Galsky Matthew D, Shahin Mohamed, Jia Rachel, Shaffer David R, Gimpel-Tetra Kiev, Tsao Che-Kai, Baker Charles, Leiter Amanda, Holland John, Sablinski Tomasz, Mehrazin Reza, Sfakianos John P, Acon Patricia, Oh William K
Matthew D. Galsky, Mohamed Shahin, Rachel Jia, Kiev Gimpel-Tetra, Che-Kai Tsao, Charles Baker, Amanda Leiter, Reza Mehrazin, John P. Sfakianos, Patricia Acon, and William K. Oh, Icahn School of Medicine at Mount Sinai; John Holland, AMC Health; Tomasz Sablinski, Transparency Life Sciences, New York; and David R. Shaffer, Albany Medical Center, Albany, NY.
JCO Clin Cancer Inform. 2017 Nov;1:1-10. doi: 10.1200/CCI.17.00044.
Clinical trials are critical to informing cancer care but often are hampered by slow accrual and lack of generalizability because of poor geographic accessibility. We tested the feasibility of replacing onsite study visits with telemedicine visits in a prospective clinical trial.
Castration-naïve patients with prostate cancer and a rising serum prostate-specific antigen after definitive local therapy were eligible. Patients were required to have a single onsite visit for enrollment. Study treatment consisted of oral metformin 850 mg daily for 1 month followed by 850 mg twice daily for 5 months. Telehealth video visits (televisits) were conducted monthly by using a Health Insurance Portability and Accountability Act-compliant smartphone application. The primary objective was to determine the feasibility of telemedicine-enabled study visits. Secondary objectives were defining safety, anticancer activity, quality of life, and patient satisfaction.
Fifteen patients with a median age of 68 years (range, 57 to 83 years) and median one-way driving time to the study center of 71 minutes (range, 12 to 147 minutes) were enrolled. The patients completed 84 eligible televisits (completion rate, 100%; 95% CI, 0.80 to 1). Diarrhea was the most common adverse event but was limited to grade 1 in severity; a single patient experienced grade ≥ 3 adverse events. Seven patients (46.7%; 95% CI, 24.8% to 69.9%) had a ≤ 20% increase in prostate-specific antigen relative to baseline. Patients agreed or strongly agreed that they would participate in a telemedicine-enabled clinical trial in the future.
To our knowledge, this interventional oncology clinical trial is the first to be conducted through telemedicine. Telemedicine-enabled trials are feasible and may overcome geographic barriers to trial participation. Metformin was generally well tolerated but associated with modest anticancer activity.
临床试验对于指导癌症治疗至关重要，但往往因入组缓慢以及地理可及性差导致缺乏普遍性而受阻。我们在一项前瞻性临床试验中测试了用远程医疗访视取代现场研究访视的可行性。
符合条件的是初次接受去势治疗的前列腺癌患者，且在确定性局部治疗后血清前列腺特异性抗原升高。患者需要进行一次现场访视以登记入组。研究治疗包括每日口服850毫克二甲双胍，持续1个月，随后每日两次，每次850毫克，持续5个月。每月使用符合《健康保险流通与责任法案》的智能手机应用程序进行远程健康视频访视（远程访视）。主要目标是确定远程医疗支持的研究访视的可行性。次要目标是确定安全性、抗癌活性、生活质量和患者满意度。
纳入了15名患者，中位年龄为68岁（范围57至83岁），到研究中心的中位单程驾车时间为71分钟（范围12至147分钟）。患者完成了84次符合条件的远程访视（完成率100%；95%置信区间，0.80至1）。腹泻是最常见的不良事件，但严重程度仅限于1级；1名患者经历了≥3级不良事件。7名患者（46.7%；95%置信区间，24.8%至69.9%）的前列腺特异性抗原相对于基线升高≤20%。患者同意或强烈同意他们未来会参与远程医疗支持的临床试验。
据我们所知，这项介入肿瘤学临床试验是首例通过远程医疗进行的试验。远程医疗支持的试验是可行的，并且可能克服试验参与的地理障碍。二甲双胍总体耐受性良好，但抗癌活性适度。
