Patient barriers to participation in clinical trials at a community cancer center.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 17-17
Author(s):  
Praveen Ramakrishnan Geethakumari ◽  
Joann R. Ackler ◽  
Mahasweta Gooptu ◽  
Leonard E Braitman ◽  
William J. Tester
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Family Support ◽  
Small Sample Size ◽  
Small Sample ◽  
Cancer Center ◽  
Final Decision ◽  
Continuous Variables ◽  
Drug Side Effects ◽  
Barriers To Participation

17 Background: Clinical trials are fundamental to innovative oncology. Participation rates in trials have declined nationally to < 5%. Barriers to participation exist at patient, physician, and protocol levels. This study seeks to identify barriers to enrollment in clinical trials at a community cancer center serving a diverse patient population. Methods: We conducted a descriptive cross-sectional study, including 160 eligible patients offered enrollment in 27 clinical trials from July 2010-December 2012. A standardized questionnaire was delivered by mail or in person. Patients who enrolled (acceptors) and decliners were compared using Fisher’s exact test for nominal variables and t test for normally distributed continuous variables. Results: Fifty-seven patients (36%) (males: 10, females: 47) returned the questionnaire. Thirty-three (58%) were enrolled in a clinical trial. Mean age of acceptors was 57 compared to 64 for decliners (p=0.007). Stage IV disease patients were more likely to enroll (Spearman rho= 0.33, p=0.01). Among patients with family support, 66% accepted participation compared to 40% of those without [p=0.05]. Twenty-eight of 33 (85%) who felt trust in their doctor affected their decision enrolled. Of those “comfortable with randomization,” 86% enrolled compared to 29% who were not [p<0.001]. 74% patients would participate in a trial if maximal information could be gathered before making a final decision. Acceptors stated altruism, contribution to research, trust in doctor and hope for cure while decliners mentioned uncertainty in research, drug side effects, mistrust in pharmaceutical industry and depression as most important reasons for their decision. Conclusions: Our results confirm barriers among diverse patients treated at a community cancer center. Study limitations include small sample size and predominance of female gender. Factors influencing enrollment identified include age, family support, patient’s insight into conduct of randomized trials, perceived drug side effects and the doctor-patient relationship. Success lies in bridging knowledge and communication gaps, careful protocol design, and establishing trusting relationships.

Patient barriers to participation in clinical trials in a community cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17578-e17578
Author(s):  
Praveen Ramakrishnan Geethakumari ◽  
Joann R. Ackler ◽  
Mahasweta Gooptu ◽  
Leonard E Braitman ◽  
William J. Tester
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Small Sample Size ◽  
Small Sample ◽  
Cancer Center ◽  
Trial Participation ◽  
Continuous Variables ◽  
Drug Side Effects ◽  
Foreign Born ◽  
Barriers To Participation

e17578 Background: Clinical trials are fundamental to research and innovative oncology treatment. Participation rates in trials have declined nationally to < 5%. Barriers to participation exist at patient, physician and protocol levels. Methods: We conducted a descriptive cross-sectional study in a community cancer center serving a diverse patient population. A total of 160 eligible patients offered enrollment in various clinical trials from July 2010-December 2012 were included. A standardized questionnaire was delivered by mail or in person. Electronic medical records and patient charts were used for disease specific data. Acceptors and decliners were compared using Fisher’s exact test for nominal variables and t test for normally distributed continuous variables. Results: Forty-nine patients (males: 9, females: 40) returned the questionnaire. Twenty-eight had accepted and 21 declined trial participation. Mean age of acceptors was 56.2 ± 2.2 compared to 63.96 ± 1.6 for decliners (p=0.007). Acceptance was highest for stage IV disease (85.71%) [p=0.077]. Of foreign-born patients, 71.4% patients were decliners [p=0.122]. Of those “comfortable with randomization,” 85.2% were acceptors compared to 22.7% who were not [p<0.001]. Of respondents encouraged by knowing that they could leave the study at any time and receive standard treatment, 79.4% were acceptors [p<0.001]. Of patients who valued trust in their doctor, 85.7% accepted compared to 19.05% who did not [p<0.001]. Among most important reasons for their decision, acceptors valued altruism, contribution to research, trust in doctor and hope for cure while decliners mentioned uncertainty in research, drug side effects, depression and need for family support. Conclusions: Results confirm barriers among diverse patients treated in a community cancer center and suggest the type of patient likely to participate in clinical trials. Study limitations include small sample size and majority of female respondents. Key factors included age, patient’s insight into the conduct of randomized trials, perceived drug side effects and the doctor-patient bond. Success lies in bridging knowledge and communication gaps, careful protocol design, and establishing trusting relationships.

Health care worker attitudes about clinical trials at a comprehensive cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20633-e20633
Author(s):  
Erica Leigh Campagnaro ◽  
Seunghee Margevicius ◽  
Barbara J. Daly ◽  
Jennifer Rachel Eads ◽  
Tyler G. Kinzy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Small Sample Size ◽  
Educational Interventions ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Normative Beliefs ◽  
The Impact

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

scholarly journals Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

2008 ◽  
Vol 4 (4) ◽  
pp. 162-168 ◽  
Author(s):  
Michele Basche ◽  
Anna E. Barón ◽  
S. Gail Eckhardt ◽  
Lodovico Balducci ◽  
Martha Persky ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Age Groups ◽  
Experimental Treatment ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Sources Of Information ◽  
Barriers To Participation ◽  
University Center ◽  
Barriers To Enrollment

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

Abstract W P224: Higher Pre-Hospital Blood Pressure Prolongs Door to Needle Thrombolysis Times

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Digvijaya Navalkele ◽  
Chunyan Cai ◽  
Mohammad Rahbar ◽  
Renganayaki Pandurengan ◽  
Tzu-Ching Wu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Small Sample Size ◽  
Heart Association ◽  
Small Sample ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Intravenous Tissue Plasminogen Activator ◽  
Number Of Patients

Background: Per American Heart Association guidelines, blood pressure (BP) should be < 185/110 to be eligible for intravenous tissue plasminogen activator (tPA). It is shown that door to needle (DTN) time is prolonged in patients who require anti-hypertensive medications prior to thrombolysis in the emergency department (ED). To our knowledge, no studies have focused on pre-hospital BP and its impact on DTN times. We hypothesize that DTN times are longer for patients with higher pre-hospital BP. Methods: We conducted a retrospective review of acute ischemic stroke patients who presented between 1/2010 and 12/2010 to our ED through Emergency Medical Services (EMS) within 3-hrs of symptom onset. Patients were identified from our registry and categorized into two groups: Pre-hospital BP ≥ 185/110 (Pre-hsp HBP) and < 185/110 (Pre-hsp LBP). BP records were abstracted from EMS sheets. Two groups were compared using two-sample t-test or Wilcoxon rank sum test for continuous variables and Chi-square test or Fisher’s exact test for categorical variables. Results: A total of 107 consecutive patients were identified. Out of these, 75 patients (70%) were treated with tPA. Among the patients who received thrombolysis, 35% had pre-hospital BP ≥ 185/110 (n= 26/75). Greater number of patients required anti-hypertensive medications in ED in high BP group compared to low BP group (Pre-hsp HBP n= 14/26, 54%; Pre-hsp LBP n= 13/49, 27%, p < 0.02). Mean door to needle times were significantly higher in Pre-hsp HBP group. (mean ± SD 87.5± 34.2 Vs. 59.7±18.3, p<0.0001). Analysis of patients only within the Pre-hsp HBP group (n= 26) revealed that DTN times were shorter if patients received pre-hsp BP medications compared to patients in the same group who did not receive pre-hsp BP medication (n= 10 vs 16; mean ± SD 76.5 ± 25.7 Vs. 94.3 ± 37.7, p = 0.20) Conclusion: Higher pre-hospital BP is associated with prolonged DTN times and it stays prolonged if pre-hospital high BP remains untreated. Although the later finding was not statistical significant due to small sample size, pre-hospital blood pressure control could be a potential area for improvement to reduce door to needle times in acute ischemic stroke.

