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This study presents a prospective randomized trial of radiotherapy versus single-dose carboplatin for clinical stage I pure seminoma. With a median follow-up of 4 years, there was an approximately 1% relapse-free survival rate both at 2 and 3 years analyses (96.7% vs. 97.7% favoring carboplatin and 95.9% vs. 94.8% favoring radiation, respectively). The authors recognize that long-term follow-up is needed to see if this equivalency holds up. It should be noted that there was a lower rate of contralateral second primary germ cell testicular cancers in the chemotherapy group versus the radiotherapy group.
Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial . Oliver et. al. Urologic Oncology: Seminars and Original Investigations, Volume 24, Issue 2 , March-April 2006, Page 175
Proceedings: Annual Meeting of the Society of Urologic Oncology (May 2005). Part I: Stem Cells, Telomerase Biology, and Systemic Therapy to Provent Tumor Progression
BACKGROUND: Adjuvant radiotherapy is effective treatment for stage I seminoma, but is associated with a risk of late non-germ-cell cancer and cardiovascular events. After good results in initial studies with one injection of carboplatin, we undertook a large randomised trial to compare the approaches of radiotherapy with chemotherapy in seminoma treatment. METHODS: Between 1996 and 2001, 1477 patients from 70 hospitals in 14 countries were randomly assigned to receive radiotherapy (para-aortic strip or dog-leg field; n = 904) or one injection of carboplatin (n = 573; dose based on the formula 7 x [glomerular filtration rate + 25] mg), at two trial centres in the UK and Belgium. The primary outcome measure was the relapse-free rate, with the trial powered to exclude absolute differences in 2-year rates of more than 3%. Analysis was by intention to treat and per protocol. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN27163214. FINDINGS: 885 and 560 patients received radiotherapy and carboplatin, respectively. With a median follow-up of 4 years (IQR 3.0-4.9), relapse-free survival rates for radiotherapy and carboplatin were similar (96.7% [95% CI 95.3-97.7] vs. 97.7% [96.0-98.6] at 2 years; 95.9% [94.4-97.1] vs. 94.8% [92.5-96.4] at 3 years, respectively; hazard ratio 1.28 [90% CI 0.85-1.93], p = 0.32). At 2 years' follow-up, the absolute differences in relapse-free rates (radiotherapy-chemotherapy) were -1.0% (90% CI -2.5 to 0.5) by direct comparison of proportions, and 0.9% (-0.5 to 3.0) by a hazard-ratio-based approach. Patients given carboplatin were less lethargic and less likely to take time off work than those given radiotherapy. New, second primary testicular germ-cell tumours were reported in ten patients allocated irradiation (all after para-aortic strip field) and two allocated carboplatin (5-year event rate 1.96% [95% CI 1.0-3.8] vs. 0.54% [0.1-2.1], p = 0.04). One seminoma-related death occurred after radiotherapy and none after carboplatin. INTERPRETATION: This trial has shown the non-inferiority of carboplatin to radiotherapy in the treatment of stage I seminoma. Although the absence of disease-related deaths and preliminary data indicating fewer second primary testicular germ-cell tumours favour carboplatin use, these findings need to be confirmed beyond 4 years' follow-up.
Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial . Oliver et. al. Urologic Oncology: Seminars and Original Investigations, Volume 24, Issue 2 , March-April 2006, Page 175
Proceedings: Annual Meeting of the Society of Urologic Oncology (May 2005). Part I: Stem Cells, Telomerase Biology, and Systemic Therapy to Provent Tumor Progression
BACKGROUND: Adjuvant radiotherapy is effective treatment for stage I seminoma, but is associated with a risk of late non-germ-cell cancer and cardiovascular events. After good results in initial studies with one injection of carboplatin, we undertook a large randomised trial to compare the approaches of radiotherapy with chemotherapy in seminoma treatment. METHODS: Between 1996 and 2001, 1477 patients from 70 hospitals in 14 countries were randomly assigned to receive radiotherapy (para-aortic strip or dog-leg field; n = 904) or one injection of carboplatin (n = 573; dose based on the formula 7 x [glomerular filtration rate + 25] mg), at two trial centres in the UK and Belgium. The primary outcome measure was the relapse-free rate, with the trial powered to exclude absolute differences in 2-year rates of more than 3%. Analysis was by intention to treat and per protocol. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN27163214. FINDINGS: 885 and 560 patients received radiotherapy and carboplatin, respectively. With a median follow-up of 4 years (IQR 3.0-4.9), relapse-free survival rates for radiotherapy and carboplatin were similar (96.7% [95% CI 95.3-97.7] vs. 97.7% [96.0-98.6] at 2 years; 95.9% [94.4-97.1] vs. 94.8% [92.5-96.4] at 3 years, respectively; hazard ratio 1.28 [90% CI 0.85-1.93], p = 0.32). At 2 years' follow-up, the absolute differences in relapse-free rates (radiotherapy-chemotherapy) were -1.0% (90% CI -2.5 to 0.5) by direct comparison of proportions, and 0.9% (-0.5 to 3.0) by a hazard-ratio-based approach. Patients given carboplatin were less lethargic and less likely to take time off work than those given radiotherapy. New, second primary testicular germ-cell tumours were reported in ten patients allocated irradiation (all after para-aortic strip field) and two allocated carboplatin (5-year event rate 1.96% [95% CI 1.0-3.8] vs. 0.54% [0.1-2.1], p = 0.04). One seminoma-related death occurred after radiotherapy and none after carboplatin. INTERPRETATION: This trial has shown the non-inferiority of carboplatin to radiotherapy in the treatment of stage I seminoma. Although the absence of disease-related deaths and preliminary data indicating fewer second primary testicular germ-cell tumours favour carboplatin use, these findings need to be confirmed beyond 4 years' follow-up.
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