The online version of this article (https://doi.org/10.1245/s10434-018-6554-y) contains supplementary material, which is available to authorized users.
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.
The aim of this study was to retrospectively compare outcomes of patients with esophageal cancer treated within and outside an RCT.
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.
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.
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.
Supplementary material 1 (DOCX 12 kb)10434_2018_6554_MOESM1_ESM.docx
Vist GE, Bryant D, Somerville L, Birminghem T, Oxman AD. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev. 2008;(3):MR000009.
Omloo JMT, Lagarde SM, Hulscher JBF, et al. Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the mid/distal esophagus: five-year survival of a randomized clinical trial. Ann Surg. 2007;246(6):992-1000-1. CrossRef
Mandard AM, Dalibard F, Mandard JC, et al. Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Clinicopathol Correl Cancer. 1994;73(11):2680–2686.
- 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)
MD Eelke Toxopeus
MD, PhD Maartje van der Schaaf
MD, PhD Jan van Lanschot
MD, PhD Jesper Lagergren
MD, PhD Pernilla Lagergren
MD, PhD Ate van der Gaast
MD, PhD Bas Wijnhoven
- Springer International Publishing
Neu im Fachgebiet Chirurgie
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