Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report
Phase 2N = 22
- Population
- 22 patients (9 men, 13 women) with histologically confirmed invasive thymoma and locally advanced unresectable disease
- Design
- Single-arm phase II study (PubMed lists an affiliation only for the first author, The University of Texas M.D. Anderson Cancer Center, Houston, and also tags the record 'Multicenter Study'; the abstract names neither the centres nor the number of centres) in 22 patients with histologically confirmed invasive thymoma (stage III 11, IVA 10, IVB 1; median age 47 years, range 25-70): three courses of induction chemotherapy, surgical resection, radiation therapy for all, and three courses of consolidation chemotherapy. 21 patients underwent surgical exploration (one refused surgery); 19 of 22 completed the planned therapy. Median follow-up 50.3 months. The abstract describes the purpose as evaluating resectability after induction chemotherapy and DFS and OS; it does not use the term primary endpoint.
- Arms
- Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy (experimental, n = 22): Three courses every 3-4 weeks of cyclophosphamide 500 mg/m2 on day 1, doxorubicin 20 mg/m2 per day on days 1-3 by continuous infusion (60 mg/m2 total), cisplatin 30 mg/m2 per day on days 1-3 (90 mg/m2 total) and prednisone 100 mg per day on days 1-5; then surgical resection and radiation therapy; then three courses of consolidation chemotherapy at 80% of the cyclophosphamide, doxorubicin and cisplatin doses and 100% of the prednisone dose
- People
- Kim ES, senior author Shin DM
Show the numbers
| Endpoint | Analysis | Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy | Control | Effect |
|---|---|---|---|---|
| ORRAll 22 patients: 17 major responses, of which 3 (14%) complete and 14 (63%) partialMajor responses to induction chemotherapy (complete plus partial response), as printed | finalKim 2004 | 77% | — | — |
| Complete resection rate21 patients who underwent surgical exploration (16 complete, 5 incomplete resections) | finalKim 2004 | 76% | — | — |
| OSAll 22 registered patients | finalmedian follow-up 50.3 monthsKim 2004 | 95% at 5 y; 79% at 7 y | — | 95% confidence intervals as printed (fractions): 0.87-1.0 at 5 years and 0.55-1.0 at 7 years. Of the 22 patients, 20 were alive at the time of analysis (one died of endocarditis, one of recurrent disease). |
| PFSAll 22 registered patients | finalmedian follow-up 50.3 monthsKim 2004 | 77% at 5 y; 77% at 7 y | — | 95% confidence intervals as printed (fractions): 0.58-1.0 at both time points. Of the 19 patients who completed the multidisciplinary approach, 18 were disease-free at analysis. |
| Endpoint | Analysis | Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy | Control | Effect |
|---|---|---|---|---|
| ORRAll 22 patients: 17 major responses, of which 3 (14%) complete and 14 (63%) partialMajor responses to induction chemotherapy (complete plus partial response), as printed | finalKim 2004 | 77% | — | — |
| Complete resection rate21 patients who underwent surgical exploration (16 complete, 5 incomplete resections) | finalKim 2004 | 76% | — | — |
| OSAll 22 registered patients | finalmedian follow-up 50.3 monthsKim 2004 | 95% at 5 y; 79% at 7 y | — | 95% confidence intervals as printed (fractions): 0.87-1.0 at 5 years and 0.55-1.0 at 7 years. Of the 22 patients, 20 were alive at the time of analysis (one died of endocarditis, one of recurrent disease). |
| PFSAll 22 registered patients | finalmedian follow-up 50.3 monthsKim 2004 | 77% at 5 y; 77% at 7 y | — | 95% confidence intervals as printed (fractions): 0.58-1.0 at both time points. Of the 19 patients who completed the multidisciplinary approach, 18 were disease-free at analysis. |
- Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy (experimental)
Data table (modelled values)
| Months | Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy |
|---|---|
| 0 | 100.0% |
| 23 | 99.2% |
| 45 | 97.7% |
| 68 | 91.2% |
| 91 | 79.0% |
- Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy (experimental)
Data table (modelled values)
| Months | Induction chemotherapy, surgery, radiation therapy, consolidation chemotherapy |
|---|---|
| 0 | 100.0% |
| 23 | 89.1% |
| 45 | 79.5% |
| 68 | 77.0% |
| 91 | 77.0% |
Appears in
Sources
Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, et al. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004;44(3):369-79.