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NCCN Recommends TTFields With Temozolomide for Newly Diagnosed GBM

Jason Harris
Published: Tuesday, Mar 20, 2018

Asaf Danziger
Asaf Danziger
The NCCN has added the combination of TTFields (Optune) and temozolomide (Temodar) to its guidelines for Category 1 treatment of newly diagnosed glioblastoma following maximal safe resection and completion of radiation therapy.

Median PFS was 6.7 months with the combination compared with 4.0 months for the monotherapy (HR, 0.63; 95% CI, 0.52-0.76; P <.001). Median OS was 20.9 months in the TTFields/temozolomide group versus 16.0 months in the temozolomide-alone group (HR, 0.63; 95% CI, 0.53-0.76; P <.001).

In posthoc analyses, TTFields plus temozolomide was associated with an increase in PFS and OS in all subgroups regardless of age, sex, Karnofsky performance score, MGMT promoter methylation status, geographic region, or extent of resection. While Investigators found that the OS benefit associated with the combination was consistent across all patient subgroups including subgroups with the worst prognosis who had less benefit from previous therapies such as patients aged ≥65 years (HR, 0.51; 95% CI, 0.33-0.77) and those with methylated and unmethylated MGMT tumors (HR, 0.66; 95% CI, 0.49-0.85).

In exploratory analyses, 43% (95% CI, 39-48) of patients were alive at 2 years from randomization, 26% (95% CI, 22-31) at 3 years, and 26% and 13% (95% CI, 9-18) at 5 years in the combination arm compared with 31% (95% CI, 25- 38; P <.001), 16% (95% CI, 12-23; P = .009), and 5% (95% CI, 2-11; P = .004) in the temozolomide-only group, respectively.

Six-month PFS was 56% (95% CI, 51- 61) in the combination arm compared with 37% (95% CI, 30-44) with temozolomide monotherapy (P <.001)

Investigators did not see an increase in systemic adverse events (AEs) with the combination (48% vs 44%; P = .58). Patients in the combination arm had a higher number of grade 3/4 AEs, but investigators attributed the difference to the longer duration of temozolomide treatment in this group due to delayed occurrence of progression. These differences disappeared when investigators controlled for duration of treatment except in the case of e higher incidence of localized skin toxic effects beneath the transducer arrays in patients treated with TTFields plus temozolomide. Fifty-two percent of patients experienced mild to moderate skin irritation and 2% experienced grade 3 skin involvement.

At the interim analysis, anxiety, confusion, insomnia, and headaches which were reported more frequently, the difference was statistically nonsignificant, in patients treated with TTFields. Investigators did not observe those AEs in the final analysis.

The incidence of seizures was identical in the 2 groups.

Based on earlier results from the EF-14 trial, the FDA approved a second-generation, lighter version of the device in July 2016. The new version weighs 2.7 lbs, about half the size and weight of the original.

The first-generation of Optune was most recently approved in 2015 for use in combination with adjuvant temozolomide as a treatment for patients with newly diagnosed GBM following surgery, chemotherapy, and radiation therapy. Optune was initially approved in 2011 for the treatment of recurrent GBM after other surgical and radiation options were exhausted.
Stupp R, Taillibert S, Kanner A, et al. Survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. doi:10.1001/jama.2017.18718.


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