Competing mortality (CM) risk in patients with resected stage I and II non-small cell lung cancer (NSCLC): A Surveillance, Epidemiology, and End Results (SEER) analysis.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7563-7563
Author(s):  
Gayathri Nagaraj ◽  
Janakiraman Subramanian ◽  
Feng Gao ◽  
Siddhartha Devarakonda ◽  
Ramaswamy Govindan

7563 Background: CM risk has been identified as a potential confounder in the interpretation of treatment effects in head and neck cancer (Rose et al. J Clin Oncol. 2011). Lung cancer patients (pts) are at considerable risk for CM due to their advanced age at diagnosis and smoking related chronic diseases. We plan to identify risk factors for CM in pts with early stage NSCLC and develop a statistical model to estimate the effect of CM on power calculation for lung cancer clinical trials. Methods: Using SEER registry we identified 32104 pts who had undergone surgical resection with or without radiation for stage I and II NSCLC between 1994 and 2006. The data set was split into two groups: training set (75%) and testing set (25%). Risk factors for lung cancer-specific mortality (LCSM) and CM were identified using training data by Gray’s sub-distribution regression of competing risk. Pts from the testing data were then stratified according to CM risk and the impact of this risk on power loss was evaluated. Results: The 5-year cumulative incidence of death from lung cancer, other causes and overall mortality was 32.7%, 14.2% and 46.9% respectively. Risk factors for CM were: age (hazard ratio [HR] 1.05), male gender (HR 1.43), divorced (HR 1.30), widowed (HR 1.23) or single (HR 1.29) marital status, squamous (HR 1.40) or not-otherwise-specified (HR 1.22) histology, stage I NSCLC (HR 1.27) and sublobar resection (HR 1.23). The 5-year cumulative incidence of CM in low, mid and high-risk tertiles was 7%, 14% and 21% respectively. Sample size calculations based on all-cause mortality (ACM) result in over-estimation of power as the risk for CM increases. In order to restore the underestimated power in LCSM, 19% and 35% more pts are required in the mid and high CM risk groups respectively (Table). Conclusions: Our findings indicate that conventional sample size calculation methods can result in significant loss of power and incorporating CM risk models in power estimation should be considered for clinical trials involving early stage NSCLC pts. [Table: see text]

Author(s):  
Jeffrey Crawford ◽  
Paul Wheatley-Price ◽  
Josephine Louella Feliciano

Outcomes for patients with lung cancer have been improved substantially through the integration of surgery, radiation, and systemic therapy for patients with early-stage disease. Meanwhile, advances in our understanding of molecular mechanisms have substantially advanced our treatment of patients with advanced lung cancer through the introduction of targeted therapies, immune approaches, improvements in chemotherapy, and better supportive care. However, the majority of these advances have occurred among patients with good functional status, normal organ function, and with the social and economic support systems to be able to benefit most from these treatments. The aim of this article is to bring greater attention to management of lung cancer in patients who are medically compromised, which remains a major barrier to care delivery. Impaired performance status is associated with poor outcomes and correlates with the high prevalence of cachexia among patients with advanced lung cancer. CT imaging is emerging as a research tool to quantify muscle loss in patients with cancer, and new therapeutics are on the horizon that may provide important adjunctive therapy in the future. The benefits of cancer therapy for patients with organ failure are poorly understood because of their exclusion from clinical trials. The availability of targeted therapy and immunotherapy may provide alternatives that may be easier to deliver in this population, but clinical trials of these new agents in this population are vital. Patients with lower socioeconomic status are disproportionately affected by lung cancer because of higher rates of tobacco addiction and the impact of socioeconomic status on delay in diagnosis, treatment, and outcomes. For all patients who are medically compromised with lung cancer, multidisciplinary approaches are particularly needed to evaluate these patients and to incorporate rapidly changing therapeutics to improve outcomes.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6058-6058
Author(s):  
M. Q. Baggstrom ◽  
E. Gilstrap ◽  
A. Skelton ◽  
A. Viswanathan ◽  
D. Morgensztern ◽  
...  

