Abstract
415 Background: The administration of HDCT in GCT pts ≥ 40 years may raise concerns, owing to the limited data on safety outcomes. Yet HDCT strategy may be the optimal one to achieve a cure in many cases. Consequently, understanding more on the outcomes of these pts and on safety of HDCT delivery has relevant clinical impact. Methods: Criteria for patient selection consisted of: GCT diagnosis, male gender, age ≥ 40 at the time of first HDCT course. Summary statistics were used to describe patient characteristics and outcomes. Probabilities for overall survival (OS) and transplant-related mortality (TRM) were calculated using the Kaplan-Meier method. TRM was defined as mortality from any cause other than disease progression within 100 days of HDCT. Results: From 11/1981 to 12/2015, 1,179 pts aged ≥ 40 have been registered, from 236 centers, in the EBMT database after having received single (n = 578) or multiple (n = 601) HDCT courses. Age distribution was: 917 pts 40-49, 236 pts 50-59, 26 pts 60-71. 56 had extragonadal GCT. Bone marrow was used as stem cell source in 85 pts (7.2%). Median follow-up was 38.6 months. Overall 74 TR deaths were found. Significant decrease of TRM was observed during the decades: 1981-1990 (8.3%), 1991-2000 (6.8%), 2001-2015 (4,1%, p = 0.024). Focusing on 2001-2015 period, no differences were found according to age: 40-49y (n = 673): 4.7%, 50-59y (n = 174): 1.8%, 60-71y (n = 23): 4,3% (p = 0.419). TRM for HD-carboplatin-etoposide regimen only (all pts > 1990) was as follows: 40-49y (n = 289): 2.9%, 50-71y (n = 90): 1.1% (p = 0.713). 2-y OS was consistent across all age subgroups. Causes of death were: infection/sepsis (46/74, 62.2%), organ failure (11/74, 14.9%), and cardiac toxicity (8/10.8%), other (9 pts). The retrospective nature of the data is a major limitation. Conclusions: The administration of HD-carboplatin-etoposide in GCT pts ≥ 40 and ≥ 50 years is feasible and is supported by adequate safety data. Collecting additional information on non-severe long-term sequelae is needed. These results may add important information to improve patient counselling.
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