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Patients were randomly assigned to receive either doxorubicin 60 mg/m2 intravenously every 3 weeks or doxorubicin 60 mg/m2 plus cisplatin 50 mg/m2, both intravenously, every 3 weeks with appropriate hydration.Patients older than 65 years and/or those completing external radiation therapy before entering the study initiated doxorubicin at 45 mg/m2 and were to be escalated to 60 mg/m2 on the second cycle, provided they experienced no toxicity worse than grade 1. Also, those individuals who entered the study with hepatic dysfunction manifested as bilirubin between 1.1 and 3.0 mg/100 mL started doxorubicin at 30 mg/m2 and escalated to 45 mg/m2 and 60 mg/m2, provided they experienced no toxicity greater than grade 1. Reassessment was performed at the time of each treatment and therapy was to be continued until unacceptable toxicity intervened, progression of disease occurred, the patient died or was lost to follow-up, or a cumulative dose of 500 mg/m2 doxorubicin was administered.
The median and interquartile range of the doxorubicin dose delivered during the first course of treatment was 45 mg/m2 (range, 44.7 to 55.3 mg/m2) and 45 mg/m2 (range, 44.7 to 59.2 mg/m2) for patients randomly assigned to the single-agent and combination regimen, respectively. These doses reflect the fact that most patients were started at the lower doxorubicin dose per protocol because of age older than 65 years or having had prior radiation therapy.
Table 2. Courses of Study Therapy
|No. of Courses||Doxorubicin (n = 150)||Doxorubicin + Cisplatin (n = 131)|
|No. of Patients||%||No. of Patients||%|
Overall survival is shown in Fig 2. Overall survival for each regimen was similar, with a median of 9.0 months for the combination arm versus 9.2 months for the single-agent arm.
Die meisten Patienten sind mit einer geringeren Anfangsdosis und fast 30% mit nur max.2 Behandlungen durch die Studie gegangen.
Mit einem OS von 9,2 Mon!!!
Das 9,2 Mon OS für Dox wird mit Sicherheit in unserer Studie überschritten!!!!!