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  1. Article: Physician Integrity, Templates, and the 'F' Word.

    Musher, Daniel M / Hayward, Christiana P / Musher, Benjamin L

    The Journal of emergency medicine

    2019  Volume 57, Issue 2, Page(s) 263–265

    Abstract: The medical profession is increasingly dependent upon electronic health records. Along with documented benefits, a number of potential ethical abuses have been outlined. Herein, we describe an ethical abuse that has received almost no attention, namely ... ...

    Abstract The medical profession is increasingly dependent upon electronic health records. Along with documented benefits, a number of potential ethical abuses have been outlined. Herein, we describe an ethical abuse that has received almost no attention, namely falsified medical records. We present three cases in which the medical record cited facts from history that were not elicited and findings from physical examination that was not performed. This is fraud. Prepopulated templates were almost certainly responsible. If a template is used, it must begin free of results-a skeleton onto which flesh is placed. If coders and third-party payers insist on having information than health care providers think relevant, then we, as a profession should "push back," but a template that has been prepopulated puts fraudulent data into electronic health record, seriously damaging physician integrity.
    MeSH term(s) Adult ; Aged ; Documentation/ethics ; Documentation/standards ; Electronic Health Records/trends ; Ethics, Medical ; Female ; Fraud/statistics & numerical data ; Humans ; Male ; Physical Examination/ethics ; Physical Examination/methods ; Physicians/standards ; Physicians/statistics & numerical data
    Language English
    Publishing date 2019-06-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 605559-x
    ISSN 0736-4679
    ISSN 0736-4679
    DOI 10.1016/j.jemermed.2019.03.046
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  2. Article ; Online: Clinical prediction of bacteremia and early antibiotics therapy in patients with solid tumors.

    Hyak, Jonathan M / Al Mohajer, Mayar / Musher, Daniel M / Musher, Benjamin L

    Infection control and hospital epidemiology

    2021  Volume 43, Issue 9, Page(s) 1112–1118

    Abstract: Objective: To investigate the relationship between the systemic inflammatory response syndrome (SIRS), early antibiotic use, and bacteremia in solid-tumor patients.: Design, setting, and participants: We conducted a retrospective observational study ... ...

    Abstract Objective: To investigate the relationship between the systemic inflammatory response syndrome (SIRS), early antibiotic use, and bacteremia in solid-tumor patients.
    Design, setting, and participants: We conducted a retrospective observational study of adults with solid tumors admitted to a tertiary-care hospital through the emergency department over a 2-year period. Patients with neutropenic fever, organ transplant, trauma, or cardiopulmonary arrest were excluded.
    Methods: Rates of SIRS, bacteremia, and early antibiotics (initiation within 8 hours of presentation) were compared using the χ
    Results: Early antibiotics were administered in 507 (37%) of 1,344 SIRS-positive cases and 492 (22%) of 2,236 SIRS-negative cases (
    Conclusions: SIRS criteria are frequently used to determine the need for early antibiotics, but they are poor predictors of bacteremia in solid-tumor patients. More reliable models are needed to guide judicious use of antibiotics in this population.
    MeSH term(s) Adult ; Anti-Bacterial Agents/therapeutic use ; Bacteremia/diagnosis ; Bacteremia/drug therapy ; Bacteremia/epidemiology ; Blood Culture ; Humans ; Neoplasms/complications ; Retrospective Studies ; Systemic Inflammatory Response Syndrome/diagnosis ; Systemic Inflammatory Response Syndrome/drug therapy ; Systemic Inflammatory Response Syndrome/epidemiology
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2021-07-28
    Publishing country United States
    Document type Journal Article ; Observational Study
    ZDB-ID 639378-0
    ISSN 1559-6834 ; 0195-9417 ; 0899-823X
    ISSN (online) 1559-6834
    ISSN 0195-9417 ; 0899-823X
    DOI 10.1017/ice.2021.314
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  3. Article ; Online: Detection of recurrent colorectal cancer with high specificity using a reporting threshold for circulating tumor DNA methylated in BCAT1 and IKZF1.

    Pedersen, Susanne K / Musher, Benjamin L / LaPointe, Lawrence C / Tuck, Melissa K / Symonds, Erin L / Loayza, Naima / Young, Graeme P

    Cancer

    2022  Volume 128, Issue 10, Page(s) 1921–1928

    Abstract: Background: A blood assay measuring methylated BCAT1 and IKZF1 can detect recurrent colorectal cancer (CRC) with high sensitivity but suboptimal specificity. This study aimed to establish an upper reference limit (URL) of these biomarkers in a reference ...

