The Ideal 7-Step Breast Cancer Diet, Lifestyle, and Dietary Supplements Program for Prevention/Recurrence: Heart Healthy = Breast Healthy!

2016 ◽  
pp. 69-140
Author(s):  
Mark A. Moyad
Keyword(s):  
Breast Cancer ◽  
Dietary Supplements ◽  
Cancer Diet ◽  
The Ideal

Difference between duration of treatment (DOT) and progression-free survival (PFS) as a marker of unbalanced censoring.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 2548-2548
Author(s):  
Laleh Amiri-Kordestani ◽  
Julia Wilkerson ◽  
Sanjeeve Balasubramaniam ◽  
Susan Elaine Bates ◽  
Antonio Tito Fojo
Keyword(s):  
Breast Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Duration Of Treatment ◽  
Free Survival ◽  
Time To Treatment Failure ◽  
Clinical Trial Results ◽  
And Control ◽  
Phase Iii Studies ◽  
The Ideal

2548 Background: In the conduct of randomized trials Kaplan and Meier envisioned rates of censoring as similar between arms, providing accurate assessment of clinical trial results. Censoring is used when patients withdraw consent, leave study due to toxicity, or reach data cut-off without disease progression or death. Censoring can lead to erroneous conclusions as it can be either beneficial or detrimental to the arm under study. Such censoring can also explain how a statistically valid difference in PFS “disappears” when overall survival (OS) is examined. We hypothesized that censoring, especially that due to toxicity, would lead to a discrepancy between DOT and PFS since two different patient populations would be scored. Methods: We reviewed all phase III randomized studies of drugs approved by FDA since 2005 for pts with metastatic solid tumors, looking for DOT and PFS. We used standard statistical analyses using SAS. Results: We identified 55 Phase III studies conducted with abiraterone, axitinib, bevacizumab, cabazitaxel, cetuximab, eribulin, erlotinib, everolimus, ipilimumab, ixabepilone, lapatinib, panitumumab, pazopanib, sorafenib, sunitinib, temsirolimus and vandetinib. DOT was not provided in 27%. Forty-four comparisons (88 arms) were included in the analysis. The median PFS, DOT, delta PFS (difference in PFS between experimental and control arms) and delta DOT were: 161, 126, 51 and 36 days, respectively. The slopes of PFS vs DOT and delta PFS vs delta DOT were 1.16 and 1.03, respectively close to the ideal of 1.0. Five trials fell above the 90% CI boundary with delta PFS/delta DOT of 3 to 36, including two everolimus studies (PNET and breast cancer) two sunitinb studies (RCC and PNET) and one bevacizumab study (E2100, breast cancer). Conclusions: PFS and DOT as well as delta PFS and delta DOT should be concordant. The most likely explanation for a discordance between these values is toxicity-driven censoring and its occurrence raises concerns regarding the degree of efficacy. A greater utilization of “Time to Treatment Failure”, an endpoint that includes toxicity in its definition would be valuable in oncology trials, particularly those with high levels of toxicities.

Complementary and alternative medicine use and hormonal therapy initiation in women with hormone receptor-positive breast cancer: The BQUAL study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e13097-e13097
Author(s):  
Heather Greenlee ◽  
Alfred I. Neugut ◽  
Zaixing Shi ◽  
Grace Hillyer ◽  
Donna Buono ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Alternative Medicine ◽  
Cancer Treatment ◽  
Complementary And Alternative Medicine ◽  
Dietary Supplements ◽  
Hormonal Therapy ◽  
Hormone Receptor ◽  
Hormone Receptor Positive ◽  
Therapy Initiation ◽  
Cam Use

