Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

Krohe, Meaghan; Hao, Yanbin; Lamoureux, Roger; Galipeau, N.; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

doi:10.4137/bcbcr.s39385

Cited by 21 publications

(25 citation statements)

References 8 publications

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“…Metastatic breast cancer, also known as stage IV, exhibits a higher rate of mortality than stage I disease, where the cancer is localized and has not spread to other areas of the body. In the United States between 2005 and 2011, while 98.6% of stage I patients achieved a 5‐year survival rate; only 25.9% of stage IV patients reached the same …”

Section: Breast Cancer Backgroundmentioning

confidence: 99%

The aryl hydrocarbon receptor (AhR) as a breast cancer drug target

Baker

Sakoff

McCluskey

2019

Medicinal Research Reviews

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Breast cancer is the most common cancer in women, with more than 1.7 million diagnoses worldwide per annum. Metastatic breast cancer remains incurable, and the presence of triplenegative phenotypes makes targeted treatment impossible. The aryl hydrocarbon receptor (AhR), most commonly associated with the metabolism of xenobiotic ligands, has emerged as a promising biological target for the treatment of this deadly disease. Ligands for the AhR can be classed as exogenous or endogenous and may have agonistic or antagonistic activity. It has been well reported that agonistic ligands may have potent and selective growth inhibition activity in a number of oncogenic cell lines, and one (aminoflavone) has progressed to phase I clinical trials for breast cancer sufferers. In this study, we examine the current state of the literature in this area and elucidate the promising advances that are being made in hijacking the cytosolic-to-nuclear pathway of the AhR for the possible future treatment of breast cancer. K E Y W O R D S aryl hydrocarbon receptor, breast cancer, cancer drugs Abbreviations: 3MC, 3-methylcholanthrene; AF, aminoflavone; AF-1, activation function domain 1; AF-2, activation function domain 2; AhR, aryl hydrocarbon receptor; AhRR, aryl hydrocarbon receptor repressor; AIP, aryl hydrocarbon receptor-interacting protein; ANI-7, (Z)-2-(3,4-dichlorophenyl)-3-(1H-pyrrol-2-yl)acrylonitrile; ARNT, aryl hydrocarbon receptor nuclear translocator; BaP, benzo[a]pyrene; BE, botanical estrogen; bHLH, basic helixloop-helix; βNF, β-naphthoflavone; BRCA1, breast cancer susceptibility gene 1; BRCA2, breast cancer susceptibility gene 2; DNF, dinaphtho[1,2-b;1′2'-d] furan; ER, estrogen receptor; FDA, US Food and Drug Administration; FICZ, 6-formylindolo[3,2-b]carbazole; HAHs, halogenated aromatic hydrocarbons; HER-2, human epidermal growth factor receptor 2; HR, hormone receptor; Hsp90, heat shock protein 90; ITE, 2-(1′H-indole-3′-carbonyl)-thiazole-4carboxylic acid ester; LBD, ligand-binding domain; NLS, nuclear localization sequences; NSAID, nonsteroidal anti-inflammatory drug; p23, prostaglandin E synthase 3; PAHs, polycyclic aromatic hydrocarbons; PAS, period-aryl hydrocarbon receptor nuclear translocator-single minded; PAS-A, period-aryl hydrocarbon receptor nuclear translocator-single minded domain A; PAS-B, period-aryl hydrocarbon receptor nuclear translocator-single minded domain B; PCB, 3,3′,4,4′,5-pentachlorobiphenyl; PPI, proton pump inhibitor; PR, progesterone receptor; PR-A, progesterone receptor form A; PR-B, progesterone receptor form B; PR-C, progesterone receptor form C; ROS, reductive oxidative species; SERMs, selective estrogen receptor modulators; SULT1A1, sulfotransferase 1A1; TAD, transactivation domain; TCDD, 2,3,7,8-tetrachlorodibenzo-p-dioxin; TCDF, 2,3,7,8-tetrachlorodibenzofuran; TNBC, triplenegative breast cancer; Tregs, regulatory T cells; XAP-2, hepatitis B virus X-associated protein 2; XRE, xenobiotic response element. | BREAST CANCER BACKGROUNDBreast cancer is the most common cancer in women. Of...

