Royal Marsden, London & Surrey, United Kingdom
Ian Chau , Markus Peck-Radosavljevic , Christophe Borg , Peter Malfertheiner , Jean Francois Seitz , Joon Oh Park , Baek-Yeol Ryoo , Chia-Jui Yen , Masatoshi Kudo , Ronnie Tung-Ping Poon , Davide Pastorelli , Jean-Frédéric Blanc , Hyun Cheol Chung , Ari David Baron , Takuji Okusaka , Zhanglin Lin Cui , Allicia C. Girvan , Paolo Abada , Ling Yang , Andrew X. Zhu
Background: REACH did not demonstrate a significant improvement in overall survival (OS) in the ITT population, but pts in the RAM group with an elevated baseline alpha-fetoprotein (AFP) ≥400ng/mL (pre-specified) had meaningful improvement in OS (HR 0.67, p < 0.05). Here we present PFOs (pt-reported FACT Hepatobiliary Symptom Indexes [FHSI-8] and clinician-reported Eastern Cooperative Oncology Group [ECOG] performance status [PS]) from the REACH study. Methods: Eligible pts had advanced HCC; Child-Pugh A; ECOG PS 0 or 1; and prior sorafenib. Pts were randomized 1:1 to receive RAM (8 mg/kg) or placebo (PBO) on day 1 of an every 2 week cycle. The FHSI-8 was completed at baseline, cycles 4, 10, 16, and end of treatment. PS was assessed at baseline, each cycle, and end of treatment. Time to deterioration (TtD) in FHSI-8 was defined as the time from the randomization date to the first date with a ≥3-point decrease (based on 32-point scale) from baseline. TtD in PS was defined as the time from the randomization date to the first date a change to PS ≥2 was observed. Kaplan-Meier method and Cox regression were used to assess TtD. Results: Compliance with FHSI-8 was balanced between treatment arms. In the ITT population, TtD in FHSI-8 and PS were similar between RAM and PBO. In the elevated AFP population, there was a strong trend toward a delay in the deterioration of symptoms in FHSI-8 (p = 0.054) and PS (p = 0.057) for RAM treated pts compared to PBO. Conclusions: In the ITT population, symptom score and TtD were comparable between treatment arms; RAM did not result in the detriment in symptoms or pt functioning. Delay in symptom and PS deterioration coupled with survival benefit was observed in pts treated with RAM in the elevated AFP population. Clinical trial information: NCT01140347
ITT | AFP ≥400 ng/ml | |||
---|---|---|---|---|
RAM | PBO | RAM | PBO | |
FHSI-8 Compliance Baseline, % | 96.5 | 94.7 | 99.2 | 94.7 |
FHSI-8 Compliance End of Treatment, % | 62.1 | 72.5 | 67.2 | 76.6 |
FHSI-8 Score Change from Baseline, mean | -2.44 | -2.86 | -2.21 | -3.73 |
TtD FHSI-8, mo | ||||
HR (95% CI) | 1.04 (0.80-1.34) | 0.69 (0.47-1.01) | ||
P value | 0.78 | 0.054 | ||
TtD ECOG PS ≥2, mo | ||||
HR (95%CI) | 0.89 (0.65-1.22) | 0.64 (0.41-1.02) | ||
P value | 0.47 | 0.057 |
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