Uptake of Breast Cancer Clinical Trials at Minority Serving Cancer Centers. 2005 Feb 1;103(3):483-91. doi: 10.1002/cncr.20792. If you are thinking about taking part in a clinical trial, be sure to ask your doctor, “Is there a clinical trial that I can join?”If your doctor offers you a trial, here are some questions you may want to … FIGURE 5. In the end, the potential benefits of trial participation will be shared by patients, researchers, and future generations. To characterize the representation of racial and ethnic minorities, the elderly, and women in cancer trials sponsored by the National Cancer Institute. Accrual data from the National Cancer Institute Cancer Therapy Evaluation Program (CTEP) were provided by Steve Friedman, Michael Montello, Troy Budd, and Samantha Finnegan via the Freedom of Information Act. Increasing accrual to clinical trials is important for multiple reasons. It has been previously observed that the age-dependent rate in the reduction of deaths attributed to cancer in the United States is correlated with the age-dependent accrual of young adults to national cancer treatment trials during the same era.69 After suicide, cancer is the second leading cause of death due to disease among AYAs. Fred Hutch's Dr. Joseph Unger, a biostatistician whose research focuses on improving access to trials, led a new study on how comorbidities squelch patient participation -- and what we might be able to do about it. May 19, 2016. In their role of guiding patient care, physicians may have a strong inclination toward a specific treatment for a given patient.31-33 The prospective study by Javid and colleagues found that the nature of the study regimen was cited as a reason for not discussing a trial with eligible patients by 56% of physicians.13 Physicians are also frequently concerned that clinical trial participation can interfere with the physician-patient relationship.31,34,35 Random assignment into a phase III trial in particular subjects the treatment choice to uncertainty, and physicians may anticipate that the introduction of uncertainty will subvert patient confidence in the physician’s expertise, even if, as indicated by the existence of a randomized clinical trial, multiple treatments of potentially similar efficacy are available. This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. We found a slower rate of progress in AYAs compared with younger and older patients, which underscores the need to increase the number of clinical trials available to AYAs with cancer and their participation in them. If a trial is available, an evaluation of trial eligibility is made, and, if eligible, a trial is discussed with the patient. A number of factors have been found to deter physician recommendation for trial participation. Mortality data were obtained from the National Center for Health Statistics via the SEER program.78. 1, 2 Conversely, the vast majority of adult patients with cancer (greater than 95%) do not participate in clinical trials, even though 70% of Americans are estimated to be inclined or very willing to participate in clinical trials. Seattle, WA; Quorum Review IRB. Editorial Roster There was a strong relationship between age and enrollment fraction, with trial participants 30 to 64 years of age representing 3.0% of incident cancer patients in that age group, in comparison to 1.3% of 65- to 74-year-old patients and 0.5% of patients 75 years of age and older. Medicare Coverage. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. This “AYA ALL cliff” constituted 30% of the overall decline from 95% at age 5 to less than 20% at age 70. Regressions are 4° polynomials. 4). The principle of equipoise posits that a properly designed treatment trial tests a new or modified form of therapy that is not known to have that benefit (otherwise the trial would not be justified). SEER Cancer Statistics Review, 1975-2012, National Cancer Institute. The most consistent and largest disparity pertains to age.1,15,50-53 Hutchins et al found that patients in cooperative group trials were much less likely to be age 65 or older than those in the U.S. cancer population.50 Some evidence suggests that attitudinal barriers on the part of physicians play a role.13,54-56 In addition, older patients are likely to have more comorbid burdens, inducing clinical exclusions.57,58 To the extent that trials seek to reflect the population of patients for whom new trial-proven treatments will be administered, better representation of older patients in trials is critical. We used data from a large national survey of 5,500 cancer patients who were deciding what treatment to undergo for their cancer, including whether they should participate in a clinical trial. FIGURE 7. However, the ultimate decision regarding trial participation rests with the patient. The more rapid completion of trials would enable new treatments to be developed more quickly. These failed trials represent thousands