Computed Tomography Colonography vs Colonoscopy for Colorectal Cancer Surveillance After Surgery.

BACKGROUND & AIMS: Recommendations for surveillance after curative surgery for colorectal cancer (CRC) include a 1-year post-resection abdominal-pelvic computed tomography (CT) scan and optical colonoscopy (OC). CT colonography (CTC), when used in CRC screening, effectively identifies colorectal polyps ≥10 mm and cancers. We performed a prospective study to determine whether CTC, concurrent with CT, could substitute for OC in CRC surveillance. METHODS: Our study enrolled 231 patients with resected stage 0-III CRC, identified at 5 tertiary care academic centers. Approximately 1 year after surgery, participants underwent outpatient CTC plus CT, followed by same-day OC. CTC results were revealed after endoscopic visualization of sequential colonic segments, which were re-examined for discordant findings. The primary outcome was performance of CTC in the detection of colorectal adenomas and cancers using endoscopy as the reference standard. RESULTS: Of the 231 participants, 116 (50.2%) had polyps of any size or histology identified by OC, and 15.6% had conventional adenomas and/or serrated polyps ≥6 mm. No intra-luminal cancers were detected. CTC detected patients with polyps of ≥6 mm with 44.0% sensitivity (95% CI, 30.2-57.8) and 93.4% specificity (95% CI, 89.7-97.0). CTC detected polyps ≥10 mm with 76.9% sensitivity (95% CI, 54.0-99.8) and 89.0% specificity (95% CI, 84.8-93.1). Similar values were found when only adenomatous polyps were considered. The negative predictive value of CTC for adenomas ≥6 mm was 90.7% (95% CI, 86.7-94.5) and for adenomas ≥10 mm the negative predictive value was 98.6% (95% CI, 97.0-100). CONCLUSIONS: In a CRC surveillance population 1 year following resection, CTC was inferior to OC for detecting patients with polyps ≥6 mm. Clinical Trials.gov Registration Number: NCT02143115.

Post-operative colorectal cancer surveillance: preference for optical colonoscopy over computerized tomographic colonography.

PURPOSE: Post-operative surveillance strategies for colorectal cancer (CRC) include periodic optical colonoscopy (OC) and abdominal-pelvic CT scan. Adherence with these recommendations is limited. For CRC screening, CT colonography (CTC) identifies larger adenomas and cancers nearly as well as OC. Most screening studies demonstrate that patients prefer CTC. However, CTC has never been compared to OC in the post-operative surveillance setting. METHODS: We hypothesized that CTC might represent an attractive substitute for the standard OC/CT scan combination. Here, 223 patients underwent CTC followed by same day OC 1 year after curative CRC resection. RESULTS: Of the 144/223 (64.6%) participants with a preference, 65.9% (95/144) preferred OC. This preference was more pronounced in women and in patients with polyps detected. No additional patient level factors significantly altered this primary result. CONCLUSIONS: In contrast to CRC screening, this first study in CRC post-operative surveillance patients demonstrates a preference for OC. Assuming patient preference is an important determinant, introduction of CTC as a method to increase patient adherence with CRC surveillance is unlikely to be effective. TRIAL REGISTRATION: Clinical Trials.gov registration number: NCT02143115.

Prospective Trial Evaluating the Surgical Anastomosis at One-Year Colorectal Cancer Surveillance: CT Colonography Versus Optical Colonoscopy and Implications for Patient Care.

