3501 ORAL Capecitabine/cisplatin vs. continuous infusion of 5-FU/cisplatin as first-line therapy in patients (pts) with advanced gastric cancer (AGC): a randomised phase III trial

Kang, Yang; Kang, Wan-Yi; Shin, Dong Yeop; Chen, J.; Xiong, JP; Wang, J.; Lichinitser, Mikhail; Philco, M.; Suarez, T.; Santamarı́a, Javier Gutiérrez

doi:10.1016/s1359-6349(07)71004-2

Cited by 21 publications

(26 citation statements)

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“…Despite new schedules and association of drugs, patients with advanced gastric cancer treated with first-line chemotherapy have median OS rarely approaching 11 months (Catalano et al, 2005;Dank et al, 2005;Al-Batran et al, 2006;Kang et al 2006;Van Cutsem et al, 2006;Cunningham et al, 2008). No significant steps ahead have been moved since the past decade.…”

Section: Discussionmentioning

confidence: 99%

“…Several chemotherapy agents are considered active in advanced gastric cancer. Over the past decades, many anticancer drugs have been investigated, such as 5-fluorouracil (5-FU), cisplatin, anthracyclines, oral fluoropyrimidines, irinotecan, oxaliplatin, and docetaxel (Catalano et al, 2005;Dank et al, 2005;Al-Batran et al, 2006;Kang et al, 2006;Van Cutsem et al, 2006;Cunningham et al, 2008). Combination chemotherapy regimens have been developed in the hopes of improving response rate and overall survival (OS).…”

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confidence: 99%

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Second-line chemotherapy for patients with advanced gastric cancer: who may benefit?

et al. 2008

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No established second-line chemotherapy is available for patients with advanced gastric cancer failing to respond or progressing to first-line chemotherapy. However, 20 -40% of these patients commonly receive second-line chemotherapy. We evaluated the influence of clinico-pathologic factors on the survival of 175 advanced gastric cancer patients, who received second-line chemotherapy at three oncology departments. Univariate and multivariate analyses found five factors which were independently associated with poor overall survival: performance status 2 (hazard ratio (HR), 1.79; 95% CI, 1.16 -2.77; P ¼ 0.008), haemoglobin p11.5 g l À1 (HR, 1.48; 95% CI, 1.06 -2.05; P ¼ 0.019), CEA level 450 ng ml À1 (HR, 1.86; 95% CI, 1.21 -2.88; P ¼ 0.004), the presence of greater than or equal to three metastatic sites of disease (HR, 1.72; 95% CI, 1.16 -2.53; P ¼ 0.006), and time-toprogression under first-line chemotherapy p6 months (HR, 1.97; 95% CI, 1.39 -2.80; Po0.0001). A prognostic index was constructed dividing patients into low-(no risk factor), intermediate-(one to two risk factors), or high-(three to five risk factors) risk groups, and median survival times for each group were 12.7 months, 7.1 months, and 3.3 months, respectively (Po0.001). In the absence of data deriving from randomised trials, this analysis suggests that some easily available clinical factors may help to select patients with advanced gastric cancer who could derive more benefit from second-line chemotherapy.

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Section: Discussionmentioning

confidence: 99%

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Second-line chemotherapy for patients with advanced gastric cancer: who may benefit?

et al. 2008

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“…In comparison with capecitabine plus cisplatin (XP) or 5-FU plus cisplatin (FP) combination reported in a recent phase III trial (Kang et al, 2006), this TX regimen was comparable in terms of RR (48.9 vs 46/32%), TTP (5.6 months vs 5.6/5.0 months), and OS (11.3 months vs 10.5/9.3 months), and even better in terms of risk of severe nausea/vomiting (0 vs 6/8%). Similarly, in comparison to ECF of REAL-2 trial (Cunningham et al, 2006), in addition to comparable efficacy, this TX regimen seems to be very safe, especially in terms of infection risk.…”

Section: Discussionmentioning

confidence: 99%

A phase II study of paclitaxel and capecitabine as a first-line combination chemotherapy for advanced gastric cancer

