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  • 1
    ISSN: 1432-0843
    Keywords: Key words Docetaxel ; Solid tumors
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of weekly administration of docetaxel for three consecutive weeks every 4 weeks in patients with advanced solid tumors. Patients and methods: A total of 26 patients with malignant tumors refractory to conventional treatment were enrolled in this phase I study; their median age was 62 years. Of the 26 patients, 16 (62%) had previously received more than one chemotherapy regimen and 17 (65%) had previously received taxanes in a 3-week schedule. Docetaxel was administered after appropriate premedication at escalating doses (starting dose 30 mg/m2) as a 1-h i.v. infusion for three consecutive weeks in cycles of 4 weeks. Results: A total of 68 chemotherapy cycles were administered with a median of three cycles per patient (range one to six). The DLT was reached at 45 mg/m2 per week and the dose-limiting events were grade 4 neutropenia, febrile neutropenia, and treatment delay due to incomplete hematologic recovery. The MTD was defined at a dose of 42 mg/m2/week. Grade 3/4 neutropenia occurred in seven patients (27%) (10% of cycles), and four patients (15%) developed febrile neutropenia. There were no deaths due to sepsis. Grade 2 peripheral neurotoxicity was observed in two patients (8%), grade 2 and 3 fatigue in 14 (54%), grade 2 edema in seven (27%), mild allergic reactions in two (8%) and lacrimation in three (12%). One (4%) complete response and eight (35%) partial responses (overall response rate 39%) were observed in 23 evaluable patients. Stable disease and progressive disease were observed in six patients (26%) and eight patients (35%), respectively. All responses were observed in patients with metastatic breast cancer, one of whom had progressed on paclitaxel-based and two of whom had progressed on docetaxel-based chemotherapy. Conclusions: The weekly administration of docetaxel for three consecutive weeks every 28 days is a feasible schedule with a favorable toxicity profile, and can be given on an outpatient basis. Moreover, this schedule of docetaxel administration seems to have an enhanced efficacy, especially in patients with advanced breast cancer who have failed front-line taxane-based chemotherapy.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1569-8041
    Keywords: gemcitabine ; non-small-cell lung cancer ; paclitaxel ; phase II trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: To evaluate the tolerance and efficacy of the combination of paclitaxel and gemcitabine as salvage treatment in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: Forty-nine patients with measurable NSCLC (PS 0–1: 80%; stage IV: 84%) who progressed or failed first-line chemotherapy were enrolled. Prior chemotherapy was cisplatin-based with (n = 20) or without (n = 22) docetaxel and docetaxel–vinorelbine (n = 7). Patients received gemcitabine (900 mg/m2 i.v.; days 1 and 8) and paclitaxel (175 mg/m2; day 8) every three weeks; G-CSF (150 µg/m2/day s.c.; days 9–15) was given prophylactically to all patients. Results: One (2%) complete and eight (16%) partial responses were achieved (overall response 18%; 95% CI: 4%–24%); 14 patients (29%) had stable disease and 26 (53%) progressive disease. Six responses were observed in 17 patients who responded to first-line chemotherapy. The median duration of response was seven months, the median TTP eight months and the median survival 11 months. The one-year survival rate was 37%. Grade 3–4 neutropenia occured in six (12%) patients, grade 2–3 neurotoxicity in 16 (32%) and grade 2–3 asthenia in 25 (51%). Other toxicities were mild. Conclusions: The paclitaxel-gemcitabine combination is a well-tolerated and relatively active salvage regimen in patients with NSCLC and it merits further investigation.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1569-8041
    Keywords: cisplatin ; CPT-11 ; NSCLC ; salvage treatment
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:A phase II study was conducted in order to determinethe toxicity and efficacy of the combination of CPT-11 and cisplatin, assalvage treatment in patients with advanced non-small-cell lung cancer(NSCLC), progressing after a docetaxel-based front-line regimen. Patients and methods:Thirty-one patients (median age 61 years)with NSCLC, were enrolled. Twenty-six (84%) patients were male,twenty-five (81%) had disease stage IV, and twenty-eight (90%)had a performance status (WHO) 0–1. CPT-11 was administered as a60-minute i.v. infusion at the dose of 100 mg/m2 on day 1 and 110mg/m2 on day 8; cisplatin was administered at the dose of 80mg/m2 on day 8, after CPT-11 administration. Treatment was repeatedevery three weeks. Results:A total of 110 chemotherapy cycles were administered. Inan intention-to-treat analysis 7 patients (23%; 95% confidenceinterval (95% CI): 8%–37%) achieved a partialresponse, 6 (19%) had stable disease, and 18 (58%) progressivedisease. Three of responders had failed a previous docetaxel–carboplatincombination. The median duration of response was 3 months, the median TTP 8months and the median survival for the entire group 8 months. Grade 3–4neutropenia was observed in 16 (52%) patients and in two cases this wasfebrile. Grade 3 and 4 thrombocytopenia occurred in two (7%) patients,respectively. Grade 3 and 4 diarrhea was seen in 10 (33%) patients,grade 2–3 neurotoxicity in 2 (6%), and fatigue grade 2–3in 12 (39%). Other toxicities were mild. Conclusions:The combination of CPT-11 and cisplatin hasmanageable toxicity and interesting activity as salvage treatment of patientswith advanced NSCLC, previously treated with a docetaxel-based front-lineregimen.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1439-0973
    Keywords: Key words Spondylodiscitis ; Klebsiella pneumoniae ; Treatment ; Diagnosis ; Biopsy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A rare case of spontaneous spondylodiscitis caused by Klebsiella pneumoniae in a 55-year-old man who presented with thoracolumbar pain is described. Increased erythrocyte sedimentation rate and C-reactive protein level were pertinent laboratory findings. Computed tomography revealed a paravertebral mass and destruction of the 10th and 11th vertebrae. Magnetic resonance imaging (MRI) showed spondylodiscitis in the same area. Culture of a biopsy sample from the mass grew Klebsiella pneumoniae, while histological examination confirmed the inflammation. A combination of ceftazidime, amikacin and ciprofloxacin resulted in disappearance of the pain. Two months later, MRI showed substantial improvement of the lesions.
    Type of Medium: Electronic Resource
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