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111: A single-arm trial evaluating one cycle of BEP as adjuvant chemotherapy in high-risk, stage 1 non-seminomatous or combined germ cell tumors of the testis (NSGCTT).

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400Background: The standard post-orchiectomy treatment for UK patients (pts.) presenting with high-risk stage 1 NSGCTT is 2 cycles of bleomycin, etoposide (360mg/m2) & cisplatin (BE360P) chemotherapy or surveillance with BEPx3… Click to show full abstract

400Background: The standard post-orchiectomy treatment for UK patients (pts.) presenting with high-risk stage 1 NSGCTT is 2 cycles of bleomycin, etoposide (360mg/m2) & cisplatin (BE360P) chemotherapy or surveillance with BEPx3 at recurrence. 111 (CRUK/09/011) investigates whether BE500P x1 would achieve recurrence rates similar to BE360P x2. Methods: Pts aged ≥16 yrs post-orchiectomy for vascular invasion positive stage 1 NSGCTT or combined seminoma + NSGCT, with normalised tumour markers, received 1 cycle of bleomycin30000IU day 1, 8 & 15, etoposide165mg/m2 day 1, 2 & 3, &cisplatin50mg/m2day 1 & 2. All pts received a prophylactic antibacterial & GCSF. Pts were assessed for tumour markers q2m, q3m, q4m in years (yrs) 1, 2, 3, respectively and q6m in yrs 4 & 5. CT scan of chest, abdo and pelvis was performed at 6, 12, 24 & 60months (m) with chest x-ray at other visits. Toxicity was assessed using NCI CTCAE v3. Recurrences were independently reviewed. A sample size of 236 pts excludes a 2-yr recurrence rate...

Keywords: chemotherapy; high risk; risk stage; cycle; stage

Journal Title: Journal of Clinical Oncology
Year Published: 2017

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