Randomized phase III trial of capecitabine/cisplatin (XP) vs. continuous infusion of 5-FU/cisplatin (FP) as first-line therapy in patients (pts) with advanced gastric cancer (AGC): Efficacy and safety results

Autor:	D. B. Shin, J. Santamaria, T. Suarez, J. Xiong, J. Chen, Mikhail Lichinitser, Yoon-Koo Kang, M. Philco, J. Wang, W. K. Kang
Rok vydání:	2006
Předmět:	Cisplatin Oncology Cancer Research medicine.medical_specialty Continuous infusion business.industry Advanced gastric cancer medicine.disease Surgery Capecitabine First line therapy Breast cancer Internal medicine medicine In patient business medicine.drug
Zdroj:	Journal of Clinical Oncology. 24:LBA4018-LBA4018
ISSN:	1527-7755 0732-183X
Popis:	LBA4018 Background: The oral fluoropyrimidine capecitabine has proven efficacy and safety in colorectal and breast cancer. Phase II data in AGC suggested that XP would show comparable efficacy to a standard FP regimen, with potential safety and convenience advantages. This phase III study evaluated XP vs. FP in first-line AGC. Methods: Pts with previously untreated measurable AGC received either oral capecitabine (1000mg/m2 bid d1–14) + cisplatin (80mg/m2 i.v. d1) q3w (XP arm) or 5-FU (800mg/m2/d continuous infusion, d1–5) + cisplatin (80mg/m2 i.v. d1) q3w (FP arm). XP requires 1 day per 3 weeks in hospital; FP requires 5 days. Pts were treated until disease progression or unacceptable toxicity. Primary endpoint: non-inferiority (NI) in progression-free survival (PFS), defined as upper limit of 95% CI of hazard ratio (HR) No significant financial relationships to disclose. [Table: see text]
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::04432557c020afa4b81a3d4ca3226556 https://doi.org/10.1200/jco.2006.24.18_suppl.lba4018 Zobrazit plný text záznamu