CliniCal CanCer AdvanCes 2008

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Clinical Cancer Advances 2008Major Research Advances in Cancer Treatment, Prevention and ScreeningA Report from theAmerican Society of Clinical OncologyPublished in the Journal of Clinical Oncology onlineahead of print at on December 22, 2008

Clinical CancerAdvances 2008Major Research Advances in Cancer Treatment,Prevention and ScreeningA Report from the American Society of Clinical OncologyCONTENTSLetter from ASCO’s President3Executive Summary4I. Cancer Research Advances8Blood and LymphaticBreastCentral Nervous SystemGastrointestinalGenitourinaryGynecologicHead and NeckLungPediatricSarcomaSkinPreventionAccess to CareQuality of Life810131416171820212324252627II. Recommendations28III. Cancer Statistics31Cancer Incidence, Mortality, andSurvival RatesCancer Mortality TrendsFDA Approvals of Anti-Cancer Agents313233

Executive EditorsJulie Gralow, MDEric P. Winer, MDEditorial BoardLisa Diller, MDBeth Karlan, MDPatrick Loehrer, MDLori Pierce, MDSpecialty EditorsGeorge D. Demetri, MDPatricia A. Ganz, MDBarnett S. Kramer, MD, MPHMark G. Kris, MDMaurie Markman, MDRobert J. Mayer, MDDavid Pfister, MDDerek Raghavan, MD, PhDScott Ramsey, MD, PhDGregory H. Reaman, MDHoward Sandler, MDRaymond Sawaya, MDLynn M. Schuchter, MDJohn W. Sweetenham, MDLinda T. Vahdat, MDASCO PresidentRichard L. Schilsky, MDASCO President-ElectDouglas W. Blayney, MDASCO Chief Executive OfficerAllen S. Lichter, MD

A Letter from ASCO’s PresidentCancer: Where We StandNearly 40 years ago, President Richard Nixon signed the National Cancer Act, mobilizing the country’sresources to make the “conquest of cancer a national crusade.” That declaration led to a major investmentin cancer research that has significantly improved cancer prevention, treatment, and survival. As a result,two-thirds of people diagnosed with cancer today will live at least five years after diagnosis, compared tojust half in the 1970s. And there are now more than 12 million cancer survivors in the United States—upfrom 3 million in 1971.Scientifically, we have never been in a better position to advance cancer treatment. Basic scientificresearch, fueled in recent years by the tools of molecular biology, has generated unprecedented knowledgeof cancer development. We now understand many of the cellular pathways that can lead to cancer.We have learned how to develop drugs that block those pathways. And increasingly, we know how topersonalize therapy to the unique genetics of the tumor, and the patient.Yet in 2008, 1.4 million people in the United States will still be diagnosed with cancer, and more thanhalf a million will die from the disease. Some cancers remain stubbornly resistant to treatment, whileothers cannot be detected until they are in their advanced, less curable stages. Biologically, the cancercell is notoriously wily; each time we throw an obstacle in its path, it finds an alternate route that mustthen be blocked.To translate our growing basic science knowledge into better treatments for patients, a new nationalcommitment to cancer research is urgently needed. But funding for cancer research has stagnated. Thebudgets of the National Institutes of Health and the National Cancer Institute have failed to keep pacewith inflation, declining up to 13 percent in real terms since 2004. Tighter budgets reduce incentives tosupport high-risk research that could have the biggest payoffs. The most significant clinical research isincreasingly conducted overseas. And talented young physicians in the U.S., seeing less opportunity in thefield of oncology, are choosing other specialties instead.While greater investment in research is critical, the need for new therapies is only part of the challenge.Far too many people in the United States lack access to the treatments that already exist, leading tounnecessary suffering and death. Uninsured cancer patients are significantly more likely to die thanthose with insurance, racial disparities in cancer incidence and mortality remain stark, and even insuredpatients struggle to keep up with the rapidly rising cost of cancer therapies.As this annual ASCO report of the major cancer research advances over the past year demonstrates, weare making important progress against cancer. But sound public policies are essential to accelerate thatprogress. In 2009, we have an opportunity to reinvest in cancer research, and to support policies that willhelp ensure that every American receives potentially life-saving cancer prevention, early detectionand treatment.Richard L. Schilsky, MDPresidentAmerican Society of Clinical Oncology3

