Scalp-sparing radiation with concurrent temozolomide and tumor treating fields (SPARE) for patients with newly diagnosed glioblastoma.

Authors

null

Ryan C Miller

Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA

Ryan C Miller , Andrew Jehyun Song , Ayesha Ali , Voichita C Bar-Ad , Nina Leyson Martinez , Jon Glass , Iyad Alnahhas , David W. Andrews , Kevin Judy , James J Evans , Christopher Farrell , Maria Werner-Wasik , Inna Chervoneva , Michele Ly , Joshua David Palmer , Haisong Liu , Wenyin Shi

Organizations

Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, The James Cancer Hospital at The Ohio State University, Columbus, OH

Research Funding

No funding received
None

Background: Standard of care for patients with newly diagnosed glioblastoma includes concurrent chemoradiation and maintenance temozolomide with Tumor Treating Fields (TTFields). Preclinical studies suggest TTFields and radiation treatment have synergistic effects. We report our clinical trial evaluating safety and tolerability of scalp-sparing radiation with concurrent temozolomide and TTFields. Methods: This is a single arm pilot study. Adult patients (age ≥ 18 years) with newly diagnosed glioblastoma and a KPS of ≥ 60 were eligible. All patients received concurrent scalp-sparing radiation (60 Gy in 30 fractions) with temozolomide (75 mg/m2 daily) and TTFields (200 kHz). Maintenance therapy included temozolomide and continuation of TTFields. Radiation treatment was delivered through TTFields arrays. The primary endpoint was safety and toxicity of TTFields concurrent with chemoradiation in patients with newly diagnosed glioblastoma. Results: A total of 30 patients were enrolled in the trial. Twenty were male and ten were female, with a median age of 58 years (range 19 to 77 years). Median KPS was 90 (range 70 to 100). Median follow-up was 8.9 months (range 1.6 to 21.4 months). Twenty (66.7%) patients had unmethylated MGMT promotor status and ten (33.3%) patients had methylated promoter status. Median time from surgery to radiation was 34 days (26 to 49 days). Scalp dose constraints were achieved for all patients, with the mean dose having a median value of 8.3 Gy (range 4.3 to 14.8 Gy), the D20cc median was 26.1 Gy (range 17.7 to 42.8 Gy), and the D30cc median was 23.5 Gy (range 14.8 to 35.4 Gy). Skin adverse events (AEs; erythema, dermatitis, irritation, folliculitis) were noted in 83.3% of patients, however, these were limited to Grade 1 or 2 events, which resolved spontaneously or with topical medications. No patient had radiation treatment interruption due to skin AEs. Other Grade 1 events included pruritus (33.3%), fatigue (30%), nausea (13.3%), headache (10%), dizziness (6.7%), and cognitive impairment (3.3%). Other Grade 2 events included headache (3.3%). Nineteen patients (63.3%) had progression, with a median PFS of 7.6 months (range 1.6 to 12.7 months). Overall survival was not reached. Conclusions: Concurrent TTFields (200 kHz) with scalp-sparing chemoradiation is a safe and feasible treatment option with limited toxicity. Future randomized prospective trials are warranted to define therapeutic advantages of concurrent TTFields with chemoradiation. Clinical trial information: NCT03477110

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Central Nervous System Tumors

Track

Central Nervous System Tumors

Sub Track

Primary CNS Tumors–Glioma

Clinical Trial Registration Number

NCT03477110

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 2056)

DOI

10.1200/JCO.2021.39.15_suppl.2056

Abstract #

2056

Poster Bd #

Online Only

Abstract Disclosures

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