Showing papers by "Bishal Gyawali published in 2022"

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

Abstract: Key Points Question When a new cancer therapy is approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are there notable differences in approval timings and review speed? Findings This cross-sectional study found that of 89 new oncology therapies approved by both the FDA and EMA from 2010 to 2019, the FDA approved 95% of therapies first, with a median delay to market authorization in Europe of 241 days. Meaning The findings of this study suggest that patients in the US have access to new oncology therapies earlier than in Europe.

Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class.

Abstract: Importance Although quality of life (QOL) is an important clinical end point, cancer drugs are often approved based on overall survival (OS) or putative surrogate end points such as progression-free survival (PFS) without QOL data. Objective To ascertain whether cancer drug trials that show improvement in OS or PFS also improve global QOL of patients with cancer compared with the control treatment, as well as to assess how unchanged or detrimental QOL outcomes are reported in trial publications. Design, Setting, and Participants This retrospective cohort study included all patients with cancer in the advanced setting who were enrolled into phase 3 randomized clinical trials (RCTs) of cancer drugs reporting QOL data and published in English language in a PubMed-indexed journal in the calendar year 2019. The systematic search of PubMed was conducted in July 2020. Main Outcomes and Measures Association of QOL outcomes with OS and PFS, framing of unchanged QOL outcomes in trial publications, and the association of favorable framing with industry funding of the trials. Results A total of 45 phase 3 RCTs enrolling 24 806 participants (13 368 in the experimental arm and 11 438 in the control arm) met the inclusion criteria and were included in the study analyses. Improvement in global QOL with the experimental agent was reported in 11 (24%) RCTs. The RCTs with improved QOL were more likely to also show improved OS vs trials with unimproved QOL (7 of 11 [64%] trials vs 10 of 34 [29%] trials; χ2 = 4.13; P = .04); there was no such association observed for PFS (6 of 11 [55%] trials vs 17 of 34 [50%] trials, χ2 = 0.03; P = .87). Six trials reported worsening QOL, of which 3 (50%) were trials of targeted drugs, and 11 trials reported improvement in QOL, of which 6 (55%) were trials of immunotherapy drugs. Of the 34 trials in which QOL was not improved compared with controls, 16 (47%) reported these results in a positive frame, an observation statistically significantly associated with industry funding (χ2 = 6.35; P = .01). Conclusions and Relevance In this cohort study, a small proportion of RCTs of cancer drugs showed benefit in global QOL with the experimental agent. These results showed an association between QOL benefit and OS benefit but no such association with PFS benefit. Trials that failed to show improved QOL often reported their QOL outcomes more favorably. Non-immunotherapy-targeted drugs led to worse QOL more often than did cytotoxic agents.

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

Abstract: Key Points Question Which upper middle–income countries (UMICs) and lower middle–income countries (LMICs) participate in oncology randomized clinical trials led by high-income countries? Findings In this cross-sectional study, among all 636 oncology randomized clinical trials published globally during 2014 to 2017, the most common participating LMICs were India (50% of trials), Ukraine (46%), and Philippines (27%). The most common participating UMICs were Russia (64% of trials), Brazil (52%), Romania (34%), China (31%), Mexico (31%), and South Africa (30%). Meaning The findings of this study suggest LMICs and UMICs that participate in randomized clinical trials do 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.

Is Clinical Research Serving the Needs of the Global Cancer Burden? An analysis of contemporary global radiotherapy randomised controlled trials.

Abstract: Randomized controlled trials (RCTs) are the cornerstone of delivering sustained improvements in cancer outcome. To inform radiation therapy research policy and prioritization, we analyze the radiation therapy RCT landscape including comparison with trials of systemic therapies over the same period, with a specific focus on funding and disparities across income settings.This retrospective cohort study identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiation therapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources.The study cohort included 694 RCTs of which 64 were radiation therapy RCTs (9%) compared with 601 systemic therapy RCTs (87%). Among all radiation therapy RCTs, 47% of them focused on 2 areas of evaluation: (1) combining radiation therapy with systemic agents (25%) and (2) changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%), and breast (14%), with cervical cancer trials representing only 3% of the cohort. Among the radiation therapy RCTs, 33% of them met their primary endpoint, and 62% assessed interventions in the curative setting compared with 31% in systemic therapy RCTs. For their country locations, 77% of radiation therapy RCTs took place in high-income countries, 13% in low-and-middle-income countries, and 11% in both high-income and low-and-middle-income countries. For funding, 17% of radiation therapy RCTs received funding from industry compared with 79% of systemic therapy RCTs.This study highlights the need for greater investment in radiation therapy RCTs and the need to look at the disparities in conducting RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in low-and-middle-income countries and more sustainable funding sources.

