interleukin-2 in patients with melanoma: results of a phase II trial.
BACKGROUND
Metastatic melanoma has an ominous prognosis. Bio-chemotherapy regimens can increase the response rate but with a high degree of toxicity due, mainly, to the use of high-dose intravenous interleukin-2.


OBJECTIVE
To test the feasibility and activity profile of a bio-chemotherapy regimen of low-dose subcutaneous interleukin-2.


METHODS
Administration scheme: dacarbazine at 200 mg/m2/d on days 1-4, cisplatin at 20 mg/m2/d intravenous on days 1-4, vinblastine at 1.5 mg/m2/d on days 1-4, IL-2 at 4.5 MUI/m2/d subcutaneous on days 5-8, IFN-alpha at 5 MU subcutaneous on days 5-9, 11, 13, 15 of every 21-day cycle.


RESULTS
Objective response was obtained in 11 patients (39.3%; 95%CI: 21-59) including 4 with complete response (14.3%; 95%CI: 4-33). With an extended follow-up of 49 months and 60 months, respectively, 2 patients continue with complete response. The main toxicities were haematological: grade 3-4 neutropenia in 8.2% of cycles, thrombocytopenia in 1.2% and anaemia in 3.2%.


CONCLUSIONS
The regimen is safe and has a good activity profile. The presence of long-term survivors, despite the use of lower doses and subcutaneous IL-2, is encouraging.
González Cao
María
M
Servicio de Oncología Médica (ICHMO), Hospital Clinic, Barcelona, IDIBAPS, Spain.
Puig
Susana
S
Malvehy
Josep
J
Herrero
Josep Eugeni
JE
Martí
Rosa María
RM
Conill
Carlos
C
Sánchez
Marcelo
M
Mellado
Begoña
B
Gascón
Pere
P
Castel
Teresa
T
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy / Q000473:pathology; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage
D007155:Immunologic Factors; D016898:Interferon-alpha; D007376:Interleukin-2; D014747:Vinblastine; D003606:Dacarbazine; D002945:Cisplatin