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      Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies

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      Journal: Journal of Clinical Oncology
      Publisher: Wolters Kluwer Health

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          PURPOSE

          The prognostic and predictive value of intrinsic subtypes in hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer treated with endocrine therapy and ribociclib (RIB) is currently unknown. We evaluated the association of intrinsic subtypes with progression-free survival (PFS) in the MONALEESA trials.

          METHODS

          A retrospective and exploratory PAM50-based analysis of tumor samples from the phase III MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials was undertaken. The prognostic relationship of PAM50-based subtypes with PFS and risk of disease progression by subtype and treatment were evaluated using a multivariable Cox proportional hazards model, adjusting for age, prior chemotherapy, performance status, visceral disease, bone-only metastases, histological grade, number of metastatic sites, prior endocrine therapy, and de novo metastatic disease.

          RESULTS

          Overall, 1,160 tumors from the RIB (n = 672) and placebo (n = 488) cohorts were robustly profiled. Subtype distribution was luminal A (LumA), 46.7%; luminal B (LumB), 24.0%; normal-like, 14.0%; HER2-enriched (HER2E), 12.7%; and basal-like, 2.6% and was generally consistent across treatment arms and trials. The associations between subtypes and PFS were statistically significant in both arms ( P < .001). The risks of disease progression for LumB, HER2E, and basal-like subtypes were 1.44, 2.31, and 3.96 times higher compared with those for LumA, respectively. All subtypes except basal-like demonstrated significant PFS benefit with RIB. HER2E (hazard ratio [HR], 0.39; P < .0001), LumB (HR, 0.52; P < .0001), LumA (HR, 0.63; P = .0007), and normal-like (HR, 0.47; P = .0005) subtypes derived benefit from RIB. Patients with basal-like subtype (n = 30) did not derive benefit from RIB (HR, 1.15; P = .77).

          CONCLUSION

          In this retrospective exploratory analysis of hormone receptor–positive and human epidermal growth factor receptor 2–negative advanced breast cancer, each intrinsic subtype exhibited a consistent PFS benefit with RIB, except for basal-like.

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          Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer

          Peter Alfons Schmid, Sylvia Adams, Hope Rugo … (2018)
          Unresectable locally advanced or metastatic triple-negative (hormone-receptor-negative and human epidermal growth factor receptor 2 [HER2]-negative) breast cancer is an aggressive disease with poor outcomes. Nanoparticle albumin-bound (nab)-paclitaxel may enhance the anticancer activity of atezolizumab.
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            Supervised risk predictor of breast cancer based on intrinsic subtypes.

            Joel S. Parker, Michael Mullins, Maggie C.U. Cheang … (2009)
            PURPOSE To improve on current standards for breast cancer prognosis and prediction of chemotherapy benefit by developing a risk model that incorporates the gene expression-based "intrinsic" subtypes luminal A, luminal B, HER2-enriched, and basal-like. METHODS A 50-gene subtype predictor was developed using microarray and quantitative reverse transcriptase polymerase chain reaction data from 189 prototype samples. Test sets from 761 patients (no systemic therapy) were evaluated for prognosis, and 133 patients were evaluated for prediction of pathologic complete response (pCR) to a taxane and anthracycline regimen. The intrinsic subtypes as discrete entities showed prognostic significance (P = 2.26E-12) and remained significant in multivariable analyses that incorporated standard parameters (estrogen receptor status, histologic grade, tumor size, and node status). A prognostic model for node-negative breast cancer was built using intrinsic subtype and clinical information. The C-index estimate for the combined model (subtype and tumor size) was a significant improvement on either the clinicopathologic model or subtype model alone. The intrinsic subtype model predicted neoadjuvant chemotherapy efficacy with a negative predictive value for pCR of 97%. CONCLUSION Diagnosis by intrinsic subtype adds significant prognostic and predictive information to standard parameters for patients with breast cancer. The prognostic properties of the continuous risk score will be of value for the management of node-negative breast cancers. The subtypes and risk score can also be used to assess the likelihood of efficacy from neoadjuvant chemotherapy.
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              Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

