Real-World Data from a Refractory Triple-Negative Breast Cancer Cohort Selected Using a Clinical Data Warehouse Approach

Kim, Hana; Kim, Hyo Jung; Kim, Hong-Sik; Kim, Hye Ryeon; Jo, Hye-Jin; Hong, Joohyun; Kim, Ryul; Kim, Jiyeon; Ahn, Jin Seok; Im, Young‐Hyuck; Lee, Se Kyung; Kim, Haeyoung; Shin, Soo-Yong; Park, Yeon Hee

doi:10.3390/cancers13225835

Cited by 9 publications

(10 citation statements)

References 31 publications

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“…Some clinical trials briefly described refractory mTNBC when selecting the research subjects or enrollment criteria. Kim et al ( 5 ), in a retrospective analysis of the real-world data of TNBC patients (n=451), defined refractory mTNBC as TNBC with local or distant recurrence/metastasis within one year after adjuvant therapy. The refractory mTNBC cohort was composed of patients with disease that recurred after surgery and adjuvant therapy (n=207, 45.9%; DFI ≤12 months) and patients in whom the disease progressed to stage IV during neoadjuvant chemotherapy (NAC) (n=44, 9.6%).…”

Section: Discussionmentioning

confidence: 99%

“…Most Chinese and foreign guidelines have not clearly defined refractory mTNBC, and only a few studies or reviews have briefly described refractory mTNBC ( 5 , 11 , 18 , 19 ). In addition, most clinical trials excluded patients with refractory mTNBC, leading to lower concerns about these patients, for whom timely identification of the disease in its early stage and precise treatments are particularly important.…”

Section: Discussionmentioning

confidence: 99%

“…At the 2021 San Antonio Breast Cancer Symposium ® (SABCS ® ) meeting, Rugo proposed the concept of stratified treatment for TNBC with a DFI of ≤12 months. As an independent prognostic factor, DFI ≤12 months has increasingly been investigated, and it was found in up to 20–45.9% of TNBC patients ( 5 , 6 , 13 , 28 ). Although DFI ≤12 months is an independent factor for poor prognosis in mTNBC patients, only one clinical study on TNBC patients with DFI ≤12 months is currently underway (Impassion132, NCT03371017) ( 29 ).…”

Section: Discussionmentioning

confidence: 99%

“…Due to the lack of definite and effective therapeutic targets, TNBC progresses rapidly and can easily become drug resistant. Relapsed and metastatic TNBC (mTNBC) has a poor prognosis, with a 5-year survival rate of less than 15% ( 4 ) and a median overall survival (OS) of only 9–17 months ( 5 ). The goals of treatment for patients with mTNBC are to prolong survival, relieve symptoms, and improve the quality of life.…”

Section: Introductionmentioning

confidence: 99%

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The pathological and clinical landscape of refractory metastatic triple negative breast cancer: a narrative review

Jiang¹,

Huang²,

Yin³

et al. 2022

Ann Transl Med

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Background and Objective Triple negative breast cancer (TNBC) refers to a special subtype of breast cancer that is negative for the estrogen receptor, the progesterone receptors, and human epidermal growth factor receptor 2. As a group of diseases, it has strong heterogeneity. Refractory metastatic triple negative breast cancer (mTNBC) has even greater heterogeneity, more susceptibility to drug resistance, and faster progression, which makes it more difficult to treat effectively and significantly reduces a patient’s overall survival. Therefore, in order to overcome this difficulty in clinical practice, we need to deeply understand the special subgroup by analyzing definition and prognostic factors of refractory mTNBC and describing the therapeutic status and future treatment directions. Methods Recent domestic and foreign guidelines, as well as clinical studies related to refractory mTNBC on PubMed and the China National Knowledge Infrastructure (CNKI) databases were retrospectively analyzed. The six keywords we selected were used for literature search. Two authors performed database searches independently, and disagreements over the results were mediated by a third reviewer. Key Content and Findings According to the guidelines, refractory mTNBC has not been clearly defined. Related studies indicated that tumor heterogeneity may be one of the main mechanisms of early relapse or drug resistance in refractory mTNBC. The clinical treatment options for refractory mTNBC are very limited. Although chemotherapy is the standard treatment, it is limited by poor efficacy and intolerance in the clinical stage. Therefore, in recent years, many studies have explored novel treatment options. Both immunotherapy and poly(ADP-ribose) polymerase (PARP) inhibitors have been selected as first-line treatment in clinical studies, but gained limited benefits. Indeed, clinical studies have shown good efficacy with novel ADCs, which may be promising in the clinical treatment of refractory mTNBC. Conclusions Currently, improving the survival time and quality of life of refractory mTNBC are major challenges for clinicians. Novel therapies including immunosuppressive agents, PARP inhibitors, and ADCs rather than chemotherapy alone have achieved good results in the exploration of first-line treatment for refractory TNBC patients, but this warrants further research and investigation.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

The pathological and clinical landscape of refractory metastatic triple negative breast cancer: a narrative review

