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Use of Preoperative Magnetic Resonance Imaging to Select Patients with Rectal Cancer for Neoadjuvant Chemoradiation—Interim Analysis of the German OCUM Trial (NCT01325649)

  • 2015 SSAT Plenary Presentation
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Introduction

Introduction of total mesorectal excision (TME) surgery for rectal cancer decreased local recurrence dramatically. Additional neoadjuvant chemoradiation (nCR) is frequently given in UICC II and III tumors based on TNM staging which is of limited accuracy. We aimed to evaluate determination of circumferential margin by magnetic resonance imaging (mrCRM) as an alternative criterium for nCR.

Methods

Multicenter prospective cohort study which enrolled 642 patients in 13 centers with non-metastasized rectal adenocarcinoma. Patients with T4 tumors or patients with a mrCRM of 1 mm or less were treated by neoadjuvant chemoradiation. All others proceeded directly to surgery when inclusion criteria and no exclusion criteria were met. Quality of TME and accuracy of mrCRM determination were assessed during pathology workup.

Results

TME was complete in 381 of 389 patients after surgery without nCR (97.9 %) and in 245 of 253 patients (96.8 %) after nCR. Negative pathology circumferential margins (pCRM) were seen in 97.4 % without nCR and in 89 % of patients after nCR. Negative pCRM was predicted by negative mrCRM in 98.3 % of rectal cancers. NCR was given to 253 of 642 patients (39.5 %). Lymph node count was 23 (range 7–79; median/range) for surgery without nCR and 19 (range 2–56) for surgery after nCR.

Conclusions

Surgical quality determined by pathology workup of specimen was very good in this study. Magnetic resonance imaging guided indication for nCR allows to achieve superb results concerning surrogate parameters for good oncological outcome. Thus, use of neoadjuvant chemoradiation with its potential detrimental side effects may be substantially reduced in selected patients.

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Acknowledgments

The study received no external funding and was only supported by commitment of surgeons in different centers in Germany and Switzerland.

Author information

Authors and Affiliations

  1. Department of Surgery, Campus Benjamin Franklin, Charité University Medicine, Berlin, Germany

    Martin E. Kreis

  2. Department of Surgery, Klinikum Neuperlach, Munich, Germany

    R. Ruppert

  3. Department of Surgery, Carl-Thiem-Klinikum, Cottbus, Germany

    H. Ptok

  4. Department of Surgery, Vivantes Klinikum Friedrichshain, Berlin, Germany

    J. Strassburg

  5. Kantonsspital Liestal, Chirurgische Klinik, Liestal, Switzerland

    P. Brosi

  6. Allgemein- und Viszeralchirurgie, Sanaklinikum Lichtenberg, Berlin, Germany

    A. Lewin

  7. Klinik für Allgemein- und Visceralchirurgie, Städtisches Klinikum, Karlsruhe, Germany

    M. R. Schön

  8. Allgemein-, Viszeral- und Minimalinvasive Chirurgie, Klinikum Arnsberg, Arnsberg, Germany

    J. Sauer

  9. Chirurgische Klinik Universitätsklinikum Mainz, Mainz, Germany

    T. Junginger

  10. Chirurgische Klinik Friedrich-Alexander-Universität Erlangen, Erlangen, Germany

    S. Merkel & P. Hermanek

  11. Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Hindenburgdamm 30, 12200, Berlin, Germany

    Martin E. Kreis

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for the OCUM study group

Corresponding author

Correspondence to Martin E. Kreis.

Additional information

Primary Discussant

Scott A. Strong, M.D. (Chicago, IL)

1. Guidelines developed by the National Comprehensive Cancer network that are used by many US centers define rectal cancer as tumors within 12 cm of the anal verge because these cancers of the more proximal rectum tend to behave like tumors of the sigmoid colon rather than the more distal rectum. Why were tumors 12–16 cm from the anal verge included in your study?

2. Your overall incidence of negative CRM as predicted by MRI was 64 % whereas the rate in the MERCURY trial was much higher at nearly 80 %. Can you explain the discrepancy?

3. Did the quality of surgery as defined by negative pathologic CRM, lymph node harvest, and completeness of TME vary between the high- and low-volume centers?

Closing Discussant

Dr. Kreis

1. In European studies on rectal cancer, the rectum is defined from 0 to 16 cm from the anal verge. We aimed to render our study results primarily comparable to other European studies, so that this definition was chosen. Furthermore, the UICC defined the rectum in this way (0–16 cm; Wittekind C, Meyer HJ: TNM Klassifikation maligner Tumoren, 7. Auflage. Wiley-VCH, Weinheim 2010).

2. The MERCURY trial included T1 tumors that were not included in our study. As T1 tumors never threaten CRM, patients with this tumor stage will increase the rate of mrCRM negative patients. This and other differences in patient population may explain this discrepancy.

3. We did not observe a difference as regards negative pathologic CRM and completeness of TME. There was a difference between centers concerning lymph node harvest which was, however, not related to hospital volume.

Kreis and Ruppert both shared co-first authorship.

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Kreis, M.E., Ruppert, R., Ptok, H. et al. Use of Preoperative Magnetic Resonance Imaging to Select Patients with Rectal Cancer for Neoadjuvant Chemoradiation—Interim Analysis of the German OCUM Trial (NCT01325649). J Gastrointest Surg 20, 25–33 (2016). https://doi.org/10.1007/s11605-015-3011-0

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