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PURPOSE: Minocycline suppresses chemotherapy-induced neuroinflammation in preclinical models, but its effects in cancer survivors are unknown. This study evaluated the longitudinal effects of minocycline on affective behaviors, cognitive functions, and inflammation in women with breast cancer (BC) undergoing chemotherapy. METHODS: This is a pilot, double-blind, randomized controlled trial of oral minocycline (100 mg BID) versus placebo for chemotherapy-induced affective disorders in women initiating chemotherapy for stage I-III BC. Participants received minocycline or placebo up to one week before chemotherapy, continuing through cycle 4 (C4). Epidemiologic Studies Depression Scale (CES-D) and State-Trait Anxiety Inventory (STAI) were assessed at baseline, each cycle of chemotherapy (C1-C4), 2-3-week post-chemotherapy (end of chemotherapy), and 6-month post-chemotherapy (6 M) as the primary outcomes. Sub-group analysis of CES-D and STAI based on the severity of symptoms was also performed. Changes in self-reported cognition and serum inflammatory markers were also evaluated. RESULTS: Fifty-seven women enrolled and 55 completed the study. Except for Interleukin-8 (p ≤ 0.03), changes in inflammatory markers, cognitive function, CES-D, and STAI were not significantly different between groups from baseline to any cycle or post-chemotherapy time point (all p > 0.05), adjusting for baseline scores. Increases in serum Interleukin-8 from baseline to C4 and 6 M were ameliorated by minocycline (p < 0.05). The sub-group symptomatic for depression (CES-D > = 16 at baseline) treated with minocycline had a greater reduction in CES-D score compared to placebo from baseline to 6 M (p = 0.01). CONCLUSION: Despite attenuation of IL-8, minocycline did not alter self-reported affective symptoms or cognition in this cohort of BC survivors undergoing chemotherapy. The effect of minocycline on BC survivors symptomatic for depression before chemotherapy warrants further investigation.
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Introduction: Dance has been proposed to support superior intrinsic motivation over non-dance forms of therapeutic physical activity. However, this hypothesis has yet to be evaluated empirically, particularly among populations living with neuropathology such as survivors of cancer with neurologic complications from chemotherapy treatment. Questions about motivation are relevant to clinical outcomes because motivation mediates neuroplasticity. We conducted this secondary analysis of a randomized-controlled study to begin to investigate the relationships between personal motivation and neurophysiologic effects of dance-based intervention for healthy aging among populations with neurologic complications of cancer. Methods: We measured motivation using the Intrinsic Motivation Inventory, a validated patient-reported outcome from the psychological approach of Self Determination Theory. We assessed intrinsic motivation, extrinsic motivation, and satisfaction with intervention within a randomized controlled trial of dance versus exercise designed to alleviate symptoms of chemotherapy-induced impairment. Fifty-two survivors of breast cancer with chemotherapy-induced neuropathy diagnosis and associated sensorimotor functional deficits were randomized (1:1) to 8 weeks of partnered dance or home exercise, performed biweekly (NCT05114005; R21-AG068831). Results: While satisfaction did not differ between interventions, intrinsic motivation was higher among participants randomized to dance than those randomized to exercise (p < 0.0001 at all timepoints: 2 weeks, 4 weeks, 6 weeks, and 8 weeks of intervention), as was extrinsic motivation at 2 weeks (p = 0.04) and 8 weeks (p = 0.01). Discussion: These data provide evidence that social dance is more motivating than the type of home exercise generally recommended as therapeutic physical activity. The results inform directions for future study of the effect of dance-based therapeutics on embodied agency, neuroplastic changes, and clinically-relevant neuropathic improvement.
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(1) Background: A significant proportion of cancer survivors report experiencing a cognitive 'fog' that affects their ability to think coherently and quickly, and reason with clarity. This has been referred to as cancer-related cognitive impairment (CRCI). CRCI has extensive impacts on the daily lives of people living with or beyond cancer, including occupational, social, and psychological functioning. Oncology health professionals report feeling under-resourced to effectively assess the needs of an individual with CRCI and then provide optimal care and referral. (2) Methods: The objective of this project is to develop and provide an initial validation of the first purpose-built unmet needs assessment for CRCI: the Unmet Needs Assessment of Cancer-Related Cognitive Impairment Impact (COG-IMPACT). We will use a multiple-stage, co-design, mixed-methods approach to develop and provide an initial validation of the COG-IMPACT. (3) Results: The primary anticipated result of this research is the production of the COG-IMPACT, the first purpose-built unmet needs assessment for CRCI. The assessment could be used by health professionals to understand the unmet needs and facilitate optimal care and referral for cancer survivors, by survivors to elucidate their supportive needs and advocate for their care, and by researchers to examine the correlates of unmet needs relating to CRCI, as well as how best to support people with CRCI.
