Magnusson M, Höglund P, Johansson K, Jönsson C, Killander F, Malmström P, Weddig A, Kjellén E, et al.
European journal of cancer (Oxford, England : 1990). Date of publication 2009 Sep 1;volume 45(14):2488-95.
1. Eur J Cancer. 2009 Sep;45(14):2488-95. doi: 10.1016/j.ejca.2009.05.015. Epub 2009
Jun 17.
Pentoxifylline and vitamin E treatment for prevention of radiation-induced
side-effects in women with breast cancer: a phase two, double-blind,
placebo-controlled randomised clinical trial (Ptx-5).
Magnusson M(1), Höglund P, Johansson K, Jönsson C, Killander F, Malmström P,
Weddig A, Kjellén E.
Author information:
(1)Department of Clinical Pharmacology, Lund University Hospital, Lund SE 221 85,
Sweden.
BACKGROUND: A previous study has shown that pentoxifylline in combination with
vitamin E can reverse radiation-induced fibrosis. The aim of the present study is
to investigate if the same drugs could prevent radiation-induced side-effects in
women with breast cancer.
PATIENTS AND METHODS: A randomised, placebo-controlled, double-blind, parallel
group trial was performed. Women with breast cancer were treated for 12 months
with 400 mg pentoxifylline t.i.d. or placebo, in combination with 100 mg vitamin
E t.i.d., starting 1-3 months after the completion of radiotherapy. The primary
end-point was passive abduction of the shoulder, and the secondary end-point was
difference in arm volumes. The trial is registered on the ISRCTN.org website,
number ISRCTN39143623.
RESULTS: 83 patients were included in the study; 42 in the pentoxifylline+vitamin
E group and 41 in the placebo+vitamin E group. Both treatments were generally
well tolerated. Seven patients were withdrawn from the treatment due to disease
progression; four in the pentoxifylline group and three in the placebo group. At
inclusion, patients had impaired passive abduction of the shoulder. During
treatment, both the groups improved significantly. Median improvement from
baseline was 3.7 degrees (p=0.0035) on pentoxifylline and was 9.4 degrees
(p=0.0041) in the placebo group, but no difference between the groups was
detected (p=0.20). Arm volumes increased over time in the placebo group (1.04%),
but not on pentoxifylline (0.50%), and differed significantly between the groups
(p=0.0172).
CONCLUSIONS: The combination of pentoxifylline and vitamin E was safe and may be
used for the prevention of some radiation-induced side-effects.
DOI: 10.1016/j.ejca.2009.05.015
PMID: 19540105 [Indexed for MEDLINE]
