32 results on '"Capucine Baldini"'
Search Results
2. 1842P Molecular testing in older patients treated for an advanced or metastatic non-squamous non-small cell lung cancer
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Didier Debieuvre, Radj Gervais, Bastien Cabarrou, Charles Ricordel, Maurice Pérol, Christos Chouaid, Clarisse Audigier-Valette, S. Schneider, David Planchard, Roland Schott, Matthieu Carton, Tina Lamy, Nicolas Girard, Thomas Filleron, M. Robain, Gaëtane Simon, Capucine Baldini, Michael Bringuier, Benjamin Besse, and Xavier Quantin
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Oncology ,medicine.medical_specialty ,Older patients ,Non squamous ,business.industry ,Internal medicine ,medicine ,Hematology ,Non small cell ,Lung cancer ,medicine.disease ,business - Published
- 2021
3. 1030TiP An open-label multicenter phase Ib study of AN0025, a selective inhibitor of the prostaglandin E2 receptor-type-4 receptor, in combination with pembrolizumab in patients with advanced solid tumors
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Michael Chisamore, Aurélien Marabelle, Philippe A. Cassier, N. Lautermilch, M. Reilley, Capucine Baldini, David S. Hong, Wallace Akerley, and T. Tang
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Oncology ,business.industry ,Prostaglandin E2 receptor ,Cancer research ,Medicine ,In patient ,Hematology ,Pembrolizumab ,Open label ,business ,Receptor - Published
- 2021
4. 1827P European Society for Medical Oncology (ESMO)/International Society of Geriatric Oncology (SIOG) Joint Working Group (WG) survey on management of older patients with cancer
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Laura Biganzoli, E. Quoix, Christopher Steer, V. Goede, Hans Wildiers, Etienne Brain, Demetris Papamichael, Siri Rostoft, Capucine Baldini, and Ravindran Kanesvaran
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Oncology ,medicine.medical_specialty ,Joint working ,Coronavirus disease 2019 (COVID-19) ,business.industry ,media_common.quotation_subject ,Hematology ,Clinical Practice ,Principal (commercial law) ,Older patients ,Geriatric oncology ,Scale (social sciences) ,Internal medicine ,medicine ,Institution ,business ,media_common - Abstract
Background: ESMO and SIOG created a joint WG in 2019. Their goals are to improve management of the older cancer patients through education, dedicated resources and guidelines and to raise awareness on their specific needs and requirements. Therefore, the WG initiated a survey to describe the practice patterns worldwide. Methods: All ESMO and SIOG members received a request by email to complete the survey online on 17 Feb 2020 with subsequent reminders. Questions were focused on clinical practices, perception of geriatric oncology (GO), use of screening tools such as geriatric-8 (G8), education and knowledge of guidelines. The survey was closed on 5 Apr 2020. Results: A total of 168 participants fully completed the survey. Most of them were female (65%), aged 30-39 (58%), medical oncologists (70%) and from Europe (50%). Professionals predominantly in charge of front-line care of older patients with cancer were medical oncologists (68%);however, only 19% had a physician coordinating a GO programme at their institution. According to respondents, GO brings to oncology: detection of frailty (83%), prediction of toxicity (77%), integrative management (70%), improving older patient’s understanding of treatment and adherence (64%), providing practice guidelines (46%) and prediction of survival (41%). Most of the respondents (95%) felt the need for other scales than ECOG Performance Status, 66% knew about the G8 scale and 52% used it in their clinical practice. Non-SIOG members were significantly less aware of the G8 screening tool (56% vs 97% for SIOG members;p
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- 2021
5. Multiple immune-related toxicities in cancer patients treated with anti-programmed cell death protein 1 immunotherapies: a new surrogate marker for clinical trials?
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Patricia Martin-Romano, Benjamin Besse, Christophe Massard, Caroline Even, Anne-Laure Voisin, Aurélien Marabelle, Capucine Baldini, Laurence Albiges, A. Laparra, Jean-Marie Michot, Olivier Lambotte, P. Vuagnat, Stéphane Champiat, A. Simonaggio, François-Xavier Danlos, Maria Kfoury, Caroline Robert, Christine Mateus, and Salim Laghouati
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Oncology ,medicine.medical_specialty ,biology ,Surrogate endpoint ,business.industry ,MEDLINE ,Cancer ,Hematology ,medicine.disease ,B7-H1 Antigen ,Clinical trial ,Immune system ,Neoplasms ,Internal medicine ,Programmed cell death 1 ,medicine ,biology.protein ,Humans ,Immunotherapy ,business - Published
- 2021
6. 1688P Outcome of older cancer patients infected with COVID-19 at Gustave Roussy Cancer Center
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Benjamin Besse, J-C. Soria, Capucine Baldini, Fanny Pommeret, Bertrand Gachot, C. Balleyguier, Samy Ammari, Florian Scotté, Frank Griscelli, Fabrice Barlesi, Laurence Albiges, Christophe Willekens, Florence Netzer, Arnaud Bayle, Fabrice Andre, Mathilde Hauchecorne, and Stéphanie Foulon
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medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Anosmia ,Cancer ,Hematology ,medicine.disease ,Article ,Diarrhea ,Oncology ,Internal medicine ,Clinical endpoint ,medicine ,Sore throat ,Thoracic ct ,medicine.symptom ,business - Abstract
Background: The SARS-CoV-2 outbreak significantly affected Gustave Roussy cancer center Here, we report the Gustave Roussy experience on older patients (OP) with cancer during the SARS-CoV-2 outbreak Methods: Cancer pts with suspected SARS-CoV-2 infection were admitted at Gustave Roussy starting March, 12th Screening indications have been adapted over time All the COVID-19 pts positively tested and managed at Gustave Roussy between March 14th and April 15th have been included in a redcap database Pts and underlying oncological and COVID-19 diseases characteristics have been collected Cancer and COVID-19 managements, and outcomes have been assessed The primary endpoint of this analysis was the clinical deterioration, defined as the need for O2 supplementation of 6l/min or more, or death of any cause Results: Among the first 137 cancer pts diagnosed with SARS-CoV-2, 36 patients were aged 70 years old or over (26%) Most of them were female (61%) with a median age of 75 5 years old Most frequent underlying cancers were solid tumors (92%) including GI (19%), lung (17%), GYN (14%) and head and neck (14%) Most OP (36%) were ECOG Performans status 2 versus 24% in younger patients (YP) The diagnosis of SARS-CoV-2 infection was made by RT-PCR or thoracic CT scan alone in 97% and 3% of the cases, respectively in OP and in 92% and 8% in YP Most OP experienced symptoms prior to testing (92%) compared to YP (80%) Symptoms differed according to age with more cough with sputum production in OP (14% versus 5%), dyspnea (39% versus 31%), diarrhea (17% versus 9%), shivers (8% versus 0%), sore throat (8% versus 4%) and no anosmia nor agueusia The majority of OP was hospitalized (81%) compared to 72% of YP and treated with HCQ/AZI (15;52%) compared to 25 (35%) YP with inclusion in the ONCOVID trial (EudraCT: 2020-01250-21) They did not receive any IL-6 inhibitor Only one OP was admitted in the ICU (3%) Clinical deterioration occurred in 10 OP (29%) There was no impact of age on clinical worsening (HR=1 157;95%CI 0 55-2 42;p=0 7) However age was associated with worse overall survival (OS) (HR=2 45 95%CI 1 02-5 92;p=0 0463) Results will be updated at the meeting Conclusions: OP with cancer had a different disease presentation, same rate of clinical worsening but worse OS in SARS-CoV-2 infection Legal entity responsible for the study: The authors Funding: Has not received any funding Disclosure: All authors have declared no conflicts of interest
