Vaugier Loïg, Mirabel Xavier, Martel-Lafay Isabelle, Racadot Séverine, Carrie Christian, Vendrely Véronique, Mahé Marc-André, Senellart Hélène, Raoul Jean-Luc, Campion Loïc, Rio Emmanuel
Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, 44800 St-Herblain, France.
Department of Radiation Oncology, Centre Oscar Lambret, 59000 Lille, France.
Cancers (Basel). 2021 Jan 11;13(2):248. doi: 10.3390/cancers13020248.
: Stereotactic body radiotherapy (SBRT) is a recognized treatment for colorectal cancer (CRC) metastases. We postulated that local responses could be improved by SBRT with a concomitant radiosensitizing agent (irinotecan). : RADIOSTEREO-CAMPTO was a prospective multi-center phase 2 trial investigating SBRT (40-48 Gy in 4 fractions) for liver and/or lung inoperable CRC oligometastases (≤3), combined with two weekly intravenous infusions of 40 mg/m Irinotecan. Primary outcome was the objective local response rate as per RECIST. Secondary outcomes were early and late toxicities, EORTC QLQ-C30 quality of life, local control and overall survival. : Forty-four patients with 51 lesions (liver = 39, lungs = 12) were included. Median age was 69 years (46-84); 37 patients (84%) had received at least two prior chemotherapy treatments. Median follow-up was 48.9 months. One patient with two lung lesions was lost during follow-up. Assuming maximum bias hypothesis, the objective local response rate in ITT was 86.3% (44/51-95% CI: [76.8-95.7]) or 82.4% (42/51-95% CI: [71.9-92.8]). The observed local response rate was 85.7% (42/49-95% CI: [75.9-95.5]). The 1 and 2-year local (distant) progression-free survivals were 84.2% (38.4%) and 67.4% (21.3%), respectively. The 1 and 2-year overall survivals were 97.5% and 75.5%. There were no severe acute or late reactions. The EORTC questionnaire scores did not significantly worsen during or after treatment. : SBRT with irinotecan was well tolerated with promising results despite heavily pretreated patients.
立体定向体部放疗（SBRT）是一种公认的用于治疗结直肠癌（CRC）转移的方法。我们推测，联合使用放射增敏剂（伊立替康）的SBRT可以改善局部反应。“RADIOSTEREO-CAMPTO”是一项前瞻性多中心2期试验，研究SBRT（4次分割，40-48 Gy）用于治疗无法手术的肝脏和/或肺部CRC寡转移（≤3个转移灶），并联合每周两次静脉输注40 mg/m²伊立替康。主要结局是根据RECIST标准评估的客观局部缓解率。次要结局包括早期和晚期毒性、欧洲癌症研究与治疗组织（EORTC）QLQ-C30生活质量、局部控制率和总生存率。44例患者共51个病灶（肝脏39个病灶，肺部12个病灶）被纳入研究。中位年龄为69岁（46-84岁）；37例患者（84%）此前至少接受过两种化疗。中位随访时间为48.9个月。1例有两个肺部病灶的患者在随访期间失访。假设最大偏倚假设，意向性分析（ITT）中的客观局部缓解率为86.3%（44/51-95%置信区间：[76.8-95.7]）或82.4%（42/51-95%置信区间：[71.9-92.8]）。观察到的局部缓解率为85.7%（42/49-95%置信区间：[75.9-95.5]）。1年和2年的局部（远处）无进展生存率分别为84.2%（38.4%）和67.4%（21.3%）。1年和2年的总生存率分别为97.5%和75.5%。未出现严重的急性或晚期反应。治疗期间及治疗后EORTC问卷评分未显著恶化。尽管患者接受过大量预处理，但联合伊立替康的SBRT耐受性良好，结果令人满意。
