A DETAILED quality-of-life analysis of the phase III EF-14 trial of tumor-treating fields (Optune) in combination with temozolomide for the treatment of newly diagnosed glioblastoma was published by Taphoorn et al in JAMA Oncology.¹ This secondary endpoint analysis showed the addition of tumor-treating fields to temozolomide did not negatively impact health-related quality of life, except for itchy skin under the tumor-treating fields device’s transducer arrays.

The analysis also demonstrated that a higher proportion of patients treated with tumor-treating fields and temozolomide reported stable or improved quality of life for global health status, pain, physical functioning, and leg weakness. The investigators concluded that the use of tumor-treating fields in combination with temozolomide extended progression-free and overall survival in patients with newly diagnosed glioblastoma, without negatively influencing their quality of life. 

Martin J.B. Taphoorn, MD

“When treating cancer patients, we must determine the net clinical benefit before introducing new or additional treatments that improve survival compared to standard of care,” said lead study author Martin J.B. Taphoorn, MD, of the Department of Neurology at Haaglanden Medical Center in The Hague and Leiden University Medical Center in Leiden, the Netherlands. “Apart from expected itchy skin reactions due to the [tumor-treating fields] device, health-related quality of life was maintained in several important predefined scales for a longer period of time in patients treated with [tumor-treating fields] together with temozolomide compared to patients treated with temozolomide alone, due to their longer progression-free survival time. The combined results of significantly improved survival together with extended duration of stable health-related quality of life support the addition of [tumor-treating fields] to temozolomide as a standard treatment for patients with newly diagnosed glioblastoma.”

More Study Findings

HEALTH-RELATED quality of life was a predefined secondary endpoint, which was measured with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire– Core 30 (EORTC QLQ-C30) and the EORTC brain module (QLQ-BN20) at the beginning of the trial and every 3 months thereafter. Of the 695 patients in the study, 639 patients completed the baseline questionnaire. Health-related quality of life over time was assessed for nine preselected scales.

The results were as follows:

• More patients treated with tumor-treating fields and temozolomide reported stable or improved scores on global health status (53% vs 38%, P = .001), pain (57% vs 36%, P < .0001), phys- ical functioning (54% vs 38%, P = .001), and leg weakness (59% vs 42%, P = .001), compared to patients treated with temozolomide alone.
• Deterioration-free survival (time until quality of life declined > 10 points or disease progression) was longer (P < .01) for patients treated with tumor-treating fields and temozolomide vs temozolomide alone for global health (4.8 vs 3.3 months); physical (5.1 vs 3.7 months) and emotional functioning (5.3 vs 3.9 months); pain (5.6 vs 3.6 months); and leg weakness (5.6 vs 3.9 months).
• Time to deterioration (time until quality of life declined > 10 points, excluding disease progression) did not significantly differ between treatment arms, except for itchy skin (shorter for tumor-treating fields plus temozolomide; P < .001) and pain (shorter for temozolomide alone; P < .001).

Longitudinal analyses of health-related quality of life over time did not significantly differ between treatment arms for any of the predefined scales except for itchy skin, which was worse with tumor-treating fields plus temozolomide vs temozolomide alone, at 3, 6, and 9 months (P = .0004). ■

DISCLOSURE: The study was funded by Novocure. For full disclosures of the study authors, visit jamanetwork.com.

REFERENCE 

1. Taphoorn MJB, et al: JAMA Oncol. February 1, 2018 (early release online).