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The MD Anderson Cancer Center Moon Shots Program®: A Global Priority
Introduction
The University of Texas MD Anderson Cancer Center’s Moon Shots Program® is a collaborative effort to accelerate the development of scientific discoveries into clinical advances that save patients’ lives. The program was inspired by President John F. Kennedy’s speech in Houston in 1962, where he declared our nation’s mission to go to the moon. Launched in 2012, the Moon Shots Program® began under the leadership of then-President of the University of Texas MD Anderson Cancer Center, Dr. Ronald DePinho. During an interview describing the motivation behind the program, he stated, “Humanity urgently needs bold action to defeat cancer. I believe that we have many of the tools we need to pick the fight of the 21st century. Let us focus our energies on approaching cancer comprehensively and systematically, with the precision of an engineer, always asking … ‘What can we do to directly impact patients? ’”
Since its inception, the Moon Shots Program® has expanded to 13 multidisciplinary teams of clinicians and researchers tasked with developing comprehensive approaches to advance cancer prevention, early detection, and treatment to improve the lives of patients and reduce cancer mortality. In addition to launching innovative clinical trials and accelerating scientific research, the achievements of the Moon Shots Program® include public awareness campaigns for cancer prevention. These accomplishments include contributing to legislation banning teenage tanning bed use in Texas and other states, expanding a smoking cessation program, and expanding HPV vaccination efforts in the United States and globally. Furthermore, significant efforts have been made to detect cancer early when patient outcomes can be profoundly impacted. In this chapter, we highlight examples of the program’s success in reducing global cancer mortality, using three salient examples: promoting smoking cessation as part of the Lung Cancer Moon Shot, enhancing HPV vaccination as part of the HPV Moon Shot, and facilitating early detection of pancreatic cancer as part of the Pancreatic Cancer Moon Shot.
Lung Cancer Moon Shot: Smoking Cessation Initiatives
Smoking is a significant public health problem and is currently responsible for nearly 6 million premature deaths each year worldwide (including 480,000 in the United States alone), with estimates as high as 8 million deaths annually by the year 2030. Tobacco plays a causal role in at least 15 types of cancer , and accounts for 85% of lung cancer cases and approximately 30% of the attributable risk for overall cancer mortality. While there are several approved smoking cessation medications, including varenicline, bupropion, and several types of nicotine replacement therapy products (NRT), each with demonstrated efficacy against placebo, there is considerable heterogeneity in treatment response. Individual variation in response to medication, in particular, suggests that “one size does not fit all” and improving our understanding of individual-level predictors of treatment outcome is critical to the advancement of the field. One of our major challenges lies in determining how to optimize a smoker’s chance of achieving initial treatment success and what approaches should be taken at treatment failure. The potential to match smokers to a specific initial treatment based on factors observable prior to quitting (at baseline) has been investigated using a variety of behavioral, genetic, biological, affective, and neurobiological factors in an effort to predict the response to pharmacotherapy. However, matching patients to a “rescue” treatment after initial failure remains unclear, and there is little guidance for providers to select the optimal follow up treatment.
A second important challenge is the delivery of the most effective treatment to the largest group of smokers. National surveys show that less than one-third of smokers who attempt to quit actually receive counseling and pharmacotherapy. Traditional state “quitlines,” while offering a service to a large number of smokers at any one time, are highly underutilized and, in comparison to the most effective treatment approaches using both counseling and pharmacotherapy, are much less effective.
Smoking Cessation Solutions
To achieve the goal of changing clinical practice for smoking cessation, we initiated a series of prospective clinical trials and conducted an extensive analysis of genetic information from previously completed trials that collectively examined the relationship between specific individual-level predictors (behavioral, affective, neurophysiologic) and response to smoking cessation treatments. While each of these trials individually addressed specific research questions, the collective goal in this effort was to extract critical information from each trial regarding individual differences that can be used to predict, or personalize, response to various treatments, including pharmacotherapy and behavioral treatments. These factors include age, sex, motivation, nicotine dependence, affect, psychiatric comorbidity (depression), neural and behavioral indicators of brain deficits in reward, metabolic (nicotine metabolic ratio), and genetic profiles, and importantly, the specific treatment pathways (which medications or series of medications they use) before they successfully quit. In parallel, we also examined the optimal treatment configuration for delivering smoking cessation in the context of lung cancer screening, focusing on older age, heavy smokers who have not yet quit, and for whom additional genetic data on lung cancer risk will be available. We expect this study to provide additional individual-level information on predictors of treatment outcome for this unique population that can be related to lung cancer risk, and may further the development of a predictive algorithm.
