HANNA: Real-world outcomes of patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab (NIVO) in Germany

Introduction HANNA, a prospective, observational, multicenter study, started in May 2017 to collect data from patients (pts) with R/M SCCHN treated with NIVO in a real-world setting.

Methods Overall, 56 clinics and practices plan to enroll 485 adult pts with R/M SCCHN starting therapy with NIVO according to the label. Pts are followed up to 5 years (y). The primary study objective is overall survival (OS), estimated using the Kaplan-Meier method. Data of 414 pts were analyzed in this interim analysis (Sept 2020, median follow-up 18.5 months [mo]) using descriptive statistics.

Results Median age of pts was 63 y, 82.1 %  male, ECOG performance status 0-1/2-3 in 57.3 % /31.4 %  of pts, respectively. Primary tumor was oropharynx, 38.2 % ; hypopharynx, 18.6 % ; oral cavity, 22.5 % ; larynx, 14.5 % . 29.7 %  of pts received NIVO as first line therapy (1L) after platinum-based chemo- or radiochemotherapy, 50.5 %  as second line and 10.4 %  as later line therapy. Overall, 1y OS probability was 45 %  with a median OS (mOS) of 10.4 mo; pts receiving 1L NIVO had a 1y OS probability of 50 %  (mOS 11.9 mo). 1y OS probabilities/mOS were highest for pts with tumors of the hypopharynx (52 % , mOS 12.5 mo). Outcomes were more favorable for pts with local recurrence (56 % , mOS 15.3 mo) vs distant metastases (40 % , mOS 8.8 mo), and pts with soft tissue metastases (44 % , mOS 10.3 mo) vs bone metastases (24 % , mOS 4.7 mo). Comorbidities (eg. diabetes mellitus, coronary heart disease) had no influence on the outcome (50 % , mOS 11 mo/40 % , mOS 10.3 mo). Conclusions Real-world data from HANNA reflect routine clinical use of NIVO and provide complementary information about special populations. OS of our older, frailer patient population is comparable to outcomes from phase III NIVO registration study CheckMate 141.

Poster-PDF A-1216.pdf

Bristol Myers Squibb Deutschland

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Artikel online veröffentlicht:
13. Mai 2021