Surgery and chemotherapy (stages II–IV)

A CCG/POG clinical trial evaluated boys younger than 10 years with stage II tumors who were treated with four cycles of PEb after diagnosis.[13]

A CCG/POG clinical trial evaluated boys younger than 10 years with stage II tumors who were treated with four cycles of PEb after diagnosis.[13]

The 6-year EFS and OS rates were 100%.

In the same CCG/POG clinical trial, boys and adolescents (aged 14 years and younger) with stage III and stage IV testicular tumors were treated with surgical resection followed by four cycles of standard-dose PEb or high-dose PEb (HD-PEb) therapy.[14]

In the same CCG/POG clinical trial, boys and adolescents (aged 14 years and younger) with stage III and stage IV testicular tumors were treated with surgical resection followed by four cycles of standard-dose PEb or high-dose PEb (HD-PEb) therapy.[14]

The 6-year survival rate for males younger than 15 years with stage III and stage IV tumors was 100%.

In the same CCG/POG clinical trial, boys and adolescents (aged 14 years and younger) with stage III and stage IV testicular tumors were treated with surgical resection followed by four cycles of standard-dose PEb or high-dose PEb (HD-PEb) therapy.[14]

The 6-year EFS rate for males younger than 15 years was 100% for stage III tumors and 94% for stage IV tumors.

In the same CCG/POG clinical trial, boys and adolescents (aged 14 years and younger) with stage III and stage IV testicular tumors were treated with surgical resection followed by four cycles of standard-dose PEb or high-dose PEb (HD-PEb) therapy.[14]

The use of HD-PEb therapy did not improve the outcome for these boys but did cause increased incidence of otologic toxic effects.

European investigators have reported excellent outcomes for boys with testicular GCTs using surgery and observation for stage I tumors and JEb and other cisplatin-containing chemotherapy regimens for stage II, stage III, and stage IV tumors.[6,9]

A phase III, single-arm COG trial (AGCT0132 [NCT00053352]) included 210 intermediate-risk patients (stages II–IV testicular, stages II–III ovarian, stages I–II extragonadal, or stage I gonadal tumors with subsequent recurrence). These patients received three, rather than four, cycles of PEb and the schedule was compressed from 5 days to 3 days per cycle. A parametric comparator model specified that the observed EFS rate would not be significantly less than 92%.[15][Level of evidence B4]

A phase III, single-arm COG trial (AGCT0132 [NCT00053352]) included 210 intermediate-risk patients (stages II–IV testicular, stages II–III ovarian, stages I–II extragonadal, or stage I gonadal tumors with subsequent recurrence). These patients received three, rather than four, cycles of PEb and the schedule was compressed from 5 days to 3 days per cycle. A parametric comparator model specified that the observed EFS rate would not be significantly less than 92%.[15][Level of evidence B4]

The 4-year EFS rate was 89% (95% confidence interval, 83%–92%), which was significantly lower than the 92% threshold of the comparison model (P = .08).

A phase III, single-arm COG trial (AGCT0132 [NCT00053352]) included 210 intermediate-risk patients (stages II–IV testicular, stages II–III ovarian, stages I–II extragonadal, or stage I gonadal tumors with subsequent recurrence). These patients received three, rather than four, cycles of PEb and the schedule was compressed from 5 days to 3 days per cycle. A parametric comparator model specified that the observed EFS rate would not be significantly less than 92%.[15][Level of evidence B4]

In a post hoc analysis, the EFS rate was compared with similar patients treated with four cycles of PEb in two previous studies. Among 181 newly diagnosed patients, the 4-year EFS rate was 87%, compared with 92% for 92 comparable children in the historical cohort (P = .15).

A phase III, single-arm COG trial (AGCT0132 [NCT00053352]) included 210 intermediate-risk patients (stages II–IV testicular, stages II–III ovarian, stages I–II extragonadal, or stage I gonadal tumors with subsequent recurrence). These patients received three, rather than four, cycles of PEb and the schedule was compressed from 5 days to 3 days per cycle. A parametric comparator model specified that the observed EFS rate would not be significantly less than 92%.[15][Level of evidence B4]

The 4-year EFS rate was significantly associated with stage (stage I, 100%; stage II, 92%; stage III, 85%; and stage IV, 54%; P < .001).

A phase III, single-arm COG trial (AGCT0132 [NCT00053352]) included 210 intermediate-risk patients (stages II–IV testicular, stages II–III ovarian, stages I–II extragonadal, or stage I gonadal tumors with subsequent recurrence). These patients received three, rather than four, cycles of PEb and the schedule was compressed from 5 days to 3 days per cycle. A parametric comparator model specified that the observed EFS rate would not be significantly less than 92%.[15][Level of evidence B4]

These data do not support a reduction in the number of cycles of PEb from four to three.