The impact of artificial intelligence on health equity in oncology: A scoping review (Preprint)

Abstract: The field of oncology is at the forefront of advances in artificial intelligence (AI) in health care, providing an opportunity to examine the early integration of these technologies in clinical research and patient care. Hope that AI will revolutionize health care delivery and improve clinical outcomes has been accompanied by concerns about the impact of these technologies on health equity.We aimed to conduct a scoping review of the literature to address the question, "What are the current and potential impacts of AI technologies on health equity in oncology?"Following PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines for scoping reviews, we systematically searched MEDLINE and Embase electronic databases from January 2000 to August 2021 for records engaging with key concepts of AI, health equity, and oncology. We included all English-language articles that engaged with the 3 key concepts. Articles were analyzed qualitatively for themes pertaining to the influence of AI on health equity in oncology.Of the 14,011 records, 133 (0.95%) identified from our review were included. We identified 3 general themes in the literature: the use of AI to reduce health care disparities (58/133, 43.6%), concerns surrounding AI technologies and bias (16/133, 12.1%), and the use of AI to examine biological and social determinants of health (55/133, 41.4%). A total of 3% (4/133) of articles focused on many of these themes.Our scoping review revealed 3 main themes on the impact of AI on health equity in oncology, which relate to AI's ability to help address health disparities, its potential to mitigate or exacerbate bias, and its capability to help elucidate determinants of health. Gaps in the literature included a lack of discussion of ethical challenges with the application of AI technologies in low- and middle-income countries, lack of discussion of problems of bias in AI algorithms, and a lack of justification for the use of AI technologies over traditional statistical methods to address specific research questions in oncology. Our review highlights a need to address these gaps to ensure a more equitable integration of AI in cancer research and clinical practice. The limitations of our study include its exploratory nature, its focus on oncology as opposed to all health care sectors, and its analysis of solely English-language articles.

Cancer Groundshot: Building a Robust Cancer Control Platform in Addition To Launching the Cancer Moonshot.

Abstract: Cancer Groundshot is a philosophy that calls for prioritization of strategies in global cancer control. The underlying principle of Cancer Groundshot is that one must ensure access to interventions that are already proven to work before focusing on the development of new interventions. In this article, we discuss the philosophy of Cancer Groundshot as it pertains to priorities in cancer care and research in low- and middle-income countries and the utility of technology in addressing global cancer disparities; we also address disparities seen in high-income countries. The oncology community needs to realign our priorities and focus on improving access to high-value cancer control strategies, rather than allocating resources primarily to the development of technologies that provide only marginal gains at a high cost. There are several "low-hanging fruit" actions that will improve access to quality cancer care in low- and middle-income countries and in high-income countries. Worldwide, cancer morbidity and mortality can be averted by implementing highly effective, low-cost interventions that are already known to work, rather than investing in the development of resource-intensive interventions to which most patients will not have access (i.e., we can use Cancer Groundshot to first save more lives before we focus on the "moonshots").

Global consequences of the US FDA's accelerated approval of cancer drugs.

Abstract: The accelerated approval system is a fast-track drug approval pathway created by the US Food and Drug Administration (FDA) in 1992 in response to the HIV-AIDS crisis to allow expedited access to life-saving drugs and fulfil an unmet medical need. Nowadays, this pathway is most commonly used for cancer drug approval. 1 Sachs RE Gavulic KA Donohue JM Dusetzina SB Recent trends in Medicaid spending and use of drugs with US Food and Drug Administration accelerated approval. JAMA Health Forum. 2021; 2e213177 Google Scholar In theory, the accelerated approval pathway strikes a balance between early access to therapies and the need for robust evidence generation. This pathway allows drugs to be approved early on the basis of improvement in surrogate outcomes that are reasonably likely to translate to clinical benefit. This approval is conditional, with a mandate that drugs are tested in a post-approval confirmatory trial to substantiate the presumed clinical benefit, in the absence of which approval will be withdrawn. Several challenges and limitations of this pathway for the US regulatory and clinical environment have been previously described. 2 Gyawali B Ross JS Kesselheim AS Fulfilling the mandate of the US Food and Drug Administration's accelerated approval pathway: the need for reforms. JAMA Intern Med. 2021; 181: 1275-1276 Google Scholar Here, we discuss the often-overlooked consequences of the accelerated approval pathway for global oncology. Consequences of US FDA approval decisions in high-income countriesAkhade and colleagues1 highlight the global consequences of approving cancer medicines on the basis of uncertain evidence through the US Food and Drug Administration (FDA)'s accelerated approval pathway. Traditionally, the concern for US regulatory standards has remained inside the USA. However, Akhade and colleagues show that the consequences can be far reaching. Their Comment has substantial implications, especially considering the nomination of a new FDA commissioner and the opportunity that this nomination brings to enforce a suitable efficacy standard. Full-Text PDF

