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Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment ; : 687-696, 2015.
Article in English | WPRIM | ID: wpr-74295
ABSTRACT

PURPOSE:

This phase I trial evaluated the question of whether the standard starting dose of axitinib could be administered in combination with therapeutic doses of cisplatin/capecitabine in patients with previously untreated advanced gastric cancer, and assessed overall safety, pharmacokinetics, and preliminary antitumor activity of this combination. MATERIALS AND

METHODS:

Patients in dose level (DL) 1 received axitinib 5 mg twice a day (days 1 to 21) with cisplatin 80 mg/m2 (day 1) and capecitabine 1,000 mg/m2 twice a day (days 1 to 14) in 21-day cycles. Maximum tolerated dose (MTD) was the highest dose at which 5 consecutive days of missed axitinib due to thrombocytopenia. DL1 was established as the MTD, since higher DL cohorts were not planned. Common grade 3/4 non-hematologic adverse events in 22 patients treated at DL1 included hypertension (36.4%) and decreased appetite and stomatitis (18.2% each). Cisplatin/capecitabine slightly increased axitinib exposure; axitinib decreased capecitabine and 5-fluorouracil exposure. Eight patients (36.4%) each had partial response or stable disease. Median response duration was 9.1 months; median progression-free survival was 3.8 months.

CONCLUSION:

In patients with advanced gastric cancer, standard doses of axitinib plus therapeutic doses of cisplatin and capecitabine could be administered in combination. Adverse events were manageable.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Appetite / Stomach Neoplasms / Stomatitis / Thrombocytopenia / Pharmacokinetics / Cohort Studies / Cisplatin / Aortic Aneurysm, Abdominal / Disease-Free Survival / Maximum Tolerated Dose Type of study: Etiology study / Incidence study / Observational study / Risk factors Limits: Humans Language: English Journal: Cancer Research and Treatment Year: 2015 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Appetite / Stomach Neoplasms / Stomatitis / Thrombocytopenia / Pharmacokinetics / Cohort Studies / Cisplatin / Aortic Aneurysm, Abdominal / Disease-Free Survival / Maximum Tolerated Dose Type of study: Etiology study / Incidence study / Observational study / Risk factors Limits: Humans Language: English Journal: Cancer Research and Treatment Year: 2015 Type: Article