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1. Guidance on mucositis assessment from the MASCC Mucositis Study Group and ISOO: an international Delphi studyResearch in context

Author

Ragda Abdalla-Aslan, Pierluigi Bonomo, Dorothy Keefe, Nicole Blijlevens, Katrina Cao, Yin Ting Cheung, Eduardo Rodrigues Fregnani, Robert Miller, Judith Raber-Durlacher, Joel Epstein, Ysabella Van Sebille, Elisa Kauark-Fontes, Abhishek Kandwal, Emma McCurdy-Franks, Joel Finkelstein, Victoria McCarvell, Yehuda Zadik, Giulia Ottaviani, Rui Amaral Mendes, Caroline Margina Speksnijder, Hannah Rose Wardill, Paolo Bossi, Alexa Laheij, Arghavan Tonkaboni, Jacqui Scott, Rania Abasaeed, Adel Kauzman, Adriana Do Socorro Lima Flato, Adwaita Gore, Anne-Marie Hardman, Agnes Horvath, Allan Hovan, Aisha Al-Jamaei, Aya koizumi, Alan Santos-Silva, Alessandra Majorana, Alexandre Giannini, Aléxia Teixeira, Muhammad Ali Shazib, Alison Melvin, Aluísio Miranda Filho, Amanda Gruza, Amber Brown-Dahl, Amit Harilall, Amr El Maghrabi, Ana Andabak Rogulj, Ana Raphaela Curvo, Ana Laura Soares, Andrea Stringer, Andréa Moreira, Andy Kurtzweil, Angelyn Salaberry, Anne Blazy, Anne Margrete Gussgard, Anne Marie Lynge Pedersen, Annette Freidank, Anura Ariyawardana, Adrian Ramseier, Jann Arends, Ariel Blanchard, Adriana Sesti Paz, Angela Thermann, Augusto Poropat, Azael Freites-Martinez, Abdul Rahman Al-Azri, Bente Brokstad Herlofson, Sitaraman BalajiSubramanian, Barbara Ballantyne, Kivanc Bektas-Kayhan, Bengt Hasséus, Benjamin Kaffenberger, Bernar Benites, Bernice Kwong, Beth Test, Fernando Chiantia, Bo Pettersson, Bomi Framroze, Božana Lončar Brzak, Brittany Dulmage, Sorin Buga, Caroline Spekssnijder, Carlton Brown, Antonio Carlos Moura de Melo, Ana Carolina Ribeiro, Caroline Silva, Caroline Fulop, Carryn Anderson, Catherine Flaitz, Cathy Massoud, Cesar Migliorati, Callie Gross, Chiara Gandini, Charles Loprinzi, Charlotte de Mooij, Catherine Hong, Ying Chu Choi, Maria Choy, Christine Boers-Doets, Leonard Schmeel, Cibele Nagano, Maria Coeli Franco, Courtney Subramaniam, Carolyn Patrick, Catherine Poh, Cristina Neuenschwander, Cesar Virgen, Dorothea Riesenbeck, Dale Weaver, Daniel Cohen Goldemberg, Daniel Sundaresan, Daniela Nunes, Danyel Perez, Daphine Travassos, David Yang, Daniela Ribeiro, Dean Kolbinson, Deborah Buick, Deborah Saunders, Juliane De Bortolli, Deepika Chugh, Denise Markstrom, Denise Travassos, Dianna Weikel, Dimitra Galiti, Dinusha Peiris, Fedja Djordjevic, Pankaj Singhai, Douglas Peterson, Douglas Fonseca, Doreen Pon, Iuliia Kovalenko, Aleksandra Polonskaia, Rogério Caldas, Kevin Saganski, Julia Néri, Dennis Abbott, Abhijna Vithal Yergolkar, Cristina Del Conte, Januaria Passos, Katia Uezu, Paula Silva, Steven Gilbert, Keng Yeoh, Kunal Jain, Madhup Rastogi, Satheeshkumar Poolakkad Sankaran, Deborah Manne, Evgeniya Shatokhina, Esther Adebayo-Olojo, Eszter Somogyi-Ganss, Eli Ehrenpreis, Wilber Bernaola-Paredes, Eduardo Fregnani, Elaci Cardoso, Elena Bardellini, Eleni Arvanitou, Elisa Kauark Fontes, Elise Bruning, Eloise Neumann, Elsa Madureira, Marcia Ramires, Erofili Papadopoulou, Etiene Munhoz, Fred Spijkervet, Fabiana Granzotto, Fabiana Martins, Fabio Alves, Farah Mougeot, Federica Aielli, Fernanda Pigatti, Fernanda Fonseca, Firoozeh Samim, Flavia Carvalho, Florence Cuadra Zelaya, Cesar Freytes, Gabriela da Silveira, Gabriela Torino, Gabriela Martins, Geisa Silva, Gemma Caro, Gemma Bryan, Georgette Radford, Ghanyah Al-Qadami, Giorgia Albini, Gisele Mainville, Georgios Gkardiakos, Gleidston Potter, Gulbin Hoeberechts, Gordon Howarth, Grace Bradley, Gunjan Verma, Gustavo dos Santos, Margaret Randles-Guzzardi, Hanlie Engelbrecht, Hannah Wardill, Heidi Hansen, Iquebal Hasan, Hironobu Hata, Helena Ullgren, Heliton Spindola Antunes, Heloísa Laís dos Santos, Howard Weld, Helen McInnes, Hans Peter Jungbluth, Hsiaofen Weng, Ian Hewson, Ingrid Santos, Jorge Illarramendi, Ines Semendric, Rol Menge, Inger Von Bultzingslowen, Maria da Gloria de Melo, Iona Leong, Isabella