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Ott OJ, Gani C, Lindner LH, et al. Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer. Cancers (Basel). 2021;13(6)doi: 10.3390/cancers13061279.
Ott, O. J., Gani, C., Lindner, L. H., Schmidt, M., Lamprecht, U., Abdel-Rahman, S., Hinke, A., Weissmann, T., Hartmann, A., Issels, R. D., Zips, D., Belka, C., Grützmann, R., & Fietkau, R. (2021). Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer. Cancers, 13(6), . https://doi.org/10.3390/cancers13061279
Ott, Oliver J, et al. "Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer." Cancers vol. 13,6 (2021). doi: https://doi.org/10.3390/cancers13061279
Ott OJ, Gani C, Lindner LH, Schmidt M, Lamprecht U, Abdel-Rahman S, Hinke A, Weissmann T, Hartmann A, Issels RD, Zips D, Belka C, Grützmann R, Fietkau R. Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer. Cancers (Basel). 2021 Mar 13;13(6). doi: 10.3390/cancers13061279. PMID: 33805731; PMCID: PMC8001688.
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Cancers (Basel). 2021 Mar 13;13(6). doi: 10.3390/cancers13061279.

Neoadjuvant Chemoradiation Combined with Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer.

Cancers

Oliver J Ott, Cihan Gani, Lars H Lindner, Manfred Schmidt, Ulf Lamprecht, Sultan Abdel-Rahman, Axel Hinke, Thomas Weissmann, Arndt Hartmann, Rolf D Issels, Daniel Zips, Claus Belka, Robert Grützmann, Rainer Fietkau

Affiliations

  1. Department of Radiation Oncology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
  2. Department of Radiation Oncology, Universitätsklinikum Tübingen, 72076 Tübingen, Germany.
  3. Department of Medicine III, University Hospital, LMU Munich, 81377 Munich, Germany.
  4. Cancer Clinical Research Consulting (CCRC), 40595 Düsseldorf, Germany.
  5. Institute of Pathology, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.
  6. Department of Radiation Oncology, University Hospital, LMU Munich, 80377 Munich, Germany.
  7. German Cancer Consortium (DKTK), 80336 Munich, Germany.
  8. Department of Surgery, Universitätsklinikum Erlangen, 91054 Erlangen, Germany.

PMID: 33805731 PMCID: PMC8001688 DOI: 10.3390/cancers13061279

Abstract

BACKGROUND: To prospectively analyze feasibility and pathological complete response (pCR) rates of neoadjuvant chemoradiotherapy combined with regional hyperthermia (RHT) in patients with locally advanced (LARC) or recurrent (LRRC) rectal cancer.

METHODS: between 2012 and 2018, 111 patients with UICC stage IIB-IV or any locally recurrent rectal cancer were included (HyRec-Trial, ClinicalTrials.gov Identifier: NCT01716949). Patients received radiotherapy with concurrent 5-Fluororuracil (5-FU)/Capecitabine and Oxaliplatin, and RHT. Stage 1 feasibility analysis evaluated dose-limiting toxicities (DLT) after 19 patients, stage 2 after 59 evaluable patients. Analysis of the pCR rate was based on histopathological reports.

RESULTS: the feasibility rates for stages 1 and 2 were 90% (17/19) and 73% (43/59), respectively. In the intention-to-treat population the pCR rate was 19% (20/105; 90% confidence interval (CI) 13.0-26.5). In the per-protocol-analysis, complete tumor regression was seen in 28% (18/64) and 38% (3/8) of the patients with LARC and LRRC, respectively. Complete resection rates (R0) among patients with LARC and LRRC who received surgery were 99% (78/84) and 67% (8/12).

CONCLUSIONS: the intensified neoadjuvant and multimodality treatment schedule was feasible and led to comparable early toxicity rates as described by other trials that used the similar chemoradiation protocol. The presented treatment regimen resulted in a very high pCR rate and appears as a promising option for patients with LRRC.

Keywords: complete remission rate; concurrent chemoradiation; locally advanced rectal cancer; locally recurrent rectal cancer; regional hyperthermia; tumor regression grading

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