Randomized phase II trial of paclitaxel plus carboplatin therapy versus irinotecan plus cisplatin therapy as first-line chemotherapy for clear cell adenocarcinoma of the ovary

A JGOG study

Satoshi Takakura, Masashi Takano, Fumiaki Takahashi, Toshiaki Saito, Daisuke Aoki, Noriyuki Inaba, Kiichiro Noda, Toru Sugiyama, Kazunori Ochiai

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Introduction: Paclitaxel plus carboplatin (TC) is generally considered to be the "gold standard" regimen for treatment of epithelial ovarian carcinomas. Little data are available, however, on the use of this regimen in patients with clear cell adenocarcinoma of the ovary (CCC). Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC. We compared these 2 combinations in patients with CCC. Methods: Patients (n = 99) with CCC were randomly assigned to receive either 180 mg/m2 paclitaxel on day 1 plus AUC 6 mg/mL x minute carboplatin on day 1 every 21 days (TC arm) or 60 mg/m2 irinotecan hydrochloride on days 1,8, 15 plus 60 mg/m 2 cisplatin on day 1 every 28 days (CPT-P arm). Results: Percentages of patients receiving the scheduled 6 cycles of chemotherapy in the TC and CPT-P arms were 70.8% and 72.0%, respectively. Although toxicity was well tolerated in both arms, the toxicity profile of each arm differed. Progression-free survival (PFS) showed no significant difference between the 2 treatment groups. Because there were more patients with large residual disease in the CPT-P arm, we performed a subset analysis by removing those patients, and then compared the PFS with that of patients without residual disease or with residual disease less than 2 cm. The PFS tended to be longer in the CPT-P group, although the difference was not statistically significant. Conclusions: A phase III randomized trial is required to elucidate the effectiveness of CPT-P combination chemotherapy for CCC. Copyright

Original languageEnglish
Pages (from-to)240-247
Number of pages8
JournalInternational Journal of Gynecological Cancer
Volume20
Issue number2
DOIs
Publication statusPublished - 2010 Feb

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irinotecan
Clear Cell Adenocarcinoma
Carboplatin
Paclitaxel
Cisplatin
Ovary
Drug Therapy
Disease-Free Survival
Combination Drug Therapy
Therapeutics
Area Under Curve

Keywords

  • Carboplatin
  • Cisplatin
  • Clear cell adenocarcinoma
  • Irinotecan hydrochloride
  • Ovarian cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology
  • Medicine(all)

Cite this

Randomized phase II trial of paclitaxel plus carboplatin therapy versus irinotecan plus cisplatin therapy as first-line chemotherapy for clear cell adenocarcinoma of the ovary : A JGOG study. / Takakura, Satoshi; Takano, Masashi; Takahashi, Fumiaki; Saito, Toshiaki; Aoki, Daisuke; Inaba, Noriyuki; Noda, Kiichiro; Sugiyama, Toru; Ochiai, Kazunori.

In: International Journal of Gynecological Cancer, Vol. 20, No. 2, 02.2010, p. 240-247.

Research output: Contribution to journalArticle

Takakura, Satoshi ; Takano, Masashi ; Takahashi, Fumiaki ; Saito, Toshiaki ; Aoki, Daisuke ; Inaba, Noriyuki ; Noda, Kiichiro ; Sugiyama, Toru ; Ochiai, Kazunori. / Randomized phase II trial of paclitaxel plus carboplatin therapy versus irinotecan plus cisplatin therapy as first-line chemotherapy for clear cell adenocarcinoma of the ovary : A JGOG study. In: International Journal of Gynecological Cancer. 2010 ; Vol. 20, No. 2. pp. 240-247.
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abstract = "Introduction: Paclitaxel plus carboplatin (TC) is generally considered to be the {"}gold standard{"} regimen for treatment of epithelial ovarian carcinomas. Little data are available, however, on the use of this regimen in patients with clear cell adenocarcinoma of the ovary (CCC). Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC. We compared these 2 combinations in patients with CCC. Methods: Patients (n = 99) with CCC were randomly assigned to receive either 180 mg/m2 paclitaxel on day 1 plus AUC 6 mg/mL x minute carboplatin on day 1 every 21 days (TC arm) or 60 mg/m2 irinotecan hydrochloride on days 1,8, 15 plus 60 mg/m 2 cisplatin on day 1 every 28 days (CPT-P arm). Results: Percentages of patients receiving the scheduled 6 cycles of chemotherapy in the TC and CPT-P arms were 70.8{\%} and 72.0{\%}, respectively. Although toxicity was well tolerated in both arms, the toxicity profile of each arm differed. Progression-free survival (PFS) showed no significant difference between the 2 treatment groups. Because there were more patients with large residual disease in the CPT-P arm, we performed a subset analysis by removing those patients, and then compared the PFS with that of patients without residual disease or with residual disease less than 2 cm. The PFS tended to be longer in the CPT-P group, although the difference was not statistically significant. Conclusions: A phase III randomized trial is required to elucidate the effectiveness of CPT-P combination chemotherapy for CCC. Copyright",
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AU - Takakura, Satoshi

AU - Takano, Masashi

AU - Takahashi, Fumiaki

AU - Saito, Toshiaki

AU - Aoki, Daisuke

AU - Inaba, Noriyuki

AU - Noda, Kiichiro

AU - Sugiyama, Toru

AU - Ochiai, Kazunori

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AB - Introduction: Paclitaxel plus carboplatin (TC) is generally considered to be the "gold standard" regimen for treatment of epithelial ovarian carcinomas. Little data are available, however, on the use of this regimen in patients with clear cell adenocarcinoma of the ovary (CCC). Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC. We compared these 2 combinations in patients with CCC. Methods: Patients (n = 99) with CCC were randomly assigned to receive either 180 mg/m2 paclitaxel on day 1 plus AUC 6 mg/mL x minute carboplatin on day 1 every 21 days (TC arm) or 60 mg/m2 irinotecan hydrochloride on days 1,8, 15 plus 60 mg/m 2 cisplatin on day 1 every 28 days (CPT-P arm). Results: Percentages of patients receiving the scheduled 6 cycles of chemotherapy in the TC and CPT-P arms were 70.8% and 72.0%, respectively. Although toxicity was well tolerated in both arms, the toxicity profile of each arm differed. Progression-free survival (PFS) showed no significant difference between the 2 treatment groups. Because there were more patients with large residual disease in the CPT-P arm, we performed a subset analysis by removing those patients, and then compared the PFS with that of patients without residual disease or with residual disease less than 2 cm. The PFS tended to be longer in the CPT-P group, although the difference was not statistically significant. Conclusions: A phase III randomized trial is required to elucidate the effectiveness of CPT-P combination chemotherapy for CCC. Copyright

KW - Carboplatin

KW - Cisplatin

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KW - Ovarian cancer

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