Marc Oliva

Institut Català d'Oncologia

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Ricard Mesı́a

Institut Català d'Ornitologia

Lillian L. Siu

Princess Margaret Cancer Centre

Anna Spreafico

Princess Margaret Cancer Centre

Miren Taberna

Institut Català d'Oncologia

A. Lozano

Institut Català d'Oncologia

Lorena Arribas

Institut Català d'Oncologia

Aaron R. Hansen

Princess Margaret Cancer Centre

J. Brenes Castro

Institut Català d'Oncologia

Scott V. Bratman

Princess Margaret Cancer Centre

Bryan Coburn

University of Toronto

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Institut Català d'Oncologia

148

Institut d'Investigació Biomédica de Bellvitge

115

Princess Margaret Cancer Centre

University of Toronto

University Health Network

Bellvitge University Hospital

Universitat de Barcelona

Duran i Reynals Hospital

Institut Català d'Ornitologia

Universitat Autònoma de Barcelona

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Nutritional characterization of patients with oropharyngeal cancers: Impact of human papillomavirus status

Research Square (Research Square) (2024)

Vickie E. Baracos M. Choulli Catherine Kubrak Francisca Morey J. Brenes Castro

Abstract Background Oropharyngeal squamous cell carcinoma (OPSCC) of human papillomavirus (HPV)-positive status is increasing relative to HPV-negative disease. Nutritional features of OPSCC patients according to HPV status is unclear. Subjects/Methods: Canadian and Spanish patients with OPSCC were assessed for body mass index (BMI), weight loss grade (WLG), and computed tomography-defined skeletal muscle index (SMI). Chi-square, t-test, Mann-Whitney-U, Kruskal-Wallis tests were conducted to compare HPV positive and negative groups. Overall survival (OS) was assessed by univariable Kaplan-Meier and Cox proportional hazard methods. Results No differences in BMI, WLG, SMI and adipose tissue index between the 308 (Canada) and 134 (Spain) patients according to HPV status; hence cohorts were pooled (n = 442). HPV-positive patients (n = 317) were overweight/obese (72.8%), had WLG of 0/1 (59.6%) and high SMI (83.4%) while HPV-negative patients were normal/underweight (61.5%), had high WLG 3/4 (50.8%), and moderate/severe SMI depletion (46.9%)(p < 0.003). These overall differences notwithstanding, there was crossover i.e. 35% of HPV-positive patients had high WLG and/or moderate/severe muscle depletion and 29% of HPV-negative patients had minimal weight loss and high SMI. HPV-negative patients had a higher risk of mortality (HR 3.78, 95% CI 2.70 to 5.29, P < 0.001) and this difference was retained after multivariable adjustment for WLG, SMI, age, and disease stage (HR 3.19, 95% CI 2.12 to 4.79, P < 0.001). Conclusion Nutrition features of patients with OPSCC did not differ between Canada and Spain. Distinctive nutrition features exist in patients according to HPV status. The high heterogeneity of individual nutritional profiles invites an individualized approach to nutrition care.

Underweight

10.21203/rs.3.rs-4803916/v1

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607O Interim results of a phase I study of SGN-PDL1V (PF-08046054) in patients with PDL1-expressing solid tumors

Annals of Oncology (2024)

Marc Oliva Sebastian Ochsenreither C. Le Tourneau Stéphane Champiat R. Saleh

Interim

Solid tumor

10.1016/j.annonc.2024.08.674

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SUN-P091: Evolution of Nutritional Status in Locally Advanced Head and Neck (LAHNC) Patients Treated with Bioradiotherapy (BRT)

Clinical Nutrition (2016)

L. Hurtós Marc Oliva M. Bergamino Antonio Rullan Miren Taberna

10.1016/s0261-5614(16)30434-4

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Cetuximab-Containing Combinations in Locally Advanced and Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Frontiers in Oncology (2019)

