Selecting a PRO-CTCAE based subset for patient reported symptom monitoring during lung cancer treatment (Preprint)

2020 ◽  
Author(s):  
Evalien Veldhuijzen ◽  
Iris Walraven ◽  
Jose Belderbos

BACKGROUND The Patient Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant for oncology care. To enable implementation of PRO-CTCAE-based symptom monitoring in clinical practice, there is a need to select a subset of items relevant for specific patient populations. OBJECTIVE The aim of this study was to develop a PRO-CTCAE subset relevant for patients with lung cancer. METHODS The PRO-CTCAE-based subset for lung cancer patients was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer (EORTC) guidelines for developing questionnaires, consisting of a literature review and semi-structured interviews with both lung cancer patients and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. Results were summarized and, after a final round of expert review, a selection of clinically relevant items for lung cancer patients was made. RESULTS A heterogeneous group of lung cancer patients (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). CONCLUSIONS Based on literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in lung cancer patients in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE lung cancer subset internationally, and in the real-world clinical practice setting.

2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost

<b><i>Background/Aim:</i></b> Chemotherapy-induced neutropenia is a common and serious complication in cancer patients receiving myelosuppressive chemotherapy. This analysis was undertaken to evaluate the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycoPEGylated granulocyte colony-stimulating factor, in lung cancer patients undergoing chemotherapy in real-world clinical practice. <b><i>Methods:</i></b> Data from two European non-interventional studies (NIS NADIR and NIS LEOS) investigating lipegfilgrastim for primary and secondary prophylaxis were pooled. Outcomes included the incidence of chemotherapy-induced neutropenia and febrile neutropenia (FN), use of anti-infectives and antimycotics, and adverse events and their relationship to lipegfilgrastim. <b><i>Results:</i></b> The safety population included 361 patients with lung cancer (median age, 66 years [range, 36–88]), of whom 322 had received 2 or more consecutive cycles of lipegfilgrastim (efficacy population [primary prophylaxis, 75.5%; secondary prophylaxis, 16.5%]). Almost 40% of the patients were considered to have a high risk (&#x3e;20%) of FN, and around 60% had an intermediate risk (10–20%). For all cycles, FN was reported in 3 patients (0.9%), neutropenia in 14 (4.3%), and grade 4 neutropenia in 9 (2.8%). Anti-infectives were used in 27 patients (8.4%) and antimycotics in 6 (1.9%). The incidence rates were lower for the patients’ first cycle (FN, 0.4%; neutropenia, 0.8%; grade 4 neutropenia, 0.8%; anti-infectives, 0.6%; antimycotics, 0.6%). Adverse drug reactions considered lipegfilgrastim related were reported in 35 patients (9.7%), and serious adverse drug reactions in 10 (2.8%). None of the fatal events reported in 28 patients (7.8%) were lipegfilgrastim related. <b><i>Conclusion:</i></b> Lipegfilgrastim administered to patients with lung cancer undergoing chemotherapy in real-world clinical practice showed similar effectiveness and safety to that reported in published pivotal trials.


2017 ◽  
Vol 12 (1) ◽  
pp. S1332-S1333
Author(s):  
Shobanya Elvarathnam ◽  
Christos Chouaid ◽  
Nadine Thiriat. ◽  
Laurence Jabot ◽  
Gaelle Rousseau-Bussac ◽  
...  

2021 ◽  
Author(s):  
Yaqian Feng ◽  
Wei Dai ◽  
Yaqin Wang ◽  
Jia Liao ◽  
Xing Wei ◽  
...  

Abstract BackgroundLung cancer patients without chief complaints have been increasingly identified by physical examination. This study aimed to profile and compare chief complaints with patient-reported symptoms of lung cancer patients before surgery.MethodsData was extracted from a multicenter, prospective longitudinal study (CN-PRO-Lung 1) in China from November 2017 and January 2020. A comparison between chief complaints and patient-reported symptoms was analyzed using the Chi-squared test.ResultsA total of 201 (50.8%) lung cancer patients without chief complaints were found by physical examination at admission, and 195(49.2%) patients had chief complaints. The top 5 chief complaints were coughing (38.1%), expectoration (25.5%), chest pain (13.6%), hemoptysis (10.6%), and shortness of breath (5.1%). There were significantly more patients with chief complaints of coughing (38.1% vs. 15.0 %, P <0.001) and pain (20.5% vs. 6.9%, P<0.001) than those with the same symptoms rated ≥4 via MDASI-LC. There were less patients with chief complaints of fatigue (1.8% vs. 10.9%, P<0.001), nausea (0.3% vs. 2.5%, P=0.006), and vomiting (0.3% vs. 1.8%, p=0.032) than those with the same symptoms rated ≥4 via MDASI-LC. In patients without chief complaints, the five most common moderate to severe patient-reported symptoms were disturbed sleep (19.5%), distress (13.5%), dry mouth (13%), sadness (12%), and difficulty remembering (11.1%).ConclusionsSymptoms of lung cancer patients not included in the chief complaint could be identified via a patient-reported outcome instrument, suggesting the necessity of implementing the patient-reported outcome assessment before lung cancer surgery for better patient care.


2021 ◽  
Vol Volume 15 ◽  
pp. 1101-1106
Author(s):  
Yaqian Feng ◽  
Wei Dai ◽  
Yaqin Wang ◽  
Jia Liao ◽  
Xing Wei ◽  
...  

2019 ◽  
Author(s):  
Duc Ha ◽  
Andrew L. Ries ◽  
Jeffrey J. Swigris

AbstractRationale/ObjectiveQuality of life (QoL) is an important issue in lung cancer survivors. We aimed to identify determinants of QoL in lung cancer survivors eligible for long-term cure.MethodsWe performed an exploratory analysis of a cross-sectional study of consecutive lung cancer survivors who completed curative-intent treatment ≥1 month previously. Variables tested included demographic, clinical, physiologic, and symptom-specific patient-reported outcome measures. We defined the primary outcome as a previously-validated cancer-specific QoL measure – the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (C30) summary score. We also verified our findings with the C30 global health status/QoL subscale and a summated score of lung cancer-specific QoL from the EORTC-Lung Cancer Module 13.ResultsIn 75 enrolled participants, measures of fatigue, depression, sleep difficulties, and dyspnea were statistically significant determinants of the C30 summary score in multivariable linear regression analyses. Together, these four symptoms accounted for approximately 85% of the variance in cancer-specific QoL (p<0.001). When we verified our findings with global QoL and lung cancer-specific QoL, fatigue and dyspnea were consistent determinants of QoL.ConclusionsWe found four symptoms – dyspnea, fatigue, depression, and sleep difficulties – that are important determinants of and together accounted for almost all of the variance in cancer-specific QoL in lung cancer survivors eligible for long-term cure. These findings have implications to reduce symptom burden and improve function and QoL in these patients.


2019 ◽  
Vol 28 (4) ◽  
pp. 1809-1816
Author(s):  
Johnny M. Hoang ◽  
Navneet Upadhyay ◽  
Dozie N. Dike ◽  
Jaekyu Lee ◽  
Michael L. Johnson ◽  
...  

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