Efficacy and Safety of Lipegfilgrastim in Lung Cancer Patients Receiving Myelosuppressive Chemotherapy in a Real-World Setting: Results of an Analysis of Pooled Data from Two Non-Interventional European Studies

2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Real World ◽  
Secondary Prophylaxis ◽  
Drug Reactions ◽  
Myelosuppressive Chemotherapy ◽  
Lung Cancer Patients ◽  
Chemotherapy Induced Neutropenia

<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.

scholarly journals Analysis of Adverse Drug Reactions due to Amrubicin Chemotherapy in Lung Cancer Patients

2008 ◽  
Vol 34 (2) ◽  
pp. 95-102
Author(s):  
Katsuhito Hori ◽  
Kayoko Kubota ◽  
Yasuhiko Mimura ◽  
Isao Adachi ◽  
Junichi Kawakami
Keyword(s):  
Lung Cancer ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Lung Cancer Patients

Preoperative lymph node assessment in surgically resected pathologic T1 lung cancer patients: Real world clinical practice in China.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20016-e20016
Author(s):  
Xu Jinming ◽  
Xingpeng Han ◽  
Lunxu Liu ◽  
Xiangning Fu ◽  
Yin Li ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Lymph Node ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Real World ◽  
Kappa Index ◽  
Lung Cancer Patients ◽  
Lymph Node Assessment ◽  
N Stage ◽  
N Staging

e20016 Background: Accurate lymph node assessment is crucial for clinical patient management and prognostic prediction. However, the procedures may not always be performed preoperatively due to time, cost or risk of procedure itself. Present study aimed to investigate the real world clinical practice of preoperative N staging in surgically resected pathologic T1 lung cancer patients in China. Methods: This is a multicenter retrospective study. Real world data on clinical and pathologic N staging was retrieved from electronic medical records in 10 thoracic surgery centers (LinkDoc Database). Kappa index was calculated to determine the agreement between clinical and pathologic N stage. Results: A total of 11360 patients who underwent surgical resection for pT1 lung cancer were identified during January 2014 to September 2017. Clinical N staging was available for 6057 (53.3%) patients. Of which, 959 (15.8%) patients were achieved by invasive procedures. Considering the 5795 patients with clinical and pathologic N staging data, the overall agreement was 89.0% with a kappa index of 0.4220 (95%CI: 0.3842-0.4598). This was 96.4% for N0, 22.1% for N1 and 39.8% for N2 when considering pathologic N stage as gold standard (Table). In general, upstaging (7.3%) was more common in our population. Conclusions: Over 50% of pathologic T1 patients had preoperative N staging in our clinical practice. Clinical N staging showed low accuracy for predicting lymph node status. The findings of our study highlight the increasing attention on clinical N staging and procedure optimization in China. [Table: see text]

PD-1/PD-L1 immunotherapy for advanced lung cancer: An electronic medical database based real world study in China.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20543-e20543
Author(s):  
Xiao Zhao ◽  
Qiong Sun ◽  
Sheng Jie Sun ◽  
Weiwei Shi ◽  
Shun Chang Jiao
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Clinical Practice ◽  
Adverse Events ◽  
Cancer Patients ◽  
Real World ◽  
Progression Free Survival ◽  
Advanced Lung Cancer ◽  
Free Survival ◽  
Lung Cancer Patients

e20543 Background: Immunotherapy has shown promising results for clinical management of various cancers. We reported our real world experience with PD-1 or PD-L1 immunotherapy in management of advanced lung cancer patients in China. Methods: This is a single-center retrospective study based on the de-identified electronic medical data collected in routine clinical practice. A total of 198 advanced lung cancer (stage IIIA-IV) patients who underwent anti-PD-1/PD-L1 therapy at Chinese People's Liberation Army General Hospital between 2015 and 2018 were included. Progression free survival and overall survival of patients were estimated by Kaplan-Meier methods. The treatment-related adverse events were also analyzed. Results: Median age of patients was 60.0 years (33.0-88.0 years). Most patients were male (150, 75.8%), smokers (116, 61.7%) and had a KPS score ≥70 (169, 97.7%). Of 198 patients, 106 (53.5%) had adenocarcinoma and 54 (17.3%) had squamous cell carcinoma. Thirty-one (15.7%) patients had CNS metastases. Seventy-one (38.8%) patients received two or more prior therapies. Estimated progression free survival was 5.6 months and overall survival was 24.5 months. One-hundred twenty-seven (64.1%) patients had documented to suffer adverse events, most commonly gastrointestinal adverse events and liver damage (Table). Conclusions: Our study showed survival benefits of PD-1/PD-L1 immunotherapy in advanced NSCLC patients in clinical practice. Safety profile was comparable to the previous studies. Our study supports the benefits of PD-1/PD-L1 immunotherapy in clinical management of advanced lung cancer patients. [Table: see text]

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
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Treatment Modalities ◽  
European Organization ◽  
Specific Patient ◽  
Symptom Monitoring ◽  
Lung Cancer Patients ◽  
Wide Range ◽  
Patient Reported

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.

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