Outcomes of patients with solid tumour malignancies treated with first-line immuno-oncology agents who do not meet eligibility criteria for clinical trials

Gan, Chun Loo; Stukalin, Igor; Meyers, Daniel E.; Dudani, Shaan; Grosjean, Heidi A.I.; Dolter, Samantha; Ewanchuk, Benjamin W.; Goutam, Siddhartha; Sander, Michael; Wells, J.C.; Pabani, Aliyah; Cheng, Tina; Monzon, Jose Gerard; Morris, Don; Basappa, Naveen S.; Pal, Sumanta K.; Wood, Lori; Donskov, Frede; Choueiri, Toni K.; Heng, Daniel Y.C.

doi:10.1016/j.ejca.2021.04.004

Cited by 27 publications

(24 citation statements)

References 30 publications

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“…Our group previously investigated this phenomenon and found that 32% of "real-world" patients treated with immunotherapy for renal-cell carcinoma, NSCLC, or melanoma would not be eligible for corresponding immunotherapy trials due clinical and laboratory exclusion criteria, including ECOG. The patients who would be ineligible had a lower median overall survival and ORR compared with the eligible patients [16]. In the current study, there was a high proportion of poor ECOG status patients (>25%), suggesting a possible explanation for the increased shortterm mortality.…”

Section: Discussionmentioning

confidence: 53%

Effectiveness and Safety of First-Line Pembrolizumab in Older Adults with PD-L1 Positive Non-Small Cell Lung Cancer: A Retrospective Cohort Study of the Alberta Immunotherapy Database

et al. 2021

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The emergence of immunotherapy revolutionized the treatment of non-small-cell-lung cancer (NSCLC), with multiple landmark clinical trials establishing the efficacy of these agents. However, many patients who receive immunotherapy in clinical practice would be considered clinical trial ineligible. One such population that is often under-represented in clinical trials is older adults. In the current study, we evaluated clinical and safety outcomes in this population. Overall, older adults (>70 years of age) and younger adults had comparable clinical outcomes with an equivalent objective response rate (ORR), time to treatment failure (TTF), and median overall survival (p = 0.67, p = 0.98, and p = 0.91, respectively). Furthermore, the safety outcomes were equivalent between the cohorts with similar rates of immune-related adverse events (irAEs), irAE-related hospitalizations, and all-cause hospitalization (p = 0.99, p = 0.63, and p = 0.74, respectively). While older age was not found to impact overall survival, multivariant analysis revealed that a poor Eastern Cooperative Oncology Group (ECOG) status, low body-mass-index (BMI), and poor/intermediate lung immune prognostic index (LIPI) were all associated with worse survival. In conclusion, age does not impact the efficacy or safety of pembrolizumab in NSCLC, and therefore advanced age should not be a deterrent for treating these patients with pembrolizumab. Physicians and care providers can thus focus on other factors that may influence therapeutic outcomes.

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Section: Discussionmentioning

confidence: 53%

Effectiveness and Safety of First-Line Pembrolizumab in Older Adults with PD-L1 Positive Non-Small Cell Lung Cancer: A Retrospective Cohort Study of the Alberta Immunotherapy Database

et al. 2021

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“…In this setting, no prospective data are available, and evidence is limited to few retrospective studies including both squamous and non-squamous histology and mixed populations. 35 , 36 Results from these studies were mainly limited to efficacy assessment. In the study by Waterhouse et al., 36 evaluating real-world outcomes of A-NSCLC patients receiving first-line ICIs, poor PS was confirmed as a negative prognostic factor in patients receiving combined chemotherapy plus immunotherapy (PS ≥2 patients: 16%; median OS 8 versus 11.6 months in squamous histology; 6.3 versus 14.2 months in non-squamous histology).…”

