Neoadjuvant chemoradiotherapy for locally advanced thymic tumors: a phase II, multi-institutional clinical trial
Needs reviewPhase 2N = 22NCT00387868
- Population
- 22 accrued patients with thymoma or thymic carcinoma meeting CT criteria for locally advanced disease
- Design
- Single-arm pilot phase II trial at 4 institutions in patients with thymoma or thymic carcinoma who met specific computed tomography criteria for locally advanced disease. Induction: 2 cycles of cisplatin and etoposide with 45 Gy of thoracic radiotherapy; computed tomography and positron emission tomography before and after induction; resection attempted; postoperative chemoradiotherapy in selected patients. 22 patients were accrued over 5 years (1 withdrew before starting induction) and 21 completed induction. On computed tomography 10 had a partial radiographic response and 11 stable disease. Of 21 patients, 13 (62%) had thymic carcinoma or B3 thymoma and 15 (71%) had Masaoka stage III or IV disease. The primary end point was the pathologic response to induction therapy; secondary end points were toxicity, surgical complications, radiographic response and R0 resection rate.
- Primary endpoint
- Pathological response
- Arms
- Induction cisplatin-etoposide with radiotherapy, then resection (experimental, n = 22): Two cycles of cisplatin and etoposide with 45 Gy thoracic radiotherapy; then attempted resection; postoperative chemoradiotherapy in selected patients
- People
- Korst RJ, senior author Keshavjee S
Show the numbers
| Endpoint | Analysis | Induction cisplatin-etoposide with radiotherapy, then resection | Control | Effect |
|---|---|---|---|---|
| R0 resectionAs printed in the abstract: 17 R0, 3 R1 (14%) and 1 debulking (5%); the denominator is unclear (see note) | finalKorst 2014 | 77% | — | The abstract writes 'Of the 21 patients, 17 (77%)'; 17 of 22 is 77% and 17 of 21 is 81%, and the R1 and debulking percentages (3 and 1) also match 22, so the denominator in the abstract text is not consistent with its percentages. Reported as printed; the full text could not be read. |
| Pathological responseFive resected specimens with less than 10% viable tumour (24% as printed; 5 of 21 is 24%)Resected specimens with less than 10% viable tumour; no patient had a complete pathologic response | primaryKorst 2014 | 24% | — | — |
| Grade 3 or 4 adverse eventsPrinted as 9 (41%) among 22 accrued patients (9 of 22 is 41%) | finalKorst 2014 | 41% | — | Printed as 'Of the 22 patients, 21 completed induction therapy, and 9 (41%) experienced grade 3 or 4 toxicity'. |
| Surgical complicationsEight patients (36%) as printed; the percentage matches 8 of 22 accrued patients (8 of 21 would be 38%) | finalKorst 2014 | 36% | — | — |
| Postoperative deathTwo patients (9%) as printed; the percentage matches 2 of 22 accrued patients (2 of 21 would be 10%) | finalKorst 2014 | 9% | — | The abstract does not state the time window for postoperative death. |
| Endpoint | Analysis | Induction cisplatin-etoposide with radiotherapy, then resection | Control | Effect |
|---|---|---|---|---|
| R0 resectionAs printed in the abstract: 17 R0, 3 R1 (14%) and 1 debulking (5%); the denominator is unclear (see note) | finalKorst 2014 | 77% | — | The abstract writes 'Of the 21 patients, 17 (77%)'; 17 of 22 is 77% and 17 of 21 is 81%, and the R1 and debulking percentages (3 and 1) also match 22, so the denominator in the abstract text is not consistent with its percentages. Reported as printed; the full text could not be read. |
| Pathological responseFive resected specimens with less than 10% viable tumour (24% as printed; 5 of 21 is 24%)Resected specimens with less than 10% viable tumour; no patient had a complete pathologic response | primaryKorst 2014 | 24% | — | — |
| Grade 3 or 4 adverse eventsPrinted as 9 (41%) among 22 accrued patients (9 of 22 is 41%) | finalKorst 2014 | 41% | — | Printed as 'Of the 22 patients, 21 completed induction therapy, and 9 (41%) experienced grade 3 or 4 toxicity'. |
| Surgical complicationsEight patients (36%) as printed; the percentage matches 8 of 22 accrued patients (8 of 21 would be 38%) | finalKorst 2014 | 36% | — | — |
| Postoperative deathTwo patients (9%) as printed; the percentage matches 2 of 22 accrued patients (2 of 21 would be 10%) | finalKorst 2014 | 9% | — | The abstract does not state the time window for postoperative death. |