Incidence and impact of thromboembolic events in lung cancer patients treated with nivolumab.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20624-e20624
Author(s):  
Aparna Madhukeshwar Hegde ◽  
Chipman Robert Geoffrey Stroud ◽  
Cynthia R. Cherry ◽  
Meera Yogarajah ◽  
Sulochana Devi Cherukuri ◽  
...  

e20624 Background: Lung cancer has one of the highest incidences of thromboembolic events (TEE) ranging from 8.4 to13.2%. Cisplatin-based chemotherapy in lung cancer is a well-established risk factor for TEE (11.8%). The incidence of TEE in lung cancer patients (pts) treated with nivolumab (nivo) is unclear. The objective of this study was to evaluate the incidence of TEE, risk factors and its impact on overall survival in lung cancer pts treated with nivo. Methods: This was a retrospective cohort study that included all lung cancer pts treated with nivo from April 2015 to October 2016 at our institution. Medical records were reviewed for incidence, timing, CTCAE grade, type and site of TEE, risk factors and patient demographics. Cox proportional hazard model was used to identify independent predictive factors for TEE. Risk factors with p <0.15 in univariate analysis were included in multivariate model using a stepwise approach. Kaplan-Meier method was used to estimate overall survival (OS). Results: The cumulative incidence (CI) of TEE over a median follow up of 10.8 months after starting nivo was 18.4% (14/76 pts). Of the 14 pts who had TEE, 8 had deep vein thrombosis (DVT), 7 had pulmonary embolism (PE), 1 had concurrent DVT/PE and 2 had arterial thrombosis (AT). 28.6% (4/14) of pts experienced recurrent TEE resulting in 18 total episodes. Median time to TEE after starting nivo was 2.9 months (95% CI 1.9 - 8.4). Gender was the only covariate included in multivariate analysis that showed a significant association with TEE (Female vs Male HR 3.1, 95% CI 1.02 – 9.5, p= 0.045). At a median follow up of 31.8 months since diagnosis of lung cancer, pts who had TEE before receiving nivo had worse OS. TEE occurring after nivo had no impact on OS. Conclusions: The CI of TEE is significantly high at 18.4% in lung cancer pts treated with nivo. However, it had no impact on OS. Further studies are needed to determine the role of prophylactic anticoagulation in this high-risk population. [Table: see text]

2016 ◽  
Vol 34 (18_suppl) ◽  
pp. LBA9006-LBA9006 ◽  
Author(s):  
Fabrice Denis ◽  
Claire Lethrosne ◽  
Nicolas Pourel ◽  
Olivier Molinier ◽  
Yoann Pointreau ◽  
...  

LBA9006 Background: We developed a web-application for an early detection of symptomatic relapse, complications and early supportive care in high-risk lung cancer patients between visits. A dynamical analysis of the weekly self-reported symptoms automatically triggered physician visit. Methods: We performed a national multi-institutional phase 3 prospective randomized study to compare web-application follow-up (experimental arm) for which patient’s self-scored symptoms that were weekly sent (between planned visits) to the oncologist and a clinical routine assessment with a CT-scan (every 3-6 months or at investigator’s discretion - standard arm). High risk lung cancer patients without progression and with a 0-2 performance status (PS) after an initial treatment were included. Maintenance chemotherapy or TKI therapy were allowed. In the experimental arm, an email alert was sent to the oncologist when some predefined clinical criteria were fulfilled: an imaging was then quickly prescribed. Early supportive cares were provided if adequate. The primary endpoint was to detect an improvement of 12% in 9 months survival in favor of the experimental arm (α = 5%, β = 20%, unilateral test). The boundary for declaring superiority with respect to overall survival at the pre-planned interim analysis was a p-value of less than 0.006. The PS at relapse, the quality of life (QOL) and cost-effectiveness were also investigated. Results: 121 patients were included in the intent-to-test survival analysis (90% were stage III/IV, median age: 65 y): 60 (61) in the experimental (standard) arms with equivalent baseline characteristics. Median follow-up was 9 months. Median overall survival in months was 19 (11.8), p=0.0014 (n  =  121; HR  =  0.33; 95 % CI, 0.16-0.67) and the PS at the first relapse was 0-1 for 81.5% (35.3%) of the patients (p<0.001) in the experimental (standard) arm. Conclusions: This trial shows a significant survival improvement using Web-application-guided follow-up that allowed better PS at relapse, earlier supportive care and reduction of routine imaging. QOL and cost analysis results will be presented during the meeting. Clinical trial information: NCT02361099.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18001-e18001
Author(s):  
Salah Eldeen Elmesidy ◽  
Mahmoud Abdelsalam ◽  
Husam Zawam

e18001 Background: Incidence of cerebral metastasis is increasing among lung cancer patients. Many factors have been reported associated with increase risk of brain metastasis. The aim of this retrospective analysis is to investigate the predictive factors for the development of brain metastasis in lung cancer patients. Methods: We retrospectively analyzed histologically proven lung cancer patients radiologically diagnosed of having brain metastases who presented to Kasr Al-Eini Center for Oncology (NEMROCK) in the period from 2004 till 2010, with follow up period of 6 months at least. The following factors were analyzed: age, gender, PS, smoking history, tumor size & grade preceding development of brain metastasis. Results: Our study included 403 patients. 67 patients (16.6%) experienced brain metastasis during the course of their disease. 40 (10%) patients had brain metastasis among other sites of distant spread at first presentation which represent 88.9% of patients presented with metastatic disease. In a median follow-up of 17.1 months (6-77) the time to develop brain metastasis (TTBM) for the whole group was 5 months (range 2-22 months) (95% CI : 4.3-7.7). The most important factor affecting the TTBM was the use of chemotherapy before developing brain metastasis with a median TTBM of 5.9 months (95%CI : 3.2-6.8) among those who received chemotherapy compared to 2 months among the patients who didn't receive chemotherapy (P= <0.0001). The second factor was PS at time of initial diagnosis (P= 0.027). The median OS after brain metastasis was 6 months (95% CI : 4.26-7.74). On univariate analysis, PS and use of chemotherapy after developing brain metastases showed statistically significant difference affecting OS. Conclusions: We concluded that PS as well as use of chemotherapy are the 2 main factors associated with shorter time to develop brain metastasis. PS and use of chemotherapy after developing brain metastases showed longer OS after developing brain metastases. Keywords: NSCLC, Brain metastasis, Egypt


2019 ◽  
Vol 17 ◽  
pp. 100251 ◽  
Author(s):  
Ben Wang ◽  
Lijie Chen ◽  
Chongan Huang ◽  
Jialiang Lin ◽  
Xiangxiang Pan ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document