Gemcitabine versus FLEC regimen given intra-arterially to patients with unresectable pancreatic cancer: a prospective, randomized phase III trial of the Italian Society for Integrated Locoregional Therapy in Oncology.

Gemcitabine is considered the gold standard treatment for unresectable pancreatic adenocarcinoma. Intra-arterial drug administration had shown some interesting results in small phase II studies. In this study, patients were randomly assigned to receive gemcitabine at a dose of 1,000 mg/m2 over 30 minutes intravenously weekly for 7 weeks, followed by 1 week of rest, then weekly for 3 weeks every 4 weeks or FLEC: 5-fluoruracil 1,000 mg/m2, leucovorin 100 mg/m2, epirubicin 60 mg/m2, carboplatin 300 mg/m2 infused bolus intra-arterially into celiac axis at a 3-week interval 3 times or 5-fluorouracil 400 mg/m2 plus folinic acid 20 mg/m2 for 5 days every 4 weeks for 6 cycles. The primary endpoint was overall survival, while time to treatment failure, response rate, clinical benefit response were secondary endpoints. Sixty-seven patients were randomly allocated gemcitabine and 71 were allocated FLEC intra-arterially. Patients treated with FLEC lived for significantly longer than patients on gemcitabine (p=0.036). Survival at 1 year increased from 21% in the gemcitabine group to 35% in the FLEC group. Median survival was 7.9 months in the FLEC group and 5.8 months in the gemcitabine group. Median time to treatment failure was longer with FLEC (5.3 vs 4.2 months for FLEC vs gemcitabine respectively; p=0.013). Clinical benefit was similar in both groups (17.9% for gemcitabine and 26.7% for FLEC; p=NS). CT-scan partial response was similar in both groups (5.9% for gemcitabine and 14% for FLEC; p=NS). Toxicity profiles were different. Compared with gemcitabine, the FLEC regimen given intra-arterially improved survival in patients with unresectable pancreatic adenocarcinoma.

Randomised trial of gemcitabine versus flec regimen given intra-arterially for patients with unresectable pancreatic cancer.

Gemcitabine is considered the golden standard treatment for unresectable pancreatic adenocarcinoma. Intra-arte-rial drug administration had shown a deep rationale with some interesting results. In a multicenter phase III trial, we compared gemcitabine given weekly with a combination of 5-fluoruracil, leucovorin, epirubicin, carboplatin (FLEC) administered intra-arteriously as first-line therapy in unresectable pancreatic adenocarcinoma. Patients were randomly assigned to receive gemcitabine at a dose of 1,000 mg/m2 over 30 minutes intravenously weekly for 7 weeks, followed by 1 week of rest, then weekly for 3 weeks every 4 weeks or 5-fluoruracil 1,000 mg/m2, leucovorin 100 mg/m2, epirubicin 60 mg/m2, carboplatin 300 mg/m2 infused bolus intra-arteriously at three-weekly interval for 3 times. The primary end point was overall survival, while time to treatment failure, response rate, clinical benefit response were secondary endpoints. Sixty-seven patients were randomly allocated gemcitabine and 71 were allocated FLEC intra-arterially. Patients treated with FLEC lived for significantly longer than patients on gemcitabine (p=.036). Survival at 1 year was increased from 21% in the gemcitabine group to 35% in the FLEC group. Median survival was 7.9 months in the FLEC group and 5.8 months in the gemcitabine group. Median time to treatment failure was longer with FLEC (5.3 vs 4.2 months for FLEC vs gemcitabine respectively; p=.013). Clinical benefit was similar in both groups (17.9% for gemcitabine and 26.7% for FLEC; p=NS). CT-scan partial response was similar in both group (5.9% for gemcitabine and 14% for FLEC; p=NS). Toxicity profiles were different. Compared with gemcitabine, FLEC regimen given intra-arteriously, improved survival in patient with unresectable pancreatic adenocarcinoma.

[Prevalence of glycopeptide resistant enterococci in hospitalized patients and in the community in Calabria (Italy)]. / Prevalenza di portatori ospedalieri e comunitari di enterococchi resistenti ai glicopeptidi.

