Biweekly Pegylated Liposomal Doxorubicin (Caelyx) in Heavily Pretreated Metastatic Breast Cancer: A Phase 2 Study
| Autor: | Philipp Hemmati, Silvia Lehenbauer-Dehm, Bernd Flath, Peter Schmid, Christian Jehn, Sherko Kümmel |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
0301 basic medicine
Adult Cancer Research medicine.medical_specialty Neutropenia Anthracycline medicine.medical_treatment Phases of clinical research Breast Neoplasms Vinorelbine Vinblastine Gastroenterology Disease-Free Survival Drug Administration Schedule Polyethylene Glycols Capecitabine 03 medical and health sciences 0302 clinical medicine Breast cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Doxorubicin Anthracyclines Aged Chemotherapy Antibiotics Antineoplastic business.industry Middle Aged medicine.disease Metastatic breast cancer Thrombocytopenia Cardiotoxicity Surgery 030104 developmental biology Treatment Outcome Oncology 030220 oncology & carcinogenesis Female Hand-Foot Syndrome Taxoids business medicine.drug |
| Zdroj: | Clinical breast cancer. 16(6) |
| ISSN: | 1938-0666 |
| Popis: | Background Pegylated liposomal doxorubicin (PLD) has shown to be as effective as conventional doxorubicin in the treatment of metastatic breast cancer but provides a lower risk of cardiotoxicity. This phase 2 study in heavily pretreated patients with metastatic breast cancer was initiated to evaluate a biweekly instead of a 4-week schedule of PLD in order to obtain a more flexible and tolerable regimen. Patients and Methods A total of 25 patients with 2 or more prior lines of chemotherapy for metastatic disease were treated with PLD (25 mg/m 2 ) at 2-week intervals for a maximum of 12 courses. Pretreatment with anthracyclines was allowed as long as the cumulative doxorubicin dose at study entry was below 400 mg/m 2 . Most patients were pretreated with anthracyclines, taxanes, vinorelbine, alkylating agents, and capecitabine. Results The clinical benefit rate, ie, objective response or stable disease, for at least 6 months was 22.7% for all patients and 22.2% in anthracycline- and taxane-pretreated patients, respectively. Median duration of clinical benefit and median time to progression were 12.5 months (95% confidence interval [CI], 10.1-32.3) and 7 weeks (95% CI, 5.4-8.6), respectively. Median overall survival was 9.6 months (95% CI, 5.4-13.9). One- and 2-year survival rates were 38% and 4%, respectively. Myelosuppression was low, with no grade 3 or 4 neutropenia or thrombocytopenia. Most common nonhematologic toxicities were nausea, alopecia, asthenia, and hand–foot syndrome. The low rate of hematologic toxicity and hand–foot syndrome is clinically noteworthy. Conclusion Biweekly PLD is an easily manageable schedule with a favorable toxicity profile. Efficacy was moderate in heavily pretreated patients. |
| Databáze: | OpenAIRE |
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