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- Killander, Fredrika, et al.
(författare)
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Radiotherapy and tamoxifen after mastectomy in postmenopausal women - 20 year follow-up of the South Sweden Breast Cancer group randomised trial SSBCG II : I
- 2007
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 1879-0852 .- 0959-8049. ; 43:14, s. 2100-2108
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To evaluate long-term effects of radiotherapy and tamoxifen after mastectomy on recurrence and survival in stage II breast cancer. Methods: A randomised phase III study with three treatment alternatives. (1) Radiotherapy 50 Gy/2S fractions to chest wall and regional lymph nodes (RT). (2) Radiotherapy and tamoxifen 30 mg/day for one year (RT + tam) and 3. Tamoxifen (tam). Results: 724 postmenopausal women were included between 1978 and 1985 and the trial was close to population based. Follow-up for survival was 23 years. Locoregional recurrences were reduced from 18.5% in the tam arm to 5.3% in the RT + tam arm. Overall mortality at 20 years was 71% in the RT arm, 68% in the RT + tam arm and 62% in the tam arm. The difference between RT + tam and tam was not significant except in the receptor positive subgroup in favour of non-irradiated patients (p = 0.047). The cumulative incidence of systemic disease at 20 years was lower in the RT + Tam arm than in the RT arm, 40% versus 50% (p = 0.047). Conclusion: Postmastectomy radiotherapy significantly reduced loco-regional recurrences, but overall survival was not improved. At 20 years, a lower mortality was recorded for non-irradiated patients treated with tam. (C) 2007 Published by Elsevier Ltd.
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- Magnusson, Marie V, et al.
(författare)
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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)
- 2009
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Ingår i: European Journal of Cancer. - Oxford : Elsevier. - 0959-8049 .- 1879-0852. ; 69:24, s. 740-740
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Tidskriftsartikel (refereegranskat)abstract
- 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. (C) 2009 Elsevier Ltd. All rights reserved.
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