e13097 Background: Use of complementary and alternative medicine (CAM) has been associated with initiation of breast cancer chemotherapy.We examined the association of CAM use with initiation of hormonal therapy in women with hormone receptor-positive (HR+) breast cancer. Methods: In aprospective cohort study designed to examine predictors of breast cancer treatment initiation and adherence, 699 women with non-metastatic stage I-III breast cancer and aged < 70 years were recruited from Kaiser Permanente Northern California during 2006-2010. Baseline interviews assessed current use of five CAM modalities (dietary supplements: vitamins/minerals, herbs/botanicals, other natural products; mind/body therapies: mind-body self-practice, mind-body practitioner-based). Based on electronic pharmacy records, hormonal therapy initiation was defined as ≥2 prescriptions of ≥30 pills of any hormonal therapy drug within 1 year after diagnosis. Multivariable logistic regression analysis examined a priori hypotheses testing whether current CAM use was associated with hormonal therapy initiation, adjusted for demographic, tumor characteristics, and cancer treatment. Results: Of the 699 participants,552 were diagnosed with HR+ breast cancer. Among the 552 women with HR+ breast cancer, 494 (89%) used at least 1 modality of CAM, 414 (76%) used dietary supplements, and 391 (71%) used mind/body therapies. Within 1 year after diagnosis, 481 (87%) participants initiated hormonal therapy. The rate of initiation was comparable between CAM users and non-users (87% vs. 86%). In multivariable analyses, baseline overall CAM use was not associated with initiation of hormonal therapy. However, vitamins/minerals users were more likely to initiate hormonal therapy compared to non-users (OR = 1.87, 95% CI: 1.04, 3.51). Conclusions: CAM use was high among early stage HR+ breast cancer patients. Overall, use of CAM was not associated with hormonal therapy initiation. Current use of vitamins/minerals was associated with higher initiation rate of hormonal chemotherapy.

scholarly journals Dietary Supplement Use and Interactions with Tamoxifen and Aromatase Inhibitors in Breast Cancer Survivors Enrolled in Lifestyle Interventions

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3730
Author(s):  
Maura Harrigan ◽  
Courtney McGowan ◽  
Annette Hood ◽  
Leah M. Ferrucci ◽  
ThaiHien Nguyen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Cancer Survivors ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Breast Cancer Survivors ◽  
Lifestyle Interventions ◽  
Supplement Use ◽  
Dietary Supplement Use ◽  
Potential Interactions

The use of dietary supplements is common in the general population and even more prevalent among cancer survivors. The World Cancer Research Fund/American Institute for Cancer Research specifies that dietary supplements should not be used for cancer prevention. Several dietary supplements have potential pharmacokinetic and pharmacodynamic interactions that may change their clinical efficacy or potentiate adverse effects of the adjuvant endocrine therapy prescribed for breast cancer treatment. This analysis examined the prevalence of self-reported dietary supplement use and the potential interactions with tamoxifen and aromatase inhibitors (AIs) among breast cancer survivors enrolled in three randomized controlled trials of lifestyle interventions conducted between 2010 and 2017. The potential interactions with tamoxifen and AIs were identified using the Natural Medicine Database. Among 475 breast cancer survivors (2.9 (mean) or 2.5 (standard deviation) years from diagnosis), 393 (83%) reported using dietary supplements. A total of 108 different types of dietary supplements were reported and 36 potential adverse interactions with tamoxifen or AIs were identified. Among the 353 women taking tamoxifen or AIs, 38% were taking dietary supplements with a potential risk of interactions. We observed a high prevalence of dietary supplement use among breast cancer survivors and the potential for adverse interactions between the prescribed endocrine therapy and dietary supplements was common.

scholarly journals Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221)

2020 ◽  
Vol 38 (8) ◽  
pp. 804-814 ◽  
Author(s):  
Christine B. Ambrosone ◽  
Gary R. Zirpoli ◽  
Alan D. Hutson ◽  
William E. McCann ◽  
Susan E. McCann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Dietary Supplements ◽  
Proportional Hazards ◽  
Disease Free Survival ◽  
Cox Proportional Hazards ◽  
Survival Outcomes ◽  
Therapeutic Trial ◽  
Supplement Use ◽  
Antioxidant Supplement

PURPOSE Despite reported widespread use of dietary supplements during cancer treatment, few empirical data with regard to their safety or efficacy exist. Because of concerns that some supplements, particularly antioxidants, could reduce the cytotoxicity of chemotherapy, we conducted a prospective study ancillary to a therapeutic trial to evaluate associations between supplement use and breast cancer outcomes. METHODS Patients with breast cancer randomly assigned to an intergroup metronomic trial of cyclophosphamide, doxorubicin, and paclitaxel were queried on their use of supplements at registration and during treatment (n =1,134). Cox proportional hazards regression adjusting for clinical and lifestyle variables was used. Recurrence and survival were indexed at 6 months after enrollment using a landmark approach. RESULTS There were indications that use of any antioxidant supplement (vitamins A, C, and E; carotenoids; coenzyme Q10) both before and during treatment was associated with an increased hazard of recurrence (adjusted hazard ratio [adjHR], 1.41; 95% CI, 0.98 to 2.04; P = .06) and, to a lesser extent, death (adjHR, 1.40; 95% CI, 0.90 to 2.18; P = .14). Relationships with individual antioxidants were weaker perhaps because of small numbers. For nonantioxidants, vitamin B12 use both before and during chemotherapy was significantly associated with poorer disease-free survival (adjHR, 1.83; 95% CI, 1.15 to 2.92; P < .01) and overall survival (adjHR, 2.04; 95% CI, 1.22 to 3.40; P < .01). Use of iron during chemotherapy was significantly associated with recurrence (adjHR, 1.79; 95% CI, 1.20 to 2.67; P < .01) as was use both before and during treatment (adjHR, 1.91; 95% CI, 0.98 to 3.70; P = .06). Results were similar for overall survival. Multivitamin use was not associated with survival outcomes. CONCLUSION Associations between survival outcomes and use of antioxidant and other dietary supplements both before and during chemotherapy are consistent with recommendations for caution among patients when considering the use of supplements, other than a multivitamin, during chemotherapy.

