N S Blencowe1, P Chana2, R N Whistance2, D Stevens2, N A C S Wong2, S J Falk2, J M Blazeby2. 1. Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, UK (NSB, PC, RNW, DS, JMB); Division of Surgery, Head and Neck (NSB, RNW, JMB) and Division of Diagnostics and Therapies (NACSW) and Division of Specialised Services (SJF), University Hospitals Bristol NHS Foundation Trust, Bristol, UK. natalie.blencowe@bristol.ac.uk. 2. Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, UK (NSB, PC, RNW, DS, JMB); Division of Surgery, Head and Neck (NSB, RNW, JMB) and Division of Diagnostics and Therapies (NACSW) and Division of Specialised Services (SJF), University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
Abstract
BACKGROUND: The use of neoadjuvant therapy before surgery for gastrointestinal cancer is increasing; however, patients may not complete both treatment components. Understanding completion rates of each treatment stage is necessary for treatment evaluation and to inform decision-making. This study evaluates reporting for recent neoadjuvant surgical trials, focusing on treatment progression and other key outcomes. METHODS: Systematic literature searches identified randomized and nonrandomized phase II and III studies evaluating neoadjuvant treatment and surgery for esophageal, stomach, and colorectal cancer, and colorectal liver metastases. Rates of reporting of failure to complete neoadjuvant treatment, nonprogression to surgery after neoadjuvant treatment, and nonresection at planned surgery were assessed. For each measure, reporting was categorized as "full," "partial," and "absent" according to predefined criteria, and reasons for nonprogression at each stage of treatment were examined to inform proposed standards. RESULTS: Of 9854 abstracts, 123 papers were reviewed and 62 articles were included, reporting outcomes for 9126 patients. Details of noncompletion of neoadjuvant treatment and nonprogression to surgery were completely absent in 21 (33.9%) and 19 (30.6%) studies, respectively. Reporting of nonresection at planned surgery was also deficient, with 21 (33.9%) studies providing no information about this outcome. Reasons for noncompletion and nonprogression were similar and included disease progression, treatment toxicity, and patient choice. Common reasons for nonresection were locally advanced disease and the discovery of unsuspected metastases. CONCLUSIONS: Reports of recent neoadjuvant surgical trials often fail to include treatment progression and other key outcomes. These findings support the need for minimum reporting standards.
BACKGROUND: The use of neoadjuvant therapy before surgery for gastrointestinal cancer is increasing; however, patients may not complete both treatment components. Understanding completion rates of each treatment stage is necessary for treatment evaluation and to inform decision-making. This study evaluates reporting for recent neoadjuvant surgical trials, focusing on treatment progression and other key outcomes. METHODS: Systematic literature searches identified randomized and nonrandomized phase II and III studies evaluating neoadjuvant treatment and surgery for esophageal, stomach, and colorectal cancer, and colorectal liver metastases. Rates of reporting of failure to complete neoadjuvant treatment, nonprogression to surgery after neoadjuvant treatment, and nonresection at planned surgery were assessed. For each measure, reporting was categorized as "full," "partial," and "absent" according to predefined criteria, and reasons for nonprogression at each stage of treatment were examined to inform proposed standards. RESULTS: Of 9854 abstracts, 123 papers were reviewed and 62 articles were included, reporting outcomes for 9126 patients. Details of noncompletion of neoadjuvant treatment and nonprogression to surgery were completely absent in 21 (33.9%) and 19 (30.6%) studies, respectively. Reporting of nonresection at planned surgery was also deficient, with 21 (33.9%) studies providing no information about this outcome. Reasons for noncompletion and nonprogression were similar and included disease progression, treatment toxicity, and patient choice. Common reasons for nonresection were locally advanced disease and the discovery of unsuspected metastases. CONCLUSIONS: Reports of recent neoadjuvant surgical trials often fail to include treatment progression and other key outcomes. These findings support the need for minimum reporting standards.
Authors: Sian Cousins; Hollie Richards; Jesmond Zahra; Daisy Elliott; Kerry Avery; Harry F Robertson; Sangeetha Paramasivan; Nicholas Wilson; Johnny Mathews; Zoe Tolkien; Barry G Main; Natalie S Blencowe; Robert Hinchliffe; Jane M Blazeby Journal: BMJ Open Date: 2019-08-26 Impact factor: 2.692
Authors: W H Allum; E C Smyth; J M Blazeby; H I Grabsch; S M Griffin; S Rowley; F H Cafferty; R E Langley; D Cunningham Journal: Br J Surg Date: 2019-07-03 Impact factor: 6.939