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The efficacy of slow-rate ventriculolumbar perfusion chemotherapy for leptomeningeal carcinomatosis: a phase II study.
Jang, Soojin; Gwak, Ho-Shin; Joo, Jungnam; Doh, Yoon-Sik; Shin, Sang-Hoon; Yoo, Heon; Wang, Kyu-Chang.
Afiliación
  • Jang S; Department of Neurosurgery, Seoul National University College of Medicine, Seoul, Korea.
  • Gwak HS; Department of Cancer Control, Graduate School of Cancer Science and Policy, National Cancer Center, 323 Ilsan-Ro, Ilsandong-Gu, Goyang, Korea. nsghs@ncc.re.kr.
  • Joo J; Biometric Research Branch, National Heart, Lung and Blood Institute, Bethesda, USA.
  • Doh YS; Neuro-Oncology Clinic, National Cancer Center, Goyang, Korea.
  • Shin SH; Neuro-Oncology Clinic, National Cancer Center, Goyang, Korea.
  • Yoo H; Neuro-Oncology Clinic, National Cancer Center, Goyang, Korea.
  • Wang KC; Neuro-Oncology Clinic, National Cancer Center, Goyang, Korea.
Acta Neurochir (Wien) ; 166(1): 117, 2024 Mar 01.
Article en En | MEDLINE | ID: mdl-38424255
ABSTRACT

PURPOSE:

This study aimed to evaluate the symptomatic response and side effects of ventriculolumbar perfusion (VLP) methotrexate chemotherapy with a low perfusion rate in patients with leptomeningeal metastasis.

METHODS:

Patients in a single-arm, two-stage phase II trial based on Simon's minimax design received VLP with a reduced (15 cc/h) perfusion rate with the purpose of decreasing constitutional side effects such as nausea/vomiting, insomnia, and confusion. The primary outcome was control of increased intracranial pressure (ICP). The secondary outcome was an occurrence of side effects. The results were compared with those of a previous trial of VLP with a 20-cc/h perfusion rate.

RESULTS:

Total 90 patients were enrolled. Out of 65 patients with increased ICP, 32 achieved normalized ICP after VLP chemotherapy (bias-adjusted response rate = 51%). The incidence of moderate-to-severe nausea/vomiting was reduced to 46% from 64% in the previous study, and that of sleep disturbance was increased to 13% from 9%, but both failed to reach statistical significance. The incidence of moderate-to-severe confusion was significantly reduced to 12% from 23% in the previous study (p = 0.04). Median overall survival was better among patients with controlled ICP than among those who remained with increased ICP (193 days vs. 94 days, p = 0.013).

CONCLUSION:

Compared with a higher perfusion rate, the low perfusion rate failed to provide non-inferior ICP control or improved side effects, except for confusion. The relationship between VLP perfusion rate and ICP control needs to be evaluated in future trials adjusting for bias from uncompleted protocol due to poor general condition.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Carcinomatosis Meníngea Límite: Humans Idioma: En Revista: Acta Neurochir (Wien) Año: 2024 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Carcinomatosis Meníngea Límite: Humans Idioma: En Revista: Acta Neurochir (Wien) Año: 2024 Tipo del documento: Article