This article is more than 5 years old. Information may no longer be current.
NovoTTF-100A improved response, time to treatment failure in recurrent glioblastoma
Click Here to Manage Email Alerts
ASCO 2010 Annual Meeting
CHICAGO — Treatment with a portable medical device that disrupts mitosis by delivering electrical fields through scalp electrodes resulted in a superior response rate and extended time to treatment failure compared with standard chemotherapy in patients with recurrent glioblastoma, according to results from an international phase 3 trial.
The NovoTTF-100A is a portable medical device that delivers low intensity, intermediate frequency, alternating electric fields through noninvasive electrodes on the scalp. Roger Stupp, MD, attending physician in the department of neurosurgery of the University of Lausanne Medical Center, Switzerland, said the device generates tumor treatment fields that interfere with cell division and organelle assembly.
“With NovoTTF, we have an entirely novel, chemotherapy-free, physically-based treatment modality that proved feasible,” Stupp said. “Toxicity was minimal and patient compliance was, even to my own surprise, excellent.”
Stupp presented the results at the 2010 ASCO Annual Meeting.
At 28 sites in the United States and Europe, 120 adults with recurrent glioblastoma were assigned treatment with the device; 117 were assigned to physician’s choice of best standard of care chemotherapy. Median Karnofsky Performance Score was 80%, and all patients had undergone prior treatment with temozolomide (Temodar, Schering) and radiation. The majority of patients had at least one prior therapy for recurrence.
Among patients who actually underwent treatment, 93 patients were assigned TTF and 92 were assigned best physician’s choice.
A greater percentage of patients in the intent-to-treat population responded to the device (11.7% vs. 5.9%). There were 11 partial responses and three complete responses in the TTF group compared with seven partial responses and no complete responses in the chemotherapy group.
In the intent-to-treat population, median OS favored TTF (6.6 months vs. 6 months), but Stupp said the difference was not statistically significant (HR=0.81; 95% CI 0.63-1.12). The 1-year survival rate for TTF was 23.6% vs. 20.7% for chemotherapy.
Stupp said that when looking at OS per protocol treated population (n=185), the difference in survival was significant (HR=0.64; 95% CI= 0.45-0.91). Median survival for TTF was 7.8 months compared with 6.1 months for best physician’s choice, and the 1-year survival rate was 29.5% for TTF vs. 19.1% for chemotherapy.
“These are fairly impressive results for the device when patients are treated without any chemotherapy,” Stupp said. “OS of all patients compared favorably with best physician’s choice, but it was not significant in the intent-to-treat analysis. But, if you look at patients who actually got treatment, this turned out to be significant, with a HR of 0.64.”
Six-month PFS in the intent-to-treat population was 24% for TTF and 17% for chemotherapy, a difference Stupp called statistically nonsignificant. In the per-protocol population, 6-month PFS was 28% vs. 14% in favor of TTF.
In the per-protocol population, time to treatment failure was also superior in the TTF group (3 months vs. 2.1 months; HR=0.60; 95% CI, 0.44-0.81). – by Jason Harris
For more information:
- Stupp R. #LBA2007. Presented at: the 2010 ASCO Annual Meeting; June 4-8; Chicago.
Follow HemOncToday.com
on Twitter.