Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors: trial

Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors

Phase 3N = 219

Population

Previously untreated patients with intermediate- or poor-risk metastatic germ cell tumours

Design

Randomised phase III trial: four cycles of BEP versus two cycles of BEP followed by two cycles of high-dose carboplatin-containing chemotherapy and then haematopoietic stem-cell rescue. Serum tumour marker (AFP, hCG) decline was a prospectively assessed secondary endpoint.

Arms

BEP alone (control, n = 111): Four cycles of bleomycin, etoposide and cisplatin
BEP plus high-dose chemotherapy (experimental, n = 108): Two cycles of BEP followed by two cycles of high-dose chemotherapy containing carboplatin, then haematopoietic stem-cell rescue

People

Motzer RJ, senior author Bosl GJ

Δ Durable complete response rate+4 pointsΔ Durable complete response rate+27 points

Show the numbers

Results reported for Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors
Endpoint	Analysis	BEP plus high-dose chemotherapy	BEP alone	Effect
Durable complete response rateAll randomised patients (219)1-year durable complete response	primaryMotzer 2007	52%	48%	P=0.53The abstract does not name the primary endpoint; the durable complete response rate is the endpoint it reports for the randomised comparison.
Durable complete response rate67 patients with unsatisfactory (slow) tumour marker decline1-year durable complete response	exploratoryMotzer 2007	61%	34%	P=0.03Subgroup defined during treatment by marker decline; not a prespecified randomised comparison of all patients.

Results reported for Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors
Endpoint	Analysis	BEP plus high-dose chemotherapy	BEP alone	Effect
Durable complete response rateAll randomised patients (219)1-year durable complete response	primaryMotzer 2007	52%	48%	P=0.53The abstract does not name the primary endpoint; the durable complete response rate is the endpoint it reports for the randomised comparison.
Durable complete response rate67 patients with unsatisfactory (slow) tumour marker decline1-year durable complete response	exploratoryMotzer 2007	61%	34%	P=0.03Subgroup defined during treatment by marker decline; not a prespecified randomised comparison of all patients.

Appears in

2007 First-line high-dose chemotherapy did not show benefit in trials

Sources

Motzer RJ, Nichols CJ, Margolin KA, Bacik J, Richardson PG, Vogelzang NJ, et al. Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoietic stem-cell rescue as first-line treatment for patients with poor-prognosis metastatic germ cell tumors. J Clin Oncol. 2007;25(3):247-56.
PubMed DOI