Myotax: A phase II trial of docetaxel plus non-pegylated liposomal doxorubicin as first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines

2011 ◽  
Vol 47 (16) ◽  
pp. 2396-2402 ◽  
Author(s):  
E. Curtit ◽  
P. Nouyrigat ◽  
N. Dohollou ◽  
E. Levy ◽  
A. Lortholary ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Liposomal Doxorubicin ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Previously Treated

Non-Pegylated Liposomal Doxorubicin in Combination with Cyclophosphamide or Docetaxel as First-Line Therapy in Metastatic Breast Cancer: A Retrospective Analysis

2009 ◽  
Vol 95 (4) ◽  
pp. 422-426 ◽  
Author(s):  
Lorenzo Livi ◽  
Icro Meattini ◽  
Carla De Luca Cardillo ◽  
Monica Mangoni ◽  
Daniela Greto ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Retrospective Analysis ◽  
Liposomal Doxorubicin ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Aims and background Anthracyclines such as doxorubicin play a central role in the management of advanced breast cancer. Unfortunately, the clinical benefits of anthracyclines are limited by cardiotoxicity that can lead to the development of potentially fatal congestive heart failure. In order to limit anthracycline-related cardiotoxicity, liposomal formulations of doxorubicin have been developed. This retrospective analysis evaluated the experience obtained with non-pegylated liposomal doxorubicin as first-line therapy in 34 patients with metastatic breast cancer. Methods Patients received non-pegylated liposomal doxorubicin in combination with either cyclophosphamide (n = 14) or docetaxel (n = 20) for up to eight cycles, and efficacy and safety were assessed according to standard criteria. Results The overall response rate was 71%. The median progression-free survival was 8 months in patients receiving non-pegylated liposomal doxorubicin plus cyclophosphamide and 13.8 months in those receiving non-pegylated liposomal doxorubicin plus docetaxel (P = 0.2). The most commonly observed toxicities were grade 1–2 leucopenia, alopecia, nausea and vomiting; no grade 3–4 toxicities were observed. Overall, three patients (9%) experienced grade 1 cardiac toxicity. Conclusions Our results support the use of non-pegylated liposomal doxorubicin as an alternative to conventional doxorubicin formulations in combination regimens for the first-line therapy of metastatic breast cancer.

Phase II Multicenter Trial of Anthracycline Rechallenge With Pegylated Liposomal Doxorubicin Plus Cyclophosphamide for First-Line Therapy of Metastatic Breast Cancer Previously Treated With Adjuvant Anthracyclines

2009 ◽  
Vol 27 (35) ◽  
pp. 5906-5910 ◽  
Author(s):  
Maureen E. Trudeau ◽  
Mark J. Clemons ◽  
Louise Provencher ◽  
Lawrence Panasci ◽  
Louise Yelle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Liposomal Doxorubicin ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Purpose Anthracyclines are a component of breast cancer chemotherapy regimens in both adjuvant and metastatic settings. Anthracycline rechallenge for metastatic disease, for those previously exposed to adjuvant anthracyclines, may not be considered because of concerns about efficacy, tolerability, and cumulative cardiotoxicity. Patients and Methods This prospective, multicenter, single-arm, phase II trial examined the efficacy and safety of pegylated liposomal doxorubicin (PLD) 35 mg/m2 plus cyclophosphamide 600 mg/m2 as first-line therapy, delivered every 3 weeks, in 70 patients who developed metastatic disease more than 12 months after completion of an adjuvant anthracycline-containing regimen. Seven patients discontinued treatment early and were excluded from the efficacy analysis. Results After a median of six cycles, the objective response rate was 38%. An additional 33% of patients achieved stable disease lasting more than 6 months, for an overall clinical benefit rate of 71%. The estimated median time to progression was 12.2 months. Median overall survival time was 16.5 months. Clinical response was equally robust in patients with and without prior taxane exposure. Treatment was well tolerated. The most common grade 3 to 4 toxicities were palmar-plantar erythrodysesthesia (PPE; 10%), dyspnea (9%), and neutropenia (9%). One (1.4%) of 70 patients discontinued treatment as a result of PPE. One patient (1.4%) experienced an infusion reaction requiring discontinuation. No symptomatic cardiac events were observed. Conclusion PLD plus cyclophosphamide is effective and well tolerated in patients with metastatic breast cancer who have received prior adjuvant anthracycline-containing chemotherapy. The majority of patients experienced a clinical benefit without any significant impact on cardiac function.

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