TY - JOUR
T1 - Pemetrexed in patients with locally advanced or metastatic breast cancer who had received previous anthracycline and taxane treatment
T2 - Phase II study
AU - Llombart-Cussac, Antonio
AU - Theodoulou, Maria
AU - Rowland, Kendrith
AU - Clark, Romnee S.
AU - Nakamura, Takashi
AU - Carrasco, Eva
AU - Cruciani, Giorgio
N1 - Funding Information:
The authors gratefully acknowledge the contributions of the following individuals: technical assistance, data management, and validation were performed by Moramy Palacios-Brown and Linda Pfeiffer; Ghulam Kalimi, PhD, provided support with manuscript preparation; Peter Fairfield provided editorial assistance; and Lori Anderson assisted with bibliography and publication preparation. This study was funded by Eli Lilly and Company, Indianapolis, IN.
PY - 2006/12
Y1 - 2006/12
N2 - Purpose: The objective of this study was to assess the efficacy and safety of pemetrexed in pretreated patients with advanced-stage breast cancer. Patients and Methods: Patients with advanced-stage or metastatic breast cancer, Eastern Cooperative Oncology Group performance status 0-2, and progressive or relapsed disease after treatment with regimens containing anthracyclines and taxanes were eligible. Pemetrexed 500 mg/m2 was administered as a 10-minute intravenous infusion on day 1 every 21 days. Results: Seventy-nine women were enrolled. After protocol amendment, 43 patients received folic acid and vitamin B12 supplementation to control pemetrexed-related toxicity. A median of 4 cycles (range, 1-23 cycles) was administered. Overall response rate was 9% (95% confidence interval, 3.7%-17.6%), median duration of response was 5.5 months, median progression-free survival was 3.1 months, and median survival was 10.5 months. Major grade 3/4 toxicities were lymphopenia (53.3%), neutropenia (36.4%), leukopenia (26.9%), and anemia (7.7%). In general, the toxicities were less frequent in patients who received vitamin supplementation than in those who did not receive vitamin supplementation. Conclusion: The response to pemetrexed salvage treatment was low in this study of heavily pretreated patients with breast cancer. Pemetrexed was generally well tolerated in patients with previously treated breast cancer. Vitamin supplementation appeared to ameliorate toxicity.
AB - Purpose: The objective of this study was to assess the efficacy and safety of pemetrexed in pretreated patients with advanced-stage breast cancer. Patients and Methods: Patients with advanced-stage or metastatic breast cancer, Eastern Cooperative Oncology Group performance status 0-2, and progressive or relapsed disease after treatment with regimens containing anthracyclines and taxanes were eligible. Pemetrexed 500 mg/m2 was administered as a 10-minute intravenous infusion on day 1 every 21 days. Results: Seventy-nine women were enrolled. After protocol amendment, 43 patients received folic acid and vitamin B12 supplementation to control pemetrexed-related toxicity. A median of 4 cycles (range, 1-23 cycles) was administered. Overall response rate was 9% (95% confidence interval, 3.7%-17.6%), median duration of response was 5.5 months, median progression-free survival was 3.1 months, and median survival was 10.5 months. Major grade 3/4 toxicities were lymphopenia (53.3%), neutropenia (36.4%), leukopenia (26.9%), and anemia (7.7%). In general, the toxicities were less frequent in patients who received vitamin supplementation than in those who did not receive vitamin supplementation. Conclusion: The response to pemetrexed salvage treatment was low in this study of heavily pretreated patients with breast cancer. Pemetrexed was generally well tolerated in patients with previously treated breast cancer. Vitamin supplementation appeared to ameliorate toxicity.
KW - Multitargeted antifolate
KW - Progressive disease
KW - Salvage treatment
KW - Vitamin supplementation
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U2 - 10.3816/CBC.2006.n.054
DO - 10.3816/CBC.2006.n.054
M3 - Article
C2 - 17239262
AN - SCOPUS:33846552380
SN - 1526-8209
VL - 7
SP - 380
EP - 385
JO - Clinical Breast Cancer
JF - Clinical Breast Cancer
IS - 5
ER -