Clinical Cancer Advances 2011: Annual Report On Progress .

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VOLUME30䡠NUMBER1䡠JANUARY12012JOURNAL OF CLINICAL ONCOLOGYA S C OS P E C I A LA R T I C L EClinical Cancer Advances 2011: Annual Report onProgress Against Cancer From the American Societyof Clinical OncologyNicholas J. Vogelzang,* Steven I. Benowitz, Sylvia Adams,† Carol Aghajanian,† Susan Marina Chang,†ZoAnn Eckert Dreyer,† Pasi A. Janne,† Andrew H. Ko,† Greg A. Masters,† Olatoyosi Odenike,† Jyoti D. Patel,†Bruce J. Roth,† Wolfram E. Samlowski,† Andrew D. Seidman,† William D. Tap,† Jennifer S. Temel,†Jamie H. Von Roenn,† and Mark G. Kris*From the American Society of ClinicalOncology, Alexandria, VA.Submitted October 21, 2011; acceptedOctober 31, 2011; published onlineahead of print at www.jco.org onDecember 5, 2011.Executive Editor*Specialty Editor†Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of thisarticle.Corresponding author: Steven I.Benowitz, MA, American Society ofClinical Oncology, 2318 Mill Rd, Suite800, Alexandria, VA 22314; e-mail:[email protected] 2011 by American Society of ClinicalOncology0732-183X/12/3001-88/ 20.00DOI: 10.1200/JCO.2011.40.1919A MESSAGE FROM ASCO’S PRESIDENTIt has been forty years since President Richard Nixon signed the National Cancer Act of 1971, which many viewas the nation’s declaration of the “War on Cancer.” The bill has led to major investments in cancer research andsignificant increases in cancer survival. Today, two-thirds of patients survive at least five years after beingdiagnosed with cancer compared with just half of all diagnosed patients surviving five years after diagnosisin 1975.The research advances detailed in this year’s Clinical Cancer Advances demonstrate that improvements in cancerscreening, treatment, and prevention save and improve lives. But although much progress has been made, cancerremains one of the world’s most serious health problems. In the United States, the disease is expected tobecome the nation’s leading cause of death in the years ahead as our population ages.I believe we can accelerate the pace of progress, provided that everyone involved in cancer care works togetherto achieve this goal. It is this viewpoint that has shaped the theme for my presidential term: Collaborating toConquer Cancer. In practice, this means that physicians and researchers must learn from every patient’sexperience, ensure greater collaboration between members of a patient’s medical team, and involve morepatients in the search for cures through clinical trials. Cancer advocates, insurers, and government agencies alsohave important roles to play.Today, we have an incredible opportunity to improve the quality of cancer care by drawing lessons from thereal-world experiences of patients. The American Society of Clinical Oncology (ASCO) is taking the lead in thisarea, in part through innovative use of health information technology. In addition to our existing quality initiatives,ASCO is working with partners to develop a comprehensive rapid-learning system for cancer care. Whencomplete, this system will provide physicians with personalized, real-time information that can inform the care ofevery patient with cancer as well as connect patients with their entire medical teams. The rapid learning systemwill form a continuous cycle of learning: securely capturing data from every patient at the point of care, drawingon evidence-based guidelines, and evaluating quality of care against those standards and the outcomes ofother patients.Clinical trials are another area in which collaboration is critical. Increasing clinical trial participation will requirecommitment across the cancer community from physicians, patients, insurers, hospitals, and industry. A 2010report by the Institute of Medicine described challenges to participation in trials by both physicians andpatients and provided recommendations for revitalizing clinical trials conducted through the National CancerInstitute’s Cooperative Group Program. ASCO has pledged its support for the full implementation ofthese recommendations.More broadly, ASCO recently outlined a bold vision for translational and clinical cancer research for the nextdecade and made recommendations to achieve that vision. Accelerating Progress Against Cancer: ASCO’sBlueprint for Transforming Clinical and Translational Research, released in November, calls for a research systemthat takes full advantage of today’s scientific and technologic opportunities and sets a high-level agenda for policymakers, regulators, and advocates.Cancer research has transformed cancer care in the past forty years, and this year’s Clinical Cancer Advancesillustrates how far we have come in the past year alone. We now have a tremendous opportunity to use today’sknowledge and collaborate across all facets of cancer care to conquer this deadly disease.Michael P. Link, MDPresidentAmerican Society of Clinical OncologyJ Clin Oncol 30:88-109. 2011 by American Society of Clinical Oncology88 2011 by American Society of Clinical OncologyInformation downloaded from jco.ascopubs.org and provided by at US Oncology on December 28, 2012 from 67.66.44.224Copyright 2012 American Society of Clinical Oncology. All rights reserved.

