Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Pellegrino, Benedetta; Cavanna, Luigi; Boggiani, Daniela; Zamagni, Claudio; Frassoldati, Antonio; Schirone, Alessio; Caldara, A.; Rocca, Andrea; Gori, Stefania; Piacentini, Federico; Berardi, Rossana; Brandes, Alba A.; Foglietta, Jennifer; Villa, F.; Todeschini, Renata; Tognetto, Michele; Naldi, Nadia; Bortesi, Beatrice; Montemurro, Filippo; Ardizzoni, Andrea; Boni, Luca; Musolino, Antonino

doi:10.1016/j.esmoop.2020.100019

Cited by 14 publications

(15 citation statements)

References 35 publications

(23 reference statements)

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“…Research on other cancers has shown that HRR mutations in the same genes as in our cohorts, such as BRCA2 and POLD1 (Figure 2), can in uence response to immunotherapy. In patients with hereditary breast and ovarian cancer 39 , BRCA2 mutations may be associated with stronger response to immunotherapy in clinical trials 40,41 . Mutations in POLD1 or POLE have been linked to stronger response to ICI in endometrial and non-small cell lung cancers 42,43 .…”

Section: Discussionmentioning

confidence: 99%

Mutations in Homologous Recombination Repair Genes in Colorectal Cancer Are Associated With Favorable Response to Immune Checkpoint Inhibitors

Yang

Luo

et al. 2022

Preprint

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Background: A small proportion of patients with metastatic colorectal cancer (CRC) who might respond well to immune checkpoint inhibitors (ICIs) can be identified based on the biomarker of high microsatellite instability. Genes involved in homologous recombination repair (HRR) have been linked to response to such therapy. Methods: HRR mutations in CRC were explored by analyzing genomic data from patients in The Cancer Genome Atlas (TCGA) (n=377), from a Chinese cohort (n=6106) and from our hospital in China (n=50). The impact of HRR mutations on prognosis of CRC patients was explored in the cohort from TCGA. A cohort of patients treated with ICIs from Memorial Sloan Kettering Cancer Center (MSKCC) (n=110), and two patients from our hospital were studied to characterize the impact of the HRR mutation in prognosis of CRC treated with ICIs.Results: HRR genes were mutated in all the cohorts examined, with frequencies ranging from 22.44% in our hospital to 52.78% in TCGA. Frequencies of HRR mutations were 43.69-50.47% among patients showing microsatellite stability. HRR mutations were associated with higher tumor mutational burden and high microsatellite instability. HRR mutations correlated with higher neoantigen and increased CD8+ T cell infiltration in the cohort from TCGA. HRR mutations were associated with significantly better overall survival in patients treated with ICIs of MSKCC cohort, particularly among patients with microsatellite stability. Conclusion: HRR mutations may be associated with stronger response to ICIs in CRC patients with microsatellite-stable, and may be useful for identifying CRC patients likely to benefit from immunotherapy.

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Section: Discussionmentioning

confidence: 99%

Mutations in Homologous Recombination Repair Genes in Colorectal Cancer Are Associated With Favorable Response to Immune Checkpoint Inhibitors

Yang

Luo

et al. 2022

Preprint

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“…However, only 4% and 22% HRD can be attributed to germline BRCA1/2 mutations in BC and TNBC, respectively. [14][15][16] On this condition, biomarkers with wider coverage are needed to identify more patients with BC with HRD. The HRD score is an algorithmic assessment of three measures of loss of heterozygosity (LOH), large-scale transition (LST) and telomeric allelic imbalance (TAI).…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…Therefore, as key genes in the process of HR, BRCA1/2 are generally detected to determine the HRD status of patients with BC. However, only 4% and 22% HRD can be attributed to germline BRCA1/2 mutations in BC and TNBC, respectively 14–16. On this condition, biomarkers with wider coverage are needed to identify more patients with BC with HRD.…”

Section: Introductionmentioning

confidence: 99%

Impact of homologous recombination deficiency biomarkers on outcomes in patients with early breast cancer: a systematic review protocol

et al. 2022

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IntroductionPatients with breast cancer with homologous recombination deficiency (HRD) such as germline BRCA1/2 mutations would respond to DNA-damaging drugs. Several clinical studies have revealed that HRD biomarkers were associated with the outcomes of patients with early breast cancer (EBC). However, no systematic review has determined the prognostic role of HRD biomarkers in patients with EBC. Therefore, this study will systematically combine and analyse the results of previous studies, to facilitate the clinical use of HRD detection in EBC.Methods and analysisWe will search five databases including PubMed, Cochrane Library, EMBASE, OVID and Web of Science through December 2021, with no language restriction. Two reviewers will independently screen all records based on pre-established inclusion and exclusion criteria. The main outcomes include pathological complete response, disease-free survival and Ooerall survival. In addition, all studies included must contain the detection of HRD score, HRD status or HRD-related gene mutational status and protein expression. Data extraction will be carried out by two reviewers independently according to a self-designed template. The Newcastle-Ottawa Quality Assessment Scale and Jadad Scale will be used for quality assessment for cohort studies and randomised clinical trials, respectively. Review Manager V.5.3.5 will be used to perform meta-analysis. Both the Q test and I2 statistic will be used to assess heterogeneity. Subgroup and sensitivity analyses will be conducted if significant heterogeneity appears and cannot be reduced by using a random-effect model.Ethics and disseminationEthical approval is not required for a systematic review. The results will be disseminated through international and national conferences or peer-reviewed publications.PROSPERO registration numberCRD42021286522.

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“…Eribulin in combination with gemcitabine also demonstrated promising antitumor activity as first- or second-line therapy for mTNBC, with an ORR and PFS of 37.3% and 14.5 months, respectively. Moreover, the study also found that compared with BRCA pathogenic variants, BRCA wild-type patients had higher efficacy with an ORR of 41.5% versus 26.7% [ 35 ]. Compared with paclitaxel plus gemcitabine, eribulin plus gemcitabine chemotherapy had similar clinical benefits in terms of PFS, but had lower neurotoxicity [ 40 ].…”

Section: Novel Chemotherapy Agentsmentioning

confidence: 99%

Current Therapeutic Strategies for Metastatic Triple-Negative Breast Cancer: From Pharmacists’ Perspective

Bao

Huang

et al. 2022

JCM

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Triple-negative breast cancer (TNBC) is characterized by its high invasiveness, high metastasis and poor prognosis. More than one-third of patients with TNBC will present with recurrence or distant metastasis. Chemotherapy based on anthracyclines and taxanes is the standard treatment strategy for metastatic TNBC (mTNBC). Due to the lack of expression of progesterone receptor, estrogen receptor, and human epidermal growth factor receptor 2, therapies targeting these receptors are ineffective for mTNBC, thus special treatment strategies are required. In recent years, the development of new chemotherapy drugs, targeted drugs and immunotherapy drugs offers good prospects for the treatment of mTNBC. However, as these drugs are still in their infancy, several problems regarding the optimization and management of the clinical application of these new options should be considered. Pharmacists can play an important role in drug selection, drug therapy management, the management of adverse drug reactions and pharmacoeconomic evaluation. In this review, we summarized traditional treatment strategies, and discussed the efficacy and safety of novel agents approved in the last ten years and combination regimens for mTNBC, with the aim of providing management strategies for the clinical management of mTNBC from pharmacists’ perspective.

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Phase II study of eribulin in combination with gemcitabine for the treatment of patients with locally advanced or metastatic triple negative breast cancer (ERIGE trial). Clinical and pharmacogenetic results on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)

Cited by 14 publications

References 35 publications

Mutations in Homologous Recombination Repair Genes in Colorectal Cancer Are Associated With Favorable Response to Immune Checkpoint Inhibitors

Mutations in Homologous Recombination Repair Genes in Colorectal Cancer Are Associated With Favorable Response to Immune Checkpoint Inhibitors

Impact of homologous recombination deficiency biomarkers on outcomes in patients with early breast cancer: a systematic review protocol

Current Therapeutic Strategies for Metastatic Triple-Negative Breast Cancer: From Pharmacists’ Perspective

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