Long term results and patterns of recurrence from SCOPE 1: A phase II/III randomised trial of definitive chemoradiotherapy (dCRT) plus or minus cetuximab (dCRT+C) in esophageal cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 118-118 ◽  
Author(s):  
Somnath Mukherjee ◽  
Chris Hurt ◽  
Stephen Falk ◽  
Simon Gollins ◽  
John Staffurth ◽  
...  

118 Background: One of the largest trials in dCRT for localised oesophageal cancer, SCOPE 1 tested the role of adding cetuximab to conventional dCRT, and showed that this was associated with greater toxicity and worse survival. Here we present the long-term outcomes. Methods: Phase II/III trial. Randomisation: cisplatin 60mg/m2 D1 and capecitabine 625mg/m2 daily D1-21 for 4 cycles with/without Cetuximab 400mg/m2 D1 followed by 250mg/m2weekly. RT: 50Gy in 25 fractions given concurrent with cycles 3 and 4. Recruitment: Feb 2008 - Feb 2012, when the IDMC recommended trial closure on the basis of futility. Results: 258 patients (dCRT = 129; dCRT+C = 129) were recruited from 36 centres. Median follow-up (IQR): 46.7 (36.0-49.0) months for all surviving pts. 65.1% (dCRT arm) and 69.8% (dCRT+C arm) of patients had died. Esophageal cancer was the cause in 82.1% and 86.7% of deaths respectively (p = 0.41). Median OS months (95% CI) was 34.5 (24.7-42.3) in dCRT and 24.7 (18.6-31.3) in dCRT+C (HR 1.25, p = 0.137); corresponding 3-year OS (95% CI) was 47.2% (38.2%-55.7%) and 37.6% (29.1%-46.0%). Median PFS (95% CI): 24.1 (15.3-29.9) and 15.9 (10.7-20.8) months respectively (HR1.28, p = 0.114). There was some evidence that local PFS (within RT field) was lower in the dCRT+C arm (HR1.38, p = 0.051). On multivariable analysis including treatment arm, Stage I-II ds (vs Stage III), full-dose RT and higher cisplatin dose intensity ( ≥ 75% vs < 75%) were associated with improved OS and PFS. Patterns of recurrence (n [%]) were similar in both arms (see table). In dCRT arm, 31/38 pts (81.6%) with local relapse within the RT field compared to 40/48 (83.3%) in the dCRT+C arm (p = 0.8). Conclusions: The mature analysis shows unprecedented survival in dCRT arm, comparable to surgical trials (e.g. 3-year OS % [95% CIs] in OE05: CF 39 [35, 44] and ECX 42 [37, 46], in OE02: 31 [27, 36]). OS inferiority of dCRT+C is no longer statistically significant. The lower PFS (within RT field) in the dCRT+C arm was consistent with the lower number of patients receiving full dose of RT in the dCRT+C arm. Clinical trial information: 47718479. [Table: see text]

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Kristina Hugova ◽  
Marek Kollar ◽  
Jana Maluskova ◽  
Jana Krajciova ◽  
Alexandr Pazdro ◽  
...  

Abstract   Esophagectomy is a standard of care for patients with "high-risk" early esophageal cancer (HRC) despite a growing evidence that endoscopic treatment may be a safe alternative. Our aims were 1. to prospectively evaluate the long-term results of endoscopic and surgical treatments in consecutive patients with HRC and 2. to determine the risk of lymph node (LN) metastases and micrometastases in patients with HRC. Methods HRC was defined as any cancer with submucosal (sm) invasion or mucosal cancer with at least one of the following: poor differentiation, invasion to blood or lymphatic vessels and high tumor cell dissociation (TCD3). All patients (n = 69) underwent endoscopic resection (ER or ESD) and after the histopathological diagnosis of HRC, patients without contraindications were referred to surgery (n = 30). The remaining patients (n = 39) continued in endoscopic treatment, if necessary. All resected LNs were stained for hematoxylin–eosin to evaluate metastases and immunohistochemistry was used for the detection of micrometastases or isolated tumor cells. Results Eighteen patients (26%) had T1a and 51 (74%) had T1b cancer; 51 had adenocarcinoma (AC) and 18 had squamous cell carcinoma (SCC). The median follow-up was 32 months (3–120). No patient with mucosal invasion (15 AC, 3 SCC) experienced LN involvement. Among 17 patients with sm1 invasion, only 2 (12%, both AC)experienced generalization or LN involvement. The further rates of LN involvement were 0% (0/5) in sm2 AC, 50% (3/6) in sm2 SCC, 25% (4/16) in sm3 AC and 29% (2/7) in sm3 SCC. 60% (18/30) of surgically treated patients would have been completely cured by endoscopy (Table 1). Conclusion The risk of LN metastases/micrometastases was lower than expected. No patients with high-risk mucosal cancer or low-risk sm1 cancer experienced lymph node involvement. Endoscopic treatment provided long-term remission (or cure) in considerable number of patients and it may represent a valid alternative to surgery in patients with high-risk early esophageal cancer.


Author(s):  
Vy Pham Trung

Objectives: Evaluating the results of thoraco-laparoscopic esophagectomy to treat esophageal cancer, prospective studies of 35 patients esophageal cancer were conducted from January 2016 to December 2019 at Hue Central Hospital. Results: Average age 57.6±6.3years (44-69), male/female 16.5/1. Clinical symptoms: 82.9% swallowing difficulty, weight loss 34.3%, increased preoperative CEA 31.4%, mean tumor size 2.6±1.2cm(3-6). Stage: I 31.4%; II 45.7%; III of 22.9%. Time of surgery 315.2±49.9minutes(240-420), mean hospital stay 15.6±7.2days(7-25). Postoperative complications: pneumonia 11.4% , leakage of neck anastomosis 8.6%, hoarseness 11.4% and mortality 2.9%. Follow-up time 2-35months, anastomotic recurrence 2.9%, local recurrence 5.9% and metastasis 8.8%. The overal survival time 28.4±1.9months, the survival time after 12 months 84.7% and after 2 years 73.9%. Conclusion: Thoraco-laparoscopic esophagectomy to treat esophageal cancer has many advantages, avoiding to the long thoracotomy-laparotomy, reducing postoperative pain, reducing respiratory complications during the postoperative period. However, a larger number of patients should be studied to accurately evaluate long-term results, especially in oncology results.


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