N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) Trial
| Autor: | E. A. Perez, S. S. Gamini, P. J. Stella, Donald W. Northfelt, D. M. Anderson, Muhammad Salim, Frances M. Palmieri, David W. Hillman, R. D. Niedringhaus, Albert M. Bernath, Winston Tan |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Oncology medicine.medical_specialty Phases of clinical research Breast Neoplasms Docetaxel Adenocarcinoma Irinotecan Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Irinotecan Hydrochloride Humans Neoplasm Metastasis skin and connective tissue diseases neoplasms Aged Aged 80 and over Salvage Therapy Taxane business.industry Original Articles Hematology Middle Aged medicine.disease Corrigenda Metastatic breast cancer digestive system diseases Survival Rate stomatognathic diseases Regimen Treatment Outcome Drug Resistance Neoplasm Camptothecin Female Taxoids Neoplasm Recurrence Local business therapeutics Follow-Up Studies medicine.drug |
| Zdroj: | Annals of Oncology. 21:493-497 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdp328 |
| Popis: | Background Because of the single-agent activity of irinotecan hydrochloride, combination of irinotecan and docetaxel treatment against metastatic breast cancer (MBC) should be evaluated. Patients and methods Single-stage phase 2 study of irinotecan and docetaxel to evaluate tumor response, toxicity, time to progression, and overall survival was carried out. Regimen of docetaxel (25 mg/m2) and irinotecan (70 mg/m2) was administered on days 1 and 8 of each 3-week cycle. Patients had histologically confirmed breast adenocarcinoma and metastatic cancer measurable with RECIST. Results Of 70 patients enrolled, 64 were assessable. Prior treatment with an anthracycline and a taxane was required. Eighteen (28%) patients [95% confidence interval (CI) 15% to 31%] had tumor response, plus four patients had stable disease (less than 30% decrease in sum of longest diameter and less than 20% increase) for >6 months. The clinical benefit rate was 34% overall. Median duration of tumor response was 6.7 months (95% CI 4.2–37.7 months); median follow-up was 18.6 months (range 8.5–37.7 months). The most common severe adverse events included fatigue [n = 16 (25%)] and neutropenia [n = 13 (20%)]. Conclusions Weekly dosing of combination of irinotecan and docetaxel is active against MBC. However, the response rate to our regimen was not significantly better than single-agent docetaxel. Other schedules of irinotecan plus docetaxel should be considered for future studies. |
| Databáze: | OpenAIRE |
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