Publications by authors named "Rinaldi Y"

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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Article Synopsis
  • The study investigates predictive markers for the benefits of LV5FU2 maintenance therapy after first-line FOLFIRINOX treatment in patients with metastatic pancreatic cancer.
  • It compares two patient groups from the PRODIGE-35 trial: one receiving 12 cycles of FOLFIRINOX, and another receiving 8 cycles followed by LV5FU2 maintenance.
  • Results indicate that certain factors, like age and metastatic sites, affect patient outcomes, suggesting that LV5FU2 maintenance is generally beneficial except for some specific cases.
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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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Purpose: GEMPAX was an open-label, randomized phase III clinical trial designed to assess the efficacy and tolerability of gemcitabine plus paclitaxel versus gemcitabine alone as second-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who previously received 5-fluorouracil, oxaliplatin, and irinotecan.

Methods: Patients with histologically or cytologically confirmed mPDAC were randomly assigned (2:1) to receive GEMPAX (paclitaxel 80 mg/m + gemcitabine 1,000 mg/m; IV; once at day (D) 1, D8, and D15/arm A) or gemcitabine (arm B) alone once at D1, D8, and D15 every 28 days until progression, toxicity, or patient's decision. The primary end point was overall survival (OS).

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Background: Colon adenocarcinoma mainly occurs in older patients. Oxaliplatin-based adjuvant chemotherapy improved disease-free survival after stage III colon cancer resection, but this improvement was not demonstrated in older patients.

Methods: The purpose of ADAGE-PRODIGE 34, randomized open phase III trial is to compare in patients over 70 years oxaliplatin plus fluoropyrimidine with fluoropyrimidine alone in fit patients (Group 1) and fluoropyrimidine with observation in frail patients (Group 2) after resection of stage III colon adenocarcinoma.

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Background: Colorectal cancer (CRC) screening with fecal immunochemical test (FIT) remains low in France, particularly in the Provence-Alpes-Côte-d'Azur (PACA) region. The aim of this study was to compare insured persons (50-74 years) who had FIT and/or colonoscopy in PACA with the general French population.

Methods: FIT and colonoscopy rates were calculated according to SP-France and National Health Data System data.

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Objective: The prognostication of metastatic pancreatic adenocarcinoma (mPDAC) patients remains uncertain, mainly based on carbohydrate antigen 19-9 (CA19-9), with limited utility. Circulating tumour DNA (ctDNA) has been suggested as a prognostic factor, but its added value has been poorly explored. The objective was to determine whether ctDNA is an independent factor for the prognostication of mPDAC.

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Article Synopsis
  • The COVID-19 pandemic led to significant decreases in cancer screenings and referrals, but its specific effects on cancer management, especially in metastatic colorectal cancer (mCRC) patients, had not been quantitatively studied until now.
  • This study compared tumor burden in mCRC patients diagnosed before versus after the lockdown in France, utilizing the PANIRINOX clinical trial data, which involved blood samples for tumor analysis from 80 patients.
  • Results indicated that patients diagnosed after the lockdown had a statistically higher concentration of circulating tumor DNA (ctDNA), suggesting a greater tumor burden in those diagnosed during that period.
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Purpose: Metastatic pancreatic cancer (mPC) still harbors a dismal prognosis. Our previous trial (PRODIGE 4-ACCORD 11) demonstrated the superiority of 6-month chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) over gemcitabine for overall survival. The high limiting oxaliplatin-related neurotoxicity supports the evaluation of an oxaliplatin stop-and-go strategy and a sequential strategy in mPC.

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Introduction: The rate of participation in organized colorectal cancer screening (DOCCR) remains insufficient in France, with strong disparities between departments.

Purpose Of Research: The aim of this work was to assess the relationship between the DOCCR response rates for the communes of the Bouches-du-Rhône (BdR) department and the boroughs of Marseille and their poverty levels. The DOCCR response rate was assessed for the 2017-2018 campaign.

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Liver transection is the most challenging part of hepatectomy due to the risk of hemorrhage which is associated with postoperative morbidity and mortality and reduced long-term survival. Parenchymal ultrasonic dissection (UD) with bipolar coagulation (BPC) has been widely recognized as a safe, effective, and standard technique during open and laparoscopic hepatectomy. We here introduce our technique of robotic liver transection using UD with BPC and report on short-term perioperative outcomes.

