Updated Efficacy Analysis Including Secondary Population Results for OAK: A Randomized Phase III Study of Atezolizumab versus Docetaxel in Patients with Previously Treated Advanced Non–Small Cell Lung Cancer

Fehrenbacher, Louis; Pawel, Joachim von; Park, Keunchil; Rittmeyer, Achim; Gandara, David R.; Aix, Santiago Ponce; Han, Ji Youn; Gadgeel, Shirish M.; Hida, Toyoaki; Cortinovis, Diego; Cobo, Manuel; Kowalski, Dariusz M.; Marinis, Filippo de; Gandhi, M.; Danner, Bradford J; Matheny, Christina; Kowanetz, Marcin; He, Pei; Felizzi, Federico; Patel, Hina; Sandler, Alan; Ballinger, Marcus; Barlési, Fabrice

doi:10.1016/j.jtho.2018.04.039

Cited by 218 publications

(212 citation statements)

References 21 publications

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“…IO targets immune pathways allowing the body to recognize cancer cells as foreign and attack them (e.g., immune checkpoint inhibitors) or enhance overall immune functioning without targeting specific cancer cells (e.g., interleukins, interferons). When administered as monotherapy for treating advanced NSCLC, IO has been associated with response rates of approximately 20% in previously treated patients [4][5][6][7][8] and more than 25% in those who are treatment naive [9][10][11][12]. Compared with conventional chemotherapy, IO has been shown to have a comparatively benign safety profile, though the management of immune-related adverse events, which are frequently grades 1-2 but can affect multiple organ systems, is a prevalent concern [13,14].…”

Section: Introductionmentioning

confidence: 99%

The value of immunotherapy for survivors of stage IV non-small cell lung cancer: patient perspectives on quality of life

Park¹,

Shaw

Korn³

et al. 2020

J Cancer Surviv

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Purpose The aim of this study was to examine what personally mattered to 24 patients who received immuno-oncology (IO) therapy for stage IV non-small cell lung cancer (NSCLC), as well as their families and friends, to understand how they evaluated their cancer treatments and the determinants of the quality of life (QoL) of long-term survivors. Methods Ethnographic research was conducted with 24 patients who had responded to IO (pembrolizumab, nivolumab, atezolizumab, or durvalumab) for stage IV NSCLC, and their families and friends, evenly split among field sites in Denmark, the USA, and the UK. Data were collected using in-depth qualitative interviews, written exercises, and participant observation. Data analysis methods included interpretative phenomenological analysis, coding, and the development of grounded theory. Researchers spent 2 days with participants in their homes and accompanied them on health-related outings.Results Our findings reveal that long-term survivors on IO experienced their journey in two phases: one in which their cancer had taken over their lives mentally, physically, and spiritually, and another in which their cancer consumed only a part of their everyday lives. Patients who survived longer than their initial prognosis existed in a limbo state in which they were able to achieve some semblance of normalcy in spite of being identified as having a terminal condition. This limbo state impacted their life priorities, decision-making, experience of patient support, and health information-seeking behaviors, all of which shaped their definitions and experience of QoL.Conclusions The results of this study, which identify the specific challenges of living in limbo, where patients are able to reclaim a portion of their pre-cancer lives while continuing to wrestle with a terminal prognosis, may inform how cancer research can more effectively define and measure the QoL impacts of IO treatments. Also, they may identify approaches that the cancer community can use to support the needs of patients living in a limbo state. These experiences may not be adequately understood by the cancer community or captured by existing QoL measures, which were designed prior to the emergence of IO and without sufficient incorporation of contextual, patient-driven experience. Implications for Cancer Survivors Increased awareness of the specific experiences that come with long-term survival on IO may direct how resources should be spent for cancer support for patients and their families. Expanding how QoL is evaluated based on patients' lived experiences of IO can reflect a more accurate depiction of the treatment's benefits and harms.

