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11/09/2020

The Unicancer network at the ESMO 2020 Congress

 

The ESMO congress is the unmissable event for all European researchers in the field of cancer The scientific and medical teams of Unicancer, the only French hospital network entirely devoted to fighting cancer, will present at the ESMO 2020 virtual congress the latest research results from its R&D department as well as from the French Comprehensive Cancer Centers (FCCC).

 

 The research results of Unicancer R&D presented at ESMO 2020

 Research in the French Comprehensive Cancer Centers presented at ESMO 2020

 

Unicancer is an academic sponsor and operator of clinical trials in cancer research. Its Research & Development department closely works with the clinical research units of the French Comprehensive Cancer Centers (FCCC) and other healthcare centers, in France and abroad.

The R&D of Unicancer is at the forefront of oncology research and places innovation at the heart of its mission. Its activity revolves around three main themes: clinical research, translational research and real-life medical data.

 

Key Figures :

 

FCCC and the R&D of Unicancer:

Production of 1/3 of French oncology publications at the international level

More than 800 active clinical trials promoted

More than 15% of patients treated in FCCC are included in a clinical trial (compared to 8.5% on average in French healthcare centers)

 

 

 

The R&D of Unicancer :

1st academic sponsor of oncology clinical trials in Europe

Approximately 6 300 patients included and more than 57000 patients registered in the ESMÉ database

17 research groups, internationally renowned, including 6 labeled by INCa

100 active clinical trials promoted by the Unicancer R&D department

 

 

 

 

The research results of Unicancer R&D presented at ESMO 2020

 

Oral presentations

Online on the ESMO 2020 website: 09/19/2020

Promoted by Unicancer, the PRODIGE 23 study investigated the role of neoadjuvant mFOLFIRINOX before preoperative chemoradiation (CRT), with TME-surgery and adjuvant chemotherapy (CT) in resectable locally advanced rectal cancer. This study is a phase III multicenter randomized clinical trial. Eligible patients had cT3 or cT4, M0 rectal adenocarcinomas <15 cm from the anal verge, age 18-75 years, and WHO PS ≤1. Primary endpoint was 3-year disease free survival (DFS). Secondary endpoints were ypT0N0 rate, OS, metastasis-free survival (MFS) and QoL. 431 patients were randomly assigned in 2 Arm A/B. In Arm A, patients received preop CRT (50 Gy, 2 Gy/fraction [fr]; 25 fr + capecitabine), surgery, then adjuvant CT for 6 months. In Arm B, patients received 6 cycles of mFOLFIRINOX every 2 weeks, followed by the same preop CRT, surgery and 3 months of adjuvant CT. Adjuvant CT consisted of mFOLFOX6 or capecitabine, depending on the centre’s choice for all patients.

It can be concluded that neoadjuvant mFOLFIRINOX plus CRT is safe, preserves the quality of resection and significantly increased ypCR rate, DFS, and MFS. Patients treated with neoadjuvant chemotherapy had more symptoms during chemotherapy, but benefits from longer time to QoL deterioration for rectal functional outcomes.

Unicancer Gastro-intestinal Group (UCGI) : 

This cooperative group brings together multidisciplinary French experts (oncologists, radiotherapists, surgeons, etc.) developing clinical trials in the gastrointestinal field.

Learn more

 

Online on the ESMO 2020 website: 20/09/2020, h. 16h20 - Channel 1

 

AcSé Pembrolizumab Study

High clinical benefit rates of single agent pembrolizumab in selected rare sarcoma histotypes: First results of the AcSé Pembrolizumab study

Presentation Number: 1619O

Speaker: Jean-Yves Blay (Lyon, France)

Presenter: Pr Jean-Yves Blay, Centre Léon Bérard, Lyon, France

Presentation nr: 1619O

 

Here we report the first results of pembrolizumab in the rare sarcoma cohort. Pembrolizumab provides prolonged PFS in selected subtypes of rare sarcomas (chordoma (35%), alveolar soft-part sarcoma (ASPS, 58%), desmoplastic small round cell tumor (DSRCT, 8%), smarca4-malignant rhabdoid tumor (SMBT, 62,5%).