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There is limited data regarding the added benefit of adjuvant systemic therapy in the management of small, node-negative, HER2+ breast cancer. In a multi-institutional retrospective analysis using the American Society of Clinical Oncology CancerLinQ database, we compared survival outcomes among T1a-c N0 HER2+ patients diagnosed between 2010 to 2021 who received locoregional therapy alone or in combination with adjuvant trastuzumab (+/- chemotherapy). Primary outcomes were invasive disease-free survival (iDFS) and overall survival (OS). Of the 1,184 patients, 436 received locoregional therapy alone. We found a statistically significant improvement in iDFS (HR 0.73, P = 0.003) and OS (HR 0.63, P = 0.023) on univariate analysis with adjuvant trastuzumab with or without chemotherapy which remained statistically significant on multivariate analysis. Three-arm univariate analysis found that iDFS was significantly improved with trastuzumab monotherapy (P = 0.003) and combination therapy (P = 0.027) compared to observation. Subgroup data suggests that T1b/c tumors derive the greatest benefit.
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BACKGROUND: The optimal adjuvant endocrine therapy (ET) in hormone receptor positive (HR+) and human epidermal growth factor receptor 2 positive (HER2+) premenopausal breast cancer (BC) remains unclear. Moreover, the benefit and clinical indications of ovarian suppression (OS) is poorly elucidated. We described real-world patterns surrounding choice of ET and clinicopathologic features which predicted treatment with OS in a contemporary cohort of premenopausal women with HR+/HER2+ BC. METHODS: This retrospective analysis included premenopausal patients with nonmetastatic HR+/HER2+ BC from the CancerLinQ Discovery database from January 2010 to May 2020. Women were less than 50 years and received chemotherapy, anti-HER2 therapy, and ET. They were categorized into 1 of 4 groups based on type of ET prescribed at initiation: aromatase inhibitor (AI) + OS, OS, tamoxifen + OS, or tamoxifen. Multivariable logistic regression assessed associations between clinicopathologic features and OS use. RESULTS: Out of 360,540 patients with BC, 937 were included. The majority (n = 818, 87%) were prescribed tamoxifen, whereas 4 (0.4%), 50 (5.3%), and 65 (6.9%) received OS, tamoxifen + OS and AI + OS, respectively. No clinicopathologic features predicted OS use apart from age; patients <35 years were more likely to receive OS compared with those ≥35 years (odds ratio 2.33, p < 0.001). CONCLUSIONS: This is the first real-world study evaluating ET treatment patterns in HR+/HER2+ premenopausal BC. OS use was uncommon and the majority received tamoxifen as the preferred ET regardless of most clinicopathologic risk factors. Additional research is needed to optimize ET decisions in young women with this distinct BC subtype.
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Antineoplastic Agents, Hormonal , Aromatase Inhibitors , Breast Neoplasms , Premenopause , Receptor, ErbB-2 , Receptors, Estrogen , Tamoxifen , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Breast Neoplasms/metabolism , Breast Neoplasms/mortality , Adult , Retrospective Studies , Receptor, ErbB-2/metabolism , Chemotherapy, Adjuvant/methods , Antineoplastic Agents, Hormonal/therapeutic use , Tamoxifen/therapeutic use , Aromatase Inhibitors/therapeutic use , Middle Aged , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Ovary/drug effects , Ovary/pathology , Ovary/metabolismABSTRACT
PURPOSE: Recognizing that receiving healthcare can be time intensive and burdensome, time toxicity has been conceptualized as the time spent by patients seeking healthcare. This study investigates the association between age at diagnosis and time toxicity for patients with Metastatic Breast Cancer (MBC) and identifies major components of care that confer the greatest time toxicity. METHODS: We conducted a retrospective cohort study among patients with MBC aged 67 or older using the SEER-Medicare database. We assessed time toxicity using the number of encounter days patients interacted with the healthcare system per 100 days, within the first year of starting cancer treatment. We used a Poisson model to analyze the association between age and encounter days, adjusting for clinical and sociodemographic factors. We stratified the mean encounter days for each age cohort by treatment types. FINDINGS: The final sample included 2949 patients; 51.4% were between 70 and 79 years old, and 81.3% were white. Although unadjusted analysis showed an association between older age and more encounter days (Rate Ratio (RR) 1.12; 95% CI 1.02, 1.22), there was no significant association after adjusting for comorbidities and treatment type. Patients with more than three comorbidities had significantly higher encounter days compared to those without comorbidities [RR 1.36 (95% CI 1.26, 1.46)]. Receipt of radiotherapy [RR: 1.45 95% CI (1.37, 1.54)] was associated with more encounter days compared to not receiving radiotherapy, while receipt of bone-modifying agents was associated with fewer encounter days compared to not using Bone modifying agents [RR 0.75 (95% CI 0.70, 0.79)]. CONCLUSION: Our study identified comorbidities and cancer treatment modality, including radiotherapy, as the factors affecting time toxicity in older patients with MBC. Assessment of an individual's comorbid medical conditions and types of treatment planned are crucial to understanding age-related impacts on encounter days and to support shared decision making in older patients.