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Section: Introductionmentioning

confidence: 99%

The value of immunotherapy for survivors of stage IV non-small cell lung cancer: patient perspectives on quality of life

Park¹,

Shaw

Korn³

et al. 2020

J Cancer Surviv

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“…Atezolizumab, an IgG1 monoclonal antibody, with the same target as pembrolizumab, offered prolongation of OS in patients with >1% PD‐L1 expression with a benefit that was present regardless of histology compared to docetaxel . As combinations of ICIs with other agents are gaining ground as initial treatments, survival of a larger number of patients with advanced disease has shown improvement . Additionally, there is few data available on the efficacy of immunotherapy for NSCLC in Hispanic patients.…”

Section: Introductionmentioning

confidence: 99%

Immunotherapy at any line of treatment improves survival in patients with advanced metastatic non‐small cell lung cancer (NSCLC) compared with chemotherapy (Quijote‐CLICaP)

et al. 2019

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Background: To compare survival outcomes of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who received immunotherapy as first-, second-or beyond line, versus matched patients receiving standard chemotherapy with special characterization of hyperprogressors. Methods: A retrospective cohort study of 296 patients with unresectable/metastatic NSCLC treated with either, first-, second-, third-or fourth-line of immunotherapy was conducted. A matched comparison with a historical cohort of first-line chemotherapy and a random forest tree analysis to characterize hyperprogressors was conducted. Results: Median age was 64 years (range 34-90), 40.2% of patients were female. A total of 91.2% of patients had an Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1. Immunotherapy as first-line was given to 39 patients (13.7%), second-line to 140 (48.8%), and as third-line and beyond to 108 (37.6%). Median overall survival was 12.7 months (95% CI 9.67-14 months) and progression-free survival (PFS) of 4.27 months (95% CI 3.97-5.0). Factors associated with increased survival included treatment with immunotherapy as first-line (P < 0.001), type of response (P < 0.001) and PD-L1 status (P = 0.0039). Compared with the historical cohort, immunotherapy proved to be superior in terms of OS (P = 0.05) but not PFS (P = 0.2). A total of 44 hyperprogressors were documented (19.8%,.1%]). Leukocyte count over 5.300 cells/dL was present in both hyperprogressors and long-term responders. Conclusions: Patients who receive immune-checkpoint inhibitors as part of their treatment for NSCLC have better overall survival (OS) compared with matched patients treated with standard chemotherapy, regardless of the line of treatment.

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“…There are reasons to believe that hospitalization and hospital death in the ICI group were mainly related to different disease characteristics and not to ICI administration itself. This would also be expected based on the toxicity results of the seminal prospective clinical studies [3][4][5][6]. However, real-world data from elderly rural patient cohorts might differ from those obtained in clinical trials.…”

Section: Discussionmentioning

confidence: 98%

“…The systemic treatment of advanced non-small cell lung cancer (NSCLC) has recently undergone significant transformations [1,2]. Platinum-based first-line chemotherapy and previous second-line regimens have been replaced by treatment with immune checkpoint inhibitors (ICI) such as pembrolizumab, atezolizumab, and nivolumab, both as monotherapy in first-or second-line treatments or in combination with chemotherapy in first-line treatment [3][4][5][6][7]. For some combinations, a specific histology or programmed cell death ligand (PD-L1) expression is required [8].…”

Section: Introductionmentioning

confidence: 99%

Initial Experience after Transition to Immune Checkpoint Inhibitors in Patients with Non-small Cell Lung Cancer Treated in a Rural Healthcare Region

Nieder¹,

Reigstad²,

Carlsen³

et al. 2020

Cureus

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Updated Efficacy Analysis Including Secondary Population Results for OAK: A Randomized Phase III Study of Atezolizumab versus Docetaxel in Patients with Previously Treated Advanced Non–Small Cell Lung Cancer

Cited by 218 publications

References 21 publications

The value of immunotherapy for survivors of stage IV non-small cell lung cancer: patient perspectives on quality of life

The value of immunotherapy for survivors of stage IV non-small cell lung cancer: patient perspectives on quality of life

Immunotherapy at any line of treatment improves survival in patients with advanced metastatic non‐small cell lung cancer (NSCLC) compared with chemotherapy (Quijote‐CLICaP)

Initial Experience after Transition to Immune Checkpoint Inhibitors in Patients with Non-small Cell Lung Cancer Treated in a Rural Healthcare Region

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