Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, Missouri.
Division of Hematology and Oncology, Department of Internal Medicine, Washington University School of Medicine, Saint Louis, Missouri.
Int J Radiat Oncol Biol Phys. 2022 Mar 1;112(3):715-725. doi: 10.1016/j.ijrobp.2021.10.004. Epub 2021 Oct 12.
This study aimed to determine the clinical efficacy and safety of nonoperative management (NOM) for patients with rectal cancer with a clinical complete response (cCR) after short-course radiation therapy and consolidation chemotherapy.
Patients with stage I-III rectal adenocarcinoma underwent short-course radiation therapy followed by consolidation chemotherapy between January 2018 and May 2019 (n = 90). Clinical response was assessed by digital rectal examination, pelvic magnetic resonance imaging, and endoscopy. Of the patients with an evaluable initial response, those with a cCR (n = 43) underwent NOM, and those with a non-cCR (n = 43) underwent surgery. The clinical endpoints included local regrowth-free survival, regional control, distant metastasis-free survival, disease-free survival, and overall survival.
Compared with patients with an initial cCR, patients with initial non-cCR had more advanced T and N stage (P = .05), larger primary tumors (P = .002), and more circumferential resection margin involvement on diagnostic magnetic resonance imaging (P < .001). With a median follow-up of 30.1 months, the persistent cCR rate was 79% (30 of 38 patients) in the NOM cohort. The 2-year local regrowth-free survival was 81% (95% confidence interval [CI], 70%-94%) in the initial cCR group, and all patients with local regrowth were successfully salvaged. Compared with those with a non-cCR, patients with a cCR had improved 2-year regional control (98% [95% CI, 93%-100%] vs 85% [95% CI, 74%-97%], P = .02), distant metastasis-free survival (100% [95% CI, 100%-100%] vs 80% [95% CI, 69%-94%], P < .01), disease-free survival (98% [95% CI, 93%-100%] vs 71% [95% CI, 59%-87%], P < .01), and overall survival (100% [95% CI, 100%-100%] vs 88% [95% CI, 79%-98%], P = .02). No late grade 3+ gastrointestinal or genitourinary toxicities were observed in the patients who underwent continued NOM.
Short-course radiation therapy followed by consolidation chemotherapy may be a feasible organ preservation strategy in rectal cancer. Additional prospective studies are necessary to evaluate the safety and efficacy of this approach.
本研究旨在确定短程放疗和巩固化疗后临床完全缓解（cCR）的直肠癌患者行非手术治疗（NOM）的临床疗效和安全性。
2018 年 1 月至 2019 年 5 月，90 例 I-III 期直肠腺癌患者接受短程放疗加巩固化疗（n=90）。通过直肠指检、盆腔磁共振成像和内镜评估临床反应。在初始反应可评估的患者中，43 例 cCR 患者行 NOM，43 例非 cCR 患者行手术。临床终点包括局部无复发生存率、区域控制率、无远处转移生存率、无病生存率和总生存率。
与初始 cCR 患者相比，初始非 cCR 患者 T 分期和 N 分期更晚（P=0.05），原发肿瘤更大（P=0.002），诊断性磁共振成像上更广泛的环周切缘累及（P<0.001）。在中位随访 30.1 个月时，NOM 组的持续 cCR 率为 79%（30/38 例）。初始 cCR 组 2 年局部无复发生存率为 81%（95%可信区间[CI]：70%-94%），所有局部复发患者均成功挽救。与非 cCR 患者相比，cCR 患者 2 年区域控制率更高（98%[95%CI：93%-100%] vs 85%[95%CI：74%-97%]，P=0.02）、无远处转移生存率更高（100%[95%CI：100%-100%] vs 80%[95%CI：69%-94%]，P<0.01）、无病生存率更高（98%[95%CI：93%-100%] vs 71%[95%CI：59%-87%]，P<0.01）和总生存率更高（100%[95%CI：100%-100%] vs 88%[95%CI：79%-98%]，P=0.02）。继续接受 NOM 的患者均未出现晚期 3+级胃肠道或泌尿生殖系统毒性。
短程放疗加巩固化疗可能是直肠癌的一种可行的器官保留策略。需要进一步的前瞻性研究来评估这种方法的安全性和疗效。
