KEY TAKEAWAYS
- DURTRE-RAD is a phase II trial that aimed to investigate if D or DT + RT was feasible and reached 50% 1-year PFS.
- Two treatment groups were studied: D (immunotherapy alone) and DT (immunotherapy plus targeted therapy).
- The study concluded that D monotherapy showed low efficacy in HPV negative LA-HNSCC. Starting immunotherapy after RT may be more effective.
Platinum-based chemo-radiotherapy (RT) is the standard treatment for locally advanced HPV-negative head and neck squamous cell carcinoma (LA-HNSCC), but it is not effective in poor-risk patients and has long-term side effects.
Researchers aimed to determine the feasibility of combining durvalumab (D) or durvalumab plus tremelimumab (DT) with RT in the patient population and whether a 1-year progression-free survival (PFS) rate of 50% could be achieved.
The study enrolled 60 patients in each of two treatment arms D (1,500 mg every 3 weeks for 13 doses) and DT (1,500 mg every 3 weeks for 13 doses + 4 x 75 mg in weeks 5, 9, 13, and 17). Radiotherapy (70 Gy over 7 weeks) was started 14 days after the start of immunotherapy. The planned treatment duration was 51 weeks for both arms. An interim analysis for feasibility was conducted after treating 6 patients per arm, and a futility analysis led to early closure of the trial after treating 18 patients.
The DT arm was stopped prematurely due to severe side effects in 5 out of 6 patients. The D arm continued, but 1 out of 12 patients discontinued treatment and 7 patients experienced disease progression or died. The median PFS was 39 weeks with a 1-year PFS rate of 42%.
The study concluded that D, which was previously effective in RM-HNSCC, was not effective in combination with RT in poor-risk HPV-negative LA-HNSCC patients. D monotherapy in combination with RT was well-tolerated, suggesting that starting immunotherapy after RT may be beneficial.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.2611
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03624231
Ulrich Keilholz, Thomas Christoph Gauler, Carmen Stromberger, Grzegorz Kofla, Maike de Wit, Ramona Mette, Susen Burock, and Konrad Friedrich Klinghammer. Journal of Clinical Oncology 2023 41:16_suppl, 2611-2611.
