TY - JOUR
T1 - Paclitaxel and carboplatin with amifostine in advanced, recurrent, or refractory endometrial adenocarcinoma
T2 - A phase II study of the Southwest Oncology Group
AU - Scudder, Sidney A.
AU - Liu, P. Y.
AU - Wilczynski, Sharon P.
AU - Smith, Harriet O.
AU - Jiang, Caroline
AU - Hallum, Alton V.
AU - Smith, Gregory B.
AU - Hannigan, Edward V.
AU - Markman, Maurie
AU - Alberts, David S.
N1 - Funding Information:
This investigation was supported in part by the following PHS Cooperative Agreement grant numbers awarded by the National Cancer Institute, DHHS: CA38926, CA32102, CA13612, CA22433, CA03096, CA35178, CA12644, CA46282, CA45461, CA42777, CA35090, CA63850, CA58861, CA35431, CA68183, CA67575, CA37981, CA35261, CA46441, CA63844, CA12213, CA46113, CA45560, CA35996, CA76462, CA76132, CA14028, CA45450, CA20319, CA46368, CA04919, CA35119.
PY - 2005/3
Y1 - 2005/3
N2 - Objectives. To evaluate the response rate and progression free and overall survival of patients with advanced endometrial cancer treated with paclitaxel, carboplatin and amifostine. To evaluate the toxicity of amifostine when used in combination with carboplatin and paclitaxel. Methods. Forty-seven eligible patients (median age: 66; range 45-82) with bidimensionally measurable advanced, recurrent, or refractory endometrial cancer were treated with carboplatin (AUC = 6), paclitaxel (175 mg/M2) and amifostine (740 mg/M2) every 4 weeks for 6 cycles or until disease progression or unacceptable toxicity. Results. There were 4 CRs (8%) (2 confirmed, 2 unconfirmed) and 15 PRs (32%) (9 confirmed, 6 unconfirmed) for a total response rate of 40% (95% confidence interval [CI], 26% to 56%). The median progression-free survival (PFS) was 7 months (95% CI, 6-9 months) and a 6-month PFS rate of 64% (95% CI, 50% to 78%). The median overall survival was 14 months (95% CI, 12 to 17 months). Toxicity was tolerable. While 79% of patients developed Grade 3/4 neutropenia (30% Grade 3, 49% Grade 4), there were no episodes of Grade 4 febrile neutropenia and one episode of infection with grades 3-4 neutropenia. Conclusion. The combination of paclitaxel and carboplatin with amifostine was well reasonably tolerated in this cohort. The regimen demonstrated significant activity in endometrial cancer, comparable to other multi-agent chemotherapy programs in terms of response rate and survival, and with a favorable toxicity profile.
AB - Objectives. To evaluate the response rate and progression free and overall survival of patients with advanced endometrial cancer treated with paclitaxel, carboplatin and amifostine. To evaluate the toxicity of amifostine when used in combination with carboplatin and paclitaxel. Methods. Forty-seven eligible patients (median age: 66; range 45-82) with bidimensionally measurable advanced, recurrent, or refractory endometrial cancer were treated with carboplatin (AUC = 6), paclitaxel (175 mg/M2) and amifostine (740 mg/M2) every 4 weeks for 6 cycles or until disease progression or unacceptable toxicity. Results. There were 4 CRs (8%) (2 confirmed, 2 unconfirmed) and 15 PRs (32%) (9 confirmed, 6 unconfirmed) for a total response rate of 40% (95% confidence interval [CI], 26% to 56%). The median progression-free survival (PFS) was 7 months (95% CI, 6-9 months) and a 6-month PFS rate of 64% (95% CI, 50% to 78%). The median overall survival was 14 months (95% CI, 12 to 17 months). Toxicity was tolerable. While 79% of patients developed Grade 3/4 neutropenia (30% Grade 3, 49% Grade 4), there were no episodes of Grade 4 febrile neutropenia and one episode of infection with grades 3-4 neutropenia. Conclusion. The combination of paclitaxel and carboplatin with amifostine was well reasonably tolerated in this cohort. The regimen demonstrated significant activity in endometrial cancer, comparable to other multi-agent chemotherapy programs in terms of response rate and survival, and with a favorable toxicity profile.
KW - Amifostine
KW - Carboplatin
KW - Paclitaxel
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U2 - 10.1016/j.ygyno.2004.11.024
DO - 10.1016/j.ygyno.2004.11.024
M3 - Article
C2 - 15721401
AN - SCOPUS:13844281651
SN - 0090-8258
VL - 96
SP - 610
EP - 615
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 3
ER -