Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non–Small-cell Lung Cancer

Abstract

These PRO data support the clinical benefit of atezolizumab in patients with previously treated advanced or metastatic NSCLC. Atezolizumab prolonged the TTD of patients' limitations in role and physical functions compared with docetaxel.

Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials

“…All trials had overall survival or progression-free survival as the primary endpoint; all reported significant differences in one of these endpoints between treatment arms. HRQOL was a secondary endpoint in nine trials [49,50,51,52,53,54,55,56,57], an exploratory endpoint in five RCTs [58,59,60,61,62] and for one trial it was unclear if the HRQOL endpoints were secondary or exploratory [63]. Seven trials discussed HRQOL in their main publication [50,59,60,52,61,56,57].…”

“…The conceptual measurement and methodology for evaluating HRQOL outcomes from the 15 RCTs included in this systematic review are summarised in Table 2 and S2 Table. HRQOL was Health-related quality of life assessment, cancer and immune checkpoint inhibitors: A systematic review , to satisfy the "a priori hypothesis stated" criterion, the study needed to predefine HRQOL end point and/or state expected changes because of the specific treatment. Only five trials of the 15 RCTs satisfied this criterion but none of them included an a priori hypothesis for the expected HRQOL outcomes [49,50,51,54,55].…”

“…If one or two of the 11 items on the checklist were assessed as not applicable, the cutoff was set at seven or six criteria respectively (although the three mandatory criteria still had to be met). Only for ten trials of the 15 RCTs HRQOL data was judged as high quality [49,58,50,59,51,60,52,54,55,63]. The others trials were considered to have some possible reported methodological limitations because of studies addressed (1) at least eight (or seven if one of the 11 items on the checklist were assessed as not applicable) issues but did not take into account the mandatory items [52,61,62]; (2) fewer than eight (or seven) issues [56,57].…”

Immunotherapy in Advanced Non-Small Cell Lung Cancer

“…The OAK trial also demonstrated that patients who received atezolizumab reported a higher health-related quality of life at baseline compared with the patients who received docetaxel. 32 This was the first study that indicated improved survival benefits with atezolizumab in NSCLC.…”

Imunoterapia no Cancro do Pulmão de Não Pequenas Células Doença Avançada: A Propósito de Dois Casos Clínicos

“…Nos casos em que a expressão de PD-L1 é superior a 50%, o pembrolizumab tornou-se mesmo o fármaco de primeira linha, após aprovação do estudo Keynote 024, 4 com um perfil de toxicidade muito inferior aos dos esquemas de quimioterapia (QT), à base de platino, utilizados. Em segunda linha, três fármacos de imunoterapia estão aprovados (pembrolizumab, 5 nivolumab 6 e atezolizumab 7 ).…”