The feasibility of same day pegfilgrastim-cbqv administration in breast cancer patients receiving myelosuppressive chemotherapy regimens at a northern Virginia cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18687-e18687
Author(s):  
Maya Leiva ◽  
Angela Pennisi ◽  
Kathleen Kiernan Harnden ◽  
Patricia Conrad Rizzo ◽  
Lauren Ann Mauro
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Small Sample Size ◽  
Standard Of Care ◽  
Secondary Prophylaxis ◽  
Small Sample ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Curative Intent ◽  
Myelosuppressive Chemotherapy

e18687 Background: The long-acting injectable G-CSF, pegfilgrastim and its biosimilars have historically been given to patients 24 hours following the administration of myelosuppressive chemotherapy for either primary or secondary prophylaxis of febrile neutropenia (FN). Previous literature has indicated that pegfilgrastim administration prior to 24 hours post chemotherapy, may result in a deepened and prolonged neutropenia due to the increase in circulating granulocytes exposed to chemotherapy. With the onset of the COVID-19 pandemic and to reduce potential SAR-CoV-2 exposure to cancer patients on therapy, we implemented same day administration of injectable pegfilgrastim-cbqv among select breast cancer patients receiving myelosuppressive chemotherapy regimens from March 2020 – February 2021. Methods: Utilizing retrospective EHR chart reviews, 55 patients among 4 medical oncologists in our breast cancer group were identified as meeting the criteria of same day pegfilgrastim-cbqv administration. Inclusion was based on completion of at least 2 consecutive cycles of same day pegfilgrastim-cbqv 6 mg subcutaneous injection for primary or secondary prophylaxis. The selected patient charts were reviewed for the incidence and severity of FN. Among the patients who had documented FN, further subgroup analyses were done regarding baseline characteristics, timing of neutropenia, regimens, regimen sequence, and reported ADRs associated with pegfilgrastim-cbqv. Results: 9 (16.4%) of the 55 patients experienced FN (Grades 3-4) and 6 (10.9%) patients were hospitalized. There were no Grade 5 events and none had therapy discontinued due to FN. 8 (88.9%) of the patients experienced FN between cycles 1 and 2. Of note, there were no cases of COVID-19 among the 9 patients who had an episode of FN. 52 (94.5%) of the 55 patients received treatment with curative intent and 3 (5.5%) had metastatic disease on a subsequent line of therapy. The median age was 49.1 years (range 29-71) and patients were 56.4% Caucasian, 18.1% Black or African American, 12.7% Asian, and 12.7% Hispanic/Latina. Conclusions: Based on the retrospective data analysis, same day pegfilgrastim-cbqv appears to be a safe and effective option in the primary and secondary prophylaxis of FN with myelosuppressive standard of care chemotherapy used in breast cancer treatment. Though our review was limited by a relatively small sample size and confined to younger (49.1 median age) breast cancer patients, this opens the door to further re-evaluation of same day pegfilgrastim-cbqv administration in other patient populations. In a post pandemic treatment world, this slight change in practice has the potential to reduce patient financial toxicity associated with multiple medical visits, provide an alternative to on-body injector formulations, and ensure treatment adherence.

scholarly journals Systematic Review and Meta-Analysis of Linezolid and Daptomycin for Treatment of Vancomycin-Resistant Enterococcal Bloodstream Infections

2013 ◽  
Vol 57 (10) ◽  
pp. 5013-5018 ◽  
Author(s):  
Donald W. Whang ◽  
Loren G. Miller ◽  
Neil M. Partain ◽  
James A. McKinnell
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Fixed Effects ◽  
Randomized Clinical Trials ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Bloodstream Infections ◽  
Small Sample ◽  
Antibiotic Selection ◽  
Vancomycin Resistant

ABSTRACTBloodstream infections due to vancomycin-resistant enterococci (VRE-BSI) result in substantial patient mortality and cost. Daptomycin and linezolid are commonly prescribed for VRE-BSI, but there are no clinical trials to determine optimal antibiotic selection. We conducted a systematic review for investigations that compared daptomycin and linezolid for VRE-BSI. We searched Medline from 1966 through 2012 for comparisons of linezolid and daptomycin for VRE-BSI. We included searches of EMBASE, clinicaltrials.gov, and national meetings. Data were extracted using a standardized instrument. Pooled odds ratios (OR) and 95% confidence intervals (95% CI) were calculated using a fixed-effects model. Our search yielded 4,243 publications, of which 482 contained data on VRE treatment. Most studies (452/482) did not present data on BSI or did not provide information on linezolid or daptomycin. Among the remaining 30 studies, 9 offered comparative data between the two agents. None were randomized clinical trials. There was no difference in microbiologic (n= 5 studies, 517 patients; OR, 1.0; 95% CI, 0.4 to 1.7;P= 0.95) and clinical (n= 3 studies, 357 patients; OR, 1.2; 95% CI, 0.7 to 2.0;P= 0.7) cures between the two antibiotics. There was a trend toward increased survival with linezolid compared to daptomycin treatment (n= 9 studies, 1,074 patients; OR, 1.3; 95% CI, 1.1 to 1.8;I2= 0 [whereI2is a measure of inconsistency]), but this did not reach statistical significance (P= 0.054). There are limited data to inform clinicians on optimal antibiotic selection for VRE-BSI. Available studies are limited by small sample size, lack of patient-level data, and inconsistent outcome definitions. Additional research, including randomized clinical trials, is needed before conclusions can be drawn about treatment options for VRE therapy.