    Abstract Background: A blood assay measuring methylated BCAT1 and IKZF1 can detect recurrent colorectal cancer (CRC) with high sensitivity but suboptimal specificity. This study aimed to establish an upper reference limit (URL) of these biomarkers in a reference population without CRC, apply that threshold to detecting clinical recurrence in patients who had undergone definitive therapy for CRC, and compare the performance of the biomarkers with carcinoembryonic antigen (CEA).
    Methods: The level of methylation was reported as the aggregate methylated BCAT1 and IKZF1 expressed as a percentage of total plasma DNA. A reference population of patients confirmed to have no colorectal neoplasia (n = 857) was used to determine the URL. Test accuracy for clinical recurrence was determined in a post-treatment surveillance population (n = 549; 77 recurrence cases).
    Results: A methylation level of 0.07%, corresponding to the 98
    Conclusions: Applying a threshold for positivity to the methylated BCAT1/IKZF1 blood assay improved the specificity for CRC recurrence without compromising sensitivity. Both the sensitivity and the specificity were superior to those of CEA.
    MeSH term(s) Biomarkers, Tumor/genetics ; Carcinoembryonic Antigen ; Circulating Tumor DNA/genetics ; Colorectal Neoplasms/diagnosis ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/pathology ; DNA Methylation ; Humans ; Ikaros Transcription Factor/genetics ; Recurrence ; Transaminases
    Chemical Substances Biomarkers, Tumor ; Carcinoembryonic Antigen ; Circulating Tumor DNA ; IKZF1 protein, human ; Ikaros Transcription Factor (148971-36-2) ; BCAT1 protein, human (EC 2.6.1.) ; Transaminases (EC 2.6.1.-)
    Language English
    Publishing date 2022-03-15
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1429-1
    ISSN 1097-0142 ; 0008-543X ; 1934-662X
    ISSN (online) 1097-0142
    ISSN 0008-543X ; 1934-662X
    DOI 10.1002/cncr.34159
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  4. Article ; Online: Outcomes Among Minority Patients With Metastatic Colorectal Cancer in a Safety-net Health Care System.

    Lau-Min, Kelsey / Prakash, Preeti / Jo, Eunji / Thrift, Aaron P / Hilsenbeck, Susan / Musher, Benjamin L

    Clinical colorectal cancer

    2020  Volume 19, Issue 2, Page(s) e49–e57

    Abstract: Background: Metastatic colorectal cancer (CRC) outcomes continue to improve, but they vary significantly by race and ethnicity. We hypothesize that these disparities arise from unequal access to care.: Materials and methods: The Harris Health System ( ...

    Abstract Background: Metastatic colorectal cancer (CRC) outcomes continue to improve, but they vary significantly by race and ethnicity. We hypothesize that these disparities arise from unequal access to care.
    Materials and methods: The Harris Health System (HHS) is an integrated health delivery network that provides medical care to the underserved, predominantly minority population of Harris County, Texas. As the largest HHS facility and an affiliate of Baylor College of Medicine's Dan L. Duncan Comprehensive Cancer Center, Ben Taub Hospital (BTH) delivers cancer care through multidisciplinary subspecialty that prioritize access to care, adherence to evidence-based clinical pathways, integration of supportive services, and mitigation of financial toxicity. We performed a retrospective analysis of minority patients diagnosed with and treated for metastatic CRC at BTH between January 2010 and December 2012. Kaplan-Meier survival curves were compared with survival curves from randomized control trials reported during that time period.
    Results: We identified 103 patients; 40% were black, 49% were Hispanic, and 12% were Asian or Middle Eastern. Thirty-five percent reported a language other than English as their preferred language. Seventy-four percent of patients with documented coverage status were uninsured. Eighty-four percent of patients received standard chemotherapy with a clinician-reported response rate of 63%. Overall survival for BTH patients undergoing chemotherapy was superior to that of subjects enrolled in the CRYSTAL (Cetuximab Combined with Irinotecan in First-Line Therapy for Metastatic Colorectal Cancer) trial (median, 24.0 vs. 19.9 months; P = .014).
    Conclusion: HHS provides a health delivery infrastructure through which minority patients with socioeconomic challenges experience clinical outcomes comparable with highly selected patients enrolled in randomized control trials. Efforts to resolve CRC disparities should focus on improving access of at-risk populations to high-quality comprehensive cancer care.
    MeSH term(s) Academic Medical Centers/economics ; Academic Medical Centers/statistics & numerical data ; Adult ; African Americans/statistics & numerical data ; Aged ; Asian Americans/statistics & numerical data ; Colorectal Neoplasms/economics ; Colorectal Neoplasms/mortality ; Colorectal Neoplasms/therapy ; European Continental Ancestry Group/statistics & numerical data ; Female ; Healthcare Disparities/statistics & numerical data ; Hispanic Americans/statistics & numerical data ; Humans ; Kaplan-Meier Estimate ; Male ; Medically Uninsured/statistics & numerical data ; Middle Aged ; Minority Groups/statistics & numerical data ; Patient Acceptance of Health Care/statistics & numerical data ; Randomized Controlled Trials as Topic/statistics & numerical data ; Retrospective Studies ; Safety-net Providers/economics ; Safety-net Providers/statistics & numerical data ; Socioeconomic Factors
    Language English
    Publishing date 2020-01-02
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2112638-0
    ISSN 1938-0674 ; 1533-0028
    ISSN (online) 1938-0674
    ISSN 1533-0028
    DOI 10.1016/j.clcc.2019.09.002
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  5. Article ; Online: LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): results from arm 1 of a non-randomised, single-centre, phase 1/2 study.

