Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial.
Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial.
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DOI：
10.1016/s1470-2045(22)00638-6
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发表时间：
2022-12
期刊：
影响因子：
51.1
通讯作者：
Bishop, Andrew J.
中科院分区：
文献类型：
--
作者：
Guadagnolo, B. Ashleigh;Bassett, Roland L.;Mitra, Devarati;Farooqi, Ahsan;Hempel, Caroline;Dorber, Courtney;Willis, Tiara;Wang, Wei-Lien;Ratan, Ravin;Somaiah, Neeta;Benjamin, Robert S.;Torres, Keila E.;Hunt, Kelly K.;Scally, Christopher P.;Keung, Emily Z.;Satcher, Robert L.;Bird, Justin E.;Lin, Patrick P.;Moon, Bryan S.;Lewis, Valerae O.;Roland, Christina L.;Bishop, Andrew J.
软组织肉瘤（STS）的标准术前放射治疗（RT）剂量为50戈伊，分25次给药，约35%的患者局部控制良好，伴有严重伤口并发症（MWC）。我们报告了一项STS术前3周大分割RT试验的2年随访主要终点结果。我们在美国的一家三级癌症护理中心进行了一项前瞻性、单组对照试验。我们对患有四肢或浅表躯干非转移性STS且ECOG体能状态评分为0-3的成人术前给予42·75戈伊（15次，每次2.85戈伊）。主要终点是手术后120天内的MWC率，定义为需要：（1）在全身麻醉或局部麻醉下进行伤口修复的二次手术，（2）广泛的伤口管理而不进行手术，或（3）再次入院进行伤口护理。我们使用贝叶斯停止规则单组事件时间模拟器，按照方案监测所有入组患者的安全性，将研究参与者术后120天的MWC与历史发生率35%进行比较。招募完成。后续行动仍在继续。本试验注册于ClinicalTrials.gov，NCT 03819985。2018年12月18日至2021年1月6日，120例患者入组，接受42·75戈伊（或CGE，如果是质子）。中位随访时间为24个月（IQR 17-30）。术后120天内的MWC发生率为31%（n=37，95% CI，24-40%），发生时间为中位37天（IQR 25-59）。无患者发生CTCAE v4.0 ≥ 3级急性毒性、治疗中严重不良事件，也无治疗相关死亡。4例患者发生RT ≥3级的晚期毒性反应：2例股骨骨折，1例水肿，1例皮肤溃疡。术前42·75戈伊，每日15次，MWC率与常规分割RT相似，并且被认为是安全的。长期肿瘤学、晚期毒性和功能结局有待观察。NIH/NCI癌症中心支持（核心）拨款CA 016672给（PI-Pisters）德克萨斯大学MD安德森癌症中心。
Standard preoperative radiation therapy (RT) dosing of 50 Gy in 25 fractions for soft tissue sarcoma (STS) results in excellent local control with major wound complications (MWC) in approximately 35% of patients. We report primary endpoint results with 2-year follow-up of a trial of hypofractionated, three-week preoperative RT for STS. We conducted a prospective, single-arm controlled trial at a single tertiary cancer care center in the US. We administered preoperative 42·75 Gy in 15 fractions of 2.85 Gy to adults with non-metastatic STS of the extremity or superficial trunk and ECOG performance status 0–3. The primary endpoint was the MWC rate within 120 days of surgery defined as requiring: (1) secondary operation under either general or regional anesthesia for wound repair, (2) extensive wound management without operation, or (3) readmission to the hospital for wound care. We monitored safety for all enrolled patients per protocol using a Bayesian stopping rule One-Arm Time-To-Event Simulator comparing MWC at 120 days post-surgery among study participants to the historical rate of 35%. Recruitment is complete. Follow-up continues. This trial is registered with ClinicalTrials.gov, NCT03819985. From December 18, 2018 to January 6, 2021, 120 patients were enrolled and received 42·75 Gy (or CGE if protons). Median follow-up was 24 months (IQR 17–30). The MWC rate within 120 days of surgery was 31% (n=37, 95% CI, 24–40%) occurring at median 37 days (IQR 25–59). No patient experienced acute toxicity of CTCAE v4.0 ≥ grade 3, on-treatment serious adverse event, nor treatment related death. Grade ≥3 late toxic effects of RT occurred in 4 patients: 2 femur fracture, 1 lymphedema, 1 skin ulceration. Preoperative 42·75 Gy in 15 daily fractions resulted in a MWC rate that was similar to conventionally fractionated RT and was found to be safe. Long-term oncologic, late toxicity and functional outcomes are awaited. NIH/NCI Cancer Center Support (Core) Grant CA016672 to (PI-Pisters) The University of Texas MD Anderson Cancer Center.