Long-term follow-up of a phase II trial of oral altretamine for consolidation of clinical complete remission in women with stage III epithelial ovarian cancer in the Southwest Oncology Group

David S Alberts, C. Jiang, P. Y. Liu, S. Wilczynski, M. Markman, M. L. Rothenberg

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24 Citations (Scopus)

Abstract

Objective: This report provides follow-up progression-free survival (PFS) and median survival data for women who achieved clinical complete remission (cCR) from stage III ovarian cancer after first-line therapy and were treated with altretamine consolidation therapy. Methods: Patients who enrolled in the SWOG 9326 study from September 1993 to July 1997 were required to have documented cCR from stage III ovarian cancer following front-line platinum-based therapy. Treatment consisted of 6 months of oral altretamine at 260 mg/m2/day for 14 consecutive days of a 28-day cycle. Results: Ninety-seven of 112 enrolled patients were evaluable for efficacy. This report presents median 6.2-year follow-up, dating from study registration. Median PFS was 28 (95% CI: 19-43) months. Median PFS for patients with optimal disease was 45 (95% CI: 27-48) months and for patients with suboptimal disease was 17 (95% CI: 12-26) months. Twenty-six of 61 (43%) patients with optimally debulked lesions and 5 of 36 (14%) patients with suboptimally debulked lesions remained disease free. Median survival of patients with optimally debulked disease has not been reached; median survival of patients with suboptimally debulked disease was 39 (95% CI: 19-51) months. No treatment-related adverse events were reported during the follow-up period. Conclusions: Consolidation therapy with oral altretamine was generally well tolerated and associated with prolonged progression-free and overall survival in the Phase II setting.

Original languageEnglish (US)
Pages (from-to)224-228
Number of pages5
JournalInternational Journal of Gynecological Cancer
Volume14
Issue number2
DOIs
StatePublished - Mar 2004

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Altretamine
Disease-Free Survival
Ovarian Neoplasms
Survival
Therapeutics
Ovarian epithelial cancer
Platinum

Keywords

  • Altretamine
  • Consolidation therapy
  • Hexamethylmelamine
  • Ovarian cancer

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology
  • Cancer Research

Cite this

Long-term follow-up of a phase II trial of oral altretamine for consolidation of clinical complete remission in women with stage III epithelial ovarian cancer in the Southwest Oncology Group. / Alberts, David S; Jiang, C.; Liu, P. Y.; Wilczynski, S.; Markman, M.; Rothenberg, M. L.

In: International Journal of Gynecological Cancer, Vol. 14, No. 2, 03.2004, p. 224-228.

Research output: Contribution to journalArticle

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abstract = "Objective: This report provides follow-up progression-free survival (PFS) and median survival data for women who achieved clinical complete remission (cCR) from stage III ovarian cancer after first-line therapy and were treated with altretamine consolidation therapy. Methods: Patients who enrolled in the SWOG 9326 study from September 1993 to July 1997 were required to have documented cCR from stage III ovarian cancer following front-line platinum-based therapy. Treatment consisted of 6 months of oral altretamine at 260 mg/m2/day for 14 consecutive days of a 28-day cycle. Results: Ninety-seven of 112 enrolled patients were evaluable for efficacy. This report presents median 6.2-year follow-up, dating from study registration. Median PFS was 28 (95{\%} CI: 19-43) months. Median PFS for patients with optimal disease was 45 (95{\%} CI: 27-48) months and for patients with suboptimal disease was 17 (95{\%} CI: 12-26) months. Twenty-six of 61 (43{\%}) patients with optimally debulked lesions and 5 of 36 (14{\%}) patients with suboptimally debulked lesions remained disease free. Median survival of patients with optimally debulked disease has not been reached; median survival of patients with suboptimally debulked disease was 39 (95{\%} CI: 19-51) months. No treatment-related adverse events were reported during the follow-up period. Conclusions: Consolidation therapy with oral altretamine was generally well tolerated and associated with prolonged progression-free and overall survival in the Phase II setting.",
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