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Though it is widely acknowledged that cancer treatments cause hair loss on the scalp, there are limited data on how they affect eyebrow and eyelash hairs. Patients with eyebrow and eyelash loss, or madarosis, seek various treatment options ranging from camouflage techniques with makeup, permanent tattoos, and prescription medications. Though not yet studied in patients with cancer-induced madarosis, techniques such as scalp cooling, cryotherapy, and topical vasoconstrictors are promising preventative options. More robust research is needed to improve both the quality and quantity of available treatment and preventative options. There is a clear need for dermatologists to play a role in supportive oncodermatology for patients who experience eyebrow and eyelash loss secondary to chemotherapy, endocrine therapies, and radiation therapy. J Drugs Dermatol. 2024;23(5):327-331. doi:10.36849/JDD.8003.
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Alopecia , Eyebrows , Eyelashes , Humans , Alopecia/etiology , Alopecia/therapy , Alopecia/diagnosis , Neoplasms/therapy , Neoplasms/complications , Antineoplastic Agents/adverse effects , Antineoplastic Agents/administration & dosage , Cryotherapy/methodsABSTRACT
OBJECTIVES: CpG ODN is a Toll-like receptor 9 agonist with immunotherapeutic potential for many cancer types, including aggressive breast cancers. There is strong interest in utilizing CpG ODN as an adjuvant to improve clinical efficacy of current treatments and immunogenicity of breast cancers not traditionally responsive to active immunotherapy, such as those that are human epidermal growth factor receptor 2 (HER2)-positive. This study aimed to study the efficacy and safety of combination CpG ODN plus anti-HER2 antibody trastuzumab treatment in patients with advanced/metastatic breast cancer. METHODS: This single-arm, open-label phase II clinical trial treated patients (n = 6) with advanced/metastatic HER2-positive breast cancer with weekly subcutaneous CpG ODN and trastuzumab. Patients may have received any number of prior therapies to be enrolled (most enrolled at median 1 prior line of chemotherapy). Peripheral blood was collected at baseline and weeks 2, 6, 12, and 18 for immune analyses. Six patients were enrolled and 50% achieved stable disease (SD) response. RESULTS: Median PFS was 8.3 months. Three of the six patients enrolled opted to stop treatment due to tolerability issues. Multiplex assay for cytokine measurements revealed significantly higher VEGF-D levels at week 2 compared to baseline. Peripheral blood mononuclear cells analyzed by flow cytometry showed a significant increase in monocytic MDSC between weeks 6 and 12. Patients with progressive disease tended to have higher levels of week 6 monocytic MDSC and PD-1+ T cells than patients with SD. NK cell populations did not significantly change throughout treatment. CONCLUSIONS: CpG ODN and trastuzumab treatment of metastatic HER2 + breast cancer was safe but was not tolerable for all patients. This combination did induce potentially predictive immune profile changes in treated patients with metastatic HER2 + breast cancer, the significance of which needs to be further explored.
