(UroToday.com) The 2023 ASCO annual meeting included a bladder cancer session, featuring a presentation by Dr. Sarah Psutka discussing results of a phase I/II randomized clinical trial of in-clinic acupuncture prior to BCG in patients with high-risk non-muscle invasive bladder cancer (NMIBC). Acupuncture can reduce pain and urinary urgency and frequency. Treatment-related dose-limiting dysuria and irritative bladder symptoms are common in patients receiving intravesical BCG for the treatment of NMIBC. As such, Dr. Psutka and colleagues evaluated the feasibility, safety, and tolerability of weekly in-clinic pre-procedure acupuncture among patients receiving induction BCG.
Patients with high-risk NMIBC undergoing induction BCG were randomized 2:1 to a standardized acupuncture protocol or an attention waitlist control. Acupuncture patients received acupuncture prior to each of 6 weekly BCG instillations. The following figure highlights the acupoints targeted in the intervention arm:
Feasibility was assessed via recruitment, retention, and intervention adherence. Acupuncture safety and tolerability were assessed via physician-reported CTCAE v5.0 and adverse events. Secondary endpoints included BCG treatment adherence, patient-reported BCG-related toxicity, and bladder cancer-specific and generic quality of life, assessed with the EORTC-QLQ-NMIBC-24 and -C30 surveys. Subjective assessments of acupuncture acceptability were assessed through patient exit surveys.
Between January 2021 and July 2022, 43 patients were randomized to acupuncture (n=28) versus control (n=15) groups. The CONSORT diagram for the trial is as follows:
The median age was 70.3 years and 76% were male. Week 7 follow-up surveys were completed by 93% of patients, and 6 patients withdrew early due to disease progression, refractory gross hematuria, or for patient preference. Acupuncture was successfully delivered prior to each BCG treatment in acupuncture patients with no acupuncture-related adverse events or interruptions to induction BCG. BCG-attributed adverse events were reported by 91% of acupuncture patients and 100% of control patients, including pain (28% vs. 43%, respectively, p=0.34) and urinary symptoms (62% vs. 79%, respectively, p=0.31). Comparing acupuncture with control patients, change in quality of life over the study period demonstrated greater improvements in median urinary symptoms (9.5, IQR 0.0-19.0 vs. 0.0, IQR -14.3-7.1, p=0.02) and a trend towards improvement in median pain scores (16.7, IQR 0.0-16.7 vs. 8.3, IQR 0.0-33.3 p=0.68) among patients in the acupuncture arm:
Overall, 95% of acupuncture patients reported that acupuncture was “very/extremely helpful” 75% would definitely and 25% would probably recommend acupuncture to other patients.
Dr. Psutka concluded her presentation by discussing the results of a phase I/II randomized clinical trial of in-clinic acupuncture prior to BCG in patients with high-risk non-muscle invasive bladder cancer with the following take-home messages:
- Acupuncture prior to induction BCG treatments is feasible and safe
- In this Phase I/II trial, there were observed reductions in pain and a trend towards improved urinary function scores over successive treatments among patients undergoing in-clinic pre-BCG instillation acupuncture
- Patients receiving acupuncture reported high degrees of satisfaction with treatments
- Future larger randomized controlled trials are needed to further characterize the efficacy of acupuncture with respect to pain, urinary symptoms and impact on quality of life, and continuation of maintenance therapy during BCG treatment
Presented by: Sarah P. Psutka, MD, University of Washington, Fred Hutchinson Cancer Center, Seattle, WA
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, Fri, June 2 – Tues, June 6, 2023.