Abstract 2150
Background
A decrease in AFP level during treatment has been associated with improved overall survival (OS) in patients with HCC. In the phase 3 RESORCE trial (NCT01774344), the multikinase inhibitor regorafenib significantly improved OS versus placebo in patients with HCC and disease progression on sorafenib. We analyzed OS in patients who had an AFP response in RESORCE.
Methods
Patients with Barcelona Clinic Liver Cancer stage B or C HCC, Child -Pugh A liver function, ECOG performance status 0 − 1, and documented radiologic progression on prior sorafenib were randomized 2:1 to regorafenib 160 mg/day (n = 379) or placebo (n = 194) for Weeks 1-3 of each 4-week cycle. Serum AFP levels were assessed at baseline, every 4 weeks during treatment, and at the end of treatment. Patients who had a baseline AFP ≥20 ng/mL and an AFP measurement at the start of Cycle 3 were evaluable for AFP response, defined as a decrease of ≥ 20% in AFP level from baseline at the start of Cycle 3.
Results
Overall, 232 of the 573 randomized patients fulfilled the above criteria and were included in the analysis. Patients with an AFP response had a median OS from randomization of 13.8 months vs 8.9 months in those without an AFP response (Table). The rate of AFP response was 46% (77/168) in the regorafenib group and 11% (7/64) in the placebo group. Among regorafenib-treated patients, the median OS was 13.8 months in patients with an AFP response vs 9.8 months in those without an AFP response. A landmark analysis of OS from the start of Cycle 3 showed that the hazard ratios for AFP response vs no response were 0.57 (95% CI 0.40, 0.82) in the regorafenib and placebo arms combined and 0.72 (95% CI 0.48, 1.08) for patients in the regorafenib arm.Table:
755P
Regorafenib + /placebo arms combined | Regorafenib arm | |||
---|---|---|---|---|
(n = 232) | (n = 168) | |||
AFP response (n = 84) | No AFP response (n = 148) | AFP response (n = 77) | No AFP response (n = 91) | |
Median OS (95% CI) from randomization, months | 13.8 (11.8, 16.5) | 8.9 (8.0, 9.7) | 13.8 (11.7, 16.5) | 9.8 (8.2, 14.2) |
HR (95% CI) AFP response yes/no | 0.57 (0.40, 0.82) | 0.72 (0.48, 1.07) | ||
CI, confidence interval; HR, hazard ratio. |
Conclusions
In this exploratory analysis of RESORCE, an AFP response with regorafenib was associated with improved OS.
Clinical trial identification
NCT01774344.
Editorial acknowledgement
Jennifer Tobin of OPEN Health Medical Communications (London, UK), with financial support from Bayer.
Legal entity responsible for the study
Bayer.
Funding
Bayer.
Disclosure
J. Bruix: Honoraria (self): Bayer; BTG; Eisai; Ipsen; Sirtex; Terumo; Advisory / Consultancy: AbbVie; Adaptimmune; Arqule; Astra-Medimmune; Basilea; Bayer; Bio-Alliance; Bristol-Myers Squibb; BTG; Eisai; Gilead; Incyte; Ipsen; Kowa; Lilly; Merck Sharp & Dohme; Nerviano; Novartis; Quirem; Roche; Sanofi Aventis; Sirtex; Terumo; Research grant / Funding (institution): Bayer; BTG. M. Reig: Honoraria (self): AstraZeneca; Bayer; Bristol-Myers Squibb; BTG; Gilead; Ipsen; Lilly; Advisory / Consultancy: AstraZeneca; Bayer; Bristol-Myers Squibb; Ipsen; Lilly; Roche; Research grant / Funding (institution): Bayer; Travel / Accommodation / Expenses: Bayer; Bristol-Myers Squibb; Gilead; Ipsen; Lilly. P. Merle: Advisory / Consultancy: AstraZeneca; Bayer; Bristol-Myers Squibb; Eisai; Exelixis; Ipsen; Merck Sharp & Dohme; Onxeo; Roche. M. Kudo: Honoraria (self): Bayer; Eisai; Merck Sharp & Dohme; Advisory / Consultancy: Bayer; Bristol-Myers Squibb; Eisai; Merck Sharp & Dohme; Ono Pharmaceutical; Research grant / Funding (institution): AbbVie; Astellas Pharma; Bristol-Myers Squibb; Chugai; Daiichi Sankyo; EA Pharma; Eisai; Gilead; Medico’s Hirata; Otsuka; Taiho; Takeda. G. Meinhardt: Shareholder / Stockholder / Stock options: Bayer; Full / Part-time employment: Bayer. M. Zhang: Shareholder / Stockholder / Stock options: Bayer; Full / Part-time employment: Bayer. K. Ozgurdal: Full / Part-time employment: Bayer.
Resources from the same session
4732 - Progesterone Receptor Isoform Ratio Dictates Antiprogestins/Progestins Effects on Metastatic Breast Cancer Models
Presenter: Maria Abascal
Session: Poster Display session 2
Resources:
Abstract
5737 - PAM50 and CGH-array genomic characterization of HER2-Equivocal Breast Cancers defined by the 2018 ASCO/CAP recommendations.
Presenter: Carine Ngo
Session: Poster Display session 2
Resources:
Abstract
1096 - OncotypeDX® predictive nomogram for recurrence score output: a machine learning system based on quantitative immunochemistry analysis - ADAPTED01
Presenter: Fabio Marazzi
Session: Poster Display session 2
Resources:
Abstract
5426 - Geriatric parameters predict both disease-related and patient-reported outcomes in older patients with breast cancer
Presenter: Willeke van der Plas-Krijgsman
Session: Poster Display session 2
Resources:
Abstract
5865 - Patients with a 21-gene assay in South East London differ from the TAILORx trial population
Presenter: Charalampos Gousis
Session: Poster Display session 2
Resources:
Abstract
1312 - Predictive tools in adjuvant breast cancer – what is the standard of evidence supporting their utility? A literature review examining validation of Adjuvant!, Cancermath and NHS Predict
Presenter: Alice Loft
Session: Poster Display session 2
Resources:
Abstract
2445 - Oncologic outcome of invasive lobular carcinoma: Is it different from that of invasive ductal carcinoma?
Presenter: Hee Jun Choi
Session: Poster Display session 2
Resources:
Abstract
2476 - Pathologic response and survival efficacy in patients with initial nodal involvement after neoadjuvant chemotherapy in early breast cancer
Presenter: SERAFIN MORALES Murillo
Session: Poster Display session 2
Resources:
Abstract
3761 - Chemotherapy-induced amenorrhea: prognostic impact on premenopausal Egyptian patients with breast cancer
Presenter: Khaled Abdel Karim
Session: Poster Display session 2
Resources:
Abstract
4687 - Predicting the presence of breast cancer using circulating small RNA in the serum
Presenter: Yumiko Koi
Session: Poster Display session 2
Resources:
Abstract