Phase II trial of biochemotherapy with interferon α, dacarbazine, cisplatin and tamoxifen in metastatic melanoma: A Southwest Oncology Group trial

Kim A. Margolin, P. Y. Liu, Joseph M. Unger, William S. Fletcher, Lawrence E. Flaherty, Walter J. Urba, Evan M Hersh, Laura E. Hutchins, Jeffrey A. Sosman, John W. Smith, Geoffrey R. Weiss, Vernon K. Sondak

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

The therapeutic benefit of adding interferon α (IFNα) to established single-agent and combination chemotherapy regimens for the treatment of metastatic melanoma has not been proven. We designed the present study to estimate the response rate of IFNα, dacarbazine, cisplatin and tamoxifen in patients who had not been treated with systemic therapy for advanced disease. Using a schedule similar to that which had previously been shown to favor IFNα plus dacarbazine over dacarbazine alone, we treated patients with an 'induction' regimen of IFNα, 15 mU m-2 day-1 intravenously 5 days/week for 3 weeks. Following induction, schedules of IFNα, 5 mU m-2 day-1 subcutaneously three times a week, and tamoxifen, 10 mg orally twice a day, were begun. Dacarbazine, 250 mg m-2 day-1 and cisplatin 33 mg m-2 day- 1 for 3 consecutive days were repeated every 4 weeks, and subcutaneous IFNα and oral tamoxifen were continued until the discontinuation of chemotherapy. We treated 25 patients (18 men and 7 women, median age 52 years) and observed only 1 objective response (response rate 4%, 95% confidence interval 0.1%- 20%). The toxicities of the regimen consisted of moderate myelosuppression and constitutional side-effects. On the basis of the low antitumor activity of this regimen, we do not recommend it for further study or for use as standard therapy of metastatic melanoma.

Original languageEnglish (US)
Pages (from-to)292-296
Number of pages5
JournalJournal of Cancer Research and Clinical Oncology
Volume125
Issue number5
DOIs
StatePublished - 1999

Fingerprint

Dacarbazine
Tamoxifen
Interferons
Cisplatin
Melanoma
Appointments and Schedules
Therapeutics
Combination Drug Therapy
Confidence Intervals
Drug Therapy

Keywords

  • Biochemotherapy
  • Interferon
  • Melanoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II trial of biochemotherapy with interferon α, dacarbazine, cisplatin and tamoxifen in metastatic melanoma : A Southwest Oncology Group trial. / Margolin, Kim A.; Liu, P. Y.; Unger, Joseph M.; Fletcher, William S.; Flaherty, Lawrence E.; Urba, Walter J.; Hersh, Evan M; Hutchins, Laura E.; Sosman, Jeffrey A.; Smith, John W.; Weiss, Geoffrey R.; Sondak, Vernon K.

In: Journal of Cancer Research and Clinical Oncology, Vol. 125, No. 5, 1999, p. 292-296.

Research output: Contribution to journalArticle

Margolin, KA, Liu, PY, Unger, JM, Fletcher, WS, Flaherty, LE, Urba, WJ, Hersh, EM, Hutchins, LE, Sosman, JA, Smith, JW, Weiss, GR & Sondak, VK 1999, 'Phase II trial of biochemotherapy with interferon α, dacarbazine, cisplatin and tamoxifen in metastatic melanoma: A Southwest Oncology Group trial', Journal of Cancer Research and Clinical Oncology, vol. 125, no. 5, pp. 292-296. https://doi.org/10.1007/s004320050276
Margolin, Kim A. ; Liu, P. Y. ; Unger, Joseph M. ; Fletcher, William S. ; Flaherty, Lawrence E. ; Urba, Walter J. ; Hersh, Evan M ; Hutchins, Laura E. ; Sosman, Jeffrey A. ; Smith, John W. ; Weiss, Geoffrey R. ; Sondak, Vernon K. / Phase II trial of biochemotherapy with interferon α, dacarbazine, cisplatin and tamoxifen in metastatic melanoma : A Southwest Oncology Group trial. In: Journal of Cancer Research and Clinical Oncology. 1999 ; Vol. 125, No. 5. pp. 292-296.
@article{7129760301e74635a425c6e9b86ee26e,
title = "Phase II trial of biochemotherapy with interferon α, dacarbazine, cisplatin and tamoxifen in metastatic melanoma: A Southwest Oncology Group trial",
abstract = "The therapeutic benefit of adding interferon α (IFNα) to established single-agent and combination chemotherapy regimens for the treatment of metastatic melanoma has not been proven. We designed the present study to estimate the response rate of IFNα, dacarbazine, cisplatin and tamoxifen in patients who had not been treated with systemic therapy for advanced disease. Using a schedule similar to that which had previously been shown to favor IFNα plus dacarbazine over dacarbazine alone, we treated patients with an 'induction' regimen of IFNα, 15 mU m-2 day-1 intravenously 5 days/week for 3 weeks. Following induction, schedules of IFNα, 5 mU m-2 day-1 subcutaneously three times a week, and tamoxifen, 10 mg orally twice a day, were begun. Dacarbazine, 250 mg m-2 day-1 and cisplatin 33 mg m-2 day- 1 for 3 consecutive days were repeated every 4 weeks, and subcutaneous IFNα and oral tamoxifen were continued until the discontinuation of chemotherapy. We treated 25 patients (18 men and 7 women, median age 52 years) and observed only 1 objective response (response rate 4{\%}, 95{\%} confidence interval 0.1{\%}- 20{\%}). The toxicities of the regimen consisted of moderate myelosuppression and constitutional side-effects. On the basis of the low antitumor activity of this regimen, we do not recommend it for further study or for use as standard therapy of metastatic melanoma.",
keywords = "Biochemotherapy, Interferon, Melanoma",
author = "Margolin, {Kim A.} and Liu, {P. Y.} and Unger, {Joseph M.} and Fletcher, {William S.} and Flaherty, {Lawrence E.} and Urba, {Walter J.} and Hersh, {Evan M} and Hutchins, {Laura E.} and Sosman, {Jeffrey A.} and Smith, {John W.} and Weiss, {Geoffrey R.} and Sondak, {Vernon K.}",
year = "1999",
doi = "10.1007/s004320050276",
language = "English (US)",
volume = "125",
pages = "292--296",
journal = "Journal of Cancer Research and Clinical Oncology",
issn = "0171-5216",
publisher = "Springer Verlag",
number = "5",

