Kunz, Pamela L.;
Nandoskar, Prachi;
Koontz, Michael Zach;
Ji, Hanlee;
Ford, James M.;
Balise, Raymond R.;
Kamaya, Aya;
Rubin, Daniel;
Fisher, George A.
A phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma
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Medientyp:
E-Artikel
Titel:
A phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma
Beteiligte:
Kunz, Pamela L.;
Nandoskar, Prachi;
Koontz, Michael Zach;
Ji, Hanlee;
Ford, James M.;
Balise, Raymond R.;
Kamaya, Aya;
Rubin, Daniel;
Fisher, George A.
Erschienen:
American Society of Clinical Oncology (ASCO), 2014
Beschreibung:
<jats:p> 115 </jats:p><jats:p> Background: Gastroesophageal junction (GEJ) and gastric adenocarcinomas constitute a major health problem worldwide. In the United States, the incidence of adenocarcinoma of the esophagus, GEJ and gastric cardia is rising rapidly. Chemotherapy for metastatic disease improves survival and quality of life when compared to best supportive care. The addition of bevacizumab to chemotherapy in a large, randomized, multinational study showed conflicting results. Methods: Patients (pts) with biopsy proven metastatic or unresectable GEJ and gastric adenocarcinomas received bevacizumab 15 mg/kg IV and carboplatin AUC 6 IV on day 1 and capecitabine 850 mg/m<jats:sup>2</jats:sup>twice daily by mouth on days 1-14 on a 21-day cycle. Pts with stable disease (SD) or partial response (PR) were allowed to continue therapy with bevacizumab with or without capecitabine. Primary endpoints were progression free survival (PFS) and toxicity; secondary endpoints were overall survival (OS) and response rate by RECIST. Results: Between April 2009 and April 2013, a total of 35 pts were enrolled. At present, 29 patients are off treatment and 6 are still actively receiving treatment. 29 pts are available for response assessment, 6 patients came off study prior to their first tumor assessment. Baseline characteristics are: M:F = 25:10; median age = 58 years (range 25-81); primary site = GEJ (17) and gastric (18); degree of differentiation = well (3), moderate (12), poor/signet ring (18), and unknown (2); race = White Non-Hispanic (24), White Hispanic (6), and Asian (5). The 1-year PFS is 21% and median PFS is 8.5 months. Median OS is 14.3 months. Best response by RECIST is as follows: PR in 17 pts (49%), SD in 6 pts (17%), and progressive disease (PD) in 6 pts (17%). The treatment was well-tolerated with toxicities as expected. Conclusions: The combination of capecitabine, carboplatin and bevacizumab in metastatic or unresectable unresectable GEJ and gastric adenocarcinomas is well tolerated and shows promising response rates, though did not meet the primary endpoint of PFS. Clinical trial information: NCT00780494. </jats:p>