Abstract
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/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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 151-156 |
| Number of pages | 6 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 36 |
| Issue number | 2 |
| DOIs | |
| State | Published - Apr 2013 |
| Externally published | Yes |
Fingerprint
Keywords
- chemotherapy
- nab-paclitaxel
- pancreatic cancer
- SPARC
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer. / Hosein, Peter J.; De Lima Lopes, Gilberto; Pastorini, Vitor H.; Gomez, Christina; MacIntyre, Jessica; Zayas, Gloria; Reis, Isildinha; Montero, Alberto J.; Merchan, Jaime R.; Rocha Lima, Caio M.
In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 36, No. 2, 04.2013, p. 151-156.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer
AU - Hosein, Peter J.
AU - De Lima Lopes, Gilberto
AU - Pastorini, Vitor H.
AU - Gomez, Christina
AU - MacIntyre, Jessica
AU - Zayas, Gloria
AU - Reis, Isildinha
AU - Montero, Alberto J.
AU - Merchan, Jaime R.
AU - Rocha Lima, Caio M.
PY - 2013/4
Y1 - 2013/4
N2 - 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/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.
AB - 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/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.
KW - chemotherapy
KW - nab-paclitaxel
KW - pancreatic cancer
KW - SPARC
UR - http://www.scopus.com/inward/record.url?scp=84876159000&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84876159000&partnerID=8YFLogxK
U2 - 10.1097/COC.0b013e3182436e8c
DO - 10.1097/COC.0b013e3182436e8c
M3 - Article
C2 - 22307213
AN - SCOPUS:84876159000
VL - 36
SP - 151
EP - 156
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 2
ER -