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Clinical Trial
. 2014 Mar;25(3):599-605.
doi: 10.1093/annonc/mdt588. Epub 2014 Feb 6.

A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG

C H Smorenburg  1 , S M de Groot  2 , A E van Leeuwen-Stok  3 , M E Hamaker  4 , A N Wymenga  5 , H de Graaf  6 , F E de Jongh  7 , J J Braun  8 , M Los  9 , E Maartense  10 , H van Tinteren  11 , J W R Nortier  12 , C Seynaeve  13
Affiliations
Clinical Trial

A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG

C H Smorenburg et al. Ann Oncol. 2014 Mar.

Abstract

Background: 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 and methods: 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).

Results: 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.

Conclusion: 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.

Clinical trial numbers: EudraCT 2006-002046-10; ISRCTN 11114726; CKTO 2006-09; BOOG 2006-02.

Keywords: capecitabine; elderly; geriatric; metastatic breast cancer; pegylated liposomal doxorubicin; phase III.

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Figures

Figure 1.
Figure 1.
CONSORT diagram for the OMEGA study.
Figure 2.
Figure 2.
The number of reported cycles of chemotherapy in relation to age.
Figure 3.
Figure 3.
Kaplan–Meier estimates of progression-free survival and overall survival comparing PLD versus capecitabine.
See this image and copyright information in PMC

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