Weekly paclitaxel plus capecitabine in advanced breast cancer patients: dose-finding trial of GOIRC and GOL.
BACKGROUND
Paclitaxel and capecitabine have demonstrated a synergic effect and significant antitumor activity in patients with advanced breast cancer. A weekly schedule of paclitaxel obtained a response rate of 50-68% in advanced breast cancer and less serious side-effects.


METHODS
Thirty-two patients with advanced breast cancer pretreated with chemotherapy were enrolled in a dose-finding trial to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of paclitaxel given on days 1, 8 and 15 of each cycle combined with capecitabine given twice daily from day 1 through day 14, every 21 days. Three patients were recruited at one of six dose levels (paclitaxel 70-100 mg/m2, capecitabine 1650-2500 mg/m2).


RESULTS
Thirty-two patients were accrued and 31 were evaluated for toxicity. One DLT has been experienced at level VI as diarrhea grade 3. We determined dose level V as the MTD, but we recommend dose level IV for phase II studies (capecitabine 1250 mg/m2 orally twice daily plus paclitaxel 80 mg/m2 intravenously weekly), owing to cumulative toxicity at level V. The objective response rate was 43%.


CONCLUSIONS
Weekly paclitaxel plus capecitabine is a safety and active chemotherapy in previously treated metastatic breast cancer.
Di Costanzo
F
F
U.O. Oncologia Medica, Azienda Ospedaliera Careggi, Firenze, Italy. oncmed02@ao-careggi.toscana.it
Gasperoni
S
S
Papaldo
P
P
Bilancia
D
D
Manzione
L
L
Landucci
E
E
Mazzoni
F
F
Cognetti
F
F
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000473:pathology; D018275:Carcinoma, Lobular / Q000188:drug therapy / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D016896:Treatment Outcome
D003841:Deoxycytidine; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil