Safety and efficacy of a combination of docetaxel and cisplatin in patients with unknown primary cancer.
OBJECTIVE
Evaluation of the safety and efficacy of docetaxel and cisplatin in the treatment of unknown primary cancer.


METHODS
Inclusion criteria included histologic evidence of carcinoma originating in an unknown primary organ, no prior chemotherapy, age range 20 to 75 years, WHO PS < or =3, measurable or evaluable lesions, and adequate organ function. Docetaxel (60 mg/m2) followed by cisplatin (80 mg/m2) was administered intravenously every 3 weeks. Patients were assessed for tumor response after 2 cycles of chemotherapy, and 4 additional cycles were administered unless disease progression was demonstrated.


RESULTS
Between September 1997 and September 2002, 45 patients were enrolled. The median age was 56.5 years (28-73 years), and their performance status (PS) were 0 (11 patients), 1 (26 patients), and 2 (6 patients), respectively, (2 patients were removed from the trial after initial enrollment). A total of 26 patients (60%) presented with lymphadenopathy, 14 patients (33%) with visceral disease, and 3 (7%) with bone and soft-tissue metastases. The overall response rate was 65.1% (4 complete response, 24 partial response, 8 NC, 7 progressive diseases: 95% confidence interval, 48.0-78.4). The median time to progression was 5.0 months. The median survival time was 11.8 months. No treatment-related deaths were observed. Commonly observed side effects included neutropenia (grade 3-4, 16 patients), nausea (grade 3, 13 patients), and nephrotoxicity (grade 2, 5 patients).


CONCLUSIONS
These results indicate that the combination of docetaxel and cisplatin is a safe and effective regimen for patients with unknown primary cancer.
Mukai
Hirofumi
H
Division of Oncology and Hematology, National Cancer Center Hospital East, Chiba, Japan. hrmukai@east.ncc.go.jp
Katsumata
Noriyuki
N
Ando
Masashi
M
Watanabe
Toru
T
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D055815:Young Adult
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin