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Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine
Open accessAbstract
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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In the citing paper
“Most chemotherapy 5-7, targeted therapy 8, and immunotherapy 9-11 are ineffective because most patients are already in the progressive stage with local invasion and distant metastases at the detection time 12,13.”
From Artificial intelligence in pancreatic cancer (2022) · cites this paper as [6]
Experimental — accuracy not yet measuredIn the citing paper
“two new combination regimens have emerged as the first-line therapy in patients with advanced PDAC. The first is a combination of 5-fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin, which carries the acronym FOLFIRINOX. The second is the combination of gemcitabine and an albumin nanoparticle conjugate of paclitaxel (nab-paclitaxel)8,9.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [9]
In the citing paper
“Polychemotherapy, either with 5-fluorouracil (5-FU), irinotecan and oxaliplatin in combination with folinic acid (FOLFIRINOX), or with gemcitabine and nab-paclitaxel (GnP), is considered the standard of care for patients suffering from metastatic PDAC (mPDAC)3,4.”
From Microbiota-derived 3-IAA influences chemotherapy efficacy in pancreatic cancer (2023) · cites this paper as [3]
In the citing paper
“However, less than half of all patients are responsive to the therapy, and patients who do not respond (NR patients) suffer from pain and eventually die within weeks3.”
From Microbiota-derived 3-IAA influences chemotherapy efficacy in pancreatic cancer (2023) · cites this paper as [3]
In the citing paper
“Less than half of all patients respond to the primary treatment for PDAC, chemotherapy3,4”
From Microbiota-derived 3-IAA influences chemotherapy efficacy in pancreatic cancer (2023) · cites this paper as [3]
In the citing paper
“patients who do not respond (NR patients) suffer from pain and eventually die within weeks3.”
From Microbiota-derived 3-IAA influences chemotherapy efficacy in pancreatic cancer (2023) · cites this paper as [3]
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Metadata
- 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
- 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
- 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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