Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial.

Abstract

BACKGROUND:

Metastatic breast cancer chemotherapy in the elderly is considered effective in carefully selected patients, but there is little data regarding its effect in vulnerable patients.

METHODS:

We evaluated tumour response (primary endpoint), feasibility and outcomes after six courses of an adapted dose of pegylated liposomal doxorubicin (PLD) (40 mg/m(2) every 28 days) as first-line chemotherapy for hormone-resistant MBC.

RESULTS:

Of 60 patients >70 years (median 77 years), 15% had performance status ≥2 and 73% had visceral metastases. Geriatric assessment included: ≥2 comorbidities, 42%; ≥1 deficiency in Activities of Daily Living (ADL), 10% and Instrumental ADL (IADL), 82%; living in residential homes, 12%; albumin <35 g/L, 17%; body mass index (BMI) <21, 20%; depression, 17%; and lymphocytes ≤1 × 10(3)/mm(3), 27%. Complete response, partial response and stable disease were observed in 5%, 15% and 60%, respectively, but only 48% completed six cycles. Treatment discontinuations were mostly due to disease progression (18%) and non-haematological (NH) toxicities (22%). Eight patients died during treatment (three possibly related to PLD), and 15 had unplanned hospital admissions. Exploratory analyses to identify geriatric covariates associated with treatment outcomes revealed severe haematological toxicities significantly correlated with lymphocytes ≤1 × 10(3)/mm(3). NH toxicities correlated with age ≥80 years and living in residential homes. Progression-free survival (median 6.1 months) decreased with age, deficiency in IADL, cardiac dysfunction and living in residential homes. Overall survival (median 15.7 months) also decreased with living in residential homes.

CONCLUSION:

Despite manageable haematological toxicities and expected response rates, PLD feasibility was poor in unselected elderly patients.

• Authors: C Falandry, E Brain, M Bonnefoy, F Mefti, N Jovenin, O Rigal, O Guillem, C El Kouri, L Uwer, S Abadie-Lacourtoisie, J Cretin, J P Jacquin, D Paraiso, G Freyer
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 49 Issue 13 Pg. 2806-14 (Sep 2013) ISSN: 1879-0852 [Electronic] England
• PMID: 23735702 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: Copyright © 2013 Elsevier Ltd. All rights reserved.

Chemical References

• Antibiotics, Antineoplastic
• liposomal doxorubicin
• Polyethylene Glycols
• Doxorubicin

Topics

• Activities of Daily Living
• Age Factors
• Aged
• Aged, 80 and over
• Antibiotics, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, mortality, secondary)
• Disease-Free Survival
• Doxorubicin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Drug Administration Schedule
• Female
• France
• Geriatric Assessment
• Heart Diseases (complications)
• Homes for the Aged
• Humans
• Kaplan-Meier Estimate
• Multivariate Analysis
• Nursing Homes
• Odds Ratio
• Polyethylene Glycols (administration & dosage, adverse effects, therapeutic use)
• Proportional Hazards Models
• Risk Assessment
• Risk Factors
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome