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Research ArticleClinical Studies

Neoadjuvant Chemotherapy with Capecitabine, Oxaliplatin and Bevacizumab Followed by Concomitant Chemoradiation and Surgical Resection in Locally Advanced Rectal Cancer with High Risk of Recurrence – A Phase II Study

WOLFGANG EISTERER, GUDRUN PIRINGER, ALEXANDER DE VRIES, DIETMAR ÖFNER, RICHARD GREIL, JÖRG TSCHMELITSCH, HELLMUT SAMONIGG, LIDIJA SÖLKNER, MICHAEL GNANT, JOSEF THALER and On behalf of the Austrian Breast and Colorectal Cancer Study Group
Anticancer Research May 2017, 37 (5) 2683-2691;
WOLFGANG EISTERER
1Department of Internal Medicine, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria
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GUDRUN PIRINGER
2Department of Internal Medicine IV, Wels-Grieskirchen Medical Hospital, Wels, Austria
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  • For correspondence: gudrun.piringer@hotmail.com
ALEXANDER DE VRIES
3Department of Radiotherapy and Radio-Oncology, Feldkirch Hospital, Feldkirch, Austria
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DIETMAR ÖFNER
4Department of Visceral-, Transplant and Thoracic Surgery, Center of Operative Medicine, Innsbruck Medical University, Innsbruck, Austria
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RICHARD GREIL
5Department of Internal Medicine III, Paracelsus Medical University, Salzburg, Austria
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JÖRG TSCHMELITSCH
6Department of Surgery, St. Veit Hospital, Sankt Veit an der Glan, Austria
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HELLMUT SAMONIGG
7Department of Internal Medicine, Medical University, Graz, Austria
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LIDIJA SÖLKNER
8Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria
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MICHAEL GNANT
9Department of Surgery and Comprehensive Cancer Center, Medical University, Vienna, Austria
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JOSEF THALER
2Department of Internal Medicine IV, Wels-Grieskirchen Medical Hospital, Wels, Austria
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Abstract

Aim: To evaluate feasibility and safety of neoadjuvant chemotherapy with capecitabine, oxaliplatin and bevacizumab followed by concomitant standard chemoradiation and surgical resection in patients with high-risk locally advanced rectal cancer. Patients and Methods: Magnetic resonance imaging (MRI)-defined high-risk cT3/4 rectal cancer patients were treated with 3 cycles of neoadjuvant chemotherapy with capecitabine (1,000 mg/m2 twice daily days 1-14, 22-35, 43-56), oxaliplatin (130 mg/sqm on days 1, 22, 43) and bevacizumab (7.5 mg/kg on days 1, 22, 43) followed by capecitabine (825 mg/m2 twice daily on radiotherapy days week 1-4) concomitantly with radiotherapy (1.8 Gy daily up to 45 Gy in 5 weeks) and surgical resection by total mesorectal excision. Feasibility, safety, response rate and postoperative morbidity were evaluated. Results: Twenty-five patients were recruited. Median age was 62 years (range=24-78 years) and all patients had Eastern Cooperation Oncology Group (ECOG) performance status 0. From all patients, 79.2% finished neoadjuvant chemotherapy. Twenty patients underwent surgery. Pathologic complete remission rate, R0 resection and T-downstaging were achieved in 25%, 95% and 54.2% of the “intention to treat” (ITT) patients. The most common grade 3 adverse events (AEs) during neoadjuvant chemotherapy were diarrhea (16.6%) and mucositis (12.5%). In one patient, a grade 4 acute renal failure occurred (4.2%). During chemoradiation, skin reactions (5.3%) were the most common grade 3 AEs. Two major perioperative complications required re-intervention. Conclusion: Neoadjuvant chemotherapy with bevacizumab, capecitabine and oxaliplatin followed by concomitant standard chemoradiation is feasible in patients with high-risk locally advanced rectal cancer (LARC) and resulted in complete pathologic remission (pCR) rate of 25% and neoadjuvant chemotherapy completion rate of 80%.

  • Neoadjuvant chemotherapy
  • rectal cancer
  • capecitabine
  • oxaliplatin and bevacizumab
  • Received March 19, 2017.
  • Revision received April 3, 2017.
  • Accepted April 4, 2017.
  • Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved
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Anticancer Research: 37 (5)
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Neoadjuvant Chemotherapy with Capecitabine, Oxaliplatin and Bevacizumab Followed by Concomitant Chemoradiation and Surgical Resection in Locally Advanced Rectal Cancer with High Risk of Recurrence – A Phase II Study
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Neoadjuvant Chemotherapy with Capecitabine, Oxaliplatin and Bevacizumab Followed by Concomitant Chemoradiation and Surgical Resection in Locally Advanced Rectal Cancer with High Risk of Recurrence – A Phase II Study
WOLFGANG EISTERER, GUDRUN PIRINGER, ALEXANDER DE VRIES, DIETMAR ÖFNER, RICHARD GREIL, JÖRG TSCHMELITSCH, HELLMUT SAMONIGG, LIDIJA SÖLKNER, MICHAEL GNANT, JOSEF THALER, On behalf of the Austrian Breast and Colorectal Cancer Study Group
Anticancer Research May 2017, 37 (5) 2683-2691;

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Neoadjuvant Chemotherapy with Capecitabine, Oxaliplatin and Bevacizumab Followed by Concomitant Chemoradiation and Surgical Resection in Locally Advanced Rectal Cancer with High Risk of Recurrence – A Phase II Study
WOLFGANG EISTERER, GUDRUN PIRINGER, ALEXANDER DE VRIES, DIETMAR ÖFNER, RICHARD GREIL, JÖRG TSCHMELITSCH, HELLMUT SAMONIGG, LIDIJA SÖLKNER, MICHAEL GNANT, JOSEF THALER, On behalf of the Austrian Breast and Colorectal Cancer Study Group
Anticancer Research May 2017, 37 (5) 2683-2691;
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Keywords

  • neoadjuvant chemotherapy
  • rectal cancer
  • capecitabine
  • oxaliplatin and bevacizumab
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