Why was the study done? Breast cancer that has metastasized (moved outside of the breast and local lymph nodes) is currently considered incurable and can be difficult to treat. Treatments that can stimulate the immune system to recognize cancer cells have been found to be useful for many types of cancers, including some types of breast cancers. This study tested a new immune stimulator (CpG ODN) in combination with a currently on-the-market antibody treatment for breast cancer (trastuzumab). What did the researchers do? The research team enrolled patients who had metastatic breast cancer and treated them all with a combination of trastuzumab and CpG ODN for 12 weeks. These patients were monitored for any side effects/toxicity, monitored for how long their breast cancer responded to this treatment, and monitored for how long they lived after beginning this treatment. Patients also had their blood drawn at different time points to observe how their immune cells and immune proteins (e.g. cytokines) changed on treatment. What did the researchers find? The research team enrolled six patients and found that the treatment was safe and that 50% of the patients treated did not have any breast cancer growth when given CpG ODN plus trastuzumab. Looking at the immune cells in the patient blood samples, some cells that are known to decrease the immune response to cancers (myeloid-derived suppressor cells) did increase towards the end of treatment. What do the findings mean? Overall, CpG ODN and trastuzumab treatment was found to be safe and potentially effective in preventing breast cancer growth.
Subject(s)
Breast Neoplasms , Oligodeoxyribonucleotides , Receptor, ErbB-2 , Trastuzumab , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Oligodeoxyribonucleotides/administration & dosage , Oligodeoxyribonucleotides/therapeutic use , Trastuzumab/therapeutic use , Trastuzumab/administration & dosage , Receptor, ErbB-2/metabolism , Middle Aged , Adult , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , AgedABSTRACT
PURPOSE: People with advanced or metastatic cancer and their caregivers may have different care goals and face unique challenges compared with those with early-stage disease or those nearing the end of life. These Multinational Association for Supportive Care in Cancer (MASCC)-ASCO standards and practice recommendations seek to establish consistent provision of quality survivorship care for people affected by advanced or metastatic cancer. METHODS: A MASCC-ASCO expert panel was formed. Standards and recommendations relevant to the provision of quality survivorship care for people affected by advanced or metastatic cancer were developed through conducting (1) a systematic review of unmet supportive care needs; (2) a scoping review of cancer survivorship, supportive care, and palliative care frameworks and guidelines; and (3) an international modified Delphi consensus process. RESULTS: A systematic review involving 81 studies and a scoping review of 17 guidelines and frameworks informed the initial standards and recommendations. Subsequently, 77 experts (including eight people with lived experience) across 33 countries (33% were low- to middle-resource countries) participated in the Delphi study and achieved ≥94.8% agreement for seven standards, (1) Person-Centered Care; (2) Coordinated and Integrated Care; (3) Evidence-Based and Comprehensive Care; (4) Evaluated and Communicated Care; (5) Accessible and Equitable Care; (6) Sustainable and Resourced Care; and (7) Research and Data-Driven Care, and ≥84.2% agreement across 45 practice recommendations. CONCLUSION: Standards of survivorship care for people affected by advanced or metastatic cancer are provided. These MASCC-ASCO standards support optimization of health outcomes and care experiences by providing guidance to stakeholders (health care professionals, leaders, and administrators; governments and health ministries; policymakers; advocacy agencies; cancer survivors and caregivers). Practice recommendations may be used to facilitate future research, practice, policy, and advocacy efforts.Additional information is available at www.mascc.org, www.asco.org/standards and www.asco.org/survivorship-guidelines.
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PURPOSE: People with advanced or metastatic cancer and their caregivers may have different care goals and face unique challenges compared to those with early-stage disease or those nearing the end-of-life. These MASCC-ASCO standards and practice recommendations seek to establish consistent provision of quality survivorship care for people affected by advanced or metastatic cancer. METHODS: An expert panel comprising MASCC and ASCO members was formed. Standards and recommendations relevant to the provision of quality survivorship care for people affected by advanced or metastatic cancer were developed through conducting: (1) a systematic review of unmet supportive care needs; (2) a scoping review of cancer survivorship, supportive care, and palliative care frameworks and guidelines; and (3) an international modified Delphi consensus process. RESULTS: A systematic review involving 81 studies and a scoping review of 17 guidelines and frameworks informed the initial standards and recommendations. Subsequently, 77 experts (including 8 people with lived experience) across 33 countries (33% were low-to-middle resource countries) participated in the Delphi study and achieved ≥ 94.8% agreement for seven standards (1. Person-Centred Care; 2. Coordinated and Integrated Care; 3. Evidence-Based and Comprehensive Care; 4. Evaluated and Communicated Care; 5. Accessible and Equitable Care; 6. Sustainable and Resourced Care; 7. Research and Data-Driven Care) and ≥ 84.2% agreement across 45 practice recommendations. CONCLUSION: Standards of survivorship care for people affected by advanced or metastatic cancer are provided. These MASCC-ASCO standards will support optimization of health outcomes and care experiences by providing guidance to stakeholders in cancer care (healthcare professionals, leaders, and administrators; governments and health ministries; policymakers; advocacy agencies; cancer survivors and caregivers. Practice recommendations may be used to facilitate future research, practice, policy, and advocacy efforts.
