Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial.

Abstract:

AIM:To evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced rectal cancer. METHODS:Between June 2004 and January 2005, 57 patients with operable, clinical stage II-III adenocarcinoma of the rectum entered the prospective phase II study. Radiation dose was 45 Gy (25x1.8 Gy). Concurrent chemotherapy with a daily dose of 1650 mg/m2 capecitabine was administered orally, divided into two equal doses per day, including weekends. Patients were evaluated weekly for acute toxicity and compliance with the protocol. Surgery was scheduled 6 weeks after the completion of the chemoradiotherapy. RESULTS:A single female patient died after receiving 27 Gy, because of pulmonary embolism. All other patients completed the preoperative chemoradiotherapy according to the protocol and a definitive operation was performed in all but one of these patients. The complete pathological response was recorded in 5 patients (9.1%). Tumor (T), lymph nodes (N), and overall downstaging rates were 40%, 52.9%, and 49.1%, respectively. Total sphincter preservation rate was 65.5% (36 out of 55 patients) and the rate in 27 patients with tumors located within 5 cm of the anal opening was 37% (10 out of 27 patients). The most frequent side-effect of the combined therapy was dermatitis (grade 3 in 19 patients). After surgery, a single patient died due to sepsis during the early perioperative period. Nonlethal perioperative complications were recorded in 24/55 patients. CONCLUSION:Preoperative chemoradiotherapy with oral capecitabine is safe and well tolerated. It has a downstaging potential and can increase the possibility for sphincter preservation surgery.

journal_name

Croat Med J

journal_title

Croatian medical journal

authors

Velenik V,Anderluh F,Oblak I,Strojan P,Zakotnik B

subject

Has Abstract

pub_date

2006-10-01 00:00:00

pages

693-700

issue

5

eissn

0353-9504

issn

1332-8166

journal_volume

47

pub_type

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