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Background: Chemotherapy is effective in metastatic pancreatic adenocarcinoma (mPA), but new approaches are still needed to improve patients' survival and quality of life. We have previously published good efficacy and tolerability results on a sequential treatment strategy of gemcitabine followed by an intensified FOLFIRI (5FU+irinotecan) regimen. In the present study, we evaluated the same sequence but replaced gemcitabine by the new gemcitabine + nab-paclitaxel standard first-line combination.

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Background: Trans-arterial chemoembolization (TACE) is one first-line option therapy for patients with hepatocellular carcinoma (HCC) not suitable for surgical resection.

Aims: We evaluated the effects of sunitinib plus doxorubicin-TACE on bleeding or liver failure.

Methods: Seventy-eight patients with HCC were included in this randomized, double-blind study.

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Article Synopsis
  • * Results showed that a baseline splenic volume greater than 180 mL linked to poorer progression-free survival (PFS) but had no significant impact on overall survival (OS).
  • * Additionally, larger splenic volume correlated with higher levels of circulating myeloid-derived suppressor cells (mMDSC), indicating that splenomegaly may reflect immune system changes in these patients.
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Background: Regorafenib significantly increases overall survival (OS) in patients with metastatic colorectal cancer previously treated but gives toxicities.

Objectives: to assess the efficacy and safety of regorafenib at it's approved dose in the older population.

Patients And Methods: This multicenter single-arm phase II enrolled patients ≥70 years old after the failure of fluoropyrimidine-based chemotherapy, anti-VEGF, and anti-EGFR treatment.

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Purpose: Older patients with colon cancer (CC) are vulnerable to chemotherapy toxicity and death. Establishing simple scores specific for patients with CC to predict severe chemotoxicity or early death is needed to select the best treatment strategy.

Subjects, Materials, And Methods: This prospective multicenter study included patients aged ≥70 years with CC receiving adjuvant or first-line metastatic chemotherapy.

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Purpose: The objective of this study was to build and validate a radiomic signature to predict early a poor outcome using baseline and 2-month evaluation CT and to compare it to the RECIST1·1 and morphological criteria defined by changes in homogeneity and borders.

Methods: This study is an ancillary study from the PRODIGE-9 multicentre prospective study for which 491 patients with metastatic colorectal cancer (mCRC) treated by 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) and bevacizumab had been analysed. In 230 patients, computed texture analysis was performed on the dominant liver lesion (DLL) at baseline and 2 months after chemotherapy.

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Background: Older patients have frailty characteristics that impair the transposition of treatment results found in younger patients. Predictive factors are needed to help with treatment choices for older patients. The PRODIGE 20 study is a randomized phase II study that evaluated chemotherapy associated with bevacizumab (BEV) or not (CT) in patients aged 75 years or older.

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Background: Metastatic colorectal cancer frequently occurs in elderly patients. Bevacizumab in combination with front line chemotherapy (CT) is a standard treatment but some concern raised about tolerance of bevacizumab for these patients. The purpose of PRODIGE 20 was to evaluate tolerance and efficacy of bevacizumab according to specific end points in this population.

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Background: The combination of an anti-VEGF or an anti-EGFR-targeted monoclonal antibody with chemotherapy has shown clinical activity in patients with metastatic colorectal cancer. However, combining both anti-VEGF and anti-EGFR antibodies with chemotherapy in first-line treatment resulted in adverse outcomes. We assessed whether the combination of erlotinib, an EGFR tyrosine kinase inhibitor, with bevacizumab could increase the efficacy of maintenance therapy in patients with unresectable metastatic colorectal cancer.

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Background/aim: Sociodemographic factors associated with colorectal cancer screening participation have been extensively analysed although few, if any, studies have focused on regional/geographical factors as determinants of non-participation rates. The purpose of this study was to investigate the effects of individual and geographical determinants on the variable participation rates seen for colorectal cancer screening.

Methods: The study population comprised 183,978 individuals in the first round of screening and 175,596 in the second round, all of whom were residents of the city of Marseille in France.

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Objectives: The French colorectal cancer screening program has planned a stepwise strategy for delivery of a fecal occult blood test kit (Hemocult II) with an initial medical phase followed by systematic mailing of the test. Our aim was to ascertain the cost effectiveness of another recall method.

Methods: In the Bouches-du-Rhône administrative area, we conducted a cost effectiveness study comparing two second line delivery methods: mailing the test kit systematically to all non-responders to the initial medical phase (conventional strategy) and mailing the test kit to non-responders to the initial medical phase who requested a kit after receiving a recall letter (experimental strategy).

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