Hypofractionation in radiotherapy for breast cancer
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文摘
Between 1998 and 2002, 2236 women with early breast cancer (pT1-3a pN0-1 M0) at 17 centres in the UK were randomly assigned after primary surgery to receive 50 Gy in 25 fractions of 2·0 Gy versus 41·6 Gy or 39 Gy in 13 fractions of 3·2 Gy or 3·0 Gy over 5 weeks. Women were eligible if they were aged over 18 years, did not have an immediate surgical reconstruction, and were available for follow-up. Randomisation method was computer generated and was not blinded. The protocol-specified principal endpoints were local-regional tumour relapse, defined as reappearance of cancer at irradiated sites, late normal tissue effects, and quality of life. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN59368779.

Findings

749 women were assigned to the 50 Gy group, 750 to the 41·6 Gy group, and 737 to the 39 Gy group. After a median follow up of 5·1 years (IQR 4·4–6·0) the rate of local-regional tumour relapse at 5 years was 3·6 % (95 % CI 2·2–5·1) after 50 Gy, 3·5 % (95 % CI 2·1–4·3) after 41·6 Gy, and 5·2 % (95 % CI 3·5–6·9) after 39 Gy. The estimated absolute differences in 5-year local-regional relapse rates compared with 50 Gy were 0·2 % (95 % CI −1·3 % to 2·6 % ) after 41·6 Gy and 0·9 % (95 % CI −0·8 % to 3·7 % ) after 39 Gy. Photographic and patient self-assessments suggested lower rates of late adverse effects after 39 Gy than with 50 Gy, with an HR for late change in breast appearance (photographic) of 0·69 (95 % CI 0·52–0·91, p=0·01). From a planned meta-analysis with the pilot trial, the adjusted estimates of α/β value for tumour control was 4·6 Gy (95 % CI 1·1–8·1) and for late change in breast appearance (photographic) was 3·4 Gy (95 % CI 2·3–4·5).

Interpretation

The data are consistent with the hypothesis that breast cancer and the dose-limiting normal tissues respond similarly to change in radiotherapy fraction size. 41·6 Gy in 13 fractions was similar to the control regimen of 50 Gy in 25 fractions in terms of local-regional tumour control and late normal tissue effects, a result consistent with the result of START Trial B. A lower total dose in a smaller number of fractions could offer similar rates of tumour control and normal tissue damage as the international standard fractionation schedule of 50 Gy in 25 fractions.


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The UK Standardisation of Breast Radiotherapy (START) T...
The Lancet
the full text of this document"" title=""You are entitled to access the full text of this document"" width=12 height=14""> The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial
The Lancet, Volume 371, Issue 9618, 29 March 2008-4 April 2008, Pages 1098-1107
The START Trialists' Group

Abstract

Summary

Background

The international standard radiotherapy schedule for early breast cancer delivers 50 Gy in 25 fractions of 2·0 Gy over 5 weeks, but there is a long history of non-standard regimens delivering a lower total dose using fewer, larger fractions (hypofractionation). We aimed to test the benefits of radiotherapy schedules using fraction sizes larger than 2·0 Gy in terms of local-regional tumour control, normal tissue responses, quality of life, and economic consequences in women prescribed post-operative radiotherapy.

Methods

Between 1999 and 2001, 2215 women with early breast cancer (pT1-3a pN0-1 M0) at 23 centres in the UK were randomly assigned after primary surgery to receive 50 Gy in 25 fractions of 2·0 Gy over 5 weeks or 40 Gy in 15 fractions of 2·67 Gy over 3 weeks. Women were eligible for the trial if they were aged over 18 years, did not have an immediate reconstruction, and were available for follow-up. Randomisation method was computer generated and was not blinded. The protocol-specified principal endpoints were local-regional tumour relapse, defined as reappearance of cancer at irradiated sites, late normal tissue effects, and quality of life. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN59368779.

Findings

1105 women were assigned to the 50 Gy group and 1110 to the 40 Gy group. After a median follow up of 6·0 years (IQR 5·0–6·2) the rate of local-regional tumour relapse at 5 years was 2·2 % (95 % CI 1·3–3·1) in the 40 Gy group and 3·3 % (95 % CI 2·2 to 4·5) in the 50 Gy group, representing an absolute difference of −0·7 % (95 % CI −1·7 % to 0·9 % )—ie, the absolute difference in local-regional relapse could be up to 1·7 % better and at most 1 % worse after 40 Gy than after 50 Gy. Photographic and patient self-assessments indicated lower rates of late adverse effects after 40 Gy than after 50 Gy.

Interpretation

A radiation schedule delivering 40 Gy in 15 fractions seems to offer rates of local-regional tumour relapse and late adverse effects at least as favourable as the standard schedule of 50 Gy in 25 fractions.


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Acute Toxicity and 2-year Adverse Effects of 30 Gy in F...
Clinical Oncology
the full text of this document"" title=""You are not entitled to access the full text of this document"" width=12 height=14""> Acute Toxicity and 2-year Adverse Effects of 30 Gy in Five Fractions over 15 Days to Whole Breast after Local Excision of Early Breast Cancer
Clinical Oncology, In Press, Corrected Proof, Available online 16 June 2008
S. Martin, M. Mannino, A. Rostom, D. Tait, E. Donovan, S. Eagle, J. Haviland, J. Yarnold

Abstract

Aims

A pilot study was undertaken with the aim of documenting acute skin reactions and 2-year late adverse effects of a five-fraction course of adjuvant whole breast radiotherapy delivered over 15 days after local tumour excision of early breast cancer.

Materials and methods

Thirty women with early invasive breast cancer aged ≥50 years with a pathological tumour size <3 cm, complete microscopic resection, negative axillary node status and no requirement for cytotoxic therapy were prescribed 30 Gy in five fractions over 15 days to the whole breast using tangential 6–10 MV X-ray beams and three-dimensional dose compensation with written informed consent. Post-surgical baseline photographs of the breasts were taken, and acute skin erythema and moist desquamation were each scored weekly for 7 weeks using four-point graded scales (grade 0 = none, 1 = mild, 2 = moderate, 3 = severe). This was followed by an annual clinical assessment, including repeat photographs at 2 years.

Results

Nine patients (30 % , 95 % confidence interval 14.7–49.4 % ) developed grade 2 erythema, with the remaining 21 patients developing milder degrees of reaction. Four (13.3 % , 95 % confidence interval 3.7–30.7) patients developed moist desquamation, grade 1 in three women and grade 2 in the fourth. At 2 years after treatment, 23/30 (77 % ) patients scored no change in photographic breast appearance compared with the pre-treatment baseline; seven (23 % , 95 % confidence interval 9.9–42.3) scored a mild change in breast appearance, and none developed a marked change. After a mean follow-up of 3.1 years (standard deviation 0.37, range 2.1–3.9 years) there have been no ipsilateral local tumour relapses.

Conclusions

Further evaluation of a five-fraction regimen of adjuvant whole breast radiotherapy in a phase III randomised trial is justified, including a regimen delivered in a total of 5 days.


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doi:10.1016/S0140-6736(08)60349-9
Copyright © 2008 Elsevier Ltd All rights reserved.

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Hypofractionation in radiotherapy for breast cancer

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