Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer
| Autor: | Linda R. Duska, Carolyn N. Krasner, Susana M. Campos, Richard T. Penson, Ursula A. Matulonis, Deborah Kendall, Julie Lee, Neil S. Horowitz, L. Pereira, Suzanne Berlin, Maria R. Roche, Hang Lee |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Guanine Time Factors Phases of clinical research Kaplan-Meier Estimate Pemetrexed Disease-Free Survival Drug Administration Schedule Carboplatin chemistry.chemical_compound Glutamates Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Fallopian Tube Neoplasms Humans Infusions Intravenous Peritoneal Neoplasms Aged Ovarian Neoplasms business.industry Area under the curve Cancer Middle Aged medicine.disease Surgery Treatment Outcome chemistry Response Evaluation Criteria in Solid Tumors Fallopian tube cancer Antifolate Female Neoplasm Recurrence Local business Boston medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 26:5761-5766 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Purpose More efficacious, less toxic combinations are needed to treat platinum-sensitive recurrent epithelial ovarian cancer (EOC). Pemetrexed is a multitargeted antifolate with manageable toxicity and has been combined with carboplatin to treat other cancers. Patients and Methods This is a phase II study of carboplatin area under the curve 5 with pemetrexed 500 mg/m2 administered intravenously on day 1 every 21 days for six cycles or for up to eight cycles if clinical benefit occurred. Eligible patients had platinum-sensitive recurrent EOC, peritoneal serous cancer, or fallopian tube cancer. The primary objective was to determine response rate defined by Response Evaluation Criteria in Solid Tumors; other end points included toxicities, progression-free survival (PFS), and overall survival (OS). Results Forty-five patients were accrued; 44 patients received treatment. Overall response rate was 51.1%; there were no complete responses (0%), 23 confirmed partial responses (51.1%), two unconfirmed partial responses (4.4%), 14 patients with stable disease (31.1%), and two patients with progressive disease after two cycles (4.4%). Grade 3 and 4 hematologic toxicities included neutropenia (41%), thrombocytopenia (23%), and anemia (9%); there were no episodes of febrile neutropenia. Grade 3 and 4 nonhematologic toxicities included fatigue (11%), nausea (5%), vomiting (5%), diarrhea (5%), syncope (5%), and pulmonary embolism (5%). Median PFS time was 7.57 months (95% CI, 6.44 to 10.18 months), mean OS time was 20.3 months, and median OS has not yet been reached with a mean follow-up time of 15.3 months. Conclusion Carboplatin/pemetrexed is a well-tolerated regimen with activity in platinum-sensitive recurrent EOC; further testing of this regimen in platinum-sensitive EOC patients is warranted. |
| Databáze: | OpenAIRE |
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