Secondary Outcome Shows Inotuzumab Ozogamicin for B-cell ALL Improves Health-Related QOL
The impact of inotuzumab ozogamicin (InO) on quality of life for patients with ALL has not been extensively investigated.
Inotuzumab ozogamicin (InO) may not only improve clinical outcomes among patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL) compared with chemotherapy, but patient quality of life (QoL) as well, according to a study published in Cancer.1
Previous studies demonstrated that InO significantly improves clinical outcomes such as complete response rates, disease burden, and durable remission rates vs standard of care chemotherapy, but impact on QoL was unknown.
For the open-label phase 3 INO-VATE study (ClinicalTrials.gov Identifier: NCT01564784), researchers randomly assigned 326 patients with R/R B-cell ALL to receive intravenous InO 1.8 mg/m2 vs investigator's choice (IC) of standard chemotherapy (eg, fludarabine, cytarabine, granulocyte-colony plus stimulating factor; high-dose ara-C).
Primary outcomes included clinical outcomes, but a secondary outcome measuring health-related QoL was evaluated through the self-administered European Organization for Research and Treatment of CancerQuality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol Group 5 Dimensions Questionnaire (EQ-5D). The assessments were completed at baseline, on day 1 of each subsequent cycle, and at the end of treatment before any further evaluation.
After a median follow-up of 7.5 months in the InO arm and 8.9 months in the chemotherapy arm, 85% and 65% of patients in the InO arm and chemotherapy arm completed the questionnaires, respectively.
Baseline results were comparable between the 2 arms, but patients treated with InO reported having a better QoL, functioning, and symptom scores (excluding constipation and emotional functioning). There were significant improvements in physical, role, and social functioning, as well as appetite loss among patients who received InO.
The EuroQoL showed non-significant improvements in favor of InO for global health status/QoL, dyspnea, and fatigue.
No measures showed worse outcomes with InO compared with chemotherapy.
The authors concluded that “these findings further demonstrate the positive benefit-risk profile of InO and support its continued development for the treatment of adults with relapsed/refractory ALL.”
Kantarjian HM, Su Y, Jabbour EJ, et al. Patient-reported outcomes from a phase 3 randomized controlled trial of inotuzumab ozogamicin versus standard therapy for relapsed/refractory acute lymphoblastic leukemia. Cancer. 2018 Mar 6. doi: 10.1002/cncr.31317 [Epub ahead of print]