Predictors of early hospice or death in patients with inoperable lung cancer treated with curative intent.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20525-e20525
Author(s):  
Anna Mary Brown Laucis ◽  
Kimberly A. Hochstedler ◽  
Thomas Pence Boike ◽  
Benjamin Movsas ◽  
Craig William Stevens ◽  
...  

e20525 Background: Treatment for inoperable stage II-III non-small cell lung cancer (NSCLC) involves aggressive chemo-radiotherapy (CRT). While outcomes have improved with immunotherapy, some patients transition to hospice or die early in their treatment course. To help identify these patients, we developed a predictive model for early poor outcomes in NSCLC patients treated with curative intent. Methods: In a statewide consortium involving 27 sites, information was collected prospectively on stage II-III NSCLC patients who received curative CRT from April 2012 to November 2019. We defined an early poor outcome as termination of treatment due to hospice enrollment or death within 5 months of initiating radiation therapy. Potential predictors included clinical characteristics and patient reported outcomes (PROs) from validated questionnaires. Logistic regression models were used to assess potential predictors and build predictive models. Multiple imputation was used to handle missing data. We used Lasso regularized logistic regression to build a predictive model with multiple predictor variables. Results: Of the total of 2267 included patients, 128 patients discontinued treatment early due to hospice enrollment or death. The mean age of the 128 patients was 71 years old (range 48-91) and 59% received concurrent chemotherapy. Significant uni-variable predictors of early hospice or death were advanced age, worse ECOG performance status, high PTV volume, short distance to normal tissue critical structures, high mean heart dose, uninsured status, lower scores on the Functional and Physical Well-Being scale and the Lung Cancer Symptoms sub-scale of the FACT-L quality of life instrument, as well as higher levels of patient-reported lack of energy, cough, and shortness of breath. The best predictive model included age, ECOG performance status, PTV volume, mean heart dose, patient insurance status, and patient-reported lack of energy and cough. The pooled estimate of area under the curve (AUC) for this multivariable model was 0.71, with a negative predictive value of 95%, specificity of 97%, positive predictive value of 23%, and sensitivity of 16% at a predicted risk threshold of 20%. Conclusions: Our models identified a combination of clinical variables and PROs that may help identify individuals with inoperable NSCLC undergoing curative intent chemo-radiotherapy who are at a high risk of early hospice enrollment or death. These preliminary results are encouraging and warrant further evaluation in a larger cohort of patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16570-e16570
Author(s):  
Shrividya Iyer ◽  
Alex Rider ◽  
Gavin Taylor-Stokes ◽  
Adam Roughley

e16570 Background: The main objective of our study was to assess patient reported symptom burden and impact on quality of life in advanced non small cell lung cancer (NSCLC) patients in the United States. Methods: Patients with advanced (stage IIIB/IV) NSCLC (N=450) were recruited with informed consent in a nationwide (US) lung cancer study from Oct-Dec 2011. Patient reported symptoms were assessed using the Lung Cancer Symptom Scale (LCSS) on a 0-100 visual analogue scale and included six symptoms: fatigue, appetite loss, shortness of breath, cough, pain and blood in sputum. An average symptom burden index was calculated. Quality of life was assessed using the Functional Assessment of Cancer Therapy- Lung (FACT-L).Higher scores indicate higher symptom severity on the LCSS and better quality of life on the FACT-L. Correlation between the total FACT-L score and LCSS symptom burden index was assessed. A multivariate regression analysis was performed with FACT-L total score as the dependent variable and LCSS symptom scores as predictors controlling for age, gender, stage and performance status. Results: Majority of the patients were male (59%), Caucasian (74%), smokers/ex-smokers (78%) with an average age of 64 years. Proportion of patients reporting each lung cancer symptom was: Fatigue (100%), loss of appetite (97%), shortness of breath (95%), cough (93%), pain (92%) and blood in sputum (63%). The average (SD) symptom burden index was 42.3 (21.5).The mean± SD severity scores on symptoms were: fatigue (53.2±24.7), loss of appetite (48.1±25.8), cough (48.4±29.9), shortness of breath (44.7± 27), pain (39.7± 28.1) and blood in sputum (18.4±23.6). The average (SD) FACT-L score was 71.7 (25.3). A significant negative correlation was found between the LCSS symptom burden index and FACT-L scores (ρ= -0.82; p<0.001). Loss of appetite (β=-0.204; p<0.001), cough (β= -0.145; p<0.01), pain (β=-0.265; p<0.001), shortness of breath (β = -0.145; p<0.01), age (β= 0.217; p<0.05) and performance status (β = 0.283; p<0.001) were found to be significant predictors of quality of life. Conclusions: Cough, pain, shortness of breath and loss of appetite contribute to symptom burden and have a significant negative impact on quality of life in advanced NSCLC patients.