              Gabriel N Hortobagyi, Salomon Stemmer, Howard Burris … (2016)
              Background The inhibition of cyclin-dependent kinases 4 and 6 (CDK4/6) could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). Methods In this randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of the selective CDK4/6 inhibitor ribociclib combined with letrozole for first-line treatment in 668 postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer who had not received previous systemic therapy for advanced disease. We randomly assigned the patients to receive either ribociclib (600 mg per day on a 3-weeks-on, 1-week-off schedule) plus letrozole (2.5 mg per day) or placebo plus letrozole. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. A preplanned interim analysis was performed on January 29, 2016, after 243 patients had disease progression or died. Prespecified criteria for superiority required a hazard ratio of 0.56 or less with P<1.29×10(-5). Results The duration of progression-free survival was significantly longer in the ribociclib group than in the placebo group (hazard ratio, 0.56; 95% CI, 0.43 to 0.72; P=3.29×10(-6) for superiority). The median duration of follow-up was 15.3 months. After 18 months, the progression-free survival rate was 63.0% (95% confidence interval [CI], 54.6 to 70.3) in the ribociclib group and 42.2% (95% CI, 34.8 to 49.5) in the placebo group. In patients with measurable disease at baseline, the overall response rate was 52.7% and 37.1%, respectively (P<0.001). Common grade 3 or 4 adverse events that were reported in more than 10% of the patients in either group were neutropenia (59.3% in the ribociclib group vs. 0.9% in the placebo group) and leukopenia (21.0% vs. 0.6%); the rates of discontinuation because of adverse events were 7.5% and 2.1%, respectively. Conclusions Among patients receiving initial systemic treatment for HR-positive, HER2-negative advanced breast cancer, the duration of progression-free survival was significantly longer among those receiving ribociclib plus letrozole than among those receiving placebo plus letrozole, with a higher rate of myelosuppression in the ribociclib group. (Funded by Novartis Pharmaceuticals; ClinicalTrials.gov number, NCT01958021 .).
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Oncol
                Journal ID (iso-abbrev): J Clin Oncol
                Journal ID (hwp): jco
                Journal ID (pmc): jco
                Journal ID (publisher-id): JCO
                Title: Journal of Clinical Oncology
                Publisher: Wolters Kluwer Health
                ISSN (Print): 0732-183X
                ISSN (Electronic): 1527-7755
                Publication date (Print): 1 May 2021
                Publication date (Electronic): 26 March 2021
                Volume: 39
                Issue: 13
                Pages: 1458-1467
                Affiliations
                [ 1 ]Department of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain
                [ 2 ]SOLTI Breast Cancer Research Group, Barcelona, Spain
                [ 3 ]Translational Genomics and Targeted Therapies in Solid Tumors, Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
                [ 4 ]Department of Medicine, University of Barcelona, Barcelona, Spain
                [ 5 ]Institute of Oncology (IOB) Quiron, Barcelona, Spain
                [ 6 ]Novartis Institutes for BioMedical Research, Cambridge, MA
                [ 7 ]Novartis Pharmaceuticals Corporation, East Hanover, NJ
                [ 8 ]Novartis Pharma AG, Basel, Switzerland
                Author notes
                Aleix Prat, MD, PhD, Hospital Clínic of Barcelona, Hospital Clínic of Barcelona, Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Villarroel 170, 08035 Barcelona, Spain; e-mail: alprat@ 123456clinic.cat .
                Author information
                https://orcid.org/0000-0001-8686-0236
                https://orcid.org/0000-0002-9945-6862
                https://orcid.org/0000-0002-4904-558X
                https://orcid.org/0000-0001-5440-9643
                Article
                Publisher ID: JCO.20.02977
                DOI: 10.1200/JCO.20.02977
                PMC ID: 8196091
                PubMed ID: 33769862
                SO-VID: f7e199b5-d392-403b-8189-573e172f9e91
                Copyright © © 2021 by American Society of Clinical Oncology
                License:

                Creative Commons Attribution Non-Commercial No Derivatives 4.0 License http://creativecommons.org/licenses/by-nc-nd/4.0/

                History
                Date received : 1 October 2020
                Date revision received : 5 February 2021
                Date accepted : 10 February 2021
                Page count
                Figures: 4, Tables: 2, Equations: 0, References: 28, Pages: 0
                Categories
                Subject: ORIGINAL REPORTS
                Subject: Breast Cancer

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