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] |