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A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial.

Publication ,  Journal Article
Farley, JH; Brady, WE; O'Malley, D; Fujiwara, K; Yonemori, K; Bonebrake, A; Secord, AA; Stephan, J-M; Walker, JL; Nam, J-H; Birrer, MJ; Gershenson, DM
Published in: Gynecol Oncol
December 2022

OBJECTIVE: The primary objective of the study was to estimate the 12-month progression-free survival (PFS) for carboplatin/paclitaxel + temsirolimus in women with newly diagnosed clear cell ovarian cancer (CCOC), compared to historical controls in this patient population. METHODS: Patients with Stage III or IV CCOC were treated with Paclitaxel 175 mg/m2 on Day 1, Carboplatin AUC 6 Day 1, and temsirolimus (CCI-779) 25 mg IV Days 1 and 8 every 3 weeks for Cycles 1-6 or disease progression, followed by consolidation therapy with temsirolimus 25 mg Days 1, 8, and 15 every 3 weeks cycles 7-17 or until disease progression. RESULTS: Ninety patients were accrued to the study: 45 in the US and Korea (US/Korea) and 45 in Japan. Twenty-two percent received ≤6 cycles of therapy while 28% completed all 17 cycles of chemotherapy. Median PFS (OS) was 11 (23) months for US/Korea and 12 (26) months for Japan. In the US, none of suboptimally debulked patients had PFS >12 months, and 49% of optimal patients did, compared to 25% and 59% in Japan. Most common grade 3-4 adverse events were neutropenia, leukopenia, anemia, thrombocytopenia, hypertension, hypertriglyceridemia, and oral mucositis. CONCLUSION: The carboplatin/paclitaxel + temsirolimus regimen was well tolerated. In optimally debulked patients, 54% had a PFS >12 months. This regimen did not statistically significantly increase PFS at 12 months compared to historical controls. No statistically significant differences in PFS or OS were observed between US/Korea vs Japan, or Asians vs non-Asians.

Duke Scholars

Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

December 2022

Volume

167

Issue

3

Start / End Page

423 / 428

Location

United States

Related Subject Headings

  • Thrombocytopenia
  • Paclitaxel
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Humans
  • Female
  • Disease Progression
  • Carboplatin
  • Antineoplastic Combined Chemotherapy Protocols
  • 3215 Reproductive medicine
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Farley, J. H., Brady, W. E., O’Malley, D., Fujiwara, K., Yonemori, K., Bonebrake, A., … Gershenson, D. M. (2022). A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial. Gynecol Oncol, 167(3), 423–428. https://doi.org/10.1016/j.ygyno.2022.10.006
Farley, John H., William E. Brady, David O’Malley, Keiichi Fujiwara, Kan Yonemori, Albert Bonebrake, Angeles Alvarez Secord, et al. “A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial.Gynecol Oncol 167, no. 3 (December 2022): 423–28. https://doi.org/10.1016/j.ygyno.2022.10.006.
Farley JH, Brady WE, O’Malley D, Fujiwara K, Yonemori K, Bonebrake A, et al. A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial. Gynecol Oncol. 2022 Dec;167(3):423–8.
Farley, John H., et al. “A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial.Gynecol Oncol, vol. 167, no. 3, Dec. 2022, pp. 423–28. Pubmed, doi:10.1016/j.ygyno.2022.10.006.
Farley JH, Brady WE, O’Malley D, Fujiwara K, Yonemori K, Bonebrake A, Secord AA, Stephan J-M, Walker JL, Nam J-H, Birrer MJ, Gershenson DM. A phase II evaluation of temsirolimus with carboplatin and paclitaxel followed by temsirolimus consolidation in clear cell ovarian cancer: An NRG oncology trial. Gynecol Oncol. 2022 Dec;167(3):423–428.
Journal cover image

Published In

Gynecol Oncol

DOI

EISSN

1095-6859

Publication Date

December 2022

Volume

167

Issue

3

Start / End Page

423 / 428

Location

United States

Related Subject Headings

  • Thrombocytopenia
  • Paclitaxel
  • Ovarian Neoplasms
  • Oncology & Carcinogenesis
  • Humans
  • Female
  • Disease Progression
  • Carboplatin
  • Antineoplastic Combined Chemotherapy Protocols
  • 3215 Reproductive medicine