SEMPET
2-18fluoro-deoxy-D-glucose positron emission tomography is a reliable predictor for viable tumor in postchemotherapy seminoma: an update of the prospective multicentric SEMPET trial
Phase observationalN = 51
- Population
- Patients with metastatic pure seminoma and radiographically defined postchemotherapy residual masses
- Design
- Prospective multicentre study. FDG-PET of postchemotherapy residual masses (1 cm or larger) in patients with metastatic pure seminoma was correlated with histology of the resected lesion or with clinical outcome on follow-up (CT, tumour markers, physical examination). The initial report had 37 scans in 33 patients at median follow-up of 23 months; the update had 56 scans in 51 patients.
- Arms
- CT size criterion (control): Residual lesion size on CT, above 3 cm versus 3 cm or less
- FDG-PET (experimental, n = 51): 2-18fluoro-2-deoxy-D-glucose positron emission tomography of the residual mass
- People
- De Santis M
Δ Specificity+26 pointsΔ Sensitivity+10 pointsΔ Positive predictive value+63 pointsΔ Negative predictive value+4 points
Show the numbers
| Endpoint | Analysis | FDG-PET | CT size criterion | Effect |
|---|---|---|---|---|
| Specificity51 patients, 56 assessable scans | long term-updateDe 2004 | 100% (92–100%) | 74% (58–85%) | All 19 residual lesions above 3 cm and 35 (95%) of 37 lesions of 3 cm or less were correctly predicted by FDG-PET. |
| Sensitivity51 patients, 56 assessable scans | long term-updateDe 2004 | 80% (44–95%) | 70% (34–90%) | — |
| Positive predictive value51 patients, 56 assessable scans | long term-updateDe 2004 | 100% | 37% | — |
| Negative predictive value51 patients, 56 assessable scans | long term-updateDe 2004 | 96% | 92% | — |
| Specificity33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 100% (87.7–100.0%) | — | Twenty-eight scans true-negative, eight true-positive and one false-negative. All 14 residual lesions above 3 cm and 22 (96%) of 23 lesions of 3 cm or less were correctly predicted. The abstract states that PET's specificity, sensitivity and predictive values were superior to residual tumour size. |
| Sensitivity33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 89% (51.7–99.7%) | — | — |
| Positive predictive value33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 100% | — | — |
| Negative predictive value33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 97% | — | — |
| Endpoint | Analysis | FDG-PET | CT size criterion | Effect |
|---|---|---|---|---|
| Specificity51 patients, 56 assessable scans | long term-updateDe 2004 | 100% (92–100%) | 74% (58–85%) | All 19 residual lesions above 3 cm and 35 (95%) of 37 lesions of 3 cm or less were correctly predicted by FDG-PET. |
| Sensitivity51 patients, 56 assessable scans | long term-updateDe 2004 | 80% (44–95%) | 70% (34–90%) | — |
| Positive predictive value51 patients, 56 assessable scans | long term-updateDe 2004 | 100% | 37% | — |
| Negative predictive value51 patients, 56 assessable scans | long term-updateDe 2004 | 96% | 92% | — |
| Specificity33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 100% (87.7–100.0%) | — | Twenty-eight scans true-negative, eight true-positive and one false-negative. All 14 residual lesions above 3 cm and 22 (96%) of 23 lesions of 3 cm or less were correctly predicted. The abstract states that PET's specificity, sensitivity and predictive values were superior to residual tumour size. |
| Sensitivity33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 89% (51.7–99.7%) | — | — |
| Positive predictive value33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 100% | — | — |
| Negative predictive value33 patients, 37 assessable scans | primarymedian follow-up 23 monthsDe 2001 | 97% | — | — |
Appears in
Sources
De Santis M, Bokemeyer C, Becherer A, Stoiber F, Oechsle K, Kletter K, et al. Predictive impact of 2-18fluoro-2-deoxy-D-glucose positron emission tomography for residual postchemotherapy masses in patients with bulky seminoma. J Clin Oncol. 2001;19(17):3740-4.
De Santis M, Becherer A, Bokemeyer C, Stoiber F, Oechsle K, Sellner F, et al. 2-18fluoro-deoxy-D-glucose positron emission tomography is a reliable predictor for viable tumor in postchemotherapy seminoma: an update of the prospective multicentric SEMPET trial. J Clin Oncol. 2004;22(6):1034-9.