Chang

et al. 2008

Br J Cancer

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Paclitaxel and capecitabine, which have distinct mechanisms of action and toxicity profiles, have each shown high activity as single agents in gastric cancer. Synergistic interaction between these two drugs was suggested by taxane-induced upregulation of thymidine phosphorylase. We, therefore, evaluated the antitumour activity and toxicities of paclitaxel and capecitabine as first-line therapy in patients with advanced gastric cancer (AGC). Patients with histologically confirmed unresectable or metastatic AGC were treated with capecitabine 825 mg m À2 p.o. twice daily on days 1 -14 and paclitaxel 175 mg m À2 i.v. on day 1 every 3 weeks until disease progression or unacceptable toxicities. Between June 2002 and May 2004, 45 patients, of median age 57 years (range ¼ 38 -73 years), were treated with the combination of capecitabine and paclitaxel. After a median 6 cycles (range ¼ 1 -9 cycles) of chemotherapy, 43 were evaluable for toxicity and response. A total of 2 patients showed complete response and 20 showed partial response making the overall response rate 48.9% (95% CI ¼ 30.3 -63.5%). After a median follow-up of 42.2 months (range ¼ 31.2 -54.3 months), median time to progression was 5.6 months (95% CI ¼ 3.9 -7.2 months) and median overall survival was 11.3 months (95% CI ¼ 8.1 -14.4 months). Grade 3 or 4 adverse events include neutropaenia (46.5% of patients), hand -foot syndrome (9.3%), arthralgia (9.3%), and asthenia (4.7%). There was no neutropaenic fever or treatment-related deaths. Paclitaxel and capecitabine combination chemotherapy was active and highly tolerable as a first-line therapy for AGC.

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“…More recently, two randomised phase III trials in patients with AGC have been completed. The first multinational study showed that capecitabine/cisplatin was noninferior to 5-FU/ cisplatin in terms of progression-free survival (Kang et al, 2006). The second trial (REAL 2), which was performed in the UK and Australia, demonstrated that capecitabine can replace 5-FU and oxaliplatin can replace cisplatin in triple combinations used for the treatment of advanced esophagogastric cancer .…”

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A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

et al. 2008

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This randomised multicentre phase II study was conducted to investigate the activity and safety of two oral fluoropyrimidines, capecitabine or S-1, in elderly patients with advanced gastric cancer (AGC). Elderly (X65 years) chemo-naive patients with AGC were randomly assigned to receive capecitabine 1250 mg m À2 two times daily on days 1 -14 every 3 weeks or S-1 40 -60 mg two times daily according to body surface area on days 1 -28 every 6 weeks. Ninety-six patients were enrolled and 91 patients were randomised to capecitabine (N ¼ 46) or S-1 (N ¼ 45). Overall response rate, the primary end point, was 27.2% (95% CI, 14.1 -40.4, 12 of 44 assessable patients) with capecitabine and 28.9% (95% CI, 15.6 -42.1, 13 of 45) with S-1. Median times to progression and overall survival in the capecitabine arm (4.7 and 9.5 months, respectively) were similar to those in the S-1 arm (4.2 and 8.2 months, respectively). The incidence of grade 3 -4 granulocytopenia was 6.8% with capecitabine and 4.8% with S-1. Grade 3 -4 nonhaematologic toxicities were: asthenia (9.1% with capecitabine vs 7.1% with S-1), anorexia (6.8 vs 9.5%), diarrhoea (2.3 vs 0%), and hand -foot syndrome (6.8 vs 0%). Both capecitabine and S-1 monotherapies were active and tolerable as first-line treatment for elderly patients with AGC.

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3501 ORAL Capecitabine/cisplatin vs. continuous infusion of 5-FU/cisplatin as first-line therapy in patients (pts) with advanced gastric cancer (AGC): a randomised phase III trial

Cited by 21 publications

References 0 publications

Second-line chemotherapy for patients with advanced gastric cancer: who may benefit?

Second-line chemotherapy for patients with advanced gastric cancer: who may benefit?

A phase II study of paclitaxel and capecitabine as a first-line combination chemotherapy for advanced gastric cancer

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

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