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. 2015 Jan;34(1):4–16. doi: 10.5732/cjc.014.10289

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

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% Behbakht et al.[25]
6-month PFS rate = 24%
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 Temkin et al.[28]
One SD for 6 months
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) Kollmannsberger et al.[30]
SD rate = 50% (3/6)
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]

PLD, pegylated liposomal doxorubicin; RR, response rate; PFS, progression-free survival; PR, partial response; SD, stable disease; NA, not available.