Clinical Cancer Advances 2011EXECUTIVE SUMMARYEach year, the American Society of Clinical Oncology (ASCO) conducts an independent review of advances in clinical cancer research toidentify those that have the greatest potential impact on patients’ lives.This year, Clinical Cancer Advances features 54 significant studies,including 12 that the editors consider major advances.This year’s Clinical Cancer Advances also recaps the year’s mostimportant cancer policy developments and ASCO policy initiativesthat are likely to influence cancer care in the coming years. Theseinclude developments that could accelerate the pace of clinical cancerresearch progress and ensure access to quality cancer care for patients.Summary of FindingsScreening and prevention. With cancer, the ultimate goal is toavoid the disease altogether. Smoking cessation efforts, lifestylechanges, and other biomedical interventions have successfully prevented thousands of cancers in the past decades. At the same time,researchers seek better ways to detect cancers early, when they are mostcurable. Screening advances are credited with improving survival ratesfor a range of cancers. Advances in cancer screening and preventionthat occurred this year include: Low-dose computed tomography (CT) scanning reduces thelung cancer death rate in people at high risk: A nationalscreening trial of more than 50,000 current and former heavysmokers found that three annual low-dose CT scans reducedthe risk of dying from lung cancer by 20% compared withthose who were screened with three annual chest x-rays. Thislandmark trial was the first to identify a screening regimen forpatients at high risk for lung cancer, despite decades of attempts. Guidance on how to apply these findings is expectedin the coming year. Exemestane reduces the risk of invasive breast cancer in highrisk, postmenopausal women: A phase III trial showed thatexemestane (Aromasin; Pfizer, New York, NY), a member of afamily of drugs called aromatase inhibitors, reduced the riskof developing breast cancer compared with placebo in highrisk, postmenopausal women. This is the first conclusive evidence, to our knowledge, that an aromatase inhibitor reducedthe risk of a first breast cancer, making exemestane an optionfor postmenopausal women who are at high risk for the disease. Two other drugs, tamoxifen and raloxifene, are alreadyapproved for this purpose, but they carry with them concernover adverse effects that deter many women who could benefitfrom such treatment.Hard-to-treat cancers. Although some cancers respond well totreatment, other forms of the disease are more resistant. Melanoma,ovarian cancer, and neuroblastoma all fall into this latter group. Inmany cases, current therapies can induce remissions or stall the disease’s progression for long periods of time, but these cancers too oftenpersist and grow. Advances in such hard-to-treat cancers in the lastyear include: BRAF inhibitor improves survival in advanced melanoma,gains US Food and Drug Administration (FDA) approval: Aphase III trial showed that the drug vemurafenib (Zelboraf;Genentech, South San Francisco, CA; Daiichi-Sankyo, Tokyo,Japan), which targets a common mutation in melanoma in agene called BRAF, improved overall survival in patients withwww.jco.orgadvanced melanoma when compared with standard chemotherapy. About half of patients have tumors that carry thismutation. Vemurafenib—which received FDA approval (Table 1) in August 2011—is a new standard treatment for patients with melanoma and this gene mutation and has helpedto usher in a personalized approach to treating the disease. First-line ipilimumab plus chemotherapy improves survivalin metastatic melanoma: A phase III study found that treatment with ipilimumab (Yervoy; Bristol-Myers Squibb, NewYork, NY), an immune therapy that activates the immunesystem’s T cells, combined with the standard chemotherapydrug dacarbazine improved overall survival by 2 months inpatients with previously untreated metastatic melanomacompared with chemotherapy alone. This is the first study showing a benefit in prolonging life of combining chemotherapy andimmunotherapy in patients with advanced melanoma. Bevacizumab delays progression in recurrent ovarian cancers:Two randomized phase III trials found that bevacizumab(Avastin; Genentech), a monoclonal antibody that inhibitsblood vessel growth and