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

Peter 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

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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.

Original languageEnglish
Pages (from-to)151-156
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume36
Issue number2
DOIs
StatePublished - Apr 1 2013

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

A phase ii trial of nab-paclitaxel as second-line therapy in patients with advanced pancreatic cancer. / Hosein, Peter; 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, 01.04.2013, p. 151-156.

Research output: Contribution to journalArticle

Hosein, Peter ; 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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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.

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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.

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.

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