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  1. Article ; Online: Systemic therapies in hepatocellular carcinoma: A revolution?

    Fortuny, Marta / Sanduzzi-Zamparelli, Marco / Reig, Maria

    United European gastroenterology journal

    2024  Volume 12, Issue 2, Page(s) 252–260

    Abstract: The evolution in systemic therapies in hepatocellular carcinoma (HCC) signifies a strategy of high-cost, high-gain innovation that originated with sorafenib, despite its limited impact on tumor response. This strategic approach paved the way for the ... ...

    Abstract The evolution in systemic therapies in hepatocellular carcinoma (HCC) signifies a strategy of high-cost, high-gain innovation that originated with sorafenib, despite its limited impact on tumor response. This strategic approach paved the way for the emergence of a second wave of the short-lived competitive advantage, exemplified by the incorporation of atezolizumab plus bevacizumab and tremelimumab plus durvalumab. In the context of safety concerns within the liver cancer domain, the IMBRAVE150 and HIMALAYA trials boldly incorporated bevacizumab and tremelimumab, respectively, demonstrating the continuation of the high-risk, high-reward innovation paradigm. This review delves into the strengths, weaknesses, opportunities, and threats analysis of systemic therapies in the field of HCC.
    MeSH term(s) Humans ; Carcinoma, Hepatocellular/drug therapy ; Bevacizumab/therapeutic use ; Liver Neoplasms/drug therapy ; Sorafenib/therapeutic use
    Chemical Substances Bevacizumab (2S9ZZM9Q9V) ; Sorafenib (9ZOQ3TZI87)
    Language English
    Publishing date 2024-01-24
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2728585-6
    ISSN 2050-6414 ; 2050-6406
    ISSN (online) 2050-6414
    ISSN 2050-6406
    DOI 10.1002/ueg2.12510
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Reply to: "Correspondence on the <BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update>".

    Reig, Maria / Bruix, Jordi

    Journal of hepatology

    2022  Volume 76, Issue 5, Page(s) 1240–1241

    MeSH term(s) Carcinoma, Hepatocellular/pathology ; Humans ; Liver Neoplasms/pathology ; Neoplasm Staging ; Prognosis ; Retrospective Studies
    Language English
    Publishing date 2022-03-11
    Publishing country Netherlands
    Document type Letter ; Comment
    ZDB-ID 605953-3
    ISSN 1600-0641 ; 0168-8278
    ISSN (online) 1600-0641
    ISSN 0168-8278
    DOI 10.1016/j.jhep.2022.02.026
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  3. Article ; Online: Analysis of individual patient data in patients with HCC treated with immunotherapy: A step forward for clinical trial design.

    Pinter, Matthias / Reig, Maria / Cabibbo, Giuseppe

    Hepatology (Baltimore, Md.)

    2023  Volume 78, Issue 6, Page(s) 1684–1687

    MeSH term(s) Humans ; Carcinoma, Hepatocellular/therapy ; Liver Neoplasms/therapy ; Clinical Trials as Topic ; Immunotherapy
    Language English
    Publishing date 2023-06-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604603-4
    ISSN 1527-3350 ; 0270-9139
    ISSN (online) 1527-3350
    ISSN 0270-9139
    DOI 10.1097/HEP.0000000000000511
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  4. Article ; Online: Antiviral therapy in the palliative setting of HCC (BCLC-B and -C).

    Reig, Maria / Cabibbo, Giuseppe

    Journal of hepatology

    2021  Volume 74, Issue 5, Page(s) 1225–1233

    Abstract: The potential impact of direct-acting antivirals (DAAs) in patients with Barcelona Clinic Liver Cancer (BCLC)-B/C stage hepatocellular carcinoma (HCC) is understudied. Patients with HCC have been systematically excluded from randomised controlled trials ... ...

