Phase II trial of biweekly paclitaxel and cisplatin in advanced breast carcinoma: an Eastern Cooperative Oncology Group study
| Autor: | L J Goldstein, W Wood, Donna Neuberg, G W Sledge, J H Glick, Joseph A. Sparano, N J Robert |
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| Rok vydání: | 1997 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Paclitaxel medicine.medical_treatment Mammary gland Urology Breast Neoplasms Drug Administration Schedule chemistry.chemical_compound Antineoplastic Combined Chemotherapy Protocols medicine Carcinoma Humans Cisplatin Chemotherapy business.industry Middle Aged medicine.disease Survival Analysis Surgery Regimen medicine.anatomical_structure Oncology chemistry Toxicity Absolute neutrophil count Female Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 15(5) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE To determine the efficacy of a biweekly paclitaxel and cisplatin regimen in patients with advanced breast carcinoma, which has previously been reported to produce an 85% response rate in such patients. PATIENTS AND METHODS Sixteen patients with metastatic breast carcinoma who had relapsed after prior doxorubicin-containing adjuvant chemotherapy were treated with paclitaxel (90 mg/m2) by intravenous (i.v.) infusion over 3 hours followed by cisplatin (60 mg/m2) given by i.v. infusion over 1 hour on an outpatient basis. Treatment was repeated every 2 weeks if the absolute neutrophil count was > or = 750/microL and platelet count > or = 75,000/microL. After a maximum of eight cycles of paclitaxel/cisplatin, patients received biweekly paclitaxel alone (90 mg/m2 with dose escalation). Thirteen patients were assessable for response and all for toxicity. Nine of 13 patients assessable for response (69%) had at least three sites of metastases and 10 patients (77%) had visceral-dominant disease. RESULTS Partial response occurred in three of 13 assessable patients (23%; 90% confidence interval, 7% to 49%). All responders had two or fewer sites of metastases. The median time to progression was 4.3 months and the median survival duration was 11.4 months. Patients received a median of seven cycles of therapy (range, two to 21). Severe and/or life-threatening toxicity occurred in 50% and 38%, respectively, and consisted primarily of granulocytopenia, anemia, and neuropathy. The trial was terminated after the first interim analysis as per its two-stage design, since it was unlikely that the response rate would exceed 70%. CONCLUSION Biweekly paclitaxel/cisplatin is not likely to produce a response rate greater than 70% in patients with metastatic breast cancer who have relapsed after prior doxorubicin-containing adjuvant chemotherapy and who have multiple sites of metastases and/or visceral-dominant disease. |
| Databáze: | OpenAIRE |
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