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Pancreatic Neoplasms: HELP
Articles by Robert Hassan El-Maraghi
Based on 3 articles published since 2009
(Why 3 articles?)

Between 2009 and 2019, Robert El-Maraghi wrote the following 3 articles about Pancreatic Neoplasms.
+ Citations + Abstracts
1 Clinical Trial Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. 2016

Chiorean, E Gabriela / Von Hoff, Daniel D / Tabernero, Josep / El-Maraghi, Robert / Ma, Wen Wee / Reni, Michele / Harris, Marion / Whorf, Robert / Liu, Helen / Li, Jack Shiansong / Manax, Victoria / Romano, Alfredo / Lu, Brian / Goldstein, David. ·Division Oncology, Department of Medicine, University of Washington, 825 Eastlake Avenue E, G4-833, Seattle, WA 98109-1023, USA. · Translational Genomics Research Institute and HonorHealth, 445 North Fifth Street, Suite 600, Phoenix, AZ 85004, USA. · Vall d'Hebron Institute of Oncology (VHIO), P Vall d'Hebron 119-129, Barcelona 08035, Spain. · Royal Victoria Hospital Barrie Canada, 201 Georgian Drive, Barrie, Ontario, Canada L4M 6M2. · Roswell Park Cancer Institute, 665 Elm Street, Buffalo, NY 14203, USA. · San Raffaele Scientific Institute, Via Olgetina 60, 20132 Milan, Italy. · Monash Health, 246 Clayton Road, Melbourne VIC 3168, Australia. · Florida Cancer Specialists, 2401 60th Street Ct W, Bradenton, FL 34209-5500, USA. · Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901, USA. · Department of Medical Oncology, Prince of Wales Hospital, South Sydney Illawarra, Barker Street, Sydney NSW 2031, Australia. ·Br J Cancer · Pubmed #27351217.

ABSTRACT: BACKGROUND: This exploratory analysis evaluated second-line (2L) therapy for metastatic pancreatic cancer in a large phase 3 trial (MPACT). METHODS: Patients who received first-line (1L) nab-paclitaxel+gemcitabine (nab-P+Gem) or Gem were assessed for survival based on 2L treatment received. Multivariate analyses tested influence of treatment effect and prognostic factors on survival. RESULTS: The majority of 2L treatments (267 out of 347, 77%) contained a fluoropyrimidine (5-fluorouracil or capecitabine). Median total survival (1L randomisation to death) for patients who received 2L treatment after 1L nab-P+Gem vs Gem alone was 12.8 vs 9.9 months (P=0.015). Median total survival for patients with a fluoropyrimidine-containing 2L therapy after nab-P+Gem vs Gem was 13.5 vs 9.5 months (P=0.012). Median 2L survival (duration from start of 2L therapy to death) was 5.3 vs 4.5 months for nab-P+Gem vs Gem, respectively (P=0.886). Factors significantly associated with longer post-1L survival by multivariate analyses included 1L nab-P+Gem, receiving 2L treatment, longer 1L progression-free survival, and Karnofsky performance status⩾70 and neutrophil-to-lymphocyte ratio⩽5 at the end of 1L treatment. CONCLUSIONS: These findings support the use of 2L therapy for patients with metastatic pancreatic cancer. Fluoropyrimidine-containing treatment after 1L nab-P+Gem is an active regimen with significant clinical effect.

2 Clinical Trial nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. 2016

Tehfe, Mustapha / Dowden, Scot / Kennecke, Hagen / El-Maraghi, Robert / Lesperance, Bernard / Couture, Felix / Letourneau, Richard / Liu, Helen / Romano, Alfredo. ·Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada. mustapha.tehfe.chum@ssss.gouv.qc.ca. · Tom Baker Cancer Centre, Calgary, AB, Canada. · British Columbia Cancer Agency, Vancouver, BC, Canada. · Royal Victoria Regional Health Centre, Barrie, ON, Canada. · Hôpital du Sacré-Coeur de Montreal, Montreal, QC, Canada. · Centre hospitalier universitaire de Québec (CHUQ), Hôtel-Dieu de Quebec, CHUM, Montreal, QC, Canada. · Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada. · Celgene Corporation, Summit, NJ, USA. ·Adv Ther · Pubmed #27085323.

