Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial

Prat, Aleix; Saura, Cristina; Pascual, Tomás; Hernándo, Cristina; Muñoz, Montserrat; Paré, Laia; Farré, Blanca González; Fernández, Pedro; Galván, Patricia; Chic, Núria; Farré, Xavier; Oliveira, Mafalda; Gil-Gil, Miguel; Arumí, Miriam; Ferrer, Neus; Montaño, Álvaro; Izarzugaza, Yann; Llombart-Cussac, Antonio; Bratos, Raquel; Santiago, Santiago González; Martínez, E.; Hoyos, Sergio; Rojas, Beatriz; Virizuela, Juan Antonio; Ortega, Vanesa; López, Rafael; Céliz, P.; Ciruelos, Eva; Villagrasa, Patricia; Gavilá, Joaquín

doi:10.1016/s1470-2045(19)30786-7

Cited by 117 publications

(116 citation statements)

References 31 publications

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“…This study also observed an increase in gene expression associated with immune activation at 2 weeks, but only a modest increase in radiological response rates [ 89 ]. The CORALLEEN trial was a randomized phase II trial of 106 patients investigating ribociclib plus letrozole vs. chemotherapy in post-menopausal women with hormone receptor-positive breast cancer of the luminal B subtype [ 90 ]. At the end of the 6 months of the CORALLEEN trial the rate of patients achieving a PEPI of 0 was 17.3% with chemotherapy and 22.4% with ribociclib and letrozole [ 90 ].…”

Section: Resultsmentioning

confidence: 99%

Neoadjuvant endocrine therapy in locally advanced estrogen or progesterone receptor-positive breast cancer: determining the optimal endocrine agent and treatment duration in postmenopausal women—a literature review and proposed guidelines

2020

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Introduction For patients with locally advanced estrogen receptor or progesterone receptor-positive breast cancer, neoadjuvant endocrine therapy (NET) facilitates down-staging of the tumor and increased rates of breast-conserving surgery. However, NET remains under-utilized, and there are very limited clinical guidelines governing which therapeutic agent to use, or the optimal duration of treatment in postmenopausal women. This literature review aims to discuss the evidence surrounding (1) biomarkers for patient selection for NET, (2) the optimal neoadjuvant endocrine agent for postmenopausal women with locally advanced breast cancer, and (3) the optimal duration of NET. In addition, we make initial recommendations towards developing a clinical guideline for the prescribing of NET. Method A wide-ranging search of online electronic databases was conducted using a truncated PIC search strategy to identify articles that were relevant to these aims and revealed a number of key findings. Results Randomized trials have consistently demonstrated that aromatase inhibitors are more effective than tamoxifen, in terms of objective response rate and rate of BCS, and should be used as first-line NET. The three available aromatase inhibitors have so far been demonstrated to be biologically equivalent, with the choice of aromatase inhibitor not having been shown to affect clinical outcomes. There is increasing evidence for extending the duration of NET beyond 3 to 4 months, to at least 6 months or until maximal clinical response is achieved. While on-treatment levels of the proliferation marker Ki67 are predictive of long-term outcome, the choice of adjuvant therapy in patients who have received NET and then surgery is best guided by the preoperative endocrine prognostic index, or PEPI, which incorporates Ki67 with other clinical parameters. Conclusion This study reveals that in appropriately selected patients, NET can provide equivalent clinical benefit to neoadjuvant chemotherapy in the same cohort, if suitable treatments and durations are chosen. Our findings highlight the need for better defined biomarkers both for guiding patient selection and for measuring outcomes. Development of standard guidelines for the prescribing of NET has the potential to improve both clinical outcomes and quality of life in this patient cohort.

