{"doi":"10.1056/nejmoa1304369","title":"Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine","abstract":"<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.).","journal":"New England Journal of Medicine","year":2013,"id":10672,"datarank":14.730902168560457,"base_score":8.792701462936309,"endowment":8.792701462936309,"self_citation_contribution":1.3189052194404465,"citation_network_contribution":13.41199694912001,"self_endowment_contribution":1.3189052194404465,"citer_contribution":13.41199694912001,"corpus_percentile":87.2,"corpus_rank":1988,"citation_count":6585,"citer_count":162,"citers_with_citation_signal":162,"citers_with_endowment":162,"datacite_reuse_total":0,"is_dataset":false,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2013-10-31","authors":[{"id":87999,"name":"Thomas Ervin","orcid":null,"position":1,"is_corresponding":false},{"id":88000,"name":"Francis P. Arena","orcid":"0000-0002-7215-2551","position":2,"is_corresponding":false},{"id":88001,"name":"E. Gabriela Chiorean","orcid":"0000-0003-3306-9592","position":3,"is_corresponding":false},{"id":88002,"name":"Jeffrey Infante","orcid":null,"position":4,"is_corresponding":false},{"id":34375,"name":"Fruzsina Molnar-Gabor","orcid":"0000-0002-9406-2776","position":5,"is_corresponding":false},{"id":88004,"name":"Thomas Seay","orcid":null,"position":6,"is_corresponding":false},{"id":88005,"name":"Sergei A. Tjulandin","orcid":null,"position":7,"is_corresponding":false},{"id":88006,"name":"Wen Wee Ma","orcid":null,"position":8,"is_corresponding":false},{"id":88007,"name":"Mansoor N. Saleh","orcid":"0000-0003-0209-8630","position":9,"is_corresponding":false},{"id":88008,"name":"Marion Harris","orcid":"0000-0003-4420-1915","position":10,"is_corresponding":false},{"id":88009,"name":"Michele Reni","orcid":"0000-0002-6463-0293","position":11,"is_corresponding":false},{"id":88010,"name":"Scot Dowden","orcid":null,"position":12,"is_corresponding":false},{"id":88011,"name":"Daniel Laheru","orcid":null,"position":13,"is_corresponding":false},{"id":88012,"name":"Nathan Bahary","orcid":"0000-0001-7317-9118","position":14,"is_corresponding":false},{"id":88013,"name":"Ramesh K. Ramanathan","orcid":null,"position":15,"is_corresponding":false},{"id":35283,"name":"Josep Tabernero","orcid":"0000-0002-2495-8139","position":16,"is_corresponding":false},{"id":88014,"name":"Manuel Hidalgo","orcid":"0000-0002-3765-3318","position":17,"is_corresponding":false},{"id":1061,"name":"David Goldstein","orcid":null,"position":18,"is_corresponding":false},{"id":88015,"name":"Eric Van Cutsem","orcid":"0000-0002-6372-1230","position":19,"is_corresponding":false},{"id":88016,"name":"Xinyu Wei","orcid":"0000-0003-2318-6912","position":20,"is_corresponding":false},{"id":88017,"name":"Jose Iglesias","orcid":null,"position":21,"is_corresponding":false},{"id":88018,"name":"Markus F. Renschler","orcid":null,"position":22,"is_corresponding":false},{"id":88019,"name":"Thomas J. Ervin","orcid":null,"position":23,"is_corresponding":false},{"id":88020,"name":"Jeffrey R. Infante","orcid":null,"position":24,"is_corresponding":false},{"id":13829,"name":"Malcolm J. Moore","orcid":"0009-0007-7493-3558","position":25,"is_corresponding":false},{"id":88021,"name":"Thomas E. Seay","orcid":null,"position":26,"is_corresponding":false},{"id":88022,"name":"Sergei Tjulandin","orcid":"0000-0001-9807-2229","position":27,"is_corresponding":false},{"id":88023,"name":"Wen Wee","orcid":"0000-0001-5899-4034","position":28,"is_corresponding":false},{"id":88024,"name":"Daniel A. Laheru","orcid":"0000-0001-6646-0200","position":29,"is_corresponding":false},{"id":88025,"name":"José Iglesias","orcid":"0000-0001-7851-0498","position":30,"is_corresponding":false},{"id":87998,"name":"Daniel D. Von Hoff","orcid":"0000-0003-4723-7681","position":0,"is_corresponding":true}],"reference_count":23,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-03-01T18:20:47.508186Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}