    Musher, Benjamin L / Rowinsky, Eric K / Smaglo, Brandon G / Abidi, Wasif / Othman, Mohamed / Patel, Kalpesh / Jawaid, Salmaan / Jing, James / Brisco, Amanda / Leen, Ann M / Wu, Mengfen / Sandin, Linda C / Wenthe, Jessica / Eriksson, Emma / Ullenhag, Gustav J / Grilley, Bambi / Leja-Jarblad, Justyna / Hilsenbeck, Susan G / Brenner, Malcolm K /
    Loskog, Angelica S I

    The Lancet. Oncology

    2024  Volume 25, Issue 4, Page(s) 488–500

    Abstract: Background: Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, ... ...

    Abstract Background: Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, activates cytotoxic T cells, and induces tumour regression in preclinical models. The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma.
    Methods: LOKON001 was a non-randomised, phase 1/2 study conducted at the Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA, and consisted of two arms conducted sequentially; the results of arm 1 are presented here. In arm 1, patients 18 years or older with previously treated or treatment-naive unresectable or metastatic pancreatic ductal adenocarcinoma were treated with standard 28-day cycles of intravenous nab-paclitaxel 125 mg/m
    Findings: Between Dec 2, 2016, and Oct 17, 2019, 23 patients were assessed for eligibility, leading to 22 patients being enrolled. One patient withdrew consent, resulting in 21 patients (13 [62%] men and eight [38%] women) assigned to a dose group (three to dose 1, four to dose 2, and 14 to dose 3). 21 patients were evaluable for safety. Median follow-up time was 6 months (IQR 4-10), and data cutoff was Jan 5, 2023. The most common treatment-emergent adverse events overall were anaemia (96 [8%] of 1237 events), lymphopenia (86 [7%] events), hyperglycaemia (70 [6%] events), leukopenia (63 [5%] events), hypertension (62 [5%] events), and hypoalbuminaemia (61 [5%] events). The most common adverse events attributed to LOAd703 were fever (14 [67%] of 21 patients), fatigue (eight [38%]), chills (seven [33%]), and elevated liver enzymes (alanine aminotransferase in five [24%], alkaline phosphatase in four [19%], and aspartate aminotransferase in four [19%]), all of which were grade 1-2, except for a transient grade 3 aminotransferase elevation occurring at dose 3. A maximum tolerated dose was not reached, thereby establishing dose 3 as the highest-evaluated safe dose when combined with nab-paclitaxel plus gemcitabine. Proportions of CD8
    Interpretation: Combining LOAd703 with nab-paclitaxel plus gemcitabine in patients with advanced pancreatic ductal adenocarcinoma was feasible and safe. To build upon this novel chemoimmunotherapeutic approach, arm 2 of LOKON001, which combines LOAd703, nab-paclitaxel plus gemcitabine, and atezolizumab, is ongoing.
    Funding: Lokon Pharma, the Swedish Cancer Society, and the Swedish Research Council.
    MeSH term(s) Male ; Humans ; Female ; Gemcitabine ; Oncolytic Viruses/genetics ; Bayes Theorem ; Pancreatic Neoplasms/therapy ; Pancreatic Neoplasms/drug therapy ; Paclitaxel ; Anemia/chemically induced ; Thrombocytopenia/chemically induced ; Adenocarcinoma/therapy ; Adenocarcinoma/drug therapy ; Albumins ; Genetic Therapy/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Tumor Microenvironment
    Chemical Substances Gemcitabine ; Paclitaxel (P88XT4IS4D) ; Albumins
    Language English
    Publishing date 2024-03-28
    Publishing country England
    Document type Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(24)00079-2
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  6. Article ; Online: Evaluating Treatment Patterns for Small Cell Carcinoma of the Colon Using the National Cancer Database (NCDB).

