Primary mediastinal and retroperitoneal malignant germ cell tumors in children and adolescents: Results of the TGM95 trial, a study of the French Society of Pediatric Oncology (Société Française des Cancers de l'Enfant)

2017 ◽  
Vol 64 (9) ◽  
pp. e26494 ◽  
Author(s):  
Hélène Sudour-Bonnange ◽  
Cécile Faure-Conter ◽  
Hélène Martelli ◽  
Frederic Hameury ◽  
Brice Fresneau ◽  
...  
2017 ◽  
Vol 35 (11) ◽  
pp. 1203-1210 ◽  
Author(s):  
Furqan Shaikh ◽  
John W. Cullen ◽  
Thomas A. Olson ◽  
Farzana Pashankar ◽  
Marcio H. Malogolowkin ◽  
...  

Purpose To investigate whether event-free survival (EFS) can be maintained among children and adolescents with intermediate-risk (IR) malignant germ cell tumors (MGCT) if the administration of cisplatin, etoposide, and bleomycin (PEb) is reduced from four to three cycles and compressed from 5 to 3 days per cycle. Patients and Methods In a phase 3, single-arm trial, patients with IR MGCT (stage II-IV testicular, II-III ovarian, I-II extragonadal, or stage I gonadal tumors with subsequent recurrence) received three cycles of PEb. A parametric comparator model specified that the observed EFS rate should not be significantly < 92%. As recommended for trials that test a reduction of therapy, a one-sided P value ≤ .10 was used to indicate statistical significance. In a post hoc analysis, we also compared results to the EFS rate of comparable patients treated with four cycles of PEb in two prior studies. Results Among 210 eligible patients enrolled from 2003 to 2011, 4-year EFS (EFS4) rate was 89% (95% confidence interval, 83% to 92%), which was significantly lower than the 92% threshold of the comparison model ( P = .08). Among 181 newly diagnosed patients, the EFS4 rate was 87%, compared with 92% for 92 comparable children in the historical cohort ( P = .15). The EFS4 rate was significantly associated with stage (stage I, 100%; stage II, 92%; stage III, 85%; and stage IV, 54%; P < .001). Conclusion The EFS rate for children with IR MGCT observed after three cycles of PEb was less than that of a prespecified parametric model, particularly for patients with higher-stage tumors. These data do not support a reduction in the number of cycles of PEb from four to three. However, further investigation of a reduction in the number of cycles for patients with lower-stage tumors is warranted.


Cancer ◽  
1986 ◽  
Vol 58 (12) ◽  
pp. 2579-2584 ◽  
Author(s):  
Edith P. Hawkins ◽  
Milton J. Finegold ◽  
Hal K. Hawkins ◽  
Jeffrey P. Krischer ◽  
Kenneth A. Starling ◽  
...  

2004 ◽  
Vol 39 (3) ◽  
pp. 424-429 ◽  
Author(s):  
D Billmire ◽  
C Vinocur ◽  
F Rescorla ◽  
B Cushing ◽  
W London ◽  
...  

2004 ◽  
Vol 22 (17) ◽  
pp. 3563-3569 ◽  
Author(s):  
Paul C. Rogers ◽  
Thomas A. Olson ◽  
John W. Cullen ◽  
Deborah F. Billmire ◽  
Neyssa Marina ◽  
...  

Purpose To determine whether children with localized gonadal malignant germ cell tumors (MGCT) stage II testicular and stages I and II ovarian treated with four cycles of standard-dose cisplatin combined with etoposide and low-dose bleomycin (PEB) have an event-free survival (EFS) of at least 85% without significant toxicity. Patients and Methods Between May 1990 and July 1995, eligible pediatric patients with stage II or recurrent from stage I (as a stage II) testicular MGCT and stages I and II ovarian MGCT were enrolled onto this Pediatric Oncology Group and Children's Cancer Group study. PEB chemotherapy consisted of bleomycin 15 U/m2 on day 1, cisplatin 20 mg/m2/d on days 1 to 5, and etoposide 100 mg/m2/d on days 1 to 5. Patients received four cycles of therapy at 21-day intervals. Results Seventy-four patients with a median age of 10.5 years (range, 8.7 months to 16.7 years) were enrolled. Primary sites included: stage II testicular (n = 17), stage I ovarian (n = 41), and stage II ovarian MGCT (n = 16). Treatment with standard PEB resulted in 6-year EFS of 95% and overall survival (OS) of 95.7%. EFS and OS by primary site were as follows: stage II testicular, 100% and 100%; stage I ovarian, 95.1% and 95.1%; and stage II ovarian, 87.5% and 93.8%, respectively. Two patients died from recurrent disease, and one patient died of secondary acute myelocytic leukemia. Infrequent grade 3 to 4 hematologic toxicity was reported. No grade 3 to 4 renal, pulmonary, or ototoxicity was observed. Conclusion Combination chemotherapy with PEB results in excellent EFS and OS with minimal toxicity in children and adolescents with localized gonadal MGCT.


Cancer ◽  
2004 ◽  
Vol 101 (3) ◽  
pp. 620-626 ◽  
Author(s):  
Sheri L. Spunt ◽  
Michael F. Walsh ◽  
Matthew J. Krasin ◽  
Kathleen J. Helton ◽  
Catherine A. Billups ◽  
...  

Cancer ◽  
1981 ◽  
Vol 48 (8) ◽  
pp. 1890-1898 ◽  
Author(s):  
Garrett M. Brodeur ◽  
Cathryn B. Howarth ◽  
Charles B. Pratt ◽  
Josefina Caces ◽  
H. Omar Hustu

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