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
3516 - Palbociclib Rechallenge in Hormone Receptor (HR)[+]/HER2[-] Advanced Breast Cancer (ABC). PALMIRA Trial
Presenter: Antonio Llombart Cussac
Session: Poster Display session 2
Resources:
Abstract
4616 - Alpelisib (ALP) + Endocrine Therapy (ET) by Last Prior Therapy in Patients (pts) With PIK3CA-Mutated Hormone-Receptor Positive (HR+) Human Epidermal Growth Factor Receptor-2-Negative (HER2–) Advanced Breast Cancer (ABC): Additional Study Cohort in BYLieve
Presenter: Eva Ciruelos
Session: Poster Display session 2
Resources:
Abstract
3592 - PRECYCLE: Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy.
Presenter: Tom Degenhardt
Session: Poster Display session 2
Resources:
Abstract
4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer
Presenter: Ning Li
Session: Poster Display session 2
Resources:
Abstract
2785 - Effect of response to last platinum-based chemotherapy in patients (pts) with platinum-sensitive, recurrent ovarian carcinoma in the phase 3 study ARIEL3 of rucaparib maintenance treatment
Presenter: Jonathan Ledermann
Session: Poster Display session 2
Resources:
Abstract
3496 - Integrated safety analysis of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients (pts) with ovarian cancer in the treatment and maintenance settings
Presenter: Rebecca Kristeleit
Session: Poster Display session 2
Resources:
Abstract
2844 - Clinical factors associated with prolonged response and survival under olaparib as maintenance therapy in BRCA mutated ovarian cancers
Presenter: S.Intidhar Labidi-Galy
Session: Poster Display session 2
Resources:
Abstract
1955 - A Prospective Evaluation of Tolerability of Niraparib Dosing Based on Baseline Body Weight (BW) and Platelet (plt) Count: Blinded Pooled Interim Safety Data from the NORA Study
Presenter: Xiaohua Wu
Session: Poster Display session 2
Resources:
Abstract
2539 - Evaluation of Niraparib 200 mg/d as Maintenance Therapy in Recurrent Ovarian Cancer and Associated Thrombocytopenia in a Real-World US Setting
Presenter: Premal Thaker
Session: Poster Display session 2
Resources:
Abstract
1290 - Niraparib initial dose and its’ management in patients with recurrent high-grade serous ovarian cancer.
Presenter: Jacek Grabowski
Session: Poster Display session 2
Resources:
Abstract