Abstract 4933
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.
Resources from the same session
2107 - Role of Individualized Intervention(s) on Quality of Life (QOL) and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women with Early-Stage Breast Cancer (BC): MyChoice Study
Presenter: Shahid Ahmed
Session: Poster Display session 2
Resources:
Abstract
5812 - Correlation between the density of tumor-infiltrating lymphocytes, immune cell subsets in tumor stroma and response to systemic therapy in breast cancer
Presenter: Cvetka Grasic Kuhar
Session: Poster Display session 2
Resources:
Abstract
4734 - BRCA1/2 Testing in HER2- Advanced Breast Cancer (ABC): Results from the European Component of a Multi-Country Real World Study
Presenter: Michael Patrick Lux
Session: Poster Display session 2
Resources:
Abstract
1686 - In vitro and in vivo rescue of resistance to BET inhibitors by targeting PLK1 in triple negative breast cancer.
Presenter: Cristina Nieto-jiménez
Session: Poster Display session 2
Resources:
Abstract
5020 - Neoadjuvant endocrine therapy in combination with melatonin and metformin in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
5082 - Melatonin and metformin in neoadjuvant chemotherapy in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
2642 - Patient-tailored tamoxifen dosing based on an increased quantitative understanding of its complex pharmacokinetics: A novel integrative modelling approach
Presenter: Anna Mueller-Schoell
Session: Poster Display session 2
Resources:
Abstract
2461 - Lack of benefit of neoadjuvant pertuzumab in high risk HER2 positive breast cancer. A retrospective case-control study of 355 cases with biomarker analysis.
Presenter: Manuela Tiako Meyo
Session: Poster Display session 2
Resources:
Abstract
4776 - Targeting CDCA3 to improve chemotherapy response in triple-negative breast cancer patients
Presenter: Kenneth O'Byrne
Session: Poster Display session 2
Resources:
Abstract
1674 - Activity of BET-proteolysis targeting chimeric (PROTAC) compounds in triple negative breast cancer
Presenter: María Del Mar Noblejas López
Session: Poster Display session 2
Resources:
Abstract