- Email: [email protected]
Five-Year Results of the Xert Phase Ii Trial: Preoperative Radiotherapy, Capecitabine and Cetuximab for Treatment of Locally Advanced Rectal Cancer
Annals of Oncology 25 (Supplement 4): iv167–iv209, 2014 doi:10.1093/annonc/mdu333.87
gastrointestinal tumours, colorectal
V. Velenik1, J. Ocvirk2, I. Oblak1, F. Anderluh1 1 Radiotherapy, Institute of Oncology, Ljubljana, SLOVENIA 2 Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, SLOVENIA
Aim: Preoperative capecitabine-based chemoradiotherapy (CRT) is widely used treatment for resectable locally advanced rectal cancer (LARC). In order to improve efficacy, we conducted a phase II study in which the epidermal growth factor receptor-targeting monoclonal antibody cetuximab was added to capecitabine-based CRT. The results for five-year survival and an analysis investigating the relationship between survival and patient and disease characteristics, including tumour KRAS mutation status, and surgery type, are presented. Methods: Patients with resectable LARC received capecitabine (1250 mg/m2 twice daily) for 2 weeks followed by cetuximab at week 3 (400 mg/m2), then cetuximab (250 mg/m2/week) and capecitabine (825 mg/m2 twice daily) at week 4. Radiotherapy started at week 4 at a 45 Gy dose (25 x 1.8-Gy) five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m2 twice daily for 14 days every 21 days) six to eight weeks after the operation. Results: Forty-three patients were enrolled and thirty-seven underwent treatment. Thirty-six patients were evaluable for efficacy. The median follow-up time for all patients was 69.0 months (range 5.0-106.0), the median follow-up time for all alive patients was also 69 months (range 64-106 months). Eight patients died. The five year overall survival, disease free survival, recurrence free survival and local control were 52.7% (95% CI 43.898-72.364), 72.2% (95% CI 51.998-72.162), 74.3 (95% CI 53.859-73.561) and 96.9% (95% CI 74.743-83.136), respectively. There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small. Conclusions: Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and resulted in excellent five-year local control rate. Disclosure: All authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv200/2241366 by guest on 24 October 2019
FIVE-YEAR RESULTS OF THE XERT PHASE II TRIAL: PREOPERATIVE RADIOTHERAPY, CAPECITABINE AND CETUXIMAB FOR TREATMENT OF LOCALLY ADVANCED RECTAL CANCER
abstracts
585P
gastrointestinal tumours, colorectal
V. Velenik1, J. Ocvirk2, I. Oblak1, F. Anderluh1 1 Radiotherapy, Institute of Oncology, Ljubljana, SLOVENIA 2 Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, SLOVENIA
Aim: Preoperative capecitabine-based chemoradiotherapy (CRT) is widely used treatment for resectable locally advanced rectal cancer (LARC). In order to improve efficacy, we conducted a phase II study in which the epidermal growth factor receptor-targeting monoclonal antibody cetuximab was added to capecitabine-based CRT. The results for five-year survival and an analysis investigating the relationship between survival and patient and disease characteristics, including tumour KRAS mutation status, and surgery type, are presented. Methods: Patients with resectable LARC received capecitabine (1250 mg/m2 twice daily) for 2 weeks followed by cetuximab at week 3 (400 mg/m2), then cetuximab (250 mg/m2/week) and capecitabine (825 mg/m2 twice daily) at week 4. Radiotherapy started at week 4 at a 45 Gy dose (25 x 1.8-Gy) five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m2 twice daily for 14 days every 21 days) six to eight weeks after the operation. Results: Forty-three patients were enrolled and thirty-seven underwent treatment. Thirty-six patients were evaluable for efficacy. The median follow-up time for all patients was 69.0 months (range 5.0-106.0), the median follow-up time for all alive patients was also 69 months (range 64-106 months). Eight patients died. The five year overall survival, disease free survival, recurrence free survival and local control were 52.7% (95% CI 43.898-72.364), 72.2% (95% CI 51.998-72.162), 74.3 (95% CI 53.859-73.561) and 96.9% (95% CI 74.743-83.136), respectively. There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small. Conclusions: Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and resulted in excellent five-year local control rate. Disclosure: All authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv200/2241366 by guest on 24 October 2019
FIVE-YEAR RESULTS OF THE XERT PHASE II TRIAL: PREOPERATIVE RADIOTHERAPY, CAPECITABINE AND CETUXIMAB FOR TREATMENT OF LOCALLY ADVANCED RECTAL CANCER
abstracts
585P