Isabella Frigerio1, Salvatore Paiella2, Emilio Barbi3, Roberto Bianco4, Gianni Boz5, Giovanni Butturini6, Maurizio Cantore7, Nadia Cardarelli8, D'Onofrio Mirko9, Gianmaria Fiorentini10, Alessandro Giardino6, Gabriella Lionetto2, Giuseppe Malleo2, Andrea Mambrini11, Michele Milella12, Alessandro Passardi13, Paolo Regi6, Roberto Salvia2, Filippo Scopelliti6, Elena Viviani2, Claudio Bassi14, Roberto Girelli6. 1. Pancreatic Surgery Unit, Pederzoli Hospital, Peschiera del Garda, Italy. Electronic address: isifrigerio@yahoo.com. 2. General and Pancreatic Surgery Unit, of the Pancreas Institute of the Verona University Hospital Trust, Verona, Italy. 3. Department of Radiology, Pederzoli Hospital, Peschiera del Garda, Italy. 4. Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. 5. Radiation Oncology Department, Centro di Riferimento Oncologico, 33081, Aviano, Italy. 6. Pancreatic Surgery Unit, Pederzoli Hospital, Peschiera del Garda, Italy. 7. Medical Oncology Unit, ASST Mantova, Mantua, Italy. 8. Department of Oncology, San Bortolo General Hospital, Vicenza, Italy. 9. Department of Radiology, Pancreas Institute, University of Verona, Verona, Italy. 10. Azienda Ospedaliera "Ospedali Riuniti Marche Nord" Pesaro, Italy. 11. Oncological Department, Azienda USL Toscana Nord Ovest, Oncological Unit of Massa Carrara, Carrara, Italy. 12. De of Oncology, University of Verona School of Medicine, Verona University Hospital Trust, Verona, Italy. 13. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 14. General and Pancreatic Surgery Unit, of the Pancreas Institute of the Verona University Hospital Trust, Verona, Italy. Electronic address: claudio.bassi@univr.it.
Abstract
BACKGROUND: Local ablation of pancreatic cancer has been suggested as an option to manage locally advanced pancreatic cancer (LAPC) although no robust evidence has been published to date to support its application. The aim of this study is to compare overall survival (OS) and progression-free survival (PFS) in patients receiving both radiofrequency ablation (RFA) and conventional chemoradiotherapy (CHRT) with patients receiving CHRT only. METHODS: This is a multicentre prospective randomized controlled trial (RCT). Patients with LAPC diagnosed by the Pancreas-Ablation-Team-Verona were randomly assigned to open RFA (Group A) or CHRT (Group B). Survival analyses were performed using the Kaplan-Meier method and compared using the log-rank test. Statistical significance was set at p < 0.05. RESULTS: One hundred LAPC patients were enrolled from January 2014 to August 2016. 33% of patients in Group A did not receive the designated procedure because of intraoperative findings of liver (18.7%) or peritoneal metastases (43.8%), or technical contraindications (37.5%). We did not observe any statistically significant survival benefit from RFA compared to CHRT, neither in terms of OS (medians of 14.2 months and 18.1 months, respectively, p = 0.639) nor PFS (medians of 8 months and 6 months respectively, p = 0.570). Mortality was nil and RFA-related morbidity was 15.6%. In 13% of subjects, conversion to surgery occurred (2 after RFA and 11 after CHRT). CONCLUSIONS: This is the first RCT evaluating the impact of upfront RFA in the multimodal treatment of LAPC. Compared to CHRT, RFA alone did not provide any advantage in terms of OS or PFS. It could be considered as a therapeutic option for LAPC within a multimodal context and after neoadjuvant therapies.
BACKGROUND: Local ablation of pancreatic cancer has been suggested as an option to manage locally advanced pancreatic cancer (LAPC) although no robust evidence has been published to date to support its application. The aim of this study is to compare overall survival (OS) and progression-free survival (PFS) in patients receiving both radiofrequency ablation (RFA) and conventional chemoradiotherapy (CHRT) with patients receiving CHRT only. METHODS: This is a multicentre prospective randomized controlled trial (RCT). Patients with LAPC diagnosed by the Pancreas-Ablation-Team-Verona were randomly assigned to open RFA (Group A) or CHRT (Group B). Survival analyses were performed using the Kaplan-Meier method and compared using the log-rank test. Statistical significance was set at p < 0.05. RESULTS: One hundred LAPC patients were enrolled from January 2014 to August 2016. 33% of patients in Group A did not receive the designated procedure because of intraoperative findings of liver (18.7%) or peritoneal metastases (43.8%), or technical contraindications (37.5%). We did not observe any statistically significant survival benefit from RFA compared to CHRT, neither in terms of OS (medians of 14.2 months and 18.1 months, respectively, p = 0.639) nor PFS (medians of 8 months and 6 months respectively, p = 0.570). Mortality was nil and RFA-related morbidity was 15.6%. In 13% of subjects, conversion to surgery occurred (2 after RFA and 11 after CHRT). CONCLUSIONS: This is the first RCT evaluating the impact of upfront RFA in the multimodal treatment of LAPC. Compared to CHRT, RFA alone did not provide any advantage in terms of OS or PFS. It could be considered as a therapeutic option for LAPC within a multimodal context and after neoadjuvant therapies.
Authors: Jana Jarosova; Peter Macinga; Lenka Krupickova; Martina Fialova; Alzbeta Hujova; Jan Mares; Ondrej Urban; Jan Hajer; Julius Spicak; Ilja Striz; Tomas Hucl Journal: Biomedicines Date: 2022-06-06