Table 2.
Summary of Prospective Randomized Trials of Postoperative Colorectal Cancer Surveillance: Strategies and Outcomes
RCT | N | Intensive Follow-up | Standard Follow-up | Time to First Recurrence (mo) | 5-Year Survival (%) | ||
---|---|---|---|---|---|---|---|
CXR, chest x-ray; CBC, complete blood count; FOBT, fecal occult blood test; LFT, liver function tests; CEA, carcinoembryonic antigen; ESR, erythrocyte sedimentation rate; DRE, digital rectal examination; CT, computed tomography; US, ultrasound; APR, abdominal perineal resection; NS, not significant. | |||||||
Ohlsson et al9 1995 | 107 | History & physical exam, Rigid proctosigmoidoscopy, CEA, LFT, FOBT, CXR | q3 mo × 2 yr then q6 mo × 2 yr then q12 mo | No organized follow-up Instructed to return if symptoms develop | 20.4 vs. 24 (NS) | 75 vs. 67 (NS) | |
Colonoscopy | At 3, 15, 30, and 60 mo | Instructed to leave fecal samples | q3 mo × 2 yr then yearly | ||||
CT scan pelvis (APR) | 3 & 6 mo then q6 mo × 24 mo | ||||||
Mäkelä et al39 1995 | 106 | History & physical exam CBC, FOBT, CEA, CXR | q3 mo × 2 yr then q6 mo × 3 yr | History & physical exam, CBC, FOBT, CEA, CXR | q3 mo × 2 yr then q6 mo × 3 yr | 10 vs. 15 (P = 0.002) | 59 vs. 54 (NS) |
Flexible sigmoidoscopy | q3 mo | Rigid proctosigmoidoscopy (rectal and sigmoid cancer) | q3 mo × 2 yr then q6 mo × 3 yr | ||||
US liver | q6 mo | Barium enema | q12 mo | ||||
CT liver + surgical site | q12 mo | ||||||
Colonoscopy | At 3 mo then q12 mo | ||||||
Kjeldsen et al38 1997 | 597 | History & physical exam, DRE, gynecologic exam, FOBT, colonoscopy, CXR, CBC, ESR, LFT | q6 mo × 3 yr then yearly × 2 yr then at 10, 12.5, and 15 yr after resection | History & physical exam, DRE, gynecologic exam, FOBT, colonoscopy, CXR, CBC, ESR, LFT | At 5, 10, & 25 yr after resection | 18 vs. 27 (P < 0.001) | 70 vs. 68 (NS) |
Pietra et al18 1998 | 207 | History & physical exam, US liver, CEA | q3 mo × 2 yr then q6 mo × 3 yr then yearly | History & physical exam, US liver, CEA | q6 mo × 1 year then yearly | 10.3 vs. 20.2 (P < 0.0003) | 73.1 vs. 58.3 (P < 0.02) |
CXR, colonoscopy, CT scan | q12 mo | CXR, colonoscopy | q12 mo | ||||
Schoemaker et al40 1998 | 325 | History & physical exam, CBC, LFT, CEA, FOBT | q3 mo × 2 yr then q6 mo × 5 yr | History & physical exam, CBC, LFT, CEA, FOBT | q3 mo × 2 yr then q6 mo × 5 yr | Not stated | 76 vs. 70 (NS) |
CXR, CT scan liver, colonoscopy | q12 mo | CXR, CT scan liver, colonoscopy | At 5 yr after resection | ||||
Secco et al19 2002 | 358 | HIGH RISK (HR)* | q3 mo × 24 mo then q4 mo × 1 year then q6 mo × 2 yr | LOW RISK (LR)* | q6 mo × 24 mo then yearly × 3 yr | RISK-ADAPTED | RISK-ADAPTED |
History & physical exam, CEA | q6 mo × 36 mo then yearly × 2 yr | History & physical exam, CEA | q6 mo × 2 yr then yearly | 13.5 (HR) vs. 16 (LR) | 50 (HR) vs. 80 (LR) (P< 0.001) | ||
US (abdomen and pelvis) | q1 yr × 5 yr | Rigid proctosigmoidoscopy (rectal ca) | q1 yr × 2 yr then q2 yr | MINIMAL | MINIMAL | ||
Rigid proctosigmoidoscopy (rectal ca) | q1 yr × 5 yr | CXR | q1 yr × 5 yr | 8 (HR) vs. 14 (LR) | 32 (HR) vs. 60 (LR) (P< 0.001) | ||
CXR |
Patients stratified into high- or low-risk groups based on prognostic; randomized to risk-adapted follow-up (outlined earlier) or minimal surveillance (yearly clinical examination and q6mo phone check-ups).