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  • 1
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    Ethical frameworks in clinical research processes during COVID-19: a scoping review
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 7 ( 2021-07), p. e047076-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 7 ( 2021-07), p. e047076-
    Abstract: In response to the COVID-19 pandemic there have been significant developments in research, its conduct and the supporting ethical framework. While many protocols have been delayed, halted or modified, other research efforts have been accelerated, generating controversy. The goal of this paper is to determine the rates of references surrounding the ethical oversight of research as reported in current COVID-19-related research publications. Design Scoping review. Setting Population-based observational or interventional studies from December 2019 to May 2020 with sample size of two or more. Studies were searched through electronic databases including Medline, EMBASE, and Cochrane CENTRAL Register of Controlled Trials. Participants Eligibility criteria included participants within published studies who tested positive for COVID-19. Main outcomes and measures Data were extracted and charting methods included taking note of references to ethical frameworks, institutional review board (IRB), ethics committee (EC) or research ethics board (REB) involvement, consent processes, and other variables. Results 11 556 articles were screened, with 656 included in the final analysis. References to ethics were present in 530 (80.8%) studies, with 491 (74.8%) involving IRB/ECs/REBs and 126 (19.2%) not referencing ethics. Consent processes were outlined in 201 (30.6%) studies, with 198 (30.2%) reporting that they obtained consent waivers, however, 257 (39.2%) did not mention consent at all. Differences (p 〈 0.001) in ethics-related references were apparent when analysed by continent, publication type, sample size and IF. Conclusions The majority of published articles pertaining to COVID-19 research made mention of ethical considerations, however, national and regional variations in research ethics review requirements introduce heterogeneity between studies and raise important questions about the conduct of scientific research during global public emergencies. Trial registration number Open Science Framework: https://osfio/z67wb .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-047076
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 2
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    Impact of population center (PC) size on access to care in advanced hepatocellular carcinoma (HCC).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 4_suppl ( 2020-02-01), p. 489-489
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 4_suppl ( 2020-02-01), p. 489-489
    Abstract: 489 Background: To evaluate access to subspecialists, local therapies, treatment at a specialized HCC center, and survival in advanced HCC patients (pts) based on geographical distribution. Methods: Retrospective chart review was performed on HCC pts who received sorafenib in British Columbia from 2008 to 2016. Pts were stratified by Statistics Canada PC size criteria: large urban PC (LUPC), medium urban PC (MUPC), and small urban PC (SUPC). Chi-square tests and Kaplan Meier were used to analyze the groups. Results: Of 288 pts, geographical distribution was: LUPC 75%, MUPC 16%, SUPC 8%, and rural 0.3%. Age, gender, and ECOG performance status were similar; a higher proportion of Asians (50 vs 9 vs 4%), Child Pugh A (93 vs 83 vs 83%), and hepatitis B (37 vs 15 vs 4%) was observed in LUPC vs MUPC and SUPC, respectively. SUPC pts were less likely to see a hepatologist (p=0.04, Table); access to other subspecialists was similar. Pts from LUPC were more likely to have transarterial chemoembolization compared to MUPC and SUPC (38 vs 20 vs 21%; p=0.04); receipt of other local therapies was similar. Sixty percent were treated at a specialized HCC center and were more likely to see a hepatologist (83 vs 19%), hepatobiliary surgeon (57 vs 42%), and/or interventional radiologist (32 vs 13%) (all p 〈 0.01). Median OS was higher for pts treated at a HCC center (24.7 vs 13.2 mo, p 〈 0.01), but similar when stratified by PC size (overall mOS 19.3 mo, p=0.59). Conclusions: Geography did not significantly impact access to care or survival, but pts treated at a specialized HCC center have improved survival. Further research is needed to better understand social and clinical factors that influence these findings. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.4_suppl.489
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Impact of adjuvant treatment in elderly patients with locally advanced rectal cancer: A population-based retrospective study.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. 3613-3613
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 3613-3613
