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A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung cancer
1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul 135-710, Korea.
Background:
The mammalian target of rapamycin (mTOR) pathway is dysregulated in small-cell lung cancer (SCLC) and everolimus is an oral mTOR inhibitor.
Methods:
This phase-1b study assessed everolimus safety at the levels of 2.5, 5, or 10 mg once daily in combination with paclitaxel (175 mg m(-2)) once every 3 weeks in previously treated SCLC patients. The primary end point was to determine the maximum tolerated dose of everolimus.
Results:
Among 21 enrolled patients, common drug-related adverse events were anaemia, neutropenia, thrombocytopenia, pain, hyperglycemia, and stomatitis. Out of 11 evaluable patients treated with everolimus at the level of 5 mg, 1 patient experienced dose-limiting toxicity (DLT) of grade 4 febrile neutropenia and grade 3 thrombocytopenia. The other two DLTs (grade 4 thrombocytopenia and grade 3 hyperglycemia) occurred in two out of three patients receiving everolimus 10 mg. The overall objective response rate was 28%.
Conclusion:
Everolimus showed an acceptable safety profile and preliminary antitumour activity at the dose of 5 mg once daily when combined with 3-weekly paclitaxel 175 mg m(-2) in patients with SCLC.
Insights
Everolimus combined with paclitaxel shows preliminary anti-tumor activity in small-cell lung cancer (SCLC). A daily dose of 5 mg everolimus demonstrated an acceptable safety profile in this phase-1b study.
Area of Science:
- Oncology
- Pharmacology
Background:
- The mammalian target of rapamycin (mTOR) pathway is frequently dysregulated in small-cell lung cancer (SCLC).
- Everolimus is an orally available inhibitor targeting the mTOR pathway.
Purpose of the Study:
- To assess the safety and determine the maximum tolerated dose (MTD) of everolimus in combination with paclitaxel in previously treated SCLC patients.
- To evaluate the preliminary anti-tumor activity of this combination therapy.
Main Methods:
- Phase 1b clinical trial involving 21 previously treated SCLC patients.
- Dose escalation of everolimus (2.5, 5, or 10 mg daily) combined with paclitaxel (175 mg/m² every 3 weeks).
- Primary endpoint was determination of the MTD; secondary endpoints included objective response rate and safety assessment.
Main Results:
- Common adverse events included anemia, neutropenia, thrombocytopenia, pain, hyperglycemia, and stomatitis.
- Dose-limiting toxicities (DLTs) were observed at higher everolimus doses (5 mg and 10 mg).
- An overall objective response rate of 28% was recorded.
Conclusions:
- Everolimus at a dose of 5 mg once daily, combined with paclitaxel 175 mg/m² every 3 weeks, demonstrated an acceptable safety profile.
- This combination exhibited preliminary anti-tumor activity in patients with previously treated SCLC.
