The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography.
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Carboplatin
/ adverse effects
Fluorodeoxyglucose F18
Humans
Male
Positron Emission Tomography Computed Tomography
/ methods
Positron-Emission Tomography
Prognosis
Radiopharmaceuticals
/ therapeutic use
Seminoma
/ diagnostic imaging
Testicular Neoplasms
/ diagnostic imaging
Treatment Outcome
Chemotherapy
Fluorodeoxyglucose positron emission tomography
Seminoma
Testis cancer
Journal
European urology
ISSN: 1873-7560
Titre abrégé: Eur Urol
Pays: Switzerland
ID NLM: 7512719
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
received:
08
01
2022
revised:
13
04
2022
accepted:
28
04
2022
pubmed:
23
5
2022
medline:
14
7
2022
entrez:
22
5
2022
Statut:
ppublish
Résumé
In metastatic seminoma, a strategy is needed for selecting patients for less intensive chemotherapy, to limit toxicities. 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). A nonrandomised, multicentre, phase 2 trial was conducted (NCT01887340). 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. The proportion of patients with negative interim FDG-PET/CT who received carboplatin was determined. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 35599187
pii: S0302-2838(22)02330-2
doi: 10.1016/j.eururo.2022.04.031
pii:
doi:
Substances chimiques
Radiopharmaceuticals
0
Fluorodeoxyglucose F18
0Z5B2CJX4D
Carboplatin
BG3F62OND5
Banques de données
ClinicalTrials.gov
['NCT01887340']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
172-179Informations de copyright
Copyright © 2022. Published by Elsevier B.V.