(ChemotherapyAdvisor) – Electrochemotherapy is safe and comparable to surgery in achieving local control in patients with recurrent head and neck cancer, according to an interim analysis of two open-label randomized phase 3 trial presented at the 8th International Conference on Head and Neck Cancer in Toronto, Canada, July 21-25, 2012.
No statistically significant differences were observed between the two arms for median time to death, 209 days for surgery and 231 days for electrochemotherapy (P=0.55) or duration of local control at 8 months, 92% for surgery vs 90% for electrochemotherapy. “Furthermore, none of the other parameters examined, including demographics, time since original diagnosis, prior therapies or tumor stage, showed any significant statistical difference between these parameters,” noted Paul Goldfarb, MD, of Oncology Associates and OncoSec Medical Inc., a company developing advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors. Electrochemotherapy also was noninferior to standard of care with no evidence of a negative impact on overall survival.
At the time of the interim analysis, 214 patients with recurrent or secondary histologically confirmed squamous cell carcinoma of the head and neck T1-3 tumors had been enrolled in the study. Among evaluable patients, 91 were treated surgically and 98 received electrochemotherapy, which involves combining electroporation with intratumoral injection of low-dose bleomycin.
Pain (all grades) occurred in 35.4% of the surgery patients and 46% of those treated with electrochemotherapy and was the most frequent side effect.
At 8 months, mean Performance Status Scale for Head and Neck Cancer (PSSHN) Scale 4 score was 269 at baseline vs 248 for the surgery patients (P=0.036) compared with 257 at baseline vs 249 for those in the electrochemotherapy arm (P=0.59). “While the scores in the electrochemotherapy arm remained relatively unchanged at 8 months, the surgery arm of each trial showed a statistically significant decrease in overall function,” Dr. Goldfarb noted.
The studies were initiated in 2004 and subsequently closed in 2007 at the interim point following an independent data monitoring committee review citing concerns regarding efficacy and safety in the electrochemotherapy arm, including mortality rates and enrollment futility; however, all treated patients were followed for up to 2 years to evaluate safety and efficacy.
“Given the potential advantage in maintaining quality of life, electrochemotherapy warrants further exploration as an alternative treatment in head and neck cancer,” the investigators concluded.