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The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron
Yohann Loriot1, Matthieu Texier2, Stéphane Culine3
1Gustave Roussy, Département de médecine oncologique, INSERM U981, Université Paris-Saclay, Villejuif, France.
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.
Insights
Selecting good-prognosis metastatic seminoma patients for less intensive chemotherapy using interim fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) appears feasible. This approach may reduce treatment toxicity by omitting chemotherapy cycles based on negative interim scans.
Area of Science:
- Oncology
- Medical Imaging
- Clinical Trials
Background:
- Metastatic seminoma treatment requires strategies to minimize chemotherapy toxicity in select patients.
- Current treatment protocols may involve intensive chemotherapy regimens with potential side effects.
Purpose of the Study:
- To evaluate the feasibility of reducing chemotherapy cycles in good-prognosis metastatic seminoma.
- To assess if negative interim fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) scans permit treatment de-escalation.
Main Methods:
- A multicentre, phase 2, nonrandomised trial (NCT01887340) enrolled 102 patients with metastatic seminoma.
- Patients received two cycles of etoposide-cisplatin (EP). Response was assessed via interim FDG-PET/CT.
- Negative scans led to one cycle of carboplatin (CARBO); positive scans led to two additional EP cycles.
Main Results:
- 68.4% of patients achieved a negative interim FDG-PET/CT and received one CARBO cycle.
- Progression-free survival rates were comparable between the EP and CARBO groups (90.0% vs 90.8%).
- Peripheral neuropathy and ototoxicity were significantly less frequent in the CARBO group.
Conclusions:
- Omitting two chemotherapy cycles based on negative interim FDG-PET/CT is feasible for good-prognosis metastatic seminoma.
- Further studies are needed due to the lack of consensus FDG-PET/CT interpretation criteria and short follow-up.
- This strategy is not yet recommended for routine clinical integration.
