Outcome of Patients Treated Within and Outside a Randomized Clinical Trial on Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: Extrapolation of a Randomized Clinical Trial (CROSS)

• Published in: Annals of surgical oncology Vol. 25; no. 8; pp. 2441 - 2448
• Main Authors: Toxopeus, Eelke, van der Schaaf, Maartje, van Lanschot, Jan, Lagergren, Jesper, Lagergren, Pernilla, van der Gaast, Ate, Wijnhoven, Bas
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.08.2018; Springer Nature B.V
• Subjects: Aged; Cancer; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - therapy; Chemoradiotherapy; Chemoradiotherapy, Adjuvant - mortality; Chemotherapy; Clinical trials; Combined Modality Therapy; Decision making; Esophageal cancer; Esophageal Neoplasms - mortality; Esophageal Neoplasms - pathology; Esophageal Neoplasms - therapy; Esophagus; Female; Follow-Up Studies; Gastrointestinal Oncology; Health risk assessment; Heart diseases; Humans; Male; Medicin och hälsovetenskap; Medicine; Medicine & Public Health; Middle Aged; Neoadjuvant Therapy - mortality; Neoplasm Recurrence, Local - mortality; Neoplasm Recurrence, Local - pathology; Neoplasm Recurrence, Local - therapy; Oncology; Patients; Prognosis; Radiation therapy; Regression analysis; Retrospective Studies; Statistical analysis; Surgery; Surgical Oncology; Survival; Survival Rate; CROSS Trial; Neoadjuvant Chemoradiotherapy; Resectable Esophageal Cancer; Cancer Followed By Surgery Study (CROSS); Poor Performance Status
• ISSN: 1068-9265; 1534-4681; 1534-4681
• DOI: 10.1245/s10434-018-6554-y

Background Randomized clinical trials (RCTs) can provide a high level of evidence for medical decision making, but it is unclear if the results apply to patients treated outside such trials. Objective The aim of this study was to retrospectively compare outcomes of patients with esophageal cancer treated within and outside an RCT. Methods All patients receiving neoadjuvant chemoradiotherapy (nCRT) plus surgery for esophageal cancer between 2002 and 2008 (ChemoRadiotherapy for Esophageal cancer followed by Surgery Study [CROSS] cohort) who participated in multicenter, phase II–III trials were compared with patients who underwent the same treatment outside the trial between 2008 and 2013 (post-CROSS cohort). The differences between these cohorts were analyzed using t tests, while logistic regression models were used to evaluate adverse events. Overall and disease-free survival were calculated using the Kaplan–Meier method and Cox regression analyses. Results A total of 208 CROSS patients and 173 post-CROSS patients were included in this study. Patients from the post-CROSS cohort were older, had more co morbidities, and had poorer performance status. Clinical N stage, but not cT stage, was worse in the post-CROSS cohort. There were no statistically significant differences in adverse events (pulmonary, cardiac, or anastomotic complications) or survival between the comparison cohorts. Conclusion The outcomes of patients treated with nCRT plus esophagectomy for cancer have a high external consistency and can be extrapolated to the daily practice of physicians involved in the treatment and care of esophageal cancer patients.