AcSé Programme

Carried out since June 2013 by French entities INCa and ANSM, the AcSé programme (Secured access to innovative targeted therapies) aims to provide controlled and equitable access to therapeutic innovation in France. ACSé immunotherapy program is investigating in multiple phase II single arm cohorts the efficacy and tolerance of an anti-PD-1 (nivolumab and pembrolizumab) in patients with metastatic rare tumors types which are resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available.

Learn more

 

Online on the ESMO 2020 website: 20/09/2020, h. 16h44 - Channel 3

AcSé Nivolumab Study

High activity of Nivolumab in patients with pathogenic exonucleasic domain POLE (edPOLE) mutated Mismatch Repair proficient (MMRp) advanced tumors

Presenter: Dr Benoît Rousseau, hôpital Henri-Mondor, Créteil, France

Presentation nr: 526O / Abstract #1755

 

We report here the initial results of nivolumab in the POLE exonuclease domain mutation cohort. The benefit of nivolumab seems restricted to patients with pathogenic mutations (ORR 50%) or with mutations with unknown significance (ORR 66%) observed mostly in mutated mismatch repair proficient (MMRp) advanced colorectal cancers (adenocarcinoma and high grade neuroendocrine) and endometrioid adenocarcinoma. AcSé Nivolumab POLE cohort reached its primary endpoint.

AcSé Programme

Carried out since June 2013 by French entities INCa and ANSM, the AcSé programme (Secured access to innovative targeted therapies) aims to provide controlled and equitable access to therapeutic innovation in France. ACSé immunotherapy program is investigating in multiple phase II single arm cohorts the efficacy and tolerance of an anti-PD-1 (nivolumab and pembrolizumab) in patients with metastatic rare tumors types which are resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available. 

Learn more

NIVOREN PRTK study

Kidney ccRCC Immune Classification (KIC) enhances the predictive value of T effector (Teff) and angiogenesis (Angio) signatures in response to Nivolumab (N)

Presenters: Dr Laurence Albiges, Gustave Roussy, Villejuif, France; Dr M. Meylan, Paris, France

 

Unicancer Genitourinary Group (GETUG) :

The Unicancer Genitourinary Group (GETUG) is developing cancer research programs on the male urological and genital tract. This cooperative group of experts defines the axes of research and the corresponding clinical trials.

Learn more

ORL 09 - TOPNIVO study

A safety study of nivolumab in patients with recurrent and/or metastatic platinium-refractory squamous cell carcinoma of the head and neck (R/M SCCHN): interim analysis on 199 patients, on behalf of the Unicancer H&N group and the GORTEC

Presenter: Dr C. Even, Gustave Roussy, Villejuif, France

Coordinateur étude ORL 09 TOPNIVO

 

In the randomized phase III Study TOPNIVO, Nivolumab demonstrated significant overall survival benefit with favorable safety profile for platinum refractory R/M SCCHN. The objectives of the current study were to provide additional insights into the frequency of high-grade adverse events related to Nivolumab and the efficacy of Nivolumab in real life. The final analysis of the TOPNIVO study shows no additional toxicities of Nivolumab compared to what was previously described, and confirms the previous results in terms of efficacy with new data for prognostic factors.

Groupe Unicancer Head & Neck :

Member of the Head&Neck Intergroup labelled by the French Institute INCa alongside the GORTEC, GETTEC and GERCOR groups, this group's major ambition is to develop and carry out innovative phase I-II clinical trials in head and neck cancers.

