■食管癌是大多数医疗保健系统的治疗挑战。大多数患者在诊断时出现局部晚期疾病。同步放化疗(CRT)是局部晚期食管癌的标准治疗方法。由于在新辅助治疗后的术后标本中获得完整的病理反应与改善患者生存率相关,本研究旨在评估局部或局部晚期食管癌对诱导化疗和术前同步化疗和大分割放疗(HFR)的病理反应.
■这项单臂临床试验(IRCT20210623051676N1)评估了食管鳞状细胞癌或腺癌患者,级cT2-T4aN0M0或cT1-T4aN+M0。患者每周接受3-5个周期的紫杉醇(50mg/m2)和卡铂(AUC=2)方案诱导化疗,随后每周同步CRT与相同的化疗方案。辐射剂量是40Gy,交付超过16个部分,每周5天(2.5灰色/分数)。患者在完成CRT后4-6周接受手术。评估手术标本的病理反应。在所有分析中,P值<0.05被认为是显著的。
■在参加本研究的54名患者中,45完成了新佐剂方案。在这45名患者中,32例接受了手术,最后进行了分析。患者的平均年龄为59.9±8.6岁(范围,37-75岁)。大多数患者的肿瘤位置在胸段食管(21,65.6%),最常见的组织学类型是SCC(29,90.6%)。诱导和同步化疗周期的中位数为5(4.8±1.3疗程,范围,1-10)和3(2.6±0.8课程,范围,0-4),分别。在完成新辅助方案的45名患者中,最常见的毒性是3级中性粒细胞减少症(15.6%),急性肾功能衰竭(4.4%),吞咽困难(37.8%)。近三分之二的患者经历了完全或接近完全的反应(71.9%,23名患者)。6例患者报告部分缓解(18.8%),3例患者报告不良缓解(9.4%)。
■术前诱导化疗后HFR同步化疗毒性和副作用低,良好的耐受性,在食管癌患者的治疗中疗效显著。
■https://irct。behdash.govir/trial/59930,标识符NCT05745545。
UNASSIGNED: Esophageal cancer is a therapeutic challenge in most healthcare systems. Most patients present with locally advanced disease at diagnosis. Concurrent chemoradiotherapy (CRT) is the standard treatment for locally advanced esophageal carcinoma. Since achieving a complete pathological response in postoperative specimens following neoadjuvant therapy is associated with improved patient survival, this study was designed to evaluate the pathologic response of localized or locally advanced esophageal carcinoma to induction chemotherapy followed by preoperative concurrent chemotherapy and hypofractionated radiotherapy (HFR).
UNASSIGNED: This single-arm clinical trial (IRCT20210623051676N1) evaluated patients with squamous cell carcinoma or adenocarcinoma of the esophagus, stage cT2-T4a N0 M0 or cT1-T4a N+ M0. Patients received 3-5 cycles of weekly induction chemotherapy with the paclitaxel (50 mg/m2) and carboplatin (AUC=2) regimen, followed by weekly concurrent CRT with the same chemotherapy regimen. The radiation dose was 40 Gy, delivered over 16 fractions, 5 days per week (2.5 Gray/fraction). Patients underwent surgery 4-6 weeks after completion of CRT. The surgical specimens were evaluated for pathological response. A p-value of < 0.05 was considered significant in all analyses.
UNASSIGNED: Out of 54 patients enrolled in this study, 45 completed the neoadjuvant protocol. Of these 45 patients, 32 underwent surgery and were finally analyzed. The mean age of the patients was 59.9 ± 8.6 years (range, 37-75 years). The location of the tumor was in the mid-thoracic esophagus in most patients (21, 65.6%) and the most common histological type was SCC (29, 90.6%). The median number of induction and concurrent chemotherapy cycles was 5 (4.8 ± 1.3 course, range, 1-10) and 3 (2.6 ± 0.8 course, range, 0-4), respectively. Among 45 patients who completed the neoadjuvant protocol, the most common toxicities were grade 3 neutropenia (15.6%), acute renal failure (4.4%), and odynophagia (37.8%). Nearly two-thirds of the patients experienced complete or near-complete responses (71.9%, 23 patients). Partial response was reported in 6 patients (18.8%) and poor response in 3 patients (9.4%).
UNASSIGNED: Preoperative induction chemotherapy followed by HFR with concurrent chemotherapy has low toxicity and side effects, good tolerance, and significant efficacy in the treatment of patients with esophageal cancer.
UNASSIGNED: https://irct.behdasht.gov.ir/trial/59930, identifier NCT05745545.