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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 AND

METHODS:

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.
Subject(s)

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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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