Efficacy and safety of capecitabine as maintenance therapy after capecitabine-based combination chemotherapy for patients with advanced esophagogastric junction adenocarcinoma.
OBJECTIVE
The aim of the present study was to investigate the efficacy and safety of single-agent capecitabine therapy after capecitabine-based combination chemotherapy for patients with advanced adenocarcinoma of the esophagogastric junction (EGJ).


METHODS
Seventy-two patients with pathologically proven advanced EGJ adenocarcinoma underwent 2-6 cycles of capecitabine-based first-line combination chemotherapy between January 2010 and October 2014. When initial disease control had been achieved, 60 patients were randomly assigned to receive the capecitabine treatment (oral capecitabine 1,250 mg/m2 twice daily on days 1-14 every 3 weeks) to see whether it is involved in maintenance regimen or not, while 12 patients were excluded. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and major adverse events were monitored.


RESULTS
The median PFS was 11.0 months (95% confidence interval [CI], 0-23.2 months) and OS was 17.0 months (95% CI, 2.1-31.9 months) for the maintenance group. In contrast, median PFS was 7.0 months (95% CI, 5.8-8.2 months) and OS was 11.0 months (95% CI, 2.07-31.9 months) for the control group. Compared to controls, patients who received capecitabine maintenance therapy showed significantly prolonged PFS and OS. The capecitabine-related adverse events included leukopenia, anemia, and thrombocytopenia, hand-foot syndrome, nausea/vomiting, neuropathy, and liver dysfunction. Treatment-related adverse events were tolerable, and there were no significant differences in the prevalence of adverse events between patients who received maintenance therapy and controls.


CONCLUSIONS
Our finding shows that single-agent capecitabine maintenance therapy was effective, well-tolerated and safe after first-line capecitabine-based combination chemotherapy in patients with advanced EGJ adenocarcinoma.
Department of Oncology, Yangzhong People's Hospital, Jiangsu Province, China. yzrylubin@163.com.
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B
Lu
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LB
Bao
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Z
Sun
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ZL
Hua
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X
Wang
C-P
CP
Qu
D000230:Adenocarcinoma / Q000175:diagnosis* / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000069287:Capecitabine / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000175:diagnosis* / Q000188:drug therapy*; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D000069287:Capecitabine