Publications by authors named "Frederic Di Fiore"

Background & Aims: ERBB2 pathway activation, through amplification or activating mutations, represents a new target for colon cancer (CC) treatment. Molecular methods were compared with the gold standard for assessing ERBB2 status, and the prognostic value of ERBB2 amplification, mutations, and expression was determined using data from 2 phase 3 trials involving nearly 3000 patients with stage III CC.

Methods: In the PETACC8 trial, immunohistochemistry and fluorescence in situ hybridization, DNA, and RNA analysis were performed on 1813, 1719, and 1733 samples, respectively.

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Background: Sunitinib, a multitarget tyrosine kinase inhibitor, showed encouraging antitumor activity and manageable toxicity in patients with advanced midgut neuroendocrine tumors (NETs) in earlier results from phase I and II trials.

Patients And Methods: In this phase II trial, patients with a nonresectable grade 1 or 2 midgut progressive NET and Eastern Cooperative Oncology Group performance status 0-1 were randomly assigned 1:1 to receive 37.5 mg sunitinib or a placebo, combined with 120 mg lanreotide autogel every 28 days.

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Background: The incidence of glioblastoma in the elderly population is increasing as the worldwide population ages. The differential and poorer survival in the elderly population compared to younger patients is partially explained. The present study aimed to investigate the clinical impact of epidermal growth factor receptor EGFR-altered glioblastoma in a real-life elderly glioblastoma population.

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Aim: To evaluate R0/R1 resection rate in patients with colorectal liver metastases (CLM) treated with aflibercept plus FOLFIRI after failure of a prior oxaliplatin-based regimen in daily clinical practice.

Methods: This French, multicentre, prospective, observational cohort (NCT05178745) included patients with CLM (alone or predominant; up to 5 lung nodules <2 cm allowed) initiating aflibercept plus FOLFIRI every 2 weeks per physician choice. Primary endpoint was R0/R1 resection rate.

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Monitoring tumor evolution and predicting survival using non-invasive liquid biopsy is an unmet need for glioblastoma patients. The era of proteomics and metabolomics blood analyzes, may help in this context. A case-control study was conducted.

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Colorectal cancer (CRC) screening has been proven to reduce both mortality and the incidence of this disease. Most CRC screening programs are based on fecal immunochemical tests (FITs), which have a low participation rate. Searching for blood protein biomarkers can lead to the development of a more accepted screening test.

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Article Synopsis
  • The CABASTY study investigated the effects of biweekly administration of a lower dose of cabazitaxel on pain and quality of life for older men with metastatic castration-resistant prostate cancer (mCRPC).
  • In a trial involving 196 patients, researchers compared biweekly dosing (16 mg/m) to a standard triweekly dosing (25 mg/m) regarding pain progression and health-related quality of life (HRQoL).
  • Results showed no significant differences in pain progression or HRQoL between treatment groups, but the biweekly group experienced a delayed onset of some adverse events, suggesting it could be a safer option for older patients.
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Objective: To investigate in patients treated for a resectable pancreatic ductal adenocarcinoma [pancreatic adenocarcinoma (PA)], the prognostic value of baseline carbohydrate antigen 19.9 (CA19-9) and circulating tumor DNA (ctDNA) for overall survival (OS), to improve death risk stratification, based on a planned ancillary study from PANACHE01-PRODIGE 48 trial.

Background: Biological borderline situation that was first used by the MD Anderson, became a standard practice following the international consensus conference in 2016 to manage PA.

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Background: Cervical cancers are mainly caused by an oncogenic HPV. For locally advanced stages, the standard treatment is radio-chemotherapy (RTCT) followed by brachytherapy. Nevertheless, the prognosis remains highly heterogeneous between patients.

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Purpose: Relative dose intensity (RDI) is a measurement of chemotherapy (CT) dose defined as the actual dose received divided by the standard calculated dose during a set period. The study objective was to assess the impact of a RDI ≥ 80% on response and survival of patients treated in first line CT by FOLFOXIRI or FOLFIRINOX ± Bevacizumab (BV) for an unresectable metastatic colorectal cancer (mCRC).

