A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer.
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.
*Department of Medicine, Division of Hematology/Oncology, Miller School of Medicine, University of Miami, Miami, FL †Department of Oncology, Johns Hopkins Singapore International Medical Center, Singapore, Republic of Singapore.
Peter J
PJ
Hosein
Gilberto
G
de Lima Lopes
Vitor H
VH
Pastorini
Christina
C
Gomez
Jessica
J
Macintyre
Gloria
G
Zayas
Isildinha
I
Reis
Alberto J
AJ
Montero
Jaime R
JR
Merchan
Caio M
CM
Rocha Lima
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018395:CA-19-9 Antigen / Q000097:blood; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D018395:CA-19-9 Antigen; D017239:Paclitaxel