Cisplatin plus doxorubicin plus cyclophosphamide in metastatic or recurrent thymoma: final results of an intergroup trial. The Eastern Cooperative Oncology Group, Southwest Oncology Group, and Southeastern Cancer Study Group
N = 30
- Population
- 30 assessable patients (29 thymoma, 1 thymic carcinoma) with metastatic or locally progressive recurrent disease following radiotherapy.
- Design
- Intergroup trial (Eastern Cooperative Oncology Group, Southwest Oncology Group, Southeastern Cancer Study Group). Intravenous cisplatin 50 mg/m2, doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (PAC) with saline hydration every 3 weeks for a maximum of eight cycles. The abstract reports 30 assessable patients and does not name a phase or response criteria.
- Arms
- PAC (experimental, n = 30): Cisplatin 50 mg/m2, doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for a maximum of eight cycles
- People
- Loehrer PJ Sr, Eastern Cooperative Oncology Group, Southwest Oncology Group and Southeastern Cancer Study Group
Show the numbers
| Endpoint | Analysis | PAC | Control | Effect |
|---|---|---|---|---|
| ORR30 assessable patients (29 thymoma, 1 thymic carcinoma) | finalLoehrer 1994 | 50% (31.3–68.7%) | — | Three complete and 12 partial responses; ten patients had stable disease. Median duration of response 11.8 months (range 0.9 to 70.5+) and time to treatment failure 18.4 months (range 0.8 to 91.9+). Toxicity was primarily haematological and mild, with one patient developing fever associated with neutropenia. |
| OS30 assessable patients (29 thymoma, 1 thymic carcinoma) | finalLoehrer 1994 | median 37.7 months | — | Median survival time 37.7 months (range 2 to 91.9+); no confidence interval is printed. |
| Endpoint | Analysis | PAC | Control | Effect |
|---|---|---|---|---|
| ORR30 assessable patients (29 thymoma, 1 thymic carcinoma) | finalLoehrer 1994 | 50% (31.3–68.7%) | — | Three complete and 12 partial responses; ten patients had stable disease. Median duration of response 11.8 months (range 0.9 to 70.5+) and time to treatment failure 18.4 months (range 0.8 to 91.9+). Toxicity was primarily haematological and mild, with one patient developing fever associated with neutropenia. |
| OS30 assessable patients (29 thymoma, 1 thymic carcinoma) | finalLoehrer 1994 | median 37.7 months | — | Median survival time 37.7 months (range 2 to 91.9+); no confidence interval is printed. |
- PAC (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | PAC |
|---|---|
| 0 | 100.0% |
| 24 | 64.3% |
| 47 | 42.1% |
| 71 | 27.1% |
| 94 | 17.8% |
Appears in
Sources
Loehrer PJ Sr, Kim K, Aisner SC, Livingston R, Einhorn LH, Johnson D, et al. Cisplatin plus doxorubicin plus cyclophosphamide in metastatic or recurrent thymoma: final results of an intergroup trial. The Eastern Cooperative Oncology Group, Southwest Oncology Group, and Southeastern Cancer Study Group. J Clin Oncol. 1994;12(6):1164-8.