A phase II study of capecitabine plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer

ArticleinCancer Chemotherapy and Pharmacology 62(5):763-768 · October 2008with11 Reads
DOI: 10.1007/s00280-007-0661-y
Abstract
Purpose: This open-label, multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus gemcitabine combination chemotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Patients and methods: We enrolled 63 patients who received capecitabine 830 mg/m(2) orally twice daily on days 1-21 plus gemcitabine 1000 mg/m(2) as a 30-min infusion on days 1, 8 and 15 every 4 weeks for up to six cycles. Results: A total of 14 patients had partial responses giving an overall response rate of 22% (95% confidence interval [CI] 13-34%) in the intent-to-treat population. The median time to progression and overall survival were 3.9 months (95% CI 3.5-5.7) and 7.5 months (95% CI 5.0-10.0), respectively, and 1-year survival rate was 27.1% in the intent-to-treat population. Capecitabine plus gemcitabine was well tolerated. Grade 3 hematological adverse events were neutropenia (21%) and thrombocytopenia (2%); the only grade 4 hematological events were anemia (2%) and neutropenia (6%). Non-hematological adverse events were mainly gastrointestinal events and hand-foot syndrome, which affected 16% of patients. Grade 3/4 non-hematological events were infrequent. Conclusion: The combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients with advanced/metastatic pancreatic cancer.
    • "RR with the gemcitabine/oxaliplatin, 8.2–17.3% with gemcitabine alone, 12.8% with gemcitabine/CPT-11, 16–23% with gemcitabine/capecitabine, 22% with oxaliplatin/capecitabine , 10% with oxaliplatin and 5-FU, 12.9% with cisplatin/ gemcitabine, 13% with bevacizumab/gemcitabine, 8.6% with erlotinib/gemcitabine, 12.5% with cetuximab/gemcitabine , and 31% with the FOLFORINOX regimen2223242526272829303132. The 10-month median OS is comparable and sometimes superior to those described in the literature. "
    [Show abstract] [Hide abstract] ABSTRACT: This prospective phase II trial aims to evaluate the sequential FOLFOX-6 and gemcitabine followed by adapted maintenance for advanced pancreatic cancer. Treatment included FOLFOX-6 for 4 cycles, followed sequentially by gemcitabine for 3 cycles. Patients, who show clinical benefit after both sequences, will receive maintenance treatment based on the investigator's discretion. From January 2005 to June 2008, 32 patients with median age of 63 were included; 75% of patients had metastatic disease, 81% had pure adenocarcinoma, while 19% had adenocarcinoma with a neuroendocrine component. There were 22% PR and 22% SD resulting in 44% tumor growth control. Under FOLFOX, grade 3/4 toxicities were neutropenia in 8 patients, thrombocytopenia and anemia in 3 patients each, and diarrhea in 2 patients. Under Gem, grade 3/4 neutropenia was observed in 4 patients, thrombocytopenia and anemia were observed in 2 patients, and hand-foot syndrome was observed in 3 patients. The median TTP and OS were 4 and 10 months, respectively. In APC, FOLFOX-6 regimen followed by gemcitabine achieved an interesting RR within a tolerable level of toxicity. This regimen seems to warrant further investigation to confirm its efficacy.
    Full-text · Article · Mar 2012
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    Article · Feb 2009
  • [Show abstract] [Hide abstract] ABSTRACT: Pancreatic cancer is one of the major causes of cancer death. Most patients present with advanced disease and only 10–15% of patients can undergo resection. Survival after curative surgery is poor, as recurrences occur either locally or in the liver. Adjuvant therapy has been employed in large randomized trials to treat systemic disease and hopefully improve the poor prognosis. Chemoradiation, chemotherapy using either 5-fluorouracil/folinic acid (5FU/FA) or gemcitabine and combination therapy have all been used in the adjuvant setting.
    Article · Feb 2009 · Pancreatology
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