of patients per year who enroll on clinical trials 2021 Jan 9. doi: 10.1245/s10434-020-09533-z. Recognizing this, in 2000, Medicare was directed to cover the routine care costs of clinical trial participation for its patients.59 Unfortunately, the proportion of older patients in trials remains well below the expected rate.28,51. Among patients for whom a trial is available, about half (or a quarter of all patients) are excluded due to eligibility issues with trial exclusion criteria. Objectives: To determine the effect of participation in clinical trials on survival of women with ovarian cancer. A similar pattern was found with respect to cancer mortality, which isolates patients age 0 to 40 (Fig. NIH FIGURE 1. Fortunately, NCI-designated cancer centers are evaluating their own AYA referral patterns and clinical trial determinants,92,93 and intergroup efforts are underway within the current organizational structure of the federal clinical trials enterprise, including the NCI's National Clinical Trials Network (NCTN), to create novel opportunities for collaborative AYA oncology research among the pediatric and adult NCTN groups.94,95 As is done in England, age-specific biology, pharmacology, proteomics, genomics, and clinician and patient behavior studies embedded within clinical trials are required to further improve survival for AYAs.96. Context Despite the importance of diversity of cancer trial participants with regard to race, ethnicity, age, and sex, there is little recent information about the representation of these groups in clinical trials.. Participation in cancer clinical trials: race-, sex-, and age-based disparities, Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials, Public attitudes toward participation in cancer clinical trials, Understanding clinical trials in childhood cancer, Improved survival for children and adolescents with acute lymphoblastic leukemia between 1990 and 2005: a report from the Children’s Oncology Group, Adolescents and young adults with cancer: the scope of the problem and criticality of clinical trials, Participation of adolescents with cancer in clinical trials, A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316), Factors influencing enrollment in clinical trials for cancer treatment, Patient income level and cancer clinical trial participation, A systematic review of the factors influencing African Americans’ participation in cancer clinical trials, Effects of health insurance and race on early detection of cancer, Association of insurance with cancer care utilization and outcomes, Insurance status, comorbidity level, and survival among colorectal cancer patients age 18 to 64 years in the National Cancer Data Base from 2003 to 2005, Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment, Cooperative groups and community hospitals. Incorporate error reduction strategies and consider regional variations in the standards of care and their effect on trial results. The local community was reached through local media outreach, public awareness advertisements, and engagement of local site liaisons. Therefore, a thorough understanding of the nature of trial enrollment patterns and barriers to enrollment is of paramount importance. Cross-sectional population-based analysis of all participants in therapeutic nonsurgical National Cancer Institute Clinical Trial Cooperative Group breast, colorectal, lung, and prostate cancer clinical trials in 2000 through 2002. Engage global partners to advance regulatory science and public health solutions. Patients and research staff may experience psychologic effects such as loss of trust and morale. Surveillance Epidemiology, and End Results (SEER) Program (. Butts CA, Socinski MA, Mitchell P, et al. U.S. Census Bureau. Kaposi sarcoma is excluded due to the HIV/AIDS epidemic during the 1980s and early 1990s; thyroid cancer is excluded because of overdiagnosis and increasing survival inflation. 6, clinical trial accruals as a proportion of ALL cases in the United States during 2000 to 2009 drops precipitously for patients age 15 to 20. 10.Pishvaian MJ, Blais EM, Brody JR, et al.
Faster accrual would enable trials to be conducted more quickly. The NCTN Budget. U.S. Department of Health and Human Services. Stewart JH, Bertoni AG, Staten JL, Levine EA, Gross CP. | On the one hand, eligibility must be sufficiently narrow to produce a treatment effect that is approximately consistent across the cohort. The US Food and Drug Administration (FDA) released the ‘Drugs Trials Snapshots’ report for 2019 , an overview of the demographic characteristics of participants in clinical trials for drugs that gained approval by the regulatory agency during the past year.. Annual Report to the Nation on the status of cancer, 1975-2011, featuring incidence of breast cancer subtypes by race/ethnicity, poverty, and state. Accrual data from the National Cancer Institute Cancer Therapy Evaluation Program (CTEP) were provided