2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi152-vi152
Author(s):  
Terry Stubbs ◽  
Kimberly DeVries ◽  
Ryan Proulx ◽  
Clement Ho ◽  
Arthur Cheung ◽  
...  

Abstract BACKGROUND Radiation therapy (RT) for brain metastases in patients with non-small cell lung cancer (NSCLC) has undergone considerable evolution but remains controversial. METHODS Records for 2212 patients with NSCLC who received RT to the brain at one of six locations between 1996-2016 were retrospectively analyzed. Data were obtained from the institutional cancer registry following ethics approval. Overall survival (OS) was calculated from diagnosis of lung cancer to death, and Kaplan-Meier curves were compared by Log-rank and Cox regression. RESULTS Median OS was 11.8 months (95%CI 11-12.6 months). Median age was 65, and 1254 patients (57%) were female. ECOG performance status at diagnosis was 0 (12%), 1 (31%), 2 (17%), 3 (14%), 4 (2%), and unknown (24%). Younger age (HR=0.99, 95%CI 0.98-0.99), female sex (HR=0.80, 95%CI 0.74-0.88), and better ECOG performance status (p&lt; 0.0001) were associated with superior OS. There was better OS in 932 patients (42%) that received chemotherapy (HR=0.63, 95%CI 0.58-0.69) and 603 (27%) that underwent surgery (HR=0.55, 95%CI 0.50-0.61). 2004 patients (91%) received 1 RT course, while 208 (9%) received multiple courses in various combinations of whole brain RT (WBRT) and stereotactic radiosurgery (SRS). SRS (HR=0.70, 95%CI 0.57-0.86) and multiple RT courses (HR=0.55, 95%CI 0.46-0.65) were associated with better OS. Median time from primary diagnosis to brain RT was 2.5 months, and from end of first brain RT to death was 3.5 months. A longer diagnosis to brain RT interval was associated with better OS (HR=0.95, 95%CI 0.95-96). CONCLUSIONS NSCLC patients with brain metastases continue to face poor prognosis, particularly when lung cancer diagnosis to first brain RT interval is short. Our analysis revealed younger age, female sex, and better ECOG performance status as predictors of superior survival. SRS and multiple RT courses also revealed superior survival, likely the result of patient selection and hence interpreted with caution.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18014-e18014
Author(s):  
Toshio Sakatani ◽  
Fumiyoshi Ohyanagi ◽  
Azusa Tanimoto ◽  
Yuko Kawano ◽  
Ryota Saito ◽  
...  

e18014 Background: Pemetrexed (P) is a key drug in the treatment of advanced non-squamous (N-Sq) non-small cell lung cancer (NSCLC). Although differential efficacies of P between squamous (Sq) and N-sq subtypes have been reported, it is difficult to get a clear histological diagnosis from a small biopsy sample. Therefore, a more objective, yet simple, biomarker for histology-based treatment is needed. Previously, we reported that serum Cytokeratin fragment 21-1 (CYFRA) was related to the outcome of P monotherapy. In this study, we examined whether serum CYFRA could predict the efficacy of the cisplatin-pemetrexed (CP) combination regimen as well as it did for P monotherapy. Methods: Pre-treatment serum concentrations of CYFRA, carcinoembryonic antigen (CEA), squamous cell carcinoma (SCC) antigen, and sialyl Lewis X-I antigen (SLX) were measured in 50 N-sq NSCLC patients who were enrolled in a phase II study of C (75 mg/m2 and 500 mg/m2) against N-Sq NSCLC. Eligibility criteria consisted of histologically or cytologically confirmed recurrent or metastatic N-Sq NSCLC previously untreated with chemotherapy, ECOG performance status (PS) 0-1. The primary endpoint was response rate, which was evaluated with RECIST. The planned sample size was 50 patients. We analyzed possible associations between these NSCLC marker levels and the efficacy of the CP regimen. Results: From April 2010 to June 2011, 50 N-sq NSCLC patients (male/female, 34/16; median age 60 y (28-74 y)) were enrolled in this study. Patients’ histological characteristics were: adeno/large/not otherwise specified (NOS), 39/5/6; PS: 0/1, 31/19. In these 50 patients, elevated levels of serum CYFRA, CEA, SCC and SLX were found in 25, 32, 5 and 32 patients, respectively. CYFRA was significantly associated with progression-free survival (PFS) (median PFS: 5.53 vs. 3.29 months; p < 0.05), whereas no significant associations were observed between PFS and CEA, SCC or SLX. In addition, multivariate analysis showed that higher CYFRA and PS levels were significant factors associated with a shorter PFS. (p < 0.05) Conclusions: Serum CYFRA is related to the outcome of CP treatment; our results suggest that serum CYFRA is a promising predictive marker of CP therapy.


