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4.
J Chemother ; 16(4): 392-9, 2004 Aug.
Article in English | MEDLINE | ID: mdl-15332716

ABSTRACT

Docetaxel was proven to be effective as second-line therapy for patients with advanced NSCLC after failure of platinum-based front-line chemotherapy. We designed this phase I/II study to define the Maximum Tolerated Dose of weekly docetaxel combined with weekly vinorelbine, and subsequently evaluate tolerability and activity of this schedule in NSCLC patients who were progressive after treatment with either cisplatin and gemcitabine or carboplatin and paclitaxel regimens. To be eligible for the study, patients were required to have a WHO performance status < or =2, failure after at least two cycles of first platinum-based chemotherapy, and no prior treatment with docetaxel and vinorelbine. A total of 27 patients were enrolled in this phase I/II study. A weekly docetaxel dose of 25 mg/m2 was recommended in combination with fixed vinorelbine dose of 20 mg/m2, and 24 patients were treated at this dose level. Severe neutropenia (62%) and febrile neutropenia (29%) were the most frequent toxicities, with 83% of patients requiring dose modification or delay. In the phase II study, 5 (21%) patients obtained a partial response, 8 (33%) patients had stable disease, whereas 10 (42%) patients progressed. After a median follow-up of 18.7 months, median survival was 8 months, with 30% surviving at 1 year. Regardless of the use of weekly docetaxel schedule, this regimen was highly myelosuppressive, and did not seem to improve response rate and survival compared to single-agent docetaxel. No further developments of this schedule are warranted.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Salvage Therapy , Taxoids/administration & dosage , Vinblastine/analogs & derivatives , Vinblastine/administration & dosage , Adolescent , Adult , Aged , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/pathology , Docetaxel , Dose-Response Relationship, Drug , Drug Administration Schedule , Humans , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Maximum Tolerated Dose , Middle Aged , Neoplasm Staging , Risk Assessment , Survival Analysis , Taxoids/adverse effects , Vinblastine/adverse effects , Vinorelbine
6.
Mol Cell Biochem ; 145(1): 45-51, 1995 Apr 12.
Article in English | MEDLINE | ID: mdl-7659077

ABSTRACT

The aim of this study was to test the effect of vitamins A and E in reducing oxyradical effects and myocardial damage after ischemia-reperfusion in the rabbit heart. Oxyradical effects were indirectly assessed by hydroperoxide initiated chemiluminescence and myocardial damage was evaluated by qualitative and quantitative electron microscopy. Left anterior coronary artery was ligated in control and vitamin-treated rabbits for 30 min and then reperfused for 10 min. Rabbits were pretreated with 150 mg vitamin E and 60,000 IU vitamin A 24 h before surgery. After 10 min of reperfusion full-thickness needle samples were obtained from five different myocardial areas (three ventricular and two septal areas) and used for the determination of hydroperoxide-initiated chemiluminescence and ultrastructural damage. In the control group, hydroperoxide-initiated chemiluminescence was 18,400 +/- 500 cpm/mg protein for the non-ischemic and non-reperfused ventricular areas, and 40,500 +/- 1,800 cpm/mg protein for ischemic-reperfused ventricular areas. In the vitamin-treated group, hydroperoxide-initiated chemiluminescence was decreased by 8% in the non ischemic and non reperfused ventricular areas and by 51-75% in the ventricular ischemic and reperfused areas. The two septal areas in the control group gave chemiluminescences of 6,800 +/- 1,200 cpm/mg protein (non ischemic-non reperfused) and 17,000 +/- 2,000 cpm/mg protein (ischemia-reperfusion). In the vitamin-treated group, chemiluminescence decreased by 4 and 58%, respectively. The ischemia-reperfused areas showed extensive edema, margination of nuclear chromatin and swollen mitochondria with disrupted cristae including rupture of the inner and outer mitochondrial membranes.(ABSTRACT TRUNCATED AT 250 WORDS)


Subject(s)
Antioxidants/pharmacology , Myocardial Reperfusion Injury/prevention & control , Myocardium/metabolism , Reactive Oxygen Species/metabolism , Vitamin A/therapeutic use , Vitamin E/therapeutic use , Animals , Biopsy, Needle , Hydrogen Peroxide/metabolism , Luminescent Measurements , Microscopy, Electron , Mitochondria, Heart/ultrastructure , Mitochondrial Swelling , Myocardial Reperfusion Injury/metabolism , Myocardial Reperfusion Injury/pathology , Myocardium/pathology , Rabbits
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