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  • 1
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 79, No. 13_Supplement ( 2019-07-01), p. 4895-4895
    Abstract: BACKGROUND: Activating PIK3CA mutations occur in 20-30% of patients with metastatic breast cancer (mBC). A recent study showed that alpha selective PI3K inhibitors improve outcome in patients with PIK3CA mutation, HR+/Her2- mBC. There is a need to better understand the natural history of PIK3CA mutant mBC to optimally position of this drug family. PATIENTS AND METHODS: 649 patients from SAFIR02 trial (NCT02299999), for which mutational profile was available and with clinical data entered in a database, were selected for this analysis. Associations between PIK3CA mutation, clinical characteristics and outcome were analyzed. RESULTS: 143 patients (22%) harbor PIK3CA mutation in tumor sample. 10% (n=27) and 34% (n=104) of TNBC and HR+/Her2- mBC presented a PIK3CA mutation respectively (p & lt;0.001). In patients with HR+/Her2- mBC, there is no significant association between PIK3CA mutation and site of metastases or number of metastases (p & lt;0.01). In the same group, patients with PIK3CA mutations were less sensitive to chemotherapy (stable disease or response: 51.3% vs. 69.2% in PIK3CA wild type; p=0.005) (Odds ratio multivariate: 0.40 [95% CI: 0.22-0.71] p=0.002). The median overall survival (OS) for patients with PIK3CA mutated HR+/Her2- mBC was of 19.6 months vs. 23.5 for patients with PIK3CA wild type (p=0.048) (HR multivariate: 1.44 [95% CI: 1.02-2.03] p=0.039). HR+/Her2- mBC with PIK3CA mutations presented more frequently a MAP3K1 mutation (16% vs. 4%, p=0.0002). In the TNBC group, the median OS in patients with PIK3CA mutated cancer was of 24.2 months vs. 14 months in the wild type group (p=0.028). CONCLUSION: Patients with PIK3CA mutated, HR+/Her2- mBC are less sensitive to chemotherapy and present a shorter survival. These data emphasize the need for new therapies in this setting, and to position these therapies earlier than chemotherapy in the treatment sequences. Citation Format: Fernanda Mosele, Benjamin Verret, Amelie Lusque, Thomas Filleron, Thomas Bachelot, Monica Arnedos, Mario Campone, Florence Dalenc, Claudia Lefeuvre, Marie Paule Sablin, Hervé Bonnefoi, Ludovic Lacroix, Ivan Bièche, Anthony Gonçalves, William Jacot, Marta Jimenez, Amelie Jacquet, Fabrice Andre, Fabrice Andre. Natural history and outcome of patients presenting a metastatic breast cancer with PIK3CA mutation [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 4895.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2019
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  • 2
    In: The Lancet Oncology, Elsevier BV, Vol. 23, No. 11 ( 2022-11), p. 1367-1377
    Type of Medium: Online Resource
    ISSN: 1470-2045
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
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  • 3
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 83, No. 5_Supplement ( 2023-03-01), p. PD17-02-PD17-02
    Abstract: Background: The combination of a CDK4/6 inhibitor and an aromatase inhibitor (AI) is the gold standard for AI-sensitive first line treatment of ER+ HER2- advanced breast cancer. Nevertheless, some patients progress rapidly and may benefit from alternative strategies. Early ctDNA dynamics have been shown to predict disease course in several clinical situations. Here, we use samples from the PADA-1 trial to assess this strategy for patients receiving AI and palbociclib as first line treatment. PADA-1 was designed to assess the