Journal
ANNALS OF ONCOLOGY
Volume 25, Issue 3, Pages 599-605Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdt588
Keywords
metastatic breast cancer; capecitabine; pegylated liposomal doxorubicin; phase III; elderly; geriatric
Categories
Funding
- Amgen BV the Netherlands [166214]
- Schering Plough the Netherlands [BCA 3001]
- Janssen Cilag BV the Netherlands
- MSD [p05028]
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Patients aged >= 80 years were less likely to complete chemotherapy.Prospective data on chemotherapy for elderly patients with metastatic breast cancer (MBC) remain scarce. We compared the efficacy and safety of first-line chemotherapy with pegylated liposomal doxorubicin (PLD) versus capecitabine in MBC patients aged >= 65 years in a multicentre, phase III trial. Patients were randomized to six cycles of PLD (45 mg/m(2) every 4 weeks) or eight cycles of capecitabine (1000 mg/m(2) twice daily, day 1-14 every 3 weeks). The study enrolled 78 of the planned 154 patients and was closed prematurely due to slow accrual and supply problems of PLD. Many included patients were aged >= 75 years (54%) and vulnerable (>= 1 geriatric condition: 71%). The median dose intensity was 85% for PLD and 84% for capecitabine, respectively. In both arms, the majority of patients completed at least 12 weeks of treatment (PLD 73%; capecitabine 74%). After a median follow-up of 39 months, 77 patients had progressed and 62 patients had died of MBC. Median progression-free survival was 5.6 versus 7.7 months (P = 0.11) for PLD and capecitabine, respectively. Median overall survival was 13.8 months for PLD and 16.8 months for capecitabine (P = 0.59). Both treatments were feasible, grade 3 toxicities consisting of fatigue (both arms: 13%), hand-foot syndrome (PLD: 10%; capecitabine: 16%), stomatitis (PLD: 10%; capecitabine: 3%), exanthema (PLD: 5%) and diarrhoea (PLD: 3%; capecitabine: 5%). Only 1 of 10 patients aged >= 80 years completed chemotherapy, while 3 and 6 patients discontinued treatment due to toxicity or progressive disease, respectively. Both PLD and capecitabine demonstrated comparable efficacy and acceptable tolerance as first-line single-agent chemotherapy in elderly patients with MBC, even in vulnerable patients or patients aged >= 75 years. However, patients aged >= 80 years were unlikely to complete chemotherapy successfully.
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