No improvement seen in two-year progression-free survival for radiotherapy with durvalumab versus radiotherapy with cetuximab
By Elana Gotkine HealthDay Reporter
MONDAY, Dec. 9, 2024 (HealthDay News) — For patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC) with a contraindication for cisplatin, radiotherapy with adjuvant durvalumab does not improve outcomes over radiotherapy with cetuximab, according to a study published online in the December issue of The Lancet Oncology.
Loren K. Mell, M.D., from the University of California San Diego in La Jolla, and colleagues conducted a randomized phase 2/phase 3 trial to examine whether radiotherapy with concurrent and adjuvant durvalumab would improve outcomes compared to radiotherapy with cetuximab among eligible patients with stage III to IVB p16-negative HNSCC or unfavorable stage I to III p16-positive oropharyngeal or unknown primary carcinoma with a contraindication to cisplatin.
The researchers of the phase 2 trial randomly assigned 186 patients: 123 to durvalumab and 63 to cetuximab. Following an interim futility analysis, phase 2 accrual was suspended and then permanently closed. The phase 3 part of the trial was not performed. The researchers found that at a median follow-up of 2.3 years, two-year progression-free survival was 50.6 and 63.7 percent in the durvalumab and cetuximab groups, respectively (hazard ratio, 1.33; 95 percent confidence interval, 0.84 to 2.12). The groups had similar adverse events.
“The final phase 2 results did not show a statistically significant signal of efficacy of durvalumab and radiotherapy,” the authors write. “These findings are consistent with the results of other trials indicating a lack of benefit of immune checkpoint inhibitors compared with cetuximab in patients with HNSCC who are ineligible for cisplatin.”
Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca, which manufactures durvalumab and partially funded the study.
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