Weekly low-dose paclitaxel as maintenance treatment in patients with advanced ovarian cancer who had microscopic residual disease at second-look surgery after 6 cycles of paclitaxel/platinum-based chemotherapy: results of an open noncomparative phase 2 multicenter Italian study (After-6 Protocol 2).
The aim of this paper was to assess whether weekly intravenous 60-mg/m2 paclitaxel for 21 weeks is feasible and effective as maintenance treatment in 64 patients with advanced ovarian cancer who had microscopic residual disease after 6 cycles of paclitaxel/platinum-based chemotherapy. Forty-eight patients completed the planned cycles of weekly paclitaxel. The worst toxicities were grade 2 leukopenia in 22.4% of the patients, grade 2 neutropenia in 25.9%, grade 2 sensorial neurotoxicity in 20.7%, and grade 2 motor neurotoxicity in 6.9%. Seventeen patients underwent a third-look surgery that showed a pathological complete response in 6 (35.3%, 95% confidence interval [CI], 17.3%-59.0%) cases. The 3-year progression-free survival rate was 18% (95% CI, 9.6%-33.8%), and the 3-year overall survival rate was 64% (95% CI, 52.0%-78.0%). Weekly low-dose paclitaxel is a feasible and well-tolerated maintenance treatment.
Gadducci
Angiolo
A
Department of Gynecology and Obstetrics, University of Pisa, Pisa, Italy. a.gadducci@obgyn.med.unipi.it
Katsaros
Dionyssios
D
Zola
Paolo
P
Scambia
Giovanni
G
Ballardini
Michela
M
Pasquini
Enzo
E
Fertonani
Carlo
C
Maggi
Lorenzo
L
Pecorelli
Sergio
S
Conte
Pier Franco
PF
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D018365:Neoplasm, Residual; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D024162:Second-Look Surgery
D009944:Organoplatinum Compounds; D017239:Paclitaxel