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- 2020
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7. 34MO Outcomes according to FGFR alteration types in patients with a solid tumour treated by a pan-FGRF tyrosine kinase inhibitor in phase I/II trials
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Andreea Varga, Capucine Baldini, C.J. Pobel, Francesco Facchinetti, Christophe Massard, Stéphane Champiat, Loic Verlingue, Aurélien Marabelle, Luc Friboulet, Antoine Hollebecque, Y. Loriot, A. Gazzah, Arthur Geraud, M. Ningarhari, Ratislav Bahleda, and J-C. Soria
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Solid tumour ,Phase i ii ,Oncology ,Fibroblast growth factor receptor ,business.industry ,medicine.drug_class ,Cancer research ,Medicine ,In patient ,Hematology ,business ,Tyrosine-kinase inhibitor - Published
- 2021
8. 1732MO Pembrolizumab and nintedanib for patients with advanced mesothelioma
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Lydie Cassard, F.X. Danlos, Severine Mouraud, Diane Letourneur, Aurélien Marabelle, Bastien Job, Andreea Varga, Christophe Massard, David Planchard, Salim Laghouati, Julien Adam, J-C. Soria, M. Texier, Audrey Rabeau, Gérard Zalcman, Capucine Baldini, Nathalie Droin, Nathalie Chaput, A. Parpaleix, and Delphine Bredel
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Drug supply ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Best Overall Response ,Hematology ,Advanced malignant mesothelioma ,Disease control ,Treatment efficacy ,Management ,Principal (commercial law) ,Oncology ,Medicine ,business ,Immune Factors - Abstract
Background: We report the results from the advanced malignant mesothelioma (aMM) expansion cohort of the PEMBIB phase Ib trial (NCT02856425) evaluating the safety, efficacy & biomarkers of an antiangiogenic TKI (nintedanib = [N]) with an anti-PD1 immunotherapy (pembrolizumab = [P]). Methods: Patients (Pts) with aMM that relapsed after at least one line of platinum-based combination were treated with a combination of oral [N] (150mg BID) & IV [P] (200mg Q3W) with 7 days [N] lead-in preceded [P] initiation. Baseline and on-treatment fresh tumor & blood samples were prospectively phenotyped immune cells by flow cytometry (FC). RNAseq was run on tumor samples. Immune factors were titrated by multiplex ELISA on tumor secretome and plasma. Results: 30 aMM Pts were treated and 29 evaluable for response. Median age was 68 years old (38-85) and 86% of aMM were epithelioid. The most frequent adverse events (AE) (grades 1-3) related to the combination were liver enzymes increase, fatigue, nausea and diarrhea. 4 (13.3%) Pts developed grade 3-5 immune- related AE. Patients died of cancer progression (n=14), myocarditis with thrombo-embolic event (n=1) and COVID-19 (n=1). Median follow-up was 14.8 months (95%CI [9.70-18.2]). Best Overall Response Rates (BORR) were Partial Response (PR;n=7), Stable Disease (SD;n=17) and Progressive Disease (PD;n=5). Disease Control Rate (DCR) (defined as PR + SD) was 68.4% and 46.6% at 3 and 6 months, respectively. Analyses on fresh tumor biopsies showed that all patients increased their CD3+ T-cells and circulating levels of soluble PD1 and CXCL9 under treatment. Pts developing PR had significantly higher CD45+ and CD3+ tumor infiltrative cells at baseline compared to Pts with SD & PD as BORR. Pts with DCR at 6 months had significantly higher expression of integrins on circulating effector memory CD4+ & CD8+ T cells by FC, and higher NK, T, and myeloid dendritic cells infiltrates on baseline tumor RNAseq. Pre & on-treatment IL6 and IL8 levels in tumor secretome & plasma were higher among Pts with PD. Conclusions: With a BORR of 23% and a DCR of 47% at 6 months, [P]+[N] combination provided valuable therapeutic benefits for Pts with aMM. Flow cytometry and secretome on fresh baseline tumor biopsies are simple techniques which could be used to predict treatment efficacy in aMM Pts. Clinical trial identification: NCT02856425. Legal entity responsible for the study: Gustave Roussy. Funding: Funding: Boehringer Ingelheim;Drug supply: Boehringer Ingelheim & MSD;Sponsor: Gustave Roussy. Disclosure: C. Baldini: Financial Interests, Personal, Invited Speaker: Sanofi;Financial Interests, Personal, Invited Speaker: BMS;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Institutional, Research Grant: Seattle Genetics;Financial Interests, Institutional, Research Grant: Iteos;Financial Interests, Institutional, Invited Speaker: Tahio;Financial Interests, Institutional, Research Grant: BMS. N. Chaput: Financial Interests, Institutional, Research Grant: AstraZeneca;Financial Interests, Institutional, Research Grant: BMS;Financial Interests, Institutional, Research Grant: GSK;Financial Interests, Institutional, Research Grant: Roche;Financial Interests, Institutional, Research Grant: Sanofi;Financial Interests, Institutional, Research Grant: Cytune Pharma. G. Zalcman: Financial Interests, Personal, Invited Speaker, outside the submitted work: BMS;Financial Interests, Personal, Invited Speaker, outside the submitted work: MSD;Financial Interests, Personal, Invited Speaker, outside the submitted work: AstraZeneca;Financial Interests, Personal, Invited Speaker, outside the submitted work: Boehringer Ingelheim;Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Roche;Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Takeda;Non-Financial Interests, Personal, Advisory Board, outside the submitted work: AstraZeneca;Non-Financial Interests, Personal, Advisory Board, outside the submitted work: AbbVie. C. Massard: Non-Financial Interests, Personal, Advisory Role: Amgen;Non-Financial Interests, Personal, Advisory Role: Astellas Pharma;Non-Financial Interests, Personal, Advisory Role: AstraZeneca;Non-Financial Interests, Personal, Advisory Role: Bayer;Non-Financial Interests, Personal, Advisory Role: BeiGene;Non-Financial Interests, Personal, Advisory Role: BMS;Non-Financial Interests, Personal, Advisory Role: Celgene;Non-Financial Interests, Personal, Advisory Role: Debiopharm Group;Non-Financial Interests, Personal, Advisory Role: Genentech/Roche;Non-Financial Interests, Personal, Advisory Role: Ipsen;Non-Financial Interests, Personal, Advisory Role: Janssen;Non-Financial Interests, Personal, Advisory Role: Lilly;Non-Financial Interests, Personal, Advisory Role: MSD;Non-Financial Interests, Personal, Advisory Role: Novartis;Non-Financial Interests, Personal, Advisory Role: Pfizer;Non-Financial Interests, Personal, Advisory Role: Sanofi;Non-Financial Interests, Personal, Advisory Role: Orion;Non-Financial Interests, Personal, Advisory Role: Taiho Pharmaceuticals;Non-Financial Interests, Personal, Advisory Role: Blueprint Medicinces;Non-Financial Interests, Personal, Advisory Role: Innate