A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer

Peter J. Hosein, Gilberto De Lima Lopes, Vitor H. Pastorini, Christina Gomez, Jessica MacIntyre, Gloria Zayas, Isildinha Reis, Alberto J. Montero, Jaime R. Merchan, Caio M. Rocha Lima

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)151-156
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume36
Issue number2
DOIs
StatePublished - Apr 2013
Externally publishedYes

Fingerprint

Pancreatic Neoplasms
gemcitabine
Therapeutics
Confidence Intervals
Disease-Free Survival
Survival
130-nm albumin-bound paclitaxel
Hypocalcemia
Anorexia
Neutropenia
Nausea
Vomiting
Cysteine
Anemia
Fever
Safety
Acids

Keywords

  • chemotherapy
  • nab-paclitaxel
  • pancreatic cancer
  • SPARC

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Hosein, P. J., De Lima Lopes, G., Pastorini, V. H., Gomez, C., MacIntyre, J., Zayas, G., ... Rocha Lima, C. M. (2013). A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer. American Journal of Clinical Oncology: Cancer Clinical Trials, 36(2), 151-156. https://doi.org/10.1097/COC.0b013e3182436e8c

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 journalArticle

Hosein, PJ, De Lima Lopes, G, Pastorini, VH, Gomez, C, MacIntyre, J, Zayas, G, Reis, I, Montero, AJ, Merchan, JR & Rocha Lima, CM 2013, 'A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 36, no. 2, pp. 151-156. https://doi.org/10.1097/COC.0b013e3182436e8c
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. / A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2013 ; Vol. 36, No. 2. pp. 151-156.
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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.",
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AU - Gomez, Christina

AU - MacIntyre, Jessica

AU - Zayas, Gloria

AU - Reis, Isildinha

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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.

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