PR R/M HNSCC pts present a poor prognosis. In the randomized phase 3 trial CheckMate141, nivo showed benefit in OS with manageable toxicity. In our region, nivo is available for clinical practice since April 2017. Aim: to evaluate the safety and activity of nivo in a real-world setting.
This multicenter, retrospective analysis included PR R/M HNSCC pts treated with nivo 3mg/kg every 2 weeks at 7 centers from Valencia region. We assessed demographics, safety (CTCAE v4.0 criteria), response evaluation (RECIST 1.1) progression-free survival (PFS) and OS. Pts included in the analysis should have received >1 dose of nivo.
A total of 50 pts were treated between May 2017 and April 2018. At the time of this analysis 38 patients were evaluable (updated data of the complete cohort and follow-up will be presented in ESMO congress). Nivo was administered as first-line palliative treatment in 8 pts (21,1%), as second-line in 18 pts (47,4%) and in third or subsequent lines in 12 pts (31,6%). The median number of doses administered was 5 (range 1-26) with 6 one-week treatment delays due to respiratory infections. Analysis of concurrent antibiotic therapy is pending. The objective response rate was (ORR) 23,7% with 9 partial responses, whereas 9 pts (23,7%) had stable disease. No confirmed hyperprogression was observed. Median time since last dose of platinum was 2,9 months (range 0-24) with 10 pts with a period time longer than 6 months. With a median follow-up of 6 months (range 1-16), median PFS was 3,4 months (CI95% 1,3-5,6) and median OS was 8,8 months (CI95% 3,8-13,9). 6-month and 9-month overall survival rates were 55% and 45% respectively. No immunorelated adverse events (irAE) grade 3-4 were reported. Most frequent grade 1-2 irAE observed were: asthenia (31,6% 12 pts) arthralgias (15,6%, 6 pts), thyroid disorders (10,5%, 4 pts) and skin rash (1pt).
To date, there are few data on the use of nivo in routine clinical practice in PR R/M HNSCC pts. In our population, more heavilyy pretreated than in ChekcMate141, RR and OS were maintained. These promising results encourage the use of nivo in this population, but further follow-up is still needed.
Clinical trial identification
Legal entity responsible for the study
G. Bruixola, Hospital Clinico Universitario de Valencia - INCLIVA.
Has not received any funding.
A. Berrocal Jaime: Honoraria: MSD; Advisory role: Bristol-Myers-Squibb. All other authors have declared no conflicts of interest.