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Randomized phase 2 trial of nab-paclitaxel plus gemcitabine, ± capecitabine, cisplatin (PAXG regimen) in unresectable or borderline resectable pancreatic adenocarcinoma

Date

08 Oct 2016

Session

Poster Display

Presenters

Michele Reni

Citation

Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371

Authors

M. Reni1, S. Zanon1, G. Balzano2, P. Passoni3, A. Costantino1, C. Pircher1, M. Chiaravalli1, R. Nicoletti4, P.G. Arcidiacono5, G. Pepe6, S. Crippa2, C. Doglioni7, C. Fugazza1, D. Ceraulo1, M. Falconi2, L. Gianni1

Author affiliations

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

A phase 1b trial defined 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). A randomized phase 2 trial of PAXG or nab-paclitaxel-gemcitabine (AG) was performed (NCT01730222).

Methods

Chemo-naive patients with 18-75 years, pathologic diagnosis of unresectable or borderline resectable pancreatic adenocarcinoma (NCCN definition), Karnofsky Performance Status ≥ 70 were eligible for the study. The primary endpoint was resectability rate. According to A' Hern design (p0 = 5%; p1 = 20%; α = 0.05; power = 80%), the total number of patients to enrol in each arm was 27. With ≥ 4 of 27 eligible patients resected, each regimen will be considered active.

Results

Between Apr 2014 and Feb 2016, 54 patients (table 1) were randomized at a single Institution to receive PAXG (arm A; N = 26) or AG (arm B; N = 28). Resection after 4-6 cycles of chemotherapy was performed only in initially borderline resectable patients (5 arm A; 5 R0; 4 N0; 5 arm B; 5 R0; 1 N0). One arm A and 2 arm B patients were deemed resectable and are waiting for surgery. Treatment is ongoing in 4 patients. Main grade 3/4 toxicity was (A/B): neutropenia 76/57%; thrombocytopenia 5/9%; fatigue 10/26%; neuropathy 0/22%; diarrhea 5/13%; nausea 5/13%; serious adverse events 22/29%. A partial response was observed in (A/B) 50/32% and stable disease in 50/61% patients. CA19-9 decreased by > 49% in 95/86%; >89% in 36/19% patients with elevated basal value. Progression was observed in 7 arm A and 17 arm B patients: PFS-6 (A/B) was 100%/61%.

Baseline Characteristic PAXG AG
Number 26 28
Male/female 13/13 lug-21
KPS 90-100 19 (73%) 24 (86%)
70-80 7 (27%) 4 (14%)
Age median 60 66
range 35-75 50-75
Unresectable 16 (62%) 13 (46%)
Borderline 10 (38%) 15 (54%)
Head 18 (69%) 20 (71%)
Biliary stent 14 15
CA19.9 >ULN 22 (85%) 21 (75%)
median 290 278

Conclusions

Both AG and PAXG regimens reached the primary endpoint. Preliminary results suggest that the addition of cisplatin and capecitabine to AG backbone is feasible and seems to improve disease control. The PAXG regimen warrant further exploration in this setting of patients.

Clinical trial identification

ClinicalTrials.gov NCT01730222

Legal entity responsible for the study

IRCCS San Raffaele, Milan, Italy

Funding

Celgene

Disclosure

M. Reni: Advisory role: Celgene, Boehringer Ingelheim, Genentech, Lilly, Merck Serono, Baxalta, Pfizer, Novocure, Halozyme. All other authors have declared no conflicts of interest.

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