Annals of Oncology Advance Access originally published online on November 9, 2005
Annals of Oncology 2006 17(2):246-251; doi:10.1093/annonc/mdj041
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© 2005 European Society for Medical Oncology
Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study
1 Departments of Radiation Oncology and Medical Oncology, C.R.O. – National Cancer Institute, Aviano; 2 Departments of Radiation Oncology and Medical Oncology, I.S.T. – National Institute of Cancer Research, Genova; 3 Departments of Radiation Oncology and Medical Oncology, University Hospital, Modena; 4 Departments of Radiation Oncology and Medical Oncology, University Hospital, Padova; 5 Departments of Radiation Oncology and Medical Oncology, Ospedali Riuniti, Bergamo; 6 Departments of Radiation Oncology and Medical Oncology, General Hospital, Ancona, Italy
* Correspondence to: Dr A. De Paoli, Department of Radiation Oncology, C.R.O. – National Cancer Institute, Aviano, Italy. Tel: +39-0434-659-528; Fax: +39-0434-659-524; E-mail: adepaoli{at}cro.it
Background: The aim of the study was to evaluate tolerance and efficacy of preoperative treatment with capecitabine in combination with radiation therapy (RT) in patients with locally advanced, resectable, rectal cancer.
Patients and methods: Fifty-three patients with potentially resectable T3, N0–2 (87%) and T4, N0–2 (13%) rectal cancer were treated with capecitabine (825 mg/m2, twice daily for 7 days/week) and concomitant RT (50.4 Gy/28 fractions). Patients underwent surgery after 6–8 weeks followed, upon physician's indications, by 4-months adjuvant capecitabine. The primary end point was to determine the rate of pathologic complete response. Secondary end points were to assess the rate of clinical response and the safety profile.
Results: All patients but two completed the RT programme and 47 (89%) received 81%–100% of the capecitabine dose (100% of dose in 72% patients, 81%–95% in 17% patients and 48%–74% in 11% of patients). No patient had grade 4 toxicity. Grade 3 toxicity occurred in six patients (11%) and consisted mainly of leucopenia (4%) and hand–foot syndrome (4%). Mild or moderate toxicity was common and included leucopenia (72%), diarrhea (40%), proctitis (34%) and skin toxicity (20%). The overall clinical response rate was 58% and the downstaging rate was 57%, with a pathologic complete response rate of 24%. Among 34 patients with low-lying tumors (
5 cm from anal verge), 20 (59%) had a sphincter-saving operation.
Conclusions: Preoperative chemoradiation with capecitabine and RT appeared to be effective in locally advanced resectable, rectal cancer. The favorable safety profile of the combination might warrant the use of capecitabine and RT with other effective new drugs.
Key words: capecitabine, chemoradiation, locally advanced rectal cancer, phase II study
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