Self-report of neuropathy from oxaliplatin-based regimens in the treatment of colorectal cancer: With or without bevacizumab.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 551-551
Author(s):  
X. S. Wang ◽  
C. Eng ◽  
D. R. Fogelman ◽  
M. Malekifar ◽  
K. E. Liao ◽  
...  

551 Background: Neuropathy attributed to oxaliplatin-based chemotherapy is a dose limiting factor in the administration of chemotherapy. With premising clinical outomes, bevacizumab (BV) has been added with colorectal cancer (CRC) patients in first line and second- line therapy. Although toxicity been well documented, there is no evidence of the impact of adding BV to oxaliplatin-based chemotherapy on patient's neuropathy development during therapy. Methods: The study enrolled 66 colorectal cancer patients naïve to oxaliplatin or to any microtubule stabilizing agents scheduled for oxaliplatin-based chemotherapy, 29 (44%) of whom also received BV. From first therapy cycle start date, patients rated symptoms weekly during chemotherapy via the M. D. Anderson Symptom Inventory (MDASI), and continued symptom assessment every two weeks for up to 48 weeks. Longitudinal symptom responses were analyzed by mixed-effect modeling which controlled for age, sex, staging, prior diabetes, and total cycles of chemotherapy received. All cases completed at least 2 cycles chemotherapy. Results: A third of the sample was female; 24% were older than 65 years; 59% with stage IV disease. The five most severe symptoms were numbness, fatigue, sleep disturbance, drowsiness, and distress on MDASI symptom items. The severity of patient-reported numbness/tingling, rated on MDASI, increased overtime in following 48 weeks after started therapy (p < 0.0001). Oxaliplatin-based therapy plus BV, compared to no BV in the regimen, resulted a significant lower severity on numbness/tingling during the study period (estimate = -1.1325, p = 0.0005). Older patients reported more numbness/tingling. In contrast, pain severity remained low during the initial cycles of therapy, but significantly increased over time during therapy. Therapy with or without BV did not produce differences in pain development. Conclusions: This prospective study suggests that adding BV to standard oxaliplitin-based therapy for CRC was associated with significantly reduced numbness/tingling development. This observation needs to be confirmed in larger studies. The mechanism(s) by which neuropathy could be attenuated by BV are unknown. No significant financial relationships to disclose.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 496-496 ◽  
Author(s):  
Kathy Beusterien ◽  
Sarah Tsay ◽  
Yun Su ◽  
Mitra Corral ◽  
Shadi Gholizadeh ◽  
...  

496 Background: Patient-reported outcomes are typically collected through structured questionnaires. Patient web forums provide a unique opportunity for patients to spontaneously post their experiences and thoughts about diseases and treatments. This study explored the impact of colorectal cancer (CRC) treatments in these forums. Methods: This was a cross-sectional qualitative analysis of web data. Two of the most active CRC web forums were identified using 4 criteria: site active for > 5 years, > 12,000 total posts on the forum, >20 individuals currently browsing, and > 10 new posts/day. All posts posted in Jul and Dec 2010 and Feb-Mar 2011 on the two forums were abstracted for review and coding using MaxQDA software. Results: A total of 1,654 posts, posted by 264 individuals, were identified on the two CRC web forums. Demographic and /or tumor information were identified for 83% of the posters. Of these, 83% were CRC patients and 17% were family members; 76% were females, and the mean age of the patients was 49 years. The majority had advanced cancer (44% stage IV or metastatic, 40% stage III). The most common topics were a variety of side effects (62.3% of posts), treatment response (13%), and impact on personal, social, and work lives, income and life styles, and resulting emotional distress (23.9%). The posters came to the online forums in part to have an emotional outlet. Another key motive was sharing experiences and seeking advice. Formal knowledge regarding the likelihood of response, magnitude of benefit, or side effects was absent however, leading to senses of uncertainty, anxiety, sometimes shock, and unrealistic expectations. On balance, although patients reported difficulties being on treatment, they also expressed resilience and appreciation for the availability of treatment options and the hope they provide. Conclusions: Online CRC communities provide patients with convenient and valuable emotional support and disease and treatment information. The profound impact of CRC and treatments goes beyond efficacy, toxicity, and structured quality of life scores. Systematic information and decision tools are needed to minimize uncertainties and help patients manage expectations and emotional distress.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6501-6501
Author(s):  
Jade Zhou ◽  
Shelly Kane ◽  
Celia Ramsey ◽  
Melody Ann Akhondzadeh ◽  
Ananya Banerjee ◽  
...  