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Section: Breast Cancer Backgroundmentioning

confidence: 99%

The aryl hydrocarbon receptor (AhR) as a breast cancer drug target

Baker

Sakoff

McCluskey

2019

Medicinal Research Reviews

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“…Of these 13 drugs, two were approved by the EMA with PRO evaluation mentioned in their label for the treatment of MDS: azacitidine and lenalidomide. In these studies, PROs were used as secondary endpoints to assess HRQOL and the iden- [35][36][37] Our study found that PRO claims were included in the EMA- EuroQol five dimensions-three levels (EQ-5D-3L) Our study provides an initial overview of the PROM landscape in AML and MDS, which was missing in the current literature.…”

Section: Proms Included In Labels Of Approved Drugs For the Treatmementioning

confidence: 93%

Patient‐reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis

Stauder

Lambert

Desruol‐Allardin

et al. 2020

European J of Haematology

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This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. AbstractObjectives: This study aims to describe the use of patient-reported outcome measures (PROMs) in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) studies and the PROMs landscape. Methods:A comprehensive literature review was performed in Medline/Embase (since 2000) and ClinicalTrials.gov (since 2013) to identify PROMs used in MDS and AML clinical studies. Additionally, PROMs included in approved drug labels since 2000 were reviewed. Results: Overall, 112 different PROMs were used in 168 published MDS studies and 152 PROMs were used in 172 AML studies. From ClinicalTrials.gov, 16 different PROMs were used in 22 ongoing registered studies in MDS, and 24 were reported in 41 AML studies. The most frequently used PROMs were cancer-specific (eg, EORTC QLQ-C30, FACT-An) or generic (SF-36, EQ-5D) instruments, whereas MDS-and AML-specific instruments (eg, QUALMS and QOL-E in MDS; FACT-Leu and EORTC QLQ-Leu in AML) were used in a minority of studies. Two EMA-approved drugs for MDS included PROMs in their label. EORTC QLQ-C30 is by far the most frequently used cancer-specific PROM in both MDS and AML studies. Conclusions: This research indicated an underuse of AML/MDS-specific PROMs for these two indications in clinical studies and labeling claims. However, AML/MDSspecific instruments in development might be considered in future studies. K E Y W O R D S acute myeloid leukemia, myelodysplastic syndromes, quality of life | 477 STAUDER ET Al.

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“…Fatigue and reduced quality of life are frequent in patients with metastatic breast cancer related to the site of metastasis and cancer treatment [ 5 , 6 ]. Evidence from meta-analyses and systematic reviews in patients with localized breast cancer has demonstrated the benefits of physical activity on multiple health outcomes [ 7 - 12 ].…”

Section: Introductionmentioning

confidence: 99%

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial

Delrieu¹,

Pérol²,

Fervers³

et al. 2018

JMIR Res Protoc

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BackgroundAbout 5% of breast cancer cases are metastatic at diagnosis, and 20%-30% of localized breast cancer cases become secondarily metastatic. Patients frequently report many detrimental symptoms related to metastasis and treatments. The physical, biological, psychological, and clinical benefits of physical activity during treatment in patients with localized breast cancer have been demonstrated; however, limited literature exists regarding physical activity and physical activity behavior change in patients with metastatic breast cancer.ObjectiveThe primary objective of this study is to assess the feasibility of a 6-month physical activity intervention with activity trackers in patients with metastatic breast cancer (the Advanced stage Breast cancer and Lifestyle Exercise, ABLE Trial). Secondary objectives are to examine the effects of physical activity on physical, psychological, anthropometrics, clinical, and biological parameters.MethodsWe plan to conduct a single-center, single-arm trial with 60 patients who are newly diagnosed with metastatic breast cancer. Patients will receive an unsupervised and personalized 6-month physical activity program that includes an activity tracker Nokia Go and is based on the physical activity recommendation. Patients will be encouraged to accumulate at least 150 minutes per week of moderate-to-vigorous intensity physical activity. Baseline and 6-month assessments will include anthropometric measures, functional tests (eg, 6-minute walk test and upper and lower limb strength), blood draws, patient-reported surveys (eg, quality of life and fatigue), and clinical markers of tumor progression (eg, Response Evaluation Criteria In Solid Tumors criteria).ResultsData collection occurred between October 2016 and January 2018, and the results are expected in August 2018.ConclusionsThe ABLE Trial will be the first study to assess the feasibility and effectiveness of an unsupervised and personalized physical activity intervention performed under real-life conditions with activity trackers in patients with metastatic breast cancer.Trial RegistrationClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 (Accessed by WebCite at http://www.webcitation.org/71yabi0la)Registered Report IdentifierRR1-10.2196/10487

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Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

Cited by 21 publications

References 8 publications

The aryl hydrocarbon receptor (AhR) as a breast cancer drug target

The aryl hydrocarbon receptor (AhR) as a breast cancer drug target

Patient‐reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis

A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial

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