Nab-Paclitaxel Therapy in Pancreatic Cancer Deemed Patient Friendly

Beth Fand Incollingo @fandincollingo
Published: Friday, Mar 28, 2014
Dr.Francis P. Arena

Francis P. Arena, MD

 

Director, NYU Langone Arena Oncology
Clinical Associate Professor
NYU Langone Medical Center
New York, NY

Dr.E. Gabriela Chiorean

E. Gabriela Chiorean, MD

 

Associate Professor, Medicine
University of Washington
Associate Member, Fred Hutchinson Cancer Research Center
Seattle, WA

A recently approved indication for nab-paclitaxel (Abraxane) in metastatic pancreatic cancer is thought to have similar efficacy to a standard first-line treatment for the disease, but offers several advantages in the eyes of community oncologists and their patients, experts said during an OncLive Peer Exchange roundtable.

The emerging role of nab-paclitaxel was among the topics that Francis P. Arena, MD, and E. Gabriela Chiorean, MD, two leading investigators in the pivotal study that led to the new indication for the drug, discussed during the Peer Exchange program, entitled “Current Therapeutic Advances in Metastatic Pancreatic Cancer.”

The panelists said that the recently approved nab-paclitaxel plus gemcitabine (Gemzar) regimen has demonstrated similar efficacy to FOLFIRINOX (leucovorin, 5-fluorouracil, irinotecan, and oxaliplatin), but that the nab-paclitaxel combination has a tendency to improve patients’ performance status. In addition, the combination that includes nab-paclitaxel has been more thoroughly tested in community settings and appears to have a more favorable toxicity profile, they said.

Arena, director of NYU Arena Oncology, and Chiorean, of the Fred Hutchinson Cancer Research Center, are among the authors of the phase III MPACT study1 that led to the FDA’s September 2013 approval of nab-paclitaxel plus gemcitabine as a first-line treatment for patients with metastatic disease. It is the third indication for Abraxane, an albumin-bound form of paclitaxel. Initially approved in 2005, the microtubule inhibitor also is indicated for the treatment of patients with metastatic breast cancer after recurrence or relapse following other chemotherapy regimens, and for first-line treatment in combination with carboplatin for locally advanced or metastatic non-small cell lung cancer.

For metastatic pancreatic cancer, the recommended nab-paclitaxel dosage is 125 mg/m2 intravenously over 30 to 40 minutes on days 1, 8, and 15 of each 28-day cycle, with gemcitabine administered immediately afterward on the same schedule.2

Therapeutic Options Compared

In the MPACT trial, the nab-paclitaxel regimen was shown to improve the median overall survival (OS) benefit offered by gemcitabine by 28%. The median OS was 8.5 months in the combination arm, compared with 6.7 months for gemcitabine alone (HR = 0.72; P <.0001) (Table).

Table. Key Clinical Trial Findings for Nab-Paclitaxel1

  Nab-Paclitaxel + gemcitabine (N = 431) Gemcitabine (N = 430)
Overall Survival (OS)
Number of deaths, n (%) 333 (77) 359 (83)
Median OS (months) 8.5 6.7
95% CI 7.9- 9.5 6.0- 7.2
HR (95% CI) 0.72 (0.62-0.83)
P valuea <.0001
1-year OS (%)2 35 22
2-year OS (%)2 10 5
3-year OS (%)2 4 0
Progression-free Survival (PFS)
Death or progression, n (%) 277 (64) 265 (62)
Median PFS (months) 5.5 3.7
95% CI 4.5-5.9 3.6-4.0
HR (95% CI) 0.69 (0.58-0.82)
P valuea <.0001
Overall Response Rate
Confirmed complete or partial overall response, n (%) 99 (23) 31 (7)
95% CI 19.1-27.2 5.0-10.1
P valueb <.0001

a Log-rank test stratified by geographic region (North America vs Others), Karnofsky performance score (70 to 80 vs 90 to 100), and presence of liver metastasis (yes versus no).
b Chi-square test
1. Abraxane [prescribing information]. Updated October 2013. Accessed March 10, 2014.
2. Goldstein et al. J Clin Oncol. 2014;32(suppl 3; abstr 178).

While there have been no head-to-head studies of nab-paclitaxel/gemcitabine versus FOLFIRINOX, the efficacy of the two regimens as first-line treatments seems about the same, the panelists agreed. Response and survival rates were a bit higher in the phase III trial that demonstrated the efficacy of FOLFIRINOX3 in this setting, but Arena argued that study design might have skewed those results.


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Online CME Activities
TitleExpiration DateCME Credits
Oncology Briefings™: Integrating Novel Targeted Treatment Strategies to Advance Pancreatic Cancer CareNov 30, 20181.0
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