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Titolo:
PHASE-III TRIAL OF DACARBAZINE VERSUS DACARBAZINE WITH INTERFERON-ALPHA-2B VERSUS DACARBAZINE WITH TAMOXIFEN VERSUS DACARBAZINE WITH INTERFERON-ALPHA-2B AND TAMOXIFEN IN PATIENTS WITH METASTATIC MALIGNANT-MELANOMA - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP STUDY
Autore:
FALKSON CI; IBRAHIM J; KIRKWOOD JM; COATES AS; ATKINS MB; BLUM RH;
Indirizzi:
UNIV PRETORIA,FAC MED,POB 667 ZA-0001 PRETORIA SOUTH AFRICA ROYAL PRINCE ALFRED HOSP CAMPERDOWN NSW 2050 AUSTRALIA TUFTS NEW ENGLAND MED CTR BOSTON MA 00000 DANA FARBER CANC INST BOSTON MA 02115 UNIV PITTSBURGH PITTSBURGH PA 00000 ST VINCENTS COMPREHENS CANC CTR NEW YORK NY 00000
Titolo Testata:
Journal of clinical oncology
fascicolo: 5, volume: 16, anno: 1998,
pagine: 1743 - 1751
SICI:
0732-183X(1998)16:5<1743:PTODVD>2.0.ZU;2-B
Fonte:
ISI
Lingua:
ENG
Soggetto:
COMBINATION CHEMOTHERAPY; RECOMBINANT INTERFERON; RANDOMIZED TRIAL; FOTEMUSTINE; EXPERIENCE; CARMUSTINE; CISPLATIN; THERAPY; CCNU;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
41
Recensione:
Indirizzi per estratti:
Citazione:
C.I. Falkson et al., "PHASE-III TRIAL OF DACARBAZINE VERSUS DACARBAZINE WITH INTERFERON-ALPHA-2B VERSUS DACARBAZINE WITH TAMOXIFEN VERSUS DACARBAZINE WITH INTERFERON-ALPHA-2B AND TAMOXIFEN IN PATIENTS WITH METASTATIC MALIGNANT-MELANOMA - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP STUDY", Journal of clinical oncology, 16(5), 1998, pp. 1743-1751

Abstract

Purpose: To investigate the response rate, time to treatment failure (TTF), overall survival, and toxicity in patients with metastatic melanoma treated with dacarbazine alone, dacarbazine plus interferon (IFN), dacarbazine plus tamoxifen (TMX), or dacarbazine plus IFN plus TMX. Materials and Methods: Two hundred seventy-one patients (258 were eligible) were randomized in a 2 x 2 factorial design to receive one of the above treatments. The trial wets designed to detect a 50% improvement in survival with 83% power. Results: Nine complete (CRs) and 18 partial responses (PRs) were observed in the patients who received treatments that contained IFN compared with four CRs and 18 PRs in the patients who received treatments that did not contain IFN. Five CRs and 20 PRs occurred in patients treated with TMX compared with eight CRs and 16 PRs in those treated without TMX. Response differences were nonsignificant. The overall median TTF was 2.6 months, and the overall median survival wets 8.9 months. There was no significant difference in TTF or survival among any of the different treatments. Poor performance status (PS), hepatic metastases, and weight loss were significant adverseprognostic factors. Twenty-three patients had a TTF greater than 20 months, and these durable responses were evenly distributed among the treatment arms, Significantly more severe and life-threatening toxic events occurred with treatments that contained IFN. Conclusion: Neither IFN, TMX, nor the combination significantly improved the response rate, TTF, or survival when added to dacarbazine, but IFN significantly increased toxicity. (C) 1998 by American Society of Clinical Oncology.

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Documento generato il 25/11/20 alle ore 10:19:54