Dataset Information

The multicenter, phase II prospective study of paclitaxel plus capecitabine as first-line chemotherapy in advanced gastric carcinoma.

ABSTRACT:

Background

The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first-line treatment in advanced gastric cancer (AGC) was evaluated.

Methods

Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate, overall survival (OS), and safety.

Results

Overall, 194 patients were treated per protocol and one patient was excluded because of allergy to paclitaxel. Response was evaluated in 175 patients, with an objective response rate of 34.8%. After a median follow-up of 33.2 months, disease progression was observed in 141 patients, 137 died, and 16 were lost to follow-up, with progression-free survival of 188 days and OS of 354 days. In multivariate Cox regression analysis, no factor remained an independent predictor of OS. Forty-five patients who received capecitabine monotherapy after PX had longer OS (531 days). Adverse events were mild (Fig. 1), and the most common grade 3-4 toxicities were leucopenia and neutropenia.

Conclusion

PX as a first-line treatment has promising efficacy in AGC. Based on these data, a phase III study has been launched for further investigation.

SUBMITTER: Gong J

PROVIDER: S-EPMC3926790 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Publications

The multicenter, phase II prospective study of paclitaxel plus capecitabine as first-line chemotherapy in advanced gastric carcinoma.

Gong Jifang J Hu Bing B Zhang Xiaotian X Zhang Fengchun F Zhang Jun J Xu Nong N Fan Qingxia Q Bai Yuxian Y Jiao Shunchang S Wang Jinwan J Bai Chunmei C Zheng Leizhen L Shi Yingqiang Y Liu Yunpeng Y Liang Jun J Hu Guoqing G Cheng Ying Y Xu Ruihua R Bai Yu Y Shen Lin L

The oncologist 20140123 2

<h4>Background</h4>The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first-line treatment in advanced gastric cancer (AGC) was evaluated.<h4>Methods</h4>Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate, overall survival ...[more]

PMID: 24457378

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Project description:An exploratory phase II biomarker-embedded trial (LPT109747; NCT00526669) designed to determine the association of lapatinib-induced fluoropyrimidine gene changes with efficacy of lapatinib plus capecitabine as first-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma independent of tumor HER2 status. Tumor biopsies obtained before and after 7-day lapatinib (1,250 mg) to analyze changes in gene expression, followed by a 14-day course of capecitabine (1,000 mg/m(2) twice daily, 14/21 days) plus lapatinib 1,250 mg daily. Blood samples were acquired for pharmacokinetic analysis. Primary clinical objectives were response rate (RR) and 5-month progression-free survival (PFS). Secondary objectives were overall survival (OS), PFS, time to response, duration of response, toxicity, and identification of associations between lapatinib pharmacokinetics and biomarker endpoints. Primary biomarker objectives were modulation of 5-FU-pathway genes by lapatinib, effects of germline SNPs on treatment outcome, and trough steady-state plasma lapatinib concentrations. Sixty-eight patients were enrolled; (75% gastric cancer, 25% gastroesophageal junction). Twelve patients (17.9%) had confirmed partial response, 31 (46.3%) had stable disease, and 16 (23.9%) had progressive disease. Median PFS and OS were 3.3 and 6.3 months, respectively. Frequent adverse events included diarrhea (45%), decreased appetite (39%), nausea (36%), and fatigue (36%). Lapatinib induced no changes in gene expression from baseline and no significant associations were found for SNPs analyzed. Elevated baseline HER3 mRNA expression was associated with a higher RR (33% vs. 0%; P = 0.008). Lapatinib plus capecitabine was well tolerated, demonstrating modest antitumor activity in patients with advanced gastric cancer. The association of elevated HER3 and RR warrants further investigation as an important player for HER-targeted regimens in combination with capecitabine. Mol Cancer Ther; 15(9); 2251-8. ©2016 AACR.

Dataset Information

The multicenter, phase II prospective study of paclitaxel plus capecitabine as first-line chemotherapy in advanced gastric carcinoma.

Background

Methods

Results

Conclusion

Publications

The multicenter, phase II prospective study of paclitaxel plus capecitabine as first-line chemotherapy in advanced gastric carcinoma.

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