📃 Paper Title: Randomized Trial of Carboplatin Versus Radiotherapy for Stage I Seminoma: Mature Results on Relapse and Contralateral Testis Cancer Rates in MRC TE19/EORTC 30982 Study (ISRCTN27163214)
🧍 Author: Oliver
🕒 Year: 2011
📚 Journal: Journal of Clinical Oncology
🌎 Country: UK
ㅤContext to the study:
Can you tell me about a study that examined the role of Carboplatin in seminomas?
ㅤ✅ Take-home message of study:
In the management of Stage 1 seminoma:
There was no difference in relapse free rates or rates of contralateral germ cell cancer (GCT) between carboplatin and radiotherapy
Significant reduction of risk of contralateral GCT by 80% with treatment
A high FSH level pretreatment was associated with an 8.6 fold increase in contralateral GCT rate
FSH levels were maintained throughout treatment, suggesting no effect on fertility
One single full dose of carboplatin (7 times area under curve (AUC)) is recommended
ㅤ RCT
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Study participants:
Number of participants: 1447
Mean age: 38.5 years
Eligibility:
Histologically confirmed stage 1 seminoma
Had normal markers
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Key study outcomes:
Median follow up: 6.5 years; 1147 patients had at least 5 years follow up
Relapse free rates were:
97.3% for carboplatin vs 96.5% radiotherapy at 2 years
94.7% carboplatin vs 96% radiotherapy at 5 years
Differences were non-significant (p=0.37 and 0.36 respectively)
Regarding contralateral GCTs:
80% reduction in risk with both treatments
Similar contralateral GCT-free rates for carboplatin and radiotherapy at 5 years (99.8% and 98.8%)
Patients with a higher pre-treatment FSH level (>12) were 8.6 times more likely to get a contralateral GCT (p=0.001)
Regarding carboplatin dose, those who did not have the full dose (dose less than 7 times area under the curve (AUC)) had a higher relapse free rate than those that did have the full dose (92.6% <7AUC vs 96.1%). However, this was non-significant (p=0.16 when adjusted to glomerular filtration rate).
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Study Limitations:
Treatment within subgroups not standardized for radiotherapy; some had centers using standard radiotherapy schedule rather than the assigned radiotherapy doses
21% lost to follow up (5 years).
FSH levels may not indicate fertility; fertility follow up may of been more useful
At the time AUC - 7 was a higher dose than in previous trials, making one unable to extrapolate course of relapses and late toxicity.
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