scholarly journals Chloroquine and Hydroxychloroquine could be an Available Weapons to Treat COVID-19 Associated Pneumonia

2020 ◽  
pp. 52-60
Author(s):  
Nehad J. Ahmed
Keyword(s):  
Clinical Trials ◽  
Angiotensin Converting Enzyme ◽  
Sample Size ◽  
Small Sample Size ◽  
Small Sample ◽  
Google Scholar ◽  
Converting Enzyme ◽  
Larger Sample

Aims: This study aims to review the efficacy of chloroquine and hydroxychloroquine to treat coronavirus disease 2019 (COVID-19) associated pneumonia. Methodology: This review includes searching Google scholar for publications about the use of hydroxychloroquinein the treatment of COVID-19 using the words of (Covid-19) AND hydroxychloroquine. Results: Chloroquine and hydroxychloroquine have proven effective in treating coronavirus in China in vitro, but till now only few clinical trials are available and these trials were conducted on a small sample size of the patients. The efficacy of chloroquine and hydroxychloroquine is mainly due to its effect on angiotensin-converting enzyme II (ACE2). Conclusion: The use of chloroquine and hydroxychloroquine could be very promising but more trials are needed that include larger sample size and more data are required about the comparison between chloroquine and hydroxychloroquine with other antivirals.

Methylated DNA markers for monitoring palliative chemotherapy response in advanced colorectal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15511-e15511
Author(s):  
Mojun Zhu ◽  
Douglas W. Mahoney ◽  
Kelli Burger ◽  
Patrick H. Foote ◽  
Karen A. Doering ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Treatment Response ◽  
Systemic Therapy ◽  
Small Sample Size ◽  
High Sensitivity ◽  
Response Assessment ◽  
Small Sample ◽  
Chemotherapy Response ◽  
Continuous Variables ◽  
Methylated Dna

e15511 Background: Aberrantly methylated DNA marker (MDM) candidates are strongly associated with primary colorectal cancer (CRC) before treatment and detect CRC recurrence with high sensitivity when assayed from plasma. The relationship of these MDMs in association to chemotherapy treatment response is unknown. Methods: In a prospective cohort of patients receiving systemic therapy for advanced CRC, peripheral blood was collected serially during restaging visits. 15 patients were retrospectively identified to have partial response (PR), stable disease (SD) and progressive disease (PD) to treatment (n=5 for each group) based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Using paired samples from each patient before and after response assessment, we analyzed 11 MDMs ( GRIN2D, ZNF671, ANKRD13B, QKI, VAV3, JAM3, SFMBT2, CHST2, ZNF568, FER1L4 and CNNM1) to assess correlation with treatment response. Cell-free DNA was extracted and bisulfite treated before MDMs were quantified by target enrichment long-probe quantitative-amplified signal assay and normalized to a methylated sequence of B3GALT6. Continuous variables are summarized as a median with corresponding interquartile ranges (IQR) and comparisons between subgroups were based on the Wilcox Rank Sums test. Results: The median interval between pre- and post-response assessment visits was 69 days (IQR: 63-83 days) and the level of tumor burden at pre-assessment was similar across all response types (Table 1). Patients with PD had higher levels of methylated GRIN2D, ZNF671 and ANKRD13B than those with PR or SD at baseline and may offer additional prognostic value over CEA which was similar in the PR and PD groups before treatment (Table 1). Elevation of pre-assessment MDMs preceded radiographic evidence of disease progression by 82 days (IQR 69-83 days). Conclusions: Three MDMs, GRIN2D, ZNF671 and ANKRD13B, were found to reflect treatment response (PD vs. PR + SD) as shown in the table. Although this pilot study was limited by a small sample size, it demonstrated the feasibility of using plasma-based MDMs in monitoring treatment response to systemic therapy for advanced CRC and should be compared to CEA in a larger study.[Table: see text]

Evaluation of fosaprepitant-associated hypersensitivity reactions at a National Cancer Center

