Objective: The objective of this study was to determine the rate of salvage resections in patients with stage II and III colorectal cancer following intensive surveillance in a comprehensive cancer center. Methods: Patients with stage II and III colorectal cancer with a minimum follow-up of 3 years were included. Carcinoembryonic antigen was obtained every 3 months for 2 years and then every 6 months for years 3–5. CT scans of the chest, abdomen and pelvis were performed every 6 months for 2 years and then yearly for years 3–5. Colonoscopy was performed at year 1 and then every 3 years. Results: One hundred and seventy-seven patients were followed for a median of 60 months; 44 patients were diagnosed with recurrent disease. CT was the first sign of recurrence in 68% of patients. Carcinoembryonic antigen test was normal in 20 patients (45%) at the time of disease recurrence. Twenty-five patients (57%) with recurrent disease underwent curative-intent resection, 12 of whom are still cancer free at a median follow-up of 81 months. Conclusions: In this retrospective study, intensive radiographic screening was associated with a high salvage resection rate, which led to favorable clinical outcomes. Randomized clinical trials are urgently needed to define the optimal duration and schedule of radiographic screening in stage II and III colorectal cancer.
598 Background: Prior clinical data suggest a dose-related response to cmab when combined with irinotecan in pts with KRAS WT tumors who do not develop grade 2 and above rash with standard cmab dosing. However, the investigation of higher doses of cmab in the setting of acquired or innate resistance to standard dose cmab has not been previously investigated. We conducted a phase II clinical trial of high-dose cmab plus irinotecan in KRAS WT pts with standard-dose cmab plus irinotecan – refractory disease to address this question. Methods: Pts with KRAS WT MCRC progressing on standard dose of cmab with irinotecan were eligible for study. Pts should have received a minimum of 6 weeks of prior standard dose cmab plus irinotecan and progressed within 4 weeks from the last dose. Cmab was administered at 500 mg/m2/week and irinotecan was administered at the same dose/schedule on which the patient previously progressed. 12-week PFS rate was the primary endpoint. Results: 8 pts were treated on study: median age 68 yrs (45-85), 5 pts were males, ECOG performance status was 1 in all 8 pts. Grade ≥ 3 toxicities consisted of hypomagnesaemia (4 pts), anemia (1 pt), leucopenia (1 pt), fatigue (1 pt), and diarrhea (1 pt). 6 pts achieved stable disease (with regression in target lesions noted in 3 pts). 12 week PFS rate is 5/8 and 18 week PFS is 4/8. 3 pts remain on study at 4.5, 5, and 8 months from enrollment. Conclusions: High-dose cmab/irinotecan is well tolerated except for hypomagnesemia. Encouraging prolonged disease stabilizations warrant further investigation of this approach in pts in KRAS WT population. Accrual is ongoing. [Table: see text]
405 Background: The objective of this study was to determine the rate of salvage resection in patients with stage II and III colorectal cancer following intensive surveillance. Methods: Patients with stage II and III colorectal cancer with a minimum follow-up of 3 years were included. CEA was obtained every 3 months for 2 years and then every 6 months for years 3 to 5. CT of the chest, abdomen and pelvis was performed every 6 months for 2 years and then yearly for years 3 to 5. Colonoscopy was performed at year 1 and then every 3 years. Results: 177 patients were followed for a median of 59.5 months. 51% were male, and 65 % had colon cancer. Compliance with screening was excellent with 92 % of patients undergoing all scheduled studies within 2 months of the planned date. At the time of this report, the median follow-up of the overall population was 5 years. 44 patients were diagnosed with recurrent disease. 91% of the recurrences were in the first 3 years of follow-up. CT and CEA were the first signs of recurrence in 68% and 14% of patients, respectively. Among the 30 patients diagnosed radiographically, 20 had a normal CEA. 25 patients (57%) with recurrent disease underwent curative intent resection, 12 of whom are still cancer free, with a median follow-up of 6.7 years from salvage surgery. The DFS and OS in the operated recurrent population from the time of salvage resection was 18.8 months (95% CI: 15.5 – 29.4) and not-reached (95% CI: 37.4, NR), respectively. The corresponding OS (from the time of recurrence) of the recurrent population without resection was 20.7 months (95% CI: 21.9, 63.4). The difference in OS between the two groups was highly significant (p = 0.0003). Among the patients undergoing resection, a significant difference was detected in the DFS of resected lung or liver metastases vs. extra-hepatic/pulmonary disease (p = 0.03) and a trend towards improved survival was noted (p = 0.07). Conclusions: Our intensive surveillance strategy resulted in the highest reported salvage rate in stage II and III colorectal cancer and led to a high rate of sustained remissions following salvage surgery. Intensive, 6-monthly, radiographic surveillance and its duration should be investigated further in randomized studies.
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