The global burden of gynecologic oncology disease as reflected in clinical trials: An analysis of over 2,000 clinical trials (427)

Abstract

Objectives: Worldwide, cervical cancer is the most common gynecologic cancer and a leading cause of death, yet there are relatively few randomized data relative to disease burden. Our objective was to analyze characteristics of randomized trials listed at ClinicalTrials. gov focused on cervical cancer. Methods: We included all studies listed at ClinicalTrials.gov registered between October 2007-March 2020 and manually reviewed for relevance to gynecologic oncology and cervical cancer. Patient and trial characteristics were analyzed. Results: A total of 223,690 trials were collected 2,152 of which were categorized as “gynecologic oncology” (0.9%). Of these, 350 (16.3%) trials investigated cervical cancer and enrolled a total of 332,309 patients, which accounted for 48.3% of all gynecologic oncology enrolled patients. Cervical cancer trials were more likely to enroll larger numbers of patients: 3.4% of cervical cancer trials (n=12) enrolled more than 1,000 patients compared to 2.0% for overall trials, 7.4% (n=26) versus 4.7% for 501-1,000 patients, and 28.9% (n=101) versus 25.5% (n=548) for 101-500 patients (p=0.03). Cervical cancer trials were more likely to draw patients only from low-income countries (27.7% vs 10.4%, p<0.001) and more likely to be single-center trials (58.3% vs 48.7%, p<0.001). Most cervical cancer trials (76.6%) focused on therapeutics (n=268) compared to 4.6% on screening (n=16), 8.0% imaging (n=28) and 7.1% supportive care (n=25). For therapeutics trials, those focusing on cervical cancer were less likely to investigate targeted therapeutics compared to overall gynecologic oncology trials, (28.3% of cervical trials compared to 57.3% overall) and chemotherapy (9.7% vs 17.7%), and more likely to focus on radiation (11.7% vs 3.6%), chemoradiation (11.7% vs 3.1%) and surgery (9.4% vs 6.0%, p<0.001). Cervical cancer trials were also less likely to have completed enrollment compared to gynecologic oncology trials overall (23.4% vs 31.4%, p<0.001). Conclusions: Cervical cancer clinical trial enrollment involves mostly large, single-institution studies from low-income countries that frequently have not achieved enrollment completion. Further attention is needed to develop pathways to ensure trial completion and balanced therapeutic foci for cervical cancer, especially in low- income countries. Objectives: Worldwide, cervical cancer is the most common gynecologic cancer and a leading cause of death, yet there are relatively few randomized data relative to disease burden. Our objective was to analyze characteristics of randomized trials listed at ClinicalTrials. gov focused on cervical cancer. Methods: We included all studies listed at ClinicalTrials.gov registered between October 2007-March 2020 and manually reviewed for relevance to gynecologic oncology and cervical cancer. Patient and trial characteristics were analyzed. Results: A total of 223,690 trials were collected 2,152 of which were categorized as “gynecologic oncology” (0.9%). Of these, 350 (16.3%) trials investigated cervical cancer and enrolled a total of 332,309 patients, which accounted for 48.3% of all gynecologic oncology enrolled patients. Cervical cancer trials were more likely to enroll larger numbers of patients: 3.4% of cervical cancer trials (n=12) enrolled more than 1,000 patients compared to 2.0% for overall trials, 7.4% (n=26) versus 4.7% for 501-1,000 patients, and 28.9% (n=101) versus 25.5% (n=548) for 101-500 patients (p=0.03). Cervical cancer trials were more likely to draw patients only from low-income countries (27.7% vs 10.4%, p<0.001) and more likely to be single-center trials (58.3% vs 48.7%, p<0.001). Most cervical cancer trials (76.6%) focused on therapeutics (n=268) compared to 4.6% on screening (n=16), 8.0% imaging (n=28) and 7.1% supportive care (n=25). For therapeutics trials, those focusing on cervical cancer were less likely to investigate targeted therapeutics compared to overall gynecologic oncology trials, (28.3% of cervical trials compared to 57.3% overall) and chemotherapy (9.7% vs 17.7%), and more likely to focus on radiation (11.7% vs 3.6%), chemoradiation (11.7% vs 3.1%) and surgery (9.4% vs 6.0%, p<0.001). Cervical cancer trials were also less likely to have completed enrollment compared to gynecologic oncology trials overall (23.4% vs 31.4%, p<0.001). Conclusions: Cervical cancer clinical trial enrollment involves mostly large, single-institution studies from low-income countries that frequently have not achieved enrollment completion. Further attention is needed to develop pathways to ensure trial completion and balanced therapeutic foci for cervical cancer, especially in low- income countries.