Postoperative radiotherapy for stage I thymoma: a prospective randomized trial in 29 cases
N = 29
- Population
- 29 patients younger than 65 years with stage I thymoma, treated 1981-1996
- Design
- Prospective randomised trial: 29 patients with stage I thymoma (complete capsule, no microscopic capsular invasion), younger than 65 years, treated between August 1981 and January 1996, randomly assigned to surgery alone (13) or surgery with postoperative radiotherapy (16). First author's affiliation: Department of Radiotherapy, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing. The abstract does not state the randomisation method, allocation concealment, a primary end point, a power calculation or the length of follow-up. Survival was estimated by the Kaplan-Meier method; the abstract gives no confidence intervals, hazard ratio or P value. No recurrence or metastasis in either group; no acute or late radiological injury in the radiotherapy group; 3 patients died (1 of myasthenia gravis, 2 of intercurrent illness). No significant correlation between myasthenia gravis and radiotherapy was found.
- Arms
- Surgery alone (control, n = 13): Surgery without postoperative radiotherapy
- Surgery plus postoperative radiotherapy (experimental, n = 16): Radiotherapy started within 4 weeks after surgery with megavoltage radiation (isocentric technique, anterior field and/or two anterior oblique wedge fields): 50 Gy in 25 daily fractions over 5 weeks for the lymphocytic-predominant type, 60 Gy in 30 daily fractions over 6 weeks for the epithelial or mixed type
- People
- Zhang H, senior author Zhang D
Δ 60-month OS−4 points
Show the numbers
| Endpoint | Analysis | Surgery plus postoperative radiotherapy | Surgery alone | Effect |
|---|---|---|---|---|
| OSAll 29 randomised patients with stage I thymoma5- and 10-year survival rates (Kaplan-Meier), as printed | finalZhang 1999 | 88% at 5 y; 88% at 10 y | 92% at 5 y; 92% at 10 y | The abstract states there was no difference in survival between the groups and reports no statistical test. Three patients died in total (1 of myasthenia gravis, 2 of intercurrent illness). |
| Endpoint | Analysis | Surgery plus postoperative radiotherapy | Surgery alone | Effect |
|---|---|---|---|---|
| OSAll 29 randomised patients with stage I thymoma5- and 10-year survival rates (Kaplan-Meier), as printed | finalZhang 1999 | 88% at 5 y; 88% at 10 y | 92% at 5 y; 92% at 10 y | The abstract states there was no difference in survival between the groups and reports no statistical test. Three patients died in total (1 of myasthenia gravis, 2 of intercurrent illness). |
- Surgery alone (control)
- Surgery plus postoperative radiotherapy (experimental)
Data table (modelled values)
| Months | Surgery alone | Surgery plus postoperative radiotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 32 | 94.7% | 92.0% |
| 65 | 92.0% | 88.0% |
| 97 | 92.0% | 88.0% |
| 130 | 92.0% | 88.0% |
Appears in
Sources
Zhang H, Lu N, Wang M, Gu X, Zhang D. Postoperative radiotherapy for stage I thymoma: a prospective randomized trial in 29 cases. Chin Med J (Engl). 1999;112(2):136-8.