    Balasubramanyam, Sadhana / O'Donnell, Barrett P / Musher, Benjamin L / Jhaveri, Pavan M / Ludwig, Michelle S

    Journal of gastrointestinal cancer

    2018  Volume 50, Issue 2, Page(s) 244–253

    Abstract: Objective(s): The objective of this study was to characterize the clinicopathological prognostic factors and treatment patterns for small cell carcinoma (SCC) of the colon, a rare disease without standard treatment guidelines.: Methods: We analyzed ... ...

    Abstract Objective(s): The objective of this study was to characterize the clinicopathological prognostic factors and treatment patterns for small cell carcinoma (SCC) of the colon, a rare disease without standard treatment guidelines.
    Methods: We analyzed clinicopathological and treatment variables for 503 cases of histologically proven SCC colon entered into the National Cancer Database (NCDB) between 2004 and 2013. Survival curves were generated using Kaplan-Meier and compared by the log-rank test. Cox proportional hazard regression was used to control for covariates and evaluate the effect of different treatment modalities on overall survival.
    Results: Four hundred seventy-two (93.8%) patients had complete clinical staging information and were therefore included in our analysis. Of these patients, 149 (31.5%) had limited stage disease (LD) and 323 (68.4%) had extensive stage disease (ED) at presentation. Median overall survival (OS) for patients with ED was significantly lower than for those with LD (4.04 months vs. 21.82 months; p < 0.001). Multivariate Cox regression analysis showed administration of chemotherapy was associated with improved survival in patients with LD and ED (p = 0.026, p < 0.001) while surgery was not associated with improved survival in patients with LD or ED (p = 0.943, p = 0.630). Radiation therapy was associated with improved survival in patients with ED (p = 0.044).
    Conclusions: SCC of the colon carries a poor prognosis, especially in patients presenting with metastatic disease. Surgery and chemotherapy are administered more frequently than radiation, and chemotherapy is associated with improved survival, unlike surgery.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Carcinoma, Small Cell/mortality ; Carcinoma, Small Cell/pathology ; Carcinoma, Small Cell/therapy ; Colonic Neoplasms/mortality ; Colonic Neoplasms/pathology ; Colonic Neoplasms/therapy ; Combined Modality Therapy ; Databases, Factual ; Drug Therapy/statistics & numerical data ; Female ; General Surgery/statistics & numerical data ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Radiotherapy/statistics & numerical data ; Survival Rate ; United States ; Young Adult
    Language English
    Publishing date 2018-01-31
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2452514-5
    ISSN 1941-6636 ; 1559-0739 ; 1941-6628 ; 1537-3649
    ISSN (online) 1941-6636 ; 1559-0739
    ISSN 1941-6628 ; 1537-3649
    DOI 10.1007/s12029-018-0054-y
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  7. Article ; Online: National Trends in Multimodality Therapy for Locally Advanced Gastric Cancer.

    Sada, Yvonne H / Smaglo, Brandon G / Tran Cao, Hop S / Mok, Henry / Musher, Benjamin L / Massarweh, Nader N

    The Journal of surgical research

    2019  Volume 237, Page(s) 41–49

    Abstract: Background: Multimodality therapy (MMT) is recommended for patients with resectable gastric cancer, but no single approach has been established as standard. Little is presently known about current national practice patterns and sequencing of MMT.: ... ...

