scholarly journals Cannabis and Alcohol Co-Use in a Smoking Cessation Pharmacotherapy Trial for Adolescents and Emerging Adults

2019 ◽  
Vol 22 (8) ◽  
pp. 1374-1382 ◽  
Author(s):  
Erin A McClure ◽  
Nathaniel L Baker ◽  
Caitlyn O Hood ◽  
Rachel L Tomko ◽  
Lindsay M Squeglia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Smoking Cessation ◽  
Emerging Adults ◽  
Secondary Analysis ◽  
Treatment Strategies ◽  
Cannabis Use ◽  
Daily Diaries ◽  
Tobacco Treatment ◽  
Prior Literature ◽  
The Impact

Abstract Introduction The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use. Methods The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14–21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment. Results Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use. Conclusions Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation. Implications Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.

scholarly journals Changes in carotid artery structure with smoking cessation

2019 ◽  
Vol 24 (6) ◽  
pp. 493-500 ◽  
Author(s):  
Carol Mitchell ◽  
Megan E Piper ◽  
Stevens S Smith ◽  
Claudia E Korcarz ◽  
Michael C Fiore ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Carotid Artery ◽  
Linear Models ◽  
Smoking Status ◽  
Secondary Analysis ◽  
Texture Features ◽  
Carotid Ultrasound ◽  
Longitudinal Effects ◽  
Status Interaction ◽  
The Impact

Carotid artery grayscale ultrasound echogenicity and texture features predict cardiovascular disease events. We evaluated the longitudinal effects of smoking cessation on four grayscale ultrasound measures. This was a secondary analysis of data from 188 age, sex, and body mass index (BMI)-matched smokers (94 eventual abstainers [EA], 94 continued smokers [CS]) from a smoking cessation trial that had carotid ultrasound examinations at baseline and after 3 years. General linear models that included time, smoking group (EA or CS), and a time*smoking interaction term were used to examine the impact of smoking abstinence on carotid artery grayscale marker values at year 3. Participants were mean (SD) 50.3 (11.4) years old (57% female, 86% white). The baseline grayscale median value (GSM) was inversely correlated with age, BMI, insulin resistance, and smoking pack-years ( r = −0.20 to –0.30, p < 0.007 for all). There was a significant time*smoking status interaction for predicting GSM at year 3: GSM decreased significantly in the EA group compared to the CS group (–3.63 [13.00] vs CS 0.39 [12.06] units; p = 0.029). BMI increased more in the EA than the CS group (2.42 [3.00] vs CS 0.35 [2.57] kg/m2; p < 0.001). After adjusting for changes in BMI, the time*smoking status interaction no longer was significant ( p = 0.138). From baseline to year 3, contrast increased similarly in both groups. Entropy and angular second moment did not change significantly in either group. Changes in carotid ultrasound echogenicity and grayscale texture features during a smoking cessation attempt are modest and mostly related to weight gain. Clinicaltrials.gov Identifier: NCT01553084

Comorbidity is associated with disease activity in MS

Neurology ◽  
2020 ◽  
Vol 95 (5) ◽  
pp. e446-e456 ◽  
Author(s):  
Amber Salter ◽  
Kaarina Kowalec ◽  
Kathryn C. Fitzgerald ◽  
Gary Cutter ◽  
Ruth Ann Marrie
Keyword(s):  
Clinical Trial ◽  
Disease Activity ◽  
Cox Regression ◽  
Secondary Analysis ◽  
Large Trial ◽  
Comorbid Conditions ◽  
Comorbidity Burden ◽  
Concomitant Medications ◽  
Comorbidity Status ◽  
The Impact

