Once-Only Sigmoidoscopy Screening for Colorectal Cancer: Incidence and Mortality Follow-up of the Italian Randomized Controlled Trial (SCORE)

ABSTRACT Background Yogurt is a commonly consumed fermented food. Regular yogurt consumption may contribute to a favorable gut microbiome and gut health, but few epidemiologic studies have considered the relation between regular yogurt consumption and the incidence of and mortality from colorectal cancer. Objectives We used data from 2 large, prospective cohort studies, the Nurses’ Health Study and the Health Professionals Follow-Up Study, to examine the role of yogurt consumption on colorectal cancer incidence and mortality. Methods During 32 years of follow-up in 83,054 women (mean age at baseline, 45.7 years) and 26 years of follow-up in 43,269 men (mean age at baseline, 52.3 years), we documented a total of 2666 newly diagnosed cases of colorectal cancer in these cohorts. We modeled yogurt consumption at baseline and cumulatively updated it throughout follow-up. Results: Baseline yogurt consumption was associated with a reduced risk of colon cancer in age-adjusted analyses (P for trend < 0.001). Associations remained statistically significant after adjusting for potential confounders, including calcium and fiber intake (P for trend = 0.03), and were restricted to proximal colon cancer. The consumption of 1 + servings per week of yogurt at baseline, compared to no yogurt consumption, was associated with a multivariable HR of 0.84 (95% CI, 0.70–0.99; P trend = 0.04) for the proximal colon cancer incidence. Latency analyses suggested that the most important window of opportunity for regular yogurt consumption to prevent colorectal cancer was 16–20 years in the past. When yogurt consumption was cumulatively updated, associations attenuated and were no longer significant. No statistically significant inverse trend was observed between yogurt consumption and the colorectal cancer mortality. Conclusions In these large cohorts, the frequency of yogurt consumption was associated with a reduced risk of proximal colon cancer with a long latency period. No significant inverse trend was observed for colorectal cancer mortality.

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Faculty Opinions recommendation of Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.6869957.7049056 ◽

2010 ◽

Author(s):

Mario Cottone

Keyword(s):

Colorectal Cancer ◽

Cancer Incidence ◽

Term Effect ◽

Randomised Trials ◽

Long Term Effect ◽

Incidence And Mortality ◽

Colorectal Cancer Incidence

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Estrogen and colorectal cancer incidence and mortality in the Women's Health Initiative clinical trial.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.3594 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 3594-3594

Author(s):

Sayeh Moazami Lavasani ◽

Rowan T. Chlebowski ◽

Ross L Prentice ◽

Ikuko Kato ◽

Jean Wactawski-Wende ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Waist Circumference ◽

Cancer Incidence ◽

Conjugated Equine Estrogen ◽

Health Initiative ◽

Increased Risk ◽

Incidence And Mortality ◽

Colorectal Cancer Incidence

3594 Background: The preponderance of observational studies associate estrogen alone use with lower colorectal cancer incidence. In contrast, no difference in colorectal cancer incidence was seen in the Women's Health Initiative (WHI) randomized, controlled trial (RCT) of estrogen versus placebo after 7.1 years mean intervention. We now assess the influence of estrogen alone use on longer-term colorectal cancer incidence and mortality after an additional 5.6 years post-intervention follow-up. Methods: The WHI study was a randomized, double-blind, placebo-controlled clinical trial involving 10,739 postmenopausal women who had undergone prior hysterectomy and who were randomly assigned to receive daily 0.625 conjugated equine estrogen (n = 5279) or matching placebo (n = 5409). Colorectal cancer diagnosis rates and mortality were assessed after a mean of 7.1 years (standard deviation [SD] 1.1) of intervention and 12.7 years follow-up. Results: Colorectal cancer incidence in the treatment and control groups were almost equivalent, 0.15% diagnoses/year v 0.13% in the estrogen therapy arm and the placebo group, respectively (Hazard ratio [HR], 1.12; 95% Confidence Interval [CI], 0.83-1.52; P = 0.46). Bowel screening examinations were comparable in both groups throughout. For women age 70-79 at study entry, hormone therapy was associated with an increased risk of colorectal cancer, HR 1.71; 95% CI, (1.02-2.86). For women age 50-59 and 60-69, the respective HR’s and 95% CI were 0.86 (0.43-1.71) and 0.98 (0.64-1.49), p-interaction 0.165. For women with a waist circumference of > 88 cm, there was an increased risk of colorectal cancer, HR 1.53; 95% CI, 0.95-2.45 compared to 0.95 (0.66-1.39) for waist circumference of < 88 cm, p-interaction 0.124. Although not statistically significant, there was a higher number of colorectal cancer deaths in the hormone therapy arm (33 v 24 deaths; 0.05% v 0.04%; HR, 1.42; 95% CI, 0.84-2.41; P = 0.19). Conclusions: There were no significant differences in colorectal cancer incidence or mortality after long-term follow-up in the WHI RCT of conjugated equine estrogen. There was a suggestion of an elevation in colorectal cancer risk among older women randomized to estrogen. Clinical trial information: NCT00000611.

