Adjuvant Opdivo, cisplatin and radiotherapy improved DFS vs different therapy amongst these with regionally superior squamous cell carcinoma of the top and neck: © inventory.adobe.com.
Amongst sufferers who’re at excessive danger of relapse with regionally superior squamous cell carcinoma of the top and neck, adjuvant Opdivo (nivolumab) with cisplatin and radiotherapy considerably improved disease-free survival in contrast with different therapies, based on information from the section 3 NIVOPOSTOP trial which had been shared in a presentation on the 2025 ASCO Annual Assembly.
On the information cutoff of April 30, 2024, 252 disease-free survival occasions had been recorded. The median follow-up was 30.3 months. The three-year disease-free survival charge was 63.1% within the Opdivo arm and 52.5% for sufferers in the usual of care arm, which was cisplatin plus radiotherapy.
Of be aware, the 12-month disease-free survival charge was 71.7% versus 64.7%, and the 24-month charges had been 64.9% versus 56.2% within the Opdivo and normal of care arms, respectively.
The cumulative incidence of loco-regional relapse at 1 12 months was 11% versus 16%, at 2 years it was 12% versus 19%, and at 3 years it was 13% versus 20% between the Opdivo and normal of care arms, respectively.
“Put up-operative Opdivo added to plain of care cisplatin-[radiotherapy] improved affected person outcomes for resected high-risk regionally superior squamous cell carcinoma of the top and neck, that could possibly be proposed as a brand new normal therapy,” Dr. Jean Bourhis, professor and chief of radiation oncology on the Lausanne College Hospital in Lausanne, Switzerland; medical director of GORTEC; and principal investigator of the research, mentioned throughout the presentation.
The trial enrolled 680 sufferers and randomly assigned them to both the Opdivo group (332 sufferers) or the usual of care group (334 sufferers). Sufferers got one dose of Opdivo at 240 milligrams (mg), adopted by 360 mg of Opdivo each three weeks for 3 doses plus 100 mg/m2 of cisplatin each three weeks and immune-modulated radiotherapy at 66 Gy, adopted by 480 mg of Opdivo each 4 weeks for six doses. The usual of care arm was given 100 mg/m2 of cisplatin each three weeks and immune-modulated radiotherapy at 66 Gy.
Sufferers had been included within the trial in the event that they had been youthful than 75, had an ECOG efficiency standing of 0 or 1, and had SCC of the oral cavity, oropharynx, or hypopharynx with: full macroscopic surgical resection, stage 3 or 4, or high-risk pathological options of relapse.
The median affected person age was 59 in each arms, 75% and 77% of sufferers had been male, 51% and 50% had an ECOG efficiency rating of 0, 54% and 48% had been present people who smoke, and 58% versus 58% had the principle tumor website within the oral cavity between the Opdivo and normal of care arms, respectively.
Investigators additionally checked out whether or not Opdivo compromised the compliance with normal of care cisplatin. Total, 301 sufferers within the Opdivo arm and 304 in the usual of care arm obtained cisplatin, with 82% of the Opdivo arm getting the cumulative dose of 200 mg/m2 or extra in contrast with 87% in the usual of care arm, and 62% versus 68% obtained cisplatin for 3 cycles. Receipt of radiotherapy was additionally analyzed with 303 sufferers within the Opdivo arm and 306 in the usual of care arm, with 95% of sufferers receiving radiotherapy for 55 days or much less in contrast with 97%, and 91% versus 95% got a dose of 66 Gy.
Of be aware, 310 sufferers got Opdivo earlier than or throughout radiotherapy, with 75% receiving it for 4 cycles. Moreover, 260 sufferers had been began on Opdivo upkeep with a median variety of 6 upkeep cycles. The median variety of complete Opdivo cycles was 10.
Grade 1/2 treatment-emergent negative effects famous in both the Opdivo or normal of care arms included stomatitis (58% versus 58%), radiation pores and skin harm (59% versus 63%), dysphagia (32% versus 33%), nausea (40% versus 45%), and dry mouth (38% versus 42%). Grade 3 (server) or 4 (life threatening) treatment-emergent negative effects included stomatitis (25% versus 24%), dysphagia (24% versus 18%), neutropenia (23% versus 23%), renal dysfunction (11% versus 5%), and radiation pores and skin harm (7% versus 7%).
Reference
Bourhis J, Auperin A, Borel C, et al. NIVOPOSTOP (GORTEC 2018-01): A section III randomized trial of adjuvant nivolumab added to radio-chemotherapy in sufferers with resected head and neck squamous cell carcinoma at excessive danger of. J Clin Oncol. 2025;43(suppl 17):LBA2. doi:10.1200/JCO.2025.43.17_suppl.LBA2
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