Tumor Treating Fields Combined With Paclitaxel: Safety Results From Pilot Study
Posted: Monday, August 20, 2018
Tumor treating fields in combination with paclitaxel appears to be safe for patients with platinum-resistant ovarian cancer, according to the results of the phase II pilot INNOVATE trial published in Gynecologic Oncology. The combination treatment seemed to be well tolerated among the patient population. The phase III INNOVATE-3 trial of this treatment is expected to be underway in the near future.
“A clear unmet need remains for patients with recurrent ovarian cancer, particularly for those patients resistant to platinum-based chemotherapy,” explained trial investigator Ignace Vergote, MD, PhD, of the Catholic University of Leuven, in Belgium, in a press statement. The study results suggest that the combination therapy “has the potential to increase survival without significantly increasing side effects for recurrent ovarian cancer patients.”
Dr. Vergote and colleagues treated 31 patients, diagnosed with recurrent, platinum-resistant ovarian carcinoma, with tumor treating fields in combination with weekly paclitaxel. A total of 7 patients achieved a partial response and 13 achieved stable disease—for a clinical benefit rate of 71%. The median 1-year survival was 61%. The median progression-free survival was 8.9 months, which, the authors noted, is favorable compared with results from other similar studies.
The frequency of grade 3 and 4 adverse events was reported to be no different in patients treated with the combination therapy than in those treated with paclitaxel monotherapy, as reported in existing studies. A total of 17 patients experienced grade 3 and 4 adverse events. The most common toxicities included blood and lymphatic system disorders, anemia, and neutropenia. As expected, the authors noted, many patients (84%) experienced dermatitis related to the tumor treating fields, although only one patient discontinued therapy as a result.