Patient-Centered Management of Chemotherapy-Induced Nausea and Vomiting

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1 Clear and accurate communication between patients and health care teams is the key to successfully controlling chemotherapy-induced nausea and vomiting. Roseate Spoonbill_2005. Photograph courtesy of Henry Domke, MD. Patient-Centered Management of Chemotherapy-Induced Nausea and Vomiting Steven Grunberg, MD Background: Oncology providers frequently underestimate the incidence of chemotherapy-induced nausea and vomiting (CINV), and patients often are reluctant to report symptoms. Inadequate patient-provider communication is a significant barrier to optimal management of this debilitating toxicity. Methods: The author reviews relevant published data and methods to optimize the clinical care of patients receiving chemotherapy with moderate-to-high emetogenic potential. Results: Patient reticence plus physician expectations that patients will report symptoms accurately lead to lapses in communication and suboptimal clinical care. Conclusions: Communication strategies should serve to encourage patients to share the responsibility for establishing goals of therapy and understanding the risks and benefits of their selected antiemetic regimen, thereby becoming active participants in their own cancer care. From the Division of Hematology/Oncology, Vermont Cancer Center, University of Vermont College of Medicine, Burlington, Vermont. Address correspondence to Steven Grunberg, MD, Division of Hematology/ Oncology, Vermont Cancer Center, University of Vermont College of Medicine, 89 Beaumont Avenue Given Building E214, Burlington, VT steven.grunberg@uvm.edu Dr. Grunberg is a consultant for Helsinn Therapeutics, Inc, Merck & Company, Inc, and Tesaro. He is also a shareholder of Merck & Company, Inc, and serves on its advisory board & speakers bureau. Introduction Despite numerous advances in the understanding and treatment of chemotherapy-induced nausea and vomiting (CINV), control of emesis remains a challenge. 1 This scenario is due in part to the underappreciation of the extent of residual nausea/vomiting and the underuse of guidelines based on state-of-the-art practices and carefully conducted clinical trials. Persistence of this problem also may be due to the existence of additional as yet unidentified relevant neurotransmitter pathways and to individual variability in drug metabolism and sensitivity. Provider-patient communication is essential to minimize and prevent symptoms of nausea and vomiting associated with moderately and highly emetogenic chemotherapy. Well-designed communication strategies can ensure that providers and patients share in the responsibility of establishing treatment goals and that patients receive appropriate education regarding their prescribed therapy, including potential adverse effects. The use of assessment tools can facilitate early reporting of symptoms to the health care team and identification of necessary modifications to the antiemetic regimen. This article examines the discrepancies between provider and patient perceptions of nausea and vomiting, the reasons for these discrepancies, and elements of evidencebased practice and patient-centered care that can ensure CINV prophylaxis and management are optimized for individual patients. Understanding the Patient Experience The existence of delayed vomiting could not be appreciated until observations were collected during the appropriate time period. Results of early antiemetic trials were based solely on observations during the first 24 hours 10 Cancer Control April 2012, Vol. 19, No. 2 Supplement

2 after chemotherapy, while patients were still hospitalized. Formal observation during the following days was not common practice, although it was known that a certain percentage of patients would require rehospitalization due to recurrent emesis. In 1985, Kris and colleagues 2 contacted a series of patients who had good acute antiemetic control daily for 4 days after treatment with cisplatin and demonstrated that significant nausea and vomiting commonly reappeared 48 to 72 hours after administration of the chemotherapeutic agent. However, this study was performed when standard antiemetic therapy consisted of metoclopramide and dexamethasone; one might question whether this same observation would be reported after the introduction of 5-hydroxytryptamine-3 (5-HT 3 ) s, as such persistent emesis did not appear to be that common. In