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

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, 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

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.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Consort diagram. pCR: pathologically confirmed complete remission. ITT: intention-to treat.
Figure 2
Figure 2
Local recurrence-free survival of locally advanced (LARC) and locally recurrent (LRRC) rectal cancer.

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Source: PubMed

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