Introduction: Among 48,835 postmenopausal women randomized in the Women's Health Initiative Dietary Modification (WHI DM) primary prevention trial, 1,767 women were diagnosed with breast cancer during the 8.3 years of dietary intervention. While differences were not statistically significant, there were fewer breast cancers diagnosed in the low fat dietary group women (HR 0.92 95% CI 0.84-1.01, P=0.09) with somewhat lower breast cancer mortality (HR 0.77 95% CI 0.48-1.22) than seen in control group women (JAMA 2006; 295:629). These findings were recently updated, and after 10.9 years (mean) post-diagnosis follow-up, breast cancer overall survival among these 1,767 women measured from diagnosis was greater in the dietary group (10 year survival, 82% vs 78%, 168 (2.24%) versus 319 (2.71%) deaths; HR 0.80 95% CI 0.66-0.97, P=0.02) (AACR Annual Meeting 2016, abstract CT0433, Clinical Trials Plenary Session). We now report low-fat dietary pattern influence on breast cancer overall survival in subgroups defined by breast cancer characteristics. Methods: The WHI DM trial, conducted at 40 US clinical centers, from1993-1998 enrolled 48,835 postmenopausal women, aged 50-79, without prior breast cancer, with normal mammogram and dietary fat intake >32% of total energy. Participants were randomly assigned to a dietary intervention group (40%, n=19,541) with goals of fat intake reduction to 20% of energy and increased fruits, vegetables and grain intake, or a usual diet control group (60%, n=29,294). As previously reported, the dietary modification program reduced fat intake, increased fruit, vegetable and grain intake and was associated with modest weight loss (all P< 0.001). The current secondary analysis outcome is breast cancer overall survival in subgroups defined by breast cancer characteristics for cases diagnosed during the dietary intervention period. Because of possible selection prior to breast cancer diagnosis, these analyses do not compare randomized outcomes. Therefore, careful attention is paid to control of risk factors for breast cancer in the analysis. Results: The examined subgroups included histology (ductal, lobular, other), estrogen receptor (ER) status (positive vs. negative by local laboratory), progesterone receptor (PR) status, HER2 status, triple negative (yes/no), stage (local, regional or distant), grade (well, moderately, poorly differentiated), tumor size (<1, 1- 2, >=2 cm), and nodal involvement (none, 1-3, 4+). None of the tests of interaction in subgroups were statistically significant. All subgroup hazard ratios (HR) were less than one except for ER negative cancers, triple negative cancers and those with 4+ positive lymph nodes. The results are suggestive of no influence of the low-fat dietary pattern on triple negative cancers (HR 1.64 95% CI 0.73-3.70 for triple negative vs. HR 0.73 95% CI 0.56-0.95 for other breast cancers, interaction P=0.06). Conclusion: Compared to a usual diet control group, women randomized to a dietary intervention group providing a low-fat dietary pattern had a significantly increased overall survival following a breast cancer diagnosis with the possible exception of those developing triple negative cancers. Citation Format: Chlebowski RT, Aragaki AK, Thomson CA, Anderson G, Manson JE, Simon MS, Rohan TE, Snetselar LG, Lane D, Barrington WE, Vitolins M, Womack C, Qi L, Hou L, Thomas F, Prentice RL. Low-fat dietary pattern and breast cancer overall survival in the women's health initiative dietary modification randomized controlled trial [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr S5-04.

No abstract

1.25-1.37], 47.2% vs. 62.0% covered time) over 5 years. Fecal testing was responsible for almost all additional covered time. Compared to intervention participants, UC individuals were more likely never to have completed any CRC testing over 5 years (17.4% vs. 10.3%, net difference 7.2%, P < 0.001) Conclusions: An organized mail and phone program led to increased CRC screening adherence over 5 years, mainly because of regular fecal testing uptake.

