在 retroperitoneal sarcoma 裡面, 手術一直是標準治療, 在手術前是否需要加上術前放射治療, 一直是個有爭議的主題, 在2020年底, Lancet oncology 發表了關於這個主題的重要研究, 雖然一年過去了, 但是這個臨床試驗還是很重要, 因此這邊來做個整理!
這個臨床試驗是phase III RCT, 總共在31個地方進行收案, 收案條件為18歲以上, 收案條件為組織學上確認的priamry soft tissue sarcoma of retroperitoneal or infraperitoneal spaces of the pelvis.
總共分成兩組, 分別為en bloc surgery versus pre-operative radiotherapy + en bloc surgery
Primary endpoint 定為 abdominal recurrence free survival
Secondary endpoint 定為 tumor response to preoperative radiotherapy, metastasis-free survival, abdominal recurrence free interval, overall survival, safety and quality of life.
結果總共收案266人, 分為兩組, 各133人, 結果發現abdominal recurrence free survival在兩組統計上並沒有差異[HR=1.01(95% CI 0.71-1.44), log-rank p=0.95]
副作用方面, 最常見的 grade 3–4 adverse events 是 lymphopenia (98 [77%] of 127 patients in the radiotherapy plus surgery group vs one [1%] of 128 patients in the surgery alone group), anaemia (15 [12%] vs ten [8%]), and hypoalbuminaemia (15 [12%] vs five [4%]).
Serious adverse events were reported in 30 (24%) of 127 patients in the radiotherapy plus surgery group, and in 13 (10%) of 128 patients in the surgery alone group. One (1%) of 127 patients in the radiotherapy plus surgery group died due to treatment-related serious adverse events (gastropleural fistula), and no patients in the surgery alone group died due to treatment-related serious adverse events.
=> 從上面的結果可以發現局部控制差不多, 但是副作用在RT 組明顯比較多, 因此這篇RCT認為不應該在手術前加上放射治療
Reference:
1. Bonvalot, S., Gronchi, A., Le Péchoux, C., Swallow, C. J., Strauss, D., Meeus, P., van Coevorden, F., Stoldt, S., Stoeckle, E., Rutkowski, P., Rastrelli, M., Raut, C. P., Hompes, D., De Paoli, A., Sangalli, C., Honoré, C., Chung, P., Miah, A., Blay, J. Y., Fiore, M., … Haas, R. L. (2020). Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. The Lancet. Oncology, 21(10), 1366–1377. https://doi.org/10.1016/S1470-2045(20)30446-0
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