Subject(s)
Cancer Survivors , Neoplasms , Palliative Care , Survivorship , Humans , Delphi Technique , Neoplasm Metastasis , Neoplasms/therapy , Palliative Care/standards , Palliative Care/methods , Patient-Centered Care/standards , Patient-Centered Care/organization & administration , Practice Guidelines as Topic , Quality of Health Care/standardsABSTRACT
The frontline immuno-chemotherapy regimen for HIV-associated non-Hodgkin Lymphoma is dose-adjusted EPOCH ± R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab). Chemotherapy-induced peripheral neuropathy (CIPN), caused by vincristine, is a common adverse effect of EPOCH ± R, negatively impacting long-term patient outcomes. The primary objective of this study was to determine the incidence of CIPN, stratified by HIV status, in patients treated with EPOCH ± R. A retrospective cohort study at a tertiary referral comprehensive cancer center evaluated patients treated with EPOCH ± R from 2011 to 2018. The final sample included 27 patients with HIV compared to 279 without HIV (total n = 306). Overall, the incidence of CIPN was 29.4% (n = 90), including 5 with HIV (18.5%) and 85 without HIV (30.5%). Propensity scores were used to match patients by HIV status. Although no relationship was found between HIV status and neuropathy, CIPN affects too many undergoing treatments for lymphoma, supporting future investigations to minimize toxicities.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Cyclophosphamide , Doxorubicin , Etoposide , HIV Infections , Lymphoma, Non-Hodgkin , Peripheral Nervous System Diseases , Prednisone , Rituximab , Vincristine , Humans , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/epidemiology , Peripheral Nervous System Diseases/diagnosis , Male , Female , Retrospective Studies , Middle Aged , Cyclophosphamide/adverse effects , Cyclophosphamide/therapeutic use , Lymphoma, Non-Hodgkin/drug therapy , Lymphoma, Non-Hodgkin/epidemiology , Lymphoma, Non-Hodgkin/complications , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Vincristine/adverse effects , Vincristine/therapeutic use , Rituximab/adverse effects , Rituximab/administration & dosage , Doxorubicin/adverse effects , Doxorubicin/therapeutic use , Prednisone/adverse effects , Prednisone/therapeutic use , HIV Infections/drug therapy , HIV Infections/complications , Etoposide/adverse effects , Etoposide/administration & dosage , Etoposide/therapeutic use , Adult , Aged , IncidenceABSTRACT
A call to action to bring stakeholders together to plan for the future of LLM-enhanced cancer survivorship.
Subject(s)
Cancer Survivors , Neoplasms , Humans , Neoplasms/therapy , Neoplasms/mortality , Neoplasms/psychology , SurvivorshipABSTRACT
PURPOSE: Although patients with metastatic breast cancer (MBC) have been living longer with the advent of more effective treatments such as targeted therapy and immunotherapy, the disease remains incurable, and most patients will undergo therapy indefinitely. When beginning therapy, patients are typically prescribed dose often based upon the maximum tolerated dose identified in phase I clinical trials. However, patients' perspectives about tolerability and willingness to discuss individualized dosing of drugs upon initiation of a new regimen and throughout the course of treatment have not been comprehensively evaluated. METHODS: Patient advocates and medical oncologists from the Patient-Centered Dosing Initiative (PCDI) developed a survey to ascertain the prevalence and severity of MBC patients' treatment-related side effects, the level of patient-physician communication, mitigation strategies, perception about the relative efficacy of higher versus lower doses, and willingness to discuss alternative dosing. The PCDI distributed the anonymous confidential online survey in August 2020 to individuals with self-reported MBC. RESULTS: One thousand and two hundred twenty-one patients with MBC completed the survey. 86.1% (n = 1,051) reported experiencing at least one significant treatment-related side effect, and of these, 20.3% (n = 213) visited the emergency room/hospital and 43.2% (n = 454) missed at least one treatment. Nearly all patients with side effects (97.6%, n = 1,026) informed their doctor and 81.7% (n = 838) received assistance. Of the 556 patients given a dose reduction for side-effect mitigation, 82.6% (n = 459) reported relief. Notably, majority of patients (53.3%, n = 651) do not believe that higher dose is always more effective than lower dose, and 92.3% (n = 1,127) would be willing to discuss flexible dosing options with their physicians based upon personal characteristics to optimize quality of life. CONCLUSION: Given that the majority of patients with MBC experienced at least one substantial treatment-related side effect and most patients given a dose reduction reported improvement, innovative dosage-related strategies are warranted to sustain and improve patients' well-being. Patient-physician discussions in which the patient's unique attributes and circumstances are assessed upon initiation of new treatment and throughout the course of therapy may facilitate the identification of the most favorable dose for each patient, and the majority of patients would be receptive to this approach.
