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

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. 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. 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. 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.

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Déclaration de conflit d'intérêts

Conflicts of interest With the exception of Dr. Gershenson, Secord and Yonemari (see details below), the co-authors have no conflicts of interest to declare. Dr. David Gershenson who reports grants received from Novartis in support of GOG-0281 to his Institution. Dr. Gershenson also reports that he received personal payments from Elsevier and UpToDte as well as personal consulting fees received from Genentech and Springworks. Dr. Gershenson also reports receiving stocks from Biogen, Inc., Johnson & Johnson and Bristol Myers Squibb. Dr. Secord reports receiving grant funding from the National Cancer Trial Network to her institution. She also reports clinical trial grants from Abbvie, Amgen, AstraZeneca, Boehringer Ingelheim, Clovis, Eisai, Immutep Ltd., Merck, Oncoquest PharmaMar, Roche/Genentech, Seagen Inc., Tesaro/GSK and VBL Therapeutics. Dr. Secord additionally reports receiving consulting fees from AstraZeneca, Clovis, Cordgenics, Eisai, Merck and Myriad as well as support for travel to attend Advisory Board meetings from AbbVie, Eisai and Tesaro. Dr. Secord served on the SGO Board of Directors, GOG Foundation Board of Directors and AAOGF Board of Trustees. Further to that, Dr. Secord reports receiving an experimental agent from Genentech for preclinical studies and participated on uncompensated advisory boards for Abbvie, Aravive, GSK, Regeneron and Tesaro as well as uncompensated Clinical Trial Steering Committees for Genentech/Roche, VBL Therapeutics and Oncoquest. Dr. Yonemori reports he received consulting fees from Novartis and Eisai. He also received honoraria for lectures from AstraZeneca, Eisai, Chugai, Takeda, Pfizer, and Eli Lilly.