6501 Background: Effective cancer screening leads to a substantial increase in the detection of earlier stages of cancer, while decreasing the incidence of later stage cancer diagnoses. Timely screening programs are critical in reducing cancer-related mortality in both breast and colorectal cancer by detecting tumors at an early, curable stage. The COVID-19 pandemic resulted in the postponement or cancellation of many screening procedures, due to both patient fears of exposures within the healthcare system as well as the cancellation of some elective procedures. We sought to identify how the COVID-19 pandemic has impacted the incidence of early and late stage breast and colorectal cancer diagnoses at our institution. Methods: We examined staging for all patients presenting to UCSD at first presentation for a new diagnosis of malignancy or second opinion in 2019 and 2020. Treating clinicians determined the stage at presentation for all patients using an AJCC staging module (8th edition) in the electronic medical record (Epic). We compared stage distribution at presentation in 2019 vs 2020, both for cancers overall and for colorectal and breast cancer, because these cancers are frequently detected by screening. Results: Total numbers of new patient visits for malignancy were similar in 2019 and 2020 (1894 vs 1915 pts), and stage distribution for all cancer patients was similar (stage I 32% in 2019 vs 29% in 2020; stage IV 26% in both 2019 and 2020). For patients with breast cancer, we saw a lower number of patients presenting with stage I disease (64% in 2019 vs 51% in 2020) and a higher number presenting with stage IV (2% vs 6%). Similar findings were seen in colorectal cancer (stage I: 22% vs 16%; stage IV: 6% vs 18%). Conclusions: Since the COVID-19 pandemic, there has been an increase in incidence of late stage presentation of colorectal and breast cancer, corresponding with a decrease in early stage presentation of these cancers at our institution. Cancer screening is integral to cancer prevention and control, specifically in colorectal and breast cancers which are often detected by screening, and the disruption of screening services has had a significant impact on our patients. We plan to continue following these numbers closely, and will present data from the first half of 2021 as it becomes available.


2021 ◽  
Vol 9 ◽  
Author(s):  
Zsofia P. Cohen ◽  
Kelly T. Cosgrove ◽  
Danielle C. DeVille ◽  
Elisabeth Akeman ◽  
Manpreet K. Singh ◽  
...  

Background: The COVID-19 pandemic has brought on far-reaching consequences for adolescents. Adolescents with early life stress (ELS) may be at particular risk. We sought to examine how COVID-19 impacted psychological functioning in a sample of healthy and ELS-exposed adolescents during the pandemic.Methods: A total of 24 adolescents (15 healthy, nine ELS) completed self-report measures prior to and during the COVID-19 pandemic. The effect of COVID-19 on symptoms of depression and anxiety were explored using linear mixed-effect analyses.Results: With the onset of the pandemic, healthy but not ELS-exposed adolescents evidenced increased symptoms of depression and anxiety (ps &lt; 0.05). Coping by talking with friends and prioritizing sleep had a protective effect against anxiety for healthy adolescents (t = −3.76, p = 0.002).Conclusions: On average, this study demonstrated large increases in depression and anxiety in adolescents who were healthy prior to the COVID-19 pandemic, while ELS-exposed adolescents evidenced high but stable symptoms over time.


F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1878 ◽  
Author(s):  
Christelle Chrea ◽  
Catherine Acquadro ◽  
Esther F. Afolalu ◽  
Erica Spies ◽  
Thomas Salzberger ◽  
...  

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers’ responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration’s “Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,” scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3557-3557
Author(s):  
Robin Park ◽  
Laércio Lopes da Silva ◽  
Sunggon Lee ◽  
Anwaar Saeed