Fonseca, Isadora Kalif, James Carroll, Janet Coller, Johann Beck-Mannagetta, Joanne Bowen, Jose Meurer, Ricky McCullough, Jennifer Powers, Jesus Gomez, Jimma Lenjisa, jaya Vangara, Jasna Leko, Jane Fall-Dickson, Jean-Luc Mougeot, Joan Fox, Jolien Robijns, Jonn Wu, Patricio Palma, Jaya Amaram-Davila, Jim Siderov, Juliana Dantas, Juliana Jasper, Juliana Monteiro, Julia Bruno, julie pfeffer, Julija Jovanovic Ristivojevic, Juliana Brito, Jyothsna Kuriakose, Yuji Kabasawa, Kanan Dave, Karin Barczyszyn, Karol Sartori Lima, Kate Secombe, Kate White, Kate Cooper, Kouji Katsura, Karen Biggs, Katharine Ciarrocca, Kristopher Dennis, Ken Tomizuka, Kevin Hendler, Ikuko Komo, Kristina Skallsjö, Kristy Hodgins, Katia Rupel, Keiko Tanaka, Seema Kurup, Luiz Gueiros, Larissa Agatti, Laura Garzona-Navas, Letícia Guerra, Leila Portela, Leilani Iossi, Linda Elting, Lene Baad-Hansen, Leslie Reeder, Leticia Lang, Liciane Menezes, Liliana Braun, Liliane Grando, Mathew Lim, Lina Fernandez, Lucy McKeage, Luana Campos, Luciana Simonato, Luciana Muniz, Leah van Draanen, Mieko Mizutani, Tsai-Wei Huang, Mahfujul Riad, Mahnoor Nazar, Maíra Souza, Mariana Minamisako, Manoela Pereira, Carlos Mantelato, Márcio Diniz-Freitas, Marco Montezuma, Marco Andrade, Marcos Santos, Margherita Gobbo, Maria Caterina Fortuna, Mariana Vitor, Joana Marinho, Alina Markova, Marlyse Knuchel, Marta Carlesimo, Marta Neves, Andrew Mazar, Maria Cristina Gomez Amarilla, Mark Chambers, Melissa de Araujo, Alexandre Melo, Melody Cole, Mohamed Elsayed, Monica Fliedner, Martin Hauer-Jensen, Micaela Bouchacourt, Michael Brennan, Michael Thirlwell, Michio Nakamura, Midori Nakagaki, Camila Rossi, Mireille Kaprilian, Michael Kase, Michael Dougan, Monique Stokman, Ragnhild Monsen, Alisha Morgan, Jocelyn Harding, Maryam Taleghani, Marie-Therese Genot, Mukund Seshadri, Brian Muzyka, Nancy Batista, Nancy Gadd, Naoko Tanda, Narmin Nasr, Natália Garcia, Nathan Lee, Natalia Palmier, Norman Brito-Dellan, Nancy Corbitt, Neli Pieralisi, Verônica Serrano, Nicola Alessandro Iacovelli, Norma Lúcia Sampaio, Nour Karra, Niveditha Venkatesh, Noam Yarom, Renata Cristina Borin, Olivia Lemenchick, Ondina Mendes, Ourania Nicolatou-Galitis, Vasiliy Shchitka, Paula Reis, Paulo Sérgio Santos, Paz Fernandez-Ortega, Ira Parker, Raquel García, Peter Fritz, Edmund Peters, Pamela Gardner, Pierre Saint Girons, Priya Tiwari, Pravin Chaturvedi, Tais de Moraes, Priscila Andrade, Raj Nair, Rachel Gibson, Rachita Gururaj, Raghu Thota, Rajesh Lalla, Raquel Almeida Prado, Ravikiran Ongole, George Taybos, Regina Mackey, Renata Rego, Renata Camilotti, Renata Ferrari, Renato Junior, Rene-Jean Bensadoun, Richard Logan, Roberta Sales, Roberta Zanicotti, Roberta Tunes, Rodolfo Mauceri, Rosiene Feitoza, Kathryn Ruddy, Cynthia Rybczyk, Stephanie Trager, Sachiyo Mitsunaga, Sahani Gunathilake, Rajan Saini, Viola Salvestrini, Sandip Mukhopadhyay, Sandrina Angeloz, Pramod Sankar S, Luciana S Barbosa Barbosa, Elena Volkova, Sharon Elad, Sergio Cantoreggi, Sharon Gordon, Shelly Brown, Shu Yie Janine Tam, Sibelle Faleiro, Silmara da Silva, Silvia de Oliveira, Siri Beier Jensen, Ivana Skrinjar, Sophie Beaumont, Felipe Sperandio, Sandra Reese, Steven Roser, Sachiko Seo, Stephanie van Leeuwen, Stephen Sonis, Stephen Bernard, Stephen Rajan Samuel, Stuart Taylor, Suranjan Maitra, Susanne Skulski, Suzanne Carlisle, Sylvie Louise Avon, Tomoya Yokota, Takashi Yurikusa, Tabata Santos Polvora, Tabitha Kelock, Tauana Fernandes, Taylor Wain, Timothy Brown, Tetsuhito konishi, Thalyta Amanda Ferreira, Tomoko Kataoka, Thomas Kelly, Takehiko Mori, Tomoko Higuchi, Toshiaki Saeki, Nikolaos Tsoukalas, Typhaine Maupoint De Vandeul, Masatoshi Usubuchi, Vanessa Lacerda, Vanessa Tilly, Emmanuelle Vigarios, Alessandro Villa, Vinicius Torregrossa, Vinodh Kumar Selvaraj, Viviane Sarmento, Vivien Heng, Wagner Gomes-Silva, Petter Wilberg, Wanessa Miranda e Silva, Wan Nor I'zzah Wan Mohamad Zain, Wonse Park, Wim Tissing, Yoshihiko Soga, Bella Van Sebille, and Yuhei Matsuda