In addition to identifying predictive markers of response, we have also worked to promulgate the basic cessation treatment model developed and refined within the MD Anderson Cancer Center Tobacco Treatment Program (TTP). TTP began modestly in 2006 with clinician referral, later incorporating automated referral using electronic health records. The program currently treats nearly 1200 new patients at MD Anderson and conducts more than 11,000 patient visits per year. The TTP is comprehensive, consisting of individualized smoking cessation counseling, over-the-counter and prescription pharmacotherapy, and the integrated assessment and treatment of mental health conditions and other psychosocial concerns. The TTP plan consists of an initial in-person consultation (60–90 min), plus 6–8 subsequent follow up treatment sessions conducted over an 8- to 12-week period, 95% of which were conducted by telephone. Treatment involves behavioral counseling for smoking cessation and other psychologic or psychiatric interventions, as needed, for related mental health issues. Counseling is based on the principles of motivational interviewing and social cognitive behavioral problem solving. Patients typically receive 10–12 weeks of pharmacotherapy, including nicotine replacement (patch or lozenge), bupropion, and varenicline, either alone or in various combinations. Each treatment plan is personalized in terms of counseling session number, duration, content, and choice of pharmacotherapy, which followed a previously defined protocol consistent with the National Comprehensive Cancer Network guidelines.
To determine the effectiveness of long-term abstinence and evaluate differences between patients with and without cancer, we analyzed data from more than 3000 individuals who received smoking cessation treatment through the MD Anderson TTP. Overall self-reported abstinence rates for the sample were 45.1% at 3 months, 45.8% at 6 months, and 43.7% at 9 months for the multiply imputed data (averaged over 10 imputed data sets), 41.1% at 3 months, 39.5% at 6 months, and 35.6% at 9 months for intention-to-treat (ITT); and 44.5% at 3 months, 45.6% at 6 months, and 43.7% at 9 months for respondents only. We also obtained expired carbon monoxide levels during all in-person visits. Congruence between self-reported, 7-day point prevalence abstinence and expired carbon monoxide was 93% for less than 8 ppm and 87% for carbon monoxide levels of less than 6 ppm. No significant differences in abstinence for the multiply imputed sample were found when comparing no cancer history versus cancer history at the 3-month (relative risk [RR], 1.03; 95% CI, 0.93–1.16; P = 0.55), 6-month (RR, 1.05; 95% CI, 0.94–1.18; P = 0.38), and 9-month (RR, 1.10; 95% CI, 0.97–1.26; P = 0.14) follow ups, as well as in the longitudinal models (RR, 1.06; 95% CI, 0.95–1.18; P = 0.27). In addition, no significant differences were noted in the comparisons of no cancer history versus those with and without smoking-related cancer (RR, 1.02; 95% CI, 0.90–1.14; P = 0.8) or patients with a history of cancer (RR, 1.04; 95% CI, 0.89–1.20; P = 0.64).
TTP dissemination occurs through two major initiatives within our Moon Shots Program®. First, we developed and oversaw the clinical content within an MD Anderson Cancer Center-certified tobacco treatment specialist training program (CTTS). This program successfully disseminates the TTP model to other health care systems and health care providers through direct training and supervision of counselors and providers from around the country. The second initiative provides clinical content and expertise for Project ECHO (Extension for Community Healthcare Outcomes), a telementoring program that provides expert consultation to providers across the country, based on the TTP treatment model.
HPV Cancer Moon Shot: The Global Burden of HPV-Associated Cancers
Human papillomavirus (HPV) infection causes nearly 5% of all new cancer cases globally, affecting the uterine cervix, vulva, vagina, anus, penis, and oropharynx. With approximately 530,000 new cases annually, cervical cancer is the most common HPV-associated cancer worldwide, compared to other HPV-associated cancers (113,000 annual cases). This global picture is driven by low- and middle-income countries (LMICs), where approximately 85% of new cases of cervical cancer occur mainly due to the lack of organized cervical screening and HPV vaccination programs ( Fig. 62.1 ). With the evolution of sexual practices in recent decades, an increasing incidence of HPV-related anal and oropharyngeal cancers has been observed. ,
Unlike LMICs, where cervical cancer is by far the most common HPV-related cancer, widespread screening programs in high-income countries (HICs) have dramatically reduced the burden of cervical cancer. To date, the burden of HPV-associated noncervical cancers outweighs that of cervical cancer in HICs. In the United States, where an average of 44,000 HPV-associated cancers are reported annually, oropharyngeal cancers (12,600) are more common than cervical cancers (9700).
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