Abstract
Background
We previously reported that uracil-tegafur with oral leucovorin (UFT/LV) treatment
for elderly patients (aged ≥ 75 years) was well-tolerated in a phase II study. In
the present study, the efficacy and safety of a modified (1-week shorter administration
period) UFT/LV schedule combined with bevacizumab for a similar population are reported.
Patients and Methods
The present study was a single-arm, open-label, multicenter, cooperative group clinical
trial. The key eligibility criteria included age ≥ 75 years, Eastern Cooperative Oncology
Group (ECOG) performance status 0 or 1, first-line chemotherapy, measurable lesions,
and preserved organ function. Patients received UFT 300 mg/m2/d and LV 75 mg/d on days 1 to 21 and intravenous bevacizumab 5 mg/kg on days 1 and
15. Treatment was repeated every 28 days. The primary endpoint was progression-free
survival (PFS), and the secondary endpoints were the objective response rate (ORR),
overall survival (OS), and safety.
Results
Of the 55 patients enrolled from 15 Japanese institutions, 52 eligible patients were
evaluated. Their median age was 80 years (range, 75-87 years), and 73% had an ECOG
performance status of 0. The median PFS was 8.2 months (95% confidence interval [CI],
6.2-10 months). The ORR was 40% (95% CI, 27%-55%). The median OS was 23 months (95%
CI, 12-33 months). The most common grade 3 and 4 treatment-related adverse events
were hypertension (12%), fatigue (8%), anemia (8%), nausea (6%), and diarrhea (6%).
Treatment-related death occurred in 2 patients.
Conclusion
UFT/LV (3 weeks of therapy and 1 week without) combined with biweekly bevacizumab
is a tolerable and effective treatment option for elderly patients (aged ≥ 75 years)
with metastatic colorectal cancer.
Keywords
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Article info
Publication history
Published online: December 16, 2015
Accepted:
December 9,
2015
Received in revised form:
December 7,
2015
Received:
August 27,
2015
Identification
Copyright
© 2015 Elsevier Inc. All rights reserved.
