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• W2923342362 abstract "The development of targeted therapies has birthed a promising era in cancer management. Lung cancer, the disease with the highest mortality of any cancer, is now seeing rapid and marked changes in prognosis in those with pathogenic and targetable mutations.1Bray F. Ferlay J. Soerjomataram I. Siegel R.L. Torre L.A. Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin. 2018; 68: 394-424Crossref PubMed Scopus (50539) Google Scholar In addition to the changes being observed in prognosis, these therapies have also ushered in the dawn of a new era in oncologic side effects. Most respiratory complications with conventional chemotherapy have historically been infectious.2Spiro S.G. Douse J. Read C. Janes S. Complications of lung cancer treatment.Semin Respir Crit Care Med. 2008; 29: 302-317Crossref PubMed Scopus (19) Google Scholar Interstitial lung disease (ILD) is observed with some chemotherapies; however, the introduction of targeted therapies has seen a reversal of the classical oncologic respiratory complications.3Ramanathan R.K. Reddy V.V. Holbert J.M. Belani C.P. Pulmonary infiltrates following administration of paclitaxel.Chest. 1996; 110: 289-292Abstract Full Text Full Text PDF PubMed Scopus (66) Google Scholar, 4Nishino M. Hatabu H. Hodi F.S. Ramaiya N.H. Drug-related pneumonitis in the era of precision cancer therapy.JCO Precision Oncology. 2017; 1: 1-12Google Scholar, 5Kudoh S. Kato H. Nishiwaki Y. et al.Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study.Am J Respir Crit Care Med. 2008; 177: 1348-1357Crossref PubMed Scopus (408) Google Scholar Although ILD as a complication of targeted therapy remains uncommon, the oncologist and pulmonologist now face the challenge of predicting, diagnosing, and managing this complication on a much greater scale. Gemma et al. are to be congratulated for detailing the occurrence of ILD as a complication of the targeted NSCLC therapeutic agent crizotinib in a large cohort of consecutive patients, which is a necessity given the relative rarity of ALK receptor tyrosine kinase gene (ALK) mutations.6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar The incidence of crizotinib-induced ILD was 5.77%, with a mortality of 20%. The incidence of ILD as a complication of targeted cancer therapy appears to be more common in Japanese cohorts.5Kudoh S. Kato H. Nishiwaki Y. et al.Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study.Am J Respir Crit Care Med. 2008; 177: 1348-1357Crossref PubMed Scopus (408) Google Scholar In addition, ALK mutations are ethnically heterogeneous and are more common in Asian populations.7Rosenbaum J.N. Bloom R. Forys J.T. et al.Genomic heterogeneity of ALK fusion breakpoints in non-small-cell lung cancer.Mod Pathol. 2018; 31: 791-808Crossref PubMed Scopus (55) Google Scholar These factors should not lessen the impact of these results, as the experience learned from high-incidence cohorts should be utilized to inform others. The lessons are that most events develop within the first 2 months of treatment and the risk factors are older age, poor performance status, history of smoking, underlying ILD, and pleural effusion. These risk factors are consistent with those reported for other targeted therapies used in NSCLC, including gefitinib and erlotinib.5Kudoh S. Kato H. Nishiwaki Y. et al.Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study.Am J Respir Crit Care Med. 2008; 177: 1348-1357Crossref PubMed Scopus (408) Google Scholar, 8Gemma A. Kudoh S. Ando M. et al.Final safety and efficacy of erlotinib in the phase 4 POLARSTAR surveillance study of 10 708 Japanese patients with non-small-cell lung cancer.Cancer Sci. 2014; 105: 1584-1590Crossref PubMed Scopus (56) Google Scholar In this real-world study, treating clinicians evaluated suspected cases of ILD locally. A total of 140 suspected cases (7%) were reported and assessed by an expert study panel consisting of medical oncologists, radiologists, and a pulmonologist. Gemma et al.6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar highlight the diagnostic challenge of pulmonary opacities in the oncologic patient: 23 patients (16%) in whom ILD was suspected were deemed by the expert panel to not have ILD. An additional 31 patients could not be evaluated by the panel owing to missing data, but those patients were assumed to have ILD for the purpose of this study. Their real diagnosis remains unknown. Other potential confounders include possible never-reported false-negative misclassification of patients who were confidently deemed by the local clinicians to not have ILD. In clinical practice, such an expert panel is not always available and the diagnosis is often easy in hindsight. When the mortality of such a presentation is as high as one in five and more than one in two in cases of diffuse alveolar damage with crizotinib, it is crucially important to make a correct diagnosis to allow for timely disease-modifying intervention. Furthermore, a correct diagnosis is essential to