1. Targit-A: 為英國針對早期乳癌病人, 45歲以上, unifocal lesion, 排除lobular carcinoma, 利用50 KV x ray(orthovoltage)技術進行治療, 其劑量為20Gy/1Fr, 使用non-inferiority trial design, 其結果如下:
接受乳房手術
|
Targit(single-dose
targeted intraoperative radiotherapy)
|
EBRT
|
5-year
risk for Local recurrence
(median follow-up: 2y5m)
|
3.3%
|
1.3%
|
p=0·042
|
||
breast cancer mortality
|
2.6%
|
1.9%
|
p=0.56
|
||
non-breast-cancer
deaths
|
1·4%
|
3·5%
|
p=0·0086
|
||
Overall mortality
|
3.9%
|
5.3%
|
p=0·099
|
||
grade 3 or 4
skin complications
|
4
|
13
|
p=0·029
|
prepathology v.s. EBRT: 2·1% vs 1·1% (p=0·31)
postpathology v.s. EBRT: 5·4% vs 1·7% (p=0·069)
結論: IORT 可以在prepathology的情況下, 被考慮當作體外放射治療的替代治療
JAMA oncology在2020年發表了長期追蹤的結果[3], 主要是針對post-pathology的部分, 發現在long-term (median = 9 yrs) mastectomy-free survival, distant disease-free survival, and overall survival 沒差, 但是locoregional recurrence, postpathology-IORT 還是比較高
BMJ 在 2020 年也發表了長期追蹤的結果, 主要是針對pre-pathology的部分, 結果發現 IORT 在 local control, mastectomy-free survival, distant disease-free survival, overall survival, and breast cancer mortality 都跟 EBRT 差不多, 在non-breast cancer mortality 方面來說還比較低
=> Targit-A 以結果來說, 比較傾向使用Pre-pathology, 如果因為某些因素使用post-pathology IORT的話, 就要付出local control 比較差的代價
2. Milan ELIOT trial:
reference:
1. Vaidya, Jayant S., et al. "Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial." The Lancet 383.9917 (2014): 603-613.
2. Veronesi, Umberto, et al. "Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial." The lancet oncology 14.13 (2013): 1269-1277.
2. Milan ELIOT trial:
接受乳房手術
|
IORT with
electron
|
WBRT+boost
|
Ipsilateral breast tumor
recurrence (IBTR) – 5 year event rate
|
4.4%
|
0.4%
|
Hazard ratio=9.3 [95% CI 3·3–26·3]
|
||
5-year overall
survival
|
96.8%
|
96.9%
|
p=0.56
|
||
Fewer skin side effect in IORT(p=0.0002)
|
reference:
1. Vaidya, Jayant S., et al. "Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial." The Lancet 383.9917 (2014): 603-613.
2. Veronesi, Umberto, et al. "Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial." The lancet oncology 14.13 (2013): 1269-1277.
4. Vaidya JS, Bulsara M, Baum M, et al. Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. BMJ. 2020;370:m2836. Published 2020 Aug 19. doi:10.1136/bmj.m2836
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