A phase II study of 5,6-dihydro-5-azacytidine hydrochloride in disseminated malignant melanoma.
Forty patients with measurable disseminated malignant melanoma and no prior chemotherapy received monthly DHAC, 5 g/m2/24 h, as a continuous infusion. Among 26 "good risk patients" (ECOG performance score 0, 1 and no prior biological therapy), we observed 3 objective regressions. Among 14 "poor-risk patients" (ECOG PS 2 or prior biological therapy), we observed no objective regressions. For all patients, median time to progression and survival were 1 month and 6.7 months, respectively. Transient pleuritic chest pain and mild nausea and vomiting were the most common complications. We were especially impressed with a complete response (CR) for 11+ months in a 43-year-old woman with extensive visceral metastases and another CR lasting > 4.7 months in a 36-year-old woman with nonvisceral metastatic disease. The absence of myelosuppression raises intriguing possibilities for combination regimens including DHAC in the management of malignant melanoma.
Creagan
E T
ET
Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota 55905.
Schaid
D J
DJ
Hartmann
L C
LC
Loprinzi
C L
CL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001374:Azacitidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D001706:Biopsy; D002637:Chest Pain / Q000139:chemically induced; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D007262:Infusions, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D012074:Remission Induction; D012307:Risk Factors; D012720:Severity of Illness Index; D015996:Survival Rate; D014839:Vomiting / Q000139:chemically induced
D000964:Antimetabolites, Antineoplastic; D007155:Immunologic Factors; C013938:5,6-dihydro-5-azacytidine; D001374:Azacitidine