clinical utility of sequential analysis of ctDNA for emerging ESR1 mutations to trigger an early switch from AI plus palbociclib to fulvestrant plus palbociclib treatment. The study included 1,017 patients and was positive on its primary end-point. The objective of this translational study was to analyze the predictive value of 4-week molecular response (MR) for patient progression. Material & Method: First, a CLIA-validated targeted next-generation sequencing-based test (Guardant360 Response) was used to characterize changes in ctDNA level via detection of somatic single-nucleotide variants (SNVs), insertion/deletion mutations (indels), and gene fusions in 74 genes frequently mutated in cancer. A second analysis was restricted to cancer-associated mutations in 11 genes commonly mutated in breast cancer (PIK3CA, GATA3, TP53, AKT1, ERBB2, BRCA1, BRCA2, ATM, ESR1, PALB2 and RB1). The threshold for molecular response was defined as ≥ 50% decrease in ctDNA (MR score & lt; 0.5). Subjects with ctDNA levels below the test’s limit of quantitation (ctDNA-low) were considered molecular responders. Results: 372 subjects with matched baseline and 4-weeks samples were available for analysis. Of these, 134 subjects (36%) were ctDNA-low, and 238 subjects (64%) quantifiable. Among the quantifiable subjects, 183 (77%) were molecular responders (MR+, MR & lt; 0.5), and 55 (23%) were not (MR–, MR ≥ 0.5). PFS was moderately improved for both MR+ and ctDNA-low relative to MR– (HR=0.61 (95%CI 0.44-0.85), p & lt; 0.01) over the full 29 months of follow up. Differential PFS event rate was observed only in the first 8 months following ctDNA assessment; during this time MR+ and ctDNA-low were associated with more significantly decreased risk of progression (HR 0.24, 95% CI 0.13 – 0.43, p=0.0001). Limiting ctDNA assessment to genes commonly mutated in breast cancer enhanced the predictive power of MR (HR=0.08, 95% CI 0.04 0.17, p & lt; 0.001, for MR+ and ctDNA-low vs. MR– across 8 months post-assessment); however, fewer samples were quantifiable by this method (169 [45%] quantifiable; 203 [55%] ctDNA-low). Combining MR status with additional molecular features (e.g.tumor mutational burden and maximum mutation allele fraction) did not improve prediction of non-response. Conclusion: Changes in ctDNA fraction during the first weeks of treatment are predictive of long term clinical benefit on an individual patient basis, particularly during the first year of therapy. Adjusting the MR threshold and/or limiting to genes known to be relevant in the specific tumor can tailor the assessment of ctDNA change to specific clinical scenarios where greater sensitivity or specificity may be required. The identification of patients at high risk for early clinical failure at the onset of treatment may allow for therapy escalation and/or change to improve outcome in this population. Funding: Pfizer and Guardant Health Citation Format: Caroline Bailleux, Thomas Bachelot, Francois-Clement Bidard, Anne-Claire Hardy-Bessard, Ivan Bièche, Anne Pradines, Florian Clatot, thibault DE LA MOTTE ROUGE, Jean-Luc Canon, Barbara Pistilli, Kyle Chang, Katie J. Quinn, Heather L. Gustafson, Florence Dalenc, Cyril Foa, Hanifa Ammarguellat, Chantal Bernard-Marty, Brigitte Lucas, Sophie Barthier, Fabrice Lorchel, Olivier Gisserot, Laurent Arnould, Marjorie Mauduit, Jérôme Lemonnier, Frédérique Berger, Suzette Delaloge, Fabrice Andre. ctDNA Molecular Response based on breast cancer driver mutations predicts progression in aromatase inhibitor-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD17-02.