Industry Relationships With Medical Oncologists: Who Are the High-Payment Physicians?

Abstract: PURPOSE: Many oncologists have relationships with industry. Previous work has shown that these payments are usually modest; however, there exist a subset of medical oncologists who receive more than $100,000 US dollars (USD) annually. Here, we describe the characteristics of these physicians. METHODS: This retrospective cohort study used the Open Payments data set to identify all US-based medical oncologists/hematologists who received $100,000+ USD in general payments linked to cancer medications in 2018. Open Payments and a web-based search were used to identify physician characteristics, demographics, research profile, and leadership positions. RESULTS: One hundred thirty-nine medical oncologists received > $100,000 USD in general payments. The median payment was $154,613 USD, and the total payment was $24.2 million USD. These high-payment physicians represent 1% of all US medical oncologists (N = 10,620) yet account for 37% of all industry payments in 2018. Sixty percent (84 of 139) and 21% (29 of 139) of these high-payment physicians hold hospital and specialty association leadership roles, respectively. One quarter (24%, 33 of 139) serve on journal editorial boards, and 10% (14 of 139) have authored clinical practice guidelines; 72% (100 of 139) hold faculty appointments. CONCLUSION: A small number of medical oncologists receive very high payments from the pharmaceutical industry. These physicians hold major leadership roles within oncology. Further work is needed to understand the extent to which these conflicts of interest may shape clinical practice and policy.

Characteristics of clinical trials for haematological malignancies from 2015 to 2020: A systematic review.

Abstract: As the landscape of haematological malignancies dramatically changes due to diagnostic and therapeutic advances, it is important to evaluate trends in clinical trial designs. The objective of our study was to describe the design of clinical trials for five common haematological malignancies with respect to randomisation and end-points. We also aimed to assess trends over time and examine the relationships of funding source and country of origin to proportions of randomisation and utilisation of clinical end-points.This systematic review identified haematological malignancy clinical trials starting in 2015-2020 registered at ClinicalTrials.gov as of 20th February 2021. Trial-related variables including randomisation status, type of primary end-point, and both projected and actual enrolment numbers were captured. Clinical end-points were defined as overall survival and quality of life, while surrogate end-points included all other end-points.Of 2609 relevant trials included in this analysis, only one-fifth were randomised (538, 21%), with a significant decrease in the proportion of randomised clinical trials from 26% of trials in 2015 to 19% in 2020 (p < 0.00001). Between the years 2015 and 2020, the proportion of randomised trials for all haematological malignancies using primary surrogate end-points remained relatively consistent, ranging from 84% in 2015 to 78% in 2020 (p = 0.352). Overall, only 15% of trials utilised primary end-points of overall survival or quality of life in a randomised design.This systematic review of haematological malignancy trials found that the majority of trials are non-randomised and that there has been an increase in the ratio of non-randomised to randomised studies over time. The vast majority of randomised haematological malignancy trials use surrogate primary end-points.

