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. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. [Int J Gynecol Cancer] Journal article | | Title | 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. | | Author(s) | Alberts DS, Jiang C, Liu PY, Wilczynski S, Markman M, Rothenberg ML | | Institution | University of Arizona Cancer Center, 1515 North Campbell Avenue, PO Box 245024, Tucson, AZ 85724-5024, USA. dalberts@azcc.arizona.edu | | Source | Int J Gynecol Cancer 2004 Mar-Apr; 14(2):224-8. | | MeSH | Administration, Oral
Adult
Aged
Aged, 80 and over
Altretamine
Antineoplastic Agents, Alkylating
Clinical Trials, Phase II
Disease-Free Survival
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Middle Aged
Neoplasm Staging
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Research Support, Non-U.S. Gov't
Salvage Therapy
Southwestern United States
Survival Analysis
| | 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. | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
| | PubMed ID | 15086720 |
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