    Type of Medium: Online Resource
    ISSN: 1538-7445
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
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  • 4
    In: The Breast, Elsevier BV, Vol. 36 ( 2017-11), p. S44-
    Type of Medium: Online Resource
    ISSN: 0960-9776
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2017
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  • 5
    In: Nature Medicine, Springer Science and Business Media LLC, Vol. 27, No. 2 ( 2021-02), p. 250-255
    Type of Medium: Online Resource
    ISSN: 1078-8956 , 1546-170X
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 15_suppl ( 2015-05-20), p. 108-108
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
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  • 7
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 82, No. 4_Supplement ( 2022-02-15), p. PD8-02-PD8-02
    Abstract: Background: The HER2-targeted antibody-drug conjugate (ADC) trastuzumab deruxtecan (T-DXd) demonstrated efficacy in heavily pretreated HER2-over- and HER2-low expressing ABC (1, 2). We aimed to assess the activity of T-DXd in HER2-over-, HER2-low and HER2-nul expressing ABC, to describe the drug mechanisms of action in the 3 cohorts and to identify biomarkers associated to drug response or resistance. Study Description: DAISY is a multicenter, open-label phase II trial designed to assess the efficacy of single agent T-DXd at 5.4 mg/kg dose in ABC with extensive biomarkers analysis. Three cohorts of patients were included: Cohort 1 (HER2 over-expressing: HER2 3+ on immunohistochemistry (IHC) or HER2 IHC2+/in situ hybridization [ISH]+), Cohort 2 (HER2 low-expressing: IHC1+ or IHC2+/ISH-) and cohort 3 (HER2-nul: IHC0+). Biopsy of metastatic sites was performed: at baseline, on treatment (mandatory for cohort 1, optional for cohort 2/3) and at tumor progression; blood samples for ctDNA were collected at baseline. The primary endpoint was the Best Overall Response (BOR) in each cohort, according to the investigator assessment. Secondary endpoints were BOR by central assessment, clinical benefit rate, duration of response (DOR), progression-free (PFS), overall survival (OS) and safety. Results:185 women and 1 man were enrolled between November 2019 and March 2021. Among the patients enrolled in the safety population (see Table 1), median (range) age was 55 (24-82) years, all received at least one prior line of therapy and 12 patients were TN. Table 2 shows investigator-reported T-Dxd activity in the 3 cohorts at a median follow-up of 10.1 months [95%CI: 9.2-11.1] . A total of 170 patients (95%) had at least one treatment-related toxicity. Key grade ≥3 treatment-related toxicities included neutropenia (10.6% of patients), fatigue (5.6%), leucopenia (4.5%), vomiting (4.5%) and anemia (3.4%). A total of 4 patients had drug-related interstitial lung disease or pneumonitis (grade 1 in 3 patients and grade 2 in 1 patient), 11 patients discontinued treatment due to treatment-related adverse events. No drug-related deaths occurred. Conclusions: T-DXd showed clinically meaningful activity in patients with HER2-overexpressing ABC and interestingly also in those with HER2low and HER2-nul ABC. Safety profile was consistent with previous reports. 1.Modi S et al N Engl J Med 2020 2.Mosi S et al J Clin Oncol 2020 Table 1.Analysis populationsTotalCohort 1 (HER2 over-expressing)Cohort 2 (HER2 low-expressing)Cohort 3 (HER2 non-detected)Enrolled population186727440Safety population*179687338 (including 12 TN)Full analysis Set**176687236TN: Triple Negative. *: safety population = enrolled population except 7 patients who did not receive at least one dose of study drug. **: Full Analysis Set = safety population except 3 patients (2 who did not have a valid first post-baseline assessment of disease status or who did not have progressive disease and 1 who did not have at least one radiologically measurable lesion according to RECIST v1.1) Table 2.T-DXd activity in the three cohorts according to investigator assessmentTotalCohort 1Cohort 2Cohort 3BOR confirmedn/N82/176 (46.6%)47/68 (69.1%)24/72 (33.3%)11/36 (30.6%)[95%CI][39.1; 54.2] [56.7; 79.8][22.7; 45.4] 