The addition of tamoxifen to dacarbazine and cisplatin in metastatic malignant melanoma. A phase II trial of the Southwest Oncology Group, (SWOG-8921)

Am J Clin Oncol. 1996 Apr;19(2):108-13. doi: 10.1097/00000421-199604000-00004.

Abstract

Based on the reports of substantial improvement in the response rate w ith the addition of tamoxifen to a multiagent chemotherapy regimen for metastatic melanoma, Southwest Oncology Group (SWOG)-8921 was initiated. A prior regimen (SWOG-8804) of dacarbazine (DTIC) 750 mg/m(2) i.v. day 1 and cisplatin 100 mg/m(2) day 1 repeated every 3 weeks produced a 13% response rate in patients with metastatic melanoma without brain metastasis. SWOG-8921 using identical chemotherapy and schedule added tamoxifen 10 mg twice daily. There were 55 eligible patients registered, median age 52, with 37 men and 18 women. Fifty (91%) patients had evidence of visceral metastasis at registration. There were 10 responders (2 complete and 8 partial responses) for an 18% response rate (95% CI, 9-31%). The response rate in women was 28% (95% CI, 10-53%; in men, 14% (95% CI, 5-29%). Tamoxifen has produced a small increase in the response rate when added to the present combination and schedule of chemotherapy. Further Phase III trials will be necessary to assess whether there is a statistical advantage to the use of tamoxifen when combined with chemotherapy and whether there are statistical differences between men and women.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents, Hormonal / administration & dosage*
  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / administration & dosage*
  • Cisplatin / adverse effects
  • Dacarbazine / administration & dosage*
  • Dacarbazine / adverse effects
  • Drug Administration Schedule
  • Estrogen Antagonists / administration & dosage*
  • Estrogen Antagonists / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Melanoma / drug therapy*
  • Melanoma / secondary*
  • Middle Aged
  • Remission Induction
  • Sex Factors
  • Tamoxifen / administration & dosage*
  • Tamoxifen / adverse effects

Substances

  • Antineoplastic Agents
  • Antineoplastic Agents, Hormonal
  • Estrogen Antagonists
  • Tamoxifen
  • Dacarbazine
  • Cisplatin