6058 Background: Despite recent advances in the treatment of pts with thoracic malignancies, the outcome continues to be poor. Only about 3% of all adult oncology pts enroll in clinical trials compared to approximately 50% of pediatric pts. The proportion of adult pts enrolled in clinical trials is low, even in tertiary cancer centers. It is critical to understand the barriers for accrual to clinical trials. Methods: We reviewed the outpatient charts of all pts with thoracic malignancies (non-small cell lung cancer [NSCLC], small cell lung cancer, and esophageal cancer) referred to the thoracic medical oncology group at our institution from 11/1/2004 to 10/31/2005. Available and appropriate clinical trials are presented to the pts routinely and reasons for non-enrollment are documented. We collected information on histology, stage, performance status (PS) and co-morbid conditions. Appropriate studies at the time of initial consultation were noted from database. Results: Of 284 consecutive patient charts reviewed, 13 pts (4.6%) did not require therapy, 6 pts (2.1%) were deemed to have a non-thoracic primary on review, and 15 pts (5.3%) had already initiated therapy at the time of consultation. Of the remaining 250 evaluable pts, 88 pts (35.2%) were not enrolled because of lack of available appropriate clinical trials at the time of initial consultation. The most common categories were adjuvant therapy for early stage NSCLC and advanced esophageal cancer. Twenty-one pts (8.4%) enrolled onto a clinical trial. The most common reasons for not participating in a clinical trial include: ineligibility due to PS (28 pts, 11.2%), geographic issues (23 pts, 9.2%), patient refusal (16 pts, 6.4%) and co-morbid conditions (9 pts, 3.6%). Ten pts (4.0%) were lost to follow up. Conclusions: 1. Lack of appropriate and available clinical trials and poor PS are the two most common reasons for lack of patient enrollment in clinical trials at our institution. 2. It is critical to develop innovative clinical trials for pts with advanced esophageal cancer, adjuvant therapy in early stage NSCLC, and poor PS. 3. More work is needed to understand patient perception about clinical trials. [Table: see text]


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8544-8544
Author(s):  
Michael J. Kelley ◽  
David Harpole ◽  
Christina D. Williams

8544 Background: The goal of this study was to determine patient factors associated with short- vs long-term survival after surgery for stage I/II NSCLC and assess the distribution of causes of death over time. Methods: Using the VA Central Cancer Registry, we identified patients diagnosed 2001-2005 with stage I/II NSCLC who had surgery and survived 30 days after resection. We used multivariate logistic regression models to determine the impact of patient characteristics on 1 year (1Y), 5 year (5Y), and 10 year (10Y) mortality. We compared causes of death at 1Y versus 5Y after diagnosis. Results: The analysis included 4,693 patients. Among these patients, the 1Y, 5Y, and 10Y overall survival (OS) rates were 87%, 45%, and 22%, respectively. 50% of patients alive at 5 year survived to 10 years. For each survival time period, highest survival rates were among patients who were younger (≤65), had stage I disease, had lobectomy, and had fewer comorbidities (all p < 0.0001). Significant differences in 1Y and 10Y OS were noted for histology, with highest 1Y OS among adenocarcinoma (88%) and squamous cell (87%) and highest 10Y OS among large cell (28%) and adenocarcinoma (25%). Racial differences were only observed in 10Y OS (whites 22%, blacks 26%, p = 0.01). In multivariate analyses, age > 65, stage II disease, surgery other than lobectomy, and ≥3 comorbidities were associated with increased likelihood of 1Y, 5Y, and 10Y mortality. Large cell and other histology were the only additional significant predictors of 1Y mortality [OR: 1.94 (1.33-2.84) and OR:1.36 (1.05-1.77), respectively], and squamous cell histology was a significant predictor of 10Y mortality [OR: 1.19 (1.02-1.40)] relative to adenocarcinoma. Among patients who died within 1 year of diagnosis (n = 616), the primary causes of death were lung cancer (63%), cardiovascular disease (10%), other cancer (8%), respiratory disease (3%), and other causes (15). The contribution of these causes of 5Y mortality (n = 2602) were 60%, 11%, 10%, 4%, and 12%, respectively. Conclusions: Half of patients alive at 5Y after resection of stage I/II NSCLC were alive at 10Y. 10Y survival is associated with younger age, earlier stage, non-squamous histology, lobectomy, and fewer comorbidities, but not race.


2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Takao Hiraki ◽  
Hideo Gobara ◽  
Toshihiro Iguchi ◽  
Hiroyasu Fujiwara ◽  
Yusuke Matsui ◽  
...  

