{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T18:55:41Z","timestamp":1789844141808,"version":"4.0.1"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2017,4,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> 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 &lt; 92%. As recommended for trials that test a reduction of therapy, a one-sided P value \u2264 .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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Among 210 eligible patients enrolled from 2003 to 2011, 4-year EFS (EFS<jats:sub>4<\/jats:sub>) 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 EFS<jats:sub>4<\/jats:sub> rate was 87%, compared with 92% for 92 comparable children in the historical cohort ( P = .15). The EFS<jats:sub>4<\/jats:sub> rate was significantly associated with stage (stage I, 100%; stage II, 92%; stage III, 85%; and stage IV, 54%; P &lt; .001). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2016.67.6544","type":"journal-article","created":{"date-parts":[[2017,2,27]],"date-time":"2017-02-27T20:58:00Z","timestamp":1488229080000},"page":"1203-1210","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":27,"title":["Reduced and Compressed Cisplatin-Based Chemotherapy in Children and Adolescents With Intermediate-Risk Extracranial Malignant Germ Cell Tumors: A Report From the Children\u2019s Oncology Group"],"prefix":"10.1200","volume":"35","author":[{"given":"Furqan","family":"Shaikh","sequence":"first","affiliation":[{"name":"Furqan Shaikh, The Hospital for Sick Children, University of Toronto, Toronto, Canada; John W. Cullen, Rocky Mountain Hospital for Children-Presbyterian Saint Luke\u2019s Medical Center, Denver, CO; Thomas A. Olson, Children\u2019s Healthcare of Atlanta, and Emory University, Atlanta, GA; Farzana Pashankar, Yale University School of Medicine, New Haven, CT; Marcio H. Malogolowkin, University of California Davis Comprehensive Cancer Center, Sacramento; Doojduen Villaluna and Mark Krailo, Children\u2019s Oncology Group,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John W.","family":"Cullen","sequence":"additional","affiliation":[{"name":"Furqan Shaikh, The Hospital for Sick Children, University of Toronto, Toronto, Canada; John W. Cullen, Rocky Mountain Hospital for Children-Presbyterian Saint Luke\u2019s Medical Center, Denver, CO; Thomas A. Olson, Children\u2019s Healthcare of Atlanta, and Emory University, Atlanta, GA; Farzana Pashankar, Yale University School of Medicine, New Haven, CT; Marcio H. Malogolowkin, University of California Davis Comprehensive Cancer Center, Sacramento; Doojduen Villaluna and Mark Krailo, Children\u2019s Oncology Group,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas A.","family":"Olson","sequence":"additional","affiliation":[{"name":"Furqan Shaikh, The Hospital for Sick Children, University of Toronto, Toronto, Canada; John W. Cullen, Rocky Mountain Hospital for Children-Presbyterian Saint Luke\u2019s Medical Center, Denver, CO; Thomas A. Olson, Children\u2019s Healthcare of Atlanta, and Emory University, Atlanta, GA; Farzana Pashankar, Yale University School of Medicine, New Haven, CT; Marcio H. Malogolowkin, University of California Davis Comprehensive Cancer Center, Sacramento; Doojduen Villaluna and Mark Krailo, Children\u2019s Oncology Group,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farzana","family":"Pashankar","sequence":"additional","affiliation":[{"name":"Furqan Shaikh, The Hospital for Sick Children, University of Toronto, Toronto, Canada; John W. Cullen, Rocky Mountain Hospital for Children-Presbyterian Saint Luke\u2019s Medical Center, Denver, CO; Thomas A. Olson, Children\u2019s Healthcare of Atlanta, and Emory University, Atlanta, GA; Farzana Pashankar, Yale University School of Medicine, New Haven, CT; Marcio H. Malogolowkin, University of California Davis Comprehensive Cancer Center, Sacramento; Doojduen Villaluna and Mark Krailo, Children\u2019s Oncology Group,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcio H.","family":"Malogolowkin","sequence":"additional","affiliation":[{"name":"Furqan Shaikh, The Hospital for Sick Children, University of Toronto, Toronto, Canada; John W. Cullen, Rocky Mountain Hospital for Children-Presbyterian Saint Luke\u2019s Medical Center, Denver, CO; Thomas A. Olson, Children\u2019s Healthcare of Atlanta, and Emory University, Atlanta, GA; Farzana Pashankar, Yale University School of Medicine, New Haven, CT; Marcio H. Malogolowkin, University of California Davis Comprehensive Cancer Center, Sacramento; Doojduen Villaluna and Mark Krailo, Children\u2019s Oncology Group,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James F.","family":"Amatruda","sequence":"additional","affiliation":[{"name":"Furqan Shaikh, The Hospital for Sick Children, University of Toronto, Toronto, Canada; John W. Cullen, Rocky Mountain Hospital for Children-Presbyterian Saint Luke\u2019s Medical Center, Denver, CO; Thomas A. Olson, Children\u2019s Healthcare of Atlanta, and Emory University, Atlanta, GA; Farzana Pashankar, Yale University School of Medicine, New Haven, CT; Marcio H. 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