Qol-Blina Protocol: Preliminary Data of a Paediatric Italian Multicentric Study

Introduction: Immunotherapy with monoclonal antibodies represents a new therapeutic approach in pediatric Acute Lymphoblastic Leukemia (ALL) both in front-line treatment and in relapse.

Previous researches have demonstrated the efficacy of blinatumomab, but no specific studies have been performed on Quality of Life (QoL) in pediatric patients during this treatment.

Based on this findings, the first observational multicenter study in pediatric hemato-oncology area, comparing the QoL of patients treated with blinatumomab (Blina) versus the standard chemotherapy (SoC), is in progress at our Department.

The aim of the study is to analyze the perceived QoL and the psychosocial risk in pediatric patients affected by ALL-B, recruited in the AIEOP-BFM-ALL-2017 protocol (intermediate/high risk) and treated, after randomisation, with standard chemiotherapy (Group 1) or blinatumomab immunotherapy (Group 2),

Methods:The study, lasting 24 months, includes a sample of about 200 patients (aged 2-17 years at diagnosis of ALL) in 26 AIEOP Centers.

In this phase of the study, descriptive analyses,with SPSS software, have been run to explore the levels of perceived QoL in patients treated with SOC or Blina and levels of perceived QoL on Psychosocial Risk. Moreover the mean of perceived QoL is described for each age group.

The following questionnaries are administered:

• PAT (Assessment Tools, Kazak, 2006) that measures seven subscales (Family Structure and Resources; (Psychosocial Social Support; Child Problems; Sibling Problems; Family Problems; Parent Stress Reactions; Family Beliefs) and a general psychosocial risk score (universal, targeted and clinical);
• PedsQoL (Pediatric Quality of Life Inventory 3.0) cancer module consisted of 8 scales: 1) pain and hurt (2 items), 2) nausea (5 items), 3) procedural anxiety (3 items), 4) treatment anxiety (3 items), 5) worry (3 items), 6) cognitive problems (5 items), 7) perceived physical appearance (3 items), and 8) communication (3 items). The format includes a General Score, with higher scores indicating better QOL.

Results:From February 2022 to July 2024, 61 patients have been recruited in 6 AIEOP Center activated.

Preliminary data show that:

• considering the levels of QoL (General QoL Score) for N=61 patients:

- of N=21 patients treated with SoC:

N=5 revealed low level of perceived QoL,

N=9 intermediate level,

N= 7 high level;

- of N=40 patients treated with Blina:

N=9 revealed low level of perceived QoL,

N=21 intermediate level,

N= 10 high level.

• considering the levels of QoL (General QoL Score) on Psychosocial risk for N= 61 patients:

-0f N=27 patients who reported universal/low risk:

N=2 revealed low level of perceived QoL,

N=16 intermediate level,

N= 9 high level;

-0f N=26 patients who reported targeted/specific risk:

N=9 revealed low level of perceived QoL,

N=9 intermediate level,

N= 8 high level;

-0f N=8 patients who reported clinical/high risk:

N=4 revealed low level of perceived QoL,

N=3 intermediate level,

N= 1 high level,

• considering General QoL Score Mean for N=61 patients divided into 4 groups by age:

N=15 patients (2-4 years) reported M=71.34,

N=14 patients (5-7 years) reported M=67.79,

N=22 patients (8-12 years) reported M=71.83 ,

N=10 patients (13-17 years) reported M=65.74,

Conclusion:These preliminary results show that there are not significant differences between the groups of patients treated with SOC or Blina about perceived QoL.

Moreover most of patients with clinical/high psychosocial risk reported low/intermediate levels of perceived QoL and most of patients with universal/low psychosocial risk reported high/ intermediate levels of perceived QoL.

These data show that the perceived QoL in patients is influenced much more by presence/absence of psychosocial risk and is independent from the administered therapy (Blina or SoC).

Finally, the group of adolescents (13-17 years) shows lower mean score than the other groups about the perceived QoL. Therefore adolescence seems the most critical period of growth.

Further patients are needed to confirm the data. According to these data we suggest to focusing on the individual and family psychosocial aspects, using personalized clinical interventions to provide adequate coping strategies and support the critical psychological issues related to disease.