Clinical examination following preoperative chemoradiation for rectal cancer is not a reliable surrogate end point Journal Article


Authors: Guillem, J. G.; Chessin, D. B.; Shia, J.; Moore, H. G.; Mazumdar, M.; Bernard, B.; Paty, P. B.; Saltz, L.; Minsky, B. D.; Weiser, M. R.; Temple, L. K. F.; Cohen, A. M.; Douglas Wong, W.
Article Title: Clinical examination following preoperative chemoradiation for rectal cancer is not a reliable surrogate end point
Abstract: Purpose: Clinical assessment of rectal cancer response to preoperative combined-modality therapy (CMT) using digital rectal examination (DRE) has been proposed as a means of assessing efficacy of therapy. However, because the accuracy of this approach has not been established, we conducted a prospective analysis to determine the operating surgeon's ability to assess response using DRE. Patients and Methods: Ninety-four prospectively accrued patients with locally advanced rectal cancer (T3/4 or N1) were evaluated with DRE and sigmoidoscopy in order to determine the following tumor characteristics: size, location, mobility, morphology, and circumference. Following preoperative CMT (50.40 Gy with fluorouracil-based chemotherapy) and under general anesthesia, the same surgeon estimated tumor response based on changes in these tumor characteristics, assessed via DRE. Percent pathologic tumor response was determined prospectively by a single pathologist using whole mount sections of the resected cancer. Results: Clinical assessment using DRE underestimated pathologic response in 73 cases (78%). In addition, DRE was able to identify only 3 of 14 cases (21%) with a pathologic complete response. There were no clinical overestimates of response. None of the clinicopathologic tumor characteristics examined had a significant impact on DRE estimation of response. Conclusion: Clinical examination underestimates the extent of rectal cancer response to preoperative CMT. Given the inaccuracy of DRE following preoperative CMT, it should not be used as a sole means of assessing efficacy of therapy nor for selecting patients following CMT for local surgical therapies. © 2005 by American Society of Clinical Oncology.
Keywords: adult; controlled study; treatment outcome; aged; major clinical study; histopathology; fluorouracil; multimodality cancer therapy; preoperative care; cancer staging; tumor localization; multiple cycle treatment; tumor volume; combination chemotherapy; continuous infusion; cancer invasion; folinic acid; rectum cancer; sigmoidoscopy; clinical examination; digital rectal examination; head circumference
Journal Title: Journal of Clinical Oncology
Volume: 23
Issue: 15
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2005-05-20
Start Page: 3475
End Page: 3479
Language: English
DOI: 10.1200/jco.2005.06.114
PROVIDER: scopus
PUBMED: 15908656
DOI/URL:
Notes: --- - "Cited By (since 1996): 44" - "Export Date: 24 October 2012" - "CODEN: JCOND" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Harvey Moore
    30 Moore
  2. David Brian Chessin
    23 Chessin
  3. Leonard B Saltz
    599 Saltz
  4. Philip B Paty
    373 Paty
  5. Bruce Minsky
    264 Minsky
  6. Madhu Mazumdar
    125 Mazumdar
  7. Jose Guillem
    373 Guillem
  8. Alfred M Cohen
    175 Cohen
  9. Jinru Shia
    465 Shia
  10. Martin R Weiser
    346 Weiser
  11. Larissa Temple
    179 Temple
  12. Douglas W Wong
    173 Wong