Sunitinib in patients with chemotherapy-refractory thymoma and thymic carcinoma: an open-label phase 2 trial
Phase 2N = 41NCT01621568
- Population
- Patients with histologically confirmed chemotherapy-refractory thymic epithelial tumours (disease progression after at least one platinum-containing regimen, ECOG performance status 2 or lower, measurable disease); 41 enrolled (25 thymic carcinoma, 16 thymoma).
- Design
- Open-label phase 2 trial, 15 May 2012 to 2 October 2013. Sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment followed by 2 weeks without) until progression or unacceptable toxicity. Primary endpoint: investigator-assessed best tumour response at any point, analysed separately in thymoma and thymic carcinoma cohorts; patients who received at least one cycle and were reassessed were included in the response analyses. Funded by the National Cancer Institute (Cancer Therapy Evaluation Program).
- Primary endpoint
- Best tumour response
- Arms
- Thymic carcinoma cohort (experimental, n = 25): Sunitinib 50 mg orally once daily in 6-week cycles (4 weeks on, 2 weeks off)
- Thymoma cohort (experimental, n = 16): Sunitinib 50 mg orally once daily in 6-week cycles (4 weeks on, 2 weeks off)
- People
- Thomas A
Show the numbers
| Endpoint | Analysis | Thymic carcinoma cohort / Thymoma cohort | Control | Effect |
|---|---|---|---|---|
| ORRAssessable patients: 23 with thymic carcinoma (of 25 enrolled) and 16 with thymoma | primarymedian follow-up 17 monthsThomas 2015 | 26% (10.2–48.4%) | — | The paper's primary endpoint is investigator-assessed best tumour response; every response reported was a partial response (6 of 23 in thymic carcinoma, 1 of 16 in thymoma). The 90% confidence interval for thymic carcinoma is 12.1-45.3. Stable disease in 15 patients (65%) with thymic carcinoma and 12 (75%) with thymoma; progressive disease in 2 (9%) and 3 (19%). Median follow-up 17 months (IQR 14.0-18.4). The most common grade 3 and 4 treatment-related adverse events were lymphocytopenia, fatigue and oral mucositis (8 of 40 patients [20%] each); left-ventricular ejection fraction decreased in 5 (13%), grade 3 in 3 (8%); 3 patients (8%) died during treatment, including one cardiac arrest that was possibly treatment-related. |
| Endpoint | Analysis | Thymic carcinoma cohort / Thymoma cohort | Control | Effect |
|---|---|---|---|---|
| ORRAssessable patients: 23 with thymic carcinoma (of 25 enrolled) and 16 with thymoma | primarymedian follow-up 17 monthsThomas 2015 | 26% (10.2–48.4%) | — | The paper's primary endpoint is investigator-assessed best tumour response; every response reported was a partial response (6 of 23 in thymic carcinoma, 1 of 16 in thymoma). The 90% confidence interval for thymic carcinoma is 12.1-45.3. Stable disease in 15 patients (65%) with thymic carcinoma and 12 (75%) with thymoma; progressive disease in 2 (9%) and 3 (19%). Median follow-up 17 months (IQR 14.0-18.4). The most common grade 3 and 4 treatment-related adverse events were lymphocytopenia, fatigue and oral mucositis (8 of 40 patients [20%] each); left-ventricular ejection fraction decreased in 5 (13%), grade 3 in 3 (8%); 3 patients (8%) died during treatment, including one cardiac arrest that was possibly treatment-related. |