prevent a highly effective therapy from being withheld unnecessarily. Without the benefit of the expert panel, this might have occurred in one in six events. The ability to make a diagnosis of ILD in the ever-changing landscape of cancer therapies is dependent on the data provided in large postmarketing cohorts such as that presented both here and previously by Gemma et al.6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar, 8Gemma A. Kudoh S. Ando M. et al.Final safety and efficacy of erlotinib in the phase 4 POLARSTAR surveillance study of 10 708 Japanese patients with non-small-cell lung cancer.Cancer Sci. 2014; 105: 1584-1590Crossref PubMed Scopus (56) Google Scholar A clinician’s individual experience is likely to be littered with the odd case of drug-induced ILD, and therefore, developing a true feel for what is and is not ILD through experience alone is likely to be insufficient. A watch and wait approach to management with broad-spectrum therapies (e.g., antibiotics, diuretics, corticosteroids) may be all-encompassing; however, each treatment is not without harm and the complications of targeted therapies should be met with a similarly targeted therapeutic approach. Gemma et al.6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar present data for a number of factors that may adjust the pretest probability of an ILD event. The timing of the event appears to be an important factor, with most fatal ILD events occurring within the first 10 weeks of treatment. An event occurring later than 2 months after the commencement of therapy may still be an ILD, but the consequences of a delayed diagnosis may not be as catastrophic. Older patients and those with poor performance status were at a higher risk of development of ILD and intuitively may also be less tolerant of this complication. They are also more likely to carry comorbidities that cloud the diagnostic picture. This and previous cohorts have demonstrated that smoking and the presence of known ILD are factors that should be thoroughly assessed before embarking on targeted therapy.5Kudoh S. Kato H. Nishiwaki Y. et al.Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study.Am J Respir Crit Care Med. 2008; 177: 1348-1357Crossref PubMed Scopus (408) Google Scholar, 8Gemma A. Kudoh S. Ando M. et al.Final safety and efficacy of erlotinib in the phase 4 POLARSTAR surveillance study of 10 708 Japanese patients with non-small-cell lung cancer.Cancer Sci. 2014; 105: 1584-1590Crossref PubMed Scopus (56) Google Scholar Missing from the article by Gemma et al.6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar are the other historical, physical, and biochemical features that might be useful to a diagnostic algorithm. A history of orthopnea or paroxysmal nocturnal dyspnea and a raised B-type natriuretic peptide level might clinch a diagnosis of congestive cardiac failure to explain bilateral pulmonary opacities. Fevers, sputum production, raised levels of inflammatory markers, and confirmation of a pathogenic microbe make an infective diagnosis straightforward. However, in oncology patients who present with pulmonary opacities, a combination of features from each diagnostic entity is inevitably present. The development of drug-induced ILD may be clinically indistinguishable from an unrelated complication. Response to treatment is also a retrospective tool through which a diagnosis can be established. It is interesting that 15 patients continued taking crizotinib after development of an ILD. Most of these patients with ILD had a treatment response, although the details (presumably parenteral corticosteroids) are not given. Treatment response is a critical factor with regard to outcomes, both for mortality and continuation of targeted therapy. A clinical scoring system, akin to the 4T score for heparin-induced thrombocytopenia, to evaluate the pretest probability of ILD may be useful.9Lo G.K. Juhl D. Warkentin T.E. Sigouin C.S. Eichler P. Greinacher A. Evaluation of pretest clinical score (4 T's) for the diagnosis of heparin-induced thrombocytopenia in two clinical settings.J Thromb Haemost. 2006; 4: 759-765Crossref PubMed Scopus (768) Google Scholar Thrombocytopenia developing in a hospitalized patient is a similarly challenging diagnostic entity. Its occurrence is rare and its consequences may be major. The 4T score greatly improves assessment of the pretest probability of heparin-induced thrombocytopenia. Drug-induced ILD does not have an easily available confirmatory test (i.e., lung biopsy), but the process of quantifying pretest probability might be similar. A low pretest clinical score may allow ruling out of ILD in most situations (high negative predictive value), whereas an intermediate or high score may suggest further diagnostic tests. Such an approach might take into account the severity and timing of the complication, comorbidity such as smoking and preexisting ILD, and alternative diagnoses. Additional factors to consider might include exposure to combination therapies with additive or multiplicative risk,10Ahn M.J. Yang J. Yu H. et al.136O: Osimertinib combined with durvalumab in EGFR-mutant non-small cell lung cancer: results from the TATTON phase Ib trial.J Thorac Oncol. 