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Strahlentherapie und Onkologie

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01-05-2012 | Original article

Simultaneous neoadjuvant radiochemotherapy with capecitabine and oxaliplatin for locally advanced rectal cancer

Treatment outcome outside clinical trials

Authors: J. Winkler, L. Zipp, J. Knoblich, Prof. Dr. F. Zimmermann

Published in: Strahlentherapie und Onkologie | Issue 5/2012

Abstract

Background

Phase II trials of neoadjuvant treatment in UICC-TNM stage II and III rectal cancer with capecitabine and oxaliplatin demonstrated favourable rates on tumour regression with acceptable toxicity.

Patients and methods

Retrospective evaluation of 34 patients treated from 2005–2008 outside clinical trials (CTR) with neoadjuvant irradiation (45–50.4 Gy) and simultaneous capecitabine 825 mg/m² b.i.d. on days 1–14 and 22–35 and oxaliplatin 50 mg/m² on days 1, 8, 22 and 29 (CAPOX). Twenty-six (77%) patients received one or two courses of capecitabine 1,000 mg/m² b.i.d. on days 1–14 and oxaliplatin 130 mg/m² on day 1 (XELOX) prior to simultaneous chemoradiotherapy.

Results

UICC-TNM stage regression was observed in 60% (n = 20). Dworak’s regression grades 3 and 4 were achieved in 18.2% (n = 6) and 15.1% (n = 5) of the patients. Sphincter-preserving surgery was performed in 53% (n = 8) of patients with a tumour of the lower rectum. Within the mean observation of 24 months, none of the patients relapsed locally, 1 patient had progressive disease and 5 patients (15%) relapsed distantly. Toxicity of grade 3 and 4 was mainly diarrhoea 18% (n = 6) and perianal pain 9% (n = 3). Nevertheless, severe cardiac events (n = 2), severe electrolyte disturbances (n = 2), and syncopes (n = 2) were observed as well.

Conclusion

Treatment efficacy and common toxicity are similar to the reports of phase I/II trials. However, several severe adverse events were observed in our cohort study. The predisposing factors for these events have yet to be studied and may have implications for the selection of patients outside CTR.

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http://www.clinicaltrials.gov, accessed 23 February 2012

Title: Simultaneous neoadjuvant radiochemotherapy with capecitabine and oxaliplatin for locally advanced rectal cancer
Treatment outcome outside clinical trials
Authors: J. Winkler
L. Zipp
J. Knoblich
Prof. Dr. F. Zimmermann
Publication date: 01-05-2012
Publisher: Springer-Verlag
Published in: Strahlentherapie und Onkologie / Issue 5/2012
Print ISSN: 0179-7158
Electronic ISSN: 1439-099X
DOI: https://doi.org/10.1007/s00066-012-0073-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Simultaneous neoadjuvant radiochemotherapy with capecitabine and oxaliplatin for locally advanced rectal cancer

Treatment outcome outside clinical trials

Abstract

Background

Patients and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Patients and methods

Results

Conclusion

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