    Abstract: 3613 Background: Little is known about the benefit and use of adjuvant chemotherapy (ADJ) in the elderly population (age ≥ 65) with locally advanced rectal cancer (LARC). We undertook a provincial review of LARC patients to evaluate the potential benefits, including survival and time to relapse (TTR), of ADJ in elderly patients. Methods: We performed a retrospective analysis of 286 LARC patients (stage 2 and 3) diagnosed between January 2010 and December 2013 from Nova Scotia, Canada, who underwent curative-intent surgery. Baseline patient, tumor and treatment characteristics were collected. Survival and TTR analysis were performed using Kaplan-Meier and Cox-regression statistics. Results: 152 patients were age ≥65, and 92 age ≥70. Median follow-up was 46 months. 178 patients (62%) received neoadjuvant chemo-radiation (NEOADJ). While 109 patients (81%) age 〈 65 received ADJ, only 68 patients (45%) age ≥ 65 received ADJ. Kaplan-Meier analysis revealed a significant survival and TTR advantage for ADJ irrespective of age (table). In cox-regression multivariate analysis, ECOG status, T stage, and ADJ were significant predictors of survival (p 〈 0.04), while age was not. Similarly, N stage, NEOADJ, and ADJ were significant predictors of TTR (p 〈 0.007). Poor ECOG status was the most common cause of ADJ omission. There was a significantly higher amount of grade≥ 1 chemotherapy-related toxicity experienced by patients age ≥ 65 treated with ADJ compared to no ADJ (77% vs 32%, p 〈 0.0001), which consisted mostly of diarrhea and mucositis. Toxicity was the main reason for non-completion of ADJ in the elderly. Conclusions: Elderly patients with LARC have significantly improved overall survival with ADJ, but the use of ADJ is lower than in patients age 〈 65. However, elderly patients experience more chemotherapy-related toxicities, leading to higher rates of early treatment discontinuation. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.3613
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 4
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    Perioperative chemotherapy alone versus preoperative chemoradiotherapy for locally advanced distal esophageal and gastroesophageal junction cancer: A 10-year review of the British Columbia (BC) Cancer Registry.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 4028-4028
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 4028-4028
    Abstract: 4028 Background: The optimal treatment strategy for resectable cancer of the distal esophagus (ESOPH) and gastroesophageal junction (GEJ) remains controversial. This study evaluates patterns of practice in BC, rates of complete surgical resection, and survival outcomes of patients treated with perioperative chemotherapy alone (CA), per MAGIC or FLOT4 protocol, versus preoperative chemoradiotherapy (CRT), per CROSS protocol. Methods: We undertook a provincial analysis of initially resectable, locally advanced, cancer of the ESOPH and/or GEJ who underwent surgery in BC, from 2008 to 2018. Baseline patient, tumor, treatment, and clinical outcome data were collected from the BC Cancer Registry. Kaplan-Meier survival and multivariate regression analyses were conducted. Results: Among 575 patients, 468 underwent surgery and were included (Table). More surgeries were aborted intraoperatively in the CA cohort compared to CRT (12% vs 2%, p 〈 0.001). There was no difference in age, sex, or ECOG performance status among the cohorts, and 83% were adenocarcinoma. While 82% of ESOPH involving GEJ (N = 251, 54%) is treated with CRT, only 53% of GEJ alone (N=217, 46%) is treated with CRT (p 〈 0.001). CRT is associated with a higher rate of complete or partial pathologic response compared to CA (59% vs 39%, p=0.002). R0 resection rate was 90% and 94% in the CA and CRT cohort, respectively (p=0.383). There is no statistically significant difference in overall survival, with medians of 29.6 and 26.0 months for patients treated with CA and CRT, respectively (p=0.723). Cancer-specific survival is also not significantly different (p=0.565). In the CA cohort, 37% of patients complete all 8 cycles of FLOT and 52% of patients complete all 6 cycles of MAGIC (p=0.396). Conclusions: Patients treated with CRT have higher rates of complete resection and pathologic response, but their survival is not significantly different compared to those treated with CA. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.4028
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 5
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    Impact of care by gynecologic oncologists on primary ovarian cancer survival: A population-based study
    Elsevier BV ; 2022
    In:  Gynecologic Oncology Vol. 164, No. 3 ( 2022-03), p. 522-528
    Details
    In: Gynecologic Oncology, Elsevier BV, Vol. 164, No. 3 ( 2022-03), p. 522-528
    Type of Medium: Online Resource
    ISSN: 0090-8258
    URL: Article
    DOI: 10.1016/j.ygyno.2022.01.003
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 1467974-7
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  • 6
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    Angiogenesis: A Pivotal Therapeutic Target in the Drug Development of Gynecologic Cancers
    MDPI AG ; 2022
    In:  Cancers Vol. 14, No. 5 ( 2022-02-22), p. 1122-
    Details
    In: Cancers, MDPI AG, Vol. 14, No. 5 ( 2022-02-22), p. 1122-
    Abstract: Since the discovery of angiogenesis and its relevance to the tumorigenesis of gynecologic malignancies, a number of therapeutic agents have been developed over the last decade, some of which have become standard treatments in combination with other therapies. Limited clinical activity has been demonstrated with anti-angiogenic monotherapies, and ongoing trials are focused on combination strategies with cytotoxic agents, immunotherapies and other targeted treatments. This article reviews the science behind angiogenesis within the context of gynecologic cancers, the evidence supporting the targeting of these pathways and future directions in clinical trials.
