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Clinical Trial
. 2018 Aug;25(8):2441-2448.
doi: 10.1245/s10434-018-6554-y. Epub 2018 Jun 12.

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)

Eelke Toxopeus  1 , Maartje van der Schaaf  2 , Jan van Lanschot  3 , Jesper Lagergren  2   4 , Pernilla Lagergren  2 , Ate van der Gaast  5 , Bas Wijnhoven  3
Affiliations
Clinical Trial

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)

Eelke Toxopeus et al. Ann Surg Oncol. 2018 Aug.

Abstract

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.

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Conflict of interest statement

There are no financial interests or potential conflicts of interest.

Figures

Fig. 1
Fig. 1
Overall survival of 381 patients, divided into the CROSS (n = 208) and post-CROSS (n = 173) cohorts for patients with oesophageal or junctional cancer who underwent chemoradiotherapy according to CROSS followed by surgery (p = 0.90). cum survival percentages of cumulative overall survival, where 1.0 means 100% of the cohort, decreasing over time, 5-year OS 5-year overall survival, expressed in months, CROSS ChemoRadiotherapy for Esophageal cancer followed by Surgery Study, mo months
Fig. 2
Fig. 2
Disease-free survival of 381 patients, divided into the CROSS (n = 208) and post-CROSS (n = 173) cohorts for patients with oesophageal or junctional cancer who underwent chemoradiotherapy according to CROSS followed by surgery (p = 0.69). cum survival percentages of cumulative disease-free survival, where 1.0 means 100% of the cohort, decreasing over time, 5-year DFS 5-year disease-free survival, expressed in months, CROSS ChemoRadiotherapy for Esophageal cancer followed by Surgery Study, mo months
See this image and copyright information in PMC

References

    1. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71–72. doi: 10.1136/bmj.312.7023.71. - DOI - PMC - PubMed
    1. Ubbink DT, Legemate DA. Evidence-based surgery. Br J Surg. 2004;91(9):1091–1092. doi: 10.1002/bjs.4717. - DOI - PubMed
    1. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004;363(9405):263–270. doi: 10.1016/S0140-6736(03)15383-4. - DOI - PubMed
    1. Engström C, Jamieson GG, Devitt PG, Irvine T, Watson DI. Impact of participation in randomized trials on outcome following surgery for gastro-oesophageal reflux. Br J Surg. 2012;99(3):381–386. doi: 10.1002/bjs.8666. - DOI - PubMed
    1. Braunholtz DA, Edwards SJ, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a”trial effect”. J Clin Epidemiol. 2001;54(3):217–224. doi: 10.1016/S0895-4356(00)00305-X. - DOI - PubMed

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