Section: Discussion On Clinical Practicementioning

confidence: 99%

“… 36 Similarly, a very recent study investigated the outcomes of trial-eligible and trial-ineligible patients treated with immunotherapy for different tumors. 35 ECOG PS >1 patients represented 61% of the trial-ineligible population within the NSCLC cohort. In this setting, the survival results of trial-ineligible versus trial-eligible patients were disappointing across treatment regimens including ICI monotherapy and ICI combinations (median OS 5.3 versus 20.4 months, P < 0.0001), 35 again confirming the negative prognostic impact of PS 2 category.…”

Section: Discussion On Clinical Practicementioning

confidence: 99%

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First-line immunotherapy in advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an International Expert Panel Meeting by the Italian Association of Thoracic Oncology

et al. 2022

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Background Immunotherapy represents the standard of care in the first-line treatment of advanced non-small-cell lung cancer (NSCLC), either as monotherapy in high programmed death-ligand 1 (PD-L1)-positive tumors (≥50%) or in combination with platinum-based chemotherapy regardless of PD-L1 status. However, most pivotal clinical trials of immune checkpoint inhibitors (ICIs) did not include patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2. Hence, a consensus is lacking on the safety and efficacy of ICIs in this specific subgroup of patients. Materials and methods A virtual International Expert Panel took place in July 2021 with the aim of reviewing the available evidence on the use of ICIs in NSCLC patients with ECOG PS 2, both in clinical practice and in a research setting. Results All panelists expressed concern about the applicability of currently available PS scales to evaluate patients for ICI treatment. The panelists agreed that, though limited, the available data support the safety of single-agent immunotherapy in PS 2 NSCLC patients, whereas concern was raised on the safety of ICI combinations, mainly related to chemotherapy and/or anti-cytotoxic T-lymphocyte-associated antigen 4 toxicity. On the basis of reviewed data, ICI efficacy may be speculated in PS 2 NSCLC patients; however, PS 2 remains a negative prognostic category as compared to PS 0-1 in patients treated with ICI, as it is for chemotherapy. The panelists defined high, medium and low priorities in clinical research. High priority was attributed to the inclusion of PS 2 patients in prospective clinical trials and the specific evaluation of combined ICI treatments with attenuated chemotherapy doses. Conclusions Based on the current evidence, the panelists outlined the major limitations affecting PS 2 patients with NSCLC and reached common considerations on the feasibility, safety and effectiveness of ICI monotherapy and ICI combinations in the first-line setting.

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“…[6] Treatment patterns post IOVE are less well characterised due to shorter follow up, but 35% of patients post 1L combination axitinib and pembrolizumab had already received 2L VEGFi directed therapy at a 30.6 median month follow up. [7] Given the established inferior outcomes of approved anti-cancer therapies noted in the majority of real world vs trial populations [8] , it is important to characterise drug activity in routine practice to clarify the relevance and reproducibility of trial data and inform practice regarding the optimum sequencing of therapies.…”

Section: Introductionmentioning

confidence: 99%

CABOSEQ: The Effectiveness of Cabozantinib in Patients With Treatment Refractory Advanced Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)

Navani¹,

Wells²,

Boyne³

et al. 2023

Clinical Genitourinary Cancer

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Outcomes of patients with solid tumour malignancies treated with first-line immuno-oncology agents who do not meet eligibility criteria for clinical trials

Cited by 27 publications

References 30 publications

Effectiveness and Safety of First-Line Pembrolizumab in Older Adults with PD-L1 Positive Non-Small Cell Lung Cancer: A Retrospective Cohort Study of the Alberta Immunotherapy Database

Effectiveness and Safety of First-Line Pembrolizumab in Older Adults with PD-L1 Positive Non-Small Cell Lung Cancer: A Retrospective Cohort Study of the Alberta Immunotherapy Database

First-line immunotherapy in advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an International Expert Panel Meeting by the Italian Association of Thoracic Oncology

CABOSEQ: The Effectiveness of Cabozantinib in Patients With Treatment Refractory Advanced Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)

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