A nationwide phase II study of delayed local treatment for children with high-risk neuroblastoma: The Japan Children's Cancer Group Neuroblastoma Committee Trial JN-H-11.

Autor: Yoneda A; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Surgery, Surgical Oncology, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.; Pediatric Surgical Oncology, National Cancer Center Hospital, Tokyo, Japan., Shichino H; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Pediatrics, National Center for Global Health and Medicine, Tokyo, Japan., Hishiki T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Pediatric Surgery, Chiba University, Chiba, Japan., Matsumoto K; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan., Ohira M; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Research Institute for Clinical Oncology, Saitama Cancer Center, Saitama, Japan., Kamijo T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Research Institute for Clinical Oncology, Saitama Cancer Center, Saitama, Japan., Kuroda T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Pediatric Surgery, Keio University School of Medicine, Tokyo, Japan., Soejima T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Kobe Proton Center, Kobe, Japan., Nakazawa A; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Clinical Research, Saitama Children's Medical Center, Saitama, Japan., Takimoto T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Clinical Epidemiology Research Center for Pediatric Cancer, National Center for Child Health and Development, Tokyo, Japan., Yokota I; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Biostatistics, Graduate School of Medicine, Hokkaido University, Hokkaido, Japan., Teramukai S; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan., Takahashi H; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; National Institute of Public Health, Saitama, Japan., Fukushima T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Department of Pediatric Hematology and Oncology, Saitama Medical University International Medical Center, Saitama, Japan., Hara J; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Pediatric Hematology and Oncology, Osaka City General Hospital, Osaka, Japan., Kaneko M; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Ibaraki Prefectural Association of Health Evaluation and Promotion, Mito, Japan., Ikeda H; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Pediatric Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan., Tajiri T; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Pediatric Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Mugishima H; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; Booth Memorial Aged Care Center GRACE, Tokyo, Japan., Nakagawara A; The Japan Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG), Nagoya, Japan.; SAGA Heavy Ion Medical Accelerator in Tosu, Tosu, Japan.
Jazyk: angličtina
Zdroj: Pediatric blood & cancer [Pediatr Blood Cancer] 2024 Jun; Vol. 71 (6), pp. e30976. Date of Electronic Publication: 2024 Apr 05.
DOI: 10.1002/pbc.30976
Abstrakt: Purpose: Survival rates of patients with high-risk neuroblastoma are unacceptable. A time-intensified treatment strategy with delayed local treatment to control systemic diseases has been developed in Japan. We conducted a nationwide, prospective, single-arm clinical trial with delayed local treatment. This study evaluated the safety and efficacy of delayed surgery to increase treatment intensity.
Patients and Methods: Seventy-five patients with high-risk neuroblastoma were enrolled in this study between May 2011 and September 2015. Delayed local treatment consisted of five courses of induction chemotherapy (cisplatin, pirarubicin, vincristine, and cyclophosphamide) and myeloablative high-dose chemotherapy (melphalan, etoposide, and carboplatin), followed by local tumor extirpation with surgery and irradiation. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), response rate, adverse events, and surgical complications.
Results: Seventy-five patients were enrolled, and 64 were evaluable (stage 3, n = 8; stage 4, n = 56). The estimated 3-year PFS and OS rates (95% confidence interval [CI]) were 44.4% [31.8%-56.3%] and 80.7% [68.5%-88.5%], resspectively. The response rate of INRC after completion of the treatment protocol was 66% (42/64; 95% CI: 53%-77%; 23 CR [complete response], 10 VGPR [very good partial response], and nine PR [partial response]). None of the patients died during the protocol treatment or within 30 days of completion. Grade 4 adverse effects, excluding hematological adverse effects, occurred in 48% of patients [31/64; 95% CI: 36%-61%]. Major Surgical complications were observed in 25% of patients [13/51; 95% CI: 14%-40%].
Conclusion: This study indicates that delayed local treatment is feasible and shows promising efficacy, suggesting that this treatment should be considered further in a comparative study of high-risk neuroblastoma.
(© 2024 Wiley Periodicals LLC.)
Databáze: MEDLINE
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