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/m(2)/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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Authors | D S Alberts, C Jiang, P Y Liu, S Wilczynski, M Markman, M L Rothenberg |
Journal | International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
(Int J Gynecol Cancer)
2004 Mar-Apr
Vol. 14
Issue 2
Pg. 224-8
ISSN: 1048-891X [Print] England |
PMID | 15086720
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Alkylating
- Altretamine
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Topics |
- Administration, Oral
- Adult
- Aged
- Aged, 80 and over
- Altretamine
(administration & dosage)
- Antineoplastic Agents, Alkylating
(administration & dosage)
- Clinical Trials, Phase II as Topic
- Disease-Free Survival
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Middle Aged
- Neoplasm Staging
- Neoplasms, Glandular and Epithelial
(drug therapy, mortality, pathology)
- Ovarian Neoplasms
(drug therapy, mortality, pathology)
- Salvage Therapy
- Southwestern United States
- Survival Analysis
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