a study performed after the introduction of ondansetron, 3 prospective estimates by physicians and nurses of the incidence of nausea and vomiting in their patients receiving chemotherapy were compared with actual occurrences of nausea and vomiting recorded by the patients in a 6-day diary. Comparison of the physician and nurse predictions with the patient-generated data demonstrated a significant underestimation of the actual incidence of delayed nausea and vomiting. Although this initial study was performed in the United States and Europe, later studies with similar methodology showed delayed nausea and vomiting was similarly underestimated in patients in Latin America 4,5 and Taiwan. 6 Collectively, these studies emphasize the importance of communication regarding nausea and vomiting, particularly during the first several days after chemotherapy, when memories are still fresh, rather than relying on recall of events several weeks later. Assessment of Nausea and Vomiting Identification of CINV requires accurate, simple, and timely data collection. Although a 6-day diary was used in the initial antiemetic studies, such an instrument may be too complex for regular use and analysis in a busy oncology practice and too much of an effort for a patient receiving active chemotherapy to complete. Instruments such as the MASCC (Multinational Association for Supportive Care in Cancer) Antiemesis Tool, 7 a questionnaire validated for 3-to-4-day recall of emetic events by the patient or caregiver, can be administered on a single occasion several days after chemotherapy to collect valuable data specific to an individual patient. Data collected with assessment instruments can play an important role in emphasizing to patients that their health care team is not only concerned about their tumor response but also their quality of life. Furthermore, although practice guidelines and findings from clinical investigations regarding large populations are respected by physicians as scientifically accurate, observations regarding physicians own patients have been shown to be more effective in leading to improved guideline adherence and prescribing practices, particularly when compared with passive didactic strategies such as distribution of pertinent literature or expert lectures. 8 The collection of data describing nausea and vomiting will have limited value unless providers and patients have set shared goals regarding treatment. The goal of effective supportive care should be to decrease or eliminate toxicities without compromising antineoplastic therapy. Accurate and timely reporting of symptoms implies a responsibility for active participation by both the health care team (physician, nurse, pharmacist) and the patient. Salsman et al 9 conducted a study on the obstacles to effective communication regarding CINV as perceived by physicians and patients. Both physicians and patients wanted to limit the number of medications administered, which is certainly a reasonable goal, provided that decreasing the number of medications does not compromise the efficacy of the treatment regimen. A percentage of physicians and patients suggested that toxicities such as emesis were indicative of the efficacy or potency of antineoplastic treatment. Although this belief was held in common by physicians and patients, it is not supported by clinical data and should be discouraged, as it may provide a rationale to limit aggressive and effective antiemetic treatment. Of utmost concern was the fi nding that patients wanted to be strong and not complain too much to their physicians, whereas physicians believed that patients would certainly report any significant symptoms. This combination of patient reticence and physician assumption may lead to severe underreporting and underestimation of treatment-related toxicities, resulting in the provision of suboptimal supportive care interventions. Thus, the ability to successfully intervene with preventive and therapeutic tools remains a question of clear and accurate communication. Distinguishing Between Nausea and Vomiting Another potential limitation to effective antiemetic treatment is the failure to distinguish between nausea and vomiting. Traditionally, the terms are used together ( chemotherapy-induced nausea and vomiting ), with the assumption that nausea is simply a feeling that presages vomiting or a residuum that follows vomiting. It is now appreciated that nausea is a phenomenon related to but distinct from vomiting, with