    Type of Medium: Online Resource
    ISSN: 2072-6694
    URL: Article
    DOI: 10.3390/cancers14051122
    Language: English
    Publisher: MDPI AG
    Publication Date: 2022
    detail.hit.zdb_id: 2527080-1
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  • 7
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    The impact of geography and center volume on access to care and outcomes in advanced hepatocellular carcinoma (HCC): A retrospective population based study.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e15597-e15597
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e15597-e15597
    Abstract: e15597 Background: Treatment of advanced HCC is complex and involves specialized multidisciplinary care. We aimed to characterize the impact of geography and center volume on access to care and outcomes in HCC patients (pts). Methods: HCC pts who received sorafenib in British Columbia from 2008 to 2016 were included. Pts were stratified by rural vs urban status (distance from cancer center), and high volume (HVC) vs lower volume (LVC) centers. Chi-square tests and Kaplan Meier were used to test for differences between groups. Results: Of 288 pts identified, median was age 62 (IQR 56-72), 81% male, 40% Asian, 82% ECOG 0/1 and 90% Child Pugh A. Hepatitis C (32%), hepatitis B (31%) and alcohol (25%) related liver disease were most common. Most pts resided within 100 km (85%) and 173 (60%) were treated at HVC. Ethnicity, liver disease etiology, ECOG and M1 disease varied by stratification (Table). Rural pts were more likely to see an internist (30% vs 16%, p=0.04); access to other subspecialists was similar (all p 〉 0.05). HVC pts were more likely to see a hepatologist (83% vs 19%), hepatobiliary surgeon (57% vs 42%), and/or interventional radiologist (32% vs 13%) compared to LVC pts (all p 〈 0.01). Number of specialists seen correlated with survival (36.4 vs 20.3 vs 12.6 mo for ≥ 3 vs 2 vs 1 specialist(s), p 〈 0.01). Median OS from time of diagnosis was higher for HVC pts (24.7 vs 13.2 mo, p 〈 0.01), but similar when stratified by distance (p=0.44) and from sorafenib initiation (p=0.66). Conclusions: HCC patients treated at a HVC are more likely to see specialized clinicians and have improved survival outcomes. Further research is needed to understand social and clinical factors that influence these findings. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e15597
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Impact of cardiac comorbidity on use and outcomes of adjuvant chemotherapy (ADJ) for colorectal cancer (CRC): A real-world population-based study.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 4_suppl ( 2019-02-01), p. 491-491
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 4_suppl ( 2019-02-01), p. 491-491
    Abstract: 491 Background: Cardiac comorbidities such as myocardial infarction (MI) and congestive heart failure (CHF) may pose challenges in the treatment of CRC. As the population ages, cancer patients (pts) will be increasingly affected by cardiac comorbidities. We performed a population-based analysis of CRC to evaluate the prevalence of MI and CHF, use of ADJ, and survival outcomes. Methods: We evaluated 8601 pts diagnosed with resected stage 2 or 3 CRC from 2004 to 2015 in Alberta, Canada. Baseline patient, tumor, and treatment characteristics were compared between those with and without MI or CHF. Survival analysis was conducted using Kaplan-Meier methods and Cox regression models. Results: In total, 506 (5.9%) patients (pts) had MI and 440 (5.1%) had CHF. CRC patients with prior MI or CHF were older (median 76 and 79 years, respectively) and had worse Charlson Comorbidity Index (median CCI 2 for both) than those without cardiac comorbidities (median age 67 and CCI 0) (p 〈 0.001). Only 24% and 15% of pts with a MI or CHF history, respectively, received ADJ when compared to their counterparts (52% and 53%, respectively, p 