Breast Cancer Index and prediction of benefit from extended endocrine therapy based on treatment compliance: An IDEAL study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 531-531
Author(s):  
Gerrit-Jan Liefers ◽  
Iris Noordhoek ◽  
Kai Treuner ◽  
Hein Putter ◽  
Jenna Wong ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Treatment Compliance ◽  
Significant Benefit ◽  
Endocrine Treatment ◽  
Breast Cancer Patients ◽  
Absolute Benefit ◽  
Breast Cancer Index ◽  
Extended Endocrine Therapy ◽  
The Ideal

531 Background: The IDEAL trial randomized hormone receptor-positive (HR+) breast cancer patients to 5 vs 2.5y of extended letrozole after completion of 5y of adjuvant endocrine therapy. In the parent trial, approximately 60% of patients overall were compliant with endocrine treatment (59% vs 74% compliance in 5y and 2.5y arms, respectively), with patient experiences as the most significant factors leading to treatment discontinuation. Breast Cancer Index is a gene expression-based signature that predicts which HR+ patients are likely to benefit from extended endocrine therapy (EET) vs those unlikely to benefit [BCI (H/I)-High and -Low, respectively]. The current study examined EET compliance and outcome by BCI (H/I) status in patients treated in the IDEAL trial. Methods: Patients with available primary tumor specimens were eligible for this blinded study. Primary endpoint was recurrence-free interval (RFI), including locoregional and distant recurrences. Kaplan-Meier and Cox proportional hazards regression analysis were used to analyze the benefit of EET. Non-compliance was defined as completion of ≤60% of treatment duration (≤3y for 5y arm; ≤1.5y for 2.5y arm) for any reason other than disease events. Overtreatment was defined as % compliant BCI (H/I)-Low patients in the 5y arm; undertreatment was % noncompliant BCI (H/I)-High patients in the 5y arm. Results: 908 HR+ patients (73% pN+, 59y, 45% pT1, 48% pT2) were included. 78% (n = 708) of patients were compliant, of which 48% (n = 338) were BCI (H/I)-High and 52% (n = 370) were BCI (H/I)-Low. In non-compliant patients (22%, n = 200), 45% (n = 91) were BCI (H/I)-High and 55% (n = 109) were BCI (H/I)-Low. BCI (H/I)-Low patients irrespective of compliance status did not derive significant benefit from EET (P = 0.922, compliant subset; 0.894 non-compliant subset). Compliant BCI (H/I)-High patients showed significant benefit from EET (HR 0.35, 95% CI 0.16-0.79; absolute benefit 11.7%; P = 0.008) whereas non-compliant BCI (H/I)-High patients did not (HR 0.75, 95% CI 0.17-3.35; absolute benefit 2.1%, P = 0.704). In this study, 38% of patients in the 5y EET arm were BCI (H/I)-Low and compliant and thus were overtreated, while 13% of patients in the 5y EET arm were BCI (H/I)-High and non-compliant and thus were undertreated. Conclusions: Patients that were BCI (H/I)-Low did not derive significant benefit from 5 vs 2.5y of EET even when compliant, and thus may be considered for treatment de-escalation. Importantly, BCI (H/I)-High patients with endocrine responsive disease showed significant improvements in outcome when compliant and should be guided to continue treatment. BCI may serve as an important genomic tool to increase EET compliance and identify patients that may be candidates for increased side effect management and support to potentially improve outcomes. Clinical trial information: NTR3077; BOOG 2006-05; Eudra-CT 2006-003958-16.

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