TY - JOUR
T1 - Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma
T2 - A gynecologic oncology group study
AU - Fleming, Gini F.
AU - Brunetto, Virginia L.
AU - Cella, David
AU - Look, Katherine Y.
AU - Reid, Gary C.
AU - Munkarah, Adnan R.
AU - Kline, Richard
AU - Burger, Robert A.
AU - Goodman, Annekathryn
AU - Burks, R. Tucker
AU - Mackey, Denise
PY - 2004
Y1 - 2004
N2 - Purpose: To determine whether the addition of paclitaxel to doxorubicin plus cisplatin improves overall survival (OS) in women with advanced or recurrent endometrial carcinoma. Secondary comparisons included progression-free survival (PFS), response rate (RR), and toxicities. Patients and Methods: Eligible, consenting patients received doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 (AP), or doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m 2 (day 2) with filgrastim support (TAP). The initial doxorubicin dose in the AP arm was reduced to 45 mg/m2 in patients with prior pelvic radiotherapy and those older than 65 years. Both regimens were repeated every 3 weeks to a maximum of seven cycles. Patients completed a neurotoxicity questionnaire before each cycle. Results: Two hundred seventy-three women (10 ineligible) were registered. Objective response (57% v 34%; P < .01), PFS (median, 8.3 v 5.3 months; P < .01), and OS (median, 15.3 v 12.3 months; P = .037) were improved with TAP. Treatment was hematologically well tolerated, with only 2% of patients receiving AP, and 3% of patients receiving TAP experiencing neutropenic fever. Neurologic toxicity was worse for those receiving TAP, with 12% grade 3, and 27% grade 2 peripheral neuropathy, compared with 1% and 4%, respectively, in those receiving AP. Patient-reported neurotoxicity was significantly higher in the TAP arm following two cycles of therapy. Conclusion: TAP significantly improves RR, PFS, and OS compared with AP. Evaluation of this regimen in the high-risk adjuvant setting is warranted, but close attention should be paid to the increased risk of peripheral neuropathy.
AB - Purpose: To determine whether the addition of paclitaxel to doxorubicin plus cisplatin improves overall survival (OS) in women with advanced or recurrent endometrial carcinoma. Secondary comparisons included progression-free survival (PFS), response rate (RR), and toxicities. Patients and Methods: Eligible, consenting patients received doxorubicin 60 mg/m2 and cisplatin 50 mg/m2 (AP), or doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m 2 (day 2) with filgrastim support (TAP). The initial doxorubicin dose in the AP arm was reduced to 45 mg/m2 in patients with prior pelvic radiotherapy and those older than 65 years. Both regimens were repeated every 3 weeks to a maximum of seven cycles. Patients completed a neurotoxicity questionnaire before each cycle. Results: Two hundred seventy-three women (10 ineligible) were registered. Objective response (57% v 34%; P < .01), PFS (median, 8.3 v 5.3 months; P < .01), and OS (median, 15.3 v 12.3 months; P = .037) were improved with TAP. Treatment was hematologically well tolerated, with only 2% of patients receiving AP, and 3% of patients receiving TAP experiencing neutropenic fever. Neurologic toxicity was worse for those receiving TAP, with 12% grade 3, and 27% grade 2 peripheral neuropathy, compared with 1% and 4%, respectively, in those receiving AP. Patient-reported neurotoxicity was significantly higher in the TAP arm following two cycles of therapy. Conclusion: TAP significantly improves RR, PFS, and OS compared with AP. Evaluation of this regimen in the high-risk adjuvant setting is warranted, but close attention should be paid to the increased risk of peripheral neuropathy.
UR - http://www.scopus.com/inward/record.url?scp=2942657617&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=2942657617&partnerID=8YFLogxK
U2 - 10.1200/JCO.2004.07.184
DO - 10.1200/JCO.2004.07.184
M3 - Article
C2 - 15169803
AN - SCOPUS:2942657617
SN - 0732-183X
VL - 22
SP - 2159
EP - 2166
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 11
ER -