Table 2.
Included studies
| References | Interventions | Type of study/study population | Scales used | QoL summary |
|---|---|---|---|---|
| Minden et al26 (abstract); Dombret et al9 | AZA vs CCR (standard induction chemotherapy, low-dose cytarabine, or supportive care only) | RCT, N=488; age ≥65 years, newly diagnosed AML, not eligible for HSCT | EORTC QLQ-C30 | 157 AZA patients and 134 CCR patients were evaluable for HRQoL. AZA or CCR showed general improvement in the four relevant domains. No HRQoL detriment was seen with AZA or CCR at the group level during treatment. “Few” statistically significant (P<0.05). “Fewer” met the MID threshold. CCR achieved meaningful improvement in fatigue (cycles 7 and 9) and GHS/QoL (cycle 9). Patients receiving AZA achieved meaningful improvement in fatigue (cycle 9). Scores varied substantially among individual patients in both treatment groups |
| Oliva et al24 (abstract) | AZA vs BSC after conventional induction (3+7) and consolidation chemotherapy | RCT, N=99; age >60 years, newly diagnosed or secondary AML (>30% myeloid marrow blasts), ECOG PS <3 | EORTC QLQ-C30, QoL-E (ver 3) | After first "3+7" regimen; QoL-E: no changes; QLQ-C30: deterioration in PF (median 80, IQR 60–93, to 67, IQR 52–87, P=0.008), role function (median 83, IQR 67–100, to 67, IQR 33–83, P=0.023), and GHS (median 50, IQR 33–69, to 67, IQR 50–75, P=0.002) and improvement in dyspnea (P=0.023). After consolidation therapy, among patients obtaining a CR QoL-E: improvement in median physical scores (56, IQR 41–72, to 63, IQR 50–84, P=0.033), disease-specific domain scores (59, IQR 48–67, to 74, IQR 67–85, P=0.003), and treatment outcome index scores (55, IQR 32–77, to 79, IQR 41–86, P=0.026); QLQ-C30: improvement in emotional function (83, IQR 67–92, to 92, IQR 77–100, P=0.015), GHS (median 50, IQR 33–65, to 67, IQR 58–83, P=0.002). Dyspnea and insomnia regressed while financial problems increased |
| Lübbert et al17 | DEC + BSC vs BSC | RCT, N=233; Age ≥60, MDS or CMML, int-1, int-2, or high-risk, ineligible for intensive treatment, ECOG ≤2 | EORTC QLQ-C30 | Patients on the DEC arm showed a significant improvement in their physical functioning and borderline improvement in GHS. No apparent effect was seen on dyspnea. Trends of most of QoL scales favors DEC |
| Sekeres et al25 | LDAC + lintuzumab vs LDAC | RCT, N=211; age ≥60 years, de novo AML, exposed to chemotherapy for different malignancies, ECOG PS ≤2 | FACT-Leu | No consistent pattern of change in FACT-Leu score was observed. The median change in FACT-Leu score was similar in both arms where the range of scores overlapped considerably |
| Tseng et al27 (abstract) | AZA | Prospective observational, N=56; MDS, treated with AZA | EORTC QLQ-C30, FACT-fatigue, EQ-5D, and a global fatigue scale | 50 were evaluable for QoL. Clinically important differences were seen in physical, role, cognitive, and social functioning, GHS between responders and nonresponders (all higher in responders). Responders had significantly superior GHS (P=0.001) and EQ-5D scores (P=0.0002) and lower levels of fatigue (P<0.0001) |
| Ingber et al28 (abstract) | AZA | Prospective observational, N=20; MDS, treated with AZA | EORTC QLQ-C30, EQ-5D, global fatigue scale | The only clinically significant improvements were observed with the EORTC physical functioning and fatigue subscales but constipation scores were higher and GHS/QoL deteriorated over time. |