Pharma;Non-Financial Interests, Personal, Advisory Role: PharmaMar;Non-Financial Interests, Personal, Advisory Role: Faron Pharmaceuticals. J-C. Soria: Financial Interests, Personal, Stocks/Shares: AstraZeneca;Financial Interests, Personal, Stocks/Shares: Gritstone Oncology;Financial Interests, Personal, Stocks/Shares: Relay Therapeutics;Financial Interests, Personal, Member of the Board of Directors: Hookipa Pharmaceuticals;Financial Interests, Personal, Full or part-time Employment, sept 2017 to dec 2019: AstraZeneca. A. Marabelle: Financial Interests, Personal, Invited Speaker: Roche/Genentech;Financial Interests, Personal, Invited Speaker: BMS;Financial Interests, Personal, Invited Speaker: Merck Serono;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Invited Speaker: Amgen;Financial Interests, Personal, Invited Speaker: Sanofi;Financial Interests, Personal, Invited Speaker: Servier;Non-Financial Interests, Personal, Principal Investigator: Roche/Genentech;Non-Financial Interests, Personal, Principal Investigator: BMS;Non-Financial Interests, Personal, Principal Investigator: MSD;Non-Financial Interests, Personal, Principal Investigator: Pfizer;Non-Financial Interests, Personal, Principal Investigator: Lytix Pharma;Non-Financial Interests, Personal, Principal Investigator: Eisai;Non-Financial Interests, Personal, Principal Investigator: AstraZeneca;Non-Financial Interests, Personal, Principal Investigator: Tesaro;Non-Financial Interests, Personal, Principal Investigator: Chugai;Non-Financial Interests, Personal, Principal Investigator: Ose Immunotherapeutics;Non-Financial Interests, Personal, Principal Investigator: Sotio;Non-Financial Interests, Personal, Principal Investigator: Molecular Partners;Non-Financial Interests, Personal, Principal Investigator: IMCheck;Non-Financial Interests, Personal, Principal Investigator: Pierre Fabre;Non-Financial Interests, Personal, Principal Investigator: Adlai Nortye;Financial Interests, Personal, Stocks/Shares: Pegascy SAS;Financial Interests, Personal, Stocks/Shares: Centessa Pharmaceuticals;Financial Interests, Personal, Stocks/Shares: HiFiBio;Financial Interests, Personal, Stocks/Shares: Shattuck Labs;Financial Interests, Institutional, Research Grant: Merus;Financial Interests, Institutional, Research Grant: BMS;Financial Interests, Institutional, Research Grant: Boehringer Ingelheim;Financial Interests, Institutional, Research Grant: Transgene;Financial Interests, Institutional, Research Grant: Fondation MSD Avenir;Financial Interests, Institutional, Research Grant: Sanofi. All other authors have declared no conflicts of interest.
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- 2021
9. 1617P Sustained cancer clinical trial activity during the COVID-19 pandemic
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A. Gazzah, Aurélien Marabelle, Vincent Ribrag, Ratislav Bahleda, Sophie Postel-Vinay, Christophe Massard, Benjamin Besse, J-M. Michot, J-C. Soria, Stéphane Champiat, Capucine Baldini, Laurence Albiges, Patricia Martin Romano, Arnaud Bayle, Loic Verlingue, Stefan Michiels, Arthur Geraud, Antoine Hollebecque, Daphné Morel, and Fabrice Barlesi
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medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Cancer clinical trial ,business.industry ,Hematology ,Limiting ,Article ,Patient care ,Clinical trial ,Oncology ,Intensive care ,Emergency medicine ,Pandemic ,medicine ,Data monitoring ,business - Abstract
Background: The COVID-19 pandemic deeply threatens the rigorous conduct of clinical trials, notably by delaying site initiation visits, patient enrolment, treatment administration, trial-associated procedures, and data monitoring. Unlike most other medical specialties, clinical trials are an integral part of patient care in oncology. Limiting access to clinical trials therefore results in a loss of chance for patients. Methods: In this retrospective single-center study, we collected clinical trial-specific items (including patient-related or trial management-related items) during the first pandemic wave (March– June 2020) and lockdown (March 17th-May 11th) at Gustave Roussy, and compared them to those of the same period in 2019. Results: In March 2020, 84 phase I (P1) and 210 phase II/III (P2/3) trials were open. During the first pandemic wave, 21 (25%) P1 and 20 (9%) P2/3 trials were temporarily halted, following a unilateral sponsor decision in virtually all cases;all but one were industry-sponsored. Despite this, all important metrics of the P1/2 trial activity remained similar to those of 2019, including the number of patients referred for inclusion (599 vs 620), inclusion consultations (215 vs 247), patients starting treatment (130 vs 130), Internal Review Board (IRB) submissions (14 vs 16), and site initiation visits (11 vs 15), all in 2020 vs 2019, respectively. The impact of the first lock-down was more marked on P2/3, with 152 patient inclusions (vs 346 in 2019), 125 randomizations (vs 278), 43 IRB submissions (vs 50) and 34 site initiation visits (vs 40). However, in parallel, 475 patients were included in three “COVID and cancer” trials. Among the 443 P1 and 2851 P2/3 patients, 198 and 628 COVID-19 PCR were performed internally, and five and 15 (2.5%) were positive, respectively. One patient with a community-based COVID-19 died after transfer in intensive care. Conclusions: Cancer clinical trials can, and must be maintained despite challenges brought by COVID-19. Sharing experiences and retrospectively evaluating the impact on patients’ safety and cancer-related outcomes will be critical to durably improve the clinical trials conduct and to anticipate at best challenges brought by future similar crises. Legal entity responsible for the study: Gustave Roussy. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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- 2021
10. 1452P Use of the Pallia 10 score in patients enrolled in phase I trials at Gustave Roussy Cancer Center
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Florian Scotté, Ratislav Bahleda, A. Gazzah, P. Martin Romano, J-C. Soria, Kaissa Ouali, Sophie Postel-Vinay, Arthur Geraud, Andreea Varga, Ariane Laparra, Antoine Hollebecque, Christophe Massard, Vincent Ribrag, Christine Mateus, Stéphane Champiat, Loic Verlingue, Capucine Baldini, A. Sampetrean, Elena Pavliuc, and Aurélien Marabelle
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medicine.medical_specialty ,Oncology ,business.industry ,Internal medicine ,medicine ,Cancer ,In patient ,Phase i trials ,Center (algebra and category theory) ,Hematology ,medicine.disease ,business - Published
- 2021
11. 1930O Genomic alterations in solid tumours according to ESMO scale for clinical actionability of molecular targets (ESCAT)
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Sophie Postel-Vinay, P. Martin Romano, Ludovic Lacroix, Capucine Baldini, Benjamin Besse, Luc Friboulet, J-C. Soria, Fabrice Andre, Mihaela Aldea, Antoine Hollebecque, A. Gazzah, Antoine Italiano, Laura Mezquita, Christophe Massard, Arthur Geraud, Y. Loriot, Etienne Rouleau, and Andreea Varga
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Oncology ,Scale (ratio) ,business.industry ,Molecular targets ,Medicine ,Hematology ,Computational biology ,business - Published
- 2020
12. 1050P Does immunotherapy impact the outcomes of future anti-tumour therapies?
