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- Title
Postoperative Adjuvant Therapy Versus Surgery Alone for Stage IIB--III Esophageal Squamous Cell Carcinoma: A Phase III Randomized Controlled Trial.
- 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
- Abstract
Background. 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. Materials and Methods. Patients with pathological stage IIB-III esophageal squamous cell carcinoma were randomly assigned to receive surgery alone (SA), postoperative radiotherapy (PORT), or postoperative concurrent chemoradiotherapy (POCRT). PORT patients received 54 Gy in 27 fractions; the POCRT group received 50.4 Gy in 28 fractions, plus concurrent chemotherapy with paclitaxel (135-150 mg/m²) and cisplatin or nedaplatin (50-75 mg/m²) every 28 days. The primary endpoint was disease-free survival DFS), and the secondary endpoint was overall survival (OS). Results. A total of 172 patients were enrolled (SA, n = 54; PORT, n = 54; POCRT, n = 64). The 3-year DFS was significantly better in PORT/POCRT patients than in SA patients (53.8% vs. 36.7%; p = .020); the 3-year OS was also better in PORT/POCRT patients (63.9% vs. 48.0%; p = .025). The 3-year DFS for SA, PORT, and POCRT patients were 36.7%, 50.0%, 57.3%, respectively (p = .048). The 3-year OS for SA, PORT, and POCRT patients were 48.0%, 60.8%, 66.5%, respectively (p=.048). Conclusion. PORT/POCRT (especially POCRT) may significantly improve DFS and OS in stage IIB-III esophageal squamous cell carcinoma.
- Subjects
TREATMENT of esophageal cancer; ANTINEOPLASTIC agents; RANDOMIZED controlled trials; COMPARATIVE studies; POSTOPERATIVE period; SURVIVAL analysis (Biometry); COMBINED modality therapy; RADIOTHERAPY; STATISTICAL sampling; SQUAMOUS cell carcinoma; ESOPHAGEAL cancer
- Publication
Oncologist, 2021, Vol 26, Issue 12, pe2151
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1002/onco.13914