Learn more

 

CANTO study

Longitudinal Evaluation of Serum Assessed Non-Adherence to Tamoxifen (TAM) among Premenopausal Patients (pts) in the prospective multicenter CANTO cohort

Presenter: Dr B. Pistilli, Gustave Roussy, Villejuif, France

 

Unicancer French Breast Cancer Intergroup (UCBG) :

This group’s objective is to promote and develop innovative clinical trials to improve the care of patients with breast cancer. The CANTO study in particular aims to describe the toxicities of treatments administered for breast cancer, to identify populations likely to develop them and to adapt treatments accordingly, in order to ensure a better quality of life to all patients.

Learn more

 

CANTO study

Long-term patient reported outcomes (PRO) and hematologic toxicity among patients (pts) who received Granulocyte-Colony Stimulating Factors (G-CSF) during chemotherapy (CT) for early breast cancer (EBC)

Presenter: Dr P. Lapidari

 

Unicancer French Breast Cancer Intergroup (UCBG) :

This group’s objective is to promote and develop innovative clinical trials to improve the care of patients with breast cancer. The CANTO study in particular aims to describe the toxicities of treatments administered for breast cancer, to identify populations likely to develop them and to adapt treatments accordingly, in order to ensure a better quality of life to all patients.

Learn more

 

Sarcome 12/Regobone 

Results of the randomized, placebo (pla)-controlled phase ii study evaluating the efficacy and safety of regorafenib (rego) in patients (pts) with metastatic relapsed Ewing sarcoma, on behalf of the French Sarcoma Group (fsg) and Unicancer

Presenter: Dr F. Duffaud, AP-HM La Timone, Marseille, France

Coordonnateur étude Sarcome 12/Regobone

 

REGOBONE is non-comparative phase 2, double-blind, PL-controlled trial designed to evaluate the activity and safety of regorafenib, in 5 independent cohorts of sarcoma originating in bone. Results for the Ewing Sarcoma cohort show that, despite a PFR at 8 weeks lower than expected, this randomized non comparative study shows a promising signal of benefit of regorafenib in relapsed Ewing Sarcoma, with a median of PFS of 11.4 weeks, and a moderate toxicity.

Unicancer Sarcoma Group

Learn more

 

Posters

 

GETUG

Study: /

A prospective phase II study of Gemcitabine + platinum salt in combination with bevacizumab for kidney metastatic medullary and collecting duct carcinoma (GETUG-AFU 24, BEVABEL trial)

 

 

GETUG

Study: GETUG-AFU 26 / NIVOREN

Primary tumor response in patients treated with nivolumab for metastatic renal cell carcinoma - Results of the GETUG-AFU 26 NIVOREN trial.

 

GIO (Immuno-oncology group)

Study: AcSé Nivolumab​

AcSé immunotherapy trials: anti-PD-1 therapy for adult patients with selected rare cancer types.

 

 

GIO (Immuno-oncology group)

Study: AcSé Pembrolizumab

AcSé immunotherapy trials: anti-PD-1 therapy for adult patients with selected rare cancer types.

 

UCGI

Study: PRODIGE 12 - ACCORD 18

Individual patient data meta analysis of adjuvant gemcitabine based chemotherapy for biliary tract cancer: combined analysis of the BCAT and PRODIGE 12 studies.

 

UCGI

Study: PRODIGE 65 - UCGI 36 -  GEMPAX

A Unicancer Phase III randomized study evaluating gemcitabine and paclitaxel versus gemcitabine alone after FOLFIRINOX failure or intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

 

Unicancer Head & Neck

Study:  ORL 09 - TOPNIVO

Germinal immunogenetics and response to Nivolumab in recurrent/metastatic head and neck squamous cell carcinoma patients: TOPNIVO ancillary study

 

UCBG

Study:  CANTO

Breast cancer and perceived discrimination in the workplace: A longitudinal cohort study.

 

UCBG

Study:  PADA-1

ESR1 mutations and outcomes in BRCA1/2 or PALB2 germline mutation carriers receiving first line aromatase inhibitor + palbociclib (AI+P) for metastatic breast cancer (MBC) in the PADA-1 trial.

