Sequential Versus Single High-Dose Chemotherapy in Patients With Relapsed or Refractory Germ Cell Tumors: Long-Term Results of a Prospective Randomized Trial

2012 ◽  
Vol 30 (8) ◽  
pp. 800-805 ◽  
Author(s):  
Anja Lorch ◽  
Antje Kleinhans ◽  
Andrew Kramar ◽  
Christian K. Kollmannsberger ◽  
Jörg T. Hartmann ◽  
...  

Purpose To evaluate the long-term survival rates in patients with relapsed or refractory germ cell tumors (GCTs) after single or sequential high-dose chemotherapy (HDCT). Patients and Methods Between November 1999 and November 2004, 211 patients with relapsed or refractory GCT were randomly assigned to treatment with either one cycle of cisplatin 100 mg/m2, etoposide 375 mg/m2, and ifosfamide 6 g/m2 (VIP) plus three cycles of high-dose carboplatin 1,500 mg/m2 and etoposide 1,500 mg/m2 (CE, arm A) or three cycles of VIP plus one cycle of high-dose carboplatin 2,200 mg/m2, etoposide 1,800 mg/m2, and cyclophosphamide 6,400 mg/m2 (CEC, arm B) followed by autologous stem-cell reinfusion. Long-term progression-free survival (PFS) and overall survival (OS) 6 years after random assignment of the last patient were compared by using the log-rank test. Results Overall, 108 and 103 patients were randomly assigned to arms A and B, respectivelyl. The study was stopped prematurely because of excess treatment-related mortality in arm B (14%) compared with that in arm A (4%; P = .01). As of December 2010, nine (5%) of 211 patients were lost to follow-up; 94 (45%) of 211 are alive and 88 (94%) of 94 patients are progression free. Five-year PFS is 47% (95% CI, 37% to 56%) in arm A and 45% (95% CI, 35% to 55%) in arm B (hazard ratio [HR], 1.16; 95% CI, 0.79 to 1.70; P = .454). Five-year OS is 49% (95% CI, 40% to 59%) in arm A and 39% (95% CI, 30% to 49%) in arm B (HR, 1.42; 95% CI, 0.99 to 2.05; P = .057). Conclusion Patients with relapsed or refractory GCT achieve durable long-term survival after single as well as sequential HDCT. Fewer early deaths related to toxicity translated into superior long-term OS after sequential HDCT.

Cancer ◽  
1997 ◽  
Vol 79 (1) ◽  
pp. 161-168 ◽  
Author(s):  
J�rg Beyer ◽  
Dorothea Kingreen ◽  
Manuela Krause ◽  
Jan Schleicher ◽  
Ingo Schwaner ◽  
...  

2000 ◽  
Vol 18 (6) ◽  
pp. 1181-1186 ◽  
Author(s):  
Pierluigi Porcu ◽  
Sumeet Bhatia ◽  
Matt Sharma ◽  
Lawrence H. Einhorn

PURPOSE: To identify therapy-related or patient-related characteristics that predict response and long-term survival after failure of high-dose chemotherapy (HDCT) for germ cell tumors (GCT). PATIENTS AND METHODS: Between 1986 and 1997, 101 GCT patients relapsed after high-dose carboplatin and etoposide (VP-16) at Indiana University (Indianapolis, IN). Median time to relapse was 10 months (range, 1 to 17 months). HDCT was the first salvage treatment in 29 patients and second or later salvage treatment in 72 patients. RESULTS: Fifty-four of 101 patients received post-HDCT treatment. Of these, 47 received chemotherapy, alone (n = 35) or in combination with surgery (n = 12). Seven patients underwent surgery alone. There were only 12 objective responses (three complete and nine partial responses) for 66 chemotherapy regimens given to 47 patients, for an overall response rate of 18.2%. Fifteen patients received platinum-based chemotherapy, with only one objective response. Chemotherapy was discontinued in 17% of cases because of toxicity. A longer interval between HDCT and post-HDCT treatment was the only variable that was associated with response. Five patients (4.9%) are disease-free at 30, 53, 57, 85, and 93 months after relapse. Of these, three responded to oral VP-16 and underwent resection of residual mediastinal, retroperitoneal, and inguinal cancer, respectively. One had resection of residual mediastinal yolk sac tumor, followed by oral VP-16. One relapsed with teratoma and received thoracoabdominal resection without chemotherapy. CONCLUSION: Patients who experience disease progression after HDCT often receive further chemotherapy and/or surgery. Chemotherapy resulted in a response rate of less than 20%, with only three complete responses. All of the long-term survivors (4.9%) had surgery as a component of their post-HDCT regimen.