ObjectiveTo determine whether comorbidity is associated with clinical (relapses, disability worsening) and MRI outcomes in multiple sclerosis (MS) by conducting a secondary analysis of the CombiRx clinical trial.MethodsCombiRx compared interferon beta-1a, glatiramer acetate, and the combination of these agents. For participants eligible for evaluation of 6-month confirmed disability worsening, we used medical history, concomitant medications, and adverse events to ascertain comorbidity status. Comorbid conditions evaluated included hypertension, dyslipidemia, diabetes mellitus, depression, anxiety disorders, and migraine. Clinical outcomes included disease activity consisting of protocol-defined relapses, disability worsening, and MRI activity. We summarized the prevalence of these comorbid conditions and their association with disease activity and its components using multivariable Cox regression.ResultsOf the 1,008 participants randomized, 959 (95.1%) were eligible for assessment of 6-month disability worsening; for this subgroup, the median length of follow-up was 3.4 years (range 0.5–6.9 years). Overall, 55.1% of participants had ≥1 comorbidity at enrollment. After adjustment, anxiety (hazard ratio [HR] 1.25, 95% confidence interval [CI] 1.01–1.55) and dyslipidemia (HR 1.32, 95% CI 1.01–1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80, 95% CI 0.67–0.97) was associated with a decreased hazard.ConclusionsIn this large trial population with rigorously obtained outcomes, comorbid conditions were common among participants and influenced disease outcomes, including relapses. The comorbidity burden of clinical trial participants with MS may be an important factor in the outcome of clinical trials. Additional investigations of the impact of comorbidity on clinical trial outcomes and response to disease-modifying therapies are warranted.

Do Stimulants Reduce the Risk for Alcohol and Substance Use in Youth With ADHD? A Secondary Analysis of a Prospective, 24-Month Open-Label Study of Osmotic-Release Methylphenidate

2016 ◽  
Vol 21 (1) ◽  
pp. 71-77 ◽  
Author(s):  
Paul Hammerness ◽  
Carter Petty ◽  
Stephen V. Faraone ◽  
Joseph Biederman
Keyword(s):  
Clinical Trial ◽  
Substance Use ◽  
Drug Use ◽  
Secondary Analysis ◽  
Self Report ◽  
Open Label ◽  
Stimulant Treatment ◽  
Alcohol And Drug Use ◽  
The Impact ◽  
Youth With Adhd

Objective: The purpose of this study was to examine the impact of stimulant treatment on risk for alcohol and illicit drug use in adolescents with ADHD. Method: Analysis of data derived from a prospective open-label treatment study of adolescent ADHD ( n = 115, 76% male), and a historical, naturalistic sample of ADHD ( n = 44, 68% male) and non-ADHD youth ( n = 52, 73% male) of similar age and sex. Treatment consisted of extended-release methylphenidate in the clinical trial or naturalistic stimulant treatment. Self-report of alcohol and drug use was derived from a modified version of the Drug Use Screening Inventory. Results: Rates of alcohol and drug use in the past year were significantly lower in the clinical trial compared with untreated and treated naturalistic ADHD comparators, and similar to rates in non-ADHD comparators. Conclusion: Well-monitored stimulant treatment may reduce the risk for alcohol and substance use in adolescent ADHD.

scholarly journals Development and Testing of a Lymphoma Clinical Trials Specific Frailty Index: A Secondary Analysis of the LY.12 Clinical Trial

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4076-4076
Author(s):  
Abi Vijenthira ◽  
Xinzhi Li ◽  
Michael Crump ◽  
Annette E. Hay ◽  
Lois E. Shepherd ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Board Of Directors ◽  
Research Funding ◽  
Frailty Index ◽  
Secondary Analysis ◽  
Advisory Committees ◽  
Frail Patients ◽  
The Impact

