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Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial.

Publication ,  Journal Article
Powell, MA; Filiaci, VL; Hensley, ML; Huang, HQ; Moore, KN; Tewari, KS; Copeland, LJ; Secord, AA; Mutch, DG; Santin, A; Warshal, DP; Ioffe, OB ...
Published in: J Clin Oncol
March 20, 2022

PURPOSE: This phase III randomized trial (NCT00954174) tested the null hypothesis that paclitaxel and carboplatin (PC) is inferior to paclitaxel and ifosfamide (PI) for treating uterine carcinosarcoma (UCS). PATIENTS AND METHODS: Adults with chemotherapy-naïve UCS or ovarian carcinosarcoma (OCS) were randomly assigned to PC or PI with 3-week cycles for 6-10 cycles. With 264 events in patients with UCS, the power for an overall survival (OS) hybrid noninferiority design was 80% for a null hazard ratio (HR) of 1.2 against a 13% greater death rate on PI with a type I error of 5% for a one-tailed test. RESULTS: The study enrolled 536 patients with UCS and 101 patients with OCS, with 449 and 90 eligible, respectively. Primary analysis was on patients with UCS, distributed as follows: 40% stage I, 6% stage II, 31% stage III, 15% stage IV, and 8% recurrent. Among eligible patients with UCS, PC was assigned to 228 and PI to 221. PC was not inferior to PI. The median OS was 37 versus 29 months (HR = 0.87; 90% CI, 0.70 to 1.075; P < .01 for noninferiority, P > .1 for superiority). The median progression-free survival was 16 versus 12 months (HR = 0.73; P = < 0.01 for noninferiority, P < .01 for superiority). Toxicities were similar, except that more patients in the PC arm had hematologic toxicity and more patients in the PI arm had confusion and genitourinary hemorrhage. Among 90 eligible patients with OCS, those in the PC arm had longer OS (30 v 25 months) and progression-free survival (15 v 10 months) than those in the PI arm, but with limited precision, these differences were not statistically significant. CONCLUSION: PC was not inferior to the active regimen PI and should be standard treatment for UCS.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 20, 2022

Volume

40

Issue

9

Start / End Page

968 / 977

Location

United States

Related Subject Headings

  • Uterine Neoplasms
  • Paclitaxel
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Ifosfamide
  • Humans
  • Female
  • Disease-Free Survival
  • Carcinosarcoma
  • Carboplatin
 

Citation

APA
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MLA
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Powell, M. A., Filiaci, V. L., Hensley, M. L., Huang, H. Q., Moore, K. N., Tewari, K. S., … Miller, D. S. (2022). Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial. J Clin Oncol, 40(9), 968–977. https://doi.org/10.1200/JCO.21.02050
Powell, Matthew A., Virginia L. Filiaci, Martee L. Hensley, Helen Q. Huang, Kathleen N. Moore, Krishnansu S. Tewari, Larry J. Copeland, et al. “Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial.J Clin Oncol 40, no. 9 (March 20, 2022): 968–77. https://doi.org/10.1200/JCO.21.02050.
Powell MA, Filiaci VL, Hensley ML, Huang HQ, Moore KN, Tewari KS, et al. Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial. J Clin Oncol. 2022 Mar 20;40(9):968–77.
Powell, Matthew A., et al. “Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial.J Clin Oncol, vol. 40, no. 9, Mar. 2022, pp. 968–77. Pubmed, doi:10.1200/JCO.21.02050.
Powell MA, Filiaci VL, Hensley ML, Huang HQ, Moore KN, Tewari KS, Copeland LJ, Secord AA, Mutch DG, Santin A, Warshal DP, Spirtos NM, DiSilvestro PA, Ioffe OB, Miller DS. Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial. J Clin Oncol. 2022 Mar 20;40(9):968–977.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 20, 2022

Volume

40

Issue

9

Start / End Page

968 / 977

Location

United States

Related Subject Headings

  • Uterine Neoplasms
  • Paclitaxel
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Ifosfamide
  • Humans
  • Female
  • Disease-Free Survival
  • Carcinosarcoma
  • Carboplatin