its own natural history, mechanisms of action, and potential remedies. Although vomiting is an objectively observable and easily measurable event, nausea is a subjective sensation that is more difficult to quantify and may appear in conjunction with or independent of vomiting. Measurement of nausea is made more difficult by the many different terms used to describe or identify this sensation. Numerous surveys in the United States 10 and Europe 11 have documented that, with current antiemetic interventions, nausea is a much greater problem than vomiting in both the acute and delayed settings. This is particularly true for delayed nausea experienced by patients with breast cancer receiving cyclophosphamide/ anthracycline chemotherapy. 3 Notably, several treatments suggested to be active specifically against nausea (eg, cannabinoids, megestrol, olanzapine) have also been sug- April 2012, Vol. 19, No. 2 Supplement Cancer Control 11

3 gested to have activity as appetite stimulants for cancer patients If agents such as the cannabinoids can prevent nausea when administered at lower doses than those recommended to prevent emesis, the intensity of toxicities associated with acute and chronic administration of these agents may also be decreased. Further investigation of a potential etiologic relationship between nausea and cancer anorexia/cachexia may lead to insights of value to both of these fields. Applying Evidence-Based Antiemetic Strategies Antiemetic guidelines from the American Society of Clinical Oncology, 15 the National Comprehensive Cancer Network, 16 the European Society for Medical Oncology, and the MASCC 17 are similar. Differences can be attributed to the level of rigor demanded for data to be considered and included in their individual designs (ie, whether the guidelines should be more evidence based or more consensus based and comprehensive ). Table 1. Emetogenic Potential of Antineoplastic Agents Without Prophylactic Antiemetics Predicted Emetogenic Potential Antineoplastic Agents High > 90% AC regimen (doxorubicin or epirubicin + cyclophosphamide) Carmustine > 250 mg/m 2 Cisplatin 50 mg/m 2 Cyclophosphamide > 1500 mg/m 2 Dacarbazine Doxorubicin > 60 mg/m 2 Epirubicin > 90 mg/m 2 Hexamethylmelamine* Ifosfamide >10 g/m 2 Mechlorethamine Procarbazine* Streptozocin Moderate 30% 90% Aldesleukin > million IU/m 2 Alemtuzumab Amifostine > 300 mg/m 2 Azacitidine Bendamustine Carboplatin Cisplatin < 50 mg/m 2 Clofarabine Cyclophosphamide* Cyclophosphamide 1500 mg/m 2 Cytarabine > 1000 mg/m 2 Daunorubicin Doxorubicin 60 mg/m 2 Epirubicin 90 mg/m 2 Idarubicin Ifosfamide 10 g/m 2 Imatinib* Interferon alpha 10 million IU/m 2 Irinotecan Melphalan Methotrexate 250 mg/m 2 Oxaliplatin Temozolomide* Vinorelbine* Low 10% < 30% Aldesleukin 12 million IU/m 2 Amifostine 300 mg/m 2 Bortezomib Cabazitaxel Capecitabine* Catumaxomab Cetuximab Cytarabine < 1000 mg/m 2 Docetaxel Doxorubicin hydrochloride liposomal injection Eribulin Etoposide* Etoposide Everolimus* Floxuridine Fludarabine* 5-Fluorouracil Gemcitabine Interferon alpha > 5 < 10 million IU/m 2 Ixabepilone Lapatinib* Lenalidomide* Methotrexate > 50 < 250 mg/m 2 Mitomycin Mitoxantrone Paclitaxel Paclitaxel-albumin bound Panitumumab Pemetrexed Pentostatin Pralatrexate Romidepsin Sunitinib* Tegafur-uracil* Temsirolimus Thalidomide* Thiotepa Topotecan Trastuzumab Minimal < 10% Alemtuzumab Asparaginase Bevacizumab Bleomycin Bortezomib Busulfan Cetuximab Chlorambucil* 2-Chlorodeoxyadenosine Cladribine Cytarabine < 100 mg/m 2 Decitabine Denileukin diftitox Erlotinib* Fludarabine Gefi tinib* Hydroxyurea* Interferon alpha < 5 million IU/m 2 Ipilimumab L-phenylalanine mustard* Methotrexate* Methotrexate < 50 mg/m 2 Nelarabine Ofatumumab Panitumumab Pegaspargase Peginterferon Rituximab Sorafenib* Temsirolimus 6-Thioguanine* Trastuzumab Valrubicin Vinblastine Vincristine Vinorelbine *Oral agent Data from references Cancer Control April 2012, Vol. 19, No. 2 Supplement

