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Titolo:
A PHASE-III RANDOMIZED, DOUBLE-BLIND, MULTIINSTITUTIONAL TRIAL OF VACCINIA MELANOMA ONCOLYSATE-ACTIVE SPECIFIC IMMUNOTHERAPY FOR PATIENTS WITH STAGE-II MELANOMA
Autore:
WALLACK MK; SIVANANDHAM M; BALCH CM; URIST MM; BLAND KI; MURRAY D; ROBINSON WA; FLAHERTY LE; RICHARDS JM; BARTOLUCCI AA; ROSEN L;
Indirizzi:
ST VINCENTS HOSP & MED CTR,NEW YORK MED COLL,DEPT SURG,153 W 11TH ST NEW YORK NY 10011 MD ANDERSON HOSP HOUSTON TX 00000 UNIV ALABAMA BIRMINGHAM AL 00000 UNIV FLORIDA GAINESVILLE FL 00000 EMORY UNIV ATLANTA GA 30322 UNIV COLORADO,HLTH SCI CTR DENVER CO 00000 WAYNE STATE UNIV,SCH MED DETROIT MI 00000 UNIV CHICAGO CHICAGO IL 60637 MIAMI HEART INST MIAMI BEACH FL 33140
Titolo Testata:
Cancer
fascicolo: 1, volume: 75, anno: 1995,
pagine: 34 - 42
SICI:
0008-543X(1995)75:1<34:APRDMT>2.0.ZU;2-1
Fonte:
ISI
Lingua:
ENG
Soggetto:
MALIGNANT-MELANOMA; SEROLOGIC RESPONSES; IMMUNIZATION; THERAPY; CANCER;
Keywords:
VACCINIA MELANOMA ONCOLYSATE; PROSPECTIVE, RANDOMIZED PHASE III TRIAL; UICC STAGE II MELANOMA, ADJUVANT IMMUNOTHERAPY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
28
Recensione:
Indirizzi per estratti:
Citazione:
M.K. Wallack et al., "A PHASE-III RANDOMIZED, DOUBLE-BLIND, MULTIINSTITUTIONAL TRIAL OF VACCINIA MELANOMA ONCOLYSATE-ACTIVE SPECIFIC IMMUNOTHERAPY FOR PATIENTS WITH STAGE-II MELANOMA", Cancer, 75(1), 1995, pp. 34-42

Abstract

Background. In a Phase II trial, surgical adjuvant active specific immunotherapy using a live vaccinia virus-augmented allogeneic polyvalent melanoma cell lysate, vaccinia melanoma oncolysate (VMO), produced asignificant disease free interval (DFI) in patients with International Union Against Cancer Stage II melanoma with positive lymph nodes. Therefore, a Phase III randomized prospective, double-blind, multiinstitutional, surgical adjuvant VMO trial was performed to determine the efficacy of VMO to increase the DFI and the overall survival in this group of patients with Stage II disease. Methods. Two hundred and fifty patients with Stage II melanoma were divided into two postsurgical groups. One group received VMO (total protein equals 2 mg/ml) and the other received the placebo of live vaccinia vaccine virus (V) (10(5.4) TCID50/ml), an adjuvant component of the VMO. Patients initially receivedthese biologics once a week for 13 weeks and then once every 2 weeks for an additional 39 weeks or until recurrence. All surviving patientshave been followed for at least 30 months. Results. Statistical analysis of survival data (n = 217) for this first interim analysis shows that there is no statistically significant (P = 0.99) increase in DFI of patients treated with VMO (n = 104) when compared with V (n = 113). The median DFI is 38.0 months for patients treated with VMO and 37.0 months for patients treated with V. At 2- and 4-year intervals, 70 and 38%, respectively, of patients treated with VMO vs. 66 and 36%, respectively, of patients treated with V were free of melanoma. The median overall survival is not available because the patients treated with VMOhave not yet reached the 50% mark and the median overall survival is 45.0 months for patients treated with V. At 2- and 4-year intervals, 70 and 38%, respectively, of VMO-treated patients survived when compared with 66 and 36%, respectively, of patients treated with V. Although the overall survival of patients treated with VMO is not statisticallysignificant (P = 0.88) at this point, there is an increasing trend inthe overall survival of patients treated with VMO; a 10% increase at the 4-year time point. Moreover, in the subset analysis, VMO-treated male patients (n = 63) showed a 17% improvement in survival at 4-year time point when compared with male patients treated with V (n = 67) (P = 0.19) at the same time point and male patients (n = 20) between the ages of 44 and 57 having 1-5 positive lymph nodes showed a 37% difference in overall survival at the 4-year time point when compared with those patients treated with V (n = 18) (P = 0.13) at the same time point. Conclusion. In this first interim analysis, active specific immunotherapy with VMO vs. V showed no difference in the disease free intervalor overall survival. Subset analyses likewise showed no significant differences in outcome but the data suggest a potential difference in immunoreactivity between male and female patients with melanoma that awaits further follow up and may merit further investigation.

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Documento generato il 25/11/20 alle ore 10:02:41