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Capucine Baldini, Stéphane Champiat, Roger Sun, Antoine Hollebecque, A. Gazzah, Ratislav Bahleda, Patricia Martin-Romano, J-M. Michot, Andreea Varga, Aurélien Marabelle, M. Tiako Meyo, and Christophe Massard
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Oncology ,medicine.medical_specialty ,Anti tumour ,business.industry ,medicine.medical_treatment ,Internal medicine ,medicine ,Hematology ,Immunotherapy ,business - Published
- 2020
13. Are epigenetic therapies modifying sensitivity to conventional chemotherapy?
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Stéphane Champiat, Capucine Baldini, P. Vuagnat, Antoine Hollebecque, A. Bizot, S. Postel Vinay, Christophe Massard, Ratislav Bahleda, J-M. Michot, P. Romano-Martin, Andreea Varga, Vincent Ribrag, and A. Gazzah
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business.industry ,Significant difference ,Phase 1 trials ,Library science ,Hematology ,Protein degradation ,Platinum salts ,Oncology ,Antiangiogenic agents ,Homogeneous ,Conventional chemotherapy ,Medicine ,business ,Objective response - Abstract
Background Epigenetic therapies (epidrugs) modify cancer cells transcriptional programmes and influence all hallmarks of cancer. Thus, epidrugs have been reported to modulate sensitivity to conventional chemotherapy (CCT) preclinically. We explored whether sensitivity to CCT differed before and after epidrug therapy. Methods Patients (pts) enrolled in phase 1 trials evaluating epidrugs at the Drug Development Department (DITEP) in Gustave Roussy between March 2010 and May 2017 who received at least one CCT just before and after epidrug therapy were eligible. Progression free survival (PFS) of the CCT line before (PFSpre) and after (PFSpost) epidrug were compared using Wilcoxon signed rank in a paired data subset (uncorrected α-risk). Results 69% of the 93 eligible pts had haematological malignancies. Epidrug treatments consisted of: IDH inhibitors (IDHi) (30%), HDACi (19%), protein degradation modulators (20%), EZH2i (17%), BETi (12%) and LSD1i (2%); 52 (56%) pts derived clinical benefit (CB) from epidrugs (objective response or SD>2 months). Median PFSpre and PFSpost were 4.2 and 3.8 months (NS), respectively; PFSpost was significantly worse for pts who did not derive CB from epidrugs (1.8 vs 5.6 months, p=0.01), whereas significance was lost for pts who derived CB (5.1 vs 3.6 months, NS). Analysis stratified on the CCT type evidenced that PFSpost was significantly worse for pts receiving anthracyclines, topoisomerase inhibitors and alkylating agents (excluding platinum salts) (p=0.004, p=0.02 and p=0.01, respectively), whereas no significant difference was observed for platinum, antimetabolites, anti-microtubule agents or antiangiogenic agents. Conclusions Epidrug therapy might modify sensitivity to certain CCT; patients who derive clinical benefit from epidrugs tend to have better PFS on CCT after epidrug treatment than patients who do not benefit from epidrugs. Further studies on larger and homogeneous series are warranted. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure P. Romano-Martin: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Jannsen; Research grant / Funding (self): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Roche. C. Baldini: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Sanofi. S. Champiat: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. A. Varga: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi; Honoraria (self): MSD; Honoraria (self): AstraZeneca; Honoraria (self): Roche. A. Gazzah: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. R. Bahleda: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (self): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. P. Vuagnat: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. A. Hollebecque: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. J. Michot: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. V. Ribrag: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi. C. Massard: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi; Advisory / Consultancy: Amgen; Advisory / Consultancy: Astellas; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy: BeiGene; Advisory / Consultancy: Lilly; Advisory / Consultancy: MedImmune; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: Jannsen. S. Postel Vinay: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Sanofi; Advisory / Consultancy: Merck; Travel / Accommodation / Expenses: AstraZeneca; Research grant / Funding (self): Roche; Research grant / Funding (self): Boehringer Ingelheim. All other authors have declared no conflicts of interest.
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- 2019
14. 22P Toxicity profile of immune and non-immune therapies in phase I/II trials: A comprehensive longitudinal analysis
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Eric Angevin, Vincent Ribrag, A. Gazzah, J.P. Armand, Sophie Postel-Vinay, Antoine Italiano, Aurélien Marabelle, Carole Helissey, Andreea Varga, Eric Deutsch, Capucine Baldini, J-C. Soria, Ratislav Bahleda, Antoine Hollebecque, L. Missri, Emilie Lanoy, Stéphane Champiat, Christophe Massard, J-M. Michot, and Patricia Martin-Romano
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Immune system ,Phase i ii ,Oncology ,business.industry ,Immunology ,Medicine ,Hematology ,business ,Toxicity profile ,Immune therapy - Published
- 2021
15. 47P Radiological patterns of tumour progression in patients treated with a combination of immune checkpoint blockers and antiangiogenic drugs
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Samy Ammari, Stéphane Champiat, Andreea Varga, Eric Angevin, M. Ningarhari, Loic Verlingue, Patricia Martin-Romano, Ratislav Bahleda, Vincent Ribrag, Aurélien Marabelle, Capucine Baldini, Arthur Geraud, Antoine Hollebecque, C.J. Pobel, J-C. Soria, J-M. Michot, Christophe Massard, E. Guiard, Sophie Postel-Vinay, and A. Gazzah
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,Radiological weapon ,Internal medicine ,Medicine ,In patient ,Hematology ,business ,Immune checkpoint - Published
- 2020
16. 66P High incidence of TP53 and epigenetic modifying oncogene mutations in a large cohort of patients enrolled in phase I clinical trials for R/R DLBCL
- Author
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David Ghez, P. Martin Romano, Clémentine Sarkozy, Cyril Quivoron, Peggy Dartigues, Julien Lazarovici, Andreea Varga, Christophe Massard, Capucine Baldini, Vincent Ribrag, Valérie Camara-Clayette, Alina Danu, Sophie Cotteret, J-M. Michot, and Julien Rossignol
- Subjects
Oncology ,Clinical trial ,medicine.medical_specialty ,Oncogene ,business.industry ,Internal medicine ,medicine ,Hematology ,High incidence ,Epigenetics ,business ,Large cohort - Published
- 2020
17. 24P Is molecular characterization useful for targeted therapy orientation in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) included in early phase clinical trials?