    Abstract The potential impact of direct-acting antivirals (DAAs) in patients with Barcelona Clinic Liver Cancer (BCLC)-B/C stage hepatocellular carcinoma (HCC) is understudied. Patients with HCC have been systematically excluded from randomised controlled trials evaluating the effectiveness of DAAs. Thus, the benefits of DAAs in patients with HCC are less well defined. The presence of active HCC before the initiation of DAA treatment is reported to be a predictor of DAA failure, and studies in patients without HCC have demonstrated that improvements in cirrhosis complications were lower or absent after DAA failure. Even if viral eradication is achieved using DAAs, reversal of liver function impairment may take longer than the development of end-stage cancer status. Additionally, the impact of DAAs on HCC recurrence is still a controversial topic. Thus, the decision of whether to use DAAs should be made on a patient-by-patient basis, and each patient should be informed of all the potential risks and benefits associated with their usage. This document summarises the current data on the usage of DAAs in BCLC-B/C patients, discusses the concept of "the point of no return" in the setting of DAAs, and proposes tools for deciding the best option for each patient profile. If liver function improvement overlaps with symptomatic HCC progression, the benefits of DAAs could be minimised, worsened, or fully counterbalanced. If the BCLC stage is defined using only liver dysfunction, the decision to prioritise DAA treatment should be based on the option (or lack thereof) of liver transplantation and/or the HCC stage. We propose applying a shared decision-making approach, informing each patient of all the potential risks and benefits of the proposed medical intervention.
    MeSH term(s) Antiviral Agents/therapeutic use ; Carcinoma, Hepatocellular/complications ; Carcinoma, Hepatocellular/therapy ; Decision Making ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Liver Neoplasms/complications ; Liver Neoplasms/therapy ; Neoplasm Staging ; Palliative Care/methods ; Risk Assessment
    Chemical Substances Antiviral Agents
    Language English
    Publishing date 2021-02-11
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 605953-3
    ISSN 1600-0641 ; 0168-8278
    ISSN (online) 1600-0641
    ISSN 0168-8278
    DOI 10.1016/j.jhep.2021.01.046
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  5. Article ; Online: Nivolumab and sorafenib in hepatocellular carcinoma: lessons from the CheckMate 459 study.

    Reig, Maria / Sanduzzi-Zamparelli, Marco

    The Lancet. Oncology

    2021  Volume 23, Issue 1, Page(s) 4–6

    MeSH term(s) Carcinoma, Hepatocellular/drug therapy ; Humans ; Liver Neoplasms/drug therapy ; Nivolumab/adverse effects ; Sorafenib/adverse effects
    Chemical Substances Nivolumab (31YO63LBSN) ; Sorafenib (9ZOQ3TZI87)
    Language English
    Publishing date 2021-12-13
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(21)00651-3
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  6. Article ; Online: Emerging Tools for Hepatocellular Carcinoma Surveillance.

    Singal, Amit G / Reig, Maria / Villanueva, Augusto

    The American journal of gastroenterology

    2022  Volume 117, Issue 12, Page(s) 1948–1951

    Abstract: Abdominal ultrasound, with or without alpha-fetoprotein, is the recommended strategy for hepatocellular carcinoma (HCC) surveillance but misses over one-third of HCC at an early stage. Emerging imaging modalities, including computed tomography and ... ...

    Abstract Abdominal ultrasound, with or without alpha-fetoprotein, is the recommended strategy for hepatocellular carcinoma (HCC) surveillance but misses over one-third of HCC at an early stage. Emerging imaging modalities, including computed tomography and magnetic resonance imaging, have early data showing high sensitivity for early-stage HCC, but potential issues such as radiologic capacity, patient acceptance, cost-effectiveness, and need for validation in Western non-hepatitis B virus populations still need to be evaluated. Similarly, blood-based biomarker panels, including GALAD and liquid biopsy techniques, have shown promising data in phase II case-control studies and may concurrently help address issues of surveillance underuse; however, these tools require validation in phase III and IV cohort studies. While awaiting prospective validation data for these emerging strategies, ultrasound with or without alpha-fetoprotein remains the current gold standard HCC surveillance strategy.
    MeSH term(s) Humans ; Carcinoma, Hepatocellular/epidemiology ; alpha-Fetoproteins ; Liver Neoplasms/epidemiology ; Ultrasonography/methods ; Magnetic Resonance Imaging/methods ; Liver Cirrhosis/pathology
    Chemical Substances alpha-Fetoproteins
    Language English
    Publishing date 2022-09-16
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 390122-1
    ISSN 1572-0241 ; 0002-9270
    ISSN (online) 1572-0241
    ISSN 0002-9270
    DOI 10.14309/ajg.0000000000002015
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  7. Article: The complex management of hepatocellular carcinoma: a major need of expertise.

    Matilla, Ana María / Varela, María / Reig, María

    Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

    2022  

    Abstract: Hepatocellular carcinoma (HCC) is the most frequent liver primary cancer and represents the sixth malignant neoplasm and the fourth cause of cancer associated deaths worldwide. Despite improvements across the last years in therapeutic options, it is ... ...

    Abstract Hepatocellular carcinoma (HCC) is the most frequent liver primary cancer and represents the sixth malignant neoplasm and the fourth cause of cancer associated deaths worldwide. Despite improvements across the last years in therapeutic options, it is still associated with a high mortality. Therefore, HCC represents a major health problem and a challenge for clinicians in terms of management of patient care.
    Language English
    Publishing date 2022-06-03
    Publishing country Spain
    Document type Journal Article
    ZDB-ID 1070381-0
    ISSN 1130-0108 ; 0212-7512
    ISSN 1130-0108 ; 0212-7512
    DOI 10.17235/reed.2022.8953/2022
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  8. Article: Multidisciplinary Clinical Approach to Cancer Patients with Immune-Related Adverse Events Induced by Checkpoint Inhibitors.

