TY - JOUR
T1 - The GETUG SEMITEP Trial
T2 - De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
AU - Loriot, Yohann
AU - Texier, Matthieu
AU - Culine, Stéphane
AU - Fléchon, Aude
AU - Thiery-Vuillemin, Antoine
AU - Gravis, Gwenaëlle
AU - Geoffrois, Lionel
AU - Chevreau, Christine
AU - Gross-Goupil, Marine
AU - Barthelemy, Philippe
AU - Bompas, Emmanuelle
AU - Mahammedi, Hakim
AU - Laguerre, Brigitte
AU - Lacourtoisie, Sophie Abadie
AU - Helissey, Carole
AU - Ladoire, Sylvain
AU - Abraham, Christine
AU - Massard, Christophe
AU - Grimaldi, Serena
AU - Fizazi, Karim
N1 - Publisher Copyright:
© 2022
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Background: In metastatic seminoma, a strategy is needed for selecting patients for less intensive chemotherapy, to limit toxicities. Objective: To assess whether men with good-prognosis metastatic seminoma could be treated with two cycles of etoposide-cisplatin (EP) followed by only one cycle of carboplatin (CARBO) based on negative interim fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT). Design, setting, and participants: A nonrandomised, multicentre, phase 2 trial was conducted (NCT01887340). Intervention: All patients with baseline-positive FDG-PET/CT received EP for two cycles. After completing the first two cycles, the patients underwent a second FDG-PET/CT to assess the response. Patients with positive FDG-PET/CT proceeded directly to two additional EP cycles; those who achieved FDG-PET/CT negativity received one cycle of CARBO. Outcome measurements and statistical analysis: The proportion of patients with negative interim FDG-PET/CT who received carboplatin was determined. Results and limitations: Between 2013 and 2017, 102 patients were enrolled. After the first two EP cycles, FDG-PET/CT was available in 98 patients. Overall, 67 patients (68.4%; 95% confidence interval [CI]: 58.2–77.4) had negative FDG-PET/CT and proceeded to a single CARBO cycle. Twenty-seven patients (27.6%; 95% CI: 19.0–37.5) had positive FDG-PET/CT after two EP cycles. The 3-yr progression-free survival rate was 90.0% (95% CI: 74.4–96.5) in the EP group and 90.8% (95% CI: 81.4–95.7) in the CARBO group. The cumulative incidences of peripheral neuropathy and ototoxicity were significantly higher in the EP group. Conclusions: Omission of two cycles of EP based on negative FDG-PET/CT after two cycles of chemotherapy appears to be feasible. However, the absence of consensus criteria for FDG-PET/CT interpretation and the short follow-up need additional studies. This strategy does not warrant routine integration yet. Patient summary: Men with good-prognosis metastatic seminoma were treated with fewer cycles of chemotherapy based on interim fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT). Omission of two cycles of chemotherapy based on negative FDG-PET/CT after two initial cycles appears to be feasible, thereby limiting the burden of treatment and toxicity.
AB - Background: In metastatic seminoma, a strategy is needed for selecting patients for less intensive chemotherapy, to limit toxicities. Objective: To assess whether men with good-prognosis metastatic seminoma could be treated with two cycles of etoposide-cisplatin (EP) followed by only one cycle of carboplatin (CARBO) based on negative interim fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT). Design, setting, and participants: A nonrandomised, multicentre, phase 2 trial was conducted (NCT01887340). Intervention: All patients with baseline-positive FDG-PET/CT received EP for two cycles. After completing the first two cycles, the patients underwent a second FDG-PET/CT to assess the response. Patients with positive FDG-PET/CT proceeded directly to two additional EP cycles; those who achieved FDG-PET/CT negativity received one cycle of CARBO. Outcome measurements and statistical analysis: The proportion of patients with negative interim FDG-PET/CT who received carboplatin was determined. Results and limitations: Between 2013 and 2017, 102 patients were enrolled. After the first two EP cycles, FDG-PET/CT was available in 98 patients. Overall, 67 patients (68.4%; 95% confidence interval [CI]: 58.2–77.4) had negative FDG-PET/CT and proceeded to a single CARBO cycle. Twenty-seven patients (27.6%; 95% CI: 19.0–37.5) had positive FDG-PET/CT after two EP cycles. The 3-yr progression-free survival rate was 90.0% (95% CI: 74.4–96.5) in the EP group and 90.8% (95% CI: 81.4–95.7) in the CARBO group. The cumulative incidences of peripheral neuropathy and ototoxicity were significantly higher in the EP group. Conclusions: Omission of two cycles of EP based on negative FDG-PET/CT after two cycles of chemotherapy appears to be feasible. However, the absence of consensus criteria for FDG-PET/CT interpretation and the short follow-up need additional studies. This strategy does not warrant routine integration yet. Patient summary: Men with good-prognosis metastatic seminoma were treated with fewer cycles of chemotherapy based on interim fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT). Omission of two cycles of chemotherapy based on negative FDG-PET/CT after two initial cycles appears to be feasible, thereby limiting the burden of treatment and toxicity.
KW - Chemotherapy
KW - Fluorodeoxyglucose positron emission tomography
KW - Seminoma
KW - Testis cancer
UR - http://www.scopus.com/inward/record.url?scp=85130585221&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2022.04.031
DO - 10.1016/j.eururo.2022.04.031
M3 - Article
C2 - 35599187
AN - SCOPUS:85130585221
SN - 0302-2838
VL - 82
SP - 172
EP - 179
JO - European Urology
JF - European Urology
IS - 2
ER -