m+Medelevator.RU
← Поиск публикаций
Cancer treatment reviews · 2022

Retrospective observational studies in ultra-rare sarcomas: A consensus paper from the Connective Tissue Oncology Society (CTOS) community of experts on the minimum requirements for the evaluation of activity of systemic treatments.

СтатьяОбзорConsensus StatementНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…

История · было → стало

Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.

Stacchiotti Silvia, Maria Frezza Anna, Demetri George D, Blay Jean-Yves, Bajpai Jyoti, Baldi Giacomo G, Baldini Elizabeth H, Benjamin Robert S, Bonvalot Sylvie, Bovée Judith V M G, Callegaro Dario, Casali Paolo G, D'Angelo Sandra P, Davis Elizabeth J, Dei Tos Angelo P, Demicco Elizabeth G, Desai Jayesh, Dileo Palma, Eriksson Mikael, Gelderblom Hans, George Suzanne, Gladdy Rebecca A, Gounder Mrinal M, Gupta Abha A, Haas Rick, Hayes Andrea, Hohenberger Peter, Jones Kevin B, Jones Robin L, Kasper Bernd, Kawai Akira, Kirsch David G, Kleinerman Eugenie S, Le Cesne Axel, Maestro Roberta, Martin Broto Javier, Maki Robert G, Miah Aisha B, Palmerini Emanuela, Patel Shreaskumar R, Raut Chandrajit P, Razak Albiruni R A, Reed Damon R, Rutkowski Piotr, Sanfilippo Roberta G, Sbaraglia Marta, Schaefer Inga-Marie, Strauss Dirk C, Strauss Sandra J, Tap William D, Thomas David M, Trama Annalisa, Trent Jonathan C, van der Graaf Winette T A, van Houdt Winan J, von Mehren Margaret, Wilky Breelyn A, Fletcher Christopher D M, Gronchi Alessandro, Miceli Rosalba, Wagner Andrew J

Аннотация

BACKGROUND: In ultra-rare sarcomas (URS) the conduction of prospective, randomized trials is challenging. Data from retrospective observational studies (ROS) may represent the best evidence available. ROS implicit limitations led to poor acceptance by the scientific community and regulatory authorities. In this context, an expert panel from the Connective Tissue Oncology Society (CTOS), agreed on the need to establish a set of minimum requirements for conducting high-quality ROS on the activity of systemic therapies in URS.

METHODS: Representatives from > 25 worldwide sarcoma reference centres met in November 2020 and identified a list of topics summarizing the main issues encountered in ROS on URS. An online survey on these topics was distributed to the panel; results were summarized by descriptive statistics and discussed during a second meeting (November 2021).

RESULTS: Topics identified by the panel included the use of ROS results as external control data, the criteria for contributing centers selection, modalities for ensuring a correct pathological diagnosis and radiologic assessment, consistency of surveillance policies across centers, study end-points, risk of data duplication, results publication. Based on the answers to the survey (55 of 62 invited experts) and discussion the panel agreed on 18 statements summarizing principles of recommended practice.

CONCLUSIONS: These recommendations will be disseminated by CTOS across the sarcoma community and incorporated in future ROS on URS, to maximize their quality and favor their use as control data when results from prospective studies are unavailable. These recommendations could help the optimal conduction of ROS also in other rare tumors.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты