Angiomyolipoma rebound tumor growth after discontinuation of everolimus in patients with tuberous sclerosis complex or sporadic...
Bissler J. J., Nonomura N., Budde K., Zonnenberg B. A., Fischereder M., Voi M., Louveau A. -., Herbst F., Bebin E. M., Curatolo P., Zonta A., Belousova E.
PLoS ONE
Vol.13, Issue9, Num.e0201005
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.1371/journal.pone.0201005
Аннотация:
Introduction The EXIST-2 (NCT00790400) study demonstrated the superiority of everolimus over placebo for the treatment of renal angiomyolipomas associated with tuberous sclerosis complex (TSC) or sporadic lymphangioleiomyomatosis (LAM). This post hoc analysis of EXIST-2 study aimed to assess angiomyolipoma tumor behavior among patients who submitted to continued radiographic examination following discontinuation of everolimus in the noninterventional follow-up phase. Methods For patients who discontinued everolimus at the completion of extension phase for reasons other than angiomyolipoma progression, a single CT/MRI scan of the kidney was collected after 1 year of treatment discontinuation. Changes from baseline and from the time of everolimus discontinuation in the sum of volumes of target angiomyolipoma lesions were assessed in the non-interventional follow-up phase (data cutoff date, November 6, 2015). Results Of the 112 patients who received 1 dose of everolimus and discontinued t
Ключевые слова:
everolimus; placebo; antineoplastic agent; everolimus; adult; anemia; arthralgia; Article; body weight disorder; clinical article; clinical assessment; clinical outcome; controlled study; disease association; drug efficacy; drug safety; drug tolerability; drug withdrawal; female; human; hypersensitivity; kidney hemangiomyolipoma; lymphangioleiomyomatosis; male; nuclear magnetic resonance imaging; post hoc analysis; postoperative pain; treatment duration; treatment response; tuberous sclerosis; tumor bleeding; tumor growth; tumor volume; x-ray computed tomography; angiomyolipoma; clinical trial; disease exacerbation; kidney tumor; lymphangioleiomyomatosis; middle aged; multicenter study; pathology; phase 3 clinical trial; randomized controlled trial; treatment withdrawal; tuberous sclerosis; young adult; Adult; Angiomyolipoma; Antineoplastic Agents; Disease Progression; Everolimus; Female; Humans; Kidney Neoplasms; Lymphangioleiomyomatosis; Male; Middle Aged; Tuberous Sclerosis; Withhol
Язык текста: Английский
ISSN: 1932-6203
Bissler J. J.
Nonomura N.
Budde K.
Zonnenberg B. A.
Fischereder M.
Voi M.
Louveau A. -. A.-L.
Herbst F.
Bebin E. M.
Curatolo P.
Zonta A.
Belousova E.
Бисслер Й. Й.
Нономура Н.
Будде К.
Зонненберг Б. А.
Фисчередер М.
Вои М.
Лоувеау А. -. А.-Л.
Хербст Ф.
Бебин Е. М.
Cуратоло П.
Зонта А.
Белоусова Е.
Angiomyolipoma rebound tumor growth after discontinuation of everolimus in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis
Angiomyolipoma rebound tumor growth after discontinuation of everolimus in patients with tuberous sclerosis complex or sporadic...
Текст визуальный непосредственный
PLoS ONE
Vol.13, Issue9 Num.e0201005
2018
Статья
everolimus placebo antineoplastic agent everolimus adult anemia arthralgia Article body weight disorder clinical article clinical assessment clinical outcome controlled study disease association drug efficacy drug safety drug tolerability drug withdrawal female human hypersensitivity kidney hemangiomyolipoma lymphangioleiomyomatosis male nuclear magnetic resonance imaging post hoc analysis postoperative pain treatment duration treatment response tuberous sclerosis tumor bleeding tumor growth tumor volume x-ray computed tomography angiomyolipoma clinical trial disease exacerbation kidney tumor lymphangioleiomyomatosis middle aged multicenter study pathology phase 3 clinical trial randomized controlled trial treatment withdrawal tuberous sclerosis young adult Adult Angiomyolipoma Antineoplastic Agents Disease Progression Everolimus Female Humans Kidney Neoplasms Lymphangioleiomyomatosis Male Middle Aged Tuberous Sclerosis Withhol
Introduction The EXIST-2 (NCT00790400) study demonstrated the superiority of everolimus over placebo for the treatment of renal angiomyolipomas associated with tuberous sclerosis complex (TSC) or sporadic lymphangioleiomyomatosis (LAM). This post hoc analysis of EXIST-2 study aimed to assess angiomyolipoma tumor behavior among patients who submitted to continued radiographic examination following discontinuation of everolimus in the noninterventional follow-up phase. Methods For patients who discontinued everolimus at the completion of extension phase for reasons other than angiomyolipoma progression, a single CT/MRI scan of the kidney was collected after 1 year of treatment discontinuation. Changes from baseline and from the time of everolimus discontinuation in the sum of volumes of target angiomyolipoma lesions were assessed in the non-interventional follow-up phase (data cutoff date, November 6, 2015). Results Of the 112 patients who received 1 dose of everolimus and discontinued t