    Abstract Background: Multimodality therapy (MMT) is recommended for patients with resectable gastric cancer, but no single approach has been established as standard. Little is presently known about current national practice patterns and sequencing of MMT.
    Methods: Retrospective cohort study of patients with gastric cancer aged 18 to 80 y in the National Cancer Database (2006-2014) with ≥T2 and/or node-positive disease (i.e., stage Ib to III) treated with MMT. Clinical nodal staging accuracy was ascertained among those treated with upfront surgery by comparing clinical and pathologic nodal staging. Multivariable Cox regression was used to evaluate the association between overall risk of death and MMT approach (i.e., radiation used versus not and treatment sequence).
    Results: Among 5817 patients, 16.1% received perioperative MMT, 50.6% preoperative only, and 33.3% postoperative only. The sensitivity, specificity, positive predictive value, and negative predictive values of clinical nodal staging were 68.4%, 88.8%, 91.1%, and 62.7%, respectively. Current clinical nodal staging modalities understage 37.3% of clinically node-negative patients. Over time, radiation utilization decreased (74.3% in 2006 versus 53.9% in 2014; trend test, P < 0.001), perioperative MMT increased (8.9% versus 22.2%%; trend test, P < 0.001), and postoperative MMT decreased (43.1% versus 21.0%; trend test, P < 0.001). Neither type of MMT nor treatment sequence is associated with risk of death.
    Conclusions: One-third of patients with gastric cancer who are candidates to receive MMT are treated with upfront surgery. Given the high false negative rate of clinical nodal staging and high noncompletion rate of postoperative treatment, efforts should be directed at improving and optimizing preoperative therapy utilization.
    MeSH term(s) Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Adenocarcinoma/therapy ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Chemotherapy, Adjuvant/statistics & numerical data ; Chemotherapy, Adjuvant/trends ; False Negative Reactions ; Female ; Gastrectomy/statistics & numerical data ; Gastrectomy/trends ; Humans ; Kaplan-Meier Estimate ; Lymph Nodes/pathology ; Lymphatic Metastasis/pathology ; Lymphatic Metastasis/therapy ; Male ; Middle Aged ; Neoadjuvant Therapy/statistics & numerical data ; Neoadjuvant Therapy/trends ; Neoplasm Staging ; Predictive Value of Tests ; Radiotherapy, Adjuvant/statistics & numerical data ; Radiotherapy, Adjuvant/trends ; Registries/statistics & numerical data ; Retrospective Studies ; Stomach/pathology ; Stomach/surgery ; Stomach Neoplasms/mortality ; Stomach Neoplasms/pathology ; Stomach Neoplasms/therapy ; United States/epidemiology ; Young Adult
    Language English
    Publishing date 2019-01-23
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 80170-7
    ISSN 1095-8673 ; 0022-4804
    ISSN (online) 1095-8673
    ISSN 0022-4804
    DOI 10.1016/j.jss.2018.12.026
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  8. Article ; Online: Prognostic Value of Nodal Response After Preoperative Treatment of Gastric Adenocarcinoma.

    Sada, Yvonne H / Smaglo, Brandon G / Tan, Joy C / Tran Cao, Hop S / Musher, Benjamin L / Massarweh, Nader N

    Journal of the National Comprehensive Cancer Network : JNCCN

    2019  Volume 17, Issue 2, Page(s) 161–168

    Abstract: Background: ...

    Abstract Background:
    MeSH term(s) Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Adenocarcinoma/therapy ; Adult ; Aged ; Aged, 80 and over ; Chemotherapy, Adjuvant ; Combined Modality Therapy/adverse effects ; Combined Modality Therapy/methods ; Comorbidity ; Female ; Humans ; Lymph Nodes/pathology ; Male ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Grading ; Neoplasm Staging ; Odds Ratio ; Preoperative Care ; Proportional Hazards Models ; Retrospective Studies ; Stomach Neoplasms/mortality ; Stomach Neoplasms/pathology ; Stomach Neoplasms/therapy ; Treatment Outcome
    Language English
    Publishing date 2019-02-19
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2250759-0
    ISSN 1540-1413 ; 1540-1405
    ISSN (online) 1540-1413
    ISSN 1540-1405
    DOI 10.6004/jnccn.2018.7093
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  9. Article ; Online: A rare presentation of choroidal metastasis from primary esophageal adenocarcinoma successfully treated with intensity-modulated radiation therapy.

    Date, Rishabh C / Adams, Matthew K / Teh, Bin S / Schefler, Amy C / Musher, Benjamin L / Farach, Andrew / Weng, Christina Y

    American journal of ophthalmology case reports

    2018  Volume 11, Page(s) 19–22

    Abstract: Purpose: In this case report, we present a case of choroidal metastasis from a primary esophageal adenocarcinoma that was treated successfully with intensity-modulated radiation therapy.: Observations: A 65-year-old male with known stage IV ... ...

