Michele Reni1, Silvia Zanon2, Gianpaolo Balzano3, Paolo Passoni4, Chiara Pircher2, Marta Chiaravalli2, Clara Fugazza2, Domenica Ceraulo2, Roberto Nicoletti5, Paolo Giorgio Arcidiacono6, Marina Macchini2, Umberto Peretti2, Renato Castoldi3, Claudio Doglioni7, Massimo Falconi8, Stefano Partelli3, Luca Gianni2. 1. Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. Electronic address: reni.michele@hsr.it. 2. Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. 3. Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. 4. Department of Radiotherapy, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. 5. Department of Radiology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. 6. Pancreato-Biliary Endoscopy and Endosonography Division, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy. 7. Pathology Unit, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy; Università Vita e Salute, Milan, Italy. 8. Pancreatic Surgery Unit, Pancreas Translational & Clinical Research Center, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy; Università Vita e Salute, Milan, Italy.
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.
RCT Entities:
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.
Authors: M Redegalli; M Schiavo Lena; M Reni; C Doglioni; M G Cangi; C E Smart; M Mori; C Fiorino; P G Arcidiacono; G Balzano; M Falconi Journal: Ann Surg Oncol Date: 2022-03-01 Impact factor: 4.339