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.
Nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer : long-term survival from a phase III trial / D. Goldstein, R.H. El-Maraghi, P. Hammel, V. Heinemann, V. Kunzmann, J. Sastre, W. Scheithauer, S. Siena, J. Tabernero, L. Teixeira, G. Tortora, J. Van Laethem, R. Young, D.N. Penenberg, B. Lu, A. Romano, D.D. Von Hoff. - In: JOURNAL OF THE NATIONAL CANCER INSTITUTE. - ISSN 0027-8874. - 107:2(2015), pp. 413.1-413.10.
|Titolo:||Nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer : long-term survival from a phase III trial|
|Parole Chiave:||Adenocarcinoma; Adult; Aged; Albumins; Antigens, Tumor-Associated, Carbohydrate; Antineoplastic Combined Chemotherapy Protocols; Deoxycytidine; Disease-Free Survival; Drug Administration Schedule; Female; Follow-Up Studies; Humans; International Cooperation; Kaplan-Meier Estimate; Liver Neoplasms; Lymphocytes; Male; Middle Aged; Neutrophils; Paclitaxel; Pancreatic Neoplasms; Prognosis; Treatment Outcome; Tumor Markers, Biological; Cancer Research; Oncology; Medicine (all)|
|Settore Scientifico Disciplinare:||Settore MED/06 - Oncologia Medica|
|Data di pubblicazione:||2015|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1093/jnci/dju413|
|Appare nelle tipologie:||01 - Articolo su periodico|