Efficacy of Endoscopic Resection and Selective Chemoradiotherapy for Stage I Esophageal Squamous Cell Carcinoma

Abstract

BACKGROUND & AIMS: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). METHODS: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. RESULTS: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%). CONCLUSIONS: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.

Endoscopic submucosal dissection/endoscopic mucosal resection guidelines for esophageal cancer

“…The JCOG0508 trial was a confirmatory study for the efficacy of ER followed by chemoradiotherapy in patients with cSM1/SM2 cancer . In that study, patients with “pMM, negative vascular invasion, and negative resection margin” based on the pathological results following ER underwent follow‐up observation, while patients with “pMM, positive vascular invasion, and negative resection margin” or “pSM and negative resection margin” underwent prophylactic chemoradiotherapy (41.4 Gy), and patients with a “positive resection margin” underwent definitive chemoradiotherapy.…”

“…The rates of treatment‐related death following surgical resection were 0–2.0% in four case‐series studies and 1.3% in a non‐RCT (1.3%, 95% CI: 0.7–2.2%). Delayed adverse events of additional chemoradiotherapy were tabulated from eight case‐series studies and one single‐arm prospective trial, with radiation pneumonitis grade ≥3 in 1.0% (3/302) of patients, grade 3 thromboembolism in 0.3% (1/302) of patients, and myocardial infarction grade ≥3 in 1.3% (4/302) of patients. A total of four treatment‐related deaths (4/302: 1.3%, 95% CI: 0.4–3.4%) were reported, comprising pneumonitis in one, sudden death in one, and myocardial infarction in two patients.…”

“…These 355 articles underwent primary screening and 57 articles were selected for secondary screening. After applying stringent selection criteria, we performed a systematic review of seven articles and also investigated articles on chemoradiotherapy as an additional treatment and articles comparing ER with surgical resection …”

History and future perspectives in Japanese guidelines for endoscopic resection of early gastric cancer

“…Meanwhile, no additional treatment after ER with eCura C‐2 has a risk of recurrence, especially in those at high risk in the eCura system . In esophageal squamous cell carcinoma, ER with selective chemoradiotherapy provided survival rates comparable to those of surgery and would be a less invasive treatment option . For patients with stage II/III gastric cancer, adjuvant chemotherapy (S‐1 monotherapy for 1 year) after surgery is recommended .…”

“…38 In esophageal squamous cell carcinoma, ER with selective chemoradiotherapy provided survival rates comparable to those of surgery and would be a less invasive treatment option. 86 For patients with stage II/III gastric cancer, adjuvant chemotherapy (S-1 monother-apyfor1year) 87 after surgery is recommended. 13 Although there is no evidence for the efficacy and safety of adjuvant chemotherapy after ER with eCura C-2, adjuvant chemotherapy may be effective for patients who prefer not to undergo additional surgery but worry about cancer recurrence (Fig.…”