Miren Taberna Marc Oliva Ricard Mesı́a

Cetuximab remains to date the only targeted therapy approved for the treatment of head and neck squamous cell carcinoma (HNSCC). The EGFR pathway plays a key role in the tumorigenesis and progression of this disease as well as in the resistance to radiotherapy (RT). While several anti-EGFR agents have been tested in HNSCC, cetuximab, an IgG1 subclass monoclonal antibody against EGFR, is the only drug with proven efficacy for the treatment of both locoregionally-advanced (LA) and recurrent/metastatic (R/M) disease. The addition of cetuximab to radiotherapy is a validated treatment option in LA-HNSCC. However, its use has been limited to patients who are considered unfit for standard of care chemoradiotherapy (CRT) with single agent cisplatin given the lack of direct comparison of these two regimens in randomized phase III trials and the inferiority suggested by metanalysis and phase II studies. The current use of cetuximab in HNSCC is about to change given the recent results from randomized prospective clinical trials in both the LA and R/M setting. Two phase III studies evaluating RT-cetuximab versus CRT in Human Papillomavirus (HPV)-positive LA oropharyngeal squamous cell carcinoma (De-ESCALaTE and RTOG 1016) showed inferior overall survival and progression-free survival for RT-cetuximab combination, and therefore CRT with cisplatin remains the standard of care in this disease. In the R/M HNSCC, the EXTREME regimen has been the standard of care as first-line treatment for the past 10 years. However, the results from the KEYNOTE-048 study will likely position the anti-PD-1 agent pembrolizumab as the new first line treatment either alone or in combination with chemotherapy in this setting based on PD-L1 status. Interestingly, the cetuximab-mediated immunogenicity through antibody dependent cell cytotoxicity (ADCC) has encouraged the evaluation of combined approaches with immune-checkpoint inhibitors in both LA and R/M-HNSCC settings. This article reviews the accumulated evidence on the role of cetuximab in HNSCC in the past decade, offering an overview of its current impact in the treatment of LA and R/M-HNSCC disease and its potential use in the era of immunotherapy.

Regimen

Chemoradiotherapy

10.3389/fonc.2019.00383

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Citations (100)

Early-drug development in the era of immuno-oncology: are we ready to face the challenges?

Annals of Oncology (2018)

María Ochoa de Olza Marc Oliva Cinta Hierro Ignacio Matos Juan Martin‐Liberal

The classical development of drugs has progressively faded away, and we are currently in an era of seamless drug-development, where first-in-human trials include unusually big expansion cohorts in the search for early signs of activity and rapid regulatory approval. The fierce competition between different pharmaceutical companies and the hype for immune combinations obliges us to question the current way in which we are evaluating these drugs. In this review, we discuss critical issues and caveats in immunotherapy development. A particular emphasis is put on the limitations of pre-clinical toxicology studies, where both murine models and cynomolgus monkeys have underpredicted toxicity in humans. Moreover, relevant issues surrounding dose determination during phase I trials, such as dose-escalation methods or flat versus body-weight dosing, are discussed. A proposal of how to face these different challenges is offered, in order to achieve maximum efficacy with minimum toxicity for our patients.

Drug Development

Maximum tolerated dose

10.1093/annonc/mdy225

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Citations (24)

Uveal melanoma as a target for immune-therapy

Annals of Translational Medicine (2016)

Marc Oliva Antonio Rullan Josep M. Piulats

Uveal melanoma (UM) is a rare disease that can be deadly in spite of adequate local treatment. Systemic therapy with chemotherapy is usually ineffective and new-targeted therapies have not improved results considerably. The eye creates an immunosuppressive environment in order to protect eyesight. UM cells use similar processes to escape immune surveillance. Regarding innate immunity the production of macrophage inhibiting factor (MIF) and TGF-β, added to MHC class I upregulation, inhibits the action of natural killer (NK) cells. UM cells produce cytokines such as IL-6 and IL-10 that favor macrophage differentiation to the M2 subtype, which promote tumor growth instead of an effective immune response. UM cells also impair the adaptive immune response through production of indoleamine 2,3-dioxygenase (IDO), overexpression of programmed death ligand-1 (PD-L1), alteration of FasL expression, and resistance to perforin. This biological background suggests that immunotherapy could be effective in fighting UM. A Phase II clinical trial with Ipilimumab has shown promising results with mean Overall Survival rate of ten months, and close to 50% of the patients alive at one year. Clinical trials with anti-PD1 antibodies in monotherapy and in combination with anti-CTLA4 are currently recruiting patients worldwide.

