SWENOTECA CS1 NSGCT
Risk-adapted treatment in clinical stage I nonseminomatous germ cell testicular cancer: the SWENOTECA management program
Phase observationalN = 745
- Population
- Patients with clinical stage I non-seminomatous germ-cell testicular cancer in Norway and Sweden
- Design
- Prospective, population-based, risk-adapted management programme in Norway and Sweden, non-randomised. Patients with vascular tumour invasion (VASC-positive) were recommended brief adjuvant BEP; VASC-negative patients could choose between adjuvant BEP and surveillance. 745 patients entered 1998 to 2005 (initial report); the 2014 report covers 517 patients who received one course of adjuvant BEP, with lymphovascular invasion (LVI) used as the risk factor.
- Arms
- Surveillance (control): Surveillance after orchidectomy; chosen by VASC-negative patients and by some VASC-positive patients (not randomised)
- Adjuvant BEP x 1 (experimental, n = 517): One course of adjuvant bleomycin, etoposide and cisplatin
- People
- Tandstad T, SWENOTECA
Δ Relapse rate−38.5 pointsΔ Relapse rate−11.9 points
Show the numbers
| Endpoint | Analysis | Adjuvant BEP x 1 | Surveillance | Effect |
|---|---|---|---|---|
| Relapse rateVASC-positive patients (vascular tumour invasion); non-randomised groups | interimmedian follow-up 4.7 yearsTandstad 2009 | 3.2% | 41.7% | Non-randomised groups; treatment followed the programme recommendation and patient choice, so the two rates are not a randomised comparison. 51 relapses overall in 745 patients. Eight patients had died, none from progressive disease. |
| Relapse rateVASC-negative patients; non-randomised groups | interimmedian follow-up 4.7 yearsTandstad 2009 | 1.3% | 13.2% | Non-randomised groups; VASC-negative patients chose between surveillance and BEP. |
| Relapse ratePatients with lymphovascular invasion who received one course of adjuvant BEP | long term-updatemedian follow-up 7.9 yearsTandstad 2014 | 3.2% at 5 y | — | Among 517 patients who received one course of BEP, 12 relapses occurred, all with IGCCC good prognosis; the latest relapse was 3.3 years after adjuvant treatment; 5-year cause-specific survival was 100%. |
| Relapse ratePatients without lymphovascular invasion who received one course of adjuvant BEP | long term-updatemedian follow-up 7.9 yearsTandstad 2014 | 1.6% at 5 y | — | — |
| Endpoint | Analysis | Adjuvant BEP x 1 | Surveillance | Effect |
|---|---|---|---|---|
| Relapse rateVASC-positive patients (vascular tumour invasion); non-randomised groups | interimmedian follow-up 4.7 yearsTandstad 2009 | 3.2% | 41.7% | Non-randomised groups; treatment followed the programme recommendation and patient choice, so the two rates are not a randomised comparison. 51 relapses overall in 745 patients. Eight patients had died, none from progressive disease. |
| Relapse rateVASC-negative patients; non-randomised groups | interimmedian follow-up 4.7 yearsTandstad 2009 | 1.3% | 13.2% | Non-randomised groups; VASC-negative patients chose between surveillance and BEP. |
| Relapse ratePatients with lymphovascular invasion who received one course of adjuvant BEP | long term-updatemedian follow-up 7.9 yearsTandstad 2014 | 3.2% at 5 y | — | Among 517 patients who received one course of BEP, 12 relapses occurred, all with IGCCC good prognosis; the latest relapse was 3.3 years after adjuvant treatment; 5-year cause-specific survival was 100%. |
| Relapse ratePatients without lymphovascular invasion who received one course of adjuvant BEP | long term-updatemedian follow-up 7.9 yearsTandstad 2014 | 1.6% at 5 y | — | — |
Appears in
Sources
Tandstad T, Dahl O, Cohn-Cedermark G, Cavallin-Stahl E, Stierner U, Solberg A, et al. Risk-adapted treatment in clinical stage I nonseminomatous germ cell testicular cancer: the SWENOTECA management program. J Clin Oncol. 2009;27(13):2122-8.
Tandstad T, Ståhl O, Håkansson U, Dahl O, Haugnes HS, Klepp OH, et al. One course of adjuvant BEP in clinical stage I nonseminoma mature and expanded results from the SWENOTECA group. Ann Oncol. 2014;25(11):2167-2172.