Executive SummaryEach year, the American Society of ClinicalOncology (ASCO) independently reviewsadvances in clinical cancer research, andidentifies those that will have the greatest impacton patient care.with advanced non-small cell lung cancer(NSCLC) that expressed the epidermal growthfactor receptor (EGFR). Gemcitabine for Pancreatic Cancer: Pancreaticcancer is notoriously difficult to treat, and justfive percent of patients survive five years ormore. A large, randomized study of patientswith early-stage pancreatic cancer that hadbeen surgically removed found that six monthsof treatment with the chemotherapy druggemcitabine (Gemzar) after surgery doubleddisease-free survival and increased overallsurvival.This report, Clinical Cancer Advances 2008:Major Research Advances in Cancer Treatment,Screening, and Prevention, highlights 31 of themost significant advances over the past year,including 12 that the editors consider to be majoradvances.While these and many other research advancesare making a real difference in patient care,cancer continues to take a tremendous toll—morethan 500,000 people in the U.S. will die of cancerthis year. In this report, ASCO recommends twostrategies for translating our growing basic scienceknowledge into new treatments for patients:increasing investment in cancer research andexpanding patient participation in clinical trials.2. NEW DRUG APPROVALSIdentifying and expanding treatment optionsfor people with cancer is critical to improvingpatient outcomes. This year, the U.S. Food andDrug Administration (FDA) approved new cancertreatments for chronic lymphocytic leukemia andmetastatic breast cancer that are likely to havesignificant impact on patient care.SUMMARY OF FINDINGS Bendamustine for Chronic LymphocyticLeukemia: Although chronic lymphocyticleukemia is incurable, it can be managed forlong periods of time. A large, internationalstudy adds another approach to the treatmentarsenal for the disease, finding that theanticancer drug bendamustine (Treanda)eliminated CLL in 30 percent of patients,compared with only 2 percent of patients whoreceive the standard chlorambucil. The dataled to the approval if bendamustine for CLL bythe FDA in March 2008.Following is a summary of the 12 major clinicalcancer research advances over the past year,grouped into six key areas:1. Hard-to-Treat CancersSome cancers remain highly resistant totreatment, or are diagnosed late in the courseof disease, when treatment is less effective.Advances against hard-to-treat cancers over thelast year include: Cetuximab for Lung Cancer: Lung cancer is the Bevacizumab for Metastatic Breast Cancer: Thebiggest cancer killer in the United States, takingthe lives of more than 160,000 people everyyear. In 2008, a large, randomized study foundthat adding the targeted therapy cetuximab(Erbitux) to initial chemotherapy increasedoverall survival by up to 21 percent in patientsmonoclonal antibody bevacizumab (Avastin) hasbeen an important treatment for patients withadvanced colorectal and non-small cell lungcancers. In February 2008, the FDA approved thedrug—in combination with the chemotherapydrug paclitaxel (Taxol)—for women with4

previously untreated metastatic breast cancerthat does not express the HER2 protein. Thisapproval was based on a 2007 trial that foundthis treatment combination doubled diseasefree-survival and improved response rates (morewomen experienced tumor shrinkage), comparedto paclitaxel alone. A second, similar trialreleased in 2008 confirmed that treatment withbevacizumab and a similar chemotherapy agentsignificantly improves outcomes for women withmetastatic breast cancer.with an aromatase inhibitor like letrozole(Femara) or possibly with additional years oftamoxifen. Zoledronic Acid for Breast Cancer: A largestudy found that giving the bone-strengtheningdrug zoledronic acid (Zometa) to premenopausalwomen undergoing ovarian suppression andadditional hormonal therapy with tamoxifenor an aromatase inhibitor reduced the riskof recurrence of early-stage breast cancer by36 percent compared with hormonal therapyalone (tamoxifen or anastrozole [Arimidex] plusgoserelin [Zoladex]).3. Reducing Cancer RecurrenceMany cancers are initially treated successfully butthen recur years later. Cancer recurrence remainsa major cause of death, and finding ways to reducethe risk of recurrence is a top research priority.Advances in reducing recurrence over the lastyear include: Interferon for Melanoma: Melanoma is thedeadliest form of skin cancer. A large randomizedEuropean study showed that one year ofpegylated interferon treatment reduced the riskof recurrence of stage III melanoma that hadbeen surgically removed by 18 percent comparedwith patients who did not receive treatment. Long-term Hormonal Therapy for BreastCancer: Several new studies suggest thatwomen who have finished the standard fiveyears of hormonal therapy with tamoxifen afterinitial breast cancer treatment may furtherreduce their risk of recurrence by takingadditional years of hormonal therapy, either4. Personalized MedicineThe growing field of personalized cancermedicine seeks to target cancer therapies basedon the unique genetic characteristics of the tumor,5

