A multicenter prospective study of immunochemical fecal occult blood testing for colorectal cancer detection.

BACKGROUND: Colorectal cancer (CRC) screening by guaiac fecal occult blood test (gFOBT) can reduce the mortality of CRC. The new immunochemical fecal occult blood test (iFOBT) has possibly improved sensitivity and specificity without any dietary restriction. OBJECTIVE: The present study aimed to evaluate the sensitivity, specificity, positive and negative predictive values of iFOBT for CRC detection compared to the colonoscopic and pathologic findings in known CRC cases. MATERIAL AND METHOD: A multicenter prospective study was conducted in three university hospitals in Bangkok, Thailand, between May and August 2006. Stool samples from 100 histologically-proven CRC patients and 64 control cases with normal colonoscopic findings were collected for iFOBT (OC-Light, Nagase, Singapore) without dietary restriction. RESULTS: The results showed the sensitivity, specificity, positive and negative predictive values of iFOBT for CRC detection to be 91.0% (95% CI: 83.8-95.2), 93.8% (95% CI: 85.0-97.5), 95.8% (95% CI: 89.7-98.4) and 87.0% (95% CI: 77.0-93.0) respectively. The sensitivity for CRC according to Dukes'stage was 71.4% (Dukes' A), 88.0% (Dukes' B), and 96.7% (Dukes' C or D). The sensitivity was 84.2% for proximal colon and 92.6% for distal colon and rectum. CONCLUSION: The iFOBT revealed high sensitivity, specificity, positive and negative predictive values for CRC detection without dietary restriction. It should be considered as a noninvasive tool for CRC detection.

Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial).

OBJECTIVE: Phase I multicenter study defined the maximal tolerated dose (MTD), dose-limiting toxicity (DLT) and safety profile of capecitabine in combination with preoperative radiation for patients with locally advanced rectal cancer (LARC). MATERIAL AND METHOD: Patients were treated with oral capecitabine (700, 800, 900, 1000, 1100 and 1200 mg/m2 twice daily continuously) plus preoperative whole pelvic irradiation (45-46 Gy in 23-25 fractions over 5-6 weeks). Surgery was performed at the median of 42 days after chemoradiation treatment. RESULTS: Twenty-seven patients were in this trial. Eighteen patients (3 per dose level) had received capecitabine from 700 mg/m2 twice daily to the highest dose level of 1200 mg/m2 twice daily. There were no grade 3/4 DLTs during dose escalation, a further nine patients were included at the highest capecitabine dose. Two of the twelve patients (16%) receiving capecitabine 1200 mg/m2 twice daily developed grade 3 diarrhea and discontinued treatment. There were no other grade 3/4 adverse events. After capecitabine chemoradiation, 24 of 27 patients (89%) received definite surgery. Primary and lymph node down staging occurred in ten patients (42%). Sphincter-sparing surgery was performed in seven patients (26%) and abdominal-perineal resection was performed in 17 patients (63%). CONCLUSION: Preoperative capecitabine chemoradiation based on continuous daily capecitabine is very well tolerated in patients with LARC. The authors did not reach the MTD in the present study.