OBJECTIVE: The aim of this study was to compare the accuracy of CT colonography versus optical colonoscopy for neoplastic involvement at the surgical anastomosis 1 year after curative-intent colorectal cancer resection. DESIGN, SETTING, PATIENTS, AND INTERVENTIONS: Two hundred one patients (mean age, 58.6 years; 117 men, 84 women) underwent same-day contrast-enhanced CT colonography and colonoscopy approximately 1 year (mean, 12.1 months; median, 11.9 months) after colorectal cancer resection as part of a prospective, multicenter trial. All patients enrolled were without clinical evidence of disease and considered low risk for recurrence (stage I-III). MAIN OUTCOME MEASURES: Suspected neoplastic lesions within 5 cm of the colonic anastomosis were recorded at CT colonography, with subsequent colonoscopy performed for the same, with segmental unblinding of colonography findings. Anastomotic region biopsy or polypectomy was performed at the endoscopist's discretion. RESULTS: None of the 201 patients had intraluminal anastomotic cancer recurrence or advanced neoplasia (or metachronous cancers). CT colonography detected extramural perianastomotic recurrence in 2 patients (1.0%); neither was detected at colonoscopy. Only 2 patients (1.0%; 2/201) were called positive at CT colonography for intraluminal anastomotic nondiminutive lesions (7- to 8-mm polyps), which were confirmed at colonoscopy but nonneoplastic at histopathology. At optical colonoscopy, the anastomosis was deemed abnormal and/or biopsied in 10.0% (20/201), yielding only 1 nondiminutive benign neoplasm (7-mm tubular adenoma). LIMITATIONS: The lack of luminal cancer recurrence in our lower-risk cohort precludes assessment of sensitivity for detection, rendering the study underpowered in this regard. Potential cost savings of combined CT/CT colonography over the standard CT/colonoscopy approach were not assessed. CONCLUSIONS: Relevant intraluminal anastomotic pathology appears to be very uncommon 1 year after colorectal cancer resection in lower-risk cohorts. Unlike colonoscopy, diagnostic contrast-enhanced CT colonography effectively evaluates both the intra- and extraluminal aspects of the anastomosis. See Video Abstract at http://links.lww.com/DCR/A471.

Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial.

BACKGROUND: New methods are needed to improve health behaviors, such as adherence to colorectal cancer (CRC) screening. Personalized genetic information to guide medical decisions is increasingly available. Whether such information motivates behavioral change is unknown. OBJECTIVE: To determine whether individualized genetic and environmental risk assessment (GERA) of CRC susceptibility improves adherence to screening in average-risk persons. DESIGN: 2-group, randomized, controlled trial. (ClinicalTrials.gov: NCT0087360). SETTING: 4 medical school-affiliated primary care practices. PARTICIPANTS: 783 participants at average risk for CRC who were not adherent to screening at study entry. INTERVENTION: Participants were randomly assigned to usual care or GERA, which evaluated methylenetetrahydrofolate reductase polymorphisms and serum folate levels. On the basis of prespecified combinations of polymorphisms and serum folate levels, GERA recipients were told that they were at elevated or average risk for CRC. MEASUREMENTS: The primary outcome was CRC screening within 6 months of study entry. RESULTS: Overall screening rates for CRC did not statistically significant differ between the usual care (35.7%) and GERA (33.1%) groups. After adjustment for baseline participant factors, the odds ratio for screening completion for GERA versus usual care was 0.88 (95% CI, 0.64 to 1.22). Within the GERA group, screening rates did not significantly differ between average-risk (38.1%) and elevated-risk (26.9%) participants. Odds ratios for elevated- versus average-risk participants remained nonsignificant after adjustment for covariates (odds ratio, 0.75 [CI, 0.39 to 1.42]). LIMITATION: Only 1 personalized genetic and environmental interaction and 1 health behavior (CRC screening) were assessed. CONCLUSION: In average-risk persons, CRC screening uptake was not positively associated with feedback from a single personalized GERA. Additional studies will be required to evaluate whether other approaches to providing GERA affect screening utilization differently. These findings raise concern about the effectiveness of moderately predictive assessment of genetic risk to promote favorable health care behavior. PRIMARY FUNDING SOURCE: National Institutes of Health.

Build it, and will they come? Unexpected findings from a study on a Web-based intervention to improve colorectal cancer screening.

Given the extensive use of the Internet for health information, Web-based health promotion interventions are widely perceived as an effective communication channel. The authors conducted this study to determine use of a Web-based intervention intended to improve colorectal cancer screening in a population of women who are at average risk and noncompliant to current screening recommendations. The study was a randomized controlled trial designed to compare the effectiveness of colorectal cancer screening educational materials delivered using the Internet versus a printed format. In 3 years, 391 women seen for routine obstetrics/gynecology follow-up at 2 academic centers provided relevant survey information. Of these, 130 were randomized to the Web intervention. Participants received voluntary access to a password-protected, study-specific Web site that provided information about colorectal cancer and colorectal cancer screening options. The main outcome measures were self-reported and actual Web site use. Only 24.6% of women logged onto the Web site. Age was the only variable that differentiated users from nonusers (p = .03). In contrast, 16% of participants self-reported Web use. There was significant discordance between the veracity of actual and self-reported use (p = .004). Among true users, most (81%) logged on once only. These findings raise questions about how to increase use of important health communication interventions.

Colorectal cancer knowledge is not associated with screening compliance or intention.