Materials And Methods: It was a retrospective, non-interventional, multicenter study calculating RDI from the first cycles of CT to the first CT-scan evaluation (CT-scan1).

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CONTRIBUTIONS OF MOLECULAR BIOLOGY TO THE MANAGEMENT OF COLORECTAL CANCER. Colorectal cancer (CRC) is a major public health problem affecting almost 43.000 people a year and causing 17.

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Article Synopsis
  • Trifluridine/tipiracil (FTD/TPI) combined with oxaliplatin is being studied for its effectiveness and safety in patients with advanced gastric cancers who can't handle standard chemotherapy.
  • The research aims to compare this combination treatment against the standard FOLFOX regimen, focusing on improving progression-free survival (PFS).
  • The ongoing PRODIGE73-UCGI40-LOGICAN trial includes 118 patients and will provide valuable insights into treatment options for HER2 negative gastric cancer in a first-line setting.
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  • * Researchers analyzed 188 tumor samples, finding that 22.3% had predisposing conditions like Lynch syndrome and Crohn's disease, with mutations in genes such as KRAS and TP53 being most common.
  • * Results indicate that certain mutations relate to disease stage, with APC mutations linked to poorer survival in localized cases, while a defective mismatch repair (dMMR) status was associated with better overall survival rates.
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Importance: Efficacy of second-line chemotherapy in advanced gastric or gastrooesphageal junction (GEJ) adenocarcinoma remains limited.

Ojectives: To determine the efficacy of 1 or 2 immune checkpoint inhibitors combined with FOLFIRI (leucovorin [folinic acid], fluorouracil, and irinotecan) in the treatment of advanced gastric/GEJ adenocarcinoma.

Design, Setting, And Participants: The PRODIGE 59-FFCD 1707-DURIGAST trial is a randomized, multicenter, noncomparative, phase 2 trial, conducted from August 27, 2020, and June 4, 2021, at 37 centers in France that included patients with advanced gastric/GEJ adenocarcinoma who had disease progression after platinum-based first-line chemotherapy.

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Background: One randomized phase III trial comparing chemotherapy (CT) with immune checkpoint inhibitors (ICI) has demonstrated significant efficacy of ICI in deficient DNA mismatch repair system/microsatellite instability-high (dMMR/MSI-H) metastatic colorectal cancer. However, few studies have compared ICI with CT in other advanced dMMR/MSI-H digestive tumors.

Methods: In this multicenter study, we included patients with advanced dMMR/MSI-H non-colorectal digestive tumors treated with chemotherapy and/or ICIs.

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Background: Liquid biopsy application is still challenging in glioblastoma patients and the usefulness of short-length DNA (slDNA) fragments is not established. The aim was to investigate slDNA concentration as a prognostic marker in unresected glioblastoma patients.

Methods: Patients with unresected glioblastoma and treated by radiochemotherapy (RT/TMZ) were included.

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Objective: Endocrine therapy is frequently administered in patients with hormone dependent (HR+) metastatic endometrial cancer. ESR1 mutations have emerged as a key mechanism of aromatase inhibitor (AI) resistance in HR + metastatic breast cancer and can be monitored using circulating tumor DNA (ctDNA). The aim of this study was to explore the incidence and clinical relevance of circulating ESR1 mutations in patients treated by AI or megestrol acetate (M) for advanced endometrial carcinoma.

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Importance: Many patients 65 years or older with metastatic castration-resistant prostate cancer (mCRPC) are denied taxane chemotherapy because this treatment is considered unsuitable.

Objective: To determine whether biweekly cabazitaxel (CBZ), 16 mg/m2 (biweekly CBZ16), plus prophylactic granulocyte colony-stimulating factor (G-CSF) at each cycle reduces the risk of grade 3 or higher neutropenia and/or neutropenic complications (eg, febrile neutropenia, neutropenic infection, or sepsis) compared with triweekly CBZ, 25 mg/m2 (triweekly CBZ25), plus G-CSF (standard regimen).