16.3; 48.1]Median DORmonths7.69.97.66.8[95%CI] [6.2; 9.7][5.4; NR] [4.4; 8.7][2.8; 8.3] Median PFSmonths6.911.16.74.2[95%CI][6.7; 8.7] [8.4; NR][4.6; 8.5] [2.1; 6.9]NR: Not Reached Citation Format: Véronique Diéras, Elise Deluche, Amélie Lusque, Barbara Pistilli, Thomas Bachelot, Jean-Yves Pierga, Frédéric Viret, Christelle Levy, Laura Salabert, Fanny Le Du, Florence Dalenc, Christelle Jouannaud, Laurence Venat-Bouvet, Jean-Philippe Jacquin, Xavier Durando, Thierry Petit, Céline Mahier - Aït Oukhatar, Thomas Filleron, Maria Fernanda Mosele, Magali Lacroix-Triki, Agnès Ducoulombier, Fabrice André. Trastuzumab deruxtecan (T-DXd) for advanced breast cancer patients (ABC), regardless HER2 status: A phase II study with biomarkers analysis (DAISY) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD8-02.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2022
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  • 8
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 80, No. 4_Supplement ( 2020-02-15), p. GS3-02-GS3-02
    Abstract: Background : While treatment with anti-PDL1 improves outcome in combination with chemotherapy in patients with metastatic triple negative breast cancer, its efficacy is not explored yet in the context of maintenance therapy after chemotherapy, in a population of Her2-negative metastatic breast cancer. Methods : In SAFIR02 trial (NCT : 02299999), patients are selected to present a Her2-negative metastatic breast cancer eligible to 1st or 2nd line chemotherapy. All patients underwent a biopsy of metastatic disease, followed by targeted sequencing and Oncoscan when & gt;30% cancer cells are present on HES slides. After 6 to 8 cycles of induction chemotherapy, patients who present an actionable genomic alteration are randomized between targeted therapies and continuation of maintenance chemotherapy, and patients without actionable alterations are randomized between durvalumab (dose, schedule) for 2 years and maintenance chemotherapy. As a substudy of the SAFIR02-breast trial, the SAFIR02-IMMUNO trial has its primary endpoint, the PFS, hierarchized as the primary end-point of the core of the study. The plan was to include 190 patients in order to have 80% power using a two-sided logrank test at the 5 % level of significance to detect an improvement from 3 months to 4.76 months corresponding to an HR of 0.63. Results : 191 patients have been randomized between durvalumab and maintenance chemotherapy (190 women) until now, 45.5% TNBC and 53.4% RH+. The median age was 55 years. . 91.6% (175/191) patients were randomized on their first line of chemotherapy in metastatic setting. Median number of metastatic sites at the beginning of the chemotherapy line was 2. PDL1 staining was performed on 89 available tumor FFPE blocks using SP142 antibody. 30% (n=27/89) patients presented a PDL1 positive tumor. PFS and OS will be presented at the conference.Conclusion : This is the first randomized trial comparing aPDL1 inhibitor to chemotherapy in the maintenance setting and to address the question of the efficacy of aPDL1i in HR+/Her2- and triple negative breast cancers. Citation Format: Florence Dalenc, Ingrid Garberis, Thomas Filleron, Amélie Lusque, Thomas Bachelot, Monica Arnedos, Mario Campone, Marie-Paule Sablin, Hervé Bonnefoi, Marta Jimenez, Jacquet Alexandra, Fabrice Andre. Durvalumab compared to maintenance chemotherapy in patients with metastatic breast cancer: Results from phase II randomized trial SAFIR02-IMMUNO [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr GS3-02.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
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  • 9
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 80, No. 4_Supplement ( 2020-02-15), p. P2-13-03-P2-13-03
