A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma

M Reni, Silvia Zanon, G Balzano, P Passoni, C Pircher, M Chiaravalli, Clara Fugazza, D Ceraulo, R Nicoletti, PG Arcidiacono, M Macchini, U Peretti, R Castoldi, C Doglioni, M Falconi, S Partelli, L Gianni

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Abstract

Background: The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel–gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). Method: Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. Results: Eight patients (31%) in the PAXG arm and nine (32%) in the AG arm underwent resection. PFS at 1-year was 58% in arm A and 39% in arm B. OS at 18-month was 69% in arm A and 54% in arm B. Conclusions: In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. Trial registration: NCT01730222. © 2018 Elsevier Ltd
Original languageEnglish
Pages (from-to)95-102
Number of pages8
JournalEuropean Journal of Cancer
Volume102
DOIs
Publication statusPublished - 2018

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gemcitabine
Cisplatin
Adenocarcinoma
Disease-Free Survival
Survival
Carbohydrates
Antigens
Capecitabine
130-nm albumin-bound paclitaxel
Neoplasms

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@article{24d153836aff4a27927160bf62db3849,
title = "A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma",
abstract = "Background: The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel–gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). Method: Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. Results: Eight patients (31{\%}) in the PAXG arm and nine (32{\%}) in the AG arm underwent resection. PFS at 1-year was 58{\%} in arm A and 39{\%} in arm B. OS at 18-month was 69{\%} in arm A and 54{\%} in arm B. Conclusions: In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. Trial registration: NCT01730222. {\circledC} 2018 Elsevier Ltd",
author = "M Reni and Silvia Zanon and G Balzano and P Passoni and C Pircher and M Chiaravalli and Clara Fugazza and D Ceraulo and R Nicoletti and PG Arcidiacono and M Macchini and U Peretti and R Castoldi and C Doglioni and M Falconi and S Partelli and L Gianni",
year = "2018",
doi = "10.1016/j.ejca.2018.07.007",
language = "English",
volume = "102",
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journal = "European Journal of Cancer",
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TY - JOUR

T1 - A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma

AU - Reni, M

AU - Zanon, Silvia

AU - Balzano, G

AU - Passoni, P

AU - Pircher, C

AU - Chiaravalli, M

AU - Fugazza, Clara

AU - Ceraulo, D

AU - Nicoletti, R

AU - Arcidiacono, PG

AU - Macchini, M

AU - Peretti, U

AU - Castoldi, R

AU - Doglioni, C

AU - Falconi, M

AU - Partelli, S

AU - Gianni, L

PY - 2018

Y1 - 2018

N2 - Background: The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel–gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). Method: Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. Results: Eight patients (31%) in the PAXG arm and nine (32%) in the AG arm underwent resection. PFS at 1-year was 58% in arm A and 39% in arm B. OS at 18-month was 69% in arm A and 54% in arm B. Conclusions: In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. Trial registration: NCT01730222. © 2018 Elsevier Ltd

AB - Background: The current trial assessed whether the addition of cisplatin and capecitabine to the nab-paclitaxel–gemcitabine backbone is feasible and active against borderline and locally advanced pancreatic adenocarcinoma (PDAC). Method: Fifty-four chemo-naive patients, aged between 18 and 75 years, with a pathological diagnosis of locally advanced or borderline resectable PDAC were randomised to receive either nab-paclitaxel, gemcitabine, cisplatin and oral capecitabine (PAXG; arm A; N = 26) or nab-paclitaxel followed by gemcitabine (AG; arm B; N = 28). The primary end-point was the tumour resection rate. If at least four such resections were performed, the treatment was considered as active. The secondary end-points were progression-free survival (PFS), overall survival (OS), Response Evaluation Criteria in Solid Tumours response rate, Hartman's pathologic response, carbohydrate antigen 19.9 response rate and toxicity. Results: Eight patients (31%) in the PAXG arm and nine (32%) in the AG arm underwent resection. PFS at 1-year was 58% in arm A and 39% in arm B. OS at 18-month was 69% in arm A and 54% in arm B. Conclusions: In this phase II study, the addition of cisplatin and capecitabine to the AG backbone was feasible and yielded promising results in terms of disease control without detrimental impact on tolerability. The approach warrants further investigation in a phase III study. Trial registration: NCT01730222. © 2018 Elsevier Ltd

U2 - 10.1016/j.ejca.2018.07.007

DO - 10.1016/j.ejca.2018.07.007

M3 - Article

VL - 102

SP - 95

EP - 102

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -