4933 - Updated data of Epitopes-HPV02 trial and external validation of efficacy of DCF in prospective Epitopes-HPV01 study in advanced anal squamous cell carcinoma. Pooled analysis of 115 patients

Background

The addition of docetaxel to cisplatin and 5FU (DCF) has shown a promising efficacy in Epitopes-HPV01 study with 4 of first 8 consecutive patients presenting a long-lasting complete response. Then, the prospective, multicenter, Epitopes-HPV02 trial, settled the modified DCF regimen as a new standard of care in metastatic or non-resectable locally advanced recurrent anal squamous cell carcinoma (ASCC). Here we present updated results of Epitopes-HPV02 study, as well as final results of Epitopes-HPV01 study.

Methods

Epitopes-HPV02 was a phase 2 study supported by the GERCOR and FFCD collaborative oncological groups, performed in 25 academic and community hospitals in France. Epitopes-HPV01 was a real-life based cohort study performed by the regional cancer network of Franche-Comté, France, and including one university hospital, 5 community hospitals, and 1 private center. Both studies included patients with histologically confirmed ASCC, with metastatic disease, or with unresectable local recurrence after chemoradiotherapy, and treated with DCF regimen.

Results

In Epitopes-HPV02, 69 patients were enrolled between Sept 2014-Dec 2016, and 66 patients were included for analysis; while 51 patients were included between Sept 2012- January 2019 in Epitopes-HPV01, and 49 patients for analysis. Pooled analysis of 115 patients showed a median PFS of 12 months (95% CI 10.6-16.0) [11.0 months (9.3-16.0) in -HPV02, and 12.7 months (11.2-34.5) in -HPV01, (p = 0.14)]. The median OS was 50.2 months (26.0-120.0) [not reached in -HPV02, and 50.2 months (21.4-120.0) in -HPV01 (p = 0.73)]. ORR was 87.7% (89% in -HPV02 and 85.1% in -HPV01) with 40.7% of CR (45% in -HPV02 and 34% in -HPV01). No difference was observed between standard DCF (n = 54) and modified DCF (n = 58) in OS (p = 0.93) and PFS (p = 0.52).No treatment-related death was observed in both studies. The median PFS in second-line was 5.9 months (3.3-7.1).

Conclusions

Pooled analysis of Epitopes-HPV01 and 2 results, confirm mDCF as the regimen of choice in fit patients with metastatic or locally advanced recurrent ASCC.

Clinical trial identification

NCT01845779, NCT02402842.

Editorial acknowledgement

Legal entity responsible for the study

CHU Jean Minjoz, Besançon.

Funding

Besançon University Hospital and Ligue Contre le Cancer Grand-Est.

Disclosure

All authors have declared no conflicts of interest.