- Author
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Andreea Varga, Peggy Dartigues, P. Martin Romano, Clémentine Sarkozy, Vincent Ribrag, Capucine Baldini, Christophe Massard, David Ghez, Julien Rossignol, Sophie Cotteret, Julien Lazarovici, Alina Danu, Cyril Quivoron, J-M. Michot, and Valérie Camara-Clayette
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Hematology ,Targeted therapy ,Clinical trial ,Orientation (mental) ,Internal medicine ,medicine ,Refractory Diffuse Large B-Cell Lymphoma ,In patient ,business ,Early phase - Published
- 2020
18. Thromboembolic risk assessment in patients receiving combination of anti-angiogenic plus anti-PD1 or anti-PD-L1: A descriptive study
- Author
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Antoine Hollebecque, P. Martin Romano, Capucine Baldini, Y. Loriot, B. Vss, Anne-Laure Voisin, Maxime Annereau, Christophe Massard, Aurélien Marabelle, Andreea Varga, P. Bravo, P. Vuagnat, J-M. Michot, Stéphane Champiat, Laurence Albiges, Olivier Lambotte, Bernard Escudier, A. Cataldi, and S. Babai
- Subjects
medicine.medical_specialty ,business.industry ,Incidence (epidemiology) ,Cancer ,Hematology ,medicine.disease ,Gastroenterology ,Oncology ,Renal cell carcinoma ,Internal medicine ,Cohort ,Pharmacovigilance ,medicine ,Mesothelioma ,business ,Prospective cohort study ,Adverse effect - Abstract
Background Patients (pts) living with cancer are exposed to higher risk for thrombotic event (TE). The thrombotic risk (TR) is related to cancer disease and could also be associated with anti-cancer drugs such as antiangiogenic (AA). AA are currently being used more and more widely, alone or in combination (combo) with anti-PD(L)1 immunotherapies. It isn’t known whether combining anti-PD1 or PD-L1 with AA drug could increase the risk of TE. This study aimed at evaluating the TR in patients receiving a combo of AA and anti-PD1 or PD-L1. Methods Observational study conducted from January 2017 to September 2019 and retrospectively investigated all consecutive adults pts with cancer treated with a combo of AA plus anti-PD(L)1. All TE (venous and arterial) occurring following investigated treatment(s) and Khorana scores (KS) were analyzed. The TR was assessed in pts receiving the combo and compared with pts treated with single anti-PD(L)1. For the single anti-PD(L)1 cohort, data were collected from the pharmacovigilance Register of Severe Adverse Effects of Immunomodulatory Monoclonal Antibody in Cancer (REISAMIC). Data were compared between the combo and REISAMIC cohort using the Fisher’s exact and CHI2 tests (α = 5%). Results Overall, 83 pts receiving a combo of anti-PD(L)1 plus AA and 484 pts treated with anti-PD(L)1 were included. Both cohorts were similar for baseline characteristics: sex ratio, age, weight. Main tumor types in single anti-PD(L)1 vs combo were (in %): renal cell carcinoma, 5 vs 37; urothelial carcinoma, 3 vs 4; thoracic (lung or mesothelioma), 45 vs 32; gynecologic, 1 vs 8. The KS score was heterogeneous. It found 334/484 (69%) pts at intermediary or high risk of TE in the REISAMIC cohort and 70/83 (84%) in combo cohort (p = 0.006). In REISAMIC cohort, TE incidence was 7% compared to 18% in the combo cohort (p value=0.0006). Conclusion These results suggest that pts treated with combo AA plus anti-PD(L)1 seem to be more at risk of developing TE compare to single therapy anti-PD(L)1, according to a KS higher in this cohort. Further prospective study're warranted to investigate the risk of TE in pts receiving AA plus anti-PD(L)1 and to investigate the benefit of preventive anticoagulants therapy. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.
- Published
- 2019
19. Applicability of the LIPI score to metastatic microsatellite instability high cancer patients treated with immune checkpoint inhibitors
- Author
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M.D.R. Vidal Tocino, Capucine Baldini, Antoine Hollebecque, Edouard Auclin, P. Martin Romano, Rocio Garcia-Carbonero, F. Longo Muñoz, Benjamin Besse, Laura Mezquita, Christophe Massard, Y. El Dakdouki, P. Vuagnat, Andreea Varga, and J. Adeva Alfonso
- Subjects
0301 basic medicine ,medicine.medical_specialty ,education.field_of_study ,business.industry ,Immune checkpoint inhibitors ,Population ,Hematology ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Overall response rate ,Oncology ,030220 oncology & carcinogenesis ,Internal medicine ,Visual accommodation ,medicine ,Overall survival ,education ,business ,Predictive biomarker - Abstract
Background Microsatellite instability high (MSI-H) is an approved tissue-agnostic predictive biomarker of benefit to immune checkpoint inhibitors (ICI). However not all patients (pts) respond to ICI and additional biomarker of response in this population is still required. The Lung-Immune Prognostic Index (LIPI), combining derived NLR (dNLR=neutrophils/[leucocytes-neutrophils]) and lactate dehydrogenase (LDH) demonstrated a strong correlation with ICI outcomes in NSCLC and other tumor types. We aimed to evaluate the value of pretreatment LIPI for predicting benefit to ICI in MSI-H population. Methods We performed a multicenter retrospective study of pts with metastatic MSI-H tumors treated with ICI from Apr 2014 to May 2019. Biological and clinical data were retrospectively collected and LIPI was calculated based as previously reported. LIPI groups were: good (dNLR≤3 + LDH≤upper limit of normality [ULN]), intermediate (dNLR>3 or LDH>ULN and poor (dNLR>3+LDH>ULN). The primary endpoint was progression-free survival (PFS) and secondary endpoints were overall survival (OS), overall response rate (ORR). Results Preliminary data is available for 111 pts, with the following characteristics: 43 (39%) male; median age of 62 (24-93), median number of previous lines 1 (range 0 – 6); most common tumor types were colorectal (43%) and endometrial cancer (15%). MSI was defined by immunochemistry and/or polymerase chain reaction (PCR) in 88% and 37 pts (38%) had a confirmed Lynch Syndrome. 98 pts (88%) were treated with a single agent-PD(L)1 inhibitor. The median (m) PFS was 14.1 months (m.) [95%CI, 8.38-not reached (NR)] and the mOS was NR [95%CI, 30-xx] with 44% of ORR. LIPI stratified the population in: good (51, 46%), intermediate (50, 45%) and poor groups (10, 9%). The good group had mPFS of 20.9m. vs. 32m. for intermediate vs. 1.8m. for poor groups (P = 0.0006). In the good group, the ORR was 55% vs. 38% for intermediate vs. 13% in poor group (P = 0.05). OS data are not mature yet. Conclusion Poor LIPI is correlated with worse ICI outcomes (PFS, ORR) in MSI-H pts, identifying potentially a MSI-H subset of pts with no benefit from ICI. This study is still ongoing for assessing the value of LIPI in a larger cohort. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure P. Vuagnat: Research grant / Funding (institution), Full / Part-time employment, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP); Non-remunerated activity/ies, AstraZeneca, Bayer, Bristol-Myers Squibb, Boringher Ingelheim, Johnson & Johnson, Lilly, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche: As part of the Drug Development Department (DITEP). E. Auclin: Travel / Accommodation / Expenses: MundiPharma; Speaker Bureau / Expert testimony: Sanofi Genzyme. L. Mezquita: Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony: Bristol-Myers Squibb, Tecnofarma, Roche, AstraZeneca; Travel / Accommodation / Expenses: Bristol-Myers Squibb, Roche, Chugai. M.R. Vidal Tocino: Advisory / Consultancy: Amgen, Celgene, Merck, Sanofi; Travel / Accommodation / Expenses: Amgen, Roche. P. Martin Romano: Research grant / Funding (institution), Full / Part-time employment, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP); Non-remunerated activity/ies, AstraZeneca, Bayer, Bristol-Myers Squibb, Boringher Ingelheim, Johnson & Johnson, Lilly, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche: As part of the Drug Development Department (DITEP). C. Baldini: Research grant / Funding (institution), Full / Part-time employment, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP); Non-remunerated activity/ies, AstraZeneca, Bayer, Bristol-Myers Squibb, Boringher Ingelheim, Johnson & Johnson, Lilly, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche: As part of the Drug Development Department (DITEP). A. Varga: Research grant / Funding (institution), Full / Part-time employment, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP); Non-remunerated activity/ies, AstraZeneca, Bayer, Bristol-Myers Squibb, Boringher Ingelheim, Johnson & Johnson, Lilly, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche: As part of the Drug Development Department (DITEP). B. Besse: Research grant / Funding (institution): Bristol-Myers Squibb, Roche, Chugai. C. Massard: Research grant / Funding (institution), Full / Part-time employment, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP); Non-remunerated activity/ies, Amgen, Astellas, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, Novartis, Pfizer, Roche, Sanofi, Orion: Consultant/Advisory fees. A. Hollebecque: Research grant / Funding (institution), Full / Part-time employment, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP); Non-remunerated activity/ies, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi: As part of the Drug Development Department (DITEP). All other authors have declared no conflicts of interest.
