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Cited by 658

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.

nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer: Long-Term Survival From a Phase III Trial

Goldstein, D., El-Maraghi, R. H., Hammel, P., Heinemann, V., Kunzmann, V., Sastre, J., Scheithauer, W., Siena, S., Tabernero, J., Teixeira, L., Tortora, G., Van Laethem, J.-L., Young, R., Penenberg, D. N., Lu, B., Romano, A., Von Hoff, D. D.·2015·JNCI Journal of the National Cancer Institute

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.

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Metadata

Authors
Goldstein, D., El-Maraghi, R. H., Hammel, P., Heinemann, V., Kunzmann, V., Sastre, J., Scheithauer, W., Siena, S., Tabernero, J., Teixeira, L., Tortora, G., Van Laethem, J.-L., Young, R., Penenberg, D. N., Lu, B., Romano, A., & Von Hoff, D. D.
Venue
JNCI Journal of the National Cancer Institute
Published
2015-01-31
Volume
107
Issue
2
Pages
dju413-dju413
ISSN
  • 0027-8874 (ISSN-L)
  • 1460-2105
OpenAlex
W2115658806
Cited by
658
References
32
FWCI
34.84
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer: Long-Term Survival From a Phase III Trial. https://app.cochat.ai/papers/10.1093/jnci/dju413
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Goldstein, D., El-Maraghi, R. H., Hammel, P., Heinemann, V., Kunzmann, V., Sastre, J., Scheithauer, W., Siena, S., Tabernero, J., Teixeira, L., Tortora, G., Van Laethem, J.-L., Young, R., Penenberg, D. N., Lu, B., Romano, A., & Von Hoff, D. D. (2015). nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer: Long-Term Survival From a Phase III Trial. JNCI Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/dju413

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.