Acupuncture-Like Transcutaneous Electrical Nerve Stimulation Versus Pilocarpine in Treating Radiation-Induced Xerostomia: Results of RTOG 0537 Phase 3 Study

作者：Wong Raimond K W^*; Deshmukh Snehal; Wyatt Gwen; Sagar Stephen; Singh Anurag K; Sultanem Khalil; Nguyen Tan Phuc F; Yom Sue S; Cardinale Joseph; Yao Min; Hodson Ian; Matthiesen Chance L; Suh John; Thakrar Harish; Pugh Stephanie L; Berk Lawrence

来源：International Journal of Radiation Oncology, Biology, Physics, 2015, 92(2): 220-227.

DOI：10.1016/j.ijrobp.2015.01.050

Purpose and Objectives: This report presents the analysis of the RTOG 0537 multi-center randomized study that compared acupuncture-like transcutaneous stimulation (ALTENS) with pilocarpine (PC) for relieving radiation-induced xerostomia.
Methods and Materials: Eligible patients were randomized to twice-weekly 20-minute ALTENS sessions for 24 sessions during 12 weeks or PC (5 mg 3 times daily for 12 weeks). The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) scores from baseline to 9 months from randomization (MFR). Secondary endpoints included basal and citric acid primed whole salivary production (WSP), ratios of positive responders (defined as patients with >= 20% reduction in overall radiation-induced xerostomia symptom burden), and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version 3. An intention-to-treat analysis was conducted.
Results: One hundred forty-eight patients were randomized. Only 96 patients completed the required XeQOLS and were evaluable at 9 MFR (representing merely 68.6% statistical power). Seventy-six patients were evaluable at 15 MFR. The median change in the overall XeQOLS in ALTENS and PC groups at 9 and 15 MFR were -0.53 and -0.27 (P = .45) and -0.6 and -0.47 (P = .21). The corresponding percentages of positive responders were 81% and 72% (P = .34) and 83% and 63% (P = .04). Changes in WSP were not significantly different between the groups. Grade 3 or less adverse events, mostly consisting of grade 1, developed in 20.8% of patients in the ALTENS group and in 61.6% of the PC group.
Conclusions: The observed effect size was smaller than hypothesized, and statistical power was limited because only 96 of the recruited 148 patients were evaluable. The primary endpoint-the change in radiation-induced xerostomia symptom burden at 9 MFR-was not significantly different between the ALTENS and PC groups. There was significantly less toxicity in patients receiving ALTENS.

• 出版日期2015-6-1
• 单位McGill