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Clinical and pharmacokinetic study of oral NK611, a new podophyllotoxin derivative (1996)

Pagani, O. ; Zucchetti, M. ; Sessa, C. ; [et al.]

Springer

Cancer chemotherapy and pharmacology 38 (1996), S. 541-547

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ISSN: 1432-0843

Keywords: Key words Podophyllotoxin derivative ; Bioavailability ; Pharmacokinetics.

Source: Springer Online Journal Archives 1860-2000

Topics: Medicine

Notes: Abstract NK611 is a novel water-soluble podophyllotoxin derivative that has comparable antitumour activity but higher potency and better bioavailability in animals as compared with etoposide. The primary objectives of this study were to determine, after both oral and intravenous administration in the same patient, the bioavailability and the pharmacokinetic profile of NK611. Secondary objectives involved evaluation of the toxicity and the antitumor activity. Patients were randomly assigned to receive oral or intravenous (30-min infusion) doses of 5, 10, and 20 mg/m2 on day 1, when pharmacokinetic studies were performed. A daily oral dose of 20 mg/m2 was then given from day 4 through day 7 for respective total doses of 85, 90, and 100 mg/m2. NK611 and its metabolites were determined in plasma and urine by two different high-performance liquid chromatography (HPLC) methods with UV detection. A total of 21 adult patients entered the study and received the complete first cycle and at least the 1st day of cycle 2; 17 of them received at least 2 complete cycles of treatment. After intravenous administration, the plasma decay curve of NK611 followed a two-exponential model, and after oral administration it declined monoexponentially in most cases. At all dose levels, bioavailability values were around 100%. At concentrations between 10 and 20 mg/m2 after both routes of administration, the pharmacokinetics were nonlinear; the terminal half-life, plasma clearance, and volume of distribution were significantly different; and the area under the plasma concentration-time curve was not correlated to the dose. The urinary excretion of NK611 corresponded to 10–15% of the dose after administration by both routes, whereas that of N-demethyl NK611 and its picroform was highly variable. The features of neutropenia were comparable with those noted for etoposide involving a high degree of interpatient variability and recovery within 1 month after treatment. A daily dose of 20 mg/m2 for 5 consecutive days every 4 weeks is the recommended regimen for phase II studies in patients who have never been treated or have undergone previous chemotherapy only once.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/s002800050524

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The last 3 months of life of cancer patients: Medical aspects and role of home-care services in southern Switzerland (1996)

Sessa, C. ; Roggero, E. ; Pampallona, S. ; [et al.]

Springer

Supportive care in cancer 4 (1996), S. 180-185

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ISSN: 1433-7339

Keywords: Home-care services ; Cancer center ; Hospital stay ; Place of death

Source: Springer Online Journal Archives 1860-2000

Topics: Medicine

Notes: Abstract The clinical data on terminal cancer patients who have died since the establishment of a program of collaboration between community services and the cancer center of Canton of Ticino, southern Switzerland, were retrospectively analyzed to describe the characteristics of patients seen and the effect on them of a home-care program coordinated by the cancer center. The home-care program is based on five geographically grouped community-based domiciliary services, with the addition of one nurse responsible for coordination and one physician from the oncology center. Selection criteria for participation in the home-care program are defined. The main outcome measures were: number of hospitalizations and median hospital stay during the last 3 months of life; reasons for and median length of last hospitalization; place of death of patients who had home care and those who did not. In the group of 993 patients analyzed, the median contact time with the cancer center was 9.5 months (10th percentile: 1 month, 90th percentile: 71 months); the most frequent neoplasm was lung cancer (22%) with the briefest contact time (7.5 months; 10th percentile: 1 month; 90th percentile: 21 months); 13.5% of patients were never hospitalized; half of the patients had a total hospital stay of 24 days or longer and 23% died at home. The sociodemographic and medical characteristics of home-care users were similar to those of the home-care nonusers and to those of the overall group. In the group of home-care users (32% of the total) 22% were never hospitalized, half of the patients had a total hospital stay of 17 days or longer, and 43.5% of them died at home. These values were significantly different (P〈0.001) from those reported in the group of home-care non-users. Palliative care, provided at home through community-based domiciliary services, is associated with less frequent and shorter hospitalizations in the last 3 months of life. Medical oncology and palliative treatments should be mutually complementary to improve patients care. Cancer centers should be involved in the planning and coordination of supportive-care domiciliary services.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF01682337

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263. Adjuvante portale Chemotherapie bei colorectalen Carcinomen, eine multizenterstudie der schweizerischen arbeitsgemeinschaft für klinische krebsforschung (SAKK) (1987)

Laffer, U. ; Metzger, U. ; Aeberhard, P. ; [et al.]

Springer

Langenbeck's archives of surgery 372 (1987), S. 889-889

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ISSN: 1435-2451

Keywords: Adenocarcinoma of the colon and rectum ; Adjuvant perioperative liver infusion ; Liver metastases ; Colorectales Carcinom ; Adjuvante, perioperative Chemotherapie ; Lebermetastasen

Source: Springer Online Journal Archives 1860-2000

Topics: Medicine

Description / Table of Contents: Zusammenfassung Untersucht wird beim colorectalen Carcinom die Wirkung einer perioperativen portalen Leberperfusion mit 5-Fluorouracil und Mitomycin C. Zur Zeit sind 409 Patienten auswertbar, 202 im Kontroll- und 207 im Behandlungsarm. Die bisherigen Resultate (März 87), bei einer Beobachtungszeit von 35 Monaten, zeigen im Behandlungsarm eine deutlich geringere Tendenz für Lebermetastasen (10,4% vs 6,3%), besonders auch in den Untergruppen (Colon 11,5% vs 6,8% und Dukes' C: 22,2% vs 6,9%). Entsprechend ist auch der Carcinom-Tod seltener (14,4% vs 12,1%; 15,8% vs 8,5% und 25,4% vs 15,5%). Die Beobachtungszeit ist für eine statistische Analyse noch zu kurz.

Notes: Summary The efficacy of adjuvant, perioperative portal liver infusion with 5-fluorouracil and mitomycin C was investigated (409 patients, 202 control subjects, 207 treated). Liver metastases were detected in 10.4% of the untreated vs 6.3% of the treated patients. The median follow-up was 35 months. For the colon subgroups (excluding the rectum) and Dukes' C tumors alone, the corresponding results were as follows: 11.5% vs 6.8% and 22.2% vs 6.9%, respectively. Death from progressive cancer disease occurred in 14.4% vs 12.1% of all patients: 15.8% vs 8.5% (colon) and 25.4% vs 15.5% (Dukes' C), respectively. The follow-up time is too short for statistical analysis, however.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF01298047

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