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Table 4. Completed clinical trials of mTOR inhibitors alone or in combination with chemotherapy in OC

From: The PI3K/Akt/mTOR pathway in ovarian cancer: therapeutic opportunities and challenges

Phase Treatment No. of all gynecologic cancer patients No. of OC patients Selected toxicities Efficacy Reference
II Temsirolimus (mTOR inhibitor) 54 54 Grade 3–4 gastrointestinal (10%), metabolic (15%), and pulmonary (6%) toxicities RR = 9% 6-month PFS rate = 24% Behbakht et al.[25]
Cohort Temsirolimus 6 6 All with hyperglycemia and hypertriglyceremia, resulted in treatment discontinuation in 1 patient PR rate = 20% Takano et al.[26]
I Temsirolimus + topotecan 15 7 Grade 3–4 neutropenia and thrombocytopenia RR = 0 One SD for 6 months Temkin et al.[28]
Ib Temsirolimus + PLD 20 NA Grade 3–4 fatigue (5%), nausea (16%), mucositis (21%), vomiting (16%), rash (11%), and hand-foot syndrome (21%) NA Boers-Sonderen et al.[29]
I Temsirolimus + carboplatin + paclitaxel 39 6 Grade 3–4 neutropenia (89%), thrombocytopenia (21%), and pulmonary toxicities (5%) RR = 50% (3/6) SD rate = 50% (3/6) Kollmannsberger et al.[30]
I Ridaforolimus + carboplatin + paclitaxel 22 9 Grade 3/4 myelotoxicity in 21 of 22 patients PR rate = 32% Chon et al.[31]
I Everolimus + paclitaxel 16 3 Grade 3 neutropenia, anemia, thrombocytopenia, mucositis, and fatigue NA Campone et al.[32]
II Temsorolimus + tranbectedin 17 17 (all clear cell OC) Not mentioned RR = 18% Takano et al.[33]
  1. PLD, pegylated liposomal doxorubicin; RR, response rate; PFS, progression-free survival; PR, partial response; SD, stable disease; NA, not available.