Analysis of patient-reported outcomes found patients with relapsed/refractory B-cell acute lymphoblastic leukemia who were treated with inotuzumab ozogamicin reported better quality of life, functioning, and symptom scores compared with patients receiving standard-of-care chemotherapies.
Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) who were treated with inotuzumab ozogamicin (InO) reported better quality of life (QoL), functioning, and symptom scores compared with patients receiving standard therapy.
The phase III INO-VATE trial showed that patients who received InO had significantly higher complete response rates compared with standard-of-care chemotherapies. As part of the study, researchers assessed patient-reported outcomes (PROs) as a secondary objective of the study. The results of the assessed PROs were published in Cancer.
“In assessing the impact of a new agent, it also is crucial to assess QoL and other [PROs],” the authors wrote. “The value of such information in the measurement of a patient's subjective experience is becoming increasingly common during clinical trials as well as in routine care and follow‐up.”
In the study, the patients were randomized 1:1 to receive either InO or a standard-of-care therapy. Patients were to complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the EuroQoL Group 5 Dimensions Questionnaire on day 1 (baseline), on day 1 of each cycle of treatment, and, finally, at the end of treatment. The questionnaire completion rate was 78% with patients in the InO arm having a higher rate (85%) than the standard therapy arm (65%).
At baseline, the PRO scores were comparable between the 2 groups. At the end of the study, patients who received InO scored better on the overall health status measurements of global health status/QoL on the questionnaires. Patients taking InO also reported higher scores for physical functioning, role functioning, and social functioning.
According to the authors, patients who received InO had high remission rates, and the improved QoL among this arm is probably partially explained by the fact that patients who achieve complete response or complete response with incomplete hematologic recovery reported better QoL outcomes than patients who didn’t respond to the treatment.
“Because disease progression often negatively affects QoL, treatments with superior clinical efficacy may result in improved patient QoL in the absence of any significant treatment‐related toxicity,” the authors explained.
The authors noted some limitations for the study, including the fact that it was an open-label study, which might have influenced patient perceptions, and that patients in the InO received treatment for longer and had higher completion rates, while the standard therapy arm had a higher discontinuation rate.
However, they also noted that the PRO benefit in the InO arm is likely even better than reported in comparison with standard therapy. Patients who were in poorer health were excluded from the analyses of the standard therapy arm, which likely improved the PROs for that arm.
“The importance of PROs for providing a timely response to patient needs and for optimizing treatment outcomes is well known,” the authors concluded. “In patients with relapsed/refractory ALL for whom the chance of a cure is modest, QoL considerations are of the utmost importance.”
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;124(10):2151-2160. doi: 10.1002/cncr.31317.