The Landscape of Randomised Controlled Trials of Therapies in Breast Cancer in Low and Middle Income Countries

Lynch-Kelly, Katharine; Singer, Matthew M.; Williams, Norman

doi:10.1155/2017/4259704

Cited by 10 publications

(14 citation statements)

References 11 publications

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“…A 2016 study that reviewed registered breast cancer studies in LMICs found that, of the LMICs, Asia had the most trial registrations, with India as the leader in the region. 16 Similar to the current study, this previously published report demonstrated that few countries on the African continent had clinical trials registered for patients with any of the three cancer subtypes of interest.…”

Section: Discussionsupporting

confidence: 83%

Disparities in Breast, Lung, and Cervical Cancer Trials Worldwide

Ramaswami

Paulino

Barrichello

et al. 2018

JGO

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PurposeAs cancer burden has risen worldwide, physicians, patients, and their advocates have become aware that the clinical cancer trial research paradigm is not ubiquitous. Furthermore, the number and characteristics of trials that are registered in low- and middle-income countries (LMICs) compared with that in high-income countries (HICs) are unknown.MethodsWe collected retrospective data on trials for breast, lung, and cervical cancer registered in ClinicalTrials.gov or with the WHO International Clinical Trial Registry Platform between 2010 and 2017. The data were then classified as trials within LMICs or HICs using definitions from the World Bank.ResultsIncluded in these analyses were 6,710 trials, of which 3,164 (47%) were breast cancer trials, 3,283 (49%) were lung cancer trials, and 263 (4%) were cervical cancer trials. There were 1,951 (29%) trials from LMICs and 4,759 (71%) trials from HICs (P < .001). Although the proportion of phase III trials in HICs versus LMICs was similar (18% v 17%; P = .66), the number of phase I trials in LMICs was significantly lower than that of HICs (20% v 2%; P < .001). For several LMICs with the highest mortality-to-incidence ratios for breast, lung, or cervical cancer, there were no cancer trials registered in the registration data bases searched for this work.ConclusionThere are differences in access to cancer clinical trials in LMICs compared with HICs. Several factors, such as excessive cost and a lack of infrastructure and expertise, may explain these differences.

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Section: Discussionsupporting

confidence: 83%

Disparities in Breast, Lung, and Cervical Cancer Trials Worldwide

Ramaswami

Paulino

Barrichello

et al. 2018

JGO

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“…Consistent with previous studies, we found that the cancers evaluated in these trials do not reflect the disease burden in these health systems. 17 …”

Section: Discussionmentioning

confidence: 99%

“…There was a general alignment between the proportion of RCTs and deaths for lung, urologic, and brain cancers. 20) 77 (17) .18…”

Section: Design Characteristics Of Rctsmentioning

confidence: 99%

Participation of Lower and Upper Middle–Income Countries in Oncology Clinical Trials Led by High-Income Countries

et al. 2022

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ImportanceMany randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle–income countries (LMICs) and upper middle–income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which countries participate in RCTs and how this participation may contribute to global research.ObjectiveTo describe which UMICs and LMICs participate in RCTs led by HICs.Design, Setting, and ParticipantsA cross-sectional study of all oncology RCTs published globally during January 1, 2014, to December 31, 2017, was conducted. The study cohort was restricted to RCTs led by HICs that enrolled participants from LMICs and UMICs. Study analyses were conducted in November 1, 2021, to May 31, 2022.Main Outcomes and MeasuresA bibliometric approach (Web of Science 2007-2017) was used to explore whether RCT participation was proportional to other measures of cancer research activity. Participation in RCTs (ie, percentage of RCTs in the cohort in which each LMIC and UMIC participated) was compared with country-level cancer research bibliometric output (ie, percentage of total cancer research bibliometric output from the same group of countries that came from a specific LMIC and UMIC).ResultsAmong the 636 HIC-led RCTs, 186 trials (29%) enrolled patients in LMICs (n = 84 trials involving 11 LMICs) and/or UMICs (n = 181 trials involving 26 UMICs). The most common participating LMICs were India (42 [50%]), Ukraine (39 [46%]), Philippines (23 [27%]), and Egypt (12 [14%]). The most common participating UMICs were Russia (115 [64%]), Brazil (94 [52%]), Romania (62 [34%]), China (56 [31%]), Mexico (56 [31%]), and South Africa (54 [30%]). Several LMICs are overrepresented in the cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (27% RCTs, 1% output), and Georgia (8% RCTs, 0.2% output). Overrepresented UMICs include Russia (64% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output), and South Africa (30% RCTs, 1% output).Conclusions and RelevanceIn this cross-sectional study, a substantial proportion of RCTs led by HICs enrolled patients in LMICs and UMICs. The LMICs and UMICs that participated in these trials did not match overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity-strengthening activities require further study.

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“…Moreover, protocols with systemic therapies are often unsuitable in SSAs given the scarcity of care facilities, drugs, and trained personnel. Therefore, the objectives of protocols and FBC healthcare strategies must be tailored to local settings 58 …”

Section: Discussionmentioning

confidence: 99%

“…The visits of obstetrician‐gynecologists are invaluable opportunities for early FBC detection or recurrence 58 given the limited availability and access to mammographic examinations. Also, the patient‐doctor communication skills of obstetrician‐gynecologists can help increase awareness, explore stigma and misconceptions related to the disease, 40 and provide FBC patients information about the balance between risks and benefits of surgeries.…”

Section: Discussionmentioning

confidence: 99%

Female breast cancer in sub‐Saharan Africa: A PRISMA‐S‐compliant systematic review of surgery

Amouzou

Ketevi

Sambiani

et al. 2021

Journal of Surgical Oncology

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Background In sub‐Saharan countries (SSAs), the advanced stage at diagnosis and the limited surgical interventions of female breast cancer (FBC) lead to poor outcomes. This study assessed current modalities of FBC surgeries. Methods Six literature databases (Medline, Embase, African Journal Online, Google Scholar, Web of Science, Cochrane Library) were searched, plus a manual search, in 2011–2021. We included primary data studies with any setting and presurgeries or postsurgeries treatments, we excluded non‐English language studies, editorials, and grey literature. Results The search yielded 21 observational studies (16 retrospective, 3 prospective, and 2 case reports). Of the total 6900 patients, 4121 (60%) patients underwent FBC surgical excision only, and 751/2779 (27%) conservative surgery (BCS) or therapy (BCT). All studies reported similar use of mastectomy (>60%), the FBC surgical excision/reconstruction studies displayed more neoadjuvant chemotherapy (536/2779, 19% vs. 215/4121, 5%), and radiotherapy or adjuvant radiotherapy (1461/2779, 52% vs. 411/3921, 4%). Patients' age, histological classification, staging, and follow‐up data were often missing. Conclusions The FBC complexity requires structured management by general and plastic surgeons, radiotherapy specialists, and obstetrician‐gynecologists through shared guidelines, protocols, and specific programs of public health. In SSAs, FBC surgical strategies should point at decreasing radical mastectomy and increasing BCS/BCT.

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The Landscape of Randomised Controlled Trials of Therapies in Breast Cancer in Low and Middle Income Countries

Cited by 10 publications

References 11 publications

Disparities in Breast, Lung, and Cervical Cancer Trials Worldwide

Disparities in Breast, Lung, and Cervical Cancer Trials Worldwide

Participation of Lower and Upper Middle–Income Countries in Oncology Clinical Trials Led by High-Income Countries

Female breast cancer in sub‐Saharan Africa: A PRISMA‐S‐compliant systematic review of surgery

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