Highlights
- •Role of combination chemotherapy has not been demonstrated in locally advanced PDAC.
- •Nab-paclitaxel/gemcitabine combination improved PFS, OS and RR in these patients.
- •Combination chemotherapy delays the onset of a metastatic disease in these patients.
Abstract
Background
The role of combination chemotherapy has not yet been established in unresectable
locally advanced pancreatic cancer (LAPC) lacking dedicated randomized trials.
Methods
This phase II trial tested the efficacy of Nab-paclitaxel (NAB-P)/Gemcitabine (G)
versus G alone. Patients were randomized, 1:1 to G 1000 mg/m2 on days 1, 8 and 15 every 28 days versus NAB-P 125 mg/m2 on days 1, 8 and 15 every 28 days plus G 1000 mg/m2 on days 1, 8 and 15 every 28 days. Disease progression rate after three cycles of
chemotherapy was the primary end-point. Progression-free survival (PFS), overall survival
(OS) and response rate were secondary end-points.
Findings
A total of124 patients were enrolled. The study showed a reduction of a progressive
disease from 45.6% with G to 25.4% with NAB-P/G (P = 0.01) at 3 months. Noteworthy,
at 6 months in the G arm, 35.6% of patients present a metastatic spread versus 20.8%
in the NAB/G arm. The response rate was 5.3% in the G arm and 27% in the NAB/G arm.
Median PFS was 4 months for the G arm and 7 months for the NAB-P/G arm. Median OS
was 10.6 in the G arm and 12.7 months in the NAB-P/G arm. One patient died during
treatment with G due to a stroke.
Interpretation.
NAB-P/G reduced the rate of LAPC patients progressing after three cycles of chemotherapy
compared with G, especially in terms of distant relapses. It positively affects PFS.
To the best of our knowledge, this is the first randomized trial providing evidence
that combination chemotherapy is superior to gemcitabine alone in this setting.
ClinicalTrials.gov Identifier
NCT02043730.
Keywords
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Article info
Publication history
Published online: March 31, 2021
Accepted:
February 15,
2021
Received in revised form:
February 10,
2021
Received:
September 4,
2020
Identification
Copyright
© 2021 Elsevier Ltd. All rights reserved.
