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A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer

Hosein, Peter J., MD*; de Lima Lopes, Gilberto Jr, MD; Pastorini, Vitor H., MD*; Gomez, Christina, MD*; Macintyre, Jessica, ARNP*; Zayas, Gloria, CCRP*; Reis, Isildinha, PhD*; Montero, Alberto J., MD*; Merchan, Jaime R., MD*; Rocha Lima, Caio M., MD*

American Journal of Clinical Oncology: April 2013 - Volume 36 - Issue 2 - p 151–156
doi: 10.1097/COC.0b013e3182436e8c
Original Articles: Gastrointestinal
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Objective: nab-Paclitaxel has been shown to disrupt pancreatic cancer stroma and was effective in combination with gemcitabine in a phase I/II trial. This study was designed to determine the efficacy of nab-paclitaxel monotherapy in previously treated pancreatic cancer patients.

Methods: In this phase II trial, patients with advanced pancreatic cancer who progressed on gemcitabine-based therapy, received nab-paclitaxel 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. The primary endpoint was 6-month overall survival (OS). Secondary endpoints were response rate (by Response Evaluation Criteria In Solid Tumors), progression-free survival, safety, and toxicity profile.

Results: Among 19 patients treated, the median age was 61 years, 9 (47%) were male patients and 18 (95%) had stage-IV disease. The primary endpoint of the study was reached with a 6-month OS of 58% [95% confidence interval (95% CI), 33%-76%] and an estimated median OS of 7.3 months (95% CI, 2.8-15.8 mo). The median progression-free survival was 1.7 months (95% CI, 1.5-3.5 mo). One patient had a confirmed partial response and 6 (32%) had stable disease as their best response. Nonhematological toxicities were generally mild with grades 1-2 nausea, anorexia, hypocalcemia, and vomiting occurring in 63%, 47%, 37%, and 26% of patients, respectively. Grades 3-4 neutropenia, neutropenic fever, and anemia occurred in 32%, 11%, and 11% of patients, respectively. Only 2 of 15 available tumors stained positive for secreted protein acid rich in cysteine, and neither of these patients benefited from the therapy.

Conclusions: nab-Paclitaxel was well tolerated, and it demonstrated preliminary evidence of activity in a subset of patients who progressed on gemcitabine-based therapy.

*Department of Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, Miami, FL

Department of Oncology, Johns Hopkins Singapore International Medical Center, Singapore, Republic of Singapore

P.J.H. and G.L.L. contributed equally to this manuscript.

Supported by Abraxis BioScience Inc.

The authors declare no conflicts of interest.

Reprints: Peter J. Hosein, MD, Department of Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, 1475 NW 12th Ave (D8-4), Suite 3300, Miami, FL 33136. E-mail: phosein@med.miami.edu.

© 2013 by Lippincott Williams & Wilkins, Inc