RTOG 0537 Phase 2/3 Study Comparing Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine (PC) in Treating Early Radiation-Induced Xerostomia (RIX): Phase 3 Preliminary Analysis

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Purpose/Objective(s)

To determine if ALTENS improves overall RIX burden compared to PC as measured by the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at 9 months from randomization (mfr).

Materials/Methods

Eligible patients had no evidence of recurrent disease and had completed either standard or IMRT radiation therapy ± chemotherapy ≥ 3 months to 2 years. All had grade 1-2 RIX (CTCAE v3.0) and basal whole salivary production (WSP) ≥ 0.1 mL/min. Use of PC/cevimeline/bethanechol was discontinued > 2 weeks prior to protocol treatments. Patients were stratified by prior use of PC (Y/N) and time from cancer treatments (3-6 months, > 6 months-1 year, 1-2 years), and then randomized to twice weekly 20

Results

One hundred forty-six eligible patients entered the study with 73 patients randomized to each arm. Pretreatment characteristics were similar between the two arms. Ninety-six (representing only 68.6% statistical power) and 76 patients were evaluable at 9 and 15 mfr, respectively. Eighteen patients (12 from the PC arm) withdrew consent prior to 9 mfr. Due to non-normality of XeQOLS scores, Wilcoxon rank sum test was used to compare treatments. Median change in overall XeQOLS in ALTENS /PC arms

Conclusions

With only 96 (out of 146) evaluable patients, the preliminary study analysis did not show a significant difference in the change of RIX symptom burden at 9 mfr between the ALTENS and PC arms. There was, however, a significantly higher response rate at 15 mfr and less toxicity in patients receiving ALTENS.

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Author Disclosure: R.K. Wong: None. S. Deshmukh: None. G. Wyatt: None. S.M. Sagar: None. A.K. Singh: None. K. Sultanem: None. P.F. Nguyen-Tan: None. S.S. Yom: None. S. Pugh: None. L. Berk: None.

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