Jiang¹,

Huang²,

Yin³

et al. 2022

Ann Transl Med

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“…However, pragmatic screening methods to determine whether the content of a data source is sufficient to answer the research questions before conducting research with RWD have not yet been established. Accurate but oversimplified instructions could lead to confusion among clinical researchers who seek to select the optimal RWD source for their hypothesis and research purpose [16][17][18][19]. In detail, specifying the research question and determining the appropriate level for understanding massive and complex RWD is still challenging for clinical researchers.…”

Section: Introductionmentioning

confidence: 99%

Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study

Kim¹,

Park²,

Kim³

et al. 2023

J Med Internet Res

Self Cite

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Background In recent decades, real-world evidence (RWE) in oncology has rapidly gained traction for its potential to answer clinical questions that cannot be directly addressed by randomized clinical trials. Integrating real-world data (RWD) into clinical research promises to contribute to more sustainable research designs, including extension, augmentation, enrichment, and pragmatic designs. Nevertheless, clinical research using RWD is still limited because of concerns regarding the shortage of best practices for extracting, harmonizing, and analyzing RWD. In particular, pragmatic screening methods to determine whether the content of a data source is sufficient to answer the research questions before conducting the research with RWD have not yet been established. Objective We examined the PAR (Preliminary Attainability Assessment of Real-World Data) framework and assessed its utility in breast cancer brain metastasis (BCBM), which has an unmet medical need for data attainability screening at the preliminary step of observational studies that use RWD. Methods The PAR framework was proposed to assess data attainability from a particular data source during the early research process. The PAR framework has four sequential stages, starting with clinical question clarification: (1) operational definition of variables, (2) data matching (structural/semantic), (3) data screening and extraction, and (4) data attainability diagramming. We identified 5 clinical questions to be used for PAR framework evaluation through interviews and validated them with a survey of breast cancer experts. We used the Samsung Medical Center Breast Cancer Registry, a hospital-based real-time registry implemented in March 2021, leveraging the institution’s anonymized and deidentified clinical data warehouse platform. The number of breast cancer patients in the registry was 45,129; it covered the period from June 1995 to December 2021. The registry consists of 24 base data marts that represent disease-specific breast cancer characteristics and care pathways. The outcomes included screening results of the clinical questions via the PAR framework and a procedural diagram of data attainability for each research question. Results Data attainability was tested for study feasibility according to the PAR framework with 5 clinical questions for BCBM. We obtained data sets that were sufficient to conduct studies with 4 of 5 clinical questions. The research questions stratified into 3 types when we developed data fields for clearly defined research variables. In the first, only 1 question could be answered using direct data variables. In the second, the other 3 questions required surrogate definitions that combined data variables. In the third, the question turned out to be not feasible for conducting further analysis. Conclusions The adoption of the PAR framework was associated with more efficient preliminary clinical research using RWD from BCBM. Furthermore, this framework helped accelerate RWE generation through clinical research by enhancing transparency and reproducibility and lowering the entry barrier for clinical researchers.

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Four Birds with One Stone: A Multifunctional Polypeptide Nanocomposite to Unify Ferroptosis, Nitric Oxide, and Photothermia for Amplifying Antitumor Immunity

Meng

Song

Wang

et al. 2023

Adv Funct Materials

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Tumor metastasis and relapse mainly results in therapy failure and becomes a big challenge in oncology. Immunogenic cell death (ICD) of tumors mediated immunotherapy (IT) is attracting widely for solving that problem although achieving sufficient ICD and strong immune response is challenging for nanoparticles‐based cancer IT. Herein, a multifunctional polypeptide coordinate nanocomposite that possesses near infrared photothermia (PT) and responsive releases of nitric oxide (NO) and iron ions is constructed, which synergistically kills cancer cells and highly prohibits metastatic 4T1 cells invasion and migration by PT‐boosted NO release and ferroptosis (FT). Remarkably, triple FT‐NO‐PT treatment amplifies the ICD effects and outperforms combo/monotherapy FT‐PT and FT in cancer cells and tumors, which further activates dendritic cells maturation, and primed CD4+T and CD8+T cells immune responses and memory effects, playing four birds with one stone (i.e., FT‐NO‐PT‐IT). The PCSFG‐based FT‐NO‐PT not only fully eradicates 4T1 primary tumors, but also induces strong ICD, immune priming, and memory effects to reject rechallenged 4T1 tumors and inhibit malignant tumor metastasis, demonstrating synergistic amplified ICD effects with strong cell immunities and memory effects by a unified FT‐NO‐PT‐IT.

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Real-World Data from a Refractory Triple-Negative Breast Cancer Cohort Selected Using a Clinical Data Warehouse Approach

Cited by 9 publications

References 31 publications

The pathological and clinical landscape of refractory metastatic triple negative breast cancer: a narrative review

The pathological and clinical landscape of refractory metastatic triple negative breast cancer: a narrative review

Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study

Four Birds with One Stone: A Multifunctional Polypeptide Nanocomposite to Unify Ferroptosis, Nitric Oxide, and Photothermia for Amplifying Antitumor Immunity

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