3557 Background: Mismatch repair deficient/microsatellite instability high (dMMR/MSI-H) colorectal cancer (CRC) defines a molecular subtype with distinct clinicopathologic characteristics including an excellent response to immunotherapy. Although BRAF mutations are established as a negative prognostic marker in CRC, whether they retain their negative prognostic impact in or alter the response to immunotherapy in dMMR/MSI-H CRC remains unknown. Herein, we present a systematic review and meta-analysis of the impact of BRAF mutations on the overall survival (OS) and immune checkpoint inhibitor (ICI) response in dMMR/MSI-H CRC. Methods: Studies published from inception to 26 January 2021 were searched in PubMed, Embase, and major conference proceedings (AACR, ASCO, and ESMO). Eligible studies included the following: 1) observational studies reporting outcomes based on BRAF mutation status in dMMR/MSI-H CRC patients and 2) experimental studies of ICI reporting outcomes based on BRAF mutation status in dMMR/MSI-H CRC patients. A summary hazard ratio (HR) was calculated for OS in BRAF mutated ( BRAFmut) vs. BRAF wild type ( BRAFwt) patients (pts) with the random effects meta-analysis (REM). A summary odds ratio (OR) was calculated for objective response rate (ORR) in BRAFmut vs. BRAFwt pts treated with ICI with the REM. Results: Database search conducted according to PRISMA guidelines found 4221 studies in total. Initial screening identified 30 studies and after full-text review, 9 studies (N = 4158 pts) were included for the meta-analysis of prognosis (analysis A) and 3 studies (N = 178 pts) were included for the meta-analysis of ICI response (analysis B). The outcome measures are summarized in the table below. Analysis A showed that in stage I-IV dMMR/MSI-H CRC pts, BRAFmut was associated with worse OS than BRAFwt (HR 1.57, 1.23-1.99). The heterogeneity was low (I2 = 21%). Subgroup analysis showed no significant difference in the prognostic impact of BRAF mutation status between stage IV only and stage I-IV CRC pts. Analysis B showed no difference in ORR (OR 1.04, 0.48-2.25) between BRAFmut vs. BRAFwt dMMR/MSI-H pts who received ICI. The heterogeneity was low (I2 = 0%). Conclusions: BRAF mutations retain their negative prognostic impact in dMMR/MSI-H stage I-IV and stage IV CRC but are not associated with differential ICI response. Limitations include the following: analysis A was based on retrospective studies; also, the impact of BRAF status on the survival outcome of ICI could not be assessed due to limited number of studies.[Table: see text]


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
J. H. Fisher ◽  
M. Kolb ◽  
M. Algamdi ◽  
J. Morisset ◽  
K. A. Johannson ◽  
...  

Abstract Background The CAnadian REgistry for Pulmonary Fibrosis (CARE-PF) is a multi-center, prospective registry designed to study the natural history of fibrotic interstitial lung disease (ILD) in adults. The aim of this cross-sectional sub-study was to describe the baseline characteristics, risk factors, and comorbidities of patients enrolled in CARE-PF to date. Methods Patients completed study questionnaires and clinical measurements at enrollment and each follow-up visit. Environmental exposures were assessed by patient self-report and comorbidities by the Charlson Comorbidity Index (CCI). Baseline characteristics, exposures, and comorbidities were described for the overall study population and for incident cases, and were compared across ILD subtypes. Results The full cohort included 1285 patients with ILD (961 incident cases (74.8%)). Diagnoses included connective tissue disease-associated ILD (33.3%), idiopathic pulmonary fibrosis (IPF) (24.7%), unclassifiable ILD (22.3%), chronic hypersensitivity pneumonitis (HP) (7.5%), sarcoidosis (3.2%), non-IPF idiopathic interstitial pneumonias (3.0%, including idiopathic nonspecific interstitial pneumonia (NSIP) in 0.9%), and other ILDs (6.0%). Patient-reported exposures were most frequent amongst chronic HP, but common across all ILD subtypes. The CCI was ≤2 in 81% of patients, with a narrow distribution and range of values. Conclusions CTD-ILD, IPF, and unclassifiable ILD made up 80% of ILD diagnoses at ILD referral centers in Canada, while idiopathic NSIP was rare when adhering to recommended diagnostic criteria. CCI had a very narrow distribution across our cohort suggesting it may be a poor discriminator in assessing the impact of comorbidities on patients with ILD.


2007 ◽  
Vol 25 (33) ◽  
pp. 5267-5274 ◽  
Author(s):  
Sung-Gyeong Kim ◽  
Eun-Cheol Park ◽  
Jae-Hyun Park ◽  
Myung-Il Hahm ◽  
Jin-Hwa Lim ◽  
...  

PurposeTo identify the initiation or discontinuation of complementary therapy (CT) and determine the impact of sociodemographic and clinical factors on CT use among cancer patients.Patients and MethodsEligible patients were age 20 or older; newly diagnosed with stomach, liver, or colorectal cancer; and started their initial treatment at the National Cancer Center, Korea, between April 1, 2001, and April 30, 2003. In total, 541 cancer patients were surveyed in face-to-face interviews at baseline, and telephone follow-up interviews were performed every 3 months for 3 years.ResultsA total of 281 patients commenced CT after diagnosis; 164 patients stopped using CT during the follow-up period. The overall cumulative probability of starting CT at 1, 2, and 3 years was 50%, 54%, and 55%, respectively. In a Cox multivariate analysis, stomach and liver cancer were associated with an increased probability of initiating CT compared with colorectal cancer. Patients who were classified as stage I, II, or III at diagnosis were associated with a decreased probability of discontinuing CT compared with stage IV.ConclusionMost cancer patients started to use CT during the initial treatment period. Thus, physicians should communicate with cancer patients about CT at this phase. In particular, more attention should be paid to women and individuals with higher household incomes because these groups are more likely to start CT.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 62-62 ◽  
Author(s):  
William F. Pirl ◽  
Daisuke Fujisawa ◽  
Jamie Stagl ◽  
Justin Eusebio ◽  
Lara Traeger ◽  
...  

