Weekly 1 hour paclitaxel infusion in patients with recurrent gynecological tumors: a pilot study.
BACKGROUND
Intensifying the dose of paclitaxel given in a weekly schedule is useful towards improving the therapeutic index of paclitaxel in treating a variety of advanced and recurrent malignancies and is suitable for outpatient administration. This pilot study was carried out to evaluate the safety of weekly paclitaxel administration by 1 h infusion in the outpatient setting.


METHODS
Eleven patients with recurrent gynecological tumors who had previously been treated with at least one platinum-based chemotherapy regimen participated in the study between May 1999 and March 2000. Paclitaxel was given at a dose of 70 mg/m(2 ) as a 1 h infusion every week for at least 20 consecutive weeks unless lesions became progressive. Intravenous dexamethasone and cimetidine and oral diphenhydramine were administered 30 min before paclitaxel infusion.


RESULTS
The 11 patients received a total of 166 cycles of therapy. All patients received 70 mg/m(2 ) doses of paclitaxel without treatment delay. No hypersensitivity reactions were elicited. Grade 3 or 4 leukopenia and neutropenia occurred in 9 and 36% of the patients, respectively. Granulocyte colony-stimulating factor was required for only one patient and no patients experienced febrile neutropenia. Neurotoxicity was the most serious adverse effect and all patients experienced grade 1 or 2 peripheral neuropathy. Grade 1 or 2 myalgias were observed in 45% of the patients. Alopecia was universal. No Grade 3 or higher non-hematological toxicities were observed.


CONCLUSIONS
Weekly 1 h paclitaxel administration is considered safe as a salvage therapy for recurrent gynecological tumors, making its use more convenient and easier in the outpatient setting. The current results support further evaluation.
Ota
S
S
Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
Sugiyama
T
T
Komai
K
K
Hirai
N
N
Kumagai
S
S
Ushijima
K
K
Nishida
T
T
Kamura
T
T
D000553:Ambulatory Care; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D016889:Endometrial Neoplasms / Q000188:drug therapy; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D011788:Quality of Life; D016879:Salvage Therapy; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel