PMID- 28476845 OWN - NLM STAT- MEDLINE DCOM- 20170810 LR - 20220317 IS - 1791-7530 (Electronic) IS - 0250-7005 (Linking) VI - 37 IP - 5 DP - 2017 May TI - 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. PG - 2683-2691 AB - 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/m(2) 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/m(2) 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%. CI - Copyright(c) 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved. FAU - Eisterer, Wolfgang AU - Eisterer W AD - Department of Internal Medicine, Klinikum Klagenfurt am Worthersee, Klagenfurt, Austria. FAU - Piringer, Gudrun AU - Piringer G AD - Department of Internal Medicine IV, Wels-Grieskirchen Medical Hospital, Wels, Austria gudrun.piringer@hotmail.com. FAU - DE Vries, Alexander AU - DE Vries A AD - Department of Radiotherapy and Radio-Oncology, Feldkirch Hospital, Feldkirch, Austria. FAU - Ofner, Dietmar AU - Ofner D AD - Department of Visceral-, Transplant and Thoracic Surgery, Center of Operative Medicine, Innsbruck Medical University, Innsbruck, Austria. FAU - Greil, Richard AU - Greil R AD - Department of Internal Medicine III, Paracelsus Medical University, Salzburg, Austria. FAU - Tschmelitsch, Jorg AU - Tschmelitsch J AD - Department of Surgery, St. Veit Hospital, Sankt Veit an der Glan, Austria. FAU - Samonigg, Hellmut AU - Samonigg H AD - Department of Internal Medicine, Medical University, Graz, Austria. FAU - Solkner, Lidija AU - Solkner L AD - Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria. FAU - Gnant, Michael AU - Gnant M AD - Department of Surgery and Comprehensive Cancer Center, Medical University, Vienna, Austria. FAU - Thaler, Josef AU - Thaler J AD - Department of Internal Medicine IV, Wels-Grieskirchen Medical Hospital, Wels, Austria. CN - Austrian Breast and Colorectal Cancer Study Group LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PL - Greece TA - Anticancer Res JT - Anticancer research JID - 8102988 RN - 0 (Antineoplastic Agents) RN - 0 (Organoplatinum Compounds) RN - 04ZR38536J (Oxaliplatin) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 6804DJ8Z9U (Capecitabine) SB - IM MH - Adult MH - Aged MH - Antineoplastic Agents/adverse effects/therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Bevacizumab/adverse effects/*therapeutic use MH - Capecitabine/adverse effects/*therapeutic use MH - *Chemoradiotherapy/adverse effects MH - Female MH - Humans MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Neoadjuvant Therapy MH - Neoplasm Recurrence, Local MH - Organoplatinum Compounds/adverse effects/*therapeutic use MH - Oxaliplatin MH - Rectal Neoplasms/diagnostic imaging/drug therapy/surgery/*therapy MH - Risk MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Neoadjuvant chemotherapy OT - capecitabine OT - oxaliplatin and bevacizumab OT - rectal cancer EDAT- 2017/05/10 06:00 MHDA- 2017/08/11 06:00 CRDT- 2017/05/07 06:00 PHST- 2017/03/19 00:00 [received] PHST- 2017/04/03 00:00 [revised] PHST- 2017/04/04 00:00 [accepted] PHST- 2017/05/07 06:00 [entrez] PHST- 2017/05/10 06:00 [pubmed] PHST- 2017/08/11 06:00 [medline] AID - 37/5/2683 [pii] AID - 10.21873/anticanres.11617 [doi] PST - ppublish SO - Anticancer Res. 2017 May;37(5):2683-2691. doi: 10.21873/anticanres.11617.