BACKGROUND: Increasing colorectal cancer (CRC) screening is a public health goal. We hypothesized that non-compliant, average risk women would demonstrate low levels of CRC knowledge and underestimate their CRC risk. METHODS: Participants identified prior to routine gynecological visits completed a survey assessing demographics, CRC knowledge, risk perception, and screening intention. RESULTS: The 318 participants demonstrated high levels of CRC knowledge. The majority estimated their risk incorrectly and had no intention of screening participation in the future. There were no consistent relationships between knowledge, risk perception, and screening intent. CONCLUSIONS: Knowledge alone is an inadequate stimulus of screening adherence.

Adherence to postresection colorectal cancer surveillance at National Cancer Institute-designated Comprehensive Cancer Centers.

Guidelines recommend surveillance after resection of colorectal cancer (CRC), but rates of adherence to surveillance are variable and have not been studied at National Cancer Institute (NCI)-designated Comprehensive Cancer Centers. The aim of this study was to determine rates of adherence to standard postresection CRC surveillance recommendations including physician visits, carcinoembryonic antigen (CEA), computed tomography (CT), and colonoscopy after CRC resection at three NCI-designated centers. Data on patients with resected CRC from 2010 to 2017 were reviewed. Adherence to physician visits was defined as having at least two visits within 14 months after surgical resection. CEA adherence was defined as having at least four CEA levels drawn within 14 months. CT and colonoscopy adherence were defined as completing each between 10 and 14 months from surgical resection. Chi-square test and logistic regression analyses were performed for overall adherence and adherence to individual components. A total of 241 CRC patients were included. Overall adherence was 23%. While adherence to physician visits was over 98%, adherence to CEA levels, CT, and colonoscopy were each less than 50%. Center was an independent predictor of adherence to CEA, CT, and/or colonoscopy. Stage III disease predicted CT adherence, while distance traveled of 40 miles or less predicted colonoscopy adherence. Overall adherence to postresection CRC guideline-recommended care is low at NCI-designated centers. Adherence rates to surveillance vary by center, stage, and distance traveled for care. Understanding factors associated with adherence is critical to ensure CRC patients benefit from postresection surveillance.

The I1307K APC polymorphism in Ashkenazi Jews with colorectal cancer: clinical and pathologic features.

Colorectal cancer is common in Ashkenazi Jews. The I1307K APC mutation occurs in 6-7% of Ashkenazi Jews and increases the risk of colorectal cancer. This study aimed to describe the clinical, pathologic and epidemiologic features of colorectal cancer in I1307K carriers to determine whether there were any features which might warrant individual screening for the mutation. In all, 215 Ashkenazi Jews with a personal history of colorectal cancer were enrolled. Clinical and family history, pathology reports, and slides were obtained and blood drawn for I1307K determination. The presence of the mutation was determined by PCR from white blood cell DNA. Colorectal cancer pathology slides were read in a blinded fashion. Of the 215 enrolled patients, 26 (12.1%) tested positive for I1307K. There was no difference in the pathologic features between colorectal cancers in Ashkenazi carriers compared to noncarriers. There was no difference in the age at diagnosis or history of second or other primaries. Carriers had an increased likelihood of having a first-degree relative with colorectal cancer (50%) compared to noncarriers (28%, P < 0.04). We could find no distinguishing feature other than family history that characterizes I1307K positive colorectal cancers. We could find no group of Ashkenazi Jews with colorectal cancer for whom screening for I1307K would be clinically useful.

A randomized comparison of print and web communication on colorectal cancer screening.

BACKGROUND: New methods to enhance colorectal cancer (CRC) screening rates are needed. The web offers novel possibilities to educate patients and to improve health behaviors, such as cancer screening. Evidence supports the efficacy of health communications that are targeted and tailored to improve the uptake of recommendations. METHODS: We identified unscreened women at average risk for CRC from the scheduling databases of obstetrics and gynecology practices in 2 large health care systems. Participants consented to a randomized controlled trial that compared CRC screening uptake after receipt of CRC screening information delivered via the web or in print form. Participants could also be assigned to a control (usual care) group. Women in the interventional arms received tailored information in a high- or low-monitoring Cognitive Social Information Processing model-defined attentional style. The primary outcome was CRC screening participation at 4 months. RESULTS: A total of 904 women were randomized to the interventional or control group. At 4 months, CRC screening uptake was not significantly different in the web (12.2%), print (12.0%), or control (12.9%) group. Attentional style had no effect on screening uptake for any group. Some baseline participant factors were associated with greater screening, including higher income (P = .03), stage of change (P < .001), and physician recommendation to screen (P < .001). CONCLUSIONS: A web-based educational intervention was no more effective than a print-based one or control (no educational intervention) in increasing CRC screening rates in women at average risk of CRC. Risk messages tailored to attentional style had no effect on screening uptake. In average-risk populations, use of the Internet for health communication without additional enhancement is unlikely to improve screening participation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00459030.

