Details

Autor(en) / Beteiligte

• Ghatalia, Pooja
• Pisarcik, David
• Koenigsberg, Rebecca
• Handorf, Elizabeth
• Geynisman, Daniel M.
• Zibelman, Matthew R.

Titel

The evolution of clinical trials in renal cell carcinoma: A status report for 2013-2016 from the clinicaltrials.gov website

Ist Teil von

• Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.e16050-e16050

Erscheinungsjahr

2017

Link zum Volltext

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Abstract only e16050 Background: The treatment paradigm for renal cell carcinoma (RCC) continues to rapidly evolve. We previously published a snapshot analysis of clinical trials in RCC using the publicly available ClinicalTrials.gov registry. Here we present a 3 year update in order to understand the current trends in RCC clinical research, to identify opportunities for improvement, and to compare this data to the landscape in 2013. Methods: The Website’s advanced search function was used to search for the terms “renal cell carcinoma”, “kidney cancer”, “kidney neoplasm” or “renal neoplasm”. The search was further refined to “open studies”, “interventional” and “age ≥18”. Basket trials with ≥7 tumors with non-RCC tumor histologies, terminated studies and pediatric studies were excluded. The phase, stage, treatment setting, type of intervention, study design, histologies, use of biomarkers, studied outcomes, sponsors and location of the trials were recorded. Results: We locked our search on May 26, 2016 and 165 trials were eligible, compared with 169 trials on Sep 25, 2013. There were more phase I and I/II trials in 2016 compared to 2013 (p = 0.05): phase I (25.6% vs 15.4%) and phase I/II (15.2% vs 9.5%). More clinical trials in 2016 compared to 2013 used immunotherapy (IT) alone or in combination with other drugs (24.2 % vs 10.7%, p = 0.001), and the use of targeted therapy alone (TT) declined (32.9% vs 47.9%, p = 0.005). IT alone was used in 15.2% of current trials, compared to 5.96% in 2013. TT+IT combination trials more than doubled (6.7% vs 2.3%, p = 0.07). The number of trials with treatment in neoadjuvant/adjuvant settings in 2016 and 2013 were similar (9.7% vs 10.6%, p = 0.77), respectively. Compared to 2013, the number of trials with non-clear cell histology remained low (n = 10). Many more trials were sponsored by pharmaceutical industry in 2016 vs 2013 (41.5% vs 16.0%, p = < 0.001). Conclusions: More clinical trials included immunotherapy in 2016 compared to 2013, and there was a significant increase in industry sponsored trials. The increase in industry sponsored studies may reflect use of new expensive drugs. More studies in (neo)adjuvant settings and for non-clear cell histologies are needed.