A phase II study of liposomal irinotecan with 5-fluorouracil, leucovorin and oxaliplatin in patients with resectable pancreatic cancer: the nITRO trial:

Published on Sep 4, 2020in Therapeutic Advances in Medical Oncology6.852
· DOI :10.1177/1758835920947969
Francesca Simionato14
Estimated H-index: 14
(University of Verona),
Camilla Zecchetto7
Estimated H-index: 7
(University of Verona)
+ 31 AuthorsDavide Melisi31
Estimated H-index: 31
(University of Verona)
Background Up-front surgery followed by postoperative chemotherapy remains the standard paradigm for the treatment of patients with resectable pancreatic cancer. However, the risk for positive surgical margins, the poor recovery after surgery that often impairs postoperative treatment, and the common metastatic relapse limit the overall clinical outcomes achieved with this strategy. Polychemotherapeutic combinations are valid options for postoperative treatment in patients with good performance status. liposomal irinotecan (Nal-IRI) is a novel nanoliposome formulation of irinotecan that accumulates in tumor-associated macrophages improving the therapeutic index of irinotecan and has been approved for the treatment of patients with metastatic pancreatic cancer after progression under gemcitabine-based therapy. Thus, it remains of the outmost urgency to investigate introduction of the most novel agents, such as nal-IRI, in perioperative approaches aimed at increasing the long-term effectiveness of surgery. Methods The nITRO trial is a phase II, single-arm, open-label study to assess the safety and the activity of nal-IRI with fluorouracil/leucovorin (5-FU/LV) and oxaliplatin in the perioperative treatment of patients with resectable pancreatic cancer. The primary tumor must be resectable with no involvement of the major arteries and no involvement or Discussion The nITRO trial will contribute to strengthen the clinical evidence supporting perioperative strategies in resectable pancreatic cancer patients. Moreover, this study represents a unique opportunity for translational analyses aimed to identify novel immune-related prognostic and predictive factors in this setting. Trial registration Clinicaltrial.gov: NCT03528785. Trial registration data: 1 January 2018Protocol number: CRC 2017_01EudraCT Number: 2017-000345-46.
#1Eva Versteijne (UvA: University of Amsterdam)H-Index: 11
#2Mustafa Suker (EUR: Erasmus University Rotterdam)H-Index: 12
Last. Geertjan van Tienhoven (UvA: University of Amsterdam)H-Index: 35
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PURPOSEPreoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.PATIENTS AND METHODSIn th...
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#1Minako Nagai (Nara Medical University)H-Index: 12
#2Masayuki Sho (Nara Medical University)H-Index: 41
Last. Kota Nakamura (Nara Medical University)H-Index: 5
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Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. Although drug development over the past decade has gradually improved the prognosis of PDAC, the prognosis remains extremely poor. The predominant determinant of a poor prognosis is that patients are already at the advanced stage when they are diagnosed. Therefore, it is essential to detect early-stage PDAC to ensure a good prognosis. However, in general, being asymptomatic at the early stage makes the detection of ...
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#1Chiara BazzichettoH-Index: 9
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The threatening notoriety of pancreatic cancer mainly arises from its negligible early diagnosis, highly aggressive progression, failure of conventional therapeutic options and consequent very poor prognosis. The most important driver genes of pancreatic cancer are the oncogene KRAS and the tumor suppressors TP53, CDKN2A, and SMAD4. Although the presence of few drivers, several signaling pathways are involved in the oncogenesis of this cancer type, some of them with promising targets for precisi...
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#1Julien TaiebH-Index: 62
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Background: FOLFIRINOX is a standard treatment for metastatic pancreatic cancer patients. The effectiveness of neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer (BRPC) remains debated. Methods: We performed a systematic review and patient-level meta-analysis on neoadjuvant FOLFIRINOX in patients with BRPC. Studies with BRPC patients who received FOLFIRINOX as first-line neoadjuvant treatment were included. Primary endpoint was overall survival (OS). Secondary endpoi...
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#1Thomas Seufferlein (University of Ulm)H-Index: 46
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Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers. Curative-intended resection and adjuvant chemotherapy represents the current standard of care. Despite substantial improvements in surgical treatment and intensified adjuvant treatment with more powerful regimens over the last years even clearly resectable pancreatic cancer still has an unfavorable prognosis with a high risk of relapse. Neoadjuvant or perioperative multimodal therapies have substantially improved the outc...
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#1Davide MelisiH-Index: 31
Last. Josep Tabernero (Autonomous University of Barcelona)H-Index: 118
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#1Richard A HubnerH-Index: 25
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Abstract Background The NAPOLI-1 study (NCT01494506) reported that liposomal irinotecan plus 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) improved overall survival vs 5-FU/LV with manageable toxicity in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy. Yet, clinicians need treatment strategies that also maintain the patient's health-related quality of life (HRQOL). Here, we report the HRQOL data. Methods Patients completed the European Organ...
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#1Cindy Neuzillet (Curie Institute)H-Index: 10
#2Sébastien Gaujoux (Paris V: Paris Descartes University)H-Index: 42
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Abstract Background This document is a summary of the French intergroup guidelines regarding the management of pancreatic adenocarcinoma (PA), updated in July 2018. Design This collaborative work was produced under the auspices of all French medical and surgical societies involved in the management of PA. It is based on the previous guidelines, recent literature review and expert opinions. Recommendations were graded in three categories, according to the level of evidence. Results Over the last ...
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