Phase II Trial of Oral Altretamine for Consolidation of Clinical Complete Remission in Women with Stage III Epithelial Ovarian Cancer: A Southwest Oncology Group Trial (SWOG-9326)
| Autor: | Verda J. Hunter, David S. Alberts, Amy Tiersten, S. Weiner, Poching Liu, Peter C. Kohler, Edward V. Hannigan, Sharon P. Wilczynski, Mace L. Rothenberg, Geoffrey R. Weiss, Julia Chapman |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Oncology medicine.medical_specialty Paclitaxel Nausea medicine.medical_treatment Administration Oral Physical examination Neutropenia Altretamine Drug Administration Schedule Internal medicine medicine Humans Antineoplastic Agents Alkylating Survival rate Aged Neoplasm Staging Aged 80 and over Ovarian Neoplasms Stage III Ovarian Cancer Chemotherapy medicine.diagnostic_test business.industry Remission Induction Obstetrics and Gynecology Epithelial Cells Middle Aged medicine.disease Antineoplastic Agents Phytogenic Survival Rate CA-125 Antigen Vomiting Female medicine.symptom business medicine.drug |
| Zdroj: | Gynecologic Oncology. 82:317-322 |
| ISSN: | 0090-8258 |
| DOI: | 10.1006/gyno.2001.6274 |
| Popis: | Objective. The aim of this study was to evaluate the 2-year survival rate in a group of women in complete clinical remission (cCR) from Stage III ovarian cancer following front-line therapy who were then treated with a 6-month course of altretamine. Methods. Patients were documented to be in cCR by physical examination, computed tomography or magnetic resonance imaging scan, and serum CA-125. Treatment consisted of altretamine (Hexalen)® 260 mg/m 2 /day po divided into four doses taken after meals and at bedtime for 14 of 28 days for six cycles. Based on previous experience in the Southwest Oncology Group, the treatment would be considered promising if the 2-year survival rate was ≥65% as measured from study registration. Results. From 9/1/93 and 7/1/97, 112 patients were registered and 97 were fully evaluable. The majority of patients had optimally debulked (≤1 cm: 63%), high-grade (Grade 3: 82%) tumors. The 2-year survival rate in this study was 75% (95% CI: 66–84%). For those patients with optimal disease, the 2-year survival rate was 82% (95% CI: 72–92%) and for those with suboptimal disease it was 64% (95% CI: 48–79%). Four patients (4%) experienced Grade 4 and 21 patients (22%) experienced Grade 3 toxicities consisting primarily of nausea/vomiting, neutropenia, fatigue, anxiety, and paresthesias. Conclusions. The 2-year survival rate in this study warrants further evaluation of consolidation therapy for women in clinical complete remission following front-line chemotherapy for Stage III ovarian cancer. Caution is advised in the interpretation of these data, however, because of the nonrandomized nature of the trial and the unknown contribution of front-line use of paclitaxel to the durability of clinical complete response. |
| Databáze: | OpenAIRE |
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