Journal of Clinical Oncology, Vol 15, 2359-2370, Copyright © 1997 by American Society of Clinical Oncology
Autologous hapten-modified melanoma vaccine as postsurgical adjuvant treatment after resection of nodal metastases
D Berd, HC Maguire Jr, LM Schuchter, R Hamilton, WW Hauck, T Sato and MJ Mastrangelo
Department of Medicine, Thomas Jefferson University, Philadelphia, PA 19107, USA. d_berd@lac.jci.tju.edu
PURPOSE: To determine whether treatment with an autologous whole-cell
vaccine modified with the hapten dinitrophenyl (DNP vaccine) is an
effective postsurgical adjuvant treatment for melanoma patients with
clinically evident nodal metastases. PATIENTS AND METHODS: Eligible
patients had regional nodal metastases that were large enough (> or = 3
cm diameter) to prepare vaccine. Following standard lymphadenectomy,
patients were treated with DNP vaccine on a monthly or weekly schedule.
RESULTS: Of 62 patients with metastasis in a single lymph node bed (stage
III), 36 are alive after a median follow-up time of 55 months (range, 29 to
76); the projected 5-year relapse-free and overall survival rates are 45%
and 58%, respectively. Of 15 patients with metastases in two nodal sites,
five are alive with a median follow-up time of 73 months. An unexpected
finding was the significantly better survival of older patients; the
projected 5-year survival of patients greater than 50 versus < or = 50
years was 71% and 47%, respectively (P = .011, log-rank test). The
development of a positive delayed-type hypersensitivity (DTH) response to
unmodified autologous melanoma cells was associated with significantly
longer 5-year survival (71% v 49%; P = .031). Finally, the median survival
time from date of first recurrence was significantly longer for patients
whose subcutaneous recurrence exhibited an inflammatory response (> 19.4
v 5.9 months; P < .001). CONCLUSION: Postsurgical adjuvant therapy with
autologous DNP- modified vaccine appears to produce survival rates that are
markedly higher than have been reported with surgery alone. Moreover, this
approach has some intriguing immunobiologic features that might provide
insights into the human tumor-host relationship.
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