 

MED PERSO (Personalised Medecine Group)

Study:  SAFIR 02 LUNG

Durvalumab (D) compared to maintenance chemotherapy (SoC) in patients (pst) with metastatic non-small cell lung cancer (NSCLC): Results from the randomized SAFIR02 LUNG-IMMUNO trial.

 

MED PERSO (Personalised Medecine Group)

Study:  MOVIE

Metronomic oral vinorelbine (MOV) combined with tremelimumab (T) + durvalumab (D) in advanced solid tumors (AST): dose finding results.

 

MED PERSO (Personalised Medecine Group)

Study: MOVIE

Metronomic oral vinorelbine (MOV) combined with tremelimumab (T) + durvalumab (D): efficacy and safety preliminary results of the advanced breast cancer (ABC) patients (pts) cohort of the MOVIE study.

 

MED PERSO (Personalised Medecine Group)

Study: AcSé Vemurafanib

Vemurafenib in non melanoma V600 and non V600 BRAF mutated cancers: results of the ACSE basket trial.

 

Research in the French Comprehensive Cancer Centers presented at ESMO 2020

Non-exhaustive list - Please look on the website of each center for more information

 

Oral presentations

Centre Antoine Lacassagne, Nice

18/09/2020, Session Gastro intestinal, mini-oral

Clinical relevance of MIR27A rs895819 polymorphism and its interaction with DPYD variants for predicting grade 4-5 fluoropyrimidine toxicity in the FUSAFE individual patient data meta-analysis

Abstract # : 1846

Author: M.-C. Etienne-Grimaldi

 

Centre Léon Bérard, Lyon / Centre François Baclesse, Caen / Gustave Roussy, Villejuif

18/09/2020, Session Mini Oral - SARS-CoV-2 and cancer 1

The GCO-002 CACOVID-19 cohort: A French nationwide multicenter study of COVID-19 infected cancer patients and consequences on cancer management

Authors: I.L. Ray-Coquard, J. Thariat, P. Gorphe

 

Centre Antoine Lacassagne, Nice

19/09/2020, 12h30

Pembrolizumab versus cetuximab, concomitant with radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Results of the GORTEC 2015-01 “PembroRad” randomized trial

Presentation # : LBA38

Author: ​Pr J. Guigay

 

Institut Curie, Paris

19/09/2020, 17h04 - Channel 1

A randomized phase 3 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC)

Presentation #: LBA17

Author: Dr D. Loirat

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

20/09/2020, 14h25 - Channel 2

LEAP-005: Phase 2 Study of Lenvatinib (Len) Plus Pembrolizumab (Pembro) in Patients (Pts) With Previously Treated Advanced Solid Tumors

Presentation # : LBA41

Author: Dr C. Gomez-Roca

 

Centre Oscar Lambret, Lille - Gustave Roussy, Villejuif

20/09/2020, 18h30 - Channel 1

An international randomized trial, comparing post-operative conformal radiotherapy (PORT) to no PORT, in patients (pts) with completely resected non-small cell lung cancer (NSCLC) and mediastinal N2 involvement. Primary end-point analysis of Lung ART (IFCT-0503, UK NCRI, SAKK)

Abstract # : LBA3_PR

Author: Dr C. Le Pechoux

 

Centre Antoine Lacassagne, Nice

21/09/2020, 16h20

Results from the phase 2 BIOmarker driven trial with Nivolumab (N) and Ipilimumab or VEGFR tyrosine Kinase inhibitor (TKI) in naïve metastatic Kidney cancer (m-ccRCC) patients (pts): the BIONIKK trial.

