428P - 'Low-dose metronomic temozolomide' in recurrent TMZ-refractory glioblastoma patients: a retrospective analysis of national data in Korea

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Central Nervous System Malignancies
Therapy
Biological therapy
Presenter Yunjung Choi
Citation Annals of Oncology (2014) 25 (suppl_4): iv137-iv145. 10.1093/annonc/mdu330
Authors Y. Choi1, M.S. Yun1, S.H. Lim1, S. Bae1, Y. Na2, Y.H. Kim3, K.S. Kang1, S. Lee4
  • 1Pharmaceutical Benefits Guideline Division, Health Insurance Review & Assessment Service, 137-927 - Seoul/KR
  • 2Drug Management Dept., Health Insurance Review & Assessment Service, 137-927 - Seoul/KR
  • 3Internal Medicine, Korea University Medical Center, KR-136-705 - Seoul/KR
  • 4Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR

Abstract

Aim

The aim of this retrospective study is to evaluate the efficacy and safety of metronomic temozolomide (TMZ) treatment in 125 Korean patients with recurrent TMZ-refractory glioblastoma from national data in Korea.

Methods

In Korea, KFDA (Korean Ministry of Food and Drug Administration) off-label use of anticancer drug has to approve its use in advance from HIRA (Health Insurance Review & Assessment Service in Republic of Korea), and report a one-year outcome data to HIRA. The KFDA approved dosage of temozolomide is TMZ 150 to 200 mg/m2 × 5 days in a 28-day cycle, while ‘low dose metronomic temozolomide’ is KFDA unapproved dosage, continuous dose-intense TMZ 50 mg/m2/day. We reviewed a total 125 patients' national clinical data retrospectively, which is reported to the efficacy and toxicity of ‘low-dose metronomic temozolomide’ in recurrent TMZ-refractory glioblastoma, as KFDA unapproved use in Korea.

Results

A total 125 patients (male 58.4%, female 41.6%, mean 50 ± 12 yrs, range 13-75yrs) in 13 hospitals received ‘low-dose metronomic temozolomide’ during Mar. 2009 to Sep. 2013 in Korea. The 6-month PFS rate was 19.2% (95% CI: 12.2 ∼ 26.1). Complete response (CR) rate was 6.5%, and the average period of this state was 32.9+ months. Partial response (PR) rate was 4.3%, A progression free survival (PFS) time was 2.1 months. Median overall survival time was 7.5 months. Only 1 patient has a grade 3+ thrombocytopenia. Total 100 patients stopped the medication. Among them, the 95 patients were due to disease progression and the 5 patients were due to toxicities

Conclusions

The results of this study show ‘Low-dose metronomic temozolomide’ also might be option for recurrent TMZ-refractory glioblastoma. And it can be necessary for some recurrent Korean GBM patients to receive KFDA unapproved low dosage.

Disclosure

All authors have declared no conflicts of interest.