2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 53-53 ◽  
Author(s):  
David R. Spigel ◽  
Jyoti D. Patel ◽  
Craig H. Reynolds ◽  
Edward B. Garon ◽  
Robert C. Hermann ◽  
...  

53 Background: Treatment (tx) impact on pt quality of life (QoL) informs pt and physician choices in the management of NSCLC. QoL, a secondary endpoint of POINTBREAK, was assessed using the patient-reported Functional Assessment of Cancer Therapy General (FACT-G), Lung (FACT-L), and Neurotoxicity (FACT&GOG-Ntx). Methods: Pts with previously untreated stage IIIB/IV NS-NSCLC and ECOG performance status 0-1 were randomized to receive induction Pem+Cb+Bev or Pac+Cb+Bev for up to 4 cycles. Pts without progressive disease received maintenance Pem+Bev (Pem Arm) or Bev (Pac Arm). Pts completed the FACT-G [physical, emotional, functional, and social well-being subscales (SS)], FACT-L (FACT-G + lung cancer SS), and FACT&GOG-Ntx (FACT-G + Ntx SS) at each visit. SS score and total score (TS) were calculated for each instrument. Tx group differences were analyzed using Linear Mixed Effects model. Toxicity was investigator assessed using CTCAE and was compared with Fisher’s exact test. Results: The primary endpoint of superior OS for the Pem arm was not met and is reported elsewhere. Pt overall compliance on the FACT was 91.2% (Pem Arm) and 90.0% (Pac Arm). For both the FACT-G and FACT-L TS, no overall significant change from baseline difference was observed between the Pem and Pac Arms. No overall differences were seen in SS scores except for Ntx. Pts on the Pem Arm had significantly less change from baseline in Ntx SS score and Ntx TS than pts in the Pac Arm at cycle 2 (p<0.001), and this significant tx effect persisted through induction and the six cycles of maintenance considered in the analysis. Significantly fewer pts on the Pem Arm experienced investigator assessed Grade 3/4 sensory neuropathy compared to the Pac Arm (0.0% vs. 4.1%, p<.00001). Conclusions: Based on the FACT results, pts on the Pem and Pac Arms reported similar changes in QoL except for less change from baseline in Ntx on the Pem Arm. Patient-reported Ntx is consistent with the clinically-measured drug-related Grade 3/4 sensory neuropathy.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21213-e21213
Author(s):  
Saleha Rizwan ◽  
Khaled Alhamad ◽  
Stephen Abel ◽  
Veli Bakalov ◽  
Robin Raquel Rodriguez ◽  
...  

e21213 Background: Lung cancer is the leading cause of death in males and females in the United States. Approximately 85% of all cases are classified as non-small cell lung cancer (NSCLC) with majority diagnosed at an advanced stage. Unfortunately, response to traditional chemotherapy (ChT) has been poor with a five-year survival rate of 6% in metastatic NSCLC. Immune checkpoint inhibitors (ICI) have changed the therapeutic landscape for advanced NSCLC and are being utilized alone or in combination with ChT as the standard first-line therapy. With widespread use of ICIs, immune-related adverse events (irAE) are commonly seen and in some studies their occurrence correlates with improved outcomes. The aim of our study was to evaluate whether development of irAEs has an impact on survival in NSCLC. Methods: We performed a retrospective analysis on stage IV NSCLC patients treated with ChT, ChT plus ICI, or ICI monotherapy from December 2016 to December 2019. Univariable and multivariable analyses identified characteristics predictive of progression-free survival (PFS) and overall survival (OS). OS was calculated using Kaplan Meier curves. Log-rank statistics were used to assess statistical significance between groups. Multivariable logistic regression was performed to identify predictors of survival. Results: 193 patients were evaluated out of which 92 (47.2%) received ChT plus pembrolizumab, 69 (35.4%) received pembrolizumab alone and 32 (16.4%) received ChT alone. 130 patients were found to have no irAEs compared to 57 patients who were noted to have any grade of irAE. The median PFS was 17.4 months (irAE group) vs. 8.5 months (non-irAE group) with hazard ratio (HR) of 0.58 (95% CI: 0.41 to 0.80, p = 0.001). The median OS was 29.4 months (irAE group) vs. 14.4 months (non-irAE group) with HR of 0.56 (95% CI: 0.39 to 0.82, p = 0.0026). A multivariate analysis was performed for age, gender, ECOG performance status, insurance status, BMI, PDL1 status and smoking history, amongst other variables. Worse survival outcomes were noted with an ECOG performance status ≥ 2, no history of smoking, and involvement of palliative care. Multivariable logistic regression analysis showed that PDL-1 expression > 50% was the only predictor of developing an irAE. Of note, receipt of ChT in combination with pembrolizumab compared to pembrolizumab alone did not predict for development of irAE. Conclusions: Development of irAEs was associated with doubling of PFS and OS, regardless of whether the ICI was administered alone or in combination with ChT. The differences were statistically significant regardless of age, gender, race, BMI, insurance status or performance status. Our study highlights the correlation between development of irAEs and improved survival outcomes in advanced NSCLC patients treated with ICIs.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chiao-En Wu ◽  
Ching-Fu Chang ◽  
Chen-Yang Huang ◽  
Cheng-Ta Yang ◽  
Chih-Hsi Scott Kuo ◽  
...  