62 Background: Treatment decisions are often based on performance status (PS), a subjective rating of patient functioning derived from observation and patient-report. Devices that monitor physical activity, such as wrist actigraphs, can accurately measure the percent of time a person is immobile while awake (awake immobile). Thus, actigraphy may have potential to better estimate true PS. We compared actigraphy to both Eastern Cooperative Oncology Group PS (ECOG PS) and patient-reported physical activity as predictors of survival in patients with stage IV non-small cell lung cancer (NSCLC). Methods: Participants (n = 41) were ambulatory patients with stage IV NSCLC receiving care at MGH. Participants wore a watch-sized accelerometer device (ACTIWATCH 2) for three consecutive 24-hour periods (72 hours) and completed a self-report questionnaire about physical activity, scored as METS (metabolic equivalents) per week. Patients’ oncologists rated their ECOG PS (0-5) at the end of the 72-hour actigraphy period. Relationships among ECOG PS, awake immobile, and METs per week were tested with Pearson correlations. A ROC curve for 6-month survival was used to determine a meaningful cut-off for awake immobile. Unadjusted Cox regression models tested associations with survival from assessment times. Results: Participants’ ECOG PS ratings were: 0 (22%), 1 (63%), 2 (12%), and 3 (2%). ECOG PS and awake immobile were correlated (r = .42, p < .01). METS per week was correlated only with ECOG PS (r = -.35, p = .03). At time of analysis, 15 patients had died with a minimum follow up of 9 months. Among all patients, survival was predicted by ECOG PS, HR = 3.77 (95% CI 1.70-8.35), p < .01; awake immobile as both as a continuous (percentage points) and categorical ( > 23%) variable, HR = 1.04 (95% CI 1.00-1.09), p = .05 and HR = 4.12 (95% CI 1.37-12.39), p = .01, respectively; but not METS per week. Among patients with good EGOC PS (0-1), only awake immobile ( > 23%) predicted survival, HR = 5.80 (95% CI 1.39-24.12), p = .02. Moreover, within the largest ECOG group (PS1), awake immobile ( > 23%) still predicted survival, HR = 5.53 (95% CI 1.18-25.94), p = .03. Conclusions: Actigraphy, an objective measure of patient activity, may have utility in determining patient PS.


2007 ◽  
Vol 25 (32) ◽  
pp. 5087-5093 ◽  
Author(s):  
Kathleen Gondek ◽  
Pierre-Philippe Sagnier ◽  
Kim Gilchrist ◽  
J. Michael Woolley

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov , the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.


2008 ◽  
Vol 26 (29) ◽  
pp. 4828-4833 ◽  
Author(s):  
Graeme J. Poston ◽  
Joan Figueras ◽  
Felice Giuliante ◽  
Gennaro Nuzzo ◽  
Alberto F. Sobrero ◽  
...  

Despite recent advances in the medical treatment of metastatic colorectal cancer (mCRC), which include irinotecan- and oxaliplatin-based first-line regimens, the concept of planned sequential therapy involving three active agents during the course of a patient's treatment and the increasing use of targeted monoclonal antibodies, 5-year survival rates for patients with advanced CRC remain unacceptably low. For patients with CRC liver metastases, liver resection remains the only chance of cure, with 5-year survival rates ranging from 25% to 40%. However, 80% to 85% of patients with stage IV CRC have liver disease which is considered unresectable at presentation. The rapid expansion in the use of improved combination chemotherapy regimens plus or minus biologics, to render initially unresectable metastases resectable has increased the percentage of patients eligible for potentially curative surgery. However, the current staging criteria for CRC patients with metastatic disease do not reflect these recent changes or the fact that there is also a large variation in the survival of patients with stage IV CRC. For example the survival for a patient with a solitary, resectable liver metastasis is better than that for a patient with stage III disease. A new staging system is therefore needed that acknowledges both the improvements that have been made in surgical techniques for resectable metastases and the impact of modern chemotherapy on rendering initially unresectable CRC liver metastases resectable, while at the same time distinguishing between patients with a chance of cure at presentation and those for whom only palliative treatment is possible.


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