Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine

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

Research output: Contribution to journalArticle

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

Original languageEnglish (US)
Pages (from-to)1691-1703
Number of pages13
JournalNew England Journal of Medicine
Volume369
Issue number18
DOIs
StatePublished - 2013

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gemcitabine
Pancreatic Neoplasms
Survival
Karnofsky Performance Status
130-nm albumin-bound paclitaxel
Body Surface Area
Disease-Free Survival
Disease Progression

ASJC Scopus subject areas

  • Medicine(all)

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Von Hoff, D. D., Ervin, T., Arena, F. P., Chiorean, E. G., Infante, J., Moore, M., ... Renschler, M. F. (2013). Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England Journal of Medicine, 369(18), 1691-1703. https://doi.org/10.1056/NEJMoa1304369

Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. / 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.

In: New England Journal of Medicine, Vol. 369, No. 18, 2013, p. 1691-1703.

Research output: Contribution to journalArticle

Von Hoff, DD, Ervin, T, Arena, FP, Chiorean, EG, Infante, J, Moore, M, Seay, T, Tjulandin, SA, Ma, WW, Saleh, MN, Harris, M, Reni, M, Dowden, S, Laheru, D, Bahary, N, Ramanathan, RK, Tabernero, J, Hidalgo, M, Goldstein, D, Van Cutsem, E, Wei, X, Iglesias, J & Renschler, MF 2013, 'Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine', New England Journal of Medicine, vol. 369, no. 18, pp. 1691-1703. https://doi.org/10.1056/NEJMoa1304369
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England Journal of Medicine. 2013;369(18):1691-1703. https://doi.org/10.1056/NEJMoa1304369
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. / Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. In: New England Journal of Medicine. 2013 ; Vol. 369, No. 18. pp. 1691-1703.
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T1 - Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine

AU - Von Hoff, Daniel D.

AU - Ervin, Thomas

AU - Arena, Francis P.

AU - Chiorean, E. Gabriela

AU - Infante, Jeffrey

AU - Moore, Malcolm

AU - Seay, Thomas

AU - Tjulandin, Sergei A.

AU - Ma, Wen Wee

AU - Saleh, Mansoor N.

AU - Harris, Marion

AU - Reni, Michele

AU - Dowden, Scot

AU - Laheru, Daniel

AU - Bahary, Nathan

AU - Ramanathan, Ramesh K.

AU - Tabernero, Josep

AU - Hidalgo, Manuel

AU - Goldstein, David

AU - Van Cutsem, Eric

AU - Wei, Xinyu

AU - Iglesias, Jose

AU - Renschler, Markus F.

PY - 2013

Y1 - 2013

N2 - 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

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