Abstract | OBJECTIVE: 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:
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Authors | Peter 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 |
Journal | American journal of clinical oncology
(Am J Clin Oncol)
Vol. 36
Issue 2
Pg. 151-6
(Apr 2013)
ISSN: 1537-453X [Electronic] United States |
PMID | 22307213
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- 130-nm albumin-bound paclitaxel
- Albumins
- CA-19-9 Antigen
- Paclitaxel
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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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