ABOUT THIS REPORTThe American Society of Clinical Oncology—the leadingmedical society representing more than 25,000 oncologistsand other professionals worldwide who care for peoplewith cancer—has developed this report to demonstrate theimportant progress being made in clinical cancer researchand to highlight emerging trends in the field.demonstrated in all types of cancer over the past year.Studies included in this year’s report are groupedas follows:yy Blood and lymphatic cancersyy Breast canceryy Central nervous system tumorsyy Gastrointestinal cancersyy Genitourinary cancersyy Gynecologic cancersyy Head and neck cancersyy Lung canceryy Pediatric cancersyy Sarcomayy Skin canceryy Cancer preventionyy Access to careyy Quality of lifeThe report is also intended to fill a gap in cancerliterature. It is the only published report to highlight themajor advances in clinical cancer research and careeach year, and it is written for everyone with an interestin cancer care: the general public, cancer patients andorganizations, policymakers, oncologists, and othermedical professionals.This report, now it its fourth year, was developed underthe guidance of a 21-person editorial board made upof leading oncologists and other cancer specialists,including specialty editors for each of the diseasespecific and issue-specific sections. The editors reviewedresearch published in peer-reviewed scientific journalsand the early results of research presented at majorscientific meetings over a one-year period (October2007-September 2008). Only studies that significantlyaltered the way a cancer is understood or had animportant impact on patient care were included. Researchin each section is divided into “major advances” and“notable advances,” depending on the impact of theadvance on patient care and survival.The research considered for this report covers the fullrange of clinical cancer issues:yy Epidemiology (populations at greatest or increasing risk)yy Preventionyy Screening/early detectionyy Treatment with traditional therapies (surgery,chemotherapy and radiation therapy) as well as newer,more targeted therapies (monoclonal antibodies, kinaseinhibitors, angiogenesis inhibitors and epidermal growthfactor receptor inhibitors)yy Personalized cancer medicine (targeting treatmentbased on genetic traits of the tumor or the patient)yy Access to high-quality careyy SurvivorshipWhile important research is underway in all cancertypes, advances that met the above criteria were not5. Risk FactorsIdentifying cancer risk factors is critical toprevention and early diagnosis. Advances over thepast year that could reduce cancer risk or increaseearly detection include:and/or the patient. The most significant advanceover the last year was in colon cancer treatment: KRAS Status and Colon Cancer Treatment: Amultinational team of investigators found thatin patients with newly diagnosed advancedcolorectal cancer, adding the monoclonalantibody cetuximab (Erbitux) to chemotherapywas beneficial only when tumors containedthe normal (wild-type) form of the gene KRAS,and not when the gene had a mutation. Thesefindings will help guide treatment for eachpatient, increasing efficacy while eliminatingunnecessary side-effects in those who will notbenefit from the treatment. Ovarian Cancer and Birth Control Pills:A large analysis of data from 45 priorepidemiological studies reported that womenwho have taken oral contraceptives loweredtheir risk of ovarian cancer by 20 percent forevery five years they took the pill, providing apotentially important and readily available wayfor women at elevated risk of ovarian cancer toreduce their risk.6

that survivors of childhood cancers are fiveto ten times more likely than their healthysiblings to develop heart disease 30 years afterdiagnosis. This finding emphasizes the need toeducate patients, their families and health careproviders about the need to monitor for delayedcardiovascular side effects of cancer treatments.SUMMARY OFRECOMMENDATIONSTo accelerate the pace of progress against cancer,ASCO makes the following recommendationsfor 2009: HPV and Oral Cancer: A major review foundthat the incidence of oral cancers related to HPVincreased by 0.8 percent per year between 1973and 2004 in the U.S. By contrast, the incidence ofHPV-unrelated cancers was stable through 1982and declined significantly from 1983 to 2004.The authors attributed the increase to possiblechanges in sexual behaviors, including oral sex.The study suggests a potential role for the HPVvaccine (approved for cervical cancer prevention)in reducing the risk of oral cancers. Increase Federal Funding for Clinical CancerResearch: The United States is in the midst ofthe longest sustained period of flat fundingfor cancer research in our history—budgetsfor the National Institutes of Health (NIH)and the National Cancer Institute (NCI) havebeen flat for five years. As a result, fewerresearch projects are funded, fewer patientscan participate in clinical trials, and youngresearchers will find it much more difficultto receive funding. ASCO and others in thecancer community are calling for an increase inannual NIH funding of at least 2 billion to keeppace with inflation, fund studies of cancers’molecular mechanisms, and accelerate progressagainst hard to treat cancers.6. Access to CareEnsuring that cancer patients and survivors haveaccess to high-quality cancer care is critical toincreasing survival rates and ensuring long-termhealth. Research over the past year providesinsight into the health care needs of cancerpatients and survivors: Remove Barriers to Participation in Clinical Looming Shortage of Oncologists: A studyTrials: Clinical trials are the engine that drivescancer research, yet only five percent of patientsparticipate. With so few patients involved,research is slow and many people with cancermiss out on opportunities to access potentiallyeffective new treatments before they are widelyavailable. To encourage and increase patientparticipation in cancer clinical trials, ASCOrecommends nationwide public and privateinsurance coverage of clinical trials; fullreimbursement to oncology practices for the costof participating in clinical trials; and measuresto increase diversity in clinical trials.examining trends in the use of oncologyservices between 1998 and 2003 in the U.S.projected a major shortage of oncologists by2020. While the total number of cancer patientsin the United States was projected to increase55 percent by 2020 as the population grows andages, the supply of oncologists is expected toincrease at a significantly slower rate. Based onthis data, ASCO estimates that the U.S. will facea shortage of up to 4,000 oncologists by 2020. Long Term Health Needs of Childhood CancerSurvivors:· A report from the large, ongoingChildhood Cancer Survivor Study showed7