    Londoño, Maria-Carlota / Reig, Maria

    Cancers

    2020  Volume 12, Issue 11

    Abstract: Immune-oncology is a major breakthrough in cancer treatment and has become the standard of care for a wide variety of solid organ malignancies. Unfortunately, manipulation of the immune system with checkpoint inhibitors may result in an immune-based ... ...

    Abstract Immune-oncology is a major breakthrough in cancer treatment and has become the standard of care for a wide variety of solid organ malignancies. Unfortunately, manipulation of the immune system with checkpoint inhibitors may result in an immune-based attack of normal tissues which can lead to treatment discontinuation. These immune-related adverse events (irAEs) are diverse and affect several organs, constituting a new clinical challenge in the management of cancer patients. The complexity of this scenario requires a multidisciplinary approach that allows the early identification, diagnosis and treatment of specific irAE, ruling out other non-related adverse events. Hospital Clinic has a multidisciplinary team seeking to develop a coordinated strategy to facilitate the access of patients with suspected irAEs to specialised care resulting in harmonised management that guarantees the best patient care. The aim of the manuscript was to describe the current evidence on the management of irAEs reflecting a coordinated multidisciplinary approach to face this clinical challenge regardless of the immunotherapy indication.
    Language English
    Publishing date 2020-11-19
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers12113446
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  9. Article ; Online: Indolent cancer and pattern of progression: Two missing parameters in trial design for hepatology.

    Iavarone, Massimo / Nault, Jean-Charles / Cabibbo, Giuseppe / Torres, Ferran / Reig, Maria

    Hepatology (Baltimore, Md.)

    2023  

    Abstract: The indolent and aggressive behaviors of HCC might have a role in clinical trial (CT) results; however, the indolent HCC is less analyzed compared to others cancer. Indolent profile could be characterized as follows: (1) patients with low risk of ... ...

    Abstract The indolent and aggressive behaviors of HCC might have a role in clinical trial (CT) results; however, the indolent HCC is less analyzed compared to others cancer. Indolent profile could be characterized as follows: (1) patients with low risk of progression itself due to the HCC molecular profile and/or due to the interaction between cancer cell their microenvironment; (2) patients who achieve objective response or present spontaneous regression; and (3) patients who develop radiological progression with no consequence on either the liver function or general status, and without trigger a change in the tumor stage. Patients with "indolent HCC" generally never develop cancer-related symptoms neither die for HCC-related causes. Thus, we hypothesize that the imbalance in the proportion of "indolent" versus "aggressive HCC" between arms or the underestimation/overestimation of HCC behavior at baseline in single-arm CT could be associated with CT failure or under-overestimation of trial results. The "indolent progression" may also explain the discrepancy between radiological progression-based end points and survival. Moreover, we discuss the related causes that explain the indolent profile of HCC and propose (1) refining the progression-related end point by the pattern of progression to minimize the limitations of the current end points; (2) considering alternative statistical tools for survival analysis such as milestone survival, or restricted mean survival time to capture the value of indolent HCC. According to these considerations, we propose incorporating novel end points into the single arm of phase I/II CT as exploratory analysis or as a secondary end point in phase III CT.
    Language English
    Publishing date 2023-07-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604603-4
    ISSN 1527-3350 ; 0270-9139
    ISSN (online) 1527-3350
    ISSN 0270-9139
    DOI 10.1097/HEP.0000000000000527
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  10. Article ; Online: Navigating the landscape of liver cancer management: Study designs in clinical trials and clinical practice.

    Cabibbo, Giuseppe / Celsa, Ciro / Rimassa, Lorenza / Torres, Ferran / Rimola, Jordi / Kloeckner, Roman / Bruix, Jordi / Cammà, Calogero / Reig, Maria

    Journal of hepatology

    2024  

    Abstract: Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden but also to the severity of underlying chronic liver disease. Moreover, advances in ... ...

    Abstract Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden but also to the severity of underlying chronic liver disease. Moreover, advances in systemic therapies for HCC have increased the complexity of patient management. Randomised-controlled trials represent the gold standard for evidence generation across all areas of medicine and especially in the oncology field, as they allow for unbiased estimates of treatment effect without confounders. Observational studies have many problems that could reduce their internal and external validity. However, large prospective (well-conducted) observational real-world studies can detect rare adverse events or monitor the occurrence of long-term adverse events. How best to harness real world data, which refers to data generated from the routine care of patients, and real-world 'evidence', which is the evidence generated from real-world data, represents an open challenge. In this review article, we aim to provide an overview of the benefits and limitations of different study designs, particularly focusing on randomised-controlled trials and observational studies, to address important and not fully resolved questions in HCC research.
    Language English
    Publishing date 2024-02-01
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 605953-3
    ISSN 1600-0641 ; 0168-8278
    ISSN (online) 1600-0641
    ISSN 0168-8278
    DOI 10.1016/j.jhep.2024.01.018
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