by Steve Friedman, Michael Montello, Troy Budd, and Samantha Finnegan via the Freedom of Information Act. About Streamline and advance bio-bank regulatory issues. The red bars indicate the adolescent and young adult (AYA) age group. The Impact of African Ancestry on Prostate Cancer Disparities in the Era of Precision Medicine. Kantor O, Chang C, Yao K, Boughey J, Roland C, Francescatti AB, Blair S, Dickson Witmer D, Hunt KK, Nelson H, Weiss A, Oseni T. Ann Surg Oncol. Utilizing data from a prospective barriers study, this observation was confirmed.13,66 Thus, the evidence to date of income disparities in trial enrollment is fairly consistent.61 Given that trial treatment costs are not substantially different than nontrial treatment costs,67 this suggests that marginal direct costs play a role. DOI: 10.1200/EDBK_156686 American Society of Clinical Oncology Educational Book
We have shown data indicating a compelling relationship between the incidence of clinical trial enrollments and improvements in cancer population survival outcomes. Increase in Absolute Percentage of Annual 5-Year Cancer-Specific Survival Rates Since 1973 to 1975 by Calendar Year and Age, Baseline is 1973 to 1975 average. The literature indicates that structural barriers preclude patient participation in trials for half of all cancer patients. 2020 Dec 8;11(12):1471. doi: 10.3390/genes11121471. Office of Inspector General. Results: All relationships are considered compensated. As shown in Fig. 2014 Apr 1;120 Suppl 7(0 7):1091-6. doi: 10.1002/cncr.28575. Often researchers using Facebook attempt to recruit from the initial audience prior to forming a relationship. DESIGN, SETTING, AND PATIENTS: Cross-sectional population-based analysis of all participants in therapeutic nonsurgical National Cancer Institute Clinical Trial Cooperative Group breast, colorectal, lung, and prostate cancer clinical trials in 2000 through 2002. The local sites were offered additional site funding for accelerated recruitment and START educational teleconferencing. 2). Advertisers, Journal of Clinical Oncology Under this rubric, greater participation leads to greater generalizability, which leads to better cancer population outcomes. TAPUR Study, Terms of Use | Privacy Policy | This inverse relationship between age and trial enrollment fraction was consistent across racial and ethnic groups. In the United States, the practice of paying patients for trial participation is widespread, but also contentious, highly variable, and lacking in general guidance.122 One concern is that a payment inducement might alter a subject’s assessment of potential risks or impair their judgment, although there is little evidence that payment inducements do or do not affect assessment.123,124 A careful calibration of the size of any monetary incentive would be necessary to avoid undue influence.125, Measures to address socioeconomic disparities in recruitment may have a preferentially beneficial impact on minority patients. This model has been the basis for multiple studies examining barriers to clinical trial participation.13-15 The model indicates that after cancer diagnosis and a clinic visit, an assessment of trial availability is made to identify whether a trial exists at the institution for the patient’s histology and stage. 2021 Jan 22:1-13. doi: 10.1007/s40487-021-00140-w. Online ahead of print. The trial may then be offered to the patient, at which point the patient makes a decision about whether to participate. Paper presented at: National Cancer Institute American Society of Clinical Oncology Cancer Trial Accrual Symposium: Science and Solutions; April 2010; Bethesda, MD. Clinical trial accrual to cancer case ratios were evaluated using a database of residents at the continental United States seen at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins from 2005 to 2007. Information and communication in the context of a clinical trial, Underrepresentation of patients 65 years of age or older in cancer-treatment trials, Participation of patients 65 years of age or older in cancer clinical trials, Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration, Impact of the year 2000 Medicare policy change on older patient enrollment to cancer clinical trials, Barriers to clinical trial participation by older women with breast cancer, Survey of oncologists’ perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials, Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials, The National Institute on Aging and the National Cancer Institute SEER collaborative study on comorbidity and early diagnosis of cancer in the elderly, Cancer burden in the aged: an epidemiologic and demographic overview, Participation in surgical oncology clinical trials: gender-, race/ethnicity-, and age-based disparities, The impact of socioeconomic status and race on trial participation for older women with breast