Imunoterapija pri ploščatoceličnem karcinomu glave in vratu Immunotherapy for squamous cell carcinoma of the head and neck

izkušnje iz Slovenije

Povzetek

Izhodišča: Imunoterapija z zaviralcem imunskih kontrolnih točk nivolumabom, zaviralnim protitelesom proti proteinu programirane celične smrti 1 (PD-1), predstavlja za bolnike z neozdravljivo ponovitvijo bolezni ali s sistemskimi zasevki ploščatoceličnega karcinoma glave in vratu (P/Z PKGV), pri katerih je bolezen neobčutljiva na preparate platine, pomembno novo možnost zdravljenja. V primerjavi s citostatiki pomembno podaljša njihovo preživetje.
Metode: Retrospektivna analiza zdravljenja z nivolumabom pri slovenskih bolnikih s P/Z PKGV, ki so prejeli prvi odmerek nivolumaba do marca 2020. Zbiranje podatkov je bilo zaključeno v septembru 2020. Uporabljene so bile opisne statistične metode in log-rank test.
Rezultati: V raziskavo je bilo vključenih 27 bolnikov. Srednji čas sledenja od prve aplikacije nivolumaba do konca opazovanja je bil 7,4 meseca, relativno šestmesečno celokupno preživetje pa 59% (95% interval zaupanja 41–78%). Odgovor na zdravljenje je bil pri 85% bolnikov ocenjen s kliničnim pregledom in rentgenskim slikanjem prsnega koša, pri čemer je bil pri 41% kot najboljši odgovor ugotovljen delen odgovor na zdravljenje. Imunsko pogojeni neželeni dogodki so se pojavili pri 30% bolnikov, pri čemer so bili vsi gradusa ≤2. En bolnik je bil sočasno z nivolumabom tudi obsevan.
Zaključek: Glede na zbrane podatke se je tudi v slovenski populaciji bolnikov s P/Z PKGV zdravljenje z nivolumabom izkazalo za varno. Zaradi kratkega časa sledenja ugotovljene učinkovitosti ni mogoče primerjati z rezultati tujih raziskav. S pričakovano odobritvijo pembrolizumaba bodo zaviralci imunskih kontrolnih točk tudi v Sloveniji dobili mesto v prvem redu zdravljenja P/Z PKGV.

Abstract (Eng)

Background: Immunotherapy with immune checkpoints inhibitor nivolumab –  inhibitory antibody against programmed death receptor-1 (anti-PD-1) – represents an important new treatment option for patients with incurable recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) unresponsive to platinum-based chemotherapy. It significantly prolongs survival compared to standard chemotherapy.
Methods: A retrospective analysis of treatment with nivolumab in patients with R/M HNSCC in Slovenia who received their first dose of nivolumab until March 2020 was performed. Data collection was completed in September 2020. Descriptive statistics and log-rank test were used.
Results: Twenty-seven patients entered the study. Median time of follow-up from the first nivolumab application onward was 7.4 months, and relative 6-month overall survival was 59% (95% confidence interval 41–78%). In 85% of patients, the response to treatment was evaluated using clinical examination and chest x-ray only. In 41% of patients the partial response to treatment was declared as the best response achieved. Thirty percent of patients experienced immune related adverse events of which all were grade ≤2. In one patient radiotherapy was delivered concurrently with nivolumab.
Conclusion: According to the presented results, treatment with nivolumab has also been shown to be safe in Slovenian patients with R/M HNSCC. Due to the short follow-up time, the observed efficacy cannot be compared with the results of foreign studies. With the expected approval of pembrolizumab, the immune checkpoint inhibitors will also be given a place in the first line treatment of R/M HNSCC in Slovenia.