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
5612 - Evaluation of germ line mutational status among women with triple-negative breast cancer in Russia
Presenter: Elena Shagimardanova
Session: Poster Display session 2
Resources:
Abstract
4142 - Association of derived neutrophil-to-lymphocyte ratio (dNLR) with pathological complete response (pCR) after neoadjuvant chemotherapy (CT)
Presenter: Alberto Ocaña
Session: Poster Display session 2
Resources:
Abstract
1733 - Competing nomogram for late-period breast cancer-specific death in patients with early-stage hormone receptor-positive breast cancer
Presenter: Jianfei Fu
Session: Poster Display session 2
Resources:
Abstract
1978 - A Nomogram to Predict Pathologic Complete Response of Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Based on Simple Blood Indicators
Presenter: Fanrong Zhang
Session: Poster Display session 2
Resources:
Abstract
3062 - Identification of GSTP1 transferred by extracellular vesicles responsible for adriamycin-resistance in breast cancer cells
Presenter: Sujin Yang
Session: Poster Display session 2
Resources:
Abstract
5274 - Expression of X-linked Inhibitor of Apoptosis Protein (XIAP) and its Association with Clinicopathological Parameters in Invasive Breast Cancers
Presenter: Gayathri Devi
Session: Poster Display session 2
Resources:
Abstract
1324 - The prognostic significance of preoperative tumor marker (CEA, CA15-3) elevation in breast cancer patients
Presenter: Soo Youn Bae
Session: Poster Display session 2
Resources:
Abstract
4877 - Correlation of clinical and pathological features with the tumour microenvironment in DCIS. An institutional experience
Presenter: Ann Eapen
Session: Poster Display session 2
Resources:
Abstract
2471 - Correlation between radiologic complete response (rCR) in contrast-enhanced magnetic resonance imaging (CE-MRI) after neoadjuvant chemotherapy for early breast cancer and pathologic complete response and their impact in recurrence-free survival
Presenter: Ariadna Gasol Cudos
Session: Poster Display session 2
Resources:
Abstract
2632 - Ring-like uptake appearance on dedicated breast positron emission tomography before chemotherapy predicts outcome of neoadjuvant chemotherapy in breast cancer
Presenter: Norio Masumoto
Session: Poster Display session 2
Resources:
Abstract