4 Generally, antiemetic guidelines divide chemotherapeutic agents into four emetogenic categories: high, moderate, low, and minimal (Table 1). 18 However, in recent iterations of several guidelines, a category of high/moderate emetogenicity has been introduced. 15 This new category is unique in that it specifically contains regimens based on a two-drug chemotherapeutic combination (cyclophosphamide/anthracycline), where all previous scales ranked only the emetogenicity of single agents. 18 Although both of the chemotherapeutic agents involved are considered individually to be moderately emetogenic, the combination is thought to fall at the high end of moderate. Because regimens used for high/moderate antiemetic protection are more similar to those used for high antiemetic protection than to those used for moderate antiemetic protection, it is possible that the high/moderate category will be formally subsumed over time into the high category. As indicated in most antiemetic guidelines, the combination of a 5-HT 3 and a corticosteroid (eg, dexamethasone) remains the mainstay of treatment for patients receiving chemotherapy with high, high/moderate, and moderate emetogenicity (Table 2). For chemotherapy with high and high/moderate emetogenicity, the addition of a neurokinin-1 ( ) is recommended. For most purposes, first-generation 5-HT 3 s (including ondansetron, granisetron, and dolasetron) are considered equally effective. However, because direct single-agent comparisons between first-generation 5-HT 3 s and the second-generation 5-HT 3 palonosetron (in the absence of corticosteroids) have favored palonosetron, 19,20 palonosetron may be recommended as the serotonin of choice for patients receiving chemotherapy with moderate (but not high/ moderate) emetogenicity. Of note, treatment of delayed CINV is not indicated for patients receiving agents with low or minimal emetogenicity, as emesis does not pose a significant problem in this setting Emetogenic Classifi cation Table 2. Common Antiemetic Guidelines Acute Emesis Antiemetics High 5-HT 3 + dexamethasone + High/moderate 5-HT 3 + dexamethasone + Moderate Palonosetron + dexamethasone Low 5-HT 3 or dexamethasone or D 2 Delayed Emesis Antiemetics Dexamethasone + Dexamethasone None Minimal None None D 2 = dopamine-2; 5-HT 3 = 5-hydroxytryptamine-3; = neurokinin-1 Data from references In a recent study, 21 a single dose of intravenous fosaprepitant on day 1 as part of an antiemetic regimen was shown to be as effective as a 3-day course of oral aprepitant for the prevention of acute and delayed emesis from chemotherapy with high emetogenicity. The initial versions of the antiemetic guidelines included tables that were designed with separate columns for acute and delayed emesis, both to emphasize that delayed emesis was a unique problem and to match antiemetic treatment for a particular stage of emesis with the days of greatest risk. However, the extended efficacy of single-dose fosaprepitant and the extended activity of palonosetron allow all major antiemetic therapy to be delivered on day 1 of chemotherapy and make the previous tabular structure with separate columns for treatment of acute and delayed emesis obsolete. Although antiemetic guidelines reflect the best evidence and state-of-the-art reasoning at the time they are published, they are not static documents, and their content is updated as knowledge regarding the etiology and management of emesis evolves. The effectiveness of guideline recommendations should be evaluated between chemotherapy cycles to determine whether modifications to the antiemetic regimen are necessary. Anticipatory emesis may complicate the management of acute and delayed CINV. 22 Other factors related to the malignancy itself, such as bowel obstruction or the development of increased intracranial pressure, may supersede chemotherapy as the primary cause of emesis in a given patient and may require totally different therapies. The tendency toward emesis may be further modified by demographic and lifestyle factors such as gender, age, history of motion sickness or morning sickness, and lack of a history of heavy alcohol use (Table 3). 18 Pharmacokinetic and Pharmacogenomic Considerations More recently, the role of pharmacokinetic and pharmacogenomic factors in antiemetic protection has come to be appreciated. Patients with different levels of expression of components of the cytochrome P450 pathway, which contribute to the metabolism of antiemetic agents, may have different levels of response to these agents. 23 Sensitivity Table 3. Factors Affecting Emetic Susceptibility Demographic Molecular Behavioral Age Gender Alcohol use Motion sickness Morning sickness Cytochrome P450 expression 5-HT 3 receptor mutation 5-HT 3 = 5-hydroxytryptamine-3 Data from reference 18. Previous emesis with chemotherapy Anxiety Expectations April 2012, Vol. 19, No. 2 Supplement Cancer Control 13