cancer, Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT), Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial, Special populations recruitment for the Women’s Health Initiative: successes and limitations, Minority recruitment in the prostate cancer prevention trial, Patient income level and cancer clinical trial participation: a prospective survey study, Incremental treatment costs in national cancer institute-sponsored clinical trials, Potential favorable impact of the affordable care act of 2010 on cancer in young adults in the United States, The distinctive biology of cancer in adolescents and young adults, Adolescents and young adults with cancer: what will it take to improve outcome, Delays in cancer diagnosis in underinsured young adults and older adolescents, Intergroup Trial C10403: a pediatric treatment approach to improve outcomes in adolescents and young adults with acute lymphoblastic leukemia, Long-term outcome of a pediatric-inspired regimen used for adults aged 18-50 years with newly diagnosed acute lymphoblastic leukemia, How NCCN guidelines can help young adults and older adolescents with cancer and the professionals who care for them, Pediatric-like therapy for adults with ALL, Treatment outcome in young adults and children >10 years of age with acute lymphoblastic leukemia in Sweden: a comparison between a pediatric protocol and an adult protocol, Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: a phase II study by the Japan Adult Leukemia Study Group, Excellent outcomes for adolescents and adults with acute lymphoblastic leukemia and lymphoma without allogeneic stem cell transplant: the FRALLE-93 pediatric protocol, Adolescents and young adults with acute lymphoblastic leukemia have a better outcome when treated with pediatric-inspired regimens: systematic review and meta-analysis, Comparison of the results of the treatment of adolescents and young adults with standard-risk acute lymphoblastic leukemia with the Programa Español de Tratamiento en Hematología pediatric-based protocol ALL-96, Acute lymphoblastic leukemia in adolescents and young adults in Finland, What determines the outcomes for adolescents and young adults with acute lymphoblastic leukemia treated on cooperative group protocols? The U.S. Food and Drug Administration (FDA) has provided no specific guidance on the use of social media in clinical research.107 The Recruitment Information Sheet states that in the case of direct advertising, the information and mode of communication should be reviewed by the IRB for evidence of coercion or implication of benefits to participation. Survival data were obtained from SEER 9 Regions.75 Kaposi sarcoma is excluded from the survival statistic because the HIV/AIDS epidemic occurred during the 1980s and early 1990s, which substantively altered the overall cancer survival rate in AYAs during those years. Case-linked analysis of clinical trial enrollment among adolescents and young adults at a National Cancer Institute-Designated comprehensive cancer center, Adolescent and young adult patients with cancer: a milieu of unique features, Children’s Oncology Group’s 2013 blueprint for research: adolescent and young adult oncology, Enhancing adolescent and young adult oncology research within the National Clinical Trials Network: Rationale, progress, and emerging strategies, Survival patterns in teenagers and young adults with cancer in the United Kingdom: Comparisons with younger and older age groups, The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations, The global conduct of cancer clinical trials: challenges and opportunities, Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy, Exploring the viability of using online social media advertising as a recruitment method for smoking cessation clinical trials, An examination of eClinical Technology usage and CDISC standard adoption, Participation of the elderly population in clinical trials: barriers and solutions, Can older cancer patients tolerate chemotherapy? Proposed Steps to Plan Digital Recruitment Campaigns109, Patients with concomitant illnesses are often excluded from trials to ensure safety and to isolate the cancer as the primary source of morbidity in the patient. Inevitably, the decision about whether to participate in a trial will reflect a patient’s personal preferences, which may also be influenced by family and friends.38, Some proportion of patients are influenced by altruistic motivations.15 However, the majority of patients are (appropriately) concerned primarily with finding the best possible treatment of their disease.15,39,40 In the absence of other barriers, a patient who believes that the best possible treatment option is to be found in a clinical trial is more likely to participate in that clinical trial.33, Patients have frequently reported being uneasy or fearful about the prospect of participating in a clinical trials.41 In some cases this could be due to a residual mistrust of medical science due to past abuses, such as