2020 ◽  
Vol 26 (6) ◽  
pp. 1369-1373 ◽  
Author(s):  
Catherine Michelle Laird ◽  
Ashley E Glode ◽  
Kerry Schwarz ◽  
Elaine T Lam ◽  
Cindy L O'Bryant
Keyword(s):  
Small Sample Size ◽  
Medication Administration ◽  
Small Sample ◽  
Patient Specific ◽  
Cancer Center ◽  
Hypersensitivity Reactions ◽  
University Of Colorado ◽  
Time Period ◽  
Systemic Hypersensitivity ◽  
The University

Introduction At our institution, an increased incidence of hypersensitivity reactions was reported following standardization of fosaprepitant as the preferred agent for the prophylaxis of chemotherapy induced nausea and vomiting (CINV) caused by highly emetogenic therapies. The purpose of this evaluation was to assess the incidence of systemic hypersensitivity reactions (HSRs) to fosaprepitant infusions compared to available literature. Methods This evaluation is a retrospective review of electronic health records of adult patients who received their first dose of fosaprepitant for CINV prophylaxis beginning January 1, 2017 through June 30, 2017 at the University of Colorado Cancer Center outpatient infusion center. Subjects were identified using medication administration reports. Individual chart reviews were performed for all patients who received fosaprepitant during the specified timeframe and had a reaction reported on the same date. Results A total of 868 patients received fosaprepitant in the outpatient infusion center during the study time period. Four patients (0.461%) had a systemic HSR attributed to fosaprepitant. Two of the reactions were reported as HSRs in the adverse reaction reporting system and two were found in provider notes during chart review. Due to the small sample size, risk factors for HSRs to fosaprepitant were not able to be determined. Conclusion The incidence of HSRs to fosaprepitant at our institution was found to be consistent with the <1% incidence currently noted in literature. Based on these findings, opportunities have been identified for education on fosaprepitant-associated HSRs, proper documentation and patient-specific precautions.

Molecular profiling of TOPO1: A way to evaluate irinotecan treatment in colorectal cancer?

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 546-546
Author(s):  
Julia Marie Cunningham ◽  
Petra Prins ◽  
Brian Conkright ◽  
Simina Boca ◽  
Shruti Rao ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Small Sample Size ◽  
Predictive Marker ◽  
Molecular Profiling ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Similar Response ◽  
Second Line

546 Background: Front-line chemotherapy for metastatic colorectal cancer (mCRC) consists of a fluoropyrimidine backbone plus either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Large, prospective trials enrolling chemotherapy-naïve patients (pts) show FOLFOX and FOLFIRI treatment to be equivalent with similar response rates. Methods: Irinotecan inhibits TOPO1, which is now a candidate marker for irinotecan treatment benefit. Thus, we retrospectively analyzed TOPO1 expression level in 49 pts with mCRC who were treated with irinotecan-containing regimens at the Lombardi Comprehensive Cancer Center between 2009 and 2014. Patient characteristics and outcomes were compiled through chart review and the effect of TOPO1 expression on clinical outcomes was assessed. TOPO1 expression in tumor tissue from each pt was analyzed using a commercially available molecular profiling (MP) service (Caris Life Sciences). Results: The median overall survival (OS) for all pts was 33.9 months (mo), defined as the time from metastasis to death or censorship. When grouped by “high” or “low” TOPO1 expression, as defined by Caris at the time of the testing, 29 pts were high-expressers and 20 were low-expressers. High TOPO1 expressers receiving irinotecan (n = 22) had a median OS of 27.2 mo, compared with median 41.5 mo for low-expressers (n = 14) (p = 0.27). Irinotecan is conventionally given as second-line therapy. The median OS of pts receiving second-line irinotecan was 38.2 mo for high-expressers [n = 11] vs. 68.5 mo for low-expressers [n = 5]) (p = 0.32). Conclusions: Our limited data do not support the use of TOPO1 expression levels as a predictive marker for irinotecan therapy in mCRC. However, our conclusions are limited by small sample size, lack of a control group to distinguish prognostic from predictive markers, and timing of TOPO1 measurement, which in many cases was after irinotecan therapy. Physicians currently lack an evidence-based way to choose between potentially efficacious regimens for mCRC. More rigorous studies are needed to assess the benefit of MP in mCRC care. We are currently planning a prospective study with the hope of validating the use of TOPO1 expression as a predictive marker for treatment of this disease.

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