5 to emetogens and to antiemetic protection may also be affected by mutations in subunits of the 5-HT 3 receptor itself. 24 A recent study 25 from Malaysia compared emetic response among Chinese, Indian, and Malay patients with the same tumor type treated with similar chemotherapy and antiemetic therapy at the same hospital; it showed that the Chinese patients were most likely to have a severe emetic response to chemotherapy. Correlation of these clinical observations with data generated from genomewide analysis might indicate particular differing genetic areas of interest, which could lead to the identification of additional pathways and mechanisms of importance in the emetic response. As molecular observations become more of a focus, one must remember that protection against emesis should be important to health care professionals because it is important to patients. 26 Studies have demonstrated that the presence or absence of nausea and vomiting during cancer treatment is a major determinant of quality of life. 27,28 In terms of both individual patient care and population science, investigation and development of improved antiemetic therapies are worthwhile endeavors. Overcoming Barriers to Patient-Centered Care Patient-centered CINV management requires meaningful and comprehensive provider-patient interactions in developing accurate, individualized treatment plans based on available evidence and consideration of the preferences, needs, and capabilities of patients and caregivers. 29 Common barriers to patient-centered care include providers lack of time to explain sensitive information and insensitivity to patients emotions and cultural perspectives. Patients may also lack the assertiveness and/or health literacy to advocate for their own health care. Strategies to address these barriers should serve to encourage patients to become active participants in their treatment. Effective methods include the use of electronic medical records (Table 4), telephone counseling and followup by nurses or pharmacists to save patients the difficulty of traveling to an outpatient clinic, and interactive voiceresponse or automated telephone systems to elicit patient Table 4. Using Electronic Medical Records to Facilitate Patient-Centered Care Create checklist of key elements in treatment planning, including psychosocial issues (eg, anxiety, fi nancial stress) Use autopopulate functionality/drop-down menus to prevent errors of omission/transcription Promote guideline adherence by preventing chemotherapy orders before a treatment plan is vetted and approved Coordinate care by automatically sending treatment plan updates to health care team and patient Track patient-reported treatment outcomes Autogenerate patient education materials on antiemetic agents (eg, dosing, adverse effects) Data from reference 30. symptoms. Automated systems have been shown to lead to faster symptom response times and referrals vs phone interviews and to enhance patient discussion of symptoms and quality of life with providers. 30,31 Perhaps one of the most essential elements of patient-centered CINV care is to provide education not only on the roles of physicians, nurses, and pharmacists in treatment and supportive care but also on the roles of patient navigators, social workers, and other health care team members who coordinate care and provide services that address psychosocial issues such as anxiety and financial stress. 29 Conclusions Despite the availability of effective antiemetic agents, control of CINV remains a challenge. Oncology providers frequently underestimate the incidence of this debilitating toxicity, and patients often are reluctant to report symptoms. Clinical decision-making regarding CINV prophylaxis should take into consideration patient risk factors, the emetogenicity of administered agents, and evidencebased guideline recommendations. In addition, providers should encourage patients to share in the responsibility of establishing treatment goals and to strive to eliminate any barriers that may prevent them from being active participants in their own cancer care. References 1. Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008;358(23): Kris MG, Gralla RJ, Clark RA, et al. Incidence, course, and severity of delayed nausea and vomiting following the administration of high-dose cisplatin. J Clin Oncol. 1985;3(10): Grunberg SM, Deuson RR, Mavros P, et al. Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer. 2004;100(10): De Jongh-Garcia C, Poli S, Ananth C, et al. Health care provider perception of nausea and vomiting and patients reported incidence: the Venezuela Emesis Registry. Support Care Cancer. 