NEW YORK (Reuters Health) Apr 08 - As a first salvage therapy, high-dose chemotherapy may improve survival in men with metastatic germ cell tumors, a retrospective study suggests.
How to manage these men when their disease progresses during first-line chemotherapy is controversial. The only phase III trial to compare high-dose chemotherapy (HDCT) with conventional-dose chemotherapy (CDCT) failed to show a benefit from HDCT.
In part because that trial has been criticized for methodological problems, Dr. J�rg Beyer from Vivantes Klinikum Am Urban, Berlin, Germany, and colleagues used an existing database to compare progression-free survival and overall survival after CDCT or HDCT as first salvage treatment.
Survival was calculated from the start of salvage chemotherapy, according to a March 28th online report in the Journal of Clinical Oncology.
The database contained information on 1,594 men. The 773 men who received CDCT were younger, with slightly more favorable responses to first-line treatment and lower human chorionic gonadotropin values at salvage. The 821 men who received HDCT had a higher rate of normal alpha-fetoprotein values but significantly more liver, bone and brain metastases.
During median follow-up of 58 months, 990 men (62%) had disease progression, with a median time to progression of 6 months (range, 0-163), and 785 (49%) died. The median survival time was 12 months (0-141 months).
Two-year progression-free survival rate was better after HDCT than after CDCT (49.6% vs 27.8%; P<0.001), as was 5-year overall survival (53.2% vs 40.8%; P<0.001).
In fact, the researchers note, progression-free survival at 2 years was significantly better with HDCT than CDCT in all five retrospectively assigned prognostic categories. In all but the low-risk group, the improved progression-free survival after HDCT translated into superior overall survival.
Results in favor of HDCT were similar for patients who could not be reliably classified into one of the prognostic categories.
"Because of the inherent methodologic limitations even of this large and robust retrospective analysis," the investigators caution, "the current analysis does not prove the superiority of HDCT versus CDCT, but it underscores the need for a prospective randomized trial comparing the best CDCT regimen with the best HDCT regimen in unselected patients with germ cell tumors after treatment failure with cisplatin-based first chemotherapy and provides background information for the design of such a trial.
How to manage these men when their disease progresses during first-line chemotherapy is controversial. The only phase III trial to compare high-dose chemotherapy (HDCT) with conventional-dose chemotherapy (CDCT) failed to show a benefit from HDCT.
In part because that trial has been criticized for methodological problems, Dr. J�rg Beyer from Vivantes Klinikum Am Urban, Berlin, Germany, and colleagues used an existing database to compare progression-free survival and overall survival after CDCT or HDCT as first salvage treatment.
Survival was calculated from the start of salvage chemotherapy, according to a March 28th online report in the Journal of Clinical Oncology.
The database contained information on 1,594 men. The 773 men who received CDCT were younger, with slightly more favorable responses to first-line treatment and lower human chorionic gonadotropin values at salvage. The 821 men who received HDCT had a higher rate of normal alpha-fetoprotein values but significantly more liver, bone and brain metastases.
During median follow-up of 58 months, 990 men (62%) had disease progression, with a median time to progression of 6 months (range, 0-163), and 785 (49%) died. The median survival time was 12 months (0-141 months).
Two-year progression-free survival rate was better after HDCT than after CDCT (49.6% vs 27.8%; P<0.001), as was 5-year overall survival (53.2% vs 40.8%; P<0.001).
In fact, the researchers note, progression-free survival at 2 years was significantly better with HDCT than CDCT in all five retrospectively assigned prognostic categories. In all but the low-risk group, the improved progression-free survival after HDCT translated into superior overall survival.
Results in favor of HDCT were similar for patients who could not be reliably classified into one of the prognostic categories.
"Because of the inherent methodologic limitations even of this large and robust retrospective analysis," the investigators caution, "the current analysis does not prove the superiority of HDCT versus CDCT, but it underscores the need for a prospective randomized trial comparing the best CDCT regimen with the best HDCT regimen in unselected patients with germ cell tumors after treatment failure with cisplatin-based first chemotherapy and provides background information for the design of such a trial.
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