Sharman J, et al. ASH 2017:683

Improvements in HRQoL and symptoms in patients with previously untreated CLL: Results from the phase II GIBB study of the combination of obinutuzumab and bendamustine

Background

The GIBB study found that the combination of obinutuzumab (also called GA101) and bendamustine (BG) provided high response rates for patients with previously untreated chronic lymphocytic leukemia (CLL), with a typical safety profile for a chemoimmunotherapy regimen.1 At the ASH 2017 Annual Meeting, investigators presented health-related quality of life (HRQoL) data from this patient cohort.2

Study design

  • The GIBB study was a single-arm, phase II, open-label, multicentre trial.
  • The objective of the HRQoL analysis was to assess the impact of BG treatment on patient-reported outcomes (PROs) in patients with previously untreated CLL.
  • PROs were assessed with two scales:
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30); and
  • The EORTC-QLQ-CLL16, a CLL-specific scale.
  • Patients completed these questionnaires on Day 1 of Cycles 1 (baseline), 3, and 6, at the end of induction treatment, at the end of treatment response visit (2–3 months after the end of induction treatment), and every three months thereafter.
  • Responses were transformed to a 0–100 scale.
  • Mean scores (± 95% CI) at each visit and mean changes from baseline were evaluated.
  • All analyses were descriptive.
  • A ≥10-point change in score represented a clinically significant change, known as a minimally important difference.

Study design

Key findings

  • A total of 98 patients comprised the PRO-evaluable population, which included patients who completed a questionnaire at baseline and at least one other scheduled assessment.
  • The median age was 61 years (range: 35–90).
  • The majority of patients were male (68.4%) and had an Eastern Cooperative Oncology Group performance status of 0 (55.1%).
  • Questionnaire completion rates ranged from 78.6% (at Cycle 6) to 100% (at baseline).
  • Baseline scores for the EORTC-QLQ-C30 and EORTC-QLQ-CLL16 are shown in Figure 1.
  • In the EORTC-QLQ-C30, clinically meaningful improvements in global health status and role functioning were observed relative to baseline. (Figure 2)
  • Patients also experienced clinically meaningful improvements in fatigue and insomnia compared to baseline. (Figure 3)
  • Results from the EORTC-QLQ-CLL16 demonstrated large improvements in fatigue, future health worries, and disease symptoms compared to baseline. (Figure 4)

Figure 1. EORTC QLQ-C30 and QLQ-CLL16: baseline scores

Figure 2. EORTC QLQ-C30 results: functional scales

Figure 3. EORTC QLQ-C30 results: symptom scales

Figure 4. EORTC QLQ-CLL16 results

Key conclusions

  • Clinically meaningful improvements were observed with BG in the areas of global health status, role functioning, fatigue, disease symptoms, and future health worries.
  • No worsening in patient-reported symptoms or functional status was reported.
  • These HRQoL results provided information on the patient-reported benefits of the BG regimen and supported the improvements previously seen with BG in clinical endpoints.

References: 1. Sharman J, Yimer, H, Boxer M, et al. Results of a phase II multicenter study of obinutuzumab plus bendamustine in patients with previously untreated chronic lymphocytic leukemia (CLL). J Clin Oncol (ASCO Annual Meeting) 2017;35(Suppl): abstr 7523. 2. Sharman J, Yimer H, Boxer M, et al. Improvements in health-related quality of life and symptoms in patients with previously untreated chronic lymphocytic leukemia: results from the phase II GIBB study of the combination of obinutuzumab and bendamustine. ASH Annual Meeting Abstracts 2017:683.