Bhattacharyya Tapesh, Arunsingh Moses, Chakraborty Santam, Harilal Vishnu, Sasidharan Rohit, Saha Saheli, Thambudorai Robin, Roy Bipradas, Banerjee Sudeep, Roy Paromita, Ray Soumendranath, Mallick Indranil
Department of Radiation Oncology, Tata Medical Center, 14, MAR(E-W), DH Block (Newtown), Action Area I, Newtown, Kolkata, West Bengal 700160, India.
Department of Gastrointestinal Surgery, Tata Medical Center, 14, MAR(E-W), DH Block (Newtown), Action Area I, Newtown, Kolkata, West Bengal 700160, India.
Ecancermedicalscience. 2021 Sep 16;15:1291. doi: 10.3332/ecancer.2021.1291. eCollection 2021.
The Chemoradiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS) trial established a new benchmark in the management of oesophageal cancer with neoadjuvant chemoradiation followed by surgery with a marked benefit for squamous cell carcinomas (SCCs). We evaluate if the CROSS protocol can be safely implemented with a broader eligibility criteria in a real-world setting.
A retrospective analysis of 80 patients of SCC oesophagus was performed, who were treated with neoadjuvant chemoradiation with radiation therapy (RT) to 41.4 Gy/23 Fr/4.5 weeks and weekly paclitaxel and carboplatin, followed by surgery at our institute between 2012 and 2019. Eligibility for the use of this regimen was expanded beyond the limits of size and stage allowed in the CROSS trial.
The median age of this cohort was 57 years (range: 39-78 years). Most of the patients (77/80; 96.3%) had T3 disease and 25% patients (20/80) had N2/N3 disease. Thirty-three patients (41.3%) had the disease beyond CROSS eligibility criteria. All patients completed planned course of RT and five cycles of weekly chemotherapy were received by 61 patients (76.2%). Overall pathological complete response (pCR) could be achieved in 33 patients (41.3%). Among 33 CROSS ineligible patients, 14 (42.4%) had pCR. Acute grade 3 dysphagia and grade ≥ 3 neutropenia were seen in seven cases (8.3%) and nine cases (10.7%), respectively. At a median follow-up of 16 months, 1-year and 2-year overall survival (OS) were 84.4% (95% confidence interval (CI): 73.5%-91.1%) and 76.3% (95% CI: 63.2%-85.2%), respectively, for the entire cohort. For CROSS ineligible patients, 1-year and 2-year OS were 82% (95% CI: 61.8%-92.2%) and 72.7% (95% CI: 50.4%-86.2%), respectively. On univariate analysis, patients who had pathologically N0 disease had significantly better 2-year OS (85.7% versus 48.4%; p = 0.03) as compared to pathologically N+ patients. On univariate and multivariate analysis, there was no significant difference in OS and progression free survival between CROSS eligible and CROSS ineligible patients.
CROSS protocol can be safely implemented for carefully selected patients of SCC oesophagus outside clinical trial settings with expanded eligibility criteria.
食管癌放化疗后手术研究（CROSS）试验为食管癌的治疗确立了新的基准，即新辅助放化疗后手术，对鳞状细胞癌（SCC）有显著益处。我们评估在现实环境中，CROSS方案是否能在更广泛的纳入标准下安全实施。
对80例食管SCC患者进行回顾性分析，这些患者在2012年至2019年期间在我院接受新辅助放化疗，放疗剂量为41.4 Gy/23次/4.5周，每周给予紫杉醇和卡铂，随后进行手术。该方案的使用纳入标准超出了CROSS试验允许的大小和分期限制。
该队列的中位年龄为57岁（范围：39 - 78岁）。大多数患者（77/80；96.3%）患有T3期疾病，25%的患者（20/80）患有N2/N3期疾病。33例患者（41.3%）的疾病超出了CROSS纳入标准。所有患者均完成了计划的放疗疗程，61例患者（76.2%）接受了5个周期的每周化疗。33例患者（41.3%）实现了总体病理完全缓解（pCR）。在33例不符合CROSS标准的患者中，14例（42.4%）达到了pCR。分别有7例（8.3%）和9例（10.7%）出现了3级急性吞咽困难和≥3级中性粒细胞减少。中位随访16个月时，整个队列的1年和2年总生存率（OS）分别为84.4%（95%置信区间（CI）：73.5% - 91.1%）和76.3%（95% CI：63.2% - 85.2%）。对于不符合CROSS标准的患者，1年和2年OS分别为82%（95% CI：61.8% - 92.2%）和72.7%（95% CI：50.4% - 86.2%）。单因素分析显示，病理分期为N0的患者2年OS（85.7%对48.4%；p = 0.03）明显优于病理分期为N +的患者。单因素和多因素分析均显示，符合CROSS标准和不符合CROSS标准的患者在OS和无进展生存期方面无显著差异。
对于经过精心挑选、纳入标准扩大的食管SCC患者，CROSS方案可在临床试验环境之外安全实施。
