Abstract 1065P
Background
The management of Basal Cell Carcinoma (BCC) patients (pts) experiencing clinical complete remission (cCR) upon HedgeHog Inhibitors (HHIs) has not been defined yet. We evaluated whether time to HHI stop after cCR is associated to better recurrence-related outcomes.
Methods
A retrospective, observational, Italian analysis was conducted in 7 onco-dermatology centers. BCC pts treated with HHI (vismodegib) from 2012 to 2019, who had achieved cCR, were considered. We analyzed the n. of Days of Treatment needed to achieve cCR (DTCR), To vismodegib Stop after cCR (DTS), the Total Treatment Days (TTD = DTCR+DTS), and the Disease-Free Survival (DFS) as the n. of days from cCR to recurrence (or to last follow-up in not recurrent patients). Reasons to stop vismodegib were classified as R1) Toxicity; R2) disease recurrence. The relationship between DTCR, DTS, and DFS in the whole population and in the R1 subgroup was assessed by Pearson’s correlation coefficient (p<0.05).
Results
Pts’ characteristics and main results are reported in the table. Among 68 BCC pts experiencing cCR, 21% (n=14) stopped early vismodegib (≤2 months, mo) while 79% (n=54) were on HHI longer (>2 mo). Thirty-eight (56%) pts recurred with a median (m) DFS of 357 (60-1792) days (d). In the R1 subgroup, 26 (52%) pts recurred. While the DTCR was not correlated to DFS, DTS and TTD significantly correlated to DFS, both in the whole population (p<0.0001 and p<0.0001, respectively), and only in the R1 subgroup (n=50, p=0.0002 and p=0.0009, respectively). In recurrent pts (n=38), DTS correlated to DFS (p=0.0056), also when considering only the R1 cohort (n=28, p=0.0002). Pts who prolonged vismodegib >2 mo after cCR had higher DFS compared to those ≤2 mo (mDFS 470 vs 174d, p=0.008). Table: 1065P
| Pts characteristics and main results | N (range or %) | |
| Median age | 75.5 (39-100) | |
| Sex | Male | 43 (63) |
| Female | 25 (37) | |
| Disease subsite | Head/neck | 51 (75) |
| Other | 17 (25) | |
| Disease stage | Locally advanced | 65 (96) |
| Metastatic | 3 (4) | |
| Gorlin syndrome | yes | 12 (18) |
| no | 56 (82) | |
| Stop Vismodegib | yes | 61 (89) |
| no | 7 (11) | |
| Stop Vismodegib reason | R1 | 50 (82) |
| R2 | 11 (18) | |
| Median DTCR | 180 d (56-595) | |
| Median DTS | 125 d (0-1018) | |
| Median TTD | 403.5 d (95-2112) | |
| Median follow-up | 414.5 d (0-2600) |
d= days
Conclusions
A prolonged intake of vismodegib after cCR achievement might improve the recurrence-related outcomes in BCC pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
L.D. Locati: Financial Interests, Invited Speaker: Eisai, Ipsen, Merck Serono, MSD, BMS; Lilly. L.F. Licitra: Financial Interests, Invited Speaker: Dr. L. Licitra further acknowledge grant/research support from Astrazeneca, BMS, Boehringer Ingelheim, Celgene International, Debiopharm International SA, Eisai, Exelixis inc, Hoffmann-La Roche ltd, IRX Therapeutics inc, Medpace inc, Merck Serono, MSD. All other authors have declared no conflicts of interest.