e16094 Background: To analyze the independent associates of outcome in metastatic germ cell cancer (MGCC) patients treated with high dose chemotherapy (HDC) and stem cell rescue. Methods: Thirty-two published patient cohorts with MGCC (encompassing 2176 patients; 510 patients treated upfront and 1666 at relapse) were identified from PUBMED and Cochrane Registry of Clinical Trials. Weighed Regression Analyses of these trials were conducted to define prognosticators. Results: Correlate of overall survival (OAS) and survival with no evidence of disease (NED) in upfront HDC trials was number of chemotherapeutics in HDC (OAS with 2 agents: 60% vs. 3 or more agents: 72%, p = 0.047, survival with NED with 2 agents: 47% vs. 3 or more agents: 64%, p = 0.009). In trials of HDC at relapse, independent associates of OAS with multivariate analysis were line of chemotherapy index, an indicator of line of chemotherapy utilization (p = 0.004), and median age (≤30: 42%, >30: 49%, p = 0.023), whereas independent correlates of better survival with NED were again number of chemotherapeutics in HDC (2 agents: 54% vs. 3 or more agents: 33%, p = 0.001), and seminoma fraction (seminoma fraction ≤9%: 28% vs. seminoma fraction >9%: 49%, p < 0.001 ). Toxic mortality of HDC regimens employed in these trials ranged between 0% and 17%. Conclusions: HDC can cure patients with MGCC both as initial or salvage therapies. However, this study shows that type and setting of HDC, as well as patient age, and seminoma fraction all appear to be linked with benefit from HDC in MGCC. Future trials should continue to address the usage of tandem HDC cycles with multiagent protocols in high risk patients with MGCC. No significant financial relationships to disclose.
A multi-center prospective phase II study of high-dose chemotherapy in germ-cell cancer patients relapsing from complete remission