development in tumors, togetherwith standard chemotherapy helped women with recurrentovarian cancer live significantly longer without disease progression than those treated with the same chemotherapyalone. In the Ovarian Cancer Evaluation of Avastin and Safety–AVF4095g (OCEANS) trial, patients treated with bevacizumablived a median of 4 months longer without disease progressionthan those who received chemotherapy alone—a 52% reductionin the risk of disease progression. In the second trial, data suggested that adding bevacizumab to standard carboplatin andpaclitaxel chemotherapy for treatment of newly diagnosed ovarian cancer helps women live longer than with treatment withchemotherapy alone, particularly for patients with more aggressive forms of the disease. By extending the time patients can livewithout disease progression, and without additional treatment with chemotherapy, these results suggest that, increasingly, ovarian cancer may be treated as a longer-term,chronic disease. Researchers await longer-term data fromboth studies to get a clearer picture of how these regimensimprove survival and which women benefit most. New high-dose chemotherapy regimen improves survival inchildren with hard-to-treat neuroblastoma: A phase III trialshowed that a new combination of chemotherapy drugs improved survival for children with high-risk, metastatic neuroblastoma. After 3 years, the event-free survival for patientstreated with an intense dose of chemotherapy drugsbusulphan-melphalan was 49% compared with 33% for thethree standard chemotherapy drugs (carboplatin, etoposide,and melphalan). These findings establish a new standard ofcare for high-risk neuroblastoma and, together with otherrecent treatment advances for the disease, are likely to lead tosurvival gains for patients.Reducing cancer recurrence. Although many cancers can betreated successfully at first, preventing disease from returning is oftendifficult, particularly when the disease is diagnosed at advanced stages.When a cancer recurs, it is usually more resistant to therapy and maynot be curable. This year, several studies marked important advancesin preventing the recurrence of a form of GI cancer, a type of leukemiain children and young adults, and breast cancer. 2011 by American Society of Clinical OncologyInformation downloaded from jco.ascopubs.org and provided by at US Oncology on December 28, 2012 from 67.66.44.224Copyright 2012 American Society of Clinical Oncology. All rights reserved.89

Vogelzang et alTable 1. FDA Approvals of Anticancer Agents, September 2010-September 2011Anticancer AgentNewly approved agentsDenosumabIpilimumabVandetanibAbiraterone acetateVemurafenibBrentuximab vedotinCrizotinibExpanded indicationsfor existing agentsTrastuzumabTrade NameXgeva (Amgen, Thousand Oaks,CA)Yervoy (Bristol-Myers Squibb,New York, NY )Vandetanib (AstraZeneca;Wilmington, DE)Zytiga (Janssen Biotech,Horsham, PA)Zelboraf (Genentech, South SanFrancisco, CA)Adcetris (Seattle Genetics,Bothell, WA)Xalkori (Pfizer; New York, NY)Herceptin (Genentech)DasatinibSprycel (Bristol-Myers Squibb)RituximabRituxan (Genentech; BiogenIdec, Weston, MA)Sylatron (Merck, WhitehouseStation, NJ)Peginterferon alfa-2bEverolimusAfinitor (Novartis, Summit, NJ)SunitinibSutent capsules (Pfizer)DenosumabProlia (Amgen)EculizumabSoliris (Alexion Pharmaceuticals,Cheshire, CT)IndicationDate of ApprovalFor prevention of skeletal-related events in patients with bonemetastases from solid tumorsFor treatment of unresectable or metastatic melanomaNovember 18, 2010March 25, 2011For treatment of symptomatic or progressive medullary thyroid cancer inpatients with unresectable, locally advanced, or metastatic diseaseFor use in combination with prednisone for the treatment of patientswith metastatic castration-resistant prostate cancer who have receivedprior chemotherapy containing docetaxelFor treatment of patients with unresectable or metastatic melanoma withthe BRAF V600E mutation as detected by an FDA-approved testFor treatment of patients with Hodgkin’s lymphoma after failure of ASCTor after failure of at least two prior multiagent chemotherapy regimensin patients who are not ASCT candidates; for the treatment of patientswith systemic anaplastic large cell lymphoma after failure of at leastone prior multiagent chemotherapy regimen (accelerated approval)For treatment of patients with locally adva