Risk and benefit for umbrella trials in oncology: a systematic review and meta-analysis

Abstract: Umbrella clinical trials in precision oncology are designed to tailor therapies to the specific genetic changes within a tumor. Little is known about the risk/benefit ratio for umbrella clinical trials. The aim of our systematic review with meta-analysis was to evaluate the efficacy and safety profiles in cancer umbrella trials testing targeted drugs or a combination of targeted therapy with chemotherapy.Our study was prospectively registered in PROSPERO (CRD42020171494). We searched Embase and PubMed for cancer umbrella trials testing targeted agents or a combination of targeted therapies with chemotherapy. We included solid tumor studies published between 1 January 2006 and 7 October 2019. We measured the risk using drug-related grade 3 or higher adverse events (AEs), and the benefit by objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). When possible, data were meta-analyzed.Of the 6207 records identified, we included 31 sub-trials or arms of nine umbrella trials (N = 1637). The pooled overall ORR was 17.7% (95% confidence interval [CI] 9.5-25.9). The ORR for targeted therapies in the experimental arms was significantly lower than the ORR for a combination of targeted therapy drugs with chemotherapy: 13.3% vs 39.0%; p = 0.005. The median PFS was 2.4 months (95% CI 1.9-2.9), and the median OS was 7.1 months (95% CI 6.1-8.4). The overall drug-related death rate (drug-related grade 5 AEs rate) was 0.8% (95% CI 0.3-1.4), and the average drug-related grade 3/4 AE rate per person was 0.45 (95% CI 0.40-0.50).Our findings suggest that, on average, one in five cancer patients in umbrella trials published between 1 January 2006 and 7 October 2019 responded to a given therapy, while one in 125 died due to drug toxicity. Our findings do not support the expectation of increased patient benefit in cancer umbrella trials. Further studies should investigate whether umbrella trial design and the precision oncology approach improve patient outcomes.

Evaluation of Information Theoretic Network Meta-analysis to Rank First-Line Anticancer Regimens for Hormone Receptor–Positive, ERBB2-Negative Metastatic Breast Cancer

Abstract: Key Points Question Can information theoretic network meta-analysis (IT-NMA) rank the estimated efficacy of regimens for hormone receptor–positive, ERBB2-negative metastatic breast cancer (HR-positive, ERBB2-negative MBC)? Findings In this network meta-analysis study, a combination of targeted and endocrine therapy, ie, letrozole and palbociclib, had the highest ranking. Rarely used regimens’ rank scores gravitated to indeterminacy, while monotherapies that compared unfavorably with novel agents or combinations in recent trials, such as anastrozole, had low rankings. Meaning In this study, combination therapies were ranked more highly than monotherapies for treating HR-positive, ERBB2-negative MBC.

Knowledge, Practice, and Attitudes of Physicians in Low- and Middle-Income Countries on Fertility and Pregnancy-Related Issues in Young Women With Breast Cancer

Abstract: PURPOSE Fertility and pregnancy-related issues are highly relevant for young (≤ 40 years) patients with breast cancer. Limited evidence exists on knowledge, practice, and attitudes of physicians from low- and middle-income countries (LMICs) regarding these issues. METHODS A 19-item questionnaire adapted from an international survey exploring issues about fertility preservation and pregnancy after breast cancer was sent by e-mail between November 2019 and January 2020 to physicians from LMICs involved in breast cancer care. Descriptive analyses were performed. RESULTS A total of 288 physicians from Asia, Africa, America, and Europe completed the survey. Median age was 38 years. Responders were mainly medical oncologists (44.4%) working in an academic setting (46.9%). Among responders, 40.2% and 53.8% reported having never consulted the available international guidelines on fertility preservation and pregnancy after breast cancer, respectively. 25.0%, 19.1%, and 24.3% of responders answered to be not at all knowledgeable about embryo, oocyte, or ovarian tissue cryopreservation, respectively; 29.2%, 23.6%, and 31.3% declared that embryo, oocyte, and ovarian tissue cryopreservation were not available in their countries, respectively. 57.6% of responders disagreed or were neutral on the statement that controlled ovarian stimulation can be considered safe in patients with breast cancer. 49.7% and 58.6% of responders agreed or were neutral on the statement that pregnancy in breast cancer survivors may increase the risk of recurrence overall or only in those with hormone receptor–positive disease, respectively. CONCLUSION This survey showed suboptimal knowledge, practice, and attitudes of physicians from LMICs on fertility preservation and pregnancy after treatment completion in young women with breast cancer. Increasing awareness and education on these aspects are needed to improve adherence to available guidelines and to promote patients' oncofertility counseling. Online in @ASCO_pubs #JCOGlobOncol large survey by @matteolambe et al. showing suboptimal practice and attitudes of physicians in #LMICs on #fertility and #pregnancy issues in young #BreastCancer patients: increased awareness and education in #oncofertility are needed@OncoAlert

CDK 4/6 inhibitors for adjuvant therapy in early breast cancer—Do we have a clear winner?