2005;13(6): Abstract. 5. Erazo Valle A, Wisniewski T, Figueroa Vadillo JI, et al. Incidence of chemotherapy-induced nausea and vomiting in Mexico: healthcare provider predictions versus observed. Curr Med Res Opin. 2006;22(12): Liau CT, Chu NM, Liu HE, et al. Incidence of chemotherapy-induced nausea and vomiting in Taiwan: physicians and nurses estimation vs patients reported outcomes. Support Care Cancer. 2005;13(5): Molassiotis A, Coventry PA, Stricker CT, et al. Validation and psychometric assessment of a short clinical scale to measure chemotherapy-induced nausea and vomiting: the MASCC antiemesis tool. J Pain Symptom Manage. 2007;34(2): Mertens WC, Higby DJ, Brown D, et al. Improving the care of patients with regard to chemotherapy-induced nausea and emesis: the effect of feedback to clinicians on adherence to antiemetic prescribing guidelines. J Clin Oncol. 2003;21(7): Salsman J, Beaumont J, Rosenbloom S, et al. Communicating about chemotherapy-induced nausea and vomiting: a comparison of patient and provider perspectives. Support Care Cancer. 2009;17(1):884. Abstract. 10. Cohen L, de Moor CA, Eisenberg P, et al. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007;15(5): Molassiotis A, Saunders MP, Valle J, et al. A prospective observational study of chemotherapy-related nausea and vomiting in routine practice in a UK cancer centre. Support Care Cancer. 2008;16(2): Storr MA, Sharkey KA. The endocannabinoid system and gut-brain signalling. Curr Opin Pharmacol. 2007;7(6): Loprinzi C, Jatoi A. Antiemetic properties of megestrol acetate. J Palliat Med. 2006;9(2): Navari RM, Brenner MC. Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial. Support Care Cancer. 2010;18(8): Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011;29(31): Ettinger DS, Armstrong DK, Barbour S, et al. Antiemesis: clinical prac- 14 Cancer Control April 2012, Vol. 19, No. 2 Supplement

6 tice guidelines in oncology. J Natl Compr Canc Netw. 2009;7(5): Roila F, Herrstedt J, Aapro M, et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. 2010;21(suppl 5):v232-v Grunberg SM, Warr D, Gralla RJ, et al. Evaluation of new antiemetic agents and defi nition of antineoplastic agent emetogenicity state of the art. Support Care Cancer. 2011;19(suppl 1):S43-S Gralla R, Lichinitser M, Van Der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14(10): Eisenberg P, Figueroa-Vadillo J, Zamora R, et al. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor : results of a phase III, single-dose trial versus dolasetron. Cancer. 2003;98(11): Grunberg S, Chua D, Maru A, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol EASE. J Clin Oncol. 2011;29(11): Roscoe JA, Morrow GR, Aapro MS, et al. Anticipatory nausea and vomiting. Support Care Cancer. 2011;19(10): Kaiser R, Sezer O, Papies A, et al. Patient-tailored antiemetic treatment with 5-hydroxytryptamine type 3 receptor s according to cytochrome P-450 2D6 genotypes. J Clin Oncol. 2002;20(12): Tremblay PB, Kaiser R, Sezer O, et al. Variations in the 5-hydroxytryptamine type 3B receptor gene as predictors of the effi cacy of antiemetic treatment in cancer patients. J Clin Oncol. 2003;21(11): Hassan BA, Yusoff ZB. Genetic polymorphisms in the three malaysian races effect granisetron clinical antiemetic actions in breast cancer patients receiving chemotherapy. Asian Pac J Cancer Prev. 2011;12(1): Coates A, Abraham S, Kaye SB, et al. On the receiving end patient perception of the side-effects of cancer chemotherapy. Eur J Cancer Clin Oncol. 1983;19(2): Grunberg SM, Boutin N, Ireland A, et al. Impact of nausea/vomiting on quality of life as a visual analogue scale-derived utility score. Support Care Cancer. 1996;4(6): Sun CC, Bodurka DC, Donato ML, et al. Patient preferences regarding side effects of chemotherapy for ovarian cancer: do they change over time? Gynecol Oncol. 2002;87(1): IOM (Institute of Medicine). Patient-Centered Cancer Treatment Planning: Improving the Quality of Oncology Care: Workshop Summary. Washington, DC: The National Academies Press; Berry DL, Blumenstein BA, Halpenny B, et al. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011;29(8): Given CW, Sikorskii A, Tamkus D, et al. Managing symptoms among patients with breast cancer during chemotherapy: results of a two-arm behavioral trial. J Clin Oncol. 2008;26(36): April 2012, Vol. 19, No. 2 Supplement Cancer Control 15

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