Yale University, New Haven, CT
Lyn M. Balsamo , John A Kairalla , Emily Hibbitts , Rozalyn L Rodwin , Meenakshi Devidas , Alexandra Dreyzin , Naomi J. Winick , William L. Carroll , Stephen Hunger , Elizabeth A. Raetz , Reuven J. Schore , Mignon L. Loh , Kirsten K. Ness , Anne L. Angiolillo , Nina S. Kadan-Lottick
Background: Children with B-acute lymphoblastic leukemia (B-ALL) undergo 2-3 years of treatment that impacts their quality of life. AALL0932 randomized reduction in vincristine and dexamethasone pulses (VCR/DEX every 4 weeks vs. every 12 weeks) during maintenance in the average-risk (AR) subset of NCI standard risk (SR) B-ALL. We longitudinally measured physical and emotional function overall and by treatment. Methods: SR AR B-ALL patients enrolled on AALL0932, aged ≥4 years, with English-speaking parents were evaluated at 5 timepoints (T1-T5: end consolidation, maintenance month 1, maintenance month 10, maintenance month 18 for boys/end of therapy for girls, end of therapy for boys). Parents completed the Pediatric Quality of Life Inventory Generic Core Scales 4.0 and a survey of supportive services received. Age- and sex-matched z scores and proportion impaired ( > 2 SD below normative mean; 2.5% expected in normative population) on the emotional and physical function subscales were measured longitudinally and compared by treatment with the Fisher’s exact test and repeated measures logistic regression. Results: Consent and data were obtained from 555 participants (mean/sd age = 6.0±1.6 years, 46.8% female). Among randomized participants with completed evaluations, 31.3% had impaired physical function at T1 decreasing to 12.5% at T4. Emotional function was impaired in 24.5% of patients at T1 decreasing to 9.8% at T4. Overall 34.9-43.8% received special education/accommodations at T1-T5; there was low use of other services (Table). In adjusted analysis, treatment group was not associated with physical or emotional function. T2 impairment predicted increased risk of impairment at T4 for physical (OR = 4.7, 95% CI 2.3-9.7, p < 0.0001) and emotional (OR = 4.7, CI 2.3-9.5, p < 0.0001) function. Conclusions: Impaired physical and emotional function were prevalent early in SR AR B-ALL therapy, improved by the end of therapy, but remained higher than norms. Outcomes did not vary with VCR/DEX frequency. Patients with early emotional and physical impairment are at elevated risk of later impairment. Clinical trial information: NCT01190930.
Timepoint | ||||||||||
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T1* | T2 | T3 | T4 | T5 | ||||||
AB | CD | AB | CD | AB | CD | AB | CD | AB | CD | |
Impaired physical function N (%) | 63 (30.1) | 58 (32.6) | 20 (10.8) | 19 (11.9) | 21 (11.8) | 15 (10.3) | 19 (11.5) | 18 (13.7) | 14 (18.4) | 5 (9.1) |
Impaired emotional function N (%) | 50 (23.9) | 45 (25.1) | 27 (14.6) | 15 (9.4) | 23 (12.9) | 20 (13.8) | 16 (9.7) | 13 (9.9) | 11 (14.5) | 1 (1.8) |
Special education/ accommodations N (%) | 76 (36.0) | 70 (38.9) | 77 (41.0) | 63 (38.9) | 70 (38.9) | 64 (43.8) | 66 (37.9) | 59 (42.7) | 29 (34.9) | 25 (39.7) |
Occupational/physical therapy N (%) | 2 (0.9) | 1 (0.6) | 10 (5.3) | 7 (4.3) | 8 (4.4) | 9 (6.2) | 9 (5.2) | 6 (4.4) | 3 (3.6) | 3 (4.8) |
Mental health services N (%) | 1 (0.5) | 0 (0) | 1 (0.5) | 4 (2.5) | 1 (0.6) | 2 (1.4) | 1 (0.6) | 2 (1.4) | 1 (1.2) | 1 (1.6) |
*Prior to randomization. AB = VCR/DEX every 4 weeks. CD = VCR/DEX every 12 weeks.
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