CLO19-050: Risk of Health- Related Quality of Life (HRQOL) Events in Patients With Advanced Solid Tumors Treated With Cabozantinib: A Combined Analysis of Four Phase 3 Randomized Controlled Trials

2019 ◽  
Vol 17 (3.5) ◽  
pp. CLO19-050
Author(s):  
Sriman Swarup ◽  
Anita Sultan ◽  
Nusrat Jahan ◽  
Upama Sharma ◽  
Nimesh Adhikari ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Solid Tumors ◽  
Meta Analysis ◽  
Health Related Quality ◽  
Phase 3 ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related

Background: VEGFR, KIT, RET, and MET pathways are implicated in several solid tumors. Cabozantinib is an oral inhibitor of these kinase pathways, and hence has found its use in treatment of multiple malignancies. However, it has several side effects that can limit tolerance amongst patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of health-related quality of life (HRQOL) events in patients with advanced solid tumors treated with cabozantinib. Methods: We systematically conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts through September 30, 2018. Phase 3 trials that mention HRQOL events like pain, arthralgia, fatigue, and reduced appetite as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR) with 95% CI. Random effects model was applied. Results: 4 phase 3 RCTs with a total of 2,703 patients with medullary thyroid cancer, prostate cancer, renal cell carcinoma, and hepatocellular carcinoma were eligible. Studies comparing cabozantinib (C) vs everolimus, C vs placebo, C vs prednisone were included in the analysis. The relative risks of all-grade side effects were as follows: fatigue, 1.378 (95% CI: 1.236–1.536; P<.0001); asthenia, 1.704 (95% CI: 1.190–2.441; P=.004); reduced appetite, 2.088 (95% CI: 1.471–2.964; P<.0001); back pain, 1.047 (95% CI: 0.871–1.259; P=.626); pain in limbs, 1.444 (95% CI: 1.128–1.847; P=.004); arthralgia, 0.982 (95% CI: 0.707–1.363; P=.912). The RR of high-grade side effects were as follows: fatigue, 1.937 (95% CI: 1.483–2.528; P<.0001); asthenia, 2.211 (95% CI: 1.536–3.184; P<.0001); reduced appetite, 4.329 (95% CI: 2.372–7.900; P<.0001); back pain, 1.227 (95% CI: 0.738–2.040; P=.431); pain in limbs, 2.933 (95% CI: 1.127–7.635; P=.028); arthralgia, 0.820 (95% CI: 0.394–1.709; P=.597). Conclusion: Our meta-analysis showed that cabozantinib contributed to significant toxicity of all grades of fatigue, asthenia, pain in limbs, and reduced appetite. Identifying and addressing these toxicities will be important in improving quality of life for these patients.

Risk of health-related quality-of-life events and pulmonary toxicities in patients with cancer treated with poly adenosine diphosphate ribose polymerase inhibitors: A meta-analysis of seven phase III trials.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 213-213
Author(s):  
Sriman Swarup ◽  
Anita Sultan ◽  
Myo Zaw ◽  
Rachana Yendala ◽  
Myat M. Han ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Meta Analysis ◽  
Adenosine Diphosphate ◽  
Parp Inhibitors ◽  
Phase Iii ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

213 Background: Poly adenosine diphosphate ribose polymerase (PARP) enzymes aide in the repair of DNA damage. PARP inhibitors showed synthetic lethality in cancer cells and were utilized in many solid tumors with notable toxicities. Fatigue and pain are the major determinants of health-related quality of life (HRQOL) in cancer patients undergoing chemotherapy. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of HRQOL events and pulmonary toxicities. Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018 were queried. Phase III RCTs that mention HRQOL events and pulmonary toxicities as adverse effects were included. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Random effects model was applied. Results: 3188 patients from 7 phase III RCTs with breast, ovarian, and gastric cancer were eligible. Studies compared olaparib or niraparib or rucaparib versus placebo, olaparib vs single agent chemotherapy, iniparib + gemcitabine / carboplatin (GC) versus GC, veliparib + C versus C and olaparib + paclitaxel versus paclitaxel. The RR of all-grade side effects were as follows: fatigue, 1.26 (95% CI: 1.07 – 1.49, P = 0.006); decreased appetite, 1.42 (95% CI: 1.18 – 1.71, P < 0.001); arthralgia, 1.05 (95% CI: 0.83 – 1.34, P = 0.65); headache, 1.35 (95% CI: 0.99 – 1.84, P = 0.05); cough, 1.75 (95% CI: 1.17 – 2.62, P = 0.006); dyspnea, 1.40 (95% CI: 0.90 – 2.18, P = 0.12); and upper respiratory infections, 1.70 (95% CI: 0.97 – 3.00, P = 0.06). The RR of high-grade side effects were as follows: fatigue, 1.94 (95% CI: 1.24 – 3.04, P = 0.004); arthralgia, 1.37 (95% CI: 0.29 – 6.51, P = 0.68); headache, 1.09 (95% CI: 0.47 – 2.55, P = 0.83); and dyspnea, 1.02 (95% CI: 0.44 – 2.36, P = 0.95). Conclusions: The risk of developing all grades of fatigue as well as any-grade cough and decreased appetite was high in PARP inhibitors group, compared to control arm. Recognizing these toxicities and providing good supportive care is vital in enhancing patients’ quality of life.

