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  • 1
    ISSN: 1569-8041
    Keywords: gemcitabine ; pancreatic cancer ; phase I ; vinorelbine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose:Gemcitabine and vinorelbine are active drugs with broadspectrum of activity and manageable toxicity in clinical trials. The aims ofthis study were to describe the toxicity, to determine the dose-limitingtoxicity, and to define the doses of gemcitabine and vinorelbine to berecommended for phase II studies in patients with advanced cancers. Patients and methods:Drugs were given as 30–min infusions on day1 and 8 (vinorelbine before gemcitabine) every 3 weeks. Thirty-six patients(male : female ratio 25 : 11; mean age 54, PS 〉60) were treated including1 retroperitoneal sarcoma, 7 head and neck, 10 lung, 4 thyroid, 6 pancreatic,1 bladder, 2 ovary, 2 gastric, 1 rectum, 1 unknown primary, and 1 renal cellcarcinoma. Doses of gemcitabine/vinorelbine ranged from 800/20mg/m2 to 1500/30 mg/m2. Results:The dose-limiting toxicity was neutropenia. A transientgrade 2–3 elevation of transaminases was frequently observed at severaldose-levels, although this toxicity did not appear to be dose dependant andwas reversible at day 21 before the next cycle. Other toxicities were mild andeasily manageable, consisting of fatigue and flu-like syndromes. Since the MTDwas not reach at the higher dose-level, the recommended dose level of thegemcitabine–vinorelbine combination was 1500/30 mg/m2. Onetoxic death due to hematologic toxicity was reported in a heavily pretreatedpatient who underwent prior chemotherapy and pelvic radiotherapy. A total of12 patients were treated at the recommended dose level which was associatedwith grade 3–4 neutropenia in 3 of 12 patients and in 22.9% ofcycles. Conclusions:This study estimates that the recommended dose forphase II studies of gemcitabine–vinorelbine is 1500/30 mg/m2at day 1 and 8 every three weeks. A careful monitoring of the hematologictoxicity is recommended in heavily pretreated patients and in patients whoreceived pelvic radiotherapy. Partial responses observed in a patient with anadvanced cisplatin–5–fluorouracil-resistant pancreatic adenocarcinomaand in a patient with mesothelioma support further evaluation of thiscombination in patients with tumors refractory to classical antitumor agents.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1569-8041
    Keywords: salvage chemotherapy ; second-line treatment ; taxanes
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Purpose: The safety and efficacy of a docetaxel-cisplatin combination (DC) were evaluated in 41 patients pretreated for advanced breast cancer (ABC). Patients and methods: The first 2 patients received 85 mg/m2 docetaxel followed, 6 hours later, by 80 mg/m2 cisplatin repeated every 3 weeks; the other 39 received the same regimen, with 75 mg/m2 docetaxel. Appropriate dose reductions but no growth factor administration were planned. Treatment was continued until disease progression, excessive toxicity or patient refusal. Results: A total of 223 chemotherapy courses were administered, with a median of 6 cycles per patient (range 1–8). All 41 patients were assessed for toxicity using NCI-CTC. Severe neutropenia was experienced by 38 patients (93%) (11 at grade 3, 27 at grade 4, 10 with febrile neutropenia). There was one death due to neutropenic septic shock. Grade 3 thrombocytopenia occurred in three patients (7%). Five patients (12%) had grade 2 neurosensory toxicity, two (5%) experiencing partial hearing loss. Grade 3 fluid retention occurred in three patients (7%). Of 38 anthracycline-resistant patients, 33 were evaluable for response. Two had a complete response (CR) and ten a partial response (PR), giving an objective response rate of 36%, (95% CI: 20%–55%). Stable disease (SD) was observed in 14 patients (42%), 7 (21%) had progressive disease (PD). Among the three non-resistant patients, two PRs and one SD were observed. Median duration of response was 29 weeks (range 18–70), median time to progression 21 weeks (4–70), and median overall survival 50 weeks (4–104+). Conclusions: This DC regimen is active, with an acceptable safety profile in anthracycline-resistant ABC patients. Its place as a second-line treatment alternative to docetaxel alone or to other second-line combination regimens remains to be determined.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Publishing Ltd
    ISSN: 1749-6632
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Natural Sciences in General
    Type of Medium: Electronic Resource
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