This review examines studies of radiofrequency ablation (RFA) of nonsmall cell lung cancer (NSCLC) and discusses the role of RFA in treatment of early-stage NSCLC. RFA is usually performed under local anesthesia with computed tomography guidance. RFA-associated mortality, while being rare, can result from pulmonary events. RFA causes pneumothorax in up to 63% of cases, although pneumothorax requiring chest drainage occurs in less than 15% of procedures. Other severe complications are rare. After RFA of stage I NSCLC, 31–42% of patients show local progression. The 1-, 2-, 3-, and 5-year overall survival rates after RFA of stage I NSCLC were 78% to 100%, 53% to 86%, 36% to 88%, and 25% to 61%, respectively. The median survival time ranged from 29 to 67 months. The 1-, 2-, and 3-year cancer-specific survival rates after RFA of stage I NSCLC were 89% to 100%, 92% to 93%, and 59% to 88%, respectively. RFA has a higher local failure rate than sublobar resection and stereotactic body radiation therapy (SBRT). Therefore, RFA may currently be reserved for early-stage NSCLC patients who are unfit for sublobar resection or SBRT. Various technologies are being developed to improve clinical outcomes of RFA for early-stage NSCLC.


2010 ◽  
Vol 28 (12) ◽  
pp. 2038-2045 ◽  
Author(s):  
Mara A. Schonberg ◽  
Edward R. Marcantonio ◽  
Donglin Li ◽  
Rebecca A. Silliman ◽  
Long Ngo ◽  
...  

Purpose Few data are available on breast cancer characteristics, treatment, and survival for women age 80 years or older. Patients and Methods We used the linked Surveillance, Epidemiology and End Results-Medicare data set from 1992 to 2003 to examine tumor characteristics, treatments (mastectomy, breast-conserving surgery [BCS] with radiation therapy or alone, or no surgery), and outcomes of women age 80 years or older (80 to 84, 85 to 89, ≥ 90 years) with stage I/II breast cancer compared with younger women (age 67 to 79 years). We used Cox proportional hazard models to examine the impact of age on breast cancer–related and other causes of death. Analyses were performed within stage, adjusted for tumor and sociodemographic characteristics, treatments received, and comorbidities. Results In total, 49,616 women age 67 years or older with stage I/II disease were included. Tumor characteristics (grade, hormone receptivity) were similar across age groups. Treatment with BCS alone increased with age, especially after age 80. The risk of dying from breast cancer increased with age, significantly after age 80. For stage I disease, the adjusted hazard ratio of dying from breast cancer for women age ≥ 90 years compared with women age 67 to 69 years was 2.6 (range, 2.0 to 3.4). Types of treatments received were significantly associated with age and comorbidity, with age as the stronger predictor (26% of women age ≥ 80 years without comorbidity received BCS alone or no surgery compared with 6% of women age 67 to 79 years). Conclusion Women age ≥ 80 years have breast cancer characteristics similar to those of younger women yet receive less aggressive treatment and experience higher mortality from early-stage breast cancer. Future studies should focus on identifying tumor and patient characteristics to help target treatments to the oldest women most likely to benefit.


2012 ◽  
Vol 12 (2) ◽  
pp. 139-145
Author(s):  
Maria Wilczynska ◽  
Angel Garcia-Alonso

AbstractIntroduction: Surgery is the treatment of choice in stage I and II non-small-cell lung cancer (NSCLC). In the management of patients who are medically unfit to tolerate surgical intervention or who refuse surgery, radiotherapy is an acceptable alternative. We have performed a retrospective analysis of the effectiveness of radical radiotherapy in patients with early stage NSCLC treated over a period of 4 years.Methods: Thirty nine patients treated with radiotherapy of radical intent were identified. All patients received hypofractionated radiotherapy with a total dose of 55Gy in 20 fractions.Results: The median survival of all cases was 29 months. The one and two-year survival was respectively 61 % and 41%. The median survival of patients ≥75 years was 28 months, and age was the only prognostic factor identified in this analysis that affected survival.Conclusions: The presented survival results are consistent with those from other series published in the literature. At present, radical radiotherapy is often offered to patients with medically inoperable stage I and II NSCLC or those who decline surgery. But there is emerging evidence that some new techniques like stereotactic radiotherapy could be also used in the operable, early stage NSCLC.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15560-e15560
Author(s):  
Katrin Heider ◽  
Davina Gillian Gale ◽  
Giovanni Marsico ◽  
Andrea Ruiz-Valdepeñas ◽  
Garima Sharma ◽  
...  