scholarly journals Effects of Exercise Intervention on Health-Related Quality of Life in Patients with Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis of Controlled Trials

Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1215
Author(s):  
Ming-Chi Lu ◽  
Malcolm Koo
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Health Related Quality ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related

Exercise and physical activity have been deemed as potentially beneficial for patients with systemic lupus erythematosus (SLE). This study aimed to evaluate the effects of exercise interventions on health-related quality of life in patients with SLE using a systematic review and meta-analysis. Randomized and non-randomized controlled trials published up to July 2021 were examined using the PubMed and Embase databases. Of the 1158 articles retrieved, nine were included for systematic review. Five of them were randomized controlled trials and these were assessed using meta-analysis. Hedges’ g effect size was 0.47; 95% (confidence interval 0.21–0.73; p < 0.001) for the physical health and function aspect of health-related quality of life. None of the other seven domains of the SF-36 showed a significant effect size. However, the latter finding was limited by the small number of available trials. In conclusion, this systematic review and meta-analysis supported that exercise intervention compared to usual care might be able to improve the physical functioning domain of health-related quality of life in patients with SLE. Future high-quality randomized controlled trials that incorporate disease-specific health-related quality of life measures are needed to elucidate the role of exercise on health-related quality of life in patients with SLE.

CLO19-059: A Systematic Review and Meta- Analysis of Randomized Controlled Trials to Evaluate the Risk of Health-Related Quality of Life Events in Patients With Hormone Receptor-Positive HER2-Negative Metastatic Breast Cancer Treated With CDK 4/6 Inhibitors

2019 ◽  
Vol 17 (3.5) ◽  
pp. CLO19-059
Author(s):  
Rachana Yendala ◽  
Kyaw Thein ◽  
Sriman Swarup ◽  
Anita Sultan ◽  
Somedeb Ball ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Meta Analysis ◽  
Hot Flushes ◽  
Health Related Quality ◽  
Randomized Controlled ◽  
Hormone Receptor Positive ◽  
Related Quality ◽  
Health Related

Background: Pain, fatigue, hot flushes, and rash significantly contribute to quality of life in breast cancer patients undergoing chemotherapy. Hormone receptor-positive breast cancer is a common entity among women worldwide. In cancer cells, CDK4/6 activity is over expressed, which can lead to amplification or overexpression of the genes encoding for CDK 4/6 or the cyclin D, ultimately leading to endocrine therapy resistance. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of health-related quality of life (HRQOL) events associated with CDK 4/6 inhibitors. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018. RTCs that mention HRQOL events as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95%CI. Random effects model was applied. Results: 8 RCTs (7 phase III and 1 phase II) with a total of 4,557 patients were eligible. The study arms used palbociclib/ribociclib/abemaciclib with letrozole or anastrozole or fulvestrant or other hormonal agent while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agent. The RR of all-grade side effects were as follows: fatigue, 1.226 (95% CI: 1.079–1.393; P=.002); back pain, 0.971 (95% CI: 0.844–1.117; P=.681); arthralgia, 0.978 (95% CI: 0.830–1.152; P=.790); headache, 1.046 (95% CI: 0.928–1.179; P=.459); alopecia, 2.635 (95% CI: 1.966–3.533; P<.001); hot flushes, 0.901 (95% CI: 0.766–1.060; P=.210); and rash, 2.068 (95% CI: 1.604–2.666; P<.001). The RR of high-grade side effects were as follows: fatigue, 3.487 (95% CI: 1.765–6.889; P<.001); back pain, 1.364 (95% CI: 0.695–2.679; P=.367); arthralgia, 1.148 (95% CI: 0.509–2.593; P=.740); headache, 0.807 (95% CI: 0.303–2.147; P=.667); and rash, 3.018(95% CI: 0.954–9.554; P=.060). Conclusions: Our study showed that the risk of developing all grades of fatigue and any-grade alopecia and rash was significantly with CDK 4/6 inhibitors. Prompt intervention with good supportive care is required.

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