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Poster display session

5333 - Randomized phase 2 trial of nab-paclitaxel plus gemcitabine, ± capecitabine, cisplatin (PAXG regimen) in metastatic pancreatic adenocarcinoma

Date

09 Sep 2017

Session

Poster display session

Presenters

Michele Reni

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

M. Reni1, S. Zanon1, C. Pircher1, M. Chiaravalli1, M. Macchini1, U. Peretti1, E. Mazza1, G. Balzano2, P. Passoni3, R. Nicoletti4, P.G. Arcidiacono5, G. Pepe6, C. Doglioni7, S. Romi1, D. Ceraulo1, M. Falconi2, L. Gianni1

Author affiliations

  • 1 Medical Oncology, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 2 Surgery, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 3 Radiotherapy, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 4 Radiology, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 5 Gastroenterology, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 6 Nuclear Medicine, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 7 Pathology, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
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Resources

Abstract 5333

Background

The recommended phase 2 dose of nab-paclitaxel (150 mg/m2) in combination with cisplatin, capecitabine, and gemcitabine (800, 30, and 1250 mg/m2 every 2 weeks, respectively; PAXG regimen) were determined in a phase Ib trial. We now report the final results of a randomized phase 2 trial of PAXG or nab-paclitaxel-gemcitabine (AG) in metastatic pancreatic adenocarcinoma (NCT01730222).

Methods

Previously untreated patients with pathologic diagnosis of metastatic pancreatic adenocarcinoma, 18-75 years, Karnofsky Performance Status ≥ 70 were eligible. Primary endpoint was the progression-free survival rate at 6 months (PFS6). With 42 eligible patients in each group, a PFS6 in ≥ 25 of 42 would support further evaluation of the PAXG regimen.

Results

Between Apr 2014 and June 2016, 83 patients (table 1) were randomized at a single Institution to receive PAXG (arm A; N = 42) or AG (arm B; N = 41). PFS6 was 31/42 (74%), and 24/41 (59%), respectively. PFS at 1 year and median PFS was 26% and 8.1 for arm A and 7% and 6.8 months for arm B. One-year survival was 62% and 41%, respectively. Median survival was not reached at 13.5 months for arm A and was 11.2 for arm B. PAXG regimen did not increase grade 3-4 extra-hematological toxicity as compared to AG.Table:

739P Baseline Characteristic

PAXGAG
Number4241
Male/female20/2223/18
KPS90-10034 (81%)26 (63%)
70-808 (19%)15 (37%)
Agemedian6663
range44-7529-75
Biliary stent9 (22%)8 (19%)
CA19.9>ULN32 (76%)31 (76%)
median14131546
Neutrophil/Lymphocyte >515%21%

Conclusions

The results show that addition of cisplatin and capecitabine to the AG backbone is feasible and linked with improved disease control. The PAXG regimen warrants further exploration in this setting of patients.

Clinical trial identification

NCT01730222

Legal entity responsible for the study

IRCCS San Raffaele Scientific Institute, Milan, Italy

Funding

This work was supported by Celgene, which provided funding for the study with an unrestricted grant and the supply of the drug.

Disclosure

M. Reni: Research funding from Celgene, Baxalta, Helsinn, and Merck-Serono; consultant or advisor for Celgene, Baxalta, Merck Serono, Boheringer, Lilly, Pfizer, AstraZeneca, Novocure, Genentech, Halozyme, Novartis. M. Falconi: Research funding to institution from Novartis. L. Gianni: Consulting/advisory role for Roche, Pfizer, GlaxoSmithKline, Synthon, Taiho Pharmaceutical, AstraZeneca, Genomic Health, Merck Sharp & Dohme, Boehringer Ingelheim, Tiziana Pharma, Synaffix, and Celgene; intellectual property with Roche. All other authors have declared no conflicts of interest.

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