A phase II study of carboplatin and paclitaxel in adenocarcinoma of unknown primary.
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.
El-Rayes
Basil F
BF
Karmanos Cancer Institute, Wayne State University, Detroit, Michigan 48201, USA. elrayesb@karmanos.org
Shields
Anthony F
AF
Zalupski
Mark
M
Heilbrun
Lance K
LK
Jain
Vikash
V
Terry
Damita
D
Ferris
Ann Marie
AM
Philip
Philip A
PA
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D016019:Survival Analysis
D016190:Carboplatin; D017239:Paclitaxel