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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. Safety and efficacy of photobiomodulation therapy in oncology: A systematic review

Author

René‐Jean Bensadoun, Joel B. Epstein, Raj G. Nair, Andrei Barasch, Judith E. Raber‐Durlacher, Cesar Migliorati, Marie‐Thérèse Genot‐Klastersky, Nathaniel Treister, Praveen Arany, Joy Lodewijckx, Jolien Robijns, and the World Association for Laser Therapy (WALT)

Subjects
cancer, photobiomodulation, safety, supportive care, systematic review, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract We performed a systematic review of the current literature addressing the safety and efficacy of photobiomodulation therapy (PBMT) in cancer patients. In this systematic review, the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines were used. In vitro, in vivo, and clinical studies, which investigated the effect of PBMT on cell proliferation/differentiation, tumor growth, recurrence rate, and/or overall survival were included. The Medline/PubMed, EMBASE, and Scopus databases were searched through April 2020. A total of 67 studies met the inclusion criteria with 43 in vitro, 15 in vivo, and 9 clinical studies identified. In vitro studies investigating the effect of PBMT on a diverse range of cancer cell lines demonstrated conflicting results. This could be due to the differences in used parameters and the frequency of PBM applications. In vivo studies and clinical trials with a follow‐up period demonstrated that PBMT is safe with regards to tumor growth and patient advantage in the prevention and treatment of specific cancer therapy‐related complications. Current human studies, supported by most animal studies, show safety with PBMT using currently recommended clinical parameters, including in Head & Neck cancer (HNC) in the area of PBMT exposure. A significant and growing literature indicates that PBMT is safe and effective, and may even offer a benefit in patient overall survival. Nevertheless, continuing research is indicated to improve understanding and provide further elucidation of remaining questions regarding PBM use in oncology.

Published
2020
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3. Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997–2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR)

Author

Charles L. Bennett, Shamia Hoque, Nancy Olivieri, Matthew A. Taylor, David Aboulafia, Courtney Lubaczewski, Andrew C. Bennett, Jay Vemula, Benjamin Schooley, Bartlett J. Witherspoon, Ashley C Godwin, Paul S. Ray, Paul R. Yarnold, Henry C. Ausdenmoore, Marc Fishman, Georgne Herring, Anne Ventrone, Juan Aldaco, William J. Hrushesky, John Restaino, Henrik S. Thomsen, Robert Marx, Cesar Migliorati, Salvatore Ruggiero, Chadi Nabhan, Kenneth R. Carson, June M. McKoy, Y. Tony Yang, Martin W. Schoen, Kevin Knopf, Linda Martin, Oliver Sartor, Steven Rosen, and William K. Smith

Subjects
Adverse drug reaction, Liability, Patient harm, Toxicity, Medicine (General), R5-920
Abstract

Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting. Methods: We reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings. Findings: Twenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards (p

Published
2021
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4. Oral manifestations of Wegener's granulomatosis: a report of three cases and a literature review

Author

Carol, Stewart, Donald, Cohen, Indraneel, Bhattacharyya, Lawrence, Scheitler, Steven, Riley, Kenneth, Calamia, Cesar, Migliorati, Ronald, Baughman, Perry, Langford, and Joseph, Katz

Subjects
Adult, Diagnosis, Differential, Male, Gingival Hyperplasia, Granulomatosis with Polyangiitis, Humans, Female, Middle Aged, Sinusitis, Oral Ulcer, Antibodies, Antineutrophil Cytoplasmic
Abstract

Hyperplastic granular gingivitis or "strawberry gingivitis" is a rare manifestation of Wegener's granulomatosis (WG), but it is nearly pathognomonic for this multisystem autoimmune vasculitis. The dentist may be the first health care professional to see patients with symptoms and findings of this condition. Early diagnosis and treatment is the most important factor in the management of this potentially fatal disease.The authors present three case reports that demonstrate the disease spectrum and conducted a literature review focused on current understanding of this disease.The first patient had only the classic gingival manifestations of the disease. The second patient had simultaneous typical gingival lesions, as well as dermatologic findings. The third patient had an atypical oral presentation of aphthous ulcers and erythematous gingiva, as well as respiratory and genital involvement. Reaching a definitive diagnosis sometimes is challenging owing to the subtle onset of the disease and variable clinical and laboratory findings.Clinicians should be familiar with the broad variety of oral and systemic components of WG, as well as strategies to facilitate prompt disease recognition and to provide continued oral health care to these medically complex patients.

Published
2007

6. A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation.

Author

Fernanda Eduardo, Katherine Guthrie, Jean-Claude Franquin, Rene-Jean Bensadoun, Cesar Migliorati, C. Lloid, Niccoli-Filho Walter, Marcia Marques, and Mohd Hamdi

Subjects
LASERS, LIGHT sources, OPTOELECTRONIC devices, NONLINEAR optics
Abstract

Abstract Introduction  Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy. Materials and methods  Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm2. Study treatment began on the first day of conditioning and continued through day post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT. Results  The 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted. Discussion  While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM. [ABSTRACT FROM AUTHOR]

Published
2007

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