医学
帕博西利布
替莫唑胺
内科学
肿瘤科
洛莫司汀
无进展生存期
少突胶质瘤
达卡巴嗪
化疗方案
人口
养生
化疗
癌症
外科
胶质瘤
乳腺癌
长春新碱
星形细胞瘤
癌症研究
转移性乳腺癌
环磷酰胺
环境卫生
作者
Juan Manuel Sepúlveda,Miguel Gil‐Gil,Miriam Alonso,María Ángeles Vaz Salgado,E. Vicente,Carlos Mesía Barroso,Ángel Rodríguez Sánchez,Gema Durán,R. de las Peñas,J. Muñoz-Langa,Guillermo Velasco,Aurelio Hernández‐Laín,Amaya Hilario,L Miguel Navarro,Manuel Benavides,Laura Oleaga,Diana Cantero,Yolanda Ruano,Pilar Sánchez‐Gómez,Estela Pineda
标识
DOI:10.1200/jco.2019.37.15_suppl.2038
摘要
2038 Background: The pRB-dependent cell cycle checkpoint is altered in the vast majority of anaplastic oligodendrogliomas (AO), either by homozygous deletion or by hypermethylation of CDKN2A and/or CDKN2B, or by amplification and/or overexpression of CDK4. Palbociclib is an oral inhibitor of CDK4 and 6 that has already been shown to be highly active in breast cancer. Methods: We conducted a multicenter, open-label, phase II trial evaluating efficacy and safety of Palbociclib in patients with AO that progressed to radiotherapy and more than one chemotherapy regimen containing Temozolomide and/or Lomustine. Inclusion criteria included: histologically and molecularly confirmed grade III oligodendroglioma (WHO 2016 classification, IDH1/2 mutation and 1p/19 codeletion were mandatory), recurrence after radiotherapy and 1 or 2 chemotherapy regimens and conserved RB protein expression by immunohistochemistry (IHC). Patients were treated with Palbociclib 125 mg/daily 3 weeks on/1off. The primary objective of the study was progression-free survival at 6 months (6M-PFS). Results: Between October 2015 and September 2018, 34 patients were enrolled across ten hospitals. The study was stopped early secondary to lack of efficacy, with 74% of evaluable patients progressing within 6 months. Number of patients alive and free from progression at 6 months after the enrollment was 9 (26%) out of the first 34 patients, below the minimum number required (18 out of 40) to consider Palbociclib as an active drug in this population. With a median follow-up of 11.2 months, the median PFS was 3 months (95% CI: 2.5-3.5 months). Median overall survival (OS) was 23.1 months (95% CI: 17.2-25 months). There were no partial or complete responses and only 11 patients (32%) achieved stable disease as best response. Palbociclib was well tolerated with neutropenia (Grade 3 or 4: 40%) and thrombocytopenia (Grade 3 or 4: 15%) as the most common adverse effects (AEs). Both AEs had no significant impact since there were no episodes of febrile neutropenia or bleeding. Conclusions: Despite the good tolerance and drug exposure, Palbociclib monotherapy did not show favorable activity in recurrent AO. Clinical trial information: NCT02530320.
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