〈 0.001). Among those who received ADJ (N = 3409), an oxaliplatin-based regimen was used in 26% of MI pts versus 42% of those without MI (p = 0.002), and in 31% of CHF pts versus 42% of those without CHF. Kaplan-Meier analysis revealed significantly worse overall survival (OS) in pts with prior MI (9.1 vs 4.3 years, p 〈 0.001) or CHF (9.2 vs. 2.7 years, p 〈 0.001) when compared to those without. However, cancer-specific survival (CSS) was not statistically different with or without MI (p = 0.348) and with or without CHF (p = 0.611). In Cox regression that adjusted for use of ADJ, MI was no longer a significant predictor of OS (HR = 1.01, 95% confidence interval (CI) 0.88-1.15), but CHF remained significant (HR 0.65, 95% CI 0.57-0.74). Neither MI nor CHF were predictors of CSS (HR 1.09, 95% CI 0.98-1.33, and HR 0.94, 95% CI 0.77-1.15). Conclusions: CRC pts with MI or CHF experienced lower use of ADJ and worse OS, but no difference in CSS was observed. ADJ-treated pts with prior MI appeared to benefit while worse outcomes in pts with prior CHF appear to be driven by non-cancer related causes.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.4_suppl.491
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Adjuvant chemotherapy and survival outcomes in diabetic patients with colon cancer: A population-based analysis.
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 15_suppl ( 2018-05-20), p. 3589-3589
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. 3589-3589
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.36.15_suppl.3589
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Relationship between PET response and pathologic response in distal esophageal/gastroesophageal junction cancers: A provincial population-based analysis.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e15506-e15506
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e15506-e15506
    Abstract: e15506 Background: The utility of PET scans (PETs) to predict outcomes after neoadjuvant treatment of DE/GEJ cancers is unclear. We aimed to explore the relationship between PET response and pathologic/clinical outcomes in a real-world setting. Methods: Patients (pts) with DE/GEJ cancer treated with curative intent perioperative chemotherapy or neoadjuvant chemoradiation followed by surgery in British Columbia from 2009-2018 were included. Retrospective chart review was conducted; pts were stratified into PET responders (R, ≥ 35% decrease in max SUV) or PET non-responders (NR, 〈 35%) groups. Chi-square and Kaplan Meier were used to test for associations between variables and outcomes. Results: Of 576 pts with locally advanced DE/GEJ cancers, 232 pts were eligible for analysis. Treatment regimens comprised of CROSS (72%), MAGIC (24%) and FLOT (4%). Median age was 66 (IQR 57-72), 85% male, 91% ECOG 0/1, 62% GEJ involvement, and 81% adenocarcinoma histology. Characteristics and treatment regimens were balanced between the PET-R and PET-NR groups (all p 〉 0.05). Median time from end of treatment to PETs was 30 days (IQR 22-36); 67% were PET-R. Pathologic complete response rates (14% vs 13%, p=0.079) were similar for PET-R vs PET-NR, respectively. Discordance rate was 34% between PET vs pathologic response (Table). Aborted surgery rate was higher in the PET-NR group (8% vs 3%, p=0.03); 70% of aborted cases were due to peritoneal involvement. Median overall survival was similar between the groups (PET-R 31.5 mo vs PET-NR 36.1 mo, p=0.616). Conclusions: In our population-based cohort, PET response did not demonstrate prognostic utility. PET-NR were more likely to have their surgeries aborted. The predictive ability of PET in determining surgical resectability should be further investigated to avoid unnecessary high morbidity surgeries.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e15506
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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