Cancer clinical trials enrolling larger proportion of adolescents, young adults
Younger patients with newly diagnosed cancer are comprising a larger proportion of participants in phase 2 and phase 3 clinical trials for treatments, research published in the journal Cancer showed.
An analysis by NCI researchers revealed a mean 4.4% increase in adolescent and young adult (AYA) trial participation after the NCI formed its National Clinical Trials Network (NCTN) in 2014.
Background
NCTN is an international cooperative group that helps coordinate cancer clinical trial research at more than 2,200 international sites. The network aims to increase enrollment of patients with rare cancers and those from the AYA population, among other established goals, according to Hari Sankaran, MD, MSc, medical officer in the division of cancer treatment and diagnosis at NCI.
“It’s important for adolescents and young adults to participate in cancer clinical trials to ensure adequate opportunities for [these] patients to contribute to, and benefit from, advances in cancer treatment,” he told Healio.
Methodology
Sankaran and colleagues collected accrual data from phase 2, phase 2/phase 3 and phase 3 clinical trials led by the NCI’s Cancer Therapy Evaluation Program (CTEP) between 2004 and 2019 to evaluate participation among AYAs before and after the launch of NCTN. The analysis found 304 trials that met the analysis criteria, including trials led by a member of the NCI’s cooperative group and that enrolled newly diagnosed patients between the ages of 15 and 39 years.
Key findings
Investigators found AYAs comprised 9.5% (95% CI, 7.6-11.8) of the accrued clinical trial population before the NCI established the NCTN in 2014. This proportion increased to 14% (95% CI, 9.9-18.3) of the entire clinical trial population after the NCTN became active.
Researchers calculated a 4.4% (95% CI, 0.7-8.3) mean difference in proportions before and after establishment of NCTN.
Implications
Results of the study suggest oncologists are “taking advantage of the NCTN” and offering their younger patients with cancer the opportunity to enroll in trials offered by the cooperative, Sankaran said.
Although not designed to identify specific policies that contributed to the increase in AYA participation since the establishment of NCTN, the study likely revealed “multiple factors,” including making it easier to open an NCTN trial at smaller institutions and increasing the visibility of trials that offer treatment for AYAs, Sankaran said.
“The NCI, through the NCTN, is working hard to make clinical trials available for AYAs and trying to engage oncologists not only at the academic centers, but also in the community and at smaller centers so their AYA patients can have access to these trials with the newest treatments,” he told Healio.
For more information :
Hari Sankaran, MD, MSc, can be reached at Biometric Research Program, Division of Cancer Treatment and Diagnosis, NIH, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892-9735; email: hari.sankaran@nih.gov.
Perspective
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The NCI National Clinical Trials Network (NCTN) was formed as a result of the IOM recommendations in 2010, and it was launched on March 1, 2014, comprising four medical oncology groups, one pediatric group (Children’s Oncology Group), and one international group (Canadian Cancer Trials Group). One of several goals of the NCTN was to increase trial accrual, particularly in rare cancers and from special populations, including AYAs.
The study by Sankaran and colleagues is the most comprehensive study examining how AYA accrual changed with the NCTN formation for patients with new cancer diagnosis. Results demonstrated that AYA accrual increased from 9.5% pre-NCTN to 14% after NCTN.
Overall, this is good news for AYA patients with cancer, but descriptive analyses of enrollments by race/ethnicity still show lack of improvements in non-Hispanic Black patients (11.8% pre-NCTN and 8.8% after NCTN). This is similar to clinical trial enrollment data from other collaborative groups such as SWOG.
Similarly, the improvements were not observed across all cancer groups. GI neoplasms and breast cancer had increased enrollments after NCTN, but the enrollment proportion for AYA patients with hematologic neoplasms was comparable before NCTN and after (2.2% vs. 2.1%).
It is noteworthy that annual total number of patients enrolled in clinical trials through NTCN seems to be decreasing based on Figure 3A, likely due to the lack of available clinical trials for localized osteosarcoma and newly diagnosed Ewing sarcoma, which are common bone cancers in the AYA population. This highlights the importance of clinical trial availability for those newly diagnosed with cancer, and this must remain a priority.
This study focused on enrollment for newly diagnosed patients and did not include clinical trials designed for refractory or relapsed cancer.
It is not possible to directly attribute this increase in AYA enrollment to the launch of the NCTN, but the results of this study are encouraging. Further analysis is needed to identify the potentially responsible factors for the increase in AYA enrollment, which can then inform future efforts to increase enrollments across all disease groups and across patients of all ethnicities, including non-Hispanic Black Americans.
Reference:
Unger JM et al; Cancer. 2021;doi:10.1002/cncr.33855.
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