Abstract: CDK4/6 inhibitors have become the mainstay of treatment for patients with advanced hormone receptor positive and Human Epidermal Receptor -2 [ HER-2 ] negative breast cancer. Three CDK 4/6 inhibitor drugs are currently approved and available, including Palbociclib, Ribociclib and Abemaciclib. All three of these drugs have similar mechanism of action and other pharmacokinetic and pharmaco-dynamic properties and hold equivalent positions in cancer care guidelines. Surprisingly, however, in the adjuvant setting of early breast cancer, two trials of palbociclib have failed to show any benefit while abemaciclib has shown some early benefits in disease-free survival and has received approval for its use in adjuvant setting. In this article, we explore several reasons for this discrepancy in the results of CDK4/6 inhibitors in the adjuvant setting. We also question if we should already adopt adjuvant abemaciclib in our clinical practice given the uncertainty in data.

Risk factors and outcomes associated with diabetes mellitus in COVID-19 patients: a meta-analytic synthesis of observational studies

Abstract: We carried out a meta-analytic synthesis to evaluate the association between diabetes mellitus (DM) and related clinical outcomes, co-morbidities, their risk factors and resource utilization in patients with COVID-19.The MEDLINE and Web of Science databases were reviewed for identification of eligible studies. Meta-analysis was carried out using Review Manager 5.3. The random- effects model was used to compute the pooled estimates of odds ratio (OR)/mean difference and 95% confidence interval (CI).A total of 14 studies including 3,644 individuals without DM and 1,428 with DM were included in the meta-analysis. Cardiovascular diseases (CVDs) [OR 2.91, 95% CI 2.34, 3.63], hypertension [OR 2.19, 95% CI 1.39, 3.46], acute kidney injury (AKI) [OR 3.59, 95% CI 1.46, 8.84], cerebrovascular disease [OR 2.09, 95% CI 1.22, 3.61], and acute respiratory distress syndrome (ARDS) [OR 3.40, 95% CI 2.09, 5.55] were significantly associated with DM in COVID-19 patients compared with non-DM patients (p < 0.05 for all instances). Mortality was significantly higher among COVID-19 patients with DM [OR 2.46, 95% CI 1.68, 3.58]. Intensive Care Unit (ICU) admission and use of mechanical ventilation were significantly associated with COVID-19 patients with DM [OR 2.79, 95% CI 1.79, 4.34], and [OR 3.33, 95% CI 2.05, 5.42], respectively. No significant difference was observed in the length of stay (LOS) and hospitalization.This meta-analysis shows that CVDs, hypertension, AKI, cerebrovascular disease, and ARDS are significantly higher among DM patients with COVID-19 compared with non-DM patients. Mortality, ICU admission and the use of mechanical ventilation were significantly associated with COVID-19 patients with DM. Further long-term, multinational and large sample size clinical studies are warranted to justify the current findings.

Training General Practitioners in Oncology: A Needs Assessment Survey From Nepal

Abstract: PURPOSE Nepal lacks enough cancer care providers to address the growing burden of cancer in the country. One way of addressing this issue is to train general practitioners (GPs) in oncology (GPOs) so that they can task-share and task-shift oncology care. However, limited information is available regarding the current level of oncology expertise of Nepali GPs and whether they perceive a need for, and have an interest in, such a GPO training program if available in Nepal. METHODS A survey was distributed to GPs in Nepal to collect data on current oncology training and clinical practice and evaluate levels of interest and need for a GPO training program. The survey was distributed electronically from February to July 2021. RESULTS The survey obtained 71 individual responses from GPs in Nepal. The majority of respondents were male (87%), and most worked as consultants or senior consultants (63%). Only 6% of respondents had a mandatory oncology rotation during their GP training, and only 15% indicated that their GP training had adequately prepared them to care for patients with cancer. Ninety-six percent of respondents perceived a need for a GPO training program in Nepal, with 94% indicating an interest in enrolling in such a program and 71% indicating that they were very interested. CONCLUSION The findings indicate an urgent need for and an encouraging interest in establishing a GPO training program in Nepal. These findings will be used to guide the development and implementation of this type of program. A survey from GPs of Nepal reveals an urgent need for and an encouraging interest in establishing a GPO training program in Nepal to task-share and task-shift the workload burden of medical oncologists.

