1. START-A: 英國研究, 收案條件為乳癌術後病人, pT1-3a pN0-1 M0, 50Gy/25Fr v.s. 39Gy/13Fr or 41.6Gy/13Fr, 實驗組和對照組的治療時間都是五周, 結果如下: 5-year local-regional relapse rates, 41.6Gy 和 50 Gy 相比是 0.2% (95% CI −1.3% to 2.6%), 39Gy 和 50Gy相比是 0·9% (95% CI −0·8% to 3·7%) ; 39Gy 和 50 Gy相比, late adverse effect 的發生比率比較低; $\alpha/\beta$ 在腫瘤控制方面是 4·6 Gy (95% CI 1·1–8·1) , 在 late change in breast appearance (photographic) 是 3·4 Gy (95% CI 2·3–4·5).
2. START-B: 英國研究, 收案條件為乳癌術後病人, pT1-3a pN0-1 M0, 50Gy/25Fr (治療五周) v.s. 40Gy/15Fr (治療三周), 追蹤年份中位數是 6·0 年 (IQR 5·0–6·2), 40 Gy組的 the rate of local-regional tumour relapse at 5 years 是 2·2% (95% CI 1·3–3·1), 50Gy組是 3·3% (95% CI 2·2 to 4·5), 40Gy的late adverse effects比50Gy少 (photographic and patient self-assessments)
3. canadian trial of hypofractionation: 加拿大研究, 收案條件為接受過BCS, pN0, 50Gy/25Fr v.s. 42.5Gy/16Fr, no boost, 10yr LR(6.2% v.s. 6.7%), DFS, OS, good/excellent cosmetic outcome 都沒有統計學上差別
4. RMH/GOC trial: 也是比較hypofractionation 跟coventional fractionation, breast cancer 接受手術, tumor stage I-III with at least one lymph node, 39Gy/13Fr, 42.9Gy/13Fr, 50Gy/25Fr, 去做比較, 治療時間是五周, 結果發現十年後同側乳房復發是 12.1% (95% CI 8.8-15.5) in the 50 Gy group, 14.8% (11.2-18.3) in the 39 Gy group, and 9.6% (6.7-12.6) in the 42.9 Gy group (difference between 39 Gy and 42.9 Gy groups, chi square test, p=0.027).
reference:
1. Trialists' Group, The START. "The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial." The lancet oncology 9.4 (2008): 331-341.
2. Bentzen, S. M., et al. "The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial." Lancet (London, England) 371.9618 (2008): 1098-1107.
3. Whelan, Timothy J., et al. "Long-term results of hypofractionated radiation therapy for breast cancer." New England Journal of Medicine 362.6 (2010): 513-520.
4. handbook of evidence-based radiation oncology
5. Kim, Kyung Su, et al. "Hypofractionated whole breast irradiation: new standard in early breast cancer after breast-conserving surgery." Radiation oncology journal 34.2 (2016): 81. (open access)
6. Owen JR, Ashton A, Bliss JM, et al. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial [published correction appears in Lancet Oncol. 2006 Aug;7(8):620]. Lancet Oncol. 2006;7(6):467-471. doi:10.1016/S1470-2045(06)70699-4
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