ABSTRACT: INTRODUCTION: The phase III MPACT trial in patients with metastatic pancreatic cancer (MPC) demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) compared with Gem monotherapy, including the primary endpoint of overall survival (OS; median 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P < 0.001). A significant treatment difference favoring nab-P + Gem over Gem was observed for OS in patients treated in North America. The majority of patients were from the US (88%) with only 12% from Canada. Healthcare systems and treatment patterns are different between the 2 countries, and there is limited published information on outcomes of Canadian patients treated with first-line nab-P + Gem. This analysis evaluated efficacy and safety outcomes in Canadian patients in the MPACT trial. METHODS: Treatment-naive patients with MPC (N = 861) received either nab-P 125 mg/m(2) + Gem 1000 mg/m(2) on days 1, 8, and 15 every 4 weeks or Gem 1000 mg/m(2) weekly for the first 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle ≥2). RESULTS: The MPACT trial enrolled 63 patients in Canada. Baseline characteristics were well balanced and comparable with those of the intent-to-treat population. Both OS (median 11.9 vs. 7.1 months; HR 0.76; P = 0.373) and progression-free survival (median 7.2 vs. 5.2 months; HR 0.65; P = 0.224) were numerically longer and overall response rate (27% vs. 17%; P = 0.312) was numerically higher with nab-P + Gem vs. Gem. The most common grade ≥3 adverse events with nab-P + Gem vs. Gem were neutropenia (22% vs. 10%), fatigue (34% vs. 33%), and neuropathy (25% vs. 0%). CONCLUSION: This subanalysis confirmed that nab-P + Gem is an efficacious treatment option and has a manageable safety profile in patients with MPC treated in Canada. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT00844649. FUNDING: Celgene Corporation, Summit, NJ, USA.

3 Clinical Trial nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. 2015

Goldstein, David / El-Maraghi, Robert Hassan / Hammel, Pascal / Heinemann, Volker / Kunzmann, Volker / Sastre, Javier / Scheithauer, Werner / Siena, Salvatore / Tabernero, Josep / Teixeira, Luis / Tortora, Giampaolo / Van Laethem, Jean-Luc / Young, Rosemary / Penenberg, Darryl Neil / Lu, Brian / Romano, Alfredo / Von Hoff, Daniel D. ·Prince of Wales Hospital, University of New South Wales, Sydney, NSW, Australia (DG) · Royal Victoria Regional Health Centre, Barrie, ON, Canada (RHEM) · Hôpital Beaujon, Clichy, France (PH) · Klinikum Grosshadern, University of Munich, Munich, Germany (VH) · Universitätsklinikum Würzburg, Würzburg, Germany (VK) · Hospital Clinico San Carlos, Madrid, Spain (JS) · Medizinische Universität Wien, Wien, Austria (WS) · Ospedale Niguarda Ca' Granda, Milan, Italy (SS) · Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain (JT) · Hôpital Saint Antoine, Paris, France (LT) · Azienda Ospedaliera Universitaria Integrata and University of Verona, Verona, Italy (GT) · Hôpital Erasme, Brussels, Belgium (JLVL) · Royal Hobart Hospital, Hobart, Australia (RY) · Celgene Corporation, Summit, NJ (DNP) · Celgene Corporation, Summit, NJ (BL) · Celgene Corporation, Boudry, Switzerland (AR) · Virginia G. Piper Cancer Center at Scottsdale Healthcare/TGen, Scottsdale, AZ (DDVH). ·J Natl Cancer Inst · Pubmed #25638248.

ABSTRACT: BACKGROUND: Positive findings from the phase III MPACT trial led to the regulatory approval of nab-paclitaxel plus gemcitabine as a treatment option for patients with metastatic pancreatic cancer. This report is an update of overall survival (OS) based on longer follow-up. METHODS: Patients (n = 861) with metastatic pancreatic cancer and a Karnofsky performance status of 70 or greater were randomly assigned one to one to receive nab-paclitaxel + gemcitabine or gemcitabine alone. Efficacy data for this post hoc analysis were collected through May 9, 2013. Exploratory analyses of carbohydrate antigen 19-9 (CA19-9) and neutrophil-to-lymphocyte ratio (NLR) were conducted. The primary efficacy endpoint was OS, which was analyzed for all randomly assigned patients by the Kaplan-Meier method. All statistical tests were two-sided. RESULTS: The median OS was statistically significantly longer for nab-paclitaxel plus gemcitabine vs gemcitabine alone (8.7 vs 6.6 months, hazard ratio [HR] = 0.72, 95% confidence interval [CI] = 0.62 to 0.83, P < .001). Long-term (>three-year) survivors were identified in the nab-paclitaxel plus gemcitabine arm only (4%). In pooled treatment arm analyses, higher CA19-9 level and NLR at baseline were statistically significantly associated with worse OS. There appeared to be a treatment effect for OS favoring nab-paclitaxel plus gemcitabine over gemcitabine alone in poor-prognosis subgroups defined by these factors (HR = 0.612, P < .001 for CA19-9 level ≥ median and HR = 0.81, P = .079 for NLR > 5). CONCLUSIONS: These data confirm and extend the primary report of OS, supporting the superior efficacy of nab-paclitaxel plus gemcitabine over gemcitabine alone. Subgroup analyses support the relevance of CA 19-9 and NLR as prognostic markers in metastatic pancreatic cancer.