Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
;
: 1324-1330, 2018.
Article
in English
| WPRIM
| ID: wpr-717520
ABSTRACT
PURPOSE:
Although gemcitabine plus cisplatin has been established as the standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC), overall prognosis remains poor. We investigated the efficacy of a novel triplet combination of oxaliplatin, irinotecan, and S-1 (OIS) for advanced BTC. MATERIALS ANDMETHODS:
Chemotherapy-naive patientswith histologically documented unresectable or metastatic BTC were eligible for this multicenter, single-arm phase II study. Patients received 65 mg/m2 oxaliplatin (day 1), 135 mg/m2 irinotecan (day 1), and 40 mg/m2 S-1 (twice a day, days 1-7) every 2 weeks. Primary endpoint was objective response rate. Targeted exome sequencing for biomarker analysis was performed using archival tissue.RESULTS:
In total, 32 patients were enrolled between October 2015 and June 2016. Median age was 64 years (range, 40 to 76 years), with 24 (75%) male patients; 97% patients had metastatic or recurrent disease. Response rate was 50%, and median progression-free survival and overall survival (OS) were 6.8 months (95% confidence interval [CI], 4.8 to 8.8) and 12.5 months (95% CI, 7.0 to 18.0), respectively. The most common grade 3-4 adverse events were neutropenia (32%), diarrhea (6%), and peripheral neuropathy (6%). TP53 and KRAS mutations were the most frequent genomic alterations (42% and 32%, respectively), and KRAS mutations showed a marginal relationship with worse OS (p=0.07).CONCLUSION:
OIS combination chemotherapy was feasible and associated with favorable efficacy outcomes as a first-line treatment in patients with advanced BTC. Randomized studies are needed to compare OIS with gemcitabine plus cisplatin.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Prognosis
/
Triplets
/
Biliary Tract
/
Biliary Tract Neoplasms
/
Cisplatin
/
Cholangiocarcinoma
/
Peripheral Nervous System Diseases
/
Disease-Free Survival
/
Diarrhea
/
Drug Therapy
Type of study:
Controlled clinical trial
/
Prognostic study
Limits:
Humans
/
Male
Language:
English
Journal:
Cancer Research and Treatment
Year:
2018
Type:
Article
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