Subjects
Oral mucositis, Gastrointestinal mucositis, Mucositis assessment tools, Patient-reported outcome measures, Medicine (General), R5-920
Abstract

Summary: Background: Mucositis is a common and highly impactful side effect of conventional and emerging cancer therapy and thus the subject of intense investigation. Although common practice, mucositis assessment is heterogeneously adopted and poorly guided, impacting evidence synthesis and translation. The Multinational Association of Supportive Care in Cancer (MASCC) Mucositis Study Group (MSG) therefore aimed to establish expert recommendations for how existing mucositis assessment tools should be used, in clinical care and trials contexts, to improve the consistency of mucositis assessment. Methods: This study was conducted over two stages (January 2022–July 2023). The first phase involved a survey to MASCC-MSG members (January 2022–May 2022), capturing current practices, challenges and preferences. These then informed the second phase, in which a set of initial recommendations were prepared and refined using the Delphi method (February 2023–May 2023). Consensus was defined as agreement on a parameter by >80% of respondents. Findings: Seventy-two MASCC-MSG members completed the first phase of the study (37 females, 34 males, mainly oral care specialists). High variability was noted in the use of mucositis assessment tools, with a high reliance on clinician assessment compared to patient reported outcome measures (PROMs, 47% vs 3%, 37% used a combination). The World Health Organization (WHO) and Common Terminology Criteria for Adverse Events (CTCAE) scales were most commonly used to assess mucositis across multiple settings. Initial recommendations were reviewed by experienced MSG members and following two rounds of Delphi survey consensus was achieved in 91 of 100 recommendations. For example, in patients receiving chemotherapy, the recommended tool for clinician assessment in clinical practice is WHO for oral mucositis (89.5% consensus), and WHO or CTCAE for gastrointestinal mucositis (85.7% consensus). The recommended PROM in clinical trials is OMD/WQ for oral mucositis (93.3% consensus), and PRO-CTCAE for gastrointestinal mucositis (83.3% consensus). Interpretation: These new recommendations provide much needed guidance on mucositis assessment and may be applied in both clinical practice and research to streamline comparison and synthesis of global data sets, thus accelerating translation of new knowledge into clinical practice. Funding: No funding was received.

