Selected poster presentations Poster Discussion Session

53P - Impact of chronic hepatitis virus infection on the feasibility and efficacy for Asian patients with hepatocellular carcinoma in phase I clinical trials

Presentation Number
53P
Lecture Time
17:05 - 17:10
Speakers
  • Takafumi Koyama (Tokyo, JP)
Session Name
Selected poster presentations
Location
Room Scene AB, Paris Marriott Rive Gauche, Paris, France
Date
05.03.2018
Time
16:50 - 17:10
Authors
  • Takafumi Koyama (Tokyo, JP)
  • Shunsuke Kondo (Tokyo, JP)
  • Toshio Shimizu (Tokyo, JP)
  • YUTAKA Fujiwara (Tokyo, JP)
  • Shigehisa Kitano (Tokyo, JP)
  • Takahiro Ebata (Chiba, JP)
  • Akihiko Shimomura (Tokyo, JP)
  • Chigusa Morizane (Tokyo, JP)
  • Takuji Okusaka (Tokyo, JP)
  • Noboru Yamamoto (Tokyo, JP)

Abstract

Background

In Asia, chronic hepatitis B and C virus infections (CHVI) are major risk factors for liver fibrosis and hepatocellular carcinoma (HCC). Patients with advanced HCC have limited effective therapeutic options and are potential candidates for early phase clinical trials for new anti-cancer agents. The impact of CHVI on the feasibility and efficacy for patients with HCC in Phase I trials (P-Is) has not been reported or elucidated in Western countries.

Methods

We retrospectively analyzed the characteristics and outcomes of HCC patients participating in P-Is, with emphasis on CHVI. Patients testing positive for anti-hepatitis C virus (HCV) antibody or hepatitis B virus surface antigen (HBsAg) were diagnosed with CHVI.

Results

Eighty-five patients were enrolled in P-Is at our center. There were no significant differences in the clinical and laboratory variables, including the liver function test results, between the 46 (54%) CHVI-positive and 39 (46%) CHVI-negative patients in this study. The median time to treatment failure (TTF) and overall survivals (OS) from enrollment of the P-I were 60 days (95% confidence interval [CI]: 51–85) and 412 days (95% CI: 267–478), respectively. There is no significant difference between positive and negative for hepatitis virus in the best response based on the RECIST. The frequency of abnormal liver function test (LFT) adverse events (grade ≥ 3) was significantly different among CHVI-positive and -negative patients. No patient discontinued P-I treatment secondary to abnormal LFT results or developed reactivation of hepatitis virus, and no treatment-related mortality was observed. Multivariate analysis revealed that the number of prior systemic treatments significantly contributed to poor TTF (≥2; HR: 2.1, 95% CI: 1.3–3.6, P = 0.004) and that poor Eastern Cooperative Oncology Group Performance Status significantly contributed to poor OS (≥1; HR: 1.9, 95% CI: 1.0–3.4, P = 0.04).

Conclusions

CHVI did not independently predict TTF and OS. Abnormal LFT adverse events could be related to CHVI but did not lead to discontinuation of P-I treatment. Thus, patients advanced HCC with CHVI can be enrolled in the P-Is.

Legal entity responsible for the study

N/A

Funding

Has not received any funding

Disclosure

All authors have declared no conflicts of interest.

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