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

Cancer Chemotherapy and Pharmacology (Impact Factor: 2.77). 09/2008; 62(5):763-768. DOI: 10.1007/s00280-007-0661-y


PurposeThis 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 methodsWe enrolled 63 patients who received capecitabine 830mg/m2 orally twice daily on days 1–21 plus gemcitabine 1000mg/m2 as a 30-min infusion on days 1, 8 and 15 every 4weeks for up to six cycles.

ResultsA 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 3.9months (95% CI 3.5–5.7) and
7.5months (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.

ConclusionThe combination of capecitabine plus gemcitabine appears to be active and well tolerated as first-line treatment in patients
with advanced/metastatic pancreatic cancer.

9 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Pancreatic cancer is the fourth leading cause of cancer death in the United States. In 2008, an estimated 34,290 people died from pancreatic cancer and 37,680 new cases were diagnosed. Despite modern treatment, 90% of patients die within 1 year of diagnosis. Pancreatectomy is still the only potentially curative approach, but most patients have incurable disease by the time they are diagnosed, and fewer than 20% are candidates for surgery. In the present paper the English-language literature addressing the medical management in pancreatic cancer was reviewed. Based on these data we will discuss the role of currently used chemotherapy and target therapy in pancreatic cancer, as well as perspectives of the emerging strategies that are arising in order to improve the outcomes of this complex disease.
    No preview · Article · Feb 2009 · Pancreatology
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: On the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile. Seventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m(2), i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m(2) b.i.d., days 1-14 every 21 days. Overall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3-4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand-foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred. Combination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancer patients.
    Full-text · Article · Nov 2009 · Annals of Oncology
  • [Show abstract] [Hide abstract]
    ABSTRACT: The structural and electronic properties of ellagic acid (EA), its derivatives and metabolites are investigated at the density functional level. Analysis shows that the compounds display estrogenic activity due to the type and number of biophores in their molecular structures. This study explores bond dissociation enthalpy, adiabatic ionization potential, proton dissociation enthalpy, proton affinity, and electron transfer enthalpy in order to understand the antioxidant properties of EA. From the thermodynamic point of view, the transfer mechanism of the hydrogen atom is the most important in free radical scavenging progress. A comparison of BDE values for different types of antioxidants shows that EA and its derivatives can be classified as potent natural antioxidants.
    No preview · Article · Jan 2011
Show more