    Abstract: Background: Persistence of unhealthy behaviors may adversely affect breast cancer (BC) outcomes and quality of life. Cancer diagnosis can represent a teachable moment and a powerful catalyst to correct such behaviors. It has been suggested that some cancer patients (pts) may be motivated towards a healthier lifestyle, particularly in case of a worse cancer-related prognosis. In this study we aimed at understanding the evolution and barriers in adoption of health behaviors after BC. Methods: We analyzed 8580 pts enrolled from 2012-2015 in a nationwide, multicenter study of stage I-III BC (CANTO, NCT01993498). Pts were longitudinally assessed at diagnosis (baseline), year(y)1 and y2 post-diagnosis. Recreational physical activity (PA) was reported using the GPAQ-16. An unhealthy smoking behavior was defined as active smoker status and an unhealthy alcohol behavior as consumption of ≥1 drink/day at y1 and y2. First, we described the longitudinal evolution of health behaviors. Then, we examined factors associated with health behaviors, to define pts that fail to adopt healthy lifestyle changes. Random effect mixed models evaluated changes in PA over time. Logistic regression models estimated odds of unhealthy smoke and alcohol behavior at y1 and y2. All models were adjusted for tumor, including BC stage, clinico-behavioral and treatment characteristics. Results: Mean age at diagnosis was 55 y (SD 11), 9% pts had stage III BC, 49% were overweight/obese (body mass index [BMI] ≥25 Kg/m2), 41% did not meet PA recommendations ( & lt;10 MET-h/week), 18% were active smokers, 14% reported ≥1 drink/day. Some small increases in PA were reported in the overall cohort (mean change from baseline [95%CI], MET-h/week: to y1 +0.8 [-0.2 to +1.9] ; to y2 +1.2 [+0.1 to +2.3]). Particularly, there were significant increases in PA among pts that did not use to meet PA recommendations at baseline, regardless of BC stage (mean change from baseline [95%CI] , MET-h/week: to y1 +8.7, to y2 +9.7 among stage I/II pts; to y1 +12.9, to y2 +10.4 among stage III pts [all p & lt;0.0001]). However, pts who had stage I/II BC and who were overweight/obese failed to improve their PA uptake over time (p & gt;0.05 at both time points). Among pts who were active smokers at baseline, 37% at y1 and 30% at y2 reported reduced tobacco, and among those who used to have ≥1 drink/day at baseline, 11% at y1 and 8% at y2 reported reduced alcohol consumption. 11% pts at y1 and 12% pts at y2 had unhealthy smoke behavior whereas 13% pts at y1 and 14% pts at y2 had unhealthy alcohol behavior (Cochran-Armitage trend test: p=0.034 for smoke and p=0.193 for alcohol). Older age (adjusted odds ratio [aOR] for a 5-year increase in age, 0.69 [95%CI 0.66-0.73] ) and being in a relationship (aOR vs not, 0.66 [95% CI 0.54-0.82]) were associated with reduced odds of unhealthy smoke behavior, although older pts (aOR for a 5-year increase in age, 1.34 [95%CI 1.22-1.40] ) and those in a relationship (aOR vs not, 1.35 [95% CI 1.10-1.68]) were also more prone to unhealthy alcohol behavior. Lower BMI was consistently associated with higher odds of unhealthy smoke and alcohol behavior (aOR for each decreasing BMI unit: for smoke behavior, 1.05 [95%CI 1.03-1.07] ; for alcohol behavior, 1.02 [95% CI 1.01-1.04]). BC stage was not associated with smoke and alcohol behavior. Conclusions: This large clinical study suggests that a substantial proportion of pts pursue a healthy lifestyle after BC. However, there are still survivors that fail to adopt positive and durable lifestyle changes. Uptake of increased levels of PA was not homogenous in this cohort, and we found an upward trend in unhealthy smoke behavior and steady rates of unhealthy alcohol behavior over time. We defined diverse behavioral profiles of pts, according, among others, to age, social status, BMI and BC characteristics. These data will help better inform targeted lifestyle interventions to improve health behaviors after BC. Citation Format: Antonio Di Meglio, Arnauld S Gbenou, Elise Martin, Laurence Vanlemmens, Charles Guenancia, Olivier Rigal, Marion Fournier, Patrick Soulie, Marie-Ange Mouret-Reynier, Carole Tarpin, Florence Boiffard, Sophie Guillermet, Sibille Everhard, Anne-Laure Martin, Sylvie Giacchetti, Thierry Petit, Florence Dalenc, Philippe Rouanet, Antoine Arnaud, Fabrice Andre, Ines Vaz-Luis. Lifestyle changes after breast cancer: A prospective study among 8580 women [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-13-03.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
