Originally published as JCO Early Release 10.1200/JCO.2008.19.5933 on May 26 2009

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Prognostic Significance of Tumor Response at the End of Therapy in Group III Rhabdomyosarcoma: A Report From the Children's Oncology Group

From the Division of Pediatric Surgery, Children's Hospital of Pittsburgh, Pittsburgh, PA; Department of Biostatistics & Epidemiology, University of Oklahoma Health Sciences Center; Department of Hematology/Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Department of Surgery, M. D. Anderson Cancer Center, Houston, TX; Department of Radiology, University of Iowa Hospital and Clinics. Iowa City, IA; Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY; Biopathology Center, Children's Hospital, Center for Childhood Cancer, Columbus, OH; and the Department of Hematology/Oncology, Children's Hospital and Regional Medical Center, Seattle, WA.

Corresponding author: David A. Rodeberg, MD, University of Pittsburgh School of Medicine, Department of Pediatric Surgery, Children's Hospital of Pittsburgh, 3705 Fifth Ave, Pittsburgh, PA 15213-2585; e-mail: david.rodeberg{at}chp.edu.

Purpose Some patients with rhabdomyosarcoma (RMS) achieve less than a complete response (CR) despite receiving all planned therapy. We assessed the impact of best response at the completion of all therapy on patient outcome.

Patients and Methods We studied 419 clinical group III participants who completed all protocol therapy without developing progressive disease for Intergroup Rhabdomyosarcoma Study (IRS) IV. Response (complete resolution [CR], partial response [PR; 50% decrease], or no response [NR; < 50% decrease and < 25% increase]) was determined by radiographic measurement and categorized by the best response.

Results At the end of therapy, 341 participants (81%) achieved a best response of CR and 78 (19%) had a best response of PR/NR. Five-year failure-free survival was similar for participants achieving CR (80%) and PR/NR (78%). After adjustment for age, nodal status, primary site, and histology, there was no significant indication of lower risk of failure (hazard ratio [HR], 0.77; 95% CI, 0.46 to 1.27; P = .3) nor death (HR, 0.63; 95% CI, 0.36 to 1.09; P = .1) for CR versus PR/NR participants. Seventeen participants with a best response of PR/NR had surgical procedures; eight (50%) of 16 with available pathology reports had residual viable tumor and only three achieved a complete resection. Resection of residual masses was not associated with improved outcome.

Conclusion CR status at the end of protocol therapy in clinical group III participants was not associated with a reduction of disease recurrence and death. Aggressive alternative therapy may not be warranted for RMS patients with a residual mass at the end of planned therapy.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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