A feasibility study using polychemotherapy (cisplatin + vindesine + dacarbazine) plus interferon-alpha or monochemotherapy with dacarbazine plus interferon-alpha in metastatic melanoma.
OBJECTIVE
This trial evaluated the feasibility and tolerability of an immunochemotherapeutic approach that uses cisplatin, vindesine, and dacarbazine (DTIC), or only DTIC, in combination with interferon alpha-2a (IFN-alpha), in patients with metastatic melanoma, considering the significant toxicity of several different regimens used up to now.


METHODS
Between May 1995 and September 1997, 51 melanoma patients (50 of whom were assessable) entered a multicentric trial and were randomized to receive cisplatin (30 mg/m2 daily for 3 days) + vindesine (2.5 mg/m2 only day 1) + DTIC (250 mg/m2 daily for 3 consecutive days) + IFN-alpha (3 MIU i.m. 3x/wk continuously) (CVD arm) versus DTIC (800 mg/m2 day 1) + IFN-alpha (3 MIU i.m. 3x/wk continuously) (DTIC arm). The chemotherapy was recycled every 21 days. Patient reevaluation was performed every two cycles, and the treatment was continued in case of objective response or stabilization of disease.


RESULTS
We observed 3 complete responses, 2 partial responses and 5 stable diseases in the CVD arm, and 2 partial responses and 4 stabilizations of disease in the DTIC arm.


CONCLUSIONS
We conclude that these chemotherapeutic regimens are well tolerated regimens with modest toxicity. Future trials will be conducted associating the CVD regimen with biological response modifiers (IFN, IL-2) in order to improve the results.
Bajetta
E
E
Unit of Medical Oncology B, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy. bajetta@istitutotumori.mi.it
Del Vecchio
M
M
Vitali
M
M
Martinetti
A
A
Ferrari
L
L
Queirolo
P
P
Sertoli
M R
MR
Cainelli
T
T
Cellerino
R
R
Cascinelli
N
N
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007167:Immunotherapy; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage
D016898:Interferon-alpha; D003606:Dacarbazine; D002945:Cisplatin; D014751:Vindesine