ORLANDO, FL – Bleomycin, etoposide, and cisplatin (BEP) for 1 cycle after orchiectomy is associated with a similar 2-year recurrence rate as BEP for 2 cycles among patients with high-risk stage 1 non-seminomatous or combined germ cell tumors of the testis (NSGCTT), according to a study presented at the 2017 Genitourinary Cancers Symposium.1
“The standard adjuvant chemotherapy regimen for patients with high-risk stage 1 NSGCTT is surveillance until recurrence with BEP for 3 cycles at the time of recurrence or adjuvant BEP for 2 cycles with etoposide given at a dose of 360 mg/m2,” explained Robert Huddart, PhD, chair of the Institute of Cancer Research in Sutton, England. “Adjuvant chemotherapy has a 2-year recurrence-free rate of 98% and avoids intensive surveillance, but delivers 33% more chemotherapy cycles on a population basis.”
For the open-label, non-randomized, phase 3 trial (ClinicalTrials.gov Identifier: NCT01726374), investigators enrolled 264 post-orchiectomy patients vascular invasion-positive stage 1 NSGCTT or combined seminoma and NSGCT, as well as normal tumor markers.
“This study used a novel design to investigate a new treatment approach for an uncommon cancer,” Dr Huddart added.
Participants received 1 cycle of bleomycin 30,000 IU IV on days 1, 8, and 15, plus etoposide 165 mg/m2 IV on days 1, 2, and 3, and cisplatin 50 mg/m2 IV on days 1 and 2. To reduce the risk for neutropenic sepsis, all participants received prophylactic fluoroquinolone and granulocyte colony-stimulating factor.
The 2-year recurrence rate was 1.3% (95% CI, 0.4-4.0) among the 236 evaluable patients. All 4 patients who developed malignant recurrence subsequently received second-line chemotherapy with or without surgery, with only 1 dying at month 9 due to refractory disease. Two-year overall survival was 99.0% (95% CI, 96.6-99.8).
“The 2-year recurrence rate is similar to that seen with BEP for 2 cycles,” said Dr Huddart.
Investigators also observed 3 instances of non-malignant recurrences with teratoma differentiated in retroperitoneal nodes. All of these patients successfully underwent retroperitoneal lymph node dissection and are now free of disease.
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About 40% of patients developed grade 3 to 4 adverse events.
“This provides robust evidence to inform the decision between adjuvant chemotherapy and surveillance,” said Dr Huddart. “Adoption of BEP for 1 cycle as a standard of care would reduce overall exposure to chemotherapy in this young population.”
- Huddart RA, Joffe JK, White JD, et al. 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). Paper presented at: 2017 Genitourinary Cancers Symposium; February 16-18, 2017; Orlando, FL.