Published
2024
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2. Baseline gut microbiota composition is associated with oral mucositis and tumour recurrence in patients with head and neck cancer: a pilot study

Author

Ghanyah Al-Qadami, Joanne Bowen, Ysabella Van Sebille, Kate Secombe, Mohsen Dorraki, Johan Verjans, Hannah Wardill, Hien Le, Al-Qadami, Ghanyah, Bowen, Joanne, Van Sebille, Ysabella, Secombe, Kate, Dorraki, Mohsen, Verjans, Johan, Wardill, Hannah, and Le, Hien

Subjects
Oncology, gut microbiome, head and neck cancer, radiotherapy, oral mucositis
Abstract

Purpose Mounting evidence suggests the gut microbiome influences radiotherapy efficacy and toxicity by modulating immune signalling. However, its contribution to radiotherapy outcomes in head and neck cancer (HNC) is yet to be investigated. This study, therefore, aimed to uncover associations between an individual’s pre-therapy gut microbiota and i) severity of radiotherapy-induced oral mucositis (OM), and ii) recurrence risk in patients with HNC. Methods In this prospective pilot study, 20 patients with HNC scheduled to receive radiotherapy or chemoradiotherapy were recruited. Stool samples were collected before treatment and microbial composition was analysed using 16S rRNA gene sequencing. OM severity was assessed using the NCI-CTCAE scoring system. Patients were also followed for 12 months of treatment completion to assess tumour recurrence. Results Overall, 80% of the patients were male with a median age of 65.5 years. 53% experienced mild/moderate OM while 47% developed severe OM. Further, 18% experienced tumour relapse within 1 year of treatment completion. A pre-treatment microbiota enriched of Eubacterium, Victivallis, and Ruminococcus was associated with severe OM. Conversely, a higher relative abundance of immunomodulatory microbes Faecalibacterium, Prevotella, and Phascolarctobacterium was associated with a lower risk of tumour recurrence. Conclusion Our results indicate that a patient’s gut microbiota composition at the start of treatment is linked to OM severity and recurrence risk. We now seek to validate these findings to determine their ability to predict treatment outcomes in HNC, with the goal of using this data to inform second-generation microbial therapeutics to optimise treatment outcomes for patients with HNC.

Published
2022

3. Guidelines For Reporting On Animal Faecal Transplantation (GRAFT) Studies: Recommendations From A Systematic Review of Murine Transplantation Protocols

Author

Kate Secombe, Ghanyah Al-Qadami, Courtney Subramaniam, Joanne Bowen, Jacqui Scott, Ysabella Van Sebille, Matthew Snelson, Caitlin Cowan, Gerard Clarke, Cassandra Gheorghe, John Cryan, and Hannah Wardill

Abstract

Background/Objectives: Faecal microbiota transplant (FMT) is a powerful tool used to connect changes in gut microbial composition with a variety of disease states and pathologies. While FMT enables potential causal relationships to be identified, the experimental details reported in preclinical FMT protocols are highly inconsistent and/or incomplete. This limitation reflects a current lack of authoritative guidance on reporting standards which would facilitate replication efforts and ultimately reproducible science. We therefore systematically reviewed all FMT protocols used in mouse models with the goal of formulating recommendations on the reporting of preclinical FMT protocols. Methods: Search strategies were applied across three databases (PubMed, EMBASE and Ovid Medline) until June 30, 2020. Data related to donor attributes, stool collection, processing/storage, recipient preparation, administration and quality control were extracted.Results: A total of 1753 papers were identified, with 241 identified for data extraction and analysis. Of the papers included, 92.5% reported a positive outcome with FMT intervention. However, the vast majority of studies failed to address core methodological aspects including the use of anaerobic conditions (91.7% of papers lacked information), storage (49.4%), homogenisation (33.6%), concentration (31.5%), volume (19.9%) and administration route (5.3%). To address these reporting limitations, we developed the Guidelines for Reporting Animal Faecal Transplant (GRAFT) that guide reporting standards for preclinical FMT. Conclusion: The GRAFT recommendations will enable robust reporting of preclinical FMT design, and facilitate high quality peer review, improving the rigour and translation of knowledge gained through preclinical FMT studies.

Published
2021
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