1997 ◽  
Vol 33 ◽  
pp. S37-S38
Author(s):  
O. Rick ◽  
J. Beyer ◽  
N. Schwella ◽  
D. Kingreen ◽  
A. Krusch ◽  
...  

2004 ◽  
Vol 22 (1) ◽  
pp. 108-114 ◽  
Author(s):  
C. Kollmannsberger ◽  
J. Beyer ◽  
R. Liersch ◽  
P. Schoeffski ◽  
B. Metzner ◽  
...  

Purpose Long-term survival is rarely achieved in patients with cisplatin-refractory germ cell cancer (GCT). Both single-agent gemcitabine and oxaliplatin have shown activity in patients who experience relapse or are refractory to cisplatin treatment. This study investigates the activity of a gemcitabine plus oxaliplatin regimen in these patients. Patients and Methods Gemcitabine was administered at a dose of 1,000 mg/m2 on days 1 and 8; oxaliplatin was administered at a dose of 130 mg/m2 on day 1. Response was evaluated every 4 weeks. Results Thirty-five patients with a median age of 37 years (range, 21 to 54 years) were enrolled onto the study. Primary tumor localization was gonadal, retroperitoneal, or mediastinal in 30, one, and four patients, respectively. Patients had been pretreated with a median of six platinum-containing cycles (range, four to 13 cycles) and 89% of patients previously had experienced treatment failure after high-dose chemotherapy with peripheral-blood stem-cell transplantation. Sixty-three percent of patients were considered absolutely cisplatin-refractory or cisplatin-refractory. A median of two cycles (range, 1 to 6 cycles) per patient were applied. Toxicity consisted mainly of myelosuppression, with Common Toxicity Criteria grade 3 occurring in 54% of patients. Only 9% of patients developed neutropenic fever. Three patients attained a complete remission (CR), two patients attained a marker-negative partial remission, and 11 patients attained a marker-positive partial remission, resulting in an overall response rate of 46% (95% CI, 30% to 64%). All three patients with CR and one patient with a marker-negative partial remission remained disease free at 16+, 12+, 4+, and 2+ months of follow-up. Seven (44%) of these 16 responses, including one CR, occurred in cisplatin-refractory patients. Conclusion Gemcitabine plus oxaliplatin demonstrates antitumor activity with acceptable toxicity in heavily pretreated patients with relapsed or cisplatin-refractory GCT, and may offer a chance of long-term survival for selected patients.


2021 ◽  
Vol 8 ◽  
Author(s):  
Juntao Qiu ◽  
Xinjin Luo ◽  
Jinlin Wu ◽  
Wei Pan ◽  
Qian Chang ◽  
...  

Aims: We describe a new aortic arch dissection (AcD) classification, which we have called the Fuwai classification. We then compare the clinical characteristics and long-term prognoses of different classifications.Methods: All AcD patients who underwent surgical procedures at Fuwai Hospital from 2010 to 2015 were included in the study. AcD procedures are divided into three types: Fuwai type Cp, Ct, and Cd. Type Cp is defined as the innominate artery or combined with the left carotid artery involved. Type Cd is defined as the left subclavian artery or combined with the left carotid artery involved. All other AcD surgeries are defined as type Ct. The Chi-square test was adopted for the pairwise comparison among the three types. Kaplan-Meier was used for the analysis of long-term survival and survival free of reoperation.Results: In total, 1,063 AcD patients were enrolled from 2010 to 2015: 54 patients were type Cp, 832 were type Ct, and 177 were type Cd. The highest operation proportion of Cp, Ct and Cd were partial arch replacement, total arch replacement, and TEVAR. The surgical mortality in type Ct was higher compared to type Cd (Ct vs. Cd = 9.38 vs. 1.69%, p < 0.01) and type Cp (Ct vs. Cp = 9.38 vs. 1.85%, p = 0.06). There was no difference in surgical mortality of type Cp and Cd (p = 0.93). There were no significant differences in the long-term survival rates (p = 0.38) and free of aorta-related re-operations (p = 0.19).Conclusion: The Fuwai classification is used to distinguish different AcDs. Different AcDs have different surgical mortality and use different operation methods, but they have similar long-term results.


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