Multicenter Phase II Study of Pegylated Liposomal Doxorubicin in Combination with Vinorelbine as First-Line Treatment in Elderly Patients with Metastatic Breast Cancer
Paracelsus Medical University Salzburg, 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectious Disease and Laboratory of Immunological and Molecular Cancer Research, Müllner Hauptstrasse 48, Salzburg, Austria. Onkologie
(Impact Factor: 0.86).
03/2009; 32(1-2):18-24. DOI: 10.1159/000180915
This multicenter phase II trial was conducted to analyze the clinical activity and toxicity of the combination of pegylated liposomal doxorubicin and vinorelbine as first-line treatment in elderly patients with metastatic breast cancer.
From August 2002 to August 2004, 42 patients with metastatic breast cancer were recruited for treatment with pegylated liposomal doxorubicin 40 mg/m(2) intravenously (i.v.) on day 1 and vinorelbine 30 mg/m(2) i.v. on days 1 and 15 every 4 weeks.
The median age of the patients in this trial was 68 years (range 60-82). 40% of patients had 2 or more sites of metastasis, 33 (78%) had predominantly visceral metastasis, and 7 (16%) mostly bone metastasis. Just 2 (5%) patients had only lymphogenous or soft tissue metastasis. All patients had an ECOG performance status of 0-1, but 70% of the patients had relevant comorbidities. In an intention-to-treat analysis, the overall clinical response rate was 36%, the complete response rate was 2%, and the rate of partial remissions was 34%; stable disease occurred in 30%, and progressive disease was observed in 36%. Median duration of response was 10 months. Median time to progression was 4 months, and median overall survival time was 24 months.
The combination of pegylated liposomal doxorubicin and vinorelbine is an active and well tolerated regimen in elderly patients with metastatic breast cancer in first-line treatment.
Available from: Armando Carpino
- "In details, the PLD/VNB combination was recently employed in two phase II trials in heavily pretreated patients, yielding a response rate of 36% and 39%, without any cardiac toxicity [37,38]. Two more recent reports with PLD/VNB combination as first-line treatment in elderly patients confirmed the good overall clinical response rate (36% and 50%, respectively), and the high tolerability of the regimen [39,40] suggesting, due to the safety profile of the combination, the employment also in such "frail" patient population. "
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ABSTRACT: To evaluate activity and tolerability of two anthracycline-containing regimens as first-line treatment for anthracycline-naïve relapsed breast cancer patients.
Patients with relapsed breast cancer not previously treated with adjuvant anthracyclines were randomly assigned to epirubicin/vinorelbine (arm A: EPI/VNB, EPI 90 mg/m2 on day 1, VNB 25 mg/m2 on days 1,5 plus G-CSF subcutaneously on days 7-12, with cycles repeated every 21 days), or to pegylated liposomal doxorubicin/VNB (arm B: PLD/VNB, PLD 40 mg/m2 on day 1, VNB 30 mg/m2 on days 1, 15, with cycles repeated every 4 weeks). Primary objective was to evaluate the efficacy of the two regimens in terms of response rate, secondarily toxicity, progression free survival and overall survival.
One hundred and four patients have been enrolled (arm A 54, arm B 50): characteristics were well balanced between the 2 arms. Responses were as follows: arm A, 3 (5.6%) CR, 20 (37%) PR, (ORR 42.6%, 95%CI 29.3%-55.9%); arm B, 8 (16%) CR, 18 (36%) PR, (ORR 52%, 95%CI 38.2%-65.8%). Median progression free survival was 10.7 months in arm A (95% CI, 8.7-12.6), and 8.8 months in arm B (95% CI, 7.1-10.5). Median overall survival was 34.6 months in arm A (95%CI, 19.5-49.8) and 24.8 months in arm B (95%CI, 15.7-33.9). As toxicity concerns, both treatment regimens were well tolerated; myelosuppression was the dose-limiting toxicity, with G3-4 neutropenia occurring in 18.5% and 22% of the patients of arm A and B, respectively. No relevant differences in main toxic effects have been observed between the two arms, except for alopecia, more common in arm A, and cutaneous toxicity, observed only in arm B. No clinical congestive heart failures have been observed, one case of tachyarrhythmia was reported after the last EPI/VNB cycle, and two reversible ≥ 20% LVEF decreases have been observed in arm A.
Both anthracycline- containing regimens evaluated in the present study seem to be active and with a satisfactory tolerability in anthracycline-naïve relapsed breast cancer patients.
Journal of Experimental & Clinical Cancer Research 04/2011; 30(1):39. DOI:10.1186/1756-9966-30-39 · 4.43 Impact Factor
Available from: umassd.edu
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ABSTRACT: A fast transversal filter (FTF) for the numerical factorization of
polynomials having zeros of different modulus is presented. When all
zeros of a polynomial are of different modulus, this algorithm can be
used for the simultaneous determination of all zeros. This method is
globally convergent in that it does not require initial conditions to
start. Additionally, this can be modified to compute all zeros of any
given polynomial by shifting the zeros. The numerical efficiency of this
algorithm is inherited from the reduced computational cost associated
with the transversal filters which require O(N) operations per sample
and N is the order of the filter
Acoustics, Speech, and Signal Processing, 1996. ICASSP-96. Conference Proceedings., 1996 IEEE International Conference on; 06/1996
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ABSTRACT: The management of older patients with cancer is historically challenging because of a lack of prospective data regarding the appropriate management of this population. In this review, we address some of the issues and challenges surrounding the treatment of older cancer patients, including the withholding of medically appropriate treatment based on chronologic age, the historical omission of elderly from clinical trials, and the impact of geriatric assessment, and age-related changes in pharmacokinetics and pharmacodynamics. Finally, we conclude by discussing the existing evidence related to cancer treatment in the elderly, focusing primarily on the malignancies most commonly seen in older patients, and making general treatment recommendations where applicable.
Oncology (Williston Park, N.Y.) 01/2010; 24(1):76-85. · 2.32 Impact Factor
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