Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma
Phase 2N = 46
- Population
- Patients with advanced, previously untreated, unresectable thymoma (n=21) or thymic carcinoma (n=23).
- Design
- Prospective multicentre phase II study, February 2001 to January 2008: 46 patients enrolled. Carboplatin (AUC 6) plus paclitaxel (225 mg/m2) every 3 weeks for a maximum of six cycles. Thymoma (n=21) and thymic carcinoma (n=23) cohorts were reported separately (the two cohort sizes printed add to 44, whereas 46 patients were enrolled; the full text explains that one patient withdrew consent before any chemotherapy and one was ineligible, leaving 44 in the primary analysis and 45 in the toxicity analysis). Primary endpoint: objective response rate by RECIST 1.0.
- Primary endpoint
- ORR
- Arms
- Thymoma cohort (experimental, n = 21): Carboplatin AUC 6 plus paclitaxel 225 mg/m2 every 3 weeks for a maximum of six cycles
- Thymic carcinoma cohort (experimental, n = 23): Carboplatin AUC 6 plus paclitaxel 225 mg/m2 every 3 weeks for a maximum of six cycles
- People
- Lemma GL, Eastern Cooperative Oncology Group
Show the numbers
| Endpoint | Analysis | Thymoma cohort / Thymic carcinoma cohort | Control | Effect |
|---|---|---|---|---|
| ORRThymoma cohort (n=21) and thymic carcinoma cohort (n=23): the 44 patients in the primary analysis (full text) | primaryLemma 2011 | 42.9% | — | The intervals printed are 90% confidence intervals (not 95%): 24.5-62.8 for thymoma and 9.0-40.4 for thymic carcinoma. Thymoma: 3 complete and 6 partial responses, 10 stable disease. Thymic carcinoma: no complete responses, 5 partial responses, 12 stable disease. RECIST 1.0. Thirteen patients had grade 4 or worse toxicity, mostly neutropenia. |
| PFSThymoma cohort (n=21) and thymic carcinoma cohort (n=23): the 44 patients in the primary analysis (full text) | primaryLemma 2011 | median 16.7 months (7.2–19.8) | — | — |
| OSThymic carcinoma cohort (n=23) | primaryLemma 2011 | median 20 months (5.0–43.6) | — | At the time of reporting 7 patients (33.3%) with thymoma and 16 patients (69.6%) with thymic carcinoma had died; median survival time had not been reached for thymoma. |
| Endpoint | Analysis | Thymoma cohort / Thymic carcinoma cohort | Control | Effect |
|---|---|---|---|---|
| ORRThymoma cohort (n=21) and thymic carcinoma cohort (n=23): the 44 patients in the primary analysis (full text) | primaryLemma 2011 | 42.9% | — | The intervals printed are 90% confidence intervals (not 95%): 24.5-62.8 for thymoma and 9.0-40.4 for thymic carcinoma. Thymoma: 3 complete and 6 partial responses, 10 stable disease. Thymic carcinoma: no complete responses, 5 partial responses, 12 stable disease. RECIST 1.0. Thirteen patients had grade 4 or worse toxicity, mostly neutropenia. |
| PFSThymoma cohort (n=21) and thymic carcinoma cohort (n=23): the 44 patients in the primary analysis (full text) | primaryLemma 2011 | median 16.7 months (7.2–19.8) | — | — |
| OSThymic carcinoma cohort (n=23) | primaryLemma 2011 | median 20 months (5.0–43.6) | — | At the time of reporting 7 patients (33.3%) with thymoma and 16 patients (69.6%) with thymic carcinoma had died; median survival time had not been reached for thymoma. |
- Thymoma cohort (experimental)
- Thymic carcinoma cohort (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Thymoma cohort | Thymic carcinoma cohort |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 10 | 66.0% | 25.0% |
| 21 | 41.8% | 5.4% |
| 31 | 27.6% | 1.4% |
| 42 | 17.5% | 0.3% |
- Thymic carcinoma cohort (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Thymic carcinoma cohort |
|---|---|
| 0 | 100.0% |
| 13 | 63.7% |
| 25 | 42.0% |
| 38 | 26.8% |
| 50 | 17.7% |