Carboplatin Not Inferior to Radiation as Adjuvant Therapy for Stage I Seminoma Slideset on: Oliver RT, Mason MD, Mead GM, et al. Radiotherapy versus single-dose.

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Carboplatin Not Inferior to Radiation as Adjuvant Therapy for Stage I Seminoma Slideset on: Oliver RT, Mason MD, Mead GM, et al. Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial. Lancet. 2005;366:

clinicaloptions.com/onco Oncology Journal Options Background  Previous research suggests metastatic seminomas more sensitive to chemotherapy than nonseminomas –Carboplatin has been evaluated as possible alternative to radiation  Current study evaluates efficacy of single-dose carboplatin vs radiation as adjuvant treatment for stage I seminomas Oliver RT, et al. Lancet. 2005;366:

clinicaloptions.com/onco Oncology Journal Options Men with stage I seminoma postorchiectomy (N = 1477)* Radiation Therapy Optional randomization to 30 Gy/15 fractions or 20 Gy/10 fractions (n = 904) Carboplatin Single intravenous dose Area under the curve x 7 (n = 573) 5:3 randomization *Number of patients receiving treatment: 885, radiation group; 560, carboplatin group. † 10-year follow-up planned. Oliver RT, et al. Lancet. 2005;366: Study Design

clinicaloptions.com/onco Oncology Journal Options Eligibility  Inclusion criteria –Histologic diagnosis of seminoma, pT1-pT3 –Stage I clinical/radiologic disease –Normal α-fetoprotein levels pre- and postorchiectomy –Normal human chorionic gonadotropin levels after orchiectomy  Exclusion criteria –Tumor at resected end of spermatic cord Oliver RT, et al. Lancet. 2005;366:

clinicaloptions.com/onco Oncology Journal Options Baseline Characteristics Oliver RT, et al. Lancet. 2005;366: Characteristic Radiation (n = 904) Carboplatin (n = 573) Mean age, yrs Elevated HCG before orchiectomy, n (%)121 (13)88 (15) Eligibility revisions Pretreatment restaging (stage II), n Nonseminoma reclassification, n Assigned treatment received, n (%)885 (98)560 (98) HCG, human chorionic gonadotropin.

clinicaloptions.com/onco Oncology Journal Options Main Findings  Relapse-free survival comparable for carboplatin and radiation at median 4-year follow-up –2-year follow-up rates –Carboplatin: 97.7% (95% confidence interval [CI]: 96.0%-98.6%) –Radiation: 96.7% (95% CI: 95.3%-97.7%) –3-year follow-up rates –Carboplatin: 94.8% (95% CI: 92.5%-96.4%) –Radiation: 95.9% (95% CI: 94% %) –Hazard ratio (HR): 1.28 (90% CI: ; P =.32) Oliver RT, et al. Lancet. 2005;366:

clinicaloptions.com/onco Oncology Journal Options Main Findings cont’d  Similar relapse-free survival rates at 2 years –Rate to rate: -1.0% (90% CI: -2.5% to 0.5%) –HR comparison: 0.9% (90% CI: -0.5% to 3.0%)  Results favoring carboplatin treatment –Less posttreatment patient lethargy and fewer missed workdays –Lower 5-year event rate for second primary germ-cell tumors (P =.04) –Carboplatin: 0.54% (95% CI: 0.1%-2.1%) –Radiation: 1.96% (95% CI: 1.0%-3.8%) Oliver RT, et al. Lancet. 2005;366:

clinicaloptions.com/onco Oncology Journal Options Other Outcomes  No deaths due to seminoma; 1 death with radiation  Significantly less thrombocytopenia with radiation –Grade 1/2: 12 (2%) vs 58 (12%) –Grade 3/4: 0 vs 17 (4%)  Rebound in testicular function following carboplatin treatment noted in some patients  Optimal dosage of carboplatin undetermined –Dose could be increased to reduce incidence of relapse Oliver RT, et al. Lancet. 2005;366:

clinicaloptions.com/onco Oncology Journal Options Summary of Key Conclusions  Single-dose carboplatin comparable to radiation as adjuvant treatment for stage I seminoma –Relapse-free survival rates similar at 2 and 3 years  Carboplatin tentatively favored over radiation –No disease- or treatment-related mortality –Lower incidence of second primary testicular (germ-cell) tumors –Fewer side effects compared with radiation  Further confirmation of findings needed Oliver RT, et al. Lancet. 2005;366: