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The use of acupuncture before the introduction of intravesical Bacillus Calmette-Guerin (BCG) therapy is safe and effective in patients with non-muscle-invasive bladder cancer, according to data presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. It is feasible for1
These data are from a phase 1/2 trial (NCT04496219) in which 43 patients were randomized 2:1 to receive acupuncture or no acupuncture before treatment. Thing. The majority of patients who receive acupuncture would recommend acupuncture to other patients undergoing this cancer treatment, said Sarah P. Pustka, M.D., who presented the data at the ASCO conference. Furthermore, no adverse events (AEs) due to acupuncture treatment were observed, but AEs due to BCG were observed. These included 28% of patients who received acupuncture had pain compared to 43% of the control group (P = 0.34), and urinary symptoms were present in 62% and 79%, respectively (P = 0.31).
Pustka, an associate professor of urology at the University of Washington Medical Center and a physician at the Fred Hutchinson Cancer Center, said the study was not authorized to determine efficacy results, but efficacy measures changes in patients’ quality of life. This was part of the secondary results shown. I received acupuncture treatment. During the study period, median urinary symptoms improved to a greater degree with scores of 9.5 (IQR, 0.0 to 19.0) vs. 0.0 (IQR, -14.3 to 7.1), respectively, in patients who received acupuncture compared to the control group. showed that(P = 0.02). Additionally, there was a trend towards improved overall pain scores for patients in the acupuncture arm.
In an interview with Targeted OncologyTMDr. Pustka discussed these findings and why acupuncture is important for patients receiving BCG treatment for non-muscle invasive bladder cancer.
Targeted OncologyTM: What was the rationale for this study?
Pustka:BCG is a live attenuated tuberculosis vaccine and is the basis of tuberculosis treatment. [patients with] High-risk non-muscle invasive bladder cancer. This is a drug that is placed in the bladder and remains there for 1 to 2 hours, after which the patient expels it. The goal is essentially to trigger an immune response aimed at reducing the risk of recurrence and progression of non-muscle-invasive disease. Bladder cancer. We’ve been using it for decades and it has a proven track record of reducing the risk of recurrence and progression, and is particularly effective in: [patients with] Although non-muscle invasive bladder cancer is a high-risk disease, it is extremely burdensome for patients. Frequent urination, painful urination, and difficulty urinating increase, as well as an increased risk of infections. The problem with these toxicities is that they are difficult to manage.
They reduce quality of life as patients continue to receive treatment and can interfere with patients’ ability to receive treatment. If cystitis becomes so severe that the patient cannot tolerate treatment, the dose may need to be reduced or delayed. Often during maintenance series, where a patient comes to her 3-week booster round at set intervals, AEs can become so severe that the patient may actually be unable to tolerate maintenance.
This has shown that the ability to receive continued maintenance dosing is critical to maximize efficacy, especially if the duration is ideally at least 1 year and preferably 3 years based on the original SWOG data. This is important because Therefore, this study aims to improve the ability of patients to treat patients by leveraging integrative medical techniques, complementary and alternative therapies to alleviate AEs and reduce the toxicity experienced by patients while receiving BCG therapy. It was intended for that purpose. Although BCG is indicated, it potentially improves quality of life during treatment and/or reduces the decrease in quality of life experienced by patients.
Please describe the study design.
[This was] Randomized controlled study. This was a phase 1/2 trial and was intended to demonstrate feasibility and safety. We considered several efficacy-focused secondary outcomes. [as well]. We wanted to know whether it would be possible to recruit participants into a clinical trial of acupuncture in high-risk non-muscle invasive bladder cancer patients undergoing BCG induction. is. Can we safely get patients through the protocol? Therefore, we needed to understand whether they were safety signals from the acupuncture itself. We also needed to understand whether it would interfere with the patient’s ability to receive her BCG. Because that’s the outcome you want to avoid. Second, we investigated patient satisfaction with the intervention in the acupuncture arm, and finally, both general cancer-related quality of life and bladder cancer-specific quality of life were reported by patients throughout the study. We have collected the results.
How was acupuncture treated in the clinical trial?
The target sample we wanted to recruit was 45 patients. Of course, this happened in the midst of COVID-19, but we had remarkable success and recruited 45 patients. Ultimately, 45 patients were randomized, and a total of 43 patients completed the study. Some patients dropped out at certain time points, but this was due to disease progression rather than due to problems with the intervention, and in one case, patients were randomly assigned to the control group and those who wished to participate Because I didn’t. There were no safety AEs, so he had two grade 1 AEs, but no grade 3 or higher AEs related to the acupuncture itself. When examining whether acupuncture interfered with patients’ ability to receive her BCG, acupuncture either did not interfere with patients’ ability to receive her BCG or was associated with a delay in receiving treatment.
In a typical practice, the workflow would be for a patient to come in and have a urine sample taken to ensure there is no blood or infection. This means it is safe to receive her BCG that day. You will then wait approximately 1 hour for that sample to be processed for your appointment. Therefore, during that 1-hour period, we returned patients to the lab, and patients randomly assigned to the acupuncture arm received 35-45 minutes of acupuncture treatment specifically aimed at managing bladder-related symptoms. received. as well as anxiety and general pain management. If patients were randomly assigned to the control waitlist group, they would receive other similar preparations, such as being wrapped in a warm blanket, and be allowed to rest in a quiet space before coming to the hospital to receive BCG treatment. Ta. Therefore, there was no increase in clinic length of stay or additional visits. This was important in terms of optimizing the efficiency of patient care.
What were the main findings of the study?
We were able to recruit and enroll patients into the trial and demonstrated that it was safe. Importantly, patients liked the therapy, with approximately 95% of patients saying they were very satisfied or extremely satisfied with the intervention. All patients were satisfied with the acupuncture treatment they received, and approximately 75% said they would recommend acupuncture to others receiving BCG. Finally, when we looked at patient-reported outcomes, which should be taken with a grain of salt because this is a small study, there was a trend towards decreased pain scores.
That is, although there were no stable pain scores or differences in pain scores between the arms, patients in the acupuncture group’s pain scores decreased over 6 weeks. More importantly, his urinary symptoms decreased over the course of six weeks. Patients in the acupuncture group finished the trial with less urinary symptoms than at the start of the trial, which is virtually unprecedented for patients receiving BCG. This is an interesting indication and one that we are excited to pursue in future research. I think this gives us good reason to move this concept forward and see if we can design a phase 3 study to address the efficacy question in more detail.
reference
Psutka SP, Veleber S, Siman J et al. A phase I/II randomized clinical trial of in-hospital acupuncture before BCG in high-risk non-muscle invasive bladder cancer patients. J Clin Oncor. 2023;41(16);4590-4590. doi:10.1200/JCO.2023.41.16_suppl.4590
