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Author Notes:

Corresponding author: Furqan Shaikh, Division of Hematology/Oncology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5S 1X8, Canada; e-mail: furqan.shaikh@sickkids. ca.

Conception and design: John W. Cullen, Thomas A. Olson, Marcio H. Malogolowkin, Mark Krailo, Deborah F. Billmire, Frederick J. Rescorla, Rachel A. Egler, Bryan J. Dicken, Jonathan H. Ross, Marc Schlatter, Carlos Rodriguez-Galindo, A. Lindsay Frazier

Provision of study materials or patients: Marcio H. Malogolowkin

Collection and assembly of data: Thomas A. Olson, Doojduen Villaluna, Mark Krailo, A. Lindsay Frazier

Data analysis and interpretation: Furqan Shaikh, John W. Cullen, Thomas A. Olson, Farzana Pashankar, Marcio H. Malogolowkin, James F. Amatruda, Doojduen Villaluna, Mark Krailo, Deborah F. Billmire, Frederick J. Rescorla, Rachel A. Egler, Marc Schlatter, Carlos Rodriguez-Galindo, A. Lindsay Frazier

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

See publication for full list of disclosures.

Clinical trial information: NCT00053352.

Subjects:

Research Funding:

Supported by Group Chair’s Grant no. U10CA180886, and by Group Statistician’s Grant no. U10CA180899 (M.K. and D.V.).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • TESTICULAR CANCER
  • STAGE-I
  • COMBINATION CHEMOTHERAPY
  • PEDIATRIC INTERGROUP
  • RANDOMIZED-TRIAL
  • INITIAL SURGERY
  • UNITED-KINGDOM
  • BLEOMYCIN
  • ETOPOSIDE
  • RECOMMENDATIONS

Reduced and Compressed Cisplatin-Based Chemotherapy in Children and Adolescents With Intermediate-Risk Extracranial Malignant Germ Cell Tumors: A Report From the Children's Oncology Group

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Journal Title:

Journal of Clinical Oncology

Volume:

Volume 35, Number 11

Publisher:

, Pages 1203-1210

Type of Work:

Article | Final Publisher PDF

Abstract:

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 (EFS 4 ) 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 4 rate was 87%, compared with 92% for 92 comparable children in the historical cohort (P = .15). The EFS 4 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.

Copyright information:

© 2017 by American Society of Clinical Oncology.

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