Background
The current HR-NBL1/SIOPEN strategy permits stem-cell leukopheresis only after completion of induction therapy due to the rapid 10-day schedule of COJEC cycles. Our aim was to define risk factors for insufficient stem cell collection of fewer than 3x106 CD34+ cells/kg body weight (BW) in this population.
Patients and Methods
Patient eligibility in this analysis was completed induction therapy (COJEC ±TVD), accrual between 2002-2015 and at least one documented peripheral stem cell collection (PSSC) attempt. A total of 1024 patients were included, of which 896 (88%) had stage 4 disease and the remaining 128 MYCN-amplified (MNA) localized or 4S disease. Median age at diagnosis was 2.7 years (range 22d – 19.8y). Median follow-up time is 5.4yrs. The minimum successful total stem cell yield was 3x106 CD34+ cells/kgBW as mandated by the trial protocol.
Results
689/1024 patients (67.3%) had a successful collection with one collection attempt while in 270 (26.5%) ≥2 collection cycles were undertaken, of whom 46/270 did not achieve the threshold of 3x106 CD34+ cells/kgBW.
In 111/1024 children (11%) ≤3x106/kg CD34+ were collected (range 0.2-2.9x106/kg, median 2.4). Failure of PBSC collection >3x106/kg was more frequent in patients without MNA disease (13.7% vs 8.4%, p=0.01 Fisher exact) and in patients aged ≥5 years at diagnosis (16.3% vs 9.8%, p=0.015). Persistent bone marrow (BM) involvement or other metastatic sites had no apparent impact on collection yield.
35/111 patients underwent additional BM harvest (0.2-14.1x106/kg CD34+ cells, median 2.6). 31/35 reached the threshold and received high-dose chemotherapy; 2/35 were transplanted with <3x106/kg CD34+ cells and 2 patients were not transplanted.
Among patients with <3x106/kg CD34+ cells collected by PSSC 90.8% (n=99) underwent high-dose chemotherapy, compared to 97.4% (n=832) in patients above threshold.
Conclusion
Unsuccessful PSSC was more common in patients aged >5 years and without MNA disease; there was no statistical correlation with metastatic site involvement at diagnosis. Overall, >3x106/kg CD34+ were collected in 92% of patients.