Open radiofrequency ablation as upfront treatment for locally advanced pancreatic cancer: Requiem from a randomized controlled trial.

Published on Jun 21, 2021in Pancreatology3.629
· DOI :10.1016/J.PAN.2021.06.005
Isabella Frigerio17
Estimated H-index: 17
Salvatore Paiella23
Estimated H-index: 23
+ 19 AuthorsG. Fiorentini14
Estimated H-index: 14
Abstract null null Background null 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. null null null Methods null 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  null null null Results null 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). null null null Conclusions null 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.
#1M.S. Walma (UU: Utrecht University)H-Index: 1
#1Marieke S. Walma (UU: Utrecht University)H-Index: 6
Last. I.Q. Molenaar (UU: Utrecht University)H-Index: 4
view all 44 authors...
BACKGROUND Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. METHODS T...
1 CitationsSource
#1Salvatore Paiella (University of Verona)H-Index: 23
#2Luca Casetti (University of Verona)H-Index: 14
Last. Olivier Turrini (AMU: Aix-Marseille University)H-Index: 37
view all 18 authors...
Abstract Purpose Ablative techniques have emerged as new potential therapeutic options for patients with locally advanced pancreatic cancer (LAPC). We explored the safety and feasibility of using TRANBERG|Thermal Therapy System (Clinical Laserthermia Systems AB, Lund, Sweden) in feedback mode for immunostimulating Interstitial Laser Thermotherapy (imILT) protocol, the newest ablative technique introduced for the treatment of LAPC. Methods The safety and feasibility results after the use of imILT...
1 CitationsSource
#1Francesca Foschini (University of Naples Federico II)H-Index: 2
#2Fabiana Napolitano (University of Naples Federico II)H-Index: 4
Last. Roberto Bianco (University of Naples Federico II)H-Index: 51
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Background:Pancreatic adenocarcinoma is the fourth leading cause of cancer-related death. In cases with metastasis, the combination of 5-fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or ge...
1 CitationsSource
#1Amaninder Dhaliwal (UNMC: University of Nebraska Medical Center)H-Index: 6
#2Sindhura Kolli (NYU: New York University)H-Index: 5
Last. Douglas G. Adler (UofU: University of Utah)H-Index: 65
view all 12 authors...
Background and study aims Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) can be used in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). We performed a systematic review and meta-analysis to evaluate the efficacy of EUS-RFA in treatment of locally advanced unresectable PDAC and other pancreatic tumors. Patients and methods A comprehensive search was done of multiple electronic databases and conference proceedings including PubMed, EMBASE, Web of Science databas...
4 CitationsSource
#1Giampaolo Perri (University of Texas MD Anderson Cancer Center)H-Index: 9
#2Laura R. Prakash (University of Texas MD Anderson Cancer Center)H-Index: 15
Last. Matthew H.G. Katz (University of Texas MD Anderson Cancer Center)H-Index: 66
view all 16 authors...
Importance Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) and gemcitabine plus nanoparticle albumin-bound (nab)–paclitaxel (GA) are first-line chemotherapy regimens for pancreatic cancer. Their relative efficacy in the setting of localized disease is unknown. Objective To evaluate radiographic and serologic measures of responses associated with first-line chemotherapy with FOLFIRINOX or GA, and to determine the association between these drug regimens, putative measures of res...
24 CitationsSource
#1Mirko D'Onofrio (University of Verona)H-Index: 58
#2Alessandro Beleù (University of Verona)H-Index: 3
Last. Claudio Bassi (University of Verona)H-Index: 110
view all 10 authors...
Purpose The aim of this study was to investigate the safety and effectiveness of percutaneous radiofrequency ablation (RFA) in locally advanced pancreatic cancer (LAPC) of the pancreatic body by assessing the overall survival of patients and evaluating the effects of the procedure in the clinical and radiological follow-up. Materials and Methods Patients with unresectable LAPC after failed chemoradiotherapy for at least six months were retrospectively included. Percutaneous RFA was performed aft...
2 CitationsSource
#1Laura Maggino (University of Verona)H-Index: 14
#2Giuseppe Malleo (University of Verona)H-Index: 8
Last. Roberto Salvia (University of Verona)H-Index: 52
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Importance Chemotherapy is the recommended induction strategy in borderline resectable and locally advanced pancreatic ductal adenocarcinoma. However, the associated results on an intention-to-treat basis are poorly understood. Objective To investigate pragmatically the treatment compliance, conversion to surgery, and survival outcomes of patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma undergoing primary chemotherapy. Design, Setting, and Participants Th...
42 CitationsSource
#1Michelle M. Holland (University of Louisville)H-Index: 1
#2Neal Bhutiani (University of Louisville)H-Index: 13
Last. Robert C.G. Martin (University of Louisville)H-Index: 81
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Abstract Background The optimal treatment and management of locally advanced pancreatic cancer (LAPC) remains unclear and controversial. This study aimed to report the initial outcomes of the AHPBA Registry and evaluate the reproducibility of existing evidence that the addition of Irreversible Electroporation (IRE), a nonthermal ablative treatment, confers survival benefits beyond standard therapeutic options for patients with LAPC. Methods From December 2015 to October 2017, patients with LAPC ...
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Abstract Background Among patients with metastatic pancreatic cancer, combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) leads to longer overall surviv...
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#1Junki MizusawaH-Index: 36
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Last. HepatobiliaryH-Index: 3
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Abstract Gemcitabine is one of the standard treatments for locally advanced pancreatic cancer. Recent studies on metastatic pancreatic cancer have shown that combination chemotherapy with oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) prolonged the overall survival compared with gemcitabine alone. To select the most promising chemotherapy, a randomized phase II selection design trial was started in July 2016 to compare between modifie...
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