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A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer.

AbstractOBJECTIVE:
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/m 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.
AuthorsPeter J Hosein, Gilberto de Lima Lopes Jr, Vitor H Pastorini, Christina Gomez, Jessica Macintyre, Gloria Zayas, Isildinha Reis, Alberto J Montero, Jaime R Merchan, Caio M Rocha Lima
JournalAmerican journal of clinical oncology (Am J Clin Oncol) Vol. 36 Issue 2 Pg. 151-6 (Apr 2013) ISSN: 1537-453X [Electronic] United States
PMID22307213 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References
  • 130-nm albumin-bound paclitaxel
  • Albumins
  • CA-19-9 Antigen
  • Paclitaxel
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Albumins (administration & dosage, adverse effects, therapeutic use)
  • CA-19-9 Antigen (blood)
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel (administration & dosage, adverse effects, therapeutic use)
  • Pancreatic Neoplasms (drug therapy, mortality, pathology)
  • Survival Analysis
  • Treatment Outcome
  • Young Adult

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