A multi-institution phase II study of poly-ICLC and radiotherapy with concurrent and adjuvant temozolomide in adults with newly diagnosed glioblastoma

2560 Background: We evaluated the survival benefit of levetiracetam as a chemosensitizer of temozolomide for patients with newly diagnosed glioblastoma. Methods: This was an open-label, multicenter, phase II study (NCT02815410). Eligible patients were aged 18 years or older and had newly diagnosed glioblastoma with an ECOG performance status of 0-2. All patients received radiotherapy with concurrent temozolomide (75 mg/m2/day) followed by adjuvant temozolomide (150-200 mg/m2/day for 5 days during six 28-day cycles). The first dose of levetiracetam was given just after the surgery at 250mg orally twice a day and increased up to 500mg twice a day prior to radiation. This prospective study was designed to test whether levetiracetam in conjunction with temozolomide improved survival. The historical control group was based on data from a study by Gwak et al. for Korean patients with newly diagnosed glioblastoma with a median overall survival(OS) of 17.5 months and a median progression-free survival (PFS) of 10.1 months. Results: Forty-six patients were enrolled between August 2016 and January 2019. The median follow-up duration was 24.9 months (range, 7.9-35.5). All patients completed standard radiation therapy with temozolomide, and 39 (84.8%) patients completed six cycles of adjuvant temozolomide. Median overall survival (OS) was 30.0 months, and median PFS was 15.0 months. OS at 6, 12, and 24 months was 100%, 91.3%, and 60.7%, respectively. PFS at 6, 12, and 24 months was 93.2%, 65.3%, and 22.6%, respectively. Conclusions: Addition of levetiracetam during concurrent and adjuvant temozolomide along with radiotherapy in patients with newly diagnosed glioblastoma may result in improved outcomes compared to historical data and merits further study. Clinical trial information: NCT02815410 .

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Interim Results of a Phase II Study of Hypofractionated Radiotherapy with Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients over 70 Years Old with Newly Diagnosed Glioblastoma

Oncology ◽

10.1159/000488395 ◽

2018 ◽

Vol 95 (1) ◽

pp. 39-42 ◽

Cited By ~ 3

Author(s):

Mehran Yusuf ◽

Beatrice Ugiliweneza ◽

Mark Amsbaugh ◽

Maxwell Boakye ◽

Brian Williams ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Hypofractionated Radiotherapy ◽

Newly Diagnosed ◽

Adjuvant Temozolomide ◽

Newly Diagnosed Glioblastoma

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Phase II Study of Iniparib with Concurrent Chemoradiation in Patients with Newly Diagnosed Glioblastoma

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-18-0110 ◽

2018 ◽

Vol 25 (1) ◽

pp. 73-79 ◽

Cited By ~ 3

Author(s):

Jaishri O. Blakeley ◽

Stuart A. Grossman ◽

Andrew S. Chi ◽

Tom Mikkelsen ◽

Myrna R. Rosenfeld ◽

...

Keyword(s):

Phase Ii ◽

Phase Ii Study ◽

Concurrent Chemoradiation ◽

Newly Diagnosed ◽

Newly Diagnosed Glioblastoma

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Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis

Tumori Journal ◽

10.1177/0300891618792483 ◽

2018 ◽

Vol 105 (1) ◽

pp. 47-54 ◽

Cited By ~ 2

Author(s):

Pierina Navarria ◽

Federico Pessina ◽

Luca Cozzi ◽

Stefano Tomatis ◽

Giacomo Reggiori ◽

...

Keyword(s):

Radiation Therapy ◽

Phase Ii ◽

Phase Ii Study ◽

Observation Time ◽

Primary Objective ◽

Karnofsky Performance Scale ◽

Newly Diagnosed ◽

Newly Diagnosed Glioblastoma ◽

Hypofractionated Radiation Therapy ◽

Hypofractionated Radiation

Objective: To evaluate hypofractionated radiation therapy (HFRT) given at therapeutic effective doses in a phase II study. Endpoints were progression-free survival (PFS) rate, overall survival (OS), and incidence of toxicity. Methods: Patients with newly diagnosed glioblastoma, age ⩾70 years, Karnofsky performance scale (KPS) score ⩽60, were enrolled. The total dose of HFRT was 52.5 Gy/15 fractions, corresponded to a biological effective dose to the tumor of 70.88 Gy. Results: Thirty patients were treated, with a median age of 75 years. Concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT) was administered in 7 (23.3%) and 11 (40.7%) patients received only adjuvant TMZ-CHT. The median, 6-month PFS, and 12-month PFS were 5.0 months, 43.3%, and 20%, respectively. The median, 6-month OS, and 12-month OS were 8 months, 90%, and 30%, respectively. At the last observation time, 26 patients (86.7%) were dead and 4 (13.3%) were alive. No increase in steroid drugs was required during radiotherapy treatment and a reduction was possible in 12 (40%). Patients with KPS=60, RPA V, MGMT methylated status, neurological status stable or improved after surgery and who underwent HFRT with concurrent and adjuvant CHT, had the better outcome. Conclusion: HFRT has proven to be feasible and effective, with limited morbidity, for selected elderly and frail patients with newly diagnosed glioblastoma. The primary objective of this study was not reached in the whole cohort but only in selected patients, who need more aggressive treatment.

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