Cited by 6,712Pancreatic and Hepatic Oncology ResearchCancer Treatment and PharmacologyPancreatitis Pathology and Treatment

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Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

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Von Hoff, Daniel D., Ervin, Thomas, Arena, Francis P., Chiorean, E. Gabriela, Infante, Jeffrey, Moore, Malcolm, Seay, Thomas, Tjulandin, Sergei A., Ma, Wen Wee, Saleh, Mansoor N., Harris, Marion, Reni, Michele, Dowden, Scot, Laheru, Daniel, Bahary, Nathan, Ramanathan, Ramesh K., Tabernero, Josep, Hidalgo, Manuel, Goldstein, David, Van Cutsem, Eric, Wei, Xinyu, Iglesias, Jose, Renschler, Markus F.·2013·New England Journal of Medicine

DOI 10.1056/nejmoa1304369PMC PMC4631139

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Abstract

BACKGROUND: In a phase 1-2 trial of albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine, substantial clinical activity was noted in patients with advanced pancreatic cancer. We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer. METHODS: We randomly assigned patients with a Karnofsky performance-status score of 70 or more (on a scale from 0 to 100, with higher scores indicating better performance status) to nab-paclitaxel (125 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks or gemcitabine monotherapy (1000 mg per square meter) weekly for 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle 2 and subsequent cycles). Patients received the study treatment until disease progression. The primary end point was overall survival; secondary end points were progression-free survival and overall response rate. RESULTS: A total of 861 patients were randomly assigned to nab-paclitaxel plus gemcitabine (431 patients) or gemcitabine (430). The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group (hazard ratio for death, 0.72; 95% confidence interval [CI], 0.62 to 0.83; P<0.001). The survival rate was 35% in the nab-paclitaxel-gemcitabine group versus 22% in the gemcitabine group at 1 year, and 9% versus 4% at 2 years. The median progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group, as compared with 3.7 months in the gemcitabine group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.58 to 0.82; P<0.001); the response rate according to independent review was 23% versus 7% in the two groups (P<0.001). The most common adverse events of grade 3 or higher were neutropenia (38% in the nab-paclitaxel-gemcitabine group vs. 27% in the gemcitabine group), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%). Febrile neutropenia occurred in 3% versus 1% of the patients in the two groups. In the nab-paclitaxel-gemcitabine group, neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days. CONCLUSIONS: In patients with metastatic pancreatic adenocarcinoma, nab-paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and response rate, but rates of peripheral neuropathy and myelosuppression were increased. (Funded by Celgene; ClinicalTrials.gov number, NCT00844649.).

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Authors: Von Hoff, D. D., Ervin, T., Arena, F. P., Chiorean, E. G., Infante, J., Moore, M., Seay, T., Tjulandin, S. A., Ma, W. W., Saleh, M. N., Harris, M., Reni, M., Dowden, S., Laheru, D., Bahary, N., Ramanathan, R. K., Tabernero, J., Hidalgo, M., Goldstein, D., Van Cutsem, E., Wei, X., Iglesias, J., & Renschler, M. F.
Affiliations: University of Washington (US)
Tennessee Oncology (US)
Princess Margaret Cancer Centre (CA)
Russian Cancer Research Center NN Blokhin (RU)
Translational Genomics Research Institute (US)
Georgia Cancer Specialists (US)
Sidney Kimmel Comprehensive Cancer Center (US)
University of Pittsburgh Medical Center (US)
Universitat Autònoma de Barcelona (ES)
Prince of Wales Hospital (AU)
Celgene (United States) (US)
Bionomics (Australia) (AU)
ORCID: Arena, Francis P.
Chiorean, E. Gabriela
Moore, Malcolm
Tjulandin, Sergei A.
Ma, Wen Wee
Saleh, Mansoor N.
Harris, Marion
Reni, Michele
Laheru, Daniel
Bahary, Nathan
Tabernero, Josep
Hidalgo, Manuel
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2013-10-31
Volume: 369
Issue: 18
Pages: 1691-1703
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1304369
PMC: PMC4631139
OpenAlex: W2165480504
Cited by: 6,712
References: 23
Citations by year: 2026: 403 · 2025: 491 · 2024: 537 · 2023: 607 · 2022: 614 · 2021: 695 · 2020: 631 · 2019: 531 · 2018: 548 · 2017: 512 · 2016: 423 · 2015: 424 · 2014: 271 · 2013: 15
FWCI: 200.89
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (P30CA006973)
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
Keywords: pancreatic cancer, metastatic pancreatic cancer, nab-paclitaxel, gemcitabine, combination chemotherapy, gemcitabine monotherapy, overall survival, progression-free survival, overall response rate, treatment safety, adverse events, chemotherapy schedule, Karnofsky performance status
MeSH terms: Gemcitabine, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Albumins, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Deoxycytidine, Female, Humans, Male, Middle Aged, Nervous System Diseases, Neutropenia, Pancreatic Neoplasms, Paclitaxel, Disease-Free Survival, Kaplan-Meier Estimate

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Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

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