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
Dans Anglais
| 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 ANDMETHODS:
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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Appétit
/
Tumeurs de l'estomac
/
Stomatite
/
Thrombopénie
/
Pharmacocinétique
/
Études de cohortes
/
Cisplatine
/
Anévrysme de l'aorte abdominale
/
Survie sans rechute
/
Dose maximale tolérée
Type d'étude:
Etude d'étiologie
/
Etude d'incidence
/
Étude observationnelle
/
Facteurs de risque
Limites du sujet:
Humains
langue:
Anglais
Texte intégral:
Cancer Research and Treatment
Année:
2015
Type:
Article
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