American journal of clinical oncology · 2005
A phase II study of carboplatin and paclitaxel in adenocarcinoma of unknown primary.
Клиническое исследованиеКлиническое исследование II фазыСтатьяПоддержка NIH: внешняя программаПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод пока не подготовлен
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El-Rayes Basil F, Shields Anthony F, Zalupski Mark, Heilbrun Lance K, Jain Vikash, Terry Damita, Ferris Ann Marie, Philip Philip A
Аннотация
BACKGROUND: Cisplatin-based combination chemotherapy is commonly used in the treatment of carcinoma of unknown primary site. Paclitaxel has shown promising activity as a single agent in a number of malignancies. This study was conducted to evaluate the efficacy and toxicity of combination carboplatin and paclitaxel in patients with adenocarcinoma of unknown primary site (ACUP).
METHODS: Twenty-two patients with ACUP were enrolled in the study. Patients were treated with 200 mg/m2 paclitaxel intravenously (IV) over 3 hours followed by carboplatin IV with a targeted plasma area under the curve (AUC) of 5 mg/h/mL.
RESULTS: A total of 73 treatment courses were administered with a median of 5 courses per patient. Five of the 22 registered patients had a major response for an objective response rate of 23% (90% confidence interval [CI], 0.11-0.40) by intention-to-treat analysis. The median response duration was 4.1 months (90% CI, 3.6-7.1). The median survival time was 6.5 months (90% CI, 5.5-10.1) and the 1-year survival rate was 27% (90% CI, 0.11-0.42). The major toxicity observed was neutropenia, with grade 3-4 neutropenia occurring in 3 patients (14%). There were no treatment-related deaths.
CONCLUSIONS: The combination of carboplatin and paclitaxel is a tolerable and moderately active regimen in ACUP.
METHODS: Twenty-two patients with ACUP were enrolled in the study. Patients were treated with 200 mg/m2 paclitaxel intravenously (IV) over 3 hours followed by carboplatin IV with a targeted plasma area under the curve (AUC) of 5 mg/h/mL.
RESULTS: A total of 73 treatment courses were administered with a median of 5 courses per patient. Five of the 22 registered patients had a major response for an objective response rate of 23% (90% confidence interval [CI], 0.11-0.40) by intention-to-treat analysis. The median response duration was 4.1 months (90% CI, 3.6-7.1). The median survival time was 6.5 months (90% CI, 5.5-10.1) and the 1-year survival rate was 27% (90% CI, 0.11-0.42). The major toxicity observed was neutropenia, with grade 3-4 neutropenia occurring in 3 patients (14%). There were no treatment-related deaths.
CONCLUSIONS: The combination of carboplatin and paclitaxel is a tolerable and moderately active regimen in ACUP.