e15560 Background: Detection of residual circulating tumour DNA (ctDNA) in patient plasma following curative intervention for localized non-small cell lung cancer (NSCLC) could identify patients who are at higher risk of relapse. These patients may benefit from adjuvant treatment, even if they have no macroscopic disease identified by radiographic imaging, which is the current standard of care. Here we evaluate the performance of the Inivata personalized sequencing assays to detect ctDNA in a cohort of 90 patients with early-stage NSCLC undergoing treatment with curative intent. Methods: The Inivata assay uses a highly sensitive next-generation sequencing platform, to identify tumor-specific variants from exome sequencing of tumor tissue and to track up to 48 patient-specific mutations in plasma specimens by multiplex PCR and ultra-high-depth next-generation sequencing. Samples from 90 patients with Stage I-III NSCLC who underwent radical treatment with curative intent, either surgery or radiotherapy ± chemotherapy, were collected as part of the LUng cancer - CIrculating tumor DNA (LUCID) study. Results: 350 plasma samples from 90 patients were analyzed using the Inivata assay, including samples collected before and after treatment and at subsequent follow-up visits. ctDNA was detected in pre-treatment samples in 38% of 32 patients (12/32) with Stage I NSCLC and in 90% of 21 patients (19/21) with Stage II/III disease, at allele fractions ranging from 6 parts per million (ppm, equivalent to 0.0006%) to over 20,000 ppm (equivalent to 2%). In plasma samples collected post-treatment, ctDNA was detected in close to 50% of cases. Conclusions: These findings highlight the Inivata assay is a sensitive method for detection of residual ctDNA and recurrence in early stage NSCLC. Initial detection rates ranged from 38% in Stage I disease to 90% for patients with Stage II/III disease prior to treatment, including detection of ctDNA to levels as low as a few parts per million. ctDNA was detected in at least one post-treatment timepoint in close to 50% patients. Together with additional data to be presented from the full 90 patient cohort, this suggests a possible route to improving treatment and designs of adjuvant trials for early stage NSCLC by detection of residual disease post-treatment and monitoring for early detection of relapse.


2020 ◽  
pp. 2002682
Author(s):  
Mina Gaga ◽  
Joanna Chorostowska-Wynimko ◽  
Ildikó Horváth ◽  
Martin C Tammemagi ◽  
David Shitrit ◽  
...  

AimLung cancer screening reduces mortality. We aim to validate the performance of Lung EpiCheck®, a 6-marker panel methylation-based plasma test, in the detection of lung cancer in European and Chinese samples.MethodsA case-control European training set (102 lung cancer cases/265 controls) was used to define the panel and algorithm. Two cut-offs were selected, low cut-off (LCO) for high sensitivity and high cut-off (HCO) for high specificity. The performance was validated in case-control European and Chinese validation sets (cases/controls: 179/137 and 30/15).ResultsThe European and Chinese validation sets achieved AUCs of 0.882 and 0.899, respectively. The respective sensitivity/specificity with LCO were 87.2%/64.2% and 76.7%/93.3% and with HCO were 74.3%/90.5% and 56.7%/100.0%, respectively. Stage I NSCLC sensitivity in European and Chinese samples with LCO was 78.4% and 70.0% and with HCO was 62.2% and 30.0%, respectively. SCLC was represented only in the European set and sensitivities with LCO and HCO were 100.0% and 93.3%. In multivariable analyses of the European validation set, the assay's ability to predict lung cancer was independent of established risk factors (age, smoking, COPD), and overall AUC was 0.942.ConclusionsLung EpiCheck demonstrated strong performance in lung cancer prediction in case-control European and Chinese samples, detecting high proportions of early stage NSCLC and SCLC and significantly improving predictive accuracy when added to established risk factors. Prospective studies are required to confirm these findings. Utilising such a simple and inexpensive blood test has the potential to improve compliance and broaden access to screening for at-risk populations.


CHEST Journal ◽  
2011 ◽  
Vol 140 (6) ◽  
pp. 1494-1502 ◽  
Author(s):  
Ryo Maeda ◽  
Junji Yoshida ◽  
Genichiro Ishii ◽  
Tomoyuki Hishida ◽  
Mitsuyo Nishimura ◽  
...  

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