Design, Setting, And Participants: A total of 196 patients 65 years or older with progressive mCRPC were enrolled in this prospective phase 3 randomized clinical trial conducted in France (18 centers) and Germany (7 centers) between May 5, 2017, and January 7, 2021.

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  • This study evaluated the effectiveness and safety of second-line tyrosine kinase inhibitors (TKIs) in patients with advanced hepatocellular carcinoma (HCC) who previously progressed after treatment with atezolizumab and bevacizumab.
  • A total of 82 patients were analyzed, with those receiving regorafenib showing significantly better overall survival (OS) compared to other TKIs like sorafenib, lenvatinib, and cabozantinib.
  • Safety results indicated that 20% of patients experienced grade 3 adverse events, but there were no severe grade 4 or 5 events reported.
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Importance: Only 1 randomized clinical trial has shown the superiority of immune checkpoint inhibitors in patients with deficient mismatch repair and/or microsatellite instability (dMMR/MSI) metastatic colorectal cancer (mCRC) in the first-line setting.

Objectives: To determine whether avelumab (an anti-programmed cell death ligand 1 antibody) improves progression-free survival (PFS) compared with standard second-line chemotherapy in patients with dMMR/MSI mCRC.

Design, Setting, And Participants: The SAMCO-PRODIGE 54 trial is a national open-label phase 2 randomized clinical trial that was conducted from April 24, 2018, to April 29, 2021, at 49 French sites.

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Background: The presence of a breast nurse is recommended to advise and guide early breast cancer patients before and during chemotherapy/radiation therapy, and at the end of planned treatments. Nevertheless, some patients will need extra guidance. Little is known about the predisposing factors for additional requests.

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Background: There is no standard second-line treatment after platinum-etoposide chemotherapy for gastroenteropancreatic neuroendocrine carcinoma. We aimed to evaluate the efficacy of FOLFIRI plus bevacizumab, and FOLFIRI alone, in this setting.

Methods: We did a randomised, non-comparative, open-label, phase 2 trial (PRODIGE 41-BEVANEC) at 26 hospitals in France.

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Article Synopsis
  • - This study looked at circulating tumor DNA (ctDNA) in patients with stage II colorectal cancer (CRC) who had surgery, using data from the PROGIGE 13 trial.
  • - Researchers matched patients who had recurrent cancer with those who did not, and analyzed ctDNA from blood samples using digital PCR to check for its impact on disease-free survival (DFS) and overall survival (OS).
  • - Results showed that ctDNA was more commonly found in patients whose cancer returned, with lower DFS and OS rates for those with detectable ctDNA, indicating a strong link between postoperative ctDNA presence and cancer recurrence or death.
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Background: The aim of the study was to prospectively evaluate different biomarkers to identify the most reliable for anticipating complications after major abdominal surgery for digestive cancer in older patients and compare their performance to the existing definition and screening algorithm of sarcopenia from EWGSOP.

Methods: Ninety-five consecutive patients aged over 65 years who underwent elective surgery for digestive cancer were prospectively included in the SAXO study. Sarcopenia was defined according to EWGSOP criteria (four level from no sarcopenia to severe sarcopenia).

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Background: Following European guidelines, patients with aggressive metastatic or locally advanced, non-resectable, duodeno-pancreatic (DP) neuroendocrine tumours (NETs) should receive systemic combination chemotherapy until progression. Aggressive disease is defined as progressive and/or symptomatic metastases with or without significant hepatic invasion (>30-50%), and/or bone metastases.

Methods: This academic randomised, double-blind, placebo-controlled phase II study aims to evaluate lanreotide autogel 120 mg (LAN) as maintenance treatment after at least 2 months of first-line treatment (L1) in aggressive G1-G2 DP-NET.

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