The study evaluated prevalence of glycopeptide (vancomycin and teicoplanin) resistant enterococci (VRE) in hospitalized patients and in the community in Calabria (Italy). Rectal swabs were collected from hospitalized and community subjects. Information was gathered on demographics, ward and duration of hospital stay and antibiotics administered; in community subjects information on previous hospitalizations and antibiotics use in the previous year were also collected. Rectal swabs were plated on Enterococcosel agar alone and with addition of vancomycin (6 mg/l) and incubated aerobically at 37 degrees for 24-48 hours. Typical colonies were tested for Gram stain and catalase production. Enterococci were identified to the species level by biochemical tests. Antimicrobial susceptibility test and E-test were performed by the disk diffusion method to evaluate vancomycin and teicoplanin susceptibility. t-test and chi square test were performed to evaluate difference in means and proportions, respectively. Samples were collected from 211 subjects; 132 (62.6%) from community and 79 (37.4%) from hospitals. Enterococci were isolated from 145 subjects (68.7%), 72.7% and 62% in community and in hospital, respectively. The most frequent isolates were E. faecium (30.4%), followed by E. faecalis and E. durans (25.5%), and, finally, by Leuconostoc (18.6%). Only one E. faecium strain was resistant to both vancomycin and teicoplanin, isolated from a non-hospitalized 45 years old woman (1.3%). The results did not show emergence of VRE in our area, although surveillance to confirm these findings is needed, considering the substantial spread of antibiotics in hospitals and in the community.

Intra-arterial chemotherapy for unresectable pancreatic cancer.

BACKGROUND: A phase II trial of a new intra-arterial chemotherapy regimen for unresectable pancreatic cancer (UPC). PATIENTS AND METHODS: Ninety-six patients with UPC were treated with intra-arterial chemotherapy at three-weekly intervals. The schedule used was FLEC: 5-fluorouracil 1000 mg/m2, folinic acid 100 mg/m2, carboplatin 300 mg/m2; epirubicin 60 mg/m2. RESULTS: The overall response rates by CT-scan evaluation were: 15% partial response (PR), 44% stable disease (SD), 17% progressive disease (PD). The overall median survival was 9.9 months, and 10.6 and 6.8 for UICC stage III and IV, respectively. Pain reduction occurred in 42% of patients. A weight gain > 7% from baseline occurred in 8% of patients. A total of 341 courses of FLEC were administered. Grade 3-4 hematological toxicity was seen in 25% of patients; ematemesis in 4%; grade 3 gastrointestinal toxicity in 3%; and grade 3 alopecia in 16%. One sudden death, a pre-infarction angina, and a transitory ischemic attack were observed. The only complication related to the angiographic procedure was an intimal dissection of the iliac artery. CONCLUSIONS: The intra-arterial FLEC regimen was well tolerated and active. It requires only one day of hospitalization. Efficacy could only be assessed in a randomized study against a gemcitabine containing regimen.

[Seroprevalence of HIV-1 virus in Zaire. Analysis of 1404 subjects]. / Séroprévalence du VIH1 au Zaïre. Analyse chez 1,404 sujets.

Between January and December 1989, 1,404 subjects (mean age 26 years) admitted or seen at the out-patient clinic of the hospital of Goma, Northern Kivu, were investigated for anti-HIV 1 antibodies by the ELISA and Western blot techniques. Seventy-eight out of 808 men (10 percent) and 127 out of 596 women (21 percent) were seropositive. Anti-HIV1 antibodies were found in 14/631 blood donors (2 percent), 25/241 in-patients awaiting blood transfusion (10 percent), 3/42 women hospitalized for complications of pregnancy (7 percent), 130/388 subjects with signs and/or symptoms of HIV1 infection (33 percent) and 33/102 patients with tuberculosis (32 percent). The difference in seropositivity between men and women was statistically significant. A significantly high seroprevalence was found in men who were having regular sexual intercourse with prostitutes (42/167 = 25 percent, P less than 0.01) and in subjects with a history of sexually transmitted disease during the last 5 years (64/180 = 36 percent, P less than 0.01), compared with subjects who had none of these risk factors. The installation of a blood bank where blood products are controlled has contributed to the reduction of HIV1 transmission throughout the town. The foundation of an association of unpaid voluntary blood donors recruited among secondary school students has been another educative measure in the anti-AIDS national plan.