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

Abstract

The routine inclusion of HDCT in first-line treatment for GCT patients with metastases and a poor predicted outcome to chemotherapy did not improve treatment outcome. Frequent serum marker determinations to estimate marker decline during the first two cycles of BEP chemotherapy provide a clinically useful estimate of outcome.

High-dose chemotherapy with autologous PBSC transplantation for poor prognosis germ cell tumors: a retrospective monocenter analysis of 44 cases

“…The results of our retrospective analysis yields results similar to the published matched-pairs analysis 2 and compare favorably with the results of the EORTC 30974 trial 5 and the results presented by Motzer et al 4 The CR rate was 73% after HD-PBSCT and resection of residual disease. With a median follow-up of 51.5 months, survival after 3 years was 79.5% for all patients and 80% for the 40 patients with poor prognosis.…”

“…Three patients who showed a marker-negative PR did not undergo surgery, because they were positron-emission tomography negative and/ or fine needle aspiration did not show viable tumor. In none of these cases progressive disease occurred in later follow-ups, however, according to Motzer et al 4 these patients were not classified as CR. After a median follow-up of 51.5 months six patients had died from progressive disease and one patient after relapse.…”

“…Motzer et al 4 have reported the results of a randomized phase III trial comparing HD-PBSCT with standard dose cisplatinetoposide-bleomycin (PEB) in 219 cases. This trial did not show a significant advantage for the HD-PBSCT group with a 2-year survival of 71% vs 72% in the standard treatment group.…”

“…4 --6 However, the randomized studies performed thus far have some shortcomings as discussed below and an important subgroup analysis in one of these studies suggests a significant advantage of HD-PBSCT over standard platinum-containing therapy for selected patients. In the subgroup of 67 poor-prognosis patients with unsatisfactory tumor marker decline after induction therapy Motzer et al 4 reported a 1-year durable response rate of 61% after HD-PBSCT vs 34% (P ¼ 0.04) after standard therapy and a trend towards an increased 2-year survival. The recently published EORTC 30974 trial, however, performed a subgroup analysis which did not demonstrate an influence of tumor marker decline.…”

Clinicopathological Features and Survival of Young Turkish Patients with Testicular Germ Cell Tumors

“…Among patients with advanced stage disease, 27.3% achieved a complete response following chemotherapy. This rate was 46% in the study by Motzer et al (2007) 33% in the study by Daugaard et al (2010) and 60% in the study by Hinton et al (2003). The lower complete response rate observed in our study may be explained by the fact that a high proportion of the patients receiving treatment consisted of the patients in the poor-risk group.…”