the infamous Tuskegee Syphilis Study or the history of human experimentation with radiation following World War II.42,43 Attention in the last several decades to the process of rigorous consent may have reduced these fears, especially for younger generations of patients. Fortunately, CGA time requirements have led to the development of prescreening tools used to determine whether full screening with CGA is required, though there are inconsistent results regarding the validity of these tools.118-120 More generally, it is important to develop prediction models capable of estimating risk of chemotherapy for octogenarians and nonagenarians with regards to toxicity and hospitalization.115 A comprehensive approach to the evaluation of the older patient with cancer considers the patient's residence and fitness and includes an interdisciplinary team to provide individualized care.121, If marginal direct costs are prohibitive for some patients, then measures to cover these costs would remove a critical barrier to enrollment. Conquer Cancer Foundation Use finite resources more efficiently, share knowledge, and optimize inspection resources. Clinical research is vital to the discovery of new cancer treatments that can enhance health and prolong life for cancer patients, but breakthroughs in cancer treatment are limited by challenges recruiting patients into cancer clinical trials (CT). START: a phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. Cancer. With over 70,000 AYAs diagnosed with cancer in the United States annually, and 7600 diagnosed in Canada, this group represents approximately 4–5% of the North American adult cancer population [1,2,3].Lack of enrolment of AYA onto cancer clinical trials (CCT) has been the focus of … doi: 10.1136/bmjopen-2020-039928. Howlader N, Noone AM, Krapcho M, et al (eds). Abuabara K, Silverberg JI, Simpson EL, Paller AS, Eichenfield LF, Bissonnette R, Krueger J, Harris JE, Dalfonso L, Watkins SE, Crawford JM, Thaçi D, Guttman-Yassky E. BMJ Open. Crit Care Med. The first used a web-based survey to engage patients in their decision-making process.15 Among the numerous demographic and socioeconomic factors examined, patients with lower income (less than $50,000 per year) were 29% less likely to participate in trials than higher-income patients. One approach would be to cover the excess costs of clinical trials for all patients, because even in an insured population, copays and coinsurance have been shown to deter clinical trial participation.53 Another potential approach would be to provide payments to patients. Another important reason to increase clinical trial accrual is to improve the generalizability of clinical trial results. American Cancer Society. Relationships may not relate to the subject matter of this manuscript. 36
Unfortunately, this has the effect of excluding many patients from trials, especially older patients with a greater comorbid burden.28,57,58 Further, trials typically exclude patients with prior cancers, even as the population of cancer survivors in the United States is growing and which currently numbers around 15 million.111 In this context, one strategy to remove barriers to trials would be to remove unnecessary eligibility criteria. NCT02043587. Although the total number of trial participants increased during our study period, the representation of racial and ethnic minorities decreased. A better approach may be to grow and engage your audience first, before patients are recruited.110, TABLE 2. But, just how important are clinical trials for progress against cancer? This is an ideal group in which to examine the impact of clinical trials given that since 1980, AYA patients have had a slower rate of cancer population survival improvement than younger and older age groups by 5% to 13% in absolute differences (Fig. This site needs JavaScript to work properly. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc. Vet all communications for sensitivity and potential for harm, even if the content does not require IRB approval. To the extent that trials are more inclusive with respect to comorbid or other conditions, adequately represent the demographic makeup of the United States, and are easier to pay for, the generalizability of trials would likely improve. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. The strategies target physicians, research staff, local sites, patients, and the local community. Clinical Trial Enrollment Patterns for Multiple Studies in the Literature. Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma. As a guide to understanding the trial decision-making process, we present a simplified flow diagram (Fig. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Efforts to improve trial enrollment of cancer patients are clearly needed. 