Abstract Background Afatinib is one of the standard treatments for patients with epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC). However, data on the use of afatinib in patients with poor performance status (PS ≥ 2) are limited. This study aimed to retrospectively review the clinical outcomes and safety of afatinib treatment in EGFR-mutation-positive (EGFRm+) NSCLC patients with PS ≥ 2. Methods The data for 62 patients who were treated at Linkou Chang Gung Memorial Hospital from January 2010 to August 2019 were retrospectively reviewed. Patients’ clinicopathological features were obtained, and univariate and multivariate analyses were performed to identify possible prognostic factors. Data on adverse events were collected to evaluate general tolerance for afatinib therapy. Results Until February 2020, the objective response rate, disease control rate, median progression-free survival (PFS), and overall survival (OS) were 58.1% (36/62), 69.4% (43/62), 8.8 months, and 12.9 months, respectively. The absence of liver metastasis (PFS: p = 0.044; OS: p = 0.061) and good disease control (p < 0.001 for PFS and OS) were independent favorable prognostic factors for PFS and OS. Bone metastasis (p = 0.036) and dose modification (reduction/interruption, p = 0.021) were predictors of disease control. Conclusion Afatinib demonstrated acceptable efficacy and safety in the current cohort. This study provided evidence to support the use of afatinib as a first-line treatment in EGFRm+ NSCLC patients with poor PS.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sha Sha ◽  
Jigang Dong ◽  
Maoyu Wang ◽  
Ziyu Chen ◽  
Peng Gao

Abstract Background The radiation-induced lung injury (RILI) in patients with advanced non-small cell lung cancer (NSCLS) is very common in clinical settings; we aimed to evaluate the risk factors of RILI in NSCLS patients, to provide insights into the treatment of NSCLS. Methods NSCLC patients undergoing three-dimensional conformal radiotherapy (3D-CRT) in our hospital from June 1, 2018, to June 30, 2020, were included. The characteristics and treatments of RILI and non-RILI patients were analyzed. Logistic regression analyses were conducted to assess the risk factors of RILI in patients with NSCLC. Results A total of 126 NSCLC patients were included; the incidence of RILI in NSCLC patients was 35.71%. There were significant differences in diabetes, smoke, chronic obstructive pulmonary disease (COPD), concurrent chemotherapy, radiotherapy dose, and planning target volume (PTV) between the RILI group and the non-RILI group (all P < 0.05). Logistic regression analyses indicated that diabetes (OR 3.076, 95%CI 1.442~5.304), smoke (OR 2.745, 95%CI 1.288~4.613), COPD (OR 3.949, 95%CI 1.067~5.733), concurrent chemotherapy (OR 2.072, 95%CI 1.121~3.498), radiotherapy dose ≥ 60 Gy (OR 3.841, 95%CI 1.932~5.362), and PTV ≥ 396 (OR 1.247, 95%CI 1.107~1.746) were the independent risk factors of RILI in patients with NSCLC (all P < 0.05). Conclusions RILI is commonly seen in NSCLS patients; early targeted measures are warranted for patients with those risk factors; future studies with larger sample sizes and different areas are needed to further elucidate the influencing factors of RILI in the treatment of NSCLS.


2021 ◽  
Vol 161 ◽  
pp. S981
Author(s):  
E. Ćirić ◽  
S. Jelerčič ◽  
M. Vrankar ◽  
J. But Hadžić ◽  
K. Stanič ◽  
...  

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