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  • 1
    ISSN: 1569-8041
    Keywords: cisplatin ; combination chemotherapy ; phase I ; phase II ; small-cell lung cancer ; topotecan
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:The aim was to define the MTD of topotecan (TPT) givenbefore cisplatin in patients with previously untreated SCLC. Patients and methods:Alternating cycles A and B to a total of 6cycles were given. Cycle A: TPT days 1–5 and cisplatin (50mg/m2) day 5. Cycle B consisted of teniposide, carboplatin,vincristine, and cisplatin. TPT was escalated at doses 0.75, 1.0, 1.25, and1.5 mg/m2. DLT was defined for the first cycle as grade 4neutropenia with fever or when lasting 〉7 days, or grade 4thrombocytopenia. Results:Fifteen patients with limited disease and six patientswith extensive disease were included. No episodes of DLT were recorded in thefirst cycles A and consequently 1.5 mg/m2 was defined as MTD. At1.5 mg/m2 (11 patients, 30 cycles), four and three episodes ofgrade 4 thrombocytopenia and neutropenia lasting more than seven days occurredin subsequent cycles A. Thrombocytopenia and anaemia were cumulative as morecycles were administrated. Non-hematological toxicity was mild. The responserate was 86% (95% confidence interval (95% CI):64%–97%) with 33% (95% CI:15%–57%) achieving CR. Conclusions:1.5 mg/m2 TPT can be delivered safely with50 mg/m2 cisplatin on day 5 in patients with previously untreatedSCLC.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1569-8041
    Keywords: cisplatin ; disseminated disease ; docetaxel ; head and neck cancer ; recurrent disease ; squamous-cell carcinoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Results with docetaxel as single drug in squamous-cellhead and neck cancer have been encouraging. The purpose of the present phaseII study is to evaluate the antitumour efficacy and toxicity of thecombination of docetaxel and cisplatin in patients with recurrent ordisseminated squamous-cell carcinoma of the head and neck (SCCHN) for whom nocurative therapy is available. Patients and methods:Eligibility criteria included: writteninformed consent; WHO performance status ≤2; age 18–70 years;adequate bone marrow, liver, and renal function; measurable or evaluabledisease; no previous systemic chemotherapy (prior radiotherapy and/or surgerywere allowed); no other previous or concurrent malignancy; no peripheralneuropathy. Treatment consisted of docetaxel 75 mg/m2 in a one-hourinfusion after pre-treatment with prednisolone, followed by cisplatin 75mg/m2 in a half-hour infusion preceded and followed by hydration.Treatment was repeated every three weeks for a maximum of eight cycles. Results:Twenty-five patients (median age 52 years, range33–66) entered the trial, all were evaluable for survival, twenty-fourfor response and toxicity. Twenty-four patients had undergone priorradiotherapy and seventeen had also had surgery. Nineteen had local-regionalrecurrence only, three had local-regional disease and distant metastases, andthree had distant metastases only. Patients received a median of 5 treatmentcycles (range 2–8). Overall response rate was 33% (8 of 24) ofpatients; complete response rate was 8% (2 of 24) of patients, lasting2.2 and 17.1 months, respectively; partial response rate was 25% (6 of24) of patients, lasting for a median of 4.9 months (range 1.7–11.6months). Median survival was 11 months. Toxicity was relatively welltolerated. However, one patient died of probable toxicity (neutropenia andinfection) and three patients discontinued treatment because of toxicity(massive oedema, myocardial infarction, persistent thrombocytopenia). The mostfrequent moderate-to-severe toxicity (75% of patients) was grade3–4 neutropenia, transient in all but one patient. Grade 3 neuropathyoccurred in one patient, none had grade 4. Grade 3 oral mucositis occurred inthree patients, none had grade 4. Grade 2–3 hypomagnesaemia occurred in10 patients requiring magnesium infusion. Conclusions:Docetaxel and cisplatin is an active combination inpatients with recurrent or disseminated SCCHN. Remissions are however fairlyshort. Toxicity is significant, but generally manageable.
    Type of Medium: Electronic Resource
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