Two induction regimens produced comparable response and survival rates, but one was associated with less acute toxicity in young patients with high-risk neuroblastoma, according to a study published in the Journal of Clinical Oncology.
The phase 3 trial (ClinicalTrials.gov Identifier: NCT01704716) was designed to compare the Memorial Sloan Kettering Cancer Center N5 induction regimen (MSKCC-N5) with the rapid COJEC regimen (rCOJEC).
The MSKCC-N5 regimen consisted of high-dose cyclophosphamide plus doxorubicin and vincristine (CAV), alternating with high-dose cisplatin and etoposide (PE), for 5 courses within 110 days (CAV, PE, CAV, PE, and CAV).
The rCOJEC regimen consisted of 8 cycles within 70 days of alternating vincristine and carboplatin (course A), vincristine and cisplatin (course B), and vincristine, etoposide, and cyclophosphamide (course C) in the sequence ABCBABCB. There was an interval of 10 days between courses regardless of hematologic recovery.
The study included 630 patients, and they were randomly assigned to receive MSKCC-N5 (n=317) or rCOJEC (n=313). The patients’ median age at diagnosis was 3.2 years (range, 1 month-20 years).
The median follow-up was 3.6 years. The metastatic complete response rate was 35% (99/281) in the MSKCC-N5 arm and 32% (86/272) in the rCOJEC arm (P =.368).
The 3-year event-free survival rate was 44% in the rCOJEC arm and 47% in the MSKCC-N5 arm (P =.527). The 3-year overall survival rate was 60% and 65%, respectively (P =.379). The rate of toxic death was 1% in both arms.
Grade 3-4 adverse events (AEs) that were significantly more common in the MSKCC-N5 arm than in the rCOJEC arm included nonhematologic AEs (68% vs 48%), infection (35% vs 25%), stomatitis (25% vs 3%), nausea and vomiting (17% vs 7%), and diarrhea (7% vs 3%).
Secondary malignancies occurred in 4 patients, 2 in each arm.
Disclosures: This research was supported by Pierre Fabre Médicament, Polymun Scientific, Apeiron Biologics, EUSA Pharma, and other organizations. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Garaventa A, Poetschger U, Valteau-Couanet D, et al. Randomized trial of two induction therapy regimens for high-risk neuroblastoma: HR-NBL1.5 International Society of Pediatric Oncology European Neuroblastoma Group study. J Clin Oncol. Published online June 21, 2021. doi:10.1200/JCO.20.03144