CPT-11 and concomitant hyperfractionated accelerated radiotherapy induce efficient local control in rectal cancer patients: results from a phase II

Patients with rectal cancer are at high risk of disease recurrence despite neoadjuvant radiochemotherapy with 5-Fluorouracil (5FU), a
<br />regimen that is now widely applied. In order to develop a regimen with increased antitumour activity, we previously established the
<br />recommended dose of neoadjuvant CPT-11 (three times weekly 90 mgm 2) concomitant to hyperfractionated accelerated
<br />radiotherapy (HART) followed by surgery within 1 week. Thirty-three patients (20 men) with a locally advanced adenocarcinoma of
<br />the rectum were enrolled in this prospective phase II trial (1 cT2, 29 cT3, 3 cT4 and 21 cNþ). Median age was 60 years (range 43–
<br />75 years). All patients received all three injections of CPT-11 and all but two patients completed radiotherapy as planned. Surgery
<br />with total mesorectal excision (TME) was performed within 1 week (range 2–15 days). The preoperative chemoradiotherapy was
<br />overall well tolerated, 24% of the patients experienced grade 3 diarrhoea that was easily manageable. At a median follow-up of 2
<br />years no local recurrence occurred, however, nine patients developed distant metastases. The 2-year disease-free survival was 66%
<br />(95% confidence interval 0.48–0.83). Neoadjuvant CPT-11 and HART allow for excellent local control; however, distant relapse
<br />remains a concern in this patient population.