    Abstract Purpose: In this case report, we present a case of choroidal metastasis from a primary esophageal adenocarcinoma that was treated successfully with intensity-modulated radiation therapy.
    Observations: A 65-year-old male with known stage IV esophageal adenocarcinoma presented with a central scotoma in his left eye and was ultimately found to have a large choroidal metastatic lesion with overlying subretinal fluid. IMRT was administered over the course of four weeks, resulting in restoration of the patient's vision, regression of the metastatic lesion, and resolution of the subretinal fluid. As of 16 months following completion of radiation, there remains no evidence of choroidal recurrence or radiation-associated ocular complications.
    Conclusions: and Importance: To our knowledge, this is the first published case report of a choroidal metastasis from esophageal cancer responding durably to IMRT. IMRT should therefore be considered a viable treatment option for this rare disease.
    Language English
    Publishing date 2018-04-23
    Publishing country United States
    Document type Case Reports
    ISSN 2451-9936
    ISSN (online) 2451-9936
    DOI 10.1016/j.ajoc.2018.04.021
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  10. Article ; Online: Prognostic value of neoadjuvant treatment response in locally advanced rectal cancer.

    Sada, Yvonne H / Tran Cao, Hop S / Chang, George J / Artinyan, Avo / Musher, Benjamin L / Smaglo, Brandon G / Massarweh, Nader N

    The Journal of surgical research

    2018  Volume 226, Page(s) 15–23

    Abstract: Background: For locally advanced rectal cancer, response to neoadjuvant radiation has been associated with improved outcomes but has not been well characterized in general practice. The goals of this study were to describe disease response rates after ... ...

    Abstract Background: For locally advanced rectal cancer, response to neoadjuvant radiation has been associated with improved outcomes but has not been well characterized in general practice. The goals of this study were to describe disease response rates after neoadjuvant treatment and to evaluate the association between disease response and survival.
    Materials and methods: Retrospective cohort study of patients aged 18-80 y with clinical stage II and III rectal adenocarcinoma in the National Cancer Database (2006-2012). All patients underwent radical resection after neoadjuvant treatment. Treatment responses were defined as follows: no tumor response; intermediate-T and/or N downstaging with residual disease; and complete-ypT0N0. Multivariable, multinomial regression was used to evaluate the association between neoadjuvant radiation use and disease response. Multivariable Cox regression was used to evaluate the association between disease response and overall risk of death.
    Results: Among 12,024 patients, 12% had a complete and 30% an intermediate response. Neoadjuvant chemotherapy alone was less likely to achieve an intermediate (relative risk ratio: 0.70 [0.56-0.88]) or a complete response (relative risk ratio: 0.59 [0.41-0.84]) relative to neoadjuvant radiation. Tumor response was associated with improved 5-y overall survival (complete = 90.2%, intermediate = 82.0%, no response = 70.5%; log-rank, P < 0.001). Complete and intermediate pathologic responses were associated with decreases in risk of death (hazard ratio: 0.40 [0.34-0.48] and 0.63 [0.57-0.69], respectively) compared to no response. Primary tumor and nodal response were independently associated with decreased risk of death.
    Conclusions: Neoadjuvant radiation is associated with treatment response, and pathologic response is associated with improved survival. Pathologic response may be an early benchmark for the oncologic effectiveness of neoadjuvant treatment.
    MeSH term(s) Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Adenocarcinoma/therapy ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Chemoradiotherapy/methods ; Disease-Free Survival ; Female ; Humans ; Kaplan-Meier Estimate ; Lymphatic Metastasis/pathology ; Lymphatic Metastasis/radiotherapy ; Male ; Middle Aged ; Neoadjuvant Therapy/methods ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Prognosis ; Rectal Neoplasms/mortality ; Rectal Neoplasms/pathology ; Rectal Neoplasms/therapy ; Rectum/drug effects ; Rectum/pathology ; Rectum/radiation effects ; Rectum/surgery ; Retrospective Studies ; Treatment Outcome ; Young Adult
    Language English
    Publishing date 2018-02-10
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 80170-7
    ISSN 1095-8673 ; 0022-4804
    ISSN (online) 1095-8673
    ISSN 0022-4804
    DOI 10.1016/j.jss.2018.01.025
    Database MEDical Literature Analysis and Retrieval System OnLINE

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