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( Thomas Yau ),( Tim Meyer ),( Ignacio Melero ),( Chiun Hsu ),( Masa-toshi Kudo ),( Su-pin Choo ),( Jorg Trojan ),( Theodore H. Welling ),( Yoon-koo Kang ),( Winnie Yeo ),( Akhil Chopra ),( Adyb Baaki 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Nivolumab (NIVO) is a fully human anti-PD-1 IgG4 mAb that demonstrated durable responses, manageable safety, and long-term survival in pts with advanced HCC (aHCC) in CheckMate-040 (El-Khoueiry AB et al. Lancet 2017). Here we present updated hepatic safety and biomarker analyses in sorafenib-experienced (sor-exp) pts in CheckMate-040. Methods: Sor-exp pts with or without chronic viral hepatitis received NIVO 3 mg/kg Q2W. Primary endpoint was objective response rate (ORR) reported by blinded independent central review using RECIST v1.1. Secondary endpoints included overall survival (OS), disease control rate (DCR), and safety. Exploratory analyses of on-treatment HCV and HBV viral kinetics and alpha-fetoprotein (AFP) levels were performed. Results: Median duration of follow-up was 14.9 mo. Baseline Child-Pugh scores of 5 or 6 and extrahepatic metastases were observed in 99% and 71% of pts, respectively. The ORR with NIVO was 14%; the DCR was 56%; median OS was 15.6 mo. Any-grade and grade 3-4 hepatic treatment-related AEs (TRAEs) occurred in 12 (8%) and 5 (3%) pts, respectively; 100% of grade 3-4 hepatic TRAEs resolved. Frequencies of grade 3-4 treatment-related ALT/AST elevations were 2%-3%. No drug-related deaths due to hepatic AEs occurred, and no new safety signals were observed. AFP levels at baseline were not associated with response; however, AFP levels in responders appeared to decrease on treatment. Updated data will be presented. Conclusions: NIVO demonstrated long-term survival and objective responses across etiologies and manageable overall and hepatic safety profile in aHCC. Responses occurred irrespective of baseline AFP levels, and AFP declines were associated with response.
Chiu, Joanne,Tang, Vikki,Leung, Roland,Wong, Hilda,Chu, Kin Wah,Poon, Jensen,Epstein, Richard J.,Yau, Thomas Asian Pacific Journal of Cancer Prevention 2013 Asian Pacific journal of cancer prevention Vol.14 No.11
Background: Although FOLFOX (infusional fluorouracil/leucovorin plus oxaliplatin) is established as a standard chemotherapeutic regimen, the long term efficacy of adjuvant XELOX (oral capecitabine plus intravenous oxaliplatin) in Asian colorectal cancer (CRC) patients remains anecdotal. Moreover, uncertainties persist as to whether pharmacogenetic differences in Asian populations preclude equally tolerable and effective administration of these drugs. Method: One hundred consecutive patients with resected colorectal cancer received adjuvant XELOX (oxaliplatin 130 $mg/m^2$ on day 1 plus capecitabine 900 $mg/m^2$ twice daily on day 1 to 14 every 3 weeks for 8 cycles) at Queen Mary Hospital, Hong Kong. Endpoints monitored during follow-up were disease-free survival (DFS) and disease recurrence, overall survival (OS) and adverse events (AEs). Results: The median patient age was 56 years, 56% were diagnosed with rectal cancer and 44% with colonic cancer. After a median follow-up of 4.3 years (95% confidence interval, 3.2-4.7), 24 recurrences were confirmed including 13 patients who died due to progressive disease. Four-year DFS was 81% in colon cancer patients and 67% in rectal cancer patients (p=0.06 by log-rank test). For the cohort as a whole, OS was 90% at 3 years and 84% at 5 years. Treatment-related AEs led to early withdrawal in four patients. The commonest non-hematological AEs were neuropathy (91%), hand-foot syndrome (49%) and diarrhea (46%), while the commonest grade 3/4 AEs were neutropenia (11%) and diarrhea (10%). Conclusion: These results confirm the favourable long term survival benefit with good tolerability in using adjuvant XELOX in treating East Asian colorectal cancer patients.