| Oliva et al29 | Intensive therapy vs palliative treatment | Prospective observational, N=113; age ≥60, newly diagnosed de novo AML | EORTC QLQ-C30 (ver. 3) and QoL-E (ver. 2) | At diagnosis, the median QoL-E general standardized score 54 (IQR 46–70)/median EORTC QLQ-C30 global score decreased 50 (IQR 41–66) Fatigue in QoL-E median 45 (IQR 32–53)/QLQ-C30 median 33 (IQR 22–66) Loss of appetite was perceived by 75% of patients |
| Deschler et al30 | BSC vs (HMA vs IC + HCT | Patient survey, N=195 | EORT QLQ-C30 and ADL (Barthel index) | At baseline, median EORTC QLQ-C30 fatigue (BSC vs HMA vs IC/HCT vs total): 53.3 vs 66.6 vs 44.3 vs 53.3, median ADL (Barthel index) (BSC vs HMA vs IC/HCT vs total): 100 vs 100 vs 100 vs 100 |
| Pandya et al31 (abstract) | NA | Patient survey, N=75; AML, 1L or R/R (75% [n=56] first line vs 25% [n=19] relapsed/refractory AML) | FACT-Leu and EQ-5D-3L | First-line patients may have a directionally better QoL scores than those on later lines of therapy 1L vs R/R: EQ-5D =0.75 vs 0.71 (P=0.51) and the FACT-Leu =103.7 vs 92.5 (P=0.098). R/R patients were significantly more likely than first-line patients to be affected physically by their AML condition 1L vs R/R: FACT-Leu-physical well-being sub-domain =13.0 vs 17.6, P=0.005 |
| Cheng et al34 (abstract) | NA | Patient survey, N=18; AML, achieved the first CR | EORTC QLQ-C30, QoL-CS, FACIT-fatigue, and HADS | Participants scored well on the EORTC QLQ-C30. The FACIT-fatigue (worst 0 to best 52) mean score was 28.7 and the median score was 33.5 (normal ≥30). On the HADS anxiety scale, two participants scored in the abnormal range. On the QoL-CS, participants scored above 6/10 in all domains, with exceptions of the psychological subscales of distress and fear (physical 8.7/psychological 7.9/distress 4.7/fear 4.5/social 7.1/spiritual 7.4) |
| Leunis et al14 | NA | Patient survey, N=92; AML survivors vs general population | EQ-5D and EORTC QLQ-C30 | The majority of the patients with AML reported problems on the five functioning scales of the QLQ-C30. The average scores on all functioning scales were significantly lower in patients with AML compared to adjusted general population scores. The differences in physical, role, cognitive, and social functioning were also clinically relevant. Despite these differences, no significant difference was found for the global quality of life |
| Levy et al33 | AZA vs CCR (BSC alone, low-dose chemotherapy + BSC, and standard-dose chemotherapy + BSC) | Utility, CEA; AML survivors vs general population | EQ-5D mapped from EORTC QLQ-C30 and SF-6D mapped from SF-12 | The utility analysis results show that, compared with patients receiving BSC, patients treated with AZA had a better quality of life and the difference increased with increasing length of treatment |
Note: SF-6D and SF-12, short form health surveys.
Abbreviations: ADL, activities of daily living; AZA, azacitidine; CEA, cost-effectiveness analysis; CCR, conventional care regimens; CMML, chronic myelomonocytic leukemia; CR, complete response; DEC, decitabine; ECOG PS, The Eastern Cooperative Oncology Group performance status; EQ-5D-3L, EuroQol 5-dimensions 3-levels; FACT-fatigue, Functional Assessment of Cancer Therapy-fatigue; FACT-Leu, Functional Assessment of Cancer Therapy-leukemia; HADS, Hospital Anxiety and Depression Scale; HCT, hematopoietic cell transplantation; HSCT, hematopoietic stem cell transplantation; MID, minimally important difference; NA, Not applicable; QoL, quality of life; QoL-CS, quality of life cancer survivor; RCT, randomized clinical trials; R/R, relapsed/refractory.