- Published
- 2019
20. Precision medicine for patients with primary brain tumours: Molecular screening for cancer treatment optimization (MOSCATO) prospective trial
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P. Martin Romano, Stéphane Champiat, W. Boulfoul, S. Postel Vinay, Loic Verlingue, Ratislav Bahleda, Capucine Baldini, Jean-Charles Soria, Eric Angevin, A. Gazzah, Christophe Massard, Andreea Varga, Aurélien Marabelle, P. Vuagnat, Etienne Rouleau, Antoine Hollebecque, Vincent Ribrag, Ludovic Lacroix, Isabelle Borget, and J-M. Michot
- Subjects
Molecular screening ,business.industry ,Hematology ,Precision medicine ,medicine.disease ,Management ,Cancer treatment ,Oncology ,Prospective trial ,Honorarium ,medicine ,In patient ,Primary Brain Tumors ,business ,Glioblastoma - Abstract
Background Primary brain tumors are highly heterogeneous and current therapy confers only modest clinical benefit. There is a tremendous need for new therapeutic options and genomic profiling could help defining new strategies. Methods Data from patients with advanced primary brain tumors enrolled in the prospective clinical trial MOSCATO at the Drug Development Department (DITEP) at Gustave Roussy Cancer Center were retrospectively reviewed. Multiple high throughput molecular techniques were used to identify genetic mutations: Next Generation Sequencing (NGS), comparative genomic hybridization array (CGHa) and Foundation one CDx (FMI). Matched therapy was decided accordingly for patients who had targeted molecular alterations. Results Between April 2016 and December 2018, 103 patients with primary brain tumors were enrolled. Median age was 48 years (range, 19-75), median number of previous systemic therapies was 2 (range, 0–5), 98% had an ECOG performance status 0 or 1. The most prevalent histology was glioblastoma (70 %). Ten patients were screen failure due to unavailability of tumor tissue and no possibility of new brain biopsy. Eighty-nine molecular analyses were successful (CGH: N = 45, NGS: N = 47, FMI: N = 42). Median time between consent and results was 49 days (range, 18-235). Tumor mutational burden (TMB) was available in 42 pts and was considered low ( Conclusions Molecular profiling in patients with primary brain tumors is feasible and can lead to orientation in clinical trials and/or treatment with targeted therapies. However the reasons for the small number of patients finally treated are currently under investigations and will be presented at the conference. Legal entity responsible for the study Christophe Massard. Funding Institut Gustave Roussy. Disclosure C. Baldini: Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Abbvie; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Amgen; Speaker Bureau / Expert testimony: Sanofi. L. Verlingue: Speaker Bureau / Expert testimony: Adaptherapy; Speaker Bureau / Expert testimony: Pierre Fabre; Research grant / Funding (self): BMS. E. Angevin: Advisory / Consultancy: Merck; Advisory / Consultancy: GSK; Advisory / Consultancy: Celgene; Travel / Accommodation / Expenses: Abbvie; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Sanofi; Travel / Accommodation / Expenses: Pfizer. A. Varga: Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: Astra Zeeneca; Speaker Bureau / Expert testimony: MSD. S. Postel Vinay: Research grant / Funding (self): Merck; Research grant / Funding (self): Boehringer; Research grant / Funding (self): Roche; Research grant / Funding (self): AstraZeneca; Speaker Bureau / Expert testimony: Merck; Speaker Bureau / Expert testimony: AstraZeneca; Travel / Accommodation / Expenses: AstraZeneca. A. Gazzah: Travel / Accommodation / Expenses: Boehringer; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Novartis. R. Bahleda: Travel / Accommodation / Expenses: Taiho; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: Boehringer. A. Marabelle: Advisory / Consultancy: Roche; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Onxeo; Advisory / Consultancy: EISAI; Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Genticel; Advisory / Consultancy: Rigontec; Advisory / Consultancy: Diachii; Advisory / Consultancy: Imaxio; Advisory / Consultancy: Sanofi; Advisory / Consultancy: BioNtech; Advisory / Consultancy: Corvus; Advisory / Consultancy: Deerfield; Advisory / Consultancy: Bioncotech; Research grant / Funding (self): Merus; Research grant / Funding (self): BMS; Research grant / Funding (self): Boehringer; Research grant / Funding (self): Transgene. V. Ribrag: Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: Pharmamar; Advisory / Consultancy: Incyte; Advisory / Consultancy: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Nanostring Technologies; Speaker Bureau / Expert testimony: Servier; Honoraria (self): Eisai. S. Champiat: Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Janssen. J. Michot: Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Janssen. A. Hollebecque: Advisory / Consultancy: Amgen; Advisory / Consultancy: Spectrum Pharmaceuticals; Advisory / Consultancy: Lilly; Travel / Accommodation / Expenses: Servier; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Lilly; Speaker Bureau / Expert testimony: Bayer. J. Soria: Full / Part-time employment: Medimmune. C. Massard: Advisory / Consultancy: Amgen; Advisory / Consultancy: Astellas; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy: Beigene; Advisory / Consultancy: BMS; Advisory / Consultancy: Celgene; Advisory / Consultancy: Debiopharm; Advisory / Consultancy: Roche/Genentech; Advisory / Consultancy: Lilly; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Janssen; Advisory / Consultancy: Medimmune; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Sanofi. All other authors have declared no conflicts of interest.