}

TY - JOUR

T1 - Phase II trial of biochemotherapy with interferon α, dacarbazine, cisplatin and tamoxifen in metastatic melanoma

T2 - A Southwest Oncology Group trial

AU - Margolin, Kim A.

AU - Liu, P. Y.

AU - Unger, Joseph M.

AU - Fletcher, William S.

AU - Flaherty, Lawrence E.

AU - Urba, Walter J.

AU - Hersh, Evan M

AU - Hutchins, Laura E.

AU - Sosman, Jeffrey A.

AU - Smith, John W.

AU - Weiss, Geoffrey R.

AU - Sondak, Vernon K.

PY - 1999

Y1 - 1999

N2 - The therapeutic benefit of adding interferon α (IFNα) to established single-agent and combination chemotherapy regimens for the treatment of metastatic melanoma has not been proven. We designed the present study to estimate the response rate of IFNα, dacarbazine, cisplatin and tamoxifen in patients who had not been treated with systemic therapy for advanced disease. Using a schedule similar to that which had previously been shown to favor IFNα plus dacarbazine over dacarbazine alone, we treated patients with an 'induction' regimen of IFNα, 15 mU m-2 day-1 intravenously 5 days/week for 3 weeks. Following induction, schedules of IFNα, 5 mU m-2 day-1 subcutaneously three times a week, and tamoxifen, 10 mg orally twice a day, were begun. Dacarbazine, 250 mg m-2 day-1 and cisplatin 33 mg m-2 day- 1 for 3 consecutive days were repeated every 4 weeks, and subcutaneous IFNα and oral tamoxifen were continued until the discontinuation of chemotherapy. We treated 25 patients (18 men and 7 women, median age 52 years) and observed only 1 objective response (response rate 4%, 95% confidence interval 0.1%- 20%). The toxicities of the regimen consisted of moderate myelosuppression and constitutional side-effects. On the basis of the low antitumor activity of this regimen, we do not recommend it for further study or for use as standard therapy of metastatic melanoma.

AB - The therapeutic benefit of adding interferon α (IFNα) to established single-agent and combination chemotherapy regimens for the treatment of metastatic melanoma has not been proven. We designed the present study to estimate the response rate of IFNα, dacarbazine, cisplatin and tamoxifen in patients who had not been treated with systemic therapy for advanced disease. Using a schedule similar to that which had previously been shown to favor IFNα plus dacarbazine over dacarbazine alone, we treated patients with an 'induction' regimen of IFNα, 15 mU m-2 day-1 intravenously 5 days/week for 3 weeks. Following induction, schedules of IFNα, 5 mU m-2 day-1 subcutaneously three times a week, and tamoxifen, 10 mg orally twice a day, were begun. Dacarbazine, 250 mg m-2 day-1 and cisplatin 33 mg m-2 day- 1 for 3 consecutive days were repeated every 4 weeks, and subcutaneous IFNα and oral tamoxifen were continued until the discontinuation of chemotherapy. We treated 25 patients (18 men and 7 women, median age 52 years) and observed only 1 objective response (response rate 4%, 95% confidence interval 0.1%- 20%). The toxicities of the regimen consisted of moderate myelosuppression and constitutional side-effects. On the basis of the low antitumor activity of this regimen, we do not recommend it for further study or for use as standard therapy of metastatic melanoma.

KW - Biochemotherapy

KW - Interferon

KW - Melanoma

UR - http://www.scopus.com/inward/record.url?scp=0032977509&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0032977509&partnerID=8YFLogxK

U2 - 10.1007/s004320050276

DO - 10.1007/s004320050276

M3 - Article

C2 - 10359134

AN - SCOPUS:0032977509

VL - 125

SP - 292

EP - 296

JO - Journal of Cancer Research and Clinical Oncology

JF - Journal of Cancer Research and Clinical Oncology

SN - 0171-5216

IS - 5

ER -