1243P Pathologic response as early endpoint for survival following neoadjuvant therapy (NEO-AT) in resectable non-small cell lung cancer (rNSCLC): Systematic literature review and meta-analysis

Waser, Nathalie; Adam, Ahmed; Schweikert, Bernd; Vo, Lien; McKenna, Mike; Breckenridge, Mary Alice B.; Penrod, John R.; Goring, Sarah

doi:10.1016/j.annonc.2020.08.116

Cited by 43 publications

(32 citation statements)

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“…The phase III trial CheckMate-816 showed promising results that the pathological complete response (pCR) was 24%, compared with 2.2 percent in the chemotherapy alone arm. (7). A recent pooled analysis showed that chemotherapy plus immunotherapy may improve efficacy outcomes over immunotherapy alone (8).…”

Section: Introductionmentioning

confidence: 99%

Immune-related adverse event profile of combination treatment of PD-(L)1 checkpoint inhibitors and bevacizumab in non-small cell lung cancer patients: data from the FDA adverse event reporting system

Bai¹,

Tian²,

Pacheco³

et al. 2021

Transl Lung Cancer Res

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Background: Immune checkpoint inhibitors (ICIs) and bevacizumab-based therapy are a promising treatment approach to significantly improving overall survival (OS) of non-small cell lung cancer (NSCLC) patients. However, the incidence of adverse events induced by a combination treatment with programmed cell death-1 or programmed death ligand 1 [PD-(L)1] inhibitor and bevacizumab remains unknown. The current evidence from prospective studies is limited. Thus, efforts using real-world data to further improve our understanding of the potential adverse events will be necessary.Methods: The present study included 15,872 participants with NSCLC in the FDA Adverse Event Reporting System (FAERS) database from April 2013 to September 2019. The definition of adverse events (AEs) relied on the Medical Dictionary for Regulatory Activities (MedDRA). Statistical analysis was performed, and odds ratio (ORs) with 95% confidence intervals (CIs) were calculated.Results: Of the 15,872 participants with NSCLC, 15,463 cases were treated with the PD-(L)1 inhibitor monotherapy, while 409 cases were treated with both PD-(L)1 inhibitor and bevacizumab. Compared with monotherapy, combination therapy had lower risks of pneumonitis, respiratory failure, edema, disease progression, and death; however, combination therapy was also associated with significantly higher risks of pyrexia, general physical health deterioration, stomatitis, dehydration, thrombocytopenia, peripheral neuropathy, nephritis, bone marrow failure, immune thrombocytopenic purpura, neutropenia, and serious AEs. The results of the multivariate analysis suggested that combination therapy was the independent risk factor for pyrexia, neutropenia, nephritis, ITP, and the independent protective factor for respiratory failure. Conclusions:We observed that the spectrum and risk of irAEs differed widely between therapeutic regimens, and irAEs involved multiple organ systems both in monotherapy or combination therapy.Deepening our understanding of irAEs has a great clinical value for improving individualized clinical patient management and the safety of medication use.

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Section: Introductionmentioning

confidence: 99%

Immune-related adverse event profile of combination treatment of PD-(L)1 checkpoint inhibitors and bevacizumab in non-small cell lung cancer patients: data from the FDA adverse event reporting system

Bai¹,

Tian²,

Pacheco³

et al. 2021

Transl Lung Cancer Res

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show abstract

“…In addition to performing a standard meta-analysis of studies evaluating pathologic response after neoadjuvant therapy and long-term clinical outcomes in NSCLC 5 —where once again a strong and favorable association with survival was noted—we have included more in-depth IPD analysis to further characterize this relationship. By extracting IPD and reconstructing KMCs from available studies, we are better able to capture the significant association between pCR and long-term clinical outcomes of EFS and OS.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have suggested the positive correlation between pathologic response, including pCR and MPR, and more established clinical end points, such as event-free survival (EFS) and overall survival (OS). 5 Nevertheless, questions have been raised over the appropriateness of these pathologic end points as surrogates for long-term clinical outcomes. Therefore, further research is needed to effectively quantify the association between pathologic responses, such as pCR, and long-term outcomes, including EFS and OS.…”

Section: Introductionmentioning

confidence: 99%

Association of Pathologic Complete Response and Long-Term Survival Outcomes Among Patients Treated With Neoadjuvant Chemotherapy or Chemoradiotherapy for NSCLC: A Meta-Analysis

Rosner

Liu

Forde

et al. 2022

JTO Clinical and Research Reports

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“…38 Many patients with early-stage NSCLC receive perioperative (neoadjuvant or adjuvant) chemotherapy, which provides only a modest improvement in 5-year overall survival. 39,40 Retrospective 41,42 and small-scale prospective studies, [43][44][45] as well as a more recently reported large meta-analysis, 46 of neoadjuvant chemotherapy in NSCLC have shown the ability of MPR and pCR after neoadjuvant therapy to predict clinical benefit as measured by improved long-term outcomes. Before the most recent phase III CheckMate-816 trial evaluating neoadjuvant chemoimmunotherapy compared with chemotherapy in localized NSCLC, the rates of MPR to neoadjuvant chemotherapy have ranged between 6.7% and 27%, with the median frequency of pCR across studies reported to be on the order of 4%.…”

Section: Neoadjuvant Immunotherapy For Nsclcmentioning

confidence: 99%

Neoadjuvant Immunotherapy: Leveraging the Immune System to Treat Early-Stage Disease

Mittendorf

Burgers

Haanen

et al. 2022

American Society of Clinical Oncology Educational Book

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Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is tremendous enthusiasm for expanding the use of immunotherapy to those with early-stage cancer. Administering immunotherapy in the neoadjuvant, preoperative setting is a biologically sound approach because preclinical studies have shown that stronger and broader immune responses can be generated if immunotherapy is administered while the tumor and/or draining lymph nodes are intact. It is therefore likely that administering immunotherapy preoperatively will generate optimal immune responses, leading to high rates of pathologic response as well as improved long-term survival. Although neoadjuvant immunotherapy is currently only approved for use in combination with chemotherapy in triple-negative breast cancer and non–small cell lung cancer, it is anticipated that ongoing and future clinical trials will further define the role of neoadjuvant immunotherapy in many cancer types. These trials should be designed with appropriate survival endpoints and rigorous correlative studies to include imaging and biospecimen-based analyses to address currently unanswered questions that must be resolved to optimize the use of immunotherapy in early-stage disease.

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1243P Pathologic response as early endpoint for survival following neoadjuvant therapy (NEO-AT) in resectable non-small cell lung cancer (rNSCLC): Systematic literature review and meta-analysis

Cited by 43 publications

References 0 publications

Immune-related adverse event profile of combination treatment of PD-(L)1 checkpoint inhibitors and bevacizumab in non-small cell lung cancer patients: data from the FDA adverse event reporting system

Immune-related adverse event profile of combination treatment of PD-(L)1 checkpoint inhibitors and bevacizumab in non-small cell lung cancer patients: data from the FDA adverse event reporting system

Association of Pathologic Complete Response and Long-Term Survival Outcomes Among Patients Treated With Neoadjuvant Chemotherapy or Chemoradiotherapy for NSCLC: A Meta-Analysis

Neoadjuvant Immunotherapy: Leveraging the Immune System to Treat Early-Stage Disease

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