10.21037/atm.2016.05.04

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Citations (75)

Residual neck disease management in squamous-cell carcinoma of the head and neck treated with radiotherapy plus cetuximab

Clinical & Translational Oncology (2016)

Robert Montal Marc Oliva Miren Taberna Leticia De avila Aleix Rovira

Concomitant

10.1007/s12094-016-1496-y

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Paclitaxel Plus Cetuximab as Induction Chemotherapy for Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma Unfit for Cisplatin-Based Chemotherapy

Frontiers in Oncology (2022)

Juan A. Marín‐Jiménez Marc Oliva Paloma Peinado Martín Santiago Cabezas‐Camarero M. Plana Serrahima

Induction chemotherapy (ICT) followed by definitive treatment is an accepted non-surgical approach for locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). However, ICT remains a challenge for cisplatin-unfit patients. We evaluated paclitaxel and cetuximab (P-C) as ICT in a cohort of LA-HNSCC patients unfit for cisplatin.This is a retrospective analysis of patients with newly diagnosed LA-HNSCC considered unfit for cisplatin-based chemotherapy (age >70 and/or ECOG≥2 and/or comorbidities) treated with weekly P-C followed by definitive radiotherapy and cetuximab (RT-C) between 2010 and 2017. Toxicity and objective response rate (ORR) to ICT and RT-C were collected. Median overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. Cox regression analysis was performed to determine baseline predictors of OS and PFS.A total of 57 patients were included. Grade 3-4 toxicity rate to ICT was 54.4%, and there was a death deemed treatment-related (G5). P-C achieved an ORR of 66.7%, including 12.3% of complete responses (CR). After P-C, 45 patients (78.9%) continued with concomitant RT-C. Twenty-six patients (45.6%) achieved a CR after definitive treatment. With a median follow-up of 21.7 months (range 1.2-94.6), median OS and PFS were 22.9 months and 10.7 months, respectively. The estimated 2-year OS and PFS rates were 48.9% and 33.7%, respectively. Disease stage had a negative impact on OS (stage IVb vs. III-IVa: HR = 2.55 [1.08-6.04], p = 0.03), with a trend towards worse PFS (HR = 1.92 [0.91-4.05], p = 0.09). Primary tumor in the larynx was associated with improved PFS but not OS (HR = 0.45 [0.22-0.92], p = 0.03, and HR = 0.69 [0.32-1.54], p = 0.37, respectively).P-C was a well-tolerated and active ICT regimen in this cohort of LA-HNSCC patients unfit for cisplatin-based chemotherapy. P-C might represent a valid ICT option for unfit patients and may aid patient selection for definitive treatment.

Concomitant

Induction chemotherapy

10.3389/fonc.2022.953020

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Citations (6)

Faculty Opinions recommendation of Paclitaxel Plus Cetuximab as 1st Line Chemotherapy in Platinum-Based Chemoradiotherapy-Refractory Patients With Squamous Cell Carcinoma of the Head and Neck.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature (2018)

Ricard Mesı́a Miren Taberna Marc Oliva

Refractory (planetary science)

Chemoradiotherapy

10.3410/f.734010824.793550984

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A risk stratification model for toxicities in phase 1 immunotherapy trials

European Journal of Cancer (2022)

Alberto Hernando‐Calvo Abdulazeez Salawu Rachel Y. Chen Daniel Vilarim Araújo Marc Oliva

Despite the increased number of novel immunotherapy (IO) agents under current development, their toxicity profile remains to be fully elucidated.An IO risk stratification model was developed based on 5 different variables: treatment-related deaths; rate of grade ≥3 treatment-related adverse events or treatment-emergent adverse events; grade ≥2 encephalopathy or central nervous system toxicity; grade ≥2 cytokine release syndrome; and the number and type of dose-limiting toxicity. Phase 1 IO trials published from January 2014 to December 2020 were reviewed and categorised based on our risk stratification model into three categories: low-, intermediate- and high-risk. Clinical trial variables were associated with the high-risk category. To review the quality of reporting across phase 1 IO trials, a subset of studies was further examined by the use of the ASCO/SITC Trial Reporting in Immuno-Oncology (TRIO) standards.Different IO compounds demonstrated diverse risk profiles. In multivariable analysis, combination versus IO single agent treatment, and testing IO agents different from anti-programmed death-1/programmed death ligand-1 (anti-PD1/L1), anti-cytotoxic t-lymphocyte antigen-4 (anti-CTLA4) antibodies and anti-cancer vaccines were associated with a higher toxicity risk. None of the studies examined in our dataset reported all the items included in the TRIO standards.Our results have important implications for future clinical trial design. Additionally, standards for reporting are urgently needed.

Risk Stratification

10.1016/j.ejca.2022.08.003

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