Vol. 37 No. 19                                                                                       May 13, 2011         ...
years to complete.Legacys Healton Demands                                                           Meanwhile, I-ELCAP, it...
and its publication is weeks away.                                cancer screening as a demonstration project for the     ...
spiral CT screening,” Mulshine said. “And this is very         “Shame on Us”problematic because we have scarce resources a...
we will be able to integrate biomarkers or any genetic        prevention, enhancing the U.S. economy and globalinformation...
“Let me just cite a couple of figures,” Collins said.   to say that about the genome project. So I decided that“If you loo...
cancers, have mutations in specific genes against which        that feels if you’re a post-doctoral fellow in the middlewe...
examples of how research dollars have translated into        Cancer Treatmentconcrete advances against cancer through basi...
announced proposal for reorganizing services that             of the damage that occurs in the genome of a cancer cellsupp...
NCI News:                                          In the Cancer Centers:Varmus to be Keynote Speaker                     ...
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Cancer letter may13_2011

  1. 1. Vol. 37 No. 19 May 13, 2011 © Copyright 2011 The Cancer Letter Inc. All rights reserved. Price $395 Per Year. To subscribe, call 800-513-7042 or visit www.cancerletter.com. PO Box 9905 Washington DC 20016 Telephone 202-362-1809Lung Cancer Screening:Henschke, Supporters Call For Urgent ActionBased on Results of NCI Randomized Trial By Conor Hale In her first public appearance following a blast of controversysurrounding her clinical studies, radiologist Claudia Henschke said that low- Lung Cancer Screening:dose helical computed tomography screening for lung cancer should become Dentzer, "Shame on Us"the standard of care for current and former smokers. . . .Page 4 At a panel discussion May 9, Henschke and her key supporters saidthat screening for early signs of lung cancer—as developed in Henschke’s Appropriations 2011:International Early Lung Cancer Action Program—should be given an “A” An Update on NCATSrecommendation from the U.S. Preventive Services Task Force. . . . Page 6 Cheryl Healton, president and CEO of the American Legacy Foundatonand one of the panel members, said there is no time to waste. “We have to get ourselves ready to save what will something on the NCI Directororder of potentially 70,000 lives every year, just by beginning to implement Harold Varmussthis screening, post-haste,” said Healton. Senate Testimony “There’s never been any single breakthrough that has the overnight, not . . . Page 7 (Continued to page 2)Appropriations 2011:NIH Grant Success Rate Drops Under 20 Percent NCI News:After 2011 Compromise Budget Cuts Take Effect Varmus to be By Conor Hale Keynote Speaker at Facing Senate appropriators, NIH Director Francis Collins said he was National Lung Cancerthankful that the budget cuts didn’t go much deeper. Partnership Meeting “Many of the proposals were vastly worse than this, and I know that . . . Page 10many people really went to bat for NIH," said Collins, testifying on CapitolHill May 11, after the 2011 compromise budget bill cut NIH funding by $322million. “And we appreciate that enormously.” In the Cancer Centers: Collins and a group of institute directors came to Capitol Hill to make Columbia Recievestheir case for the institutes’ 2012 budget. $1.35 Million Grant From In his testimony, Collins listed the benefits NIH has contributed tothe country in terms of public health, advances in clinical and translational ASCO and Komenresearch, and—in the most important measure of the day—impact on the . . . Page 10economy. Though the president’s budget request for the next fiscal year calls foran increase in NIH funding, the prevailing mood is not wondering whetherthere will be cuts, but wondering how large these cuts will be. The budget cut this year has forced the NIH to only approve one outof every six grant applications—a success rate of 17-18 percent and the (Continued to page 5)
  2. 2. years to complete.Legacys Healton Demands Meanwhile, I-ELCAP, its investigators and hostQuick Action by USPSTF institutions are under scrutiny by medical journals,(Continued from page 1) following revelations that the consent forms could be missing for as many as 90 percent of participants andliterally, but the overnight potential to save as many as that the groups principal study was designed without ahalf the people who in any given year are destined to sample size calculation. With 53,000 patients scanned,die of lung cancer in this country,” she said. it’s essentially a registry that has no stopping point and “And I actually am quite startled that, at least by can go on forever without producing a result.all external measures, it looks like the U.S. Preventive This criticism emerged in a confidential documentServices Task Force and those who lead its decision produced by a committee of four experts who reviewedmaking are treating this as a business as usual situation,” I-ELCAP for its former host institution, Weill-Cornellsaid Healton. Medical College (The Cancer Letter, April 29; The “And if I asked everyone here who ever smoked New York Times, April 30). The operations center hasto put their hands up and how many of you have gotten since moved to the Arizona State Universitys Biodesigna CT scan, I could probably do a back-of-the-envelope Institute.estimate of how many of you are walking around Since then, at least three journal editors havepotentially dying because of the inaction that we may mailed letters to Henschke and Weill Cornell, requestingactually proceed with.” additional information and copies of the report. The The discussion was sponsored by Henschke’s most letters were sent by the New England Journal ofloyal supporters: the Lung Cancer Alliance and Legacy. Medicine, the journals of the American Cancer Society, CT screening of former and current smokers may and The Oncologist.indeed become the standard of care, but this would One editor said that without an absolute responsehappen as a result of the NCI-sponsored National Lung from the group, they would publish a retraction of theScreening Trial, a randomized study that measured group’s work (The Cancer Letter, May 6).cause-specific mortality in a high-risk population of However, this was not mentioned directly bycurrent and former smokers monitored via CT screening the panel members, who largely agreed that the workor standard chest x-ray. done in I-ELCAP and NLST was ready for a leap from If USPSTF gives CT screening a high mark, clinical research into public policy—and that the federalit would almost certainly do so for a well-defined government should give it its highest rating, and do sopopulation, and as a result of review process that takes quickly. Healton alluded to the controversy while describing her decision to become Henschke’s patient: “I did the math…and I concluded that I had a one in six chance of developing lung cancer…so the minute I ® The Cancer Letter is a registered trademark. heard about Claudia, I became one of Claudia’s patients. Editor & Publisher: Paul Goldberg “And I hasten to add that I signed the fully Intern: Conor Hale executed consent,” she said, drawing laughs from the crowd. Editorial, Subscriptions and Customer Service: Legacy funds an I-ELCAP study, called the Legacy 202-362-1809 Fax: 202-379-1787 Project, where smokers over the age of 50 receive CT PO Box 9905, Washington DC 20016 scans and smoking cessation materials. General Information: www.cancerletter.com The main premise behind advancing the practice of early CT lung cancer screening would be based on Subscription $395 per year worldwide. ISSN 0096-3917. Published 46 times a year by The Cancer Letter Inc. Other the results of the NLST, which concluded in November than "fair use" as specified by U.S. copyright law, none of 2010 (The Cancer Letter, Nov. 5, 2010). the content of this publication may be reproduced, stored in The trial was stopped after demonstrating a 20.3 a retrieval system, or transmitted in any form (electronic, percent mortality benefit in current and former smokers photocopying, or facsimile) without prior written permis- between ages 55 and 74, with at least a 30 pack-year sion of the publisher. Violators risk criminal penalties and smoking history. damages. Founded Dec. 21, 1973, by Jerry D. Boyd. A manuscript based on the study is in preparation, The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 2
  3. 3. and its publication is weeks away. cancer screening as a demonstration project for the Computer models would be required to assess the nation on how we approach population-based medicineimpact of different frequencies of screening, ages at in a thoughtful quality outcomes kind of way, it couldstarting, and risk levels. It’s not at all clear what the risks be an extraordinarily important pivot point for medicineