Paclitaxel and carboplatin with amifostine in advanced, recurrent, or refractory endometrial adenocarcinoma

A phase II study of the Southwest Oncology Group

Sidney A. Scudder, P. Y. Liu, Sharon P. Wilczynski, Harriet O. Smith, Caroline Jiang, Alton V. Hallum, Gregory B. Smith, Edward V. Hannigan, Maurie Markman, David S Alberts

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)610-615
Number of pages6
JournalGynecologic Oncology
Volume96
Issue number3
DOIs
StatePublished - Mar 2005

Fingerprint

Amifostine
Carboplatin
Paclitaxel
Adenocarcinoma
Endometrial Neoplasms
Confidence Intervals
Disease-Free Survival
Neutropenia
Survival Rate
Febrile Neutropenia
Area Under Curve
Disease Progression
Drug Therapy
Survival
Infection

Keywords

  • Amifostine
  • Carboplatin
  • Paclitaxel

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Paclitaxel and carboplatin with amifostine in advanced, recurrent, or refractory endometrial adenocarcinoma : A phase II study of the Southwest Oncology Group. / Scudder, Sidney A.; Liu, P. Y.; Wilczynski, Sharon P.; Smith, Harriet O.; Jiang, Caroline; Hallum, Alton V.; Smith, Gregory B.; Hannigan, Edward V.; Markman, Maurie; Alberts, David S.

In: Gynecologic Oncology, Vol. 96, No. 3, 03.2005, p. 610-615.

Research output: Contribution to journalArticle

Scudder, Sidney A. ; Liu, P. Y. ; Wilczynski, Sharon P. ; Smith, Harriet O. ; Jiang, Caroline ; Hallum, Alton V. ; Smith, Gregory B. ; Hannigan, Edward V. ; Markman, Maurie ; Alberts, David S. / Paclitaxel and carboplatin with amifostine in advanced, recurrent, or refractory endometrial adenocarcinoma : A phase II study of the Southwest Oncology Group. In: Gynecologic Oncology. 2005 ; Vol. 96, No. 3. pp. 610-615.
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abstract = "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.",
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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

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.

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