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Pegylated liposomal doxorubicin (Lipo-Dox¬ģ) combined with cyclophosphamide and 5-fluorouracil is effective and safe as salvage chemotherapy in taxane-treated metastatic breast cancer: an open-label, multi-center, non-comparative phase II study.

Rau KM, Lin YC, Chen YY, Chen JS, Lee KD, Wang CH, Chang HK - BMC Cancer (2015)

Bottom Line: Other non-hematologic adverse effects were mild to moderate and were manageable.No decrease in left ventricular ejection function was noted.This regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects.

View Article: PubMed Central - PubMed

Affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. liu07822@ms57.hinet.net.

ABSTRACT

Background: Anthracycline and taxane are classes of drugs that are frequently used in the adjuvant and palliative settings of metastatic breast cancer (MBC); however, treatment failure occurs in most cases. Limited data demonstrated favorable response in MBC after previous taxane-based treatment. The aim of this study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (Lipo-Dox¬ģ) used as part of a combination salvage therapy for patients with MBC whose tumors progressed during or after taxane-based treatment.

Methods: Patients with MBC who failed to respond to previous taxane-based treatments were recruited. Treatment with pegylated liposomal doxorubicin (40 mg/m(2)), cyclophosphamide (500 mg/m(2)), and 5-fluorouracil (500 mg/m(2)) was administered every 3 weeks. Tumor response to treatment was determined by using the Response Evaluation Criteria in Solid Tumor criteria version 1.0, and left ventricular ejection fraction was measured before and after treatment using echocardiography. Each patient was followed for 30 days after the last dose of study medication or until resolution/stabilization of any drug-related adverse event.

Results: Forty-five patients were recruited. As of December 2012, the median follow-up duration was 29.8 months, the overall response rate was 41.9 %, the median progression-free survival was 8.2 months, and the median overall survival was 36.6 months for all treated patients. Grade 3/4 neutropenia, leucopenia, and neutropenic fever were observed in 14 %, 9 %, and 1 % of the cycles, respectively. Other non-hematologic adverse effects were mild to moderate and were manageable. No decrease in left ventricular ejection function was noted.

Conclusion: This regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects. This regimen could be considered as a treatment option for patients with MBC whose tumors progressed during or after taxane-based treatment.

No MeSH data available.


Related in: MedlinePlus

(a) Progression free survival (PFS) and (b) Overall survival (OS) of intent-to-treat (ITT) patients. The median PFS was 8.2 months, and the median OS was 36.6 months
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Related In: Results  -  Collection

License 1 - License 2
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Fig1: (a) Progression free survival (PFS) and (b) Overall survival (OS) of intent-to-treat (ITT) patients. The median PFS was 8.2 months, and the median OS was 36.6 months

Mentions: Efficacy analyses were based on the total patients enrolled (i.e. the evaluable and ITT populations). Because only two patients were not evaluable in the ITT group, the efficacy evaluation was essentially the same for these two groups. In the ITT and evaluable populations, 36 patients achieved stable disease (SD) or partial response (PR) as their best response. Disease control rates (DCR) were nearly identical in the ER-positive (PR of 46¬†%, DCR of 88.5¬†%) and Her2-positive populations (PR of 20¬†%, DCR of 80.0¬†%) (Table¬†3). We also checked the response rate at different metastatic sites, lymph nodes had the best response. In general, most visceral organs had response rates more than 50¬†% (Table¬†4). The PFS and OS of the ITT patients were identical to those of the evaluable patients (Fig.¬†1; median PFS‚ÄČ=‚ÄČ8.2¬†months, median OS‚ÄČ=‚ÄČ36.6¬†months). For patients who achieved partial response, the median PFS was 9.96¬†months and the median OS was 41.48¬†months, as compared to the patients who achieved SD, who had a median PFS of 6.16¬†months and a median OS of 36.62¬†months (Table¬†5).Table 3


Pegylated liposomal doxorubicin (Lipo-Dox¬ģ) combined with cyclophosphamide and 5-fluorouracil is effective and safe as salvage chemotherapy in taxane-treated metastatic breast cancer: an open-label, multi-center, non-comparative phase II study.

Rau KM, Lin YC, Chen YY, Chen JS, Lee KD, Wang CH, Chang HK - BMC Cancer (2015)

(a) Progression free survival (PFS) and (b) Overall survival (OS) of intent-to-treat (ITT) patients. The median PFS was 8.2 months, and the median OS was 36.6 months
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4440506&req=5

Fig1: (a) Progression free survival (PFS) and (b) Overall survival (OS) of intent-to-treat (ITT) patients. The median PFS was 8.2 months, and the median OS was 36.6 months
Mentions: Efficacy analyses were based on the total patients enrolled (i.e. the evaluable and ITT populations). Because only two patients were not evaluable in the ITT group, the efficacy evaluation was essentially the same for these two groups. In the ITT and evaluable populations, 36 patients achieved stable disease (SD) or partial response (PR) as their best response. Disease control rates (DCR) were nearly identical in the ER-positive (PR of 46¬†%, DCR of 88.5¬†%) and Her2-positive populations (PR of 20¬†%, DCR of 80.0¬†%) (Table¬†3). We also checked the response rate at different metastatic sites, lymph nodes had the best response. In general, most visceral organs had response rates more than 50¬†% (Table¬†4). The PFS and OS of the ITT patients were identical to those of the evaluable patients (Fig.¬†1; median PFS‚ÄČ=‚ÄČ8.2¬†months, median OS‚ÄČ=‚ÄČ36.6¬†months). For patients who achieved partial response, the median PFS was 9.96¬†months and the median OS was 41.48¬†months, as compared to the patients who achieved SD, who had a median PFS of 6.16¬†months and a median OS of 36.62¬†months (Table¬†5).Table 3

Bottom Line: Other non-hematologic adverse effects were mild to moderate and were manageable.No decrease in left ventricular ejection function was noted.This regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects.

View Article: PubMed Central - PubMed

Affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. liu07822@ms57.hinet.net.

ABSTRACT

Background: Anthracycline and taxane are classes of drugs that are frequently used in the adjuvant and palliative settings of metastatic breast cancer (MBC); however, treatment failure occurs in most cases. Limited data demonstrated favorable response in MBC after previous taxane-based treatment. The aim of this study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (Lipo-Dox¬ģ) used as part of a combination salvage therapy for patients with MBC whose tumors progressed during or after taxane-based treatment.

Methods: Patients with MBC who failed to respond to previous taxane-based treatments were recruited. Treatment with pegylated liposomal doxorubicin (40 mg/m(2)), cyclophosphamide (500 mg/m(2)), and 5-fluorouracil (500 mg/m(2)) was administered every 3 weeks. Tumor response to treatment was determined by using the Response Evaluation Criteria in Solid Tumor criteria version 1.0, and left ventricular ejection fraction was measured before and after treatment using echocardiography. Each patient was followed for 30 days after the last dose of study medication or until resolution/stabilization of any drug-related adverse event.

Results: Forty-five patients were recruited. As of December 2012, the median follow-up duration was 29.8 months, the overall response rate was 41.9 %, the median progression-free survival was 8.2 months, and the median overall survival was 36.6 months for all treated patients. Grade 3/4 neutropenia, leucopenia, and neutropenic fever were observed in 14 %, 9 %, and 1 % of the cycles, respectively. Other non-hematologic adverse effects were mild to moderate and were manageable. No decrease in left ventricular ejection function was noted.

Conclusion: This regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects. This regimen could be considered as a treatment option for patients with MBC whose tumors progressed during or after taxane-based treatment.

No MeSH data available.


Related in: MedlinePlus