David Goldstein1, Robert Hassan El-Maraghi2, Pascal Hammel2, Volker Heinemann2, Volker Kunzmann2, Javier Sastre2, Werner Scheithauer2, Salvatore Siena2, Josep Tabernero2, Luis Teixeira2, Giampaolo Tortora2, Jean-Luc Van Laethem2, Rosemary Young2, Darryl Neil Penenberg2, Brian Lu2, Alfredo Romano2, Daniel D Von Hoff2. 1. 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). david.goldstein@sesiahs.health.nsw.gov.au. 2. 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).
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.
RCT Entities:
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.
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