From the Guidelines
Yes, you can start pembrolizumab for a head and neck cancer patient with PD-L1 expression level of CPS=3 (CPS≥1). Pembrolizumab is approved for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) patients whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 1. The standard dosing is 200 mg intravenously every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months of treatment.
Key Considerations
- Before starting treatment, baseline laboratory tests including liver and thyroid function should be obtained, and patients should be monitored for immune-related adverse events during therapy.
- The CPS=3 indicates sufficient PD-L1 expression to predict potential response to pembrolizumab.
- This immunotherapy works by blocking the PD-1/PD-L1 pathway, allowing T cells to recognize and attack cancer cells that would otherwise evade immune detection.
- Patients with higher PD-L1 expression generally show better response rates, but even with CPS=1 or greater, clinical benefit has been demonstrated in clinical trials compared to standard chemotherapy 1.
Treatment Approaches
- Two different approaches are validated for patients with locoregional relapse not amenable to locoregional salvage treatment and/or with distant metastases:
- A ‘chemo-free’ approach with pembrolizumab monotherapy in patients with CPS 1 SCCHN should be considered, especially when a rapid tumour shrinkage is not needed 1.
- A second option, independent of PD-L1 status, is the combination of pembrolizumab and chemotherapy (cisplatin or carboplatin plus 5-FU), particularly in symptomatic patients or when a rapid tumour shrinkage is needed 1.
Clinical Evidence
- The KEYNOTE-048 study showed that a combination of chemotherapy (cisplatin or carboplatin plus 5-FU) plus pembrolizumab significantly improved overall survival (OS) compared with the EXTREME regimen (cisplatin or carboplatin plus 5-FU plus cetuximab): median OS 13 versus 10.7 months (P = 0.0034) 1.
- Pembrolizumab monotherapy also improved median OS in patients with PD-L1-expressing SCCHN: 14.9 versus 10.7 months in the CPS 20 subgroup and 12.3 versus 10.3 months in the CPS 1 subgroup 1.
From the FDA Drug Label
as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. The patient has a PD-L1 expression level of CPS=3, which meets the criteria of CPS ≥1. Therefore, pembrolizumab can be started for the head and neck cancer patient. 2
From the Research
PD-L1 Ekspresijos Lygis CPS=3 (CPS>=1) ir Pembrolizumabas Naudojimas
- PD-L1 ekspresijos lygis CPS=3 (CPS>=1) gali būti pakankamas pembrolizumabo naudojimui, kadangi tyrime 3 buvo nustatyta, jog CPS>=1 gali būti naudojamas kaip PD-L1 ekspresijos lygio rodiklis.
- Pembrolizumabas naudojimas pacientams su galvos ir kaklo vėžiu, turintiems PD-L1 ekspresijos lygį CPS>=1, parodė geresnę visuotinę išgyvenamumą ir atsaką į gydymą, palyginus su chemoterapija 4, 5.
- Tačiau reikia atsižvelgti į tai, kad pembrolizumabo naudojimas turi būti individualizuotas, atsižvelgiant į kiekvieno paciento specifines sąlygas ir PD-L1 ekspresijos lygį 6.
Pembrolizumabo Naudojimo Saugumas
- Pembrolizumabo naudojimas galvos ir kaklo vėžio pacientams su PD-L1 ekspresijos lygiu CPS>=1 buvo parodytas saugus, su palyginus mažu tokio gydymo komplikacijų skaičiumi 4, 5.
- Tačiau, kaip ir su bet kuriuo vaistu, reikia stebėti paciento būklę ir kreiptis į gydytoją, jei atsiranda bet kokios nepageidaujamos puses efektų.
Rekomendacijos
- Pacientams su galvos ir kaklo vėžiu, turintiems PD-L1 ekspresijos lygį CPS=3 (CPS>=1), gali būti siūlomas pembrolizumabo gydymas, atsižvelgiant į kiekvieno paciento specifines sąlygas ir PD-L1 ekspresijos lygį 3, 5.
- Reikia konsultuotis su gydytoju, kad nuspręsti, ar pembrolizumabo gydymas yra tinkamas konkrečiam pacientui.