Shah Rema, Boffa Daniel, Khan Sajid, Judson Benjamin
Yale University School of Medicine, New Haven, CT, USA.
Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, Yale University School of Medicine, New Haven, CT, USA.
Ann Surg Oncol. 2023 Nov;30(12):7275-7280. doi: 10.1245/s10434-023-14064-4. Epub 2023 Aug 9.
Surgery is a mainstay of cancer care. Since the advancement of cancer treatment occurs through clinical trials, it is critical to investigate the degree and nature of representation of surgery in oncological clinical trials.
This observational analysis used publicly available data from clinicaltrials.gov to investigate non-industry-funded oncological clinical trials in the United States between 2012 and 2022.
From 2012 to 2022, 1,861 (15.7%) of the 11,843 registered oncologic clinical trials were surgical. There was a 43.2% increase in proportional surgical trials and an 18.9% increase in oncology trials over the last two decades. Surgery+diagnostic-technique trials increased from 5.14 to 12.6% (P < 0.001, 95%CI [- 0.097, - 0.052]), surgery+radiation trials increased from 5.24 to 8.1% (P = 0.004, 95%CI [- 0.047, - 0.0088]), surgery+systemic-therapy trials decreased from 34.5 to 29.2% (P = 0.003, 95%CI [0.018, 0.088]), surgery+supportive-therapy trials increased from 8.0 to 11.3% (P = 0.004, 95%CI [- 0.056, - 0.01]) and 'surgery-as-the-variable' trials decreased from 12.0 to 3.5% (P < 0.001, 95%CI[0.065, 0.1]). Systemic therapy with biologics increased from 38.1 to 53.9% (P < 0.001, 95%CI [- 0.22, - 0.091]). Surgery-vs.-no-surgery trials increased from 16.8 to 37.3% (P = 0.001, 95%CI [- 0.32, - 0.078]).
Surgical oncology trials increased by 43.2% over the last 10 years. The focus of clinical trials is changing to the encouragement of innovation in more diagnostic and less invasive techniques, and targeted therapies.
手术是癌症治疗的主要手段。由于癌症治疗的进展是通过临床试验实现的，因此调查手术在肿瘤学临床试验中的参与程度和性质至关重要。
本观察性分析使用了来自clinicaltrials.gov的公开数据，以调查2012年至2022年期间美国非行业资助的肿瘤学临床试验。
2012年至2022年期间，11843项注册肿瘤学临床试验中有1861项（15.7%）为手术相关试验。在过去二十年中，手术相关试验的比例增加了43.2%，肿瘤学试验增加了18.9%。手术+诊断技术试验从5.14%增加到12.6%（P<0.001，95%CI[-0.097，-0.052]），手术+放疗试验从5.24%增加到8.1%（P=0.004，95%CI[-0.047，-0.0088]），手术+全身治疗试验从34.5%降至29.2%（P=0.003，95%CI[0.018，0.088]），手术+支持治疗试验从8.0%增加到11.3%（P=0.004，95%CI[-0.056，-0.01]），“以手术为变量”的试验从12.0%降至3.5%（P<0.001，95%CI[0.065，0.1]）。生物制剂的全身治疗从38.1%增加到53.9%（P<0.001，95%CI[-0.22，-0.091]）。手术与非手术试验从16.8%增加到37.3%（P=0.001，95%CI[-0.32，-0.078]）。
在过去10年中，外科肿瘤学试验增加了43.2%。临床试验的重点正在转向鼓励在更多诊断性和侵入性较小的技术以及靶向治疗方面进行创新。
