Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma: A Japanese Gynecologic Oncology Group study (JGOG2041)

Hiroyuki Nomura, Daisuke Aoki, F. Takahashi, N. Katsumata, Y. Watanabe, I. Konishi, T. Jobo, M. Hatae, M. Hiura, N. Yaegashi

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Background: The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma. Patients and methods: Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity. Results: Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7%, 48.3%, and 60.0% in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC. These toxicity profiles were not significantly different. Conclusion: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.

Original languageEnglish
Pages (from-to)636-642
Number of pages7
JournalAnnals of Oncology
Volume22
Issue number3
DOIs
Publication statusPublished - 2011 Mar

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docetaxel
Carboplatin
Endometrial Neoplasms
Paclitaxel
Cisplatin
Platinum
Febrile Neutropenia
Poisons
Neutropenia
Disease Progression
Diarrhea
Neoplasms
Therapeutics
Safety

Keywords

  • Advanced
  • Endometrial carcinoma
  • Recurrent
  • Taxane plus platinum combination

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Medicine(all)

Cite this

Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma : A Japanese Gynecologic Oncology Group study (JGOG2041). / Nomura, Hiroyuki; Aoki, Daisuke; Takahashi, F.; Katsumata, N.; Watanabe, Y.; Konishi, I.; Jobo, T.; Hatae, M.; Hiura, M.; Yaegashi, N.

In: Annals of Oncology, Vol. 22, No. 3, 03.2011, p. 636-642.

Research output: Contribution to journalArticle

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abstract = "Background: The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma. Patients and methods: Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity. Results: Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7{\%}, 48.3{\%}, and 60.0{\%} in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3{\%}, 90.0{\%}, and 76.6{\%}; febrile neutropenia in 10.0{\%}, 6.7{\%}, and 3.3{\%}; grade 3/4 thrombocytopenia in 6.7{\%}, 10.0{\%}, and 10.0{\%}; grade 3/4 diarrhea in 13.3{\%}, 3.3{\%}, and 0{\%}, respectively; and grade 3 neurotoxicity in 10.0{\%} of TC. These toxicity profiles were not significantly different. Conclusion: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.",
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T1 - Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma

T2 - A Japanese Gynecologic Oncology Group study (JGOG2041)

AU - Nomura, Hiroyuki

AU - Aoki, Daisuke

AU - Takahashi, F.

AU - Katsumata, N.

AU - Watanabe, Y.

AU - Konishi, I.

AU - Jobo, T.

AU - Hatae, M.

AU - Hiura, M.

AU - Yaegashi, N.

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N2 - Background: The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma. Patients and methods: Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity. Results: Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7%, 48.3%, and 60.0% in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC. These toxicity profiles were not significantly different. Conclusion: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.

AB - Background: The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma. Patients and methods: Patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma were randomly assigned to receive docetaxel plus cisplatin (DP), docetaxel plus carboplatin (DC), or paclitaxel plus carboplatin (TC) every 3 weeks until disease progression or adverse events prohibited further therapy. Among these regimens, the study evaluated the tumor response rate as the primary end point as well as toxicity. Results: Ninety patients were enrolled. Of them, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Tumor response rates were 51.7%, 48.3%, and 60.0% in DP, DC, and TC, respectively (P = 0.65). The following toxic effects were observed: grade 3/4 neutropenia in 83.3%, 90.0%, and 76.6%; febrile neutropenia in 10.0%, 6.7%, and 3.3%; grade 3/4 thrombocytopenia in 6.7%, 10.0%, and 10.0%; grade 3/4 diarrhea in 13.3%, 3.3%, and 0%, respectively; and grade 3 neurotoxicity in 10.0% of TC. These toxicity profiles were not significantly different. Conclusion: The taxane plus platinum combination therapies could be candidates in further phase III trials for endometrial carcinoma.

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KW - Recurrent

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