Presentation # : LBA25

Author: Dr D. Borchiellini

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

17/10/2020, 12h10 - Channel 3​

Established and new treatments, old and new toxicities (in collaboration with MASCC), session “Skin toxicity: More than just a rash”

Author: Dr V. Sibaud

 

Posters

Centre Antoine Lacassagne, Nice

Evaluation of practice variation for cancer patients care in a French cancer center during the COVID-19 outbreak

Poster # : 1691P

Author: Dr D. Borchiellini

 

Centre Antoine Lacassagne, Nice

Avelumab (anti-PD-L1) in patients with platinum-refractory/ineligible recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Results from a phase Ib cohort 

Poster # : 920P

Author: Pr J. Guigay

 

Centre Antoine Lacassagne, Nice

Germinal immunogenetics and response to nivolumab in recurrent/metastatic head and neck squamous cell carcinoma (RM HNSCC) patients (pts): TopNIVO ancillary study 

Poster # : 946P

Dr E. B. Saada

 

Centre Antoine Lacassagne, Nice

Metastatic renal medullary and collecting duct carcinoma in the era of antiangiogenic and immune checkpoint inhibitors: A multicentric retrospective study 

Poster # : 735P

Author: Dr D. Borchiellini

 

Centre Antoine Lacassagne, Nice

Urachal carcinoma: Large retrospective multicentric GETUG-AFU study 

Poster # : 788P

Author: Dr D. Borchiellini

 

Centre Antoine Lacassagne, Nice

A randomized phase I-II trial evaluating efficacy and safety of dose dense MVAC (ddMVAC) + durvalumab +/- tremelimumab as neoadjuvant treatment in patients with bladder muscle-invasive urothelial carcinoma

Poster # : 1059P - NEMIO

Author: Dr D. Borchiellini

 

Centre Oscar Lambret, Lille 

Association between hospital stays with infection and overall survival in patients treated with ipilimumab, analysis of the French nationwide exhaustive hospital discharge database (PMSI)

Poster # : 1115P

Author: P.-Y. Cren 

 

Centre Oscar Lambret, Lille 

FOLFIRINOX relative dose intensity and disease control in advanced pancreatic adenocarcinoma

Poster # : 1531P

Author: A. Vary

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

The impact of patients’ and physicians’ characteristics on surgery decision for head and neck cancer: Results of a national survey

Poster # : 933P

Author: A. Dupret-Bories

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

Safety and efficacy of Xevinapant (Debio 1143), an antagonist of inhibitor of apoptosis proteins (IAPs),
in combination with nivolumab in a Phase Ib/II trial in patients failing prior PD-1/PD-L1 treatment

Abstract # 1520 / Poster # : 560P

Author: C. Gomez Roca & i. Korakis

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

Cabozantinib in non-clear-cell metastatic renal cell carcinoma and sarcomatoid renal cell carcinoma: real-world data from the CABOREAL study

Poster # : 732P

Author: C. Chevreau

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

Primary tumor response in patients treated with nivolumab for metastatic renal cell carcinoma - Results of the GETUG-AFU 26 NIVOREN trial.

Author: C. Chevreau

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

METASYN: Patterns of care and outcomes of 417 METAstatic SYNovial sarcoma: Real-Life Data French Sarcoma Group (FSG)

Author: C. Chevreau

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

Oligometastatic breast cancer incidence and clinical presentation at diagnosis: about 131 case

Poster # : 320P

Author: J. Lacaze

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

Clinical relevance of MIR27A rs895819 polymorphism and its interaction with DPYD variants for predicting grade 4-5 fluoropyrimidine (FP) toxicity (tox) in the FUSAFE individual patient data meta-analysis (IPD-MA) 

Abstract # : 1846

Author: F. Thomas

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

First real-life data on olaparib in 1st line maintenance BRCA1/2 mutated Epithelial Ovarian Cancer in France: Descriptive analysis of 201 patients enrolled in the Cohort Temporary Authorization for Use (ATUc)

Poster # : 827P

Author: L. Gladieff

 

Institut Claudius Regaud - IUCT Oncopole, Toulouse

Balstilimab (anti-PD-1) Alone and in Combination with Zalifrelimab (anti-CTLA-4) for Recurrent/Metastatic (R/M) Cervical Cancer (CC) Preliminary Results of Two Independent Ph2 Trials (NCT03104699 and NCT03495882)

Abstract # : 5401

Author: L. Gladieff