Subject(s)
Breast Neoplasms , Quality of Life , Humans , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Female , Middle Aged , Surveys and Questionnaires , Aged , Adult , Patient Advocacy , Neoplasm Metastasis , Drug-Related Side Effects and Adverse Reactions , Aged, 80 and overABSTRACT
PURPOSE: Aromatase inhibitor (AI) therapy reduces risk of recurrence and death for postmenopausal women with breast cancer (BC); however, AI-induced arthralgia (AIIA) can lead to discontinuation of treatment. Curcumin, a bioactive polyphenolic substance, may help ameliorate inflammation-related conditions including osteoarthritis and pain. METHODS: We conducted a multisite randomized placebo-controlled, double-blind pilot trial (Alliance A22_Pilot9) to evaluate the effects of nanoemulsion curcumin (NEC, 200 mg/day) in postmenopausal women experiencing AIIA for ≥ 3 months. The primary objective was to determine the feasibility of using Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) to detect changes from 0 (T0) to 3 months (T3) of NEC treatment in AI-induced symptoms and well-being; secondary objectives included evaluation of changes in Disabilities of the Shoulder, Arm, and Hand (DASH), Brief Pain Inventory-short form (BPI-SF), grip strength, and biomarkers at T0 and T3. RESULTS: Forty-two patients were randomized to NEC or placebo; 34 women completed the 3-month study. Patient-reported outcome measures (PROMs: FACT-ES, DASH, BPI-SF) and biospecimens were collected at T0-T3 in > 80% of participants. Adherence was ≥ 90% for both arms. PROMs and grip strength did not differ significantly by treatment arm. Plasma curcumin was detected only in NEC arm participants. Serum estradiol and estrone levels were below detection or low on study agent. Gastrointestinal adverse effects were commonly reported in both arms. CONCLUSION: NEC versus placebo in a multisite randomized trial is feasible and well-tolerated. Additional studies with larger sample size are needed to further evaluate the efficacy and safety of NEC in treatment of AIIA. CLINICALTRIALS: gov Identifier: NCT03865992, first posted March 7, 2019.
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Aromatase Inhibitors , Breast Neoplasms , Curcumin , Humans , Female , Curcumin/therapeutic use , Curcumin/administration & dosage , Aromatase Inhibitors/adverse effects , Aromatase Inhibitors/administration & dosage , Pilot Projects , Middle Aged , Aged , Breast Neoplasms/drug therapy , Double-Blind Method , Emulsions , Treatment Outcome , Postmenopause , Arthralgia/chemically induced , Arthralgia/drug therapyABSTRACT
PURPOSE: Ketogenic diets may positively influence cancer through pleiotropic mechanisms, but only a few small and short-term studies have addressed feasibility and efficacy in cancer patients. The primary goals of this study were to evaluate the feasibility and the sustained metabolic effects of a personalized well-formulated ketogenic diet (WFKD) designed to achieve consistent blood beta-hydroxybutyrate (ßHB) >0.5 mM in women diagnosed with stage IV metastatic breast cancer (MBC) undergoing chemotherapy. METHODS: Women (n = 20) were enrolled in a six month, two-phase, single-arm WFKD intervention (NCT03535701). Phase I was a highly-supervised, ad libitum, personalized WFKD, where women were provided with ketogenic-appropriate food daily for three months. Phase II transitioned women to a self-administered WFKD with ongoing coaching for an additional three months. Fasting capillary ßHB and glucose were collected daily; weight, body composition, plasma insulin, and insulin resistance were collected at baseline, three and six months. RESULTS: Capillary ßHB indicated women achieved nutritional ketosis (Phase I mean: 0.8 mM (n = 15); Phase II mean: 0.7 mM (n = 9)). Body weight decreased 10% after three months, primarily from body fat. Fasting plasma glucose, plasma insulin, and insulin resistance also decreased significantly after three months (p < 0.01), an effect that persisted at six months. CONCLUSIONS: Women diagnosed with MBC undergoing chemotherapy can safely achieve and maintain nutritional ketosis, while improving body composition and insulin resistance, out to six months.
