Phase II multicenter study of neoadjuvant biochemotherapy for patients with stage III malignant melanoma.
OBJECTIVE
To determine the relapse-free survival, overall survival, and response rate of patients with stage III melanoma treated with neoadjuvant biochemotherapy in a multicenter setting.


METHODS
Patients with pathologically proven stage III melanoma, either via clinical detection or sentinel lymph node positivity, were eligible for enrollment. Patients received two cycles of preoperative biochemotherapy followed by complete regional lymphadenectomy and two postoperative courses of biochemotherapy. The biochemotherapy regimen consisted of the following: cisplatin 20 mg/m2 on days 1 to 4, dacarbazine 800 mg/m2 on day 1 only, vinblastine 1.6 mg/m2 on days 1 to 4, interleukin-2 total dose of 36 MU/m2 during 4 days, and interferon alfa 5 MU/m2 on days 1 to 5. Growth factor support was administered with each cycle.


RESULTS
Ninety-two patients were eligible for the study. At a median follow-up of 40.4 months, relapse-free survival and overall survival are 64% and 78%, respectively. There was a lower relapse rate and improved survival for patients with a positive sentinel lymph node compared with patients with clinically detected lymph nodes, although this difference did not reach statistical significance. Of the 50 patients with measurable disease, the overall response rate was 26%. Toxicity of the biochemotherapy was high but generally manageable.


CONCLUSIONS
The current study has expanded the preliminary evidence on neoadjuvant biochemotherapy for stage III melanoma.
Lewis
Karl D
KD
University of Colorado Health Sciences Center, Aurora, CO, USA.
Robinson
William A
WA
McCarter
Martin
M
Pearlman
Nathan
N
O'Day
Steven J
SJ
Anderson
Clay
C
Amatruda
Thomas T
TT
Baron
Anna
A
Zeng
Chan
C
Becker
Maude
M
Dollarhide
Susan
S
Matijevich
Karen
K
Gonzalez
Rene
R
D000293:Adolescent; 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; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage; D008197:Lymph Node Excision; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage
D016898:Interferon-alpha; D007376:Interleukin-2; D014747:Vinblastine; D003606:Dacarbazine; D002945:Cisplatin