- Published
- 2019
21. Clinical significance of immune-related creatine phosphokinase increase associated with anti PD1/PD-L1 immunotherapies
- Author
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Antoine Hollebecque, P. Romano-Martin, Olivier Lambotte, S.S. Hajem, C. Robert, J-M. Michot, Stéphane Champiat, Christine Mateus, Frédéric Troalen, P. Vuagnat, Capucine Baldini, Andreea Varga, Christophe Massard, Cécile Cauquil, Stéphane Ederhy, and M. Berhoune
- Subjects
medicine.medical_specialty ,biology ,business.industry ,Early detection ,Mean age ,Hematology ,Clinical Practice ,Clinical trial ,Oncology ,Internal medicine ,PD-L1 ,Cpk increase ,medicine ,biology.protein ,business ,Head and neck ,Anti pd1 - Abstract
Background Anti-PD1 and anti-PD-L1 are effective checkpoints inhibitors to stimulate the immune system against many types of cancers. The flip side of these immunotherapies is the generation of immune-related adverse events (irAE), which can theoretically affect all organs including muscle tissue. Immune-related creatine phosphokinase (irCPK) increase is associated with immune related myositis. The meaning of CPK monitoring in clinical practice remains poorly understood. In this observational study, all the grade ≥ 2 increased CPK occurring in patients treated with anti-PD-1 or anti-PD-L1 were investigated to determine their clinical significance. Methods All consecutive pts treated with anti-PD1 or anti-PD-L1, in monotherapy or in combine therapy with other agents, monitored by routine CPK in the Drug Development Department (DITEP) and in the Dermatology Unit of Gustave Roussy between January 2016 and December 2018 were retrospectively reviewed. Patients CPK monitoring level were extracted from biological chart and all the patients with grade ≥ 2 increased CPK were selected for the analysis. Results Among the 1151 patients treated with anti PD1/PD-L1, 53 (4.6%) had grade ≥ 2 increased CPK regardless of immune causality and 31 (2.7%) had a grade ≥ 2 irCPK increase. Among the 53 pts with CPK increase, mean age was 54 years old, tumor types were skin (n = 21), bladder and urothelial (n = 5), head and neck (n = 4) and others (n = 23). CPK increase was not related to the treatment in 22 (41%) pts, was immune-related to anti-PD1/PDL1 and not clinically significant in 19 (36%) pts, was immune-related with muscular adverse events in 10 (19%) pts, including 2 myositis and 2 acute polyradiculoneuritis; and was immune-related with myocarditis in 2 (4%) pts. The mean of CPK maximal peak was significantly higher in patients with immune-related cardiac or muscular adverse event that in the asymptomatic CPK increase pts (1271 UI/L vs. 771 UI/L, p-value = 0.02). Conclusions The frequency of grade ≥ 2 irCPK increase is estimated at 2.7% of patients treated with anti-PD1 or anti-PD-L1. For patients treated with anti PD1/PD-L1, regular CPK monitoring appears as clinically relevant in the early detection of immune-related cardiac and muscular adverse events. Legal entity responsible for the study Jean-Marie Michot. Funding Has not received any funding. Disclosure C. Baldini: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. P. Romano-Martin: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. P. Vuagnat: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. S. Champiat: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. A. Varga: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. A. Hollebecque: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. C. Robert: Advisory / Consultancy: Roche, BMS, MSD, Amgen, Novartis. C. Massard: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. O. Lambotte: Advisory / Consultancy: BMS, MSD, AstraZeneca, LFB, CSL Behring, Janssen. J. Michot: Advisory / Consultancy: Consultant/Advisory fees from Amgen, Astellas, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Debiopharm, Genentech, Ipsen, Janssen, Lilly, MedImmune, MSD, Novartis, Pfizer, Roche, Sanofi, Orion Principal/sub-Investigator of Clinical Trials for AbbVie, Aduro. All other authors have declared no conflicts of interest.
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- 2019
22. Safety profile of epigenetic therapies in early phase trials: Do epidrugs deserve specific drug development processes?
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Xavier Paoletti, Capucine Baldini, L. Leroy, S. Postel Vinay, Antoine Hollebecque, Vincent Ribrag, T. Satar, Christophe Massard, Patricia Martin-Romano, and J-M. Michot
- Subjects
Safety profile ,Oncology ,Drug development ,business.industry ,Medicine ,Hematology ,Epigenetics ,Early phase ,Bioinformatics ,business - Published
- 2019
23. Applicability of the lung immune prognostic index (LIPI) in patients with metastatic solid tumors when treated with immune checkpoint inhibitors (ICI) in early clinical trials
- Author
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Andreea Varga, David Planchard, A. Bernard-Tessier, Capucine Baldini, Benjamin Besse, L. Mezquita Pérez, Aurélien Marabelle, Antoine Hollebecque, Christophe Massard, and Edouard Auclin
- Subjects
Oncology ,medicine.medical_specialty ,Lung ,business.industry ,Immune checkpoint inhibitors ,Hematology ,Clinical trial ,Immune system ,medicine.anatomical_structure ,Internal medicine ,medicine ,In patient ,business - Published
- 2019
24. Patterns of progression to immune checkpoint targeted monoclonal antibodies in phase I trials
- Author
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E. Castanon Alvarez, P. Martin Romano, Ratislav Bahleda, Vincent Ribrag, Stéphane Champiat, Capucine Baldini, Jeannette Soria, A. Gazzah, A. Bernard-Tessier, A. Hollebecque, Sophie Postel-Vinay, Aurélien Marabelle, Christophe Massard, J-M. Michot, Samy Ammari, J.P. Armand, and Andreea Varga
- Subjects
Oncology ,medicine.drug_class ,business.industry ,Cancer research ,medicine ,Phase i trials ,Hematology ,Monoclonal antibody ,business ,Immune checkpoint - Published
- 2018
25. Incidence of immune related adverse events in patients 70 years old treated with anti-PD-(L)1 therapy
- Author
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F.X. Danlos, Anne-Laure Voisin, J-M. Michot, Vincent Ribrag, Benjamin Besse, Patricia Martin-Romano, Aurélien Marabelle, Andreea Varga, Stéphane Champiat, Salim Laghouati, Olivier Lambotte, Jean-Charles Soria, Sophie Postel-Vinay, M. Kfouri, Capucine Baldini, Antoine Hollebecque, Christophe Massard, Celine Nagera, and H. Vincent
- Subjects
medicine.medical_specialty ,business.industry ,Incidence (epidemiology) ,Hematology ,03 medical and health sciences ,0302 clinical medicine ,Immune system ,Oncology ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,In patient ,030212 general & internal medicine ,Adverse effect ,business - Published
- 2018
26. Applicability of the lung immune prognostic index (LIPI) to metastatic triple negative breast cancer (mTNBC) patients treated with immune checkpoint targeted monoclonal antibodies (ICT mAbs)
- Author
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Capucine Baldini, Benjamin Besse, Vincent Ribrag, Andreea Varga, Stéphane Champiat, Edouard Auclin, Jean-Charles Soria, Ratislav Bahleda, Sophie Postel-Vinay, Suzette Delaloge, Patricia Martin-Romano, A. Simonaggio, Laura Mezquita, Christophe Massard, A. Gazzah, Aurore Vozy, Fabrice Andre, and Barbara Pistilli
- Subjects
Lung ,business.industry ,medicine.drug_class ,Hematology ,Monoclonal antibody ,Immune checkpoint ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,medicine.anatomical_structure ,Immune system ,Oncology ,030220 oncology & carcinogenesis ,Cancer research ,Medicine ,business ,Triple-negative breast cancer - Published
- 2018
27. Molecular alterations and matched treatment in older patients: Results from the MOSCATO 01 trial
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Antoine Hollebecque, A. Gazzah, Sophie Postel-Vinay, Andreea Varga, P. Martin Romano, Aurélien Marabelle, Capucine Baldini, Vincent Ribrag, Ratislav Bahleda, J-M. Michot, Loic Verlingue, P. Vuagnat, Jean-Charles Soria, Christophe Massard, and Stéphane Champiat