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  • 10
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 82, No. 4_Supplement ( 2022-02-15), p. P1-18-16-P1-18-16
    Abstract: Background: Aromatase inhibitors (AI) in combination with a CDK 4/6 inhibitor have been established as the standard first line treatment of non AI-resistant hormone receptor-positive (HR+) HER2- metastatic breast cancer (mBC) patients (pts). ESR1 mutations are known drivers of resistance to AIs in the metastatic setting but their actionability remains unknown. The phase 3 PADA-1 trial aimed both at refining the global safety of palbociclib combined to any AI as first line treatment of HR+ HER2- mBC pts, and at evaluating the clinical benefit associated with a switch to fulvestrant-palbociclib upon detection of a rising ESR1 mutation in blood (bESR1mut). Methods: PADA-1 (NCT03079011), a multicenter, randomized, open-label, phase 3 trial, enrolled HR+ HER2- mBC pts with no prior therapy for mBC, in the absence of AI-resistance. In the first step, pts received a combination of any AI and palbociclib at standard recommended doses and underwent centralized bESR1mut screening every two months. In the second step, bESR1mut+ pts with no clinical/imaging concomitant disease progression were randomized between continuing the same therapy (standard arm) or switching to fulvestrant-palbociclib (experimental arm). The third step consisted in an optional cross-over after tumor progression for patients randomized in the standard arm. PADA-1 co-primary endpoints were global safety of the combination of palbociclib + endocrine therapy in the whole population of patients, throughout the study, with focus on hematological toxicities; and PFS in the second step. We present here the results of the global safety co-primary endpoint. Results: From 3/2017 to 01/2019, 1017 pts were accrued in 83 sites. As per 05/2021, 272 pts were still in step 1, 35 in step 2, and 8 in step 3. The overall follow-up was 33.7 months. 232 pts have deceased. 333 SAEs have been reported, including 21 grade 5, 35 grade 4, 183 grade 3, 53 grade 2, 26 grade 1 and 15 unknown grade. Among the grade 5 cases, 2 have been declared as potentially related to the underlying treatment (Death of unknown cause, pulmonary embolism). No pt died of SARS-CoV2 infection. The main hematological toxicities encountered, as well as selected non-hematological events are described in Table 1. Permanent discontinuation of the treatment due to toxicity occurred in 39 pts/1017 (3.8%). Palbociclib dose decreases occurred in 419 (41.2%) pts. Conclusion: By the number of included patients, PADA-1 is the largest prospective trial with 1st line AI and palbociclib. Data confirm the favorable safety profile of palbociclib when combined to any AI +/- switch to fulvestrant. Hematological toxicity appears limited and is mostly restricted to non-clinically significant neutropenia. Permanent discontinuation was exceptional. Detailed per-step analyses will be presented. Table 1.Adverse events (% pts)Grade 3, N (%)Grade 4, N (%)Neutropenia628 (61.8%)83 (8.2%)Febrile neutropenia4 (0.4%)0Thrombocytopenia18 (1.8%)3 (0.3%)Anemia24 (2.4%)0Lymphocytopenia58 (5.7%)5 (0.5%)Insterstitial lung disease4 (0.4%)0Liver enzymes increase (AST/ALT)5 (0.5%)0Mucositis10 (1%)0 Citation Format: Suzette Delaloge, Anne-Claire Hardy-Bessard, Thomas Bachelot, Jean-Yves Pierga, Jean-Luc Canon, Florian Clatot, Fabrice André, Thibault De La Motte Rouge, Barbara Pistilli, Florence Dalenc, Nadine Dohollou, Olivier Arsene, Thierry Petit, Cecilia Riedl, François Morvan, Adina Marti, Emma Lachaier, Mihaela Achille, Michel Gozy, Anne Escande, Dominique Mille, Fanny Trouboul, Sandrine Marques, Jerome Lemonnier, Frederique Berger, François-Clément Bidard. First line aromatase inhibitor (AI) + palbociclib with randomized switch to fulvestrant + palbociclib upon detection of circulating ESR1 mutation in HR+ HER2- metastatic breast cancer patients: Global safety results of PADA-1, a UCBG-GINECO phase III trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-18-16.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2022
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