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Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials

Yearbook of Gastroenterology ◽

10.1016/j.ygas.2011.07.134 ◽

2011 ◽

Vol 2011 ◽

pp. 123-125

Author(s):

R.K. Pearson

Keyword(s):

Colorectal Cancer ◽

Cancer Incidence ◽

Term Effect ◽

Randomised Trials ◽

Long Term Effect ◽

Incidence And Mortality ◽

Colorectal Cancer Incidence

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Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening

Trials ◽

10.1186/1745-6215-14-40 ◽

2013 ◽

Vol 14 (1) ◽

pp. 40 ◽

Cited By ~ 9

Author(s):

Arthur D Wong ◽

John Kirby ◽

Gordon H Guyatt ◽

Paul Moayyedi ◽

Parag Vora ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Randomized Controlled Trial ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Controlled Trial ◽

Randomized Controlled

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Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone for Liver-Only Metastatic Colorectal Cancer (JCOG0603): A Phase II or III Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.21.01032 ◽

2021 ◽

pp. JCO.21.01032

Author(s):

Yukihide Kanemitsu ◽

Yasuhiro Shimizu ◽

Junki Mizusawa ◽

Yoshitaka Inaba ◽

Tetsuya Hamaguchi ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Adjuvant Chemotherapy ◽

Metastatic Colorectal Cancer ◽

Phase Ii ◽

Controlled Trial ◽

Disease Free Survival ◽

Phase Iii ◽

Randomized Controlled

PURPOSE Adjuvant chemotherapy after hepatectomy is controversial in liver-only metastatic colorectal cancer (CRC). We conducted a randomized controlled trial to examine if adjuvant modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) is superior to hepatectomy alone for liver-only metastasis from CRC. PATIENTS AND METHODS In this phase II or III trial (JCOG0603), patients age 20-75 years with confirmed CRC and an unlimited number of liver metastatic lesions were randomly assigned to hepatectomy alone or 12 courses of adjuvant mFOLFOX6 after hepatectomy. The primary end point of phase III was disease-free survival (DFS) in intention-to-treat analysis. RESULTS Between March 2007 and January 2019, 300 patients were randomly assigned to hepatectomy alone (149 patients) or hepatectomy followed by chemotherapy (151 patients). At the third interim analysis of phase III with median follow-up of 53.6 months, the trial was terminated early according to the protocol because DFS was significantly longer in patients treated with hepatectomy followed by chemotherapy. With median follow-up of 59.2 months, the updated 5-year DFS was 38.7% (95% CI, 30.4 to 46.8) for hepatectomy alone compared with 49.8% (95% CI, 41.0 to 58.0) for chemotherapy (hazard ratio, 0.67; 95% CI, 0.50 to 0.92; one-sided P = .006). However, the updated 5-year overall survival (OS) was 83.1% (95% CI, 74.9 to 88.9) with hepatectomy alone and 71.2% (95% CI, 61.7 to 78.8) with hepatectomy followed by chemotherapy. In the chemotherapy arm, the most common grade 3 or higher severe adverse event was neutropenia (50% of patients), followed by sensory neuropathy (10%) and allergic reaction (4%). One patient died of unknown cause after three courses of mFOLFOX6 administration. CONCLUSION DFS did not correlate with OS for liver-only metastatic CRC. Adjuvant chemotherapy with mFOLFOX6 improves DFS among patients treated with hepatectomy for CRC liver metastasis. It remains unclear whether chemotherapy improves OS.

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