2016; 11: S115Abstract Full Text Full Text PDF PubMed Scopus (210) Google Scholar, 11Nishino M. Giobbie-Hurder A. Hatabu H. Ramaiya N.H. Hodi F.S. Incidence of programmed cell death 1 inhibitor-related pneumonitis in patients with advanced cancer: a systematic review and meta-analysis.JAMA Oncol. 2016; 2: 1607-1616Crossref PubMed Scopus (458) Google Scholar ethnicity, the presence of certain radiological features, and the results of serum and bronchoscopic pathology tests. Development and validation of scoring algorithms for this clinical dilemma are eagerly awaited. It is hoped that biomarkers for drug-induced ILD will be assessed as they have in general ILD.12Maher T.M. Oballa E. Simpson J.K. et al.An epithelial biomarker signature for idiopathic pulmonary fibrosis: an analysis from the multicentre PROFILE cohort study.Lancet Respir Med. 2017; 5: 946-955Abstract Full Text Full Text PDF PubMed Scopus (123) Google Scholar Improvements in the prognosis of targeted therapy–induced ILD will be dependent on diagnostic strategies that yield the early institution of targeted intervention. The role of the expert panel in relation to the research participant is similar to that of the multidisciplinary team (MDT) in relation to the clinician. For the most common ILD, idiopathic pulmonary fibrosis, the ILD MDT has been proved to strengthen diagnostic confidence compared with the individual clinician or radiologist working alone, resulting in a greater likelihood of a successful treatment strategy.13Walsh S.L.F. Wells A.U. Desai S.R. et al.Multicentre evaluation of multidisciplinary team meeting agreement on diagnosis in diffuse parenchymal lung disease: a case-cohort study.Lancet Respir Med. 2016; 4: 557-565Abstract Full Text Full Text PDF PubMed Scopus (268) Google Scholar In the article by Gemma et al.,6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar the fact that 16% of suspected ILD cases were reclassified by an expert panel suggests that a formalized multidisciplinary approach might also be valuable in the diagnosis of oncologic pulmonary complications. This approach may also improve clinician confidence to prevent the unnecessary cessation of effective therapies in cases in which ILD can be excluded. Whether artificial intelligence may in the future aid in this task is a promising hypothesis. A second benefit of the MDT may be in the pretreatment risk assessment of patients with lung cancer when an underlying ILD is present. Approximately 5% of this crizotinib-treated cohort had a history of ILD. This prevalence is similar to that reported by Miller et al., who demonstrated subclinical ILD, termed interstitial lung abnormality (ILA), in 6% of precancer resection computed tomography (CT) scans.14Miller E.R. Putman R.K. Vivero M. et al.Histopathology of interstitial lung abnormalities in the context of lung nodule resections.Am J Respir Crit Care Med. 2018; 197: 955-958Crossref PubMed Scopus (58) Google Scholar This is only the tip of the iceberg. An additional 33% of patients had an indeterminate CT scan for interstitial lung abnormality, and a further 52% of those with a negative CT scan had pulmonary fibrosis present on histopathologic examination. The ILD MDT may provide significant expertise in the pretreatment setting. A diagnosis of idiopathic pulmonary fibrosis will have a significant impact on treatment discussions. The risks of cancer surgery, radiation therapy, and pharmacotherapy are greater in this scenario. It may now be time for the lung cancer MDT and the ILD MDT to unite forces. Both groups have much to gain from each other, which can only be of benefit to patients. Gemma et al.6Gemma A. Kusumoto M. Kurihara Y. et al.Interstitial lung disease onset and its risk factors in Japanese patients with ALK-positive NSCLC after treatment with crizotinib.J Thorac Oncol. 2019; 14: 672-682Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar should be congratulated on this article; it provides a wealth of information on the challenges of ILD as a complication of targeted therapy. It is hoped that future studies will evaluate targeted diagnostic and treatment algorithms to strengthen clinician confidence when managing such patients, thereby resulting in improved outcomes in parallel with the prognostic improvements that are being seen for the current generation of patients with lung cancer with targetable mutations. Interstitial Lung Disease Onset and Its Risk Factors in Japanese Patients With ALK-Positive NSCLC After Treatment With CrizotinibJournal of Thoracic OncologyVol. 14Issue 4PreviewThe study objective was to determine the incidence and characteristics of drug-induced interstitial lung disease (ILD) associated with an orally available small-molecule tyrosine kinase inhibitor, crizotinib, in a real-world clinical setting. Full-Text PDF Open Archive" @default.
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