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Breast Neoplasms , Diet, Ketogenic , Insulin Resistance , Insulins , Ketosis , Humans , Female , Breast Neoplasms/drug therapy , Feasibility Studies , 3-Hydroxybutyric AcidABSTRACT
PURPOSE: The American College of Surgeons Standard 4.8 requires an institution to implement a survivorship program to become a Commission on Cancer (CoC)-accredited cancer center. The online information offered by these cancer centers can help educate patients and their caregivers about available services. We assessed the content of survivorship program websites of CoC-accredited cancer centers in the United States. METHODS: Of the 1245 CoC-accredited centers for adults, we sampled 325 institutions (26%) based proportionately on the 2019 new cancer cases by state. Website pages of the institutions' survivorship programs were assessed for information and services offered using the COC Standard 4.8. We included programs for adult survivors of adult- and childhood-onset cancers. RESULTS: 54.5% of the cancer centers did not have a survivorship program website. Of the 189 included programs, most were aimed at adult survivors in general, rather than those with specific cancer types. On average, five essential CoC-recommended services were described, most commonly nutrition, care plans, and psychology services. The least mentioned services were genetic counseling, fertility, and smoking cessation. Most programs described services offered to patients who had completed treatment, while 7.4% of described services for those with metastatic disease. CONCLUSION: More than half of CoC-accredited programs did have information about cancer survivorship programs on their websites and when included, had variable and limited description of services. IMPLICATIONS FOR CANCER SURVIVORS: Our study provides an overview of online cancer survivorship services and offers a methodology that may be used by cancer centers to review, expand, and improve the information described on their websites.
Subject(s)
Cancer Survivors , Neoplasms , Adult , Humans , Health Services Accessibility , Neoplasms/therapy , Neoplasms/psychology , Survivors , Survivorship , United StatesABSTRACT
PURPOSE: Approximately 5% of breast cancers each year are diagnosed in young women < 40 years who tend to have worse clinical outcomes. We compared genomic alterations using comprehensive genomic profiling (CGP) of tumor tissue among very young women (< 30 years) and young women (30-39 years) compared to women ≥ 40 years at diagnosis. METHODS: 2049 advanced breast cancer cases were submitted to Foundation Medicine within a 22-month window for CGP. Hybrid-capture based CGP was performed to evaluate all classes of genomic alterations. Tumor mutational burden was determined on at least 0.8 Mbp of sequenced DNA and microsatellite instability was determined on at least 95 loci. Immunocyte PD-L1 expression was determined by immunohistochemistry. RESULTS: Of the total cases, 28 (1.37%) were < 30 years, 159 (7.76%) were 30-39 years, and 1862 (90.87%) were ≥ 40 at time of diagnosis. Breast tumors were less likely to be estrogen receptor positive in younger women (54% of < 30 years, p > 0.05; 60% of 30-39 years, p < 0.001; 69.4% of ≥ 40 years) and more likely to be triple negative (43%, p = 0.05; 33%, p = 0.05; 26.1% respectively). Young women had higher rates of BRCA1 mutations (17.9% <30 years, p < 0.001; 10.1% 30-39 years, p < 0.001; 2.6% ≥40 years), but lower rates of CDH1 (7.1% <30 years, p > 0.05; 5.0% 30-39 years, p < 0.001; 15.4% ≥40 years) and PIK3CA mutations (17.9% <30 years, p = 0.02; 17.6% 30-39 years, p < 0.001; 40.0% ≥40 years). CONCLUSION: Our findings contribute to the growing literature demonstrating unique genetic profiles among young women diagnosed with breast cancer, compared to older women.