Highlights
- •Local treatments and even SHH inhibitors can be insufficient to treat advanced BCC.
- •We evaluate Nivolumab in monotherapy for advanced BCC as an alternative.
- •Nivolumab seem to be a relevant option when there is no other treatment available.
Abstract
Background
Basal cell carcinoma (BCC) is the most common human malignancy. In most cases, BCC
has slow progression and can be definitively cured by surgery or radiotherapy. However,
in rare cases, it can become locally advanced or, even more rarely, metastatic. The
alternative recommended treatments are Sonic Hedgehog pathway inhibitors; however,
the response is often short-lived.
Methods
This was a phase 2 basket study (NCT03012581) evaluating the efficacy and safety of
nivolumab in a cohort of 32 advanced BCC patients, enrolled after failure of Sonic
Hedgehog inhibitors, including 29 laBCC (91%) and 3 mBCC (9%).
Results
Compared to previously published studies, our population consisted of severe patients
with a poor prognosis because they had already received multiple lines of treatment:
all patients received previous Sonic Hedgehog inhibitors, 53% of patients already
had chemotherapy and 75% radiotherapy. At 12 weeks, we reported 3.1% of complete responses,
18.8% of partial responses, and 43.8% of stable diseases. The best response rate to
nivolumab reached 12.5% of complete responses (four patients), 18.8% of partial responses
(three patients), and 43.8% of stable diseases (14 patients). Adverse events (AE)
were mostly grade 2 or 3, slightly different to the adverse events observed in the
treatment of metastatic melanoma (higher rate of diabetes, no thyroid dysfunction).
Conclusion
Nivolumab is a relevant therapeutic option for patients with advanced relapsing/refractory
BCC.
Keywords
Abbreviations:
AE (adverse event), BCC (basal cell carcinoma), CR (complete response), ECOG (Eastern Cooperative Oncology Group (Performans Status)), EMA (European Medicines Agency), FDA (Food and Drug Administration), ITT (intent-to-treat), laBCC (locally advanced BCC), mBCC (metastatic BCC), NCI CTCAE v4 (National Cancer Institute Common Terminology Criteria for Adverse Event version 4), ORR (objective response rate), OS (overall survival), PDL1 (programmed death ligand 1), PFS (progression-free survival), PR (partial response), RECIST (Response Evaluation Criteria In Solid Tumors), SHH (sonic Hedgehog), TMB (tumour mutation burden)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: November 03, 2022
Accepted:
September 14,
2022
Received in revised form:
September 12,
2022
Received:
July 29,
2022
Identification
Copyright
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