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tumores del estroma gastrointestinal (GIST)




Reunión Anual de ASCO 2014

Resumen N º:



J Clin Oncol 32:5 s, 2014 (suppl; abstr 10551)

Autor (s): Marco Maruzzo, Attila Kollar, Charlotte Benson, Christina mesiú, Elizabeth Cartwright, Beatrice M. Seddon, Palma Dileo, Aisha Miah, Juan Martin-Liberal, Khin Thway, Ellen McGrath, Alison Dunlop, Ian Robert Judson, Mark David Linch; Unidad del sarcoma, del Royal Marsden Hospital, Londres, Reino Unido; Oncología Médica Inselspital Bern, Berna, Suiza; Unidad del sarcoma, el Royal Marsden NHS Foundation Trust, Londres, Reino Unido; University College London Hospitals NHS Foundation Trust, Londres, Reino Unido; El Royal Marsden NHS Foundation Trust, Londres, Reino Unido; El Royal Marsden Hospital, Sutton, Reino Unido



Los inhibidores de la tirosina cinasa (TKI) han revolucionado el tratamiento de los tumores del estroma gastrointestinal (GIST), aunque la mayoría de los pacientes desarrollan resistencia a la primera y segunda línea de terapias. Regorafenib, una exposición oral TKI multi-objetivo, ha demostrado beneficio en pacientes con GIST tratados previamente.


Se evaluó la seguridad y la actividad preliminar de regorafenib en los pacientes tratados en el Programa de Acceso Gestionado (MAP). Todos los pacientes consecutivos con GIST avanzado que habían progresado durante o eran intolerantes a imatinib y sunitinib fueron reclutados en el Hospital Royal Marsden Hospital University College. Revisamos retrospectivamente los datos de respuesta, la toxicidad y la duración del tratamiento. La respuesta se evaluó por RECIST y criterios Choi. La toxicidad fue clasificado de acuerdo a los criterios de CTCAE v4.0.


20 pacientes fueron incluidos en el MAP en el Reino Unido entre 3/2013 y 9/2013. La media de edad fue de 68 (rango 45-87), 65% de los pacientes eran hombres. Estado funcional fue 0-1 para los 18 pacientes (90%), 2 de 2 pacientes (10%). La duración media del tratamiento fue de 29 semanas (rango 1-50). 18 pacientes fueron evaluables para la respuesta y todos los pacientes alcanzaron una mejor respuesta de la enfermedad al menos estable. Con una media de seguimiento de 6,7 meses, no hubo 2 respuestas parciales (11%) por RECIST y 7 respuestas parciales (39%) de acuerdo con los criterios de Choi. Un paciente que tenía un PR en regorafenib no se había beneficiado de sunitinib anterior. 3 pacientes presentaron progresión de la enfermedad y 3 pacientes interrumpieron el tratamiento debido a las toxicidades inaceptables; fistulización, mialgia y fatiga. 10 (50%) pacientes tuvieron toxicidades grado 3 y 11 (55%) pacientes requirieron una reducción de la dosis. 5 pacientes comenzaron a la dosis reducida debido a la toxicidad TKI significativa anterior, sin embargo 2 pacientes pudieron ser dosis escalada. La media de la SLP (Supervivencia Libre de Progresión) y la SG (Supervivencia Global) aún no se han alcanzado, pero sobre todo, una enfermedad estable prolongada se observó en 1 paciente con mutación exón 9 y 1 paciente con mutación D842V PDGFR.


Estos datos demuestran que se debe fomentar la actividad de regorafenib en la práctica clínica habitual. Los eventos adversos documentados están en línea con los datos de ensayos anteriores


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