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Section: Resultsmentioning

confidence: 99%

Neoadjuvant endocrine therapy in locally advanced estrogen or progesterone receptor-positive breast cancer: determining the optimal endocrine agent and treatment duration in postmenopausal women—a literature review and proposed guidelines

2020

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“…The phase II CORALEEN study (NCT03248427) compared six 28-days cycles of ribociclib plus letrozole versus chemotherapy (four cycles of doxorubicin plus cyclophosphamide every 21 days followed by weekly paclitaxel for 12 weeks) in women with luminal B stage I-IIIA early BC and then evaluated the proportion of patients with PAM50 low risk-of-relapse (ROR) disease at surgery: results did not show any significant difference between the two groups (low ROR 46.9% vs. 46.1%, pCR rate 2.0% vs. 5.8%, ORR 57.2% vs. 78.8%), moreover, the ribociclib arm resulted in a lower residual cancer burden (RCB) 0-1 rate, of 6.1%, versus 11.8% with chemotherapy [109].…”

Section: Comparison With Chemotherapymentioning

confidence: 91%

Targeting Cell Cycle in Breast Cancer: CDK4/6 Inhibitors

Piezzo

Cocco

Caputo

et al. 2020

IJMS

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Deregulation of cell cycle, via cyclin D/CDK/pRb pathway, is frequently observed in breast cancer lending support to the development of drugs targeting the cell cycle control machinery, like the inhibitors of the cycline-dependent kinases (CDK) 4 and 6. Up to now, three CDK4/6 inhibitors have been approved by FDA for the treatment of hormone receptor-positive (HR+), HER2-negative metastatic breast cancer. These agents have been effective in improving the clinical outcomes, but the development of intrinsic or acquired resistance can limit the efficacy of these treatments. Clinical and translational research is now focused on investigation of the mechanism of sensitivity/resistance to CDK4/6 inhibition and novel therapeutic strategies aimed to improve clinical outcomes. This review summarizes the available knowledge regarding CDK4/6 inhibitor, the discovery of new biomarkers of response, and the biological rationale for new combination strategies of treatment.

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“…It showed similar efficacy to palbociclib with a similar toxicity profile, with the addition of higher hepatotoxicity and rare cardiac QT time prolongation effects (Hortobagyi et al, 2016). Interestingly, whereas palbociclib is generally used for advanced states of cancer, ribociclib has also shown a positive effect in high-risk early-stage ER positive breast cancer (Prat et al, 2020).…”

Section: Ribociclibmentioning

confidence: 95%

Transcription and Translation Inhibitors in Cancer Treatment

et al. 2020

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Transcription and translation are fundamental cellular processes that govern the protein production of cells. These processes are generally up regulated in cancer cells, to maintain the enhanced metabolism and proliferative state of these cells. As such cancerous cells can be susceptible to transcription and translation inhibitors. There are numerous druggable proteins involved in transcription and translation which make lucrative targets for cancer drug development. In addition to proteins, recent years have shown that the "undruggable" transcription factors and RNA molecules can also be targeted to hamper the transcription or translation in cancer. In this review, we summarize the properties and function of the transcription and translation inhibitors that have been tested and developed, focusing on the advances of the last 5 years. To complement this, we also discuss some of the recent advances in targeting oncogenes tightly controlling transcription including transcription factors and KRAS. In addition to natural and synthetic compounds, we review DNA and RNA based approaches to develop cancer drugs. Finally, we conclude with the outlook to the future of the development of transcription and translation inhibitors.

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Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial

Cited by 117 publications

References 31 publications

Neoadjuvant endocrine therapy in locally advanced estrogen or progesterone receptor-positive breast cancer: determining the optimal endocrine agent and treatment duration in postmenopausal women—a literature review and proposed guidelines

Neoadjuvant endocrine therapy in locally advanced estrogen or progesterone receptor-positive breast cancer: determining the optimal endocrine agent and treatment duration in postmenopausal women—a literature review and proposed guidelines

Targeting Cell Cycle in Breast Cancer: CDK4/6 Inhibitors

Transcription and Translation Inhibitors in Cancer Treatment

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