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Localized Infant Neuroblastomas Often Show Spontaneous Regression: Results of the Prospective Trials NB95-S and NB97

Barbara Hero, Thorsten Simon, Ruediger Spitz, Karen Ernestus, Astrid K. Gnekow, Hans-Guenther Scheel-Walter, Dirk Schwabe, Freimut H. Schilling, Gabriele Benz-Bohm, Frank Berthold

From the Children's Hospital, University of Cologne; Children's Hospital, Augsburg; Children's Hospital, University of Tuebingen; Children's Hospital, University of Frankfurt, Frankfurt; and the Olgahospital, Stuttgart, Germany

Corresponding author: Barbara Hero, MD, Children's Hospital, Department of Pediatric Oncology and Hematology, University of Cologne, Kerpener Str. 62, 50924 Cologne, Germany; e-mail: barbara.hero{at}uk-koeln.de

Purpose The excellent prognosis of localized neuroblastoma in infants, the overdiagnosis observed in neuroblastoma screening studies, and several case reports of regression of localized neuroblastoma prompted us to initiate a prospective cooperative trial on observation of localized neuroblastoma without cytotoxic treatment.

Patients and Methods For infants with localized neuroblastoma without MYCN amplification, chemotherapy was scheduled only in cases with threatening symptoms; otherwise, the tumor was either resected or observed by ultrasound and magnetic resonance imaging (MRI).

Results Of 340 eligible participants, 190 underwent resection, 57 were treated with chemotherapy, and 93 were observed with gross residual tumor. Of those 93 patients with unresected tumors, spontaneous regression was seen in 44, local progression in 28, progression to stage 4S in seven, and progression to stage 4 in four. Time to regression was quite variable, with first signs of regression noted 1 to 18 months after diagnosis and in 15 of 44 patients even after the first year of life. So far, complete regression was observed in 17 of 44 patients 4 to 20 months after diagnosis. Known clinical risk factors were not able to differentiate between patients with regression and regional or metastatic progression. Overall survival (OS; 3-year OS, 0.99 ± 0.01) and metastases-free survival (rate at 3 years, 0.94 ± 0.03) for patients with unresected tumors was excellent and was not different from patients treated with surgery or chemotherapy.

Conclusion Spontaneous regression is regularly seen in infants with localized neuroblastoma and is not limited to the first year of life. A wait-and-see strategy is justified in those patients.

Supported by grants from the Deutsche Krebshilfe.

Presented in part at the Advances of Neuroblastoma Research Meeting, May 17-20, 2006, Los Angeles, CA.

Clinical trials Nos. NCT00002803 [ClinicalTrials.gov] and NCT00017225 [ClinicalTrials.gov] .

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

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