PHILADELPHIAThe autologous, dinitrophenyl (DNP)-modified
vaccine M-Vax has previously been shown to produce a 5-year overall
survival rate of 58% in melanoma patients with large, resectable
metastases in one regional nodal site.
Now, an analysis of 40 patients who received M-Vax following surgery
for resectable metastases in two regional nodal sites shows a
predicted 5-year overall survival rate of 31%, David A. Berd, MD,
principal investigator and inventor of the vaccine, said at the 90th
annual meeting of the American Association for Cancer Research (AACR)
We pulled out the 40 worst of 200 patients, Dr. Berd said
in an interview. Of those 40, each had metastases in two regional
nodal sitesseven with bilateral axillary nodal metastases;
eight with metastases in both axillary and neck nodes; 15 with both
inguinal and pelvic node metastases; eight with two sites in the
neck; and two with miscellaneous sites.
Currently, we can say with confidence that 3-year overall
survival for the melanoma vaccine treatment in these patients is
40%, said Dr. Berd, professor of medicine, Kimmel Cancer
Center, Thomas Jefferson University Hospital.
To prepare the vaccine, melanoma cells are dissociated from surgical
specimens and cryopreserved. Before each vaccine administration,
these cells are thawed and irradiated, then modified with DNP. The
vaccine is mixed with BCG just before intradermal injection. Patients
received one of four dosage schedules over a 2- to 6-month period.
No serious adverse events occurred. All patients developed
inflammatory or pustular reactions at the injection site, which
caused itching or mild discomfort.
At the time of the presentation, 17 of the 40 patients (43%) were
alive with a median follow-up of 33 months. Twelve (30%) were
continuously relapse-free with a median follow-up of 36 months. The
Kaplan-Meier estimates for overall and relapse-free survival at 5
years were 31% and 27%, respectively.
For the subgroup of patients with metastases to pelvic nodes, who
have an expected surgical cure rate of less than 10%, the estimates
for 5-year overall and relapse-free survival were 47% and 38%,
Although these results require corroboration in our ongoing
multicenter randomized trial, Dr. Berd said, they provide
additional evidence that M-Vax is an effective postsurgical adjuvant
treatment for patients with regionally metastatic melanoma.
The ongoing phase III trial, he said, conducted by the vaccines
manufacturer, AVAX Technologies, Inc., Kansas City, Missouri, is
comparing M-Vax with alfa-interferon in postsurgical stage III