Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer.
Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer.
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II 期，局部晚期直肠癌术前短程放疗随后化疗和卡瑞利珠单抗的单臂试验
DOI：
10.1136/jitc-2021-003554
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发表时间：
2021-11
影响因子：
10.9
通讯作者：
Zhang T
中科院分区：
文献类型：
--
作者：
Lin Z;Cai M;Zhang P;Li G;Liu T;Li X;Cai K;Nie X;Wang J;Liu J;Liu H;Zhang W;Gao J;Wu C;Wang L;Fan J;Zhang L;Wang Z;Hou Z;Ma C;Yang K;Wu G;Tao K;Zhang T
背景：在局部进展期直肠癌（LARC）中，术前短程放疗（SCRT）加延迟手术已被证明与长期放化疗一样有效，但获益有限。本研究旨在评价术前SCRT联合后续CAPOX（卡培他滨和奥沙利铂）和抗PD-1抗体camrelizumab治疗LARC患者的疗效和安全性。方法这是一项前瞻性、单组、II期试验。未经治疗的组织学确诊为T3- 4 N 0 M0或T1- 4 N +M0直肠腺癌的患者接受5×5戈伊SCRT，随后在1周后接受两个21天周期的CAPOX加卡瑞珠单抗，然后在1周后进行根治性手术。主要终点为病理学完全缓解（pCR）率。进行生物标志物分析，以确定治疗pCR的潜在预测因子。结果从2019年11月7日至2020年9月14日，30例患者入组，27例患者接受了至少一剂CAPOX + camrelizumab。27例（100%）患者接受了手术。pCR（ypT 0 N 0）率为48.1%（13/27），其中错配修复（MMR）阳性组为46.2%（12/26），错配修复缺陷组为100%（1/1）。免疫相关不良事件均为1-2级，最常见的是反应性皮肤毛细血管内皮细胞增殖（81.5%）。未发生4/5级不良事件。生物标志物分析显示，无FGFR 1 -3缺失的患者有更好的pCR倾向。结论SCRT联合随后的CAPOX加camrelizumab随后延迟手术在LARC患者中显示了良好的pCR率和良好的耐受性，特别是在熟练的MMR环境中。一项随机对照试验正在进行中，以证实这些结果。试验注册号ClinicalTrials.gov标识符：NCT 04231552。
Background In locally advanced rectal cancer (LARC), preoperative short-course radiotherapy (SCRT) with delayed surgery has been shown to be as effective as long-course chemoradiotherapy, with only modest benefits. This study aimed to evaluate the efficacy and safety of preoperative SCRT combined with subsequent CAPOX (capecitabine and oxaliplatin) and the anti-PD-1 antibody camrelizumab in patients with LARC. Methods This was a prospective, single-arm, phase II trial. Treatment-naïve patients with histologically confirmed T3-4N0M0 or T1-4N+M0 rectal adenocarcinoma received 5×5 Gy SCRT with two subsequent 21-day cycles of CAPOX plus camrelizumab after 1 week, followed by radical surgery after 1 week. The primary endpoint was pathological complete response (pCR) rate. Biomarker analysis was performed to identify a potential predictor of pCR to treatment. Results From November 7, 2019 to September 14, 2020, 30 patients were enrolled, and 27 patients received at least one dose of CAPOX plus camrelizumab. Surgery was performed in 27 (100%) patients. The pCR (ypT0N0) rate was 48.1% (13/27), including 46.2% (12/26) for proficient mismatch repair (MMR) tumors and 100% (1/1) for deficient MMR tumors. Immune-related adverse events were all grade 1–2, with the most common being reactive cutaneous capillary endothelial proliferation (81.5%). No grade 4/5 adverse events occurred. Biomarker analysis showed patients without FGFR1–3 deletions had a better tendency for pCR. Conclusions SCRT combined with subsequent CAPOX plus camrelizumab followed by delayed surgery showed a favorable pCR rate with good tolerance in patients with LARC, especially in the proficient MMR setting. A randomized controlled trial is ongoing to confirm these results. Trial registration number ClinicalTrials.gov identifier: NCT04231552.
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影响因子：
16.2
作者：
Feng, Rui-Mei;Zong, Yi-Nan;Xu, Rui-Hua
通讯作者：
Xu, Rui-Hua
影响因子：
6.4
作者：
Ryan, R;Gibbons, D;Sheahan, K
通讯作者：
Sheahan, K
影响因子：
51.1
作者：
Erlandsson, Johan;Holm, Torbjorn;Martling, Anna
通讯作者：
Martling, Anna
DOI：
10.1200/jco.19.00308
发表时间：
2019-12-01
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Fokas, Emmanouil;Allgauer, Michael;Rodel, Claus
通讯作者：
Rodel, Claus
影响因子：
10.9
作者：
Gong J;Le TQ;Massarelli E;Hendifar AE;Tuli R
通讯作者：
Tuli R