Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial
Needs reviewPhase 2N = 42NCT00003283
- Population
- Patients with unresectable, advanced thymoma or thymic carcinoma and a positive pretreatment octreotide scan; 42 entered, 38 fully assessable.
- Design
- Eastern Cooperative Oncology Group phase II trial in patients with unresectable, advanced thymic malignancies and a positive pretreatment octreotide scan: 42 entered, 38 fully assessable (one with inconclusive histology, three with a negative octreotide scan). Octreotide 0.5 mg subcutaneously three times daily; at 2 months responders continued octreotide alone, patients with progression were removed and all others received prednisone 0.6 mg/kg orally (printed as 'qid') for a maximum of 1 year. The abstract states the aim as determining objective response rate, duration of remission and toxicity.
- Arms
- Octreotide, with prednisone added at 2 months if not progressing (experimental, n = 42): Octreotide 0.5 mg subcutaneously three times daily; prednisone 0.6 mg/kg orally for a maximum of 1 year added after 2 months in patients who had not responded or progressed
- People
- Loehrer PJ Sr, Eastern Cooperative Oncology Group
Show the numbers
| Endpoint | Analysis | Octreotide, with prednisone added at 2 months if not progressing | Control | Effect |
|---|---|---|---|---|
| Complete response rateDenominator not stated in the abstract (38 of 42 entered were fully assessable) | finalLoehrer 2004 | 5.3% | — | Two complete responses (5.3% as printed, which equals 2 of 38). None of the six patients without pure thymoma responded. |
| Partial response rateDenominator not stated in the abstract (38 of 42 entered were fully assessable) | finalLoehrer 2004 | 25% | — | Ten partial responses (25% as printed): four with octreotide alone, the remainder with octreotide plus prednisone. The printed percentages do not share one denominator: 10 of 38 would be 26.3%, whereas 25% equals 10 of 40; the abstract does not say which patients each percentage is based on. |
| OSPatients as analysed in the abstract (denominator for survival not stated) | finalLoehrer 2004 | 86.6% at 12 mo; 75.7% at 2 y | — | 1-year and 2-year survival rates; no confidence intervals are printed. Patients with ECOG performance status 0 lived significantly longer than those with performance status 1 (P = .031). |
| Endpoint | Analysis | Octreotide, with prednisone added at 2 months if not progressing | Control | Effect |
|---|---|---|---|---|
| Complete response rateDenominator not stated in the abstract (38 of 42 entered were fully assessable) | finalLoehrer 2004 | 5.3% | — | Two complete responses (5.3% as printed, which equals 2 of 38). None of the six patients without pure thymoma responded. |
| Partial response rateDenominator not stated in the abstract (38 of 42 entered were fully assessable) | finalLoehrer 2004 | 25% | — | Ten partial responses (25% as printed): four with octreotide alone, the remainder with octreotide plus prednisone. The printed percentages do not share one denominator: 10 of 38 would be 26.3%, whereas 25% equals 10 of 40; the abstract does not say which patients each percentage is based on. |
| OSPatients as analysed in the abstract (denominator for survival not stated) | finalLoehrer 2004 | 86.6% at 12 mo; 75.7% at 2 y | — | 1-year and 2-year survival rates; no confidence intervals are printed. Patients with ECOG performance status 0 lived significantly longer than those with performance status 1 (P = .031). |
- Octreotide, with prednisone added at 2 months if not progressing (experimental)
Data table (modelled values)
| Months | Octreotide, with prednisone added at 2 months if not progressing |
|---|---|
| 0 | 100.0% |
| 6 | 93.1% |
| 13 | 85.6% |
| 19 | 80.1% |
| 26 | 75.7% |