Induction Chemotherapy, Chemoradiotherapy, and Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer – Long-Term Results of Phase II OIGIT-01 Trial

Danijela Golo, Jasna But-Hadzic, Franc Anderluh, Erik Brecelj, Ibrahim Edhemovic, Ana Jeromen, Mirko Omejc, Irena Oblak, Ajra Secerov-Ermenc, Vaneja Velenik


Background and Purpose

To improve the treatment efficacy for locally advanced rectal cancer (LARC) by shifting half of adjuvant chemotherapy preoperatively to one induction and two consolidation cycles.


Materials and Methods

Between October 2011 and April 2013, 66 patients with LARC were treated with one induction chemotherapy cycle followed by chemoradiotherapy (CRT), two consolidation cycles, surgery and three adjuvant capecitabine cycles. Radiation doses were 50,4 Gy for T2-3 and 54 Gy for T4 tumours in 1,8 Gy daily fraction. The doses of concomitant and neo/adjuvant capecitabine were 825 mg/m²/12h and 1250mg/m²/12h, respectively. The primary endpoint was pathologic complete response (pCR).



Forty-three (65.1 %) patients were treated according to protocol. The compliance rates for induction, consolidation, and adjuvant chemotherapy were 98.5 %, 93.8 % and 87.3 %, respectively. CRT was completed by 65/66 patients, with G ≥ 3 non-hematologic toxicity at 13.6 %. The rate of pCR (17.5 %) was not increased, but N and the total-down staging rates were 77.7 % and 79.3 %, respectively. In a median follow-up of 55 months, we recorded one local relapse (LR = 1.6 %). The 5-year disease-free survival and overall survival rates were 64.0 % (95 % CI 63.89 – 64.11) and69.5 % (95 % CI 69.39 – 69.61), respectively.



In LARC preoperative treatment intensification with capecitabine before and after radiotherapy is well tolerated, with a high compliance rate and acceptable toxicity. Though it does not improve the local effect, it achieves a high LR rate, DFS, and OS.

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RADIOLOGY AND ONCOLOGY, Association of Radiology and Oncology,
Zaloska 2, P.O.Box 2217, SI-1000 Ljubljana, Slovenia, T/F: +386 1 5879 434, Open access on the web: ISSN 1518-3207, De Gruyter
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