Objective: Tamoxifen (TAM) lowers breast cancer recurrence by 40-50% with evidence of individual variability in responsiveness. A ≥10% decrease in mammography-determined breast density (BD) after 12–18 months of TAM use has been associated with clinical benefit. Early determination of changes in BD may offer a strategy to tailor hormone therapy in non-responders; for responders, it may encourage adherence. Fat-water decomposition MRI (FWD-MRI) is an accurate and fast (&lt; 5 minutes) method for measuring BD without ionizing radiation or contrast agent. Here, we examined whether change in FWD-MRI-derived BD predicts decrease in BD at earlier time points than observable with a 12-month measure of BD. Methods: The study population included a subset of 44 pre- and post-menopausal women receiving TAM for treatment of early-stage breast cancer or prevention who were enrolled in a randomized, placebo-controlled trial of diindolylmethane. Eligibility for this analysis included participants with FWD-MRI scans at baseline, 6 and 12 months. Median time on TAM at baseline was 13 months (IQR, 5–26 months). All MRI images were acquired on a 1.5T GE Signa NV-CV/i scanner. Automated breast segmentation was performed using MATLAB software and validated against manual ROI drawings. MRI-based BD was calculated as the ratio of breast voxels with &lt;80% apparent fat fraction (Fra80) over the entire breast, a measure previously shown by our group to be highly correlated with mammography-derived BD. For 40 participants, the unaffected, contralateral breast was analyzed. For 4 patients with two unaffected breasts, BD data from the left breast were analyzed. Change in BD was conservatively defined as &gt; 2 times the test-retest variability of Fra80 (0.032). McNemar's test was used to test the association between change from baseline to 6 months and change from baseline to 12 months. Results and Discussion: At 12 months, 15 (34%) participants had a decrease in BD, whereas 29 (66%) remained unchanged or increased. Of these 29, 28 also had no decrease at 6 months (specificity = 97%), and 9 of the 15 women who showed a decrease at 12 months had a decrease at 6 months (sensitivity = 60%; McNemar's test, P = 0.06). Conversely, for those women with a measured decrease in BD from baseline to 6 months, 9 of 10 had a measured decrease at 12 months. A study limitation is inclusion of participants on TAM for varying duration as the greatest change in BD likely would have occurred earlier. Ongoing efforts will focus on FWD-MRI for measures of change in BD in patients initiating TAM. Conclusion: Use of the specified cut point would fail to detect a decrease in BD at 12 months in 40% of women. However, a decrease in BD from baseline to 6 months was highly associated with decrease from baseline to 12 months and in some women may be useful as an early biomarker of effect. Ongoing effort is needed to determine the impact of factors such as baseline BD, menopausal status, and time on TAM in misclassification of BD change using the 6-month measure. Acknowledgement: NIH grants CA149417, CA161534.Objective: Tamoxifen (TAM) lowers breast cancer recurrence by 40-50% with evidence of individual variability in responsiveness. A ≥10% decrease in mammography-determined breast density (BD) after 12–18 months of TAM use has been associated with clinical benefit. Early determination of changes in BD may offer a strategy to tailor hormone therapy in non-responders; for responders, it may encourage adherence. Fat-water decomposition MRI (FWD-MRI) is an accurate and fast (&lt; 5 minutes) method for measuring BD without ionizing radiation or contrast agent. Here, we examined whether change in FWD-MRI-derived BD predicts decrease in BD at earlier time points than observable with a 12-month measure of BD. Methods: The study population included a subset of 44 pre- and post-menopausal women receiving TAM for treatment of early-stage breast cancer or prevention who were enrolled in a randomized, placebo-controlled trial of diindolylmethane. Eligibility for this analysis included participants with FWD-MRI scans at baseline, 6 and 12 months. Median time on TAM at baseline was 13 months (IQR, 5–26 months). All MRI images were acquired on a 1.5T GE Signa NV-CV/i scanner. Automated breast segmentation was performed using MATLAB software and validated against manual ROI drawings. MRI-based BD was calculated as the ratio of breast voxels with &lt;80% apparent fat fraction (Fra80) over the entire breast, a measure previously shown by our group to be highly correlated with mammography-derived BD. For 40 participants, the unaffected, contralateral breast was analyzed. For 4 patients with two unaffected breasts, BD data from the left breast were analyzed. Change in BD was conservatively defined as &gt; 2 times the test-retest variability of Fra80 (0.032). McNemar's test was used to test the association between change from baseline to 6 months and change from baseline to 12 months. Results and Discussion: At 12 months, 15 (34%) participants had a decrease in BD, whereas 29 (66%) remained unchanged or increased. Of these 29, 28 also had no decrease at 6 months (specificity = 97%), and 9 of the 15 women who showed a decrease at 12 months had a decrease at 6 months (sensitivity = 60%; McNemar's test, P = 0.06). Conversely, for those women with a measured decrease in BD from baseline to 6 months, 9 of 10 had a measured decrease at 12 months. A study limitation is inclusion of participants on TAM for varying duration as the greatest change in BD likely would have occurred earlier. Ongoing efforts will focus on FWD-MRI for measures of change in BD in patients initiating TAM. Conclusion: Use of the specified cut point would fail to detect a decrease in BD at 12 months in 40% of women. However, a decrease in BD from baseline to 6 months was highly associated with decrease from baseline to 12 months and in some women may be useful as an early biomarker of effect. Ongoing effort is needed to determine the impact of factors such as baseline BD, menopausal status, and time on TAM in misclassification of BD change using the 6-month measure. Acknowledgement: NIH grants CA149417, CA161534. Citation Format: Ding J, Thompson PA, Wertheim BC, Roe DJ, Marron MT, Altbach MI, Galons J-P, Wang F, Thomson CA, Huang C, Stopeck A. Breast density change at 6 months is associated with change at 12 months as measured by fat-water decomposition MRI in women on tamoxifen [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-09-19.

No abstract