3 Thus, a large gap exists between trial participation rates and the willingness of patients to participate, … Fewer barriers to trial participation would enable trials to be completed more quickly and would improve the generalizability of trial results. The Cancer Therapy Evaluation Program (CTEP) of NCI’s Division of Cancer Therapy and Diagnosis has patient accrual data from phase I, II, and III cancer treatment trials conducted by the NCI cooperative groups and NCI-designated cancer centers. Context: Washington, DC: The National Academies Press; 2010. Clinical trials are the key step in advancing new treatments from the research setting to the cancer care clinic. Accrual proportion (%) was estimated from cancer incidence in SEER 9, SEER 13, and SEER 18 regions and population data from the U.S. Census Bureau.73,75-77. An important note is that under this model, patient attitudes toward clinical trial participation only come into play at the end of an otherwise long process. International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale. The survival disparity between AYAs and other patients may be due in part to early achievements in improving survival for AYAs, after which resources were directed toward research in other age groups. Such an approach would improve access to trials, especially for older patients, and—because histology and stage explain the vast majority of variation in cancer outcomes, rather than comorbid conditions—would result in only limited loss of power to test the efficacy of new treatments.28 One study estimated that if protocol exclusions related to organ system abnormalities and functional status were relaxed, participation of older patients in clinical trials would approach 60%, in line with cancer population rates.51, Researchers should also consider increasing the number of trials targeted to older patients, with due consideration to potential safety issues.112 Several trials found no more toxicity in elderly patients in chemotherapy-containing trials than in younger patients, when patients were appropriately selected.113,114 However, when chemotherapy was given to patients age 80 or older, high risk of hospitalization or treatment discontinuation as a result of toxicity (even with frequent dose modifications) were observed.115 The International Society of Geriatric Oncology recommends the use of comprehensive geriatric assessment (CGA) in cancer patients older than age 70.116,117 The CGA is time consuming, often leading to physician abandonment. Online ahead of print. Gossen R. Great Facebook pages for research sites. Yet few adults with cancer participate in trials, with typical estimates around 5%, 1 even though most patients express a willingness to participate. Summary recommendations centered on the patient, community, physician/provider, and site.97 This symposium led to many recommendations at each level consistent with the overarching view that one size does not fit all when it comes to recruitment to clinical trials. The heavy curves represent 2007 to 2009 and the thin curves 2001 to 2003. Domestic trials may also partner with international collaborators to augment trial enrollment. The predominant reason that trials fail to complete is poor accrual.126 These failures represent a lost investment on the part of funding agencies. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and … doi: 10.1371/journal.pmed.0030019. Conclusions: For the SELECT trial, several strategies specifically addressed patients with low socioeconomic status.61,62 SELECT provided funds to sites semiannually to offset travel expenses and meals, in addition to providing patient retention items. Permissions, Authors Adolescents and young adults (AYA), aged 15 to 39 years, represent a unique subset of cancer patients. Joinpoint analysis identified two inflections, ages 17 and 20, during which the 5-year survival rate decreased 23%. 2318 Mill Road, Suite 800, Alexandria, VA 22314, © 2021 American Society of Clinical Oncology. A comparison of Children’s Cancer Group and Cancer and Leukemia Group B studies. The National Cancer Institute’s (NCI) cooperative group clinical trial treatment program caps enrollment for its funded groups at 17,000 total patients per year, representing 1% of the estimated 1.7 million new cancer diagnoses in the United States in 2015.4, 5, To understand the effect of clinical trial participation on cancer population mortality and survival, one might imagine a counterfactual system in which the cancer clinical trial participation rate was much higher. Globalization of clinical research in the process are clinical trials on prostate cancer disparities in the States! Significantly across racial/ethnic and age groups with cancer pathway through which a patient may receive care all this... Suite 800, Alexandria, VA 22314, © 2021 American Society of clinical educational! 2005 Feb 1 ; 103 ( 3 ):483-91. doi: 10.3390/genes11121471 for! Society of clinical Oncology sponsored a cancer clinic is asparaginase a critical component in the end, Kaplan-Meier. 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