Section iCancer Research AdvancesCANCERS OF THE BLOOD ANDLYMPHATIC SYSTEMCancers of the blood and lymphatic system(also called “hematologic” cancers) includeleukemias, lymphomas, multiple myeloma andmyelodysplastic syndromes. Important advanceswere made in the treatment of chronic leukemiaand Hodgkin lymphoma in the last year.Major AdvanceBendamustine Is Effective Against ChronicLymphocytic Leukemia (CLL)CLL is diagnosed in more than 15,000 people eachyear, primarily in adults age 50 and older. There isno cure, though chemotherapy (with chlorambucil,cyclophosphamide, or fludarabine) is often used toslow the progression of the disease.Bendamustine (Trenda) has been used in Europefor some 30 years. It was thought to have thesame properties of similar drugs called alkylatingagents, but researchers have recently learnedmore about its modes of action and its potentialuse for treating a variety of hematologic cancers.1An international Phase III study found thatbendamustine eliminated cancer completelyin 30 percent of patients with CLL, comparedwith only 2 percent of patients who receivedchlorambucil, often used to treat symptomaticCLL. Bendamustine also increased progressionfree survival by more than a year (21.7 monthsversus 9.3 months). The data supported the use ofbendamustine as first-line treatment for CLL andled to the approval of bendamustine for CLL bythe U.S. Food and Drug Administration (FDA) inMarch 2008.agent SGN-35 induced partial remission in 9 of 28patients and an additional 11 patients had stabledisease. Of 13 patients who received 1.2 m/kg, ormore, there were 7 partial remissions. SGN-35 wasgenerally well tolerated, with fatigue, diarrhea andcough as the most common side effects.SGN-35 is an engineered antibody attachedto a chemotherapy drug called monomethylauristatin E. The antibody component binds toa protein called CD30 on Hodgkin lymphomacells, and the monomethyl auristatin E disruptscell growth and division and prompts cancer cellsto self-destruct. About 5 percent of people withHodgkin lymphoma experience a relapse or stopNotable AdvanceSGN-35 Is Active in Patients with Relapsed/Refractory Hodgkin LymphomaA Phase I study found that the investigational8

responding to treatment. If confirmed in furtherstudies, these findings suggest that SGN-35may play a role in the treatment of this cancer,offering an approach that is more targeted thanconventional chemotherapy and radiation therapyand potentially associated with fewer side effects.2References1. Knauf WU, et al. Bendamustine versus chlorambucil intreatment-naive patients with B-cell chronic lymphocyticleukemia (B-CLL): Results of an international phaseIII study. Presented at the 49th Annual Meeting of theAmerican Society of Hematology; December 2007;Atlanta, GA.2. Younes A, et al. Objective responses in a phase I doseescalation study of SGN-35, a novel antibody-drugconjugate (ADC) targeting CD30, in patients withrelapsed or refractory Hodgkin lymphoma. Presentedat the 44th Annual Meeting of the American Society ofClinical Oncology; May-June 2008; Chicago, IL.9

BREAST CANCEROver the past several decades, improvementsin early detection and the development of moreeffective treatments have led to significantdeclines in breast cancer deaths, improvingthe outlook for women living with the disease.Increasi

advances in clinical cancer research, and identifies those that will have the greatest impact on patient care. This report, Clinical Cancer Advances 2008: Major Research Advances in Cancer Treatment, Screening, and Prevention, highlights 31 of the most significant advances over the past

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