Highlights from Choosing Wisely 2022 for Resource Limited Settings: Reducing Low Value Cancer Care for Sustainability conference, 17th-18th September, Mumbai, India

Abstract: The ‘Choosing Wisely 2022’ conference, organised by the ecancer foundation, was held at the Tata Memorial Hospital, Mumbai, India, on 17 and 18 September. It was a successful event with 159 delegates attending it in person and around 328 delegates attending online. Thirty oncology experts from across the world shared their thoughts during this meeting. The theme of the conference was to focus on cancer care, in low- and middle-income countries (LMICs). The emphasis of discussion was on ways to select more cost-effective and high value treatments and interventions and minimise financial toxicity. In addition, cancer research from LMICs needs to be improved substantially. Collaboration and networking amongst cancer institutions in LMICs is essential.

Radiographic progression-free survival in the ACIS trial for prostate cancer.

Abstract: In The Lancet Oncology, Fred Saad and colleagues 1 Saad F Efstathiou E Attard G et al. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021; 22: 1541-1559 Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar report the findings from the ACIS randomised, controlled trial comparing apalutamide with placebo added to abiraterone and prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are two ways apalutamide could provide benefit to patients, improvement in either their duration or their quality of survival. Yet the primary endpoint of the ACIS trial was radiographic progression-free survival. Despite US Food and Drug Administration acceptance, radiographic progression-free survival is a poor primary endpoint in any phase 3 trial because it does not assess benefit to patients and would only have value if it were a surrogate for overall survival or quality of life. The ACIS trial shows that radiographic progression-free survival is not a surrogate: survival curves were superimposable and there was a non-significant trend for the control group to have better pain control and delayed deterioration of quality of life. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 studyDespite the use of an active and established therapy as the comparator, apalutamide plus abiraterone–prednisone improved radiographic progression-free survival. Additional studies to identify subgroups of patients who might benefit the most from combination therapy are needed to further refine the treatment of mCRPC. Full-Text PDF Radiographic progression-free survival in the ACIS trial for prostate cancer – Authors' replyWe thank Shai Gilboa and colleagues and Ian F Tannock and colleagues for their comments on our Article reporting on the ACIS study published in The Lancet Oncology.1 Full-Text PDF

Think Globally, Start Locally: Value-Based Breast Cancer Care for Newly Diagnosed Patients in A Safety-Net Medical Center

Abstract: Purpose We assessed the efficacy of a multidisciplinary, patient-focused approach emphasizing appropriate use of medical resources among a population of breast cancer patients at our safety-net hospital. Methods A multidisciplinary program coordinated and provided value-based care. Surgery, oncology, and navigation were physically co-located. Real time decisions were made by medical and surgical oncologists. Focused institution-specific protocols initiated in 2018, advised against four specific cancer resources that our team had determined as lower-value: imaging tests for indications not recommended in NCCN guidelines, inappropriate Oncotype Dx testing, radiation for patients ≥65 years with stage I hormone-positive disease, and administration of pertuzumab and neratinib as adjuvant therapy in HER2+ breast cancer patients. Time to treatment and rates of use of these resources were monitored. Results Newly diagnosed breast cancer patients from 2015-2019 were compared to the pre-protocol era (2015-2017). Time from first breast clinic visit to oncology appointment decreased 39 days (60% decrease, median of 63.0 vs 22.5 days, p<0.001), no patients ≥65 years with stage I hormone-positive breast cancer in 2018-2019 received radiation therapy, and rates of ordering of CT, PET, and bone scans for asymptomatic patients decreased by 80%. Overall survival did not differ by cohort protocol category/treatment choices (p=0.69) Compared to the pre-protocol cohort, the post-protocol cohort did not have a significantly lower risk of death (Hazard Ratio 0.66, 95% Confidence Interval 0.08-5.38, p=0.69). Overall breast cancer care cost decreased by $3,675,374 between 2018 and 2019 versus 2015 to 2017. Conclusions After initiating a breast cancer program focused on reducing rates of use of four commonly excessively ordered breast cancer resources our team identified as lower-value, care at our safety-net hospital achieved high compliance with NCCN maging guidelines and also reduced use of a low-value diagnostic test, and low-value radiation and chemotherapy.