- Subjects
medicine.medical_specialty ,Oncology ,Older patients ,business.industry ,Internal medicine ,Medicine ,Hematology ,business - Published
- 2018
28. Self-questionnaire to assess patient’s preferences for participation in phase I clinical trials
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Sophie Postel-Vinay, Benjamin Verret, Antoine Hollebecque, Capucine Baldini, A. Le Cesne, A. Perret, Christophe Massard, Benjamin Besse, J-C. Soria, and Suzette Delaloge
- Subjects
Clinical trial ,medicine.medical_specialty ,Oncology ,business.industry ,Physical therapy ,Medicine ,Phases of clinical research ,Hematology ,business ,Phase (combat) - Published
- 2018
29. Long term survival in patients responding to an Anti-PD-1/PD-L1 therapy and disease outcome upon treatment discontinuation
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Emilie Lanoy, Loic Verlingue, Capucine Baldini, Ratislav Bahleda, Stéphane Champiat, Eric Angevin, Christophe Massard, M-L. Gauci, Eduardo Castanon, J-C. Soria, Antoine Hollebecque, J-M. Michot, Sandrine Aspeslagh, Aurélien Marabelle, Sophie Postel-Vinay, F. Bigot, Andreea Varga, and A. Gazzah
- Subjects
medicine.medical_specialty ,biology ,business.industry ,Disease outcome ,Anti pd 1 ,Hematology ,Term (time) ,Discontinuation ,Oncology ,Internal medicine ,PD-L1 ,biology.protein ,Medicine ,In patient ,business - Published
- 2017
30. Immunotherapy phase I trials in patients over 70 years with advanced solid tumours: The Gustave Roussy experience
- Author
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J-C. Soria, Sophie Postel-Vinay, Olivier Mir, Sandrine Aspeslagh, Valérie Dyevre, Andreea Varga, Ratislav Bahleda, Capucine Baldini, A. Gazzah, Eduardo Castanon, Christophe Massard, A. Hollebecque, J-M. Michot, H. Herin, Vincent Ribrag, and Aurélien Marabelle
- Subjects
medicine.medical_specialty ,Oncology ,business.industry ,Medicine ,Phase i trials ,In patient ,Hematology ,Radiology ,business - Published
- 2017
31. Outcome of patients with relapsed/refractory lymphoma in a large cohort inside a phase 1 clinic department
- Author
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Andreea Varga, Laura Faivre, Capucine Baldini, Lina Benajiba, Vincent Ribrag, A. Gazzah, J-C. Soria, Antoine Hollebecque, Alina Danu, Christophe Massard, Ratislav Bahleda, and J-M. Michot
- Subjects
medicine.medical_specialty ,Pathology ,Performance status ,business.industry ,Therapeutic effect ,Hematology ,medicine.disease ,Gastroenterology ,Lymphoma ,Oncology ,hemic and lymphatic diseases ,Internal medicine ,medicine ,T-cell lymphoma ,Mantle cell lymphoma ,Progression-free survival ,business ,Diffuse large B-cell lymphoma ,Survival analysis - Abstract
Background: Treating relapsed/refractory lymphoma remains a challenge. While phase 1 trials classically aim to determine the recommended phase 2 dose (RP2D), the search of anti-tumor activity is increasingly evaluated. We aimed to assess the tolerance and efficacy of phase 1 trial and to determine a simple scoring system to identify patients who will prematurely discontinue phase 1 studies (before six weeks), in a large cohort of patients with relapsed/refractory lymphoma. Patients and Methods: Data from 105 consecutive patients with relapsed/refractory lymphoma treated within a panel of 17 phase 1 trials were collected, between 2008 and 2014. At inclusion, median age was 66 years [range: 23-83]. Lymphoma histological patient's types were: 58 (55%) aggressive non-Hodgkin lymphoma (34 diffuse large B-cell lymphoma, 7 T-cell lymphoma and 17 Mantle cell lymphoma), 31 (30%) indolent non-Hodgkin lymphoma and 16 (15%) Hodgkin lymphoma. The predefined Gustave Roussy (GR) score combined two simple variables, PS and baseline serum albumin (+1 if PS = 0, +1 if albumin ≤ 35g/l). Results: Grade 3 or 4 adverse events were experienced by 40/105 (38%) patients. With a median follow-up of 10 months, median OS and progression free survival (PFS) were respectively 19 (CI95%: 12-37) and 4 (CI95%: 2-5) months. Best overall response rate and disease control rate were 22% and 56%, respectively. Histological type's analysis shown median OS was 10, 45 and 47 months in aggressive-NHL, Hodgkin and indolent-NHL, respectively (p 0, baseline albumin ≤ 35 g/l and baseline LDH ≥ 250 UI/L were significantly associated with poorer OS. Patients with a GR score = 0 experienced significantly better OS compared to patients with a score = 1 and a score = 2 (37 months vs 17 months vs 9 months; p = 0.007). A premature study discontinuation was recorded in 28/105 patients (27%). The GR score distinguishes patients most likely to remain on study for more than 6 weeks. Conclusion: The three parameters WHO performance status (PS) > 0, baseline albumin ≤ 35 g/l and baseline LDH ≥ 250 UI/L are associated with OS and premature withdrew of study. Both PFS and OS survival curves demonstrates a plateau, in favor of therapeutic effect potentially maintained.
- Published
- 2015
32. Tumor Characteristics, Treatment and Overall Survival (OS) in Breast Cancer Patients (PTS) Over 80 Years: A Cohort From a Single Institution
- Author
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V. Servent, Capucine Baldini, A. Kramar, A. Donnadieu, and Jacques Bonneterre
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medicine.medical_specialty ,Relative survival ,business.industry ,medicine.medical_treatment ,Sentinel lymph node ,Hematology ,medicine.disease ,Gastroenterology ,Radiation therapy ,Log-rank test ,Breast cancer ,Oncology ,Median follow-up ,Internal medicine ,medicine ,Adjuvant therapy ,business ,Mastectomy - Abstract
Patients and methods Data were collected for 208 non metastatic breast cancer pts over 80 years (213 tumors), treated from January 2000 to December 2009. Pathological data were obtained on a biopsy or on mastectomy specimens if patients had not received presurgical treatment. Statistical methods Survival rates were estimated by Kaplan-Meier method. Tests were performed with the logrank test. Five year relative survival rates were estimated by Ederer2 method. Results Median age at diagnosis was 83 years (80-95). 29% tumors were T1, 58% T2 and 15% T3, 141 (66%) were ductular, 34 (16%) lobular and 38 (18%) had another histological type. SBR grade (I/II/III) was 22%/49%/29% and unspecified in 42 (20%). 167 pts (80%) were ER + , 129 (62%) PR + ; 40 (19%) ER–PgR–, and 171 (81%) ER + PgR+. HER2 status, known in 126 pts, was positive in 18 (14%), and negative in 108 (86%). Ten pts were strictly triple negative (5%)(ER = 0, PgR = 0, HER2 = 0). Ki 67 among 59 tumors was over 15% in 43 pts (73%). Forty-nine pts (23%) had conservative surgery, 80 mastectomy (38%), 72 axillary dissection (34%) and 30 sentinel lymph node biopsy (14%). Axillary lymph node metastasis were observed in 52 pts (38%). 195 pts received hormonotherapy (68 as adjuvant therapy, 89 before surgery or alone), 72 patients radiotherapy (37%), 5 chemotherapy (3%) and 1 had trastuzumab (0.5%). Median overall survival was 59 months. Median follow up was 76 months. The only significant prognostic factors on overall survival were age (48 months over 83 years, 79 before), ER and PgR status. ER positive and negative pts had a median survival of 60 months and 32 months respectively. Five year relative survival rate was 63%. Conclusion Even if most pts had a ER+ tumor, the rate of poor prognosis factors is high: 29% SBR III, 14% HER2 positive, 5% triple negative and 73% had a KI67 index over 15%. Despite these poor prognostic factors, survival was rather long with a median OS of 5 years. Disclosure All authors have declared no conflicts of interest. The incidence rate of breast cancer in elderly women over 75 years old is 220 per 100000 in France and is likely to increase in the future. We studied the impact of tumor and treatment characteristics on overall survival.
- Published
- 2012
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