Study shows paucity of surgical oncology trials
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Only 7.5% of oncology trials conducted between 2008 and 2020 investigated surgical interventions, according to study results published in JAMA Network Open.
The most common cancer sites studied in surgical oncology trials included colorectal, breast and gastric, researchers wrote.
Rationale and methodology
“Clinical trials are considered the gold standard for establishing best practices and pushing clinical progress. Even though surgery is crucial to treatment of most solid-organ cancers, it was unclear how many cancer trials involve or evaluate surgical interventions,” Bonnie O. Wong, MSc, MD, student at Stanford University School of Medicine, told Healio. “We set out to understand the landscape of surgical oncology clinical trials during the past decade, especially in comparison with medical oncology and radiation oncology — which dominate clinical trials.”
Wong and colleagues reviewed 27,915 clinical trials included in the ClinicalTrials.gov database between Oct. 1, 2008, and March 9, 2020. Trial focus and funding served as the primary exposure variables. Primary outcomes included early trial discontinuation and results reporting in the ClinicalTrials.gov database.
Key findings
Results showed that among 26,815 clinical trials with an oncology focus, 22,079 focused on solid organ tumor types and only 1,646 (7.5%) involved surgical intervention.
More than half of surgical oncology trials (58.5%) were randomized, 76.6% were unblinded, 68.5% were single-institution and 58.4% included two groups.
Compared with a compound annual growth rate of 5% for oncology trials overall, surgical oncology trials increased at a rate of 9.5% between 2008 and 2020. Surgical oncology trials that originated from North America (2.3%), East Asia (11%) and Europe (13.9%) had slower growth rates than those in countries outside of these areas (25.1%), according to the researchers.
Researchers also found that 83.1% of surgical trials received academic funding compared with 54.8% of all other oncology trials, but only 7.7% of surgical trials reported results compared with 15.1% of all other oncology trials.
Moreover, U.S. government-funded surgical trials had the lowest risk for early discontinuation (P = .05) and academic-funded clinical trials had lower odds of results reporting (OR = 0.29; 95% CI, 0.17-0.49) with industry-funded trials serving as a reference.
The most common neoplasia sites studied in surgical oncology trials included colorectal (17.6%), breast (10.8%) and gastric (10.6%). Those with comparably higher percentages of trials that involved surgical interventions included stomach (18.1%), colorectal (11.7%) and bladder (11.9%) neoplasia sites. Most oncology trials focused on lung and breast cancer, but only 4.2% and 4.9% of these involved surgical intervention.
Implications
More surgical clinical trials are needed to continue improving outcomes for patients with cancer, according to Wong.
“The majority of clinical trials are focused on medical oncology therapies, and the cost of these medical therapies has skyrocketed during the past decade. Focusing on refining surgical techniques and developing innovative surgical approaches in collaboration with our medical and radiation oncology colleagues is crucial in our fight against cancer,” Wong said.
“We recognize the challenges of studying surgical interventions via clinical trials and we encourage increased surgeon involvement in cooperative research groups, which have proved productive in launching and managing seminal multi-institutional trials,” she added. “We also call for increased funding by U.S. government sources, such as the NCI, to provide necessary long-term funding that allows for adequate accrual of patients and minimizes risk for early discontinuation of trials. We hope to continue our research examining the global landscape of clinical trials, and oncology trials specifically, understanding the growth of oncology trials in non-U.S. settings, as well.”
For more information:
Bonnie O. Wong, MSc, can be reached at Stanford University School of Medicine, 291 Campus Drive, Stanford, CA 94305; email: bowong@stanford.edu.
Perspective
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Nicholas J. Petrelli, MD, FACS
Having spent more than 30 years helping develop protocols through the NCI cooperative groups, the low percentage of clinical trials related to surgical aspects of cancer treatment did not surprise me. However, it certainly has improved during the past several years.
Clinical trials on the surgical side, to a certain degree, are dependent on the development of technology, such as one of the early clinical trials that investigated laparoscopic colon resection vs. open resection.
Sentinel lymph node biopsy is another perfect example, such as to avoid unnecessary lymph node dissections with melanoma. This later moved to clinical trials in breast cancer and other cancer sites. These technical aspects have contributed to better outcomes and, in many cases, a better quality of life during the early postoperative period. As artificial intelligence and robotic surgery continue to evolve, we will see more of these trials.
However, it takes resources to conduct these trials, and more resources are needed. The best environment in which to learn about and contribute to clinical trials is with the NCI cooperative groups — especially with the next generation of surgeons. It is a good infrastructure for young surgeons to give their input into clinical trials and start thinking outside the box for at least surgical components of trials. This is critical if we are going to move toward increasing that 7.5% of oncology clinical trials that investigated surgical interventions, as revealed in this study. This type of movement — with the next generation of surgeons being involved with their medical and radiation oncology colleagues in the clinical trials program — is critical.
Also, more oncologists would become interested in clinical trials if the process was not laborious. We need to streamline the process. Investigators want to be involved in a clinical trial that is still relevant when the trial reaches its accrual goal. In addition, many eligibility criteria are too strict and not applicable to the general population.
These factors, which are being addressed, will result in increased involvement of my surgical oncology colleagues in the development of clinical trials answering surgical questions.
Wistar Cancer Institute
HemOnc Today Editorial Board member
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