Abstract Background: Frailty is common in older patients with lymphoma. However, it remains unknown whether frailty is prevalent in patients included in clinical trials of lymphoma, as those with frailty may meet inclusion criteria of a trial which do not include functional information beyond performance status (PS). Understanding the prevalence and impact of frailty in clinical trials is important to direct future stratification criteria, as well as to have robust data to counsel frail patients on their potential outcomes. Methods: We conducted a secondary analysis using data from the phase III LY.12 clinical trial in which patients with relapsed aggressive non-Hodgkin lymphoma were randomized to gemcitabine-dexamethasone-cisplatin or dexamethasone-high dose cytarabine-cisplatin chemotherapy prior to autologous stem cell transplant. The primary objective of our study was to construct a lymphoma clinical trials specific frailty index (FI) using previously described methods (Searle. BMC Geriatr. 2008;8:24). Secondary objectives were to describe the association of frailty (binary variable) with overall survival (OS), event-free survival (EFS), hospitalization, adverse events (AE), serious adverse events (SAE), and proceeding to transplant, and to describe the association of frailty with these outcomes, controlling for important covariates (age, sex, immunophenotype, revised international prognostic index score (rIPI), Eastern Cooperative Oncology Group (ECOG) PS, stage, and response to previous chemotherapy). Results: 619 patients in the LY12 trial were used to construct the frailty index (Table 1). Using a binary cut-off for frailty (&lt;0.2), 15% (N=93) of patients were classified as frail. There were no differences in age or sex between frail and non-frail patients; however they differed in terms of other lymphoma-related characteristics (Table 2). Frailty was strongly associated with OS (HR 2.012, 95% CI 1.57-2.58), EFS (HR 1.94, 95% CI 1.53-2.46), frequency of the worst overall Grade &gt;3 AE (OR 2.65 (15% vs. 6%), p=0.003), and likelihood of proceeding to ASCT (OR 0.26, 95% CI 0.15-0.43), but not hospitalization (OR 1.52, 95% CI 0.97-2.40) or SAE (6% vs. 4%, p=0.3). In multivariable analysis, frailty was not significantly associated with OS, EFS, likelihood of proceeding to ASCT, nor hospitalization (Table 3), though there was a trend to significance for ASCT. However, rIPI remained significantly associated with OS and EFS, ECOG remained significantly associated with OS (Table 3) Conclusion: A potentially broadly applicable lymphoma clinical trials specific FI was constructed through secondary analysis of LY12 data. 15% of patients were classified as frail. Frailty was significantly associated with OS, EFS, frequency of grade &gt;3 AE and likelihood of proceeding to transplant. However, this relationship no longer was significant when controlling for lymphoma-related prognostic variables, suggesting that the impact of poor prognostic features of lymphoma supersede the impact of frailty alone in this younger clinical trial population. Interestingly, rIPI and ECOG demonstrated their value as simple predictors that are highly associated with OS and/or EFS even when controlling for other important covariates including frailty. These findings require further testing in an external data set, and would be particularly valuable to test in an older population. Calibration of the FI against clinical frailty assessment (e.g. Clinical Frailty Scale, Comprehensive Geriatric Assessment) would also be meaningful to confirm its ability to classify frail versus non-frail patients. Figure 1 Figure 1. Disclosures Crump: Epizyme: Research Funding; Roche: Research Funding; Kyte/Gilead: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Hay: Merck: Research Funding; Roche: Research Funding; Abbvie: Research Funding; Amgen: Research Funding; Karyopharm: Research Funding; Seattle Genetics: Research Funding. Prica: Astra-Zeneca: Honoraria; Kite Gilead: Honoraria.

scholarly journals Secure Asynchronous Communication Between Smokers and Tobacco Treatment Specialists: Secondary Analysis of a Web-Assisted Tobacco Intervention in the QUIT-PRIMO and National Dental PBRN Networks

10.2196/13289 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e13289
Author(s):  
Rajani Shankar Sadasivam ◽  
Ariana Kamberi ◽  
Kathryn DeLaughter ◽  
Barrett Phillips ◽  
Jessica H Williams ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Motivational Interviewing ◽  
Secondary Analysis ◽  
Asynchronous Communication ◽  
Evidence Based ◽  
Behavioral Strategies ◽  
Multivariable Model ◽  
Participant Engagement ◽  
Tobacco Treatment ◽  
Tobacco Intervention

