Abstract 434P
Background
Squamous cell anal carcinoma (SCAC) is an uncommon neoplasia often cured by surgery and/or chemo-radiation therapy at the localized stage. Although the first-line of treatment for metastatic SCAC (mSCAC) is better codified with two validated treatment regimens, carboplatin-paclitaxel and modified DCF (docetaxel-cisplatin-5FU), there is no consensus regarding subsequent lines. EGFR (epidermal growth factor receptor) inhibitors have proven efficacy in HPV+ tumors such as head and neck SCC. Up to 80% of SCAC are related to HPV infection and 90% of SCAC overexpress EGFR, supporting the use of anti-EGFR in the treatment of mSCAC. In this study, we report the safety and efficacy of cetuximab (an EGFR inhibitor) in combination with 5-FU plus irinotecan base chemotherapy (FOLFIRI).
Methods
We retrospectively analyze the data of patients with mSCAC who failed on at least one prior line of treatment, treated with the combination FOLFIRI cetuximab in Gustave Roussy between March 2015 and February 2022. The main evaluation criterion was safety. Secondary evaluation criteria were overall response rate (ORR), disease-control rate (DCR), progression-free survival (PFS) and overall survival (OS).
Results
A total of 33 patients with a pre-treated mSCAC who received FOLFIRI cetuximab treatment were analyzed. A total of 356 cycles of FOLFIRI cetuximab have been administered with a median of 8 cycles per patient. Fourteen patients (42%) experienced a grade III/IV adverse event, mainly diarrhea (21%) and anemia (21%) that remained manageable. Two patients acheived a complete response (6%), 8 had a partial response (24%). The combination of FOLFIRI and cetuximab provided a DCR of 73%, and ORR of 30%. With a median follow-up of 38 months, the median PFS was 5.5 months [CI95% 4,2-9,9], and the median OS was 13.7 months [CI95% 10,6-21,6].
Conclusions
This study suggests that FOLFIRI cetuximab is a promising combination in the management of mSCAC with a very good DCR and a manageable toxicity profile. Metastatic SCAC is a quite rare pathology with few approved treatment lines. Therefore, patients with mSCAC need more therapeutic options, including treatments already well known in other localizations and innovative treatments.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
V. Boige: Financial Interests, Personal, Invited Speaker: Bayer, Merck Serono, Roche, Ipsen, MSD, BMS, Eisai, Novartis, Amgen; Non-Financial Interests, Personal, Invited Speaker: Bayer, Merck Serono, Roche, Sanofi, Ipsen, Msd, Amgen. D. Malka: Financial Interests, Institutional, Invited Speaker: Amgen, Bayer, BMS, Incyte, Merck Serono, MSD, Pierre Fabre, Roche, Sanofi, Servier, Viatris. A. Hollebecque: Financial Interests, Personal, Invited Speaker: Amgen, BMS, Eisai, Incyte, Astra Zeneca, Debiopharm; Non-Financial Interests, Personal, Invited Speaker: lilly; Other, Personal, Invited Speaker: Roche, Servier. M.P. Ducreux: Financial Interests, Personal, Invited Speaker: Roche, Amgen, Pierre Fabre, Merck Kga, Pfizer, Bayer, Lilly; Financial Interests, Personal, Advisory Board: Roche, Basilea, Sotio, Pierre Fabre, Bohringer, Rafael, Servier, Zymeworks, Ipsen, Bayer, Glaxo Smith Kline, HalioDX, Lilly; Financial Interests, Institutional, Funding, Partial funding of a trial evaluating the role of bevacizumab in NET: Roche; Financial Interests, Institutional, Funding, Partial funding of a trial evaluating the role of steptozotocin in NET: Keocyt; Financial Interests, Institutional, Invited Speaker: Rafael, Amgen; Financial Interests, Institutional, Funding: Bayer; Other, My wife is head of the oncology business unit in the French Affiliate of Sandoz: Sandoz France. All other authors have declared no conflicts of interest.