Postoperative Adjuvant Therapy Versus Surgery Alone for Stage IIB–III Esophageal Squamous Cell Carcinoma: A Phase III Randomized Controlled Trial

• DOI: 10.1002/onco.13914
• Publication Date: 2021-07-26T10:54:14Z
• Authors: Wenjie Ni; Shufei Yu; Zefen Xiao; Zongmei Zhou; Dongfu Chen; Qinfu Feng; Jun Liang; Jima Lv; Shugeng Gao; Yousheng Mao; Qi Xue; Kelin Sun; Xiangyang Liu; Dekang Fang; Jian Li; Dali Wang; Jun Zhao; Yushun Gao
• Keywords: Clinical endpoint; Nedaplatin; Chemoradiotherapy

Retrospective studies have shown that adjuvant treatment improves survival of patients with stage IIB-III esophageal squamous cell carcinoma, but there is no evidence from prospective trials so far.Patients pathological carcinoma were randomly assigned to receive surgery alone (SA), postoperative radiotherapy (PORT), or concurrent chemoradiotherapy (POCRT). PORT received 54 Gy in 27 fractions; the POCRT group 50.4 28 fractions, plus chemotherapy paclitaxel (135-150 mg/m2 ) and cisplatin nedaplatin (50-75 every days. The primary endpoint was disease-free (DFS), secondary overall (OS).A total 172 enrolled (SA, n = 54; PORT, POCRT, 64). 3-year DFS significantly better PORT/POCRT than SA (53.8% vs. 36.7%; p .020); OS also (63.9% 48.0%; .025). for SA, 36.7%, 50.0%, 57.3%, respectively (p .048). 48.0%, 60.8%, 66.5%, .048).PORT/POCRT (especially POCRT) may improve carcinoma.The results this phase III study indicated radiotherapy/postoperative (PORT/POCRT) could compared acceptable toxicities. In-field out-of-field recurrences comparable between groups, which demonstrates rationality safety radiation field used study. regimens trial might be accepted as standard options cancer. Larger sample size randomized identify value are warranted.