Predictors of patient uptake of colorectal cancer gene environment risk assessment.

BACKGROUND: In an ongoing clinical trial, the genetic and environmental risk assessment (GERA) blood test offers subjects information about personal colorectal cancer risk through measurement of two novel low-to-moderate risk factors. We sought to examine predictors of uptake of the GERA blood test among participants randomized to the Intervention arm. METHODS: Primary care patients aged 50 to 74 years eligible for colorectal cancer screening are randomized to receive a mailed stool blood test kit to complete at home (Control) or to the control condition plus an in-office blood test called GERA that includes assessment of red blood cell folate and DNA-testing for two MTHFR (methylenetetrahydrofolate reductase) single nucleotide polymorphisms (SNPs) (Intervention). For the present study, baseline survey data are examined in participants randomized to the Intervention. RESULTS: The first 351 intervention participants (161 African American/190 white) were identified. Overall, 249 (70.9%) completed GERA testing. Predictors of GERA uptake included race (African American race, odds ratio (OR) 0.51 (0.29 to 0.87)), and being more knowledgeable about GERA and colorectal cancer screening (OR 1.09 (1.01 to 1.18)). Being married (OR 1.81 (1.09 to 3.00)) was also significant in the multivariable model. CONCLUSIONS: Participant uptake of GERA testing was high. GERA uptake varied, however, according to socio-demographic background and knowledge.

Phase I trial of concurrent hyperfractionated split course radiotherapy (HFx RT), cisplatin (cDDP), and paclitaxel in patients with recurrent, previously irradiated, or treatment-naïve locally advanced upper aerodigestive malignancy.

PURPOSE: Phase I study to determine the maximally tolerated dose (MTD) of cisplatin (cDDP), paclitaxel (P), and concurrent split course hyperfractionated (BID) RT in advanced squamous cell carcinoma of the head and neck (SCCHN) and other upper aerodigestive tumors. MATERIALS AND METHODS: Eligibility stipulated ECOG performance status 0-2 and either Tx-naïve, locally advanced, or locally recurrent, previously radiated, surgically unresectable upper aerodigestive cancer. Metastases were permitted if disease was predominantly locoregional. RT-naïve patients received 150 cGy bid x 5 d Q 2 wks x 4. Previously radiated patients received 150 cGy bid x 5, wk 1; then 120 cGy bid x 5 Q 2 wk x 3 (later increased to 150 cGy BID for the entire treatment). Treatment fields included recurrent tumor only with 2 cm margins. Whenever possible, conventional and 3-D conformal techniques were used. Elective nodal radiation was not administered. Starting doses of cDDP and P were 12 mg/m2/d x 5 and 15 mg/m2/d x 5, respectively, Q 2 wk x 4, each given on RT days only. At dose level 2, cDDP was increased to 15 mg/m2/d x 5. At dose level 3, P was increased to 20 mg/m2/d x 5. Granulocyte colony stimulating factor (G-CSF) days 6-12 (off treatment week) was added if cumulative neutropenia precipitated treatment delays. RESULTS: Thirty-one patients (21 men, 10 women) were treated. Eight had received prior chemotherapy, 27 prior RT. At dose level three, regular treatment delays of >or=1 week due to slow neutrophil recovery occurred. Addition of G-CSF (dose level 3b) reduced treatment delays from 100 percent to 28 percent and decreased the incidence of Grade >or=2 neutropenia and mucositis. Six of 7 patients at this dose level completed all 4 cycles of treatment and all received full dose RT (60 Gy). No other dose-limiting toxicities occurred. Of 22 assessable patients with locally recurrent SCCHN, 12 (55 percent) responded. Median time to progression in this group was 6 months, with median and one-year survival of 9.5 mos and 41 percent, respectively. CONCLUSION: Concurrent daily cisplatin/paclitaxel and split course hyperfractionated RT (60 Gy) is feasible in previously radiated patients. G-CSF, administered between each cycle, reduces the incidence of treatment delays. Activity is promising and toxicity acceptable.