Background Within a web-assisted tobacco intervention, we provided a function for smokers to asynchronously communicate with a trained tobacco treatment specialist (TTS). Previous studies have not attempted to isolate the effect of asynchronous counseling on smoking cessation. Objective This study aimed to conduct a semiquantitative analysis of TTS-smoker communication and evaluate its association with smoking cessation. Methods We conducted a secondary analysis of data on secure asynchronous communication between trained TTSs and a cohort of smokers during a 6-month period. Smokers were able to select their preferred TTS and message them using a secure web-based form. To evaluate whether the TTS used evidence-based practices, we coded messages using the Motivational Interviewing Self-Evaluation Checklist and Smoking Cessation Counseling (SCC) Scale. We assessed the content of messages initiated by the smokers by creating topical content codes. At 6 months, we assessed the association between smoking cessation and the amount of TTS use and created a multivariable model adjusting for demographic characteristics and smoking characteristics at baseline. Results Of the 725 smokers offered asynchronous counseling support, 33.8% (245/725) messaged the TTS at least once. A total of 1082 messages (TTSs: 565; smokers 517) were exchanged between the smokers and TTSs. The majority of motivational interviewing codes were those that supported client strengths (280/517, 54.1%) and promoted engagement (280/517, 54.1%). SCC code analysis showed that the TTS provided assistance to smokers if they were willing to quit (247/517, 47.8%) and helped smokers prepare to quit (206/517, 39.8%) and anticipate barriers (197/517, 38.1%). The majority of smokers’ messages discussed motivations to quit (234/565, 41.4%) and current and past treatments (talking about their previous use of nicotine replacement therapy and medications; 201/565, 35.6%). The majority of TTS messages used behavioral strategies (233/517, 45.1%), offered advice on treatments (189/517, 36.5%), and highlighted motivations to quit (171/517, 33.1%). There was no association between the amount of TTS use and cessation. In the multivariable model, after adjusting for gender, age, race, education, readiness at baseline, number of cigarettes smoked per day at baseline, and the selected TTS, smokers messaging the TTS one or two times had a smoking cessation odds ratio (OR) of 0.8 (95% CI 0.4-1.4), and those that messaged the TTS more than two times had a smoking cessation OR of 1.0 (95% CI 0.4-2.3). Conclusions Our study demonstrated the feasibility of using asynchronous counseling to deliver evidence-based counseling. Low participant engagement or a lack of power could be potential explanations for the nonassociation with smoking cessation. Future trials should explore approaches to increase participant engagement and test asynchronous counseling in combination with other approaches for improving the rates of smoking cessation.

scholarly journals COVID-19’s impact on cannabis use: Can we trust retrospective cross-sectional data?

2021 ◽  
Author(s):  
Sara Bartel ◽  
Simon Sherry ◽  
Sherry Stewart
Keyword(s):  
Substance Use ◽  
Emerging Adults ◽  
Cannabis Use ◽  
Cross Sectional ◽  
Change Scores ◽  
Subjective Change ◽  
Retrospective Reports ◽  
Self Reports ◽  
Design And Methods ◽  
The Impact

Background: Emergent research suggests there has been an increase in cannabis use levels during the COVID-19 pandemic; however, several gaps remain. It is unclear what impact the pandemic has had on the frequency vs. quantity of cannabis use. Additionally, research has not focused on emerging adults, a population often more likely to use cannabis. Moreover, as existing studies are cross-sectional and retrospective, it is not clear whether participant reports of increasing cannabis use during COVID-19 are accurate. We sought to fill these gaps to provide further information about the impact of COVID-19 on cannabis use and the accuracy of related retrospective self-reports. Design and Methods: Seventy emerging adults in an ongoing longitudinal study on alcohol and cannabis users completed surveys on COVID-19 and substance use between March 23rd-June 5th. Their substance use four months earlier was extracted from the existing dataset. Results: 54% of participants reported an increase in cannabis use frequency during the pandemic, while 39% reported an increase in cannabis quantity. An examination of objective change scores indicated 50% of participants actually increased their cannabis use frequency during the pandemic, while 32% actually increased their cannabis quantity. A comparison of retrospective subjective change with longitudinal objective change scores indicated participants were relatively accurate in their retrospective reports of change in cannabis use frequency but were relatively inaccurate in their retrospective reports of change in cannabis use quantity. Discussion: The COVID-19 pandemic appears to increase cannabis use frequency in the slight majority of cannabis using emerging adults. Our results suggest that retrospective cross-sectional reports may be a reasonable proxy for COVID-19 related cannabis use change in the case of cannabis use frequency. But our results question their use for determining how the pandemic is impacting cannabis use quantity. Importantly, our results suggest the COVID-19 pandemic poses health threats that extend beyond the virus itself. It is essential that public health efforts address the increasing frequency of cannabis use in emerging adult users.

Secure Asynchronous Communication Between Smokers and Tobacco Treatment Specialists: Secondary Analysis of a Web-Assisted Tobacco Intervention in the QUIT-PRIMO and National Dental PBRN Networks (Preprint)

2019 ◽  
Author(s):  
Rajani Shankar Sadasivam ◽  
Ariana Kamberi ◽  
Kathryn DeLaughter ◽  
Barrett Phillips ◽  
Jessica H Williams ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Motivational Interviewing ◽  
Secondary Analysis ◽  
Asynchronous Communication ◽  
Evidence Based ◽  
Behavioral Strategies ◽  
Multivariable Model ◽  
Participant Engagement ◽  
Tobacco Treatment ◽  
Tobacco Intervention

BACKGROUND Within a web-assisted tobacco intervention, we provided a function for smokers to asynchronously communicate with a trained tobacco treatment specialist (TTS). Previous studies have not attempted to isolate the effect of asynchronous counseling on smoking cessation. OBJECTIVE This study aimed to conduct a semiquantitative analysis of TTS-smoker communication and evaluate its association with smoking cessation. METHODS We conducted a secondary analysis of data on secure asynchronous communication between trained TTSs and a cohort of smokers during a 6-month period. Smokers were able to select their preferred TTS and message them using a secure web-based form. To evaluate whether the TTS used evidence-based practices, we coded messages using the Motivational Interviewing Self-Evaluation Checklist and Smoking Cessation Counseling (SCC) Scale. We assessed the content of messages initiated by the smokers by creating topical content codes. At 6 months, we assessed the association between smoking cessation and the amount of TTS use and created a multivariable model adjusting for demographic characteristics and smoking characteristics at baseline. RESULTS Of the 725 smokers offered asynchronous counseling support, 33.8% (245/725) messaged the TTS at least once. A total of 1082 messages (TTSs: 565; smokers 517) were exchanged between the smokers and TTSs. The majority of motivational interviewing codes were those that supported client strengths (280/517, 54.1%) and promoted engagement (280/517, 54.1%). SCC code analysis showed that the TTS provided assistance to smokers if they were willing to quit (247/517, 47.8%) and helped smokers prepare to quit (206/517, 39.8%) and anticipate barriers (197/517, 38.1%). The majority of smokers’ messages discussed motivations to quit (234/565, 41.4%) and current and past treatments (talking about their previous use of nicotine replacement therapy and medications; 201/565, 35.6%). The majority of TTS messages used behavioral strategies (233/517, 45.1%), offered advice on treatments (189/517, 36.5%), and highlighted motivations to quit (171/517, 33.1%). There was no association between the amount of TTS use and cessation. In the multivariable model, after adjusting for gender, age, race, education, readiness at baseline, number of cigarettes smoked per day at baseline, and the selected TTS, smokers messaging the TTS one or two times had a smoking cessation odds ratio (OR) of 0.8 (95% CI 0.4-1.4), and those that messaged the TTS more than two times had a smoking cessation OR of 1.0 (95% CI 0.4-2.3). CONCLUSIONS Our study demonstrated the feasibility of using asynchronous counseling to deliver evidence-based counseling. Low participant engagement or a lack of power could be potential explanations for the nonassociation with smoking cessation. Future trials should explore approaches to increase participant engagement and test asynchronous counseling in combination with other approaches for improving the rates of smoking cessation.

A Pilot Randomized Controlled Trial of Text Messaging to Increase Tobacco Treatment Reach in the Emergency Department

2021 ◽  
Author(s):  
Lorien C Abroms ◽  
Keng-Chieh Wu ◽  
Nandita Krishnan ◽  
Michael Long ◽  
Sarah Belay ◽  
...  
Keyword(s):  
Emergency Department ◽  
Smoking Cessation ◽  
Treatment Program ◽  
Low Income ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Messages ◽  
Program Text ◽  
Tobacco Treatment ◽  
The Impact

Abstract Background Automated text messaging programs have been studied as a treatment tool, but have not been studied as an outreach tool to increase the reach of smoking cessation treatment. Methods Two distinct text messaging programs were developed. One was aimed at connecting smokers to quitline phone counseling via text message (Text4Coach (T4C)) and the other was aimed at connecting smokers to a smoking cessation text messaging program (Text&Quit (T&Q)). Adult daily smokers with Medicaid insurance (N=80) were recruited from the Emergency Department at an urban hospital and randomized to T4C or T&Q. The primary outcome was program reach. Results Outreach text messages were found to have moderately high uptake, with the majority of participants (63.8%) opting into their assigned tobacco treatment program and younger and female participants more likely to opt in (p&lt;.01). Receipt of the treatment portion of the program differed among the programs with 67.5% of T&Q receiving the treatment program and 27.5 % of T4C receiving the program (p&lt;.001). Most participants across both groups replied to at least 1 message (71.3%) and very few unsubscribed from the service over the 3 week trial. The majority of participants reported overall satisfaction with their program (63.8%), found it helpful for quitting smoking (60.0%) and would recommend the program to a friend (62.5%). Overall, 11 (13.8 %) participants reported being abstinent from smoking for the past 7 days at follow-up, with no differences between groups. Conclusion Outreach text messages were found to have moderately high reach among Medicaid smokers. Larger trials are needed to evaluate the impact of such programs on helping low-income smokers quit.

scholarly journals Impact of lymphopenia on survival for elderly patients with glioblastoma: A secondary analysis of the CCTG CE.6 (EORTC 26062-22061, TROG03.01) randomized clinical trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2547-2547
Author(s):  
Andrew Jehyun Song ◽  
Keyue Ding ◽  
Normand Laperriere ◽  
James R. Perry ◽  
Warren P. Mason ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Regression Models ◽  
Cox Regression ◽  
Multinomial Logistic Regression ◽  
Secondary Analysis ◽  
Extent Of Resection ◽  
Logistic Regression Models ◽  
Short Course ◽  
Grade 3 ◽  
The Impact

2547 Background: Lymphopenia (LMP) may lead to worse outcomes for patients with glioblastoma (GBM). This study is a secondary analysis of the CCTG CE.6 trial evaluating the impact of chemotherapy and radiation on LMP, as well as the association of LMP with overall survival. Methods: CCTG clinical trial CE.6 randomized elderly GBM patients (≥ 65 yrs) to short course radiation alone (RT) or short course radiation with temozolomide (RT + TMZ). In this study LMP (mild-mod: grade 1-2; severe: grade 3-4) was defined per CTCAE v3.0 criteria, and measured at baseline, 1 wk and 4 wks post-RT. Pre-selected key factors for the analysis included age, sex, ECOG, extent of resection, MGMT methylation, MMSE, and steroid use. Multinomial logistic regression models were used to identify factors associated with LMP and multivariable Cox regression models were used to study effect of LMP on survival. Results: A total of 562 patients were included for analysis (281 RT vs 281 RT+TMZ). At baseline, both arms (RT vs RT+TMZ) had similar rates of mild-mod (21.4% vs 21.4%) and severe (3.2% vs 2.9%) LMP. The 1 wk post-RT LMP rates were also similar (p = 0.25). However, RT+TMZ pts were more likely to develop both mild-mod LMP (18.2% vs 27.9%) and severe LMP (1.8% vs 9.3%) [p < 0.001] at 4 wks post-RT. Developing mild-mod and severe LMP post-RT were both associated with baseline LMP (p < 0.001) and RT+TMZ (p < 0.001). Severe LMP at 4 wks post-RT was also associated with biopsy only (p < 0.02). After adjusting for confounding factors, 4 wks post-RT LMP was not significantly associated with PFS or OS regardless of severity. However, baseline LMP (HR 1.3) was significantly associated with worse OS (HR: 1.30, 95% C.I.: 1.05-1.62, p = 0.02), regardless of MGMT status. Other factors significantly associated with worse outcome included: males (HR 1.41), biopsy only (HR 1.59), and lower MMSE (HR 1.03). Conclusions: Short course RT alone does not lead to LMP after treatment. Development of LMP post-RT is associated with addition of TMZ and baseline LMP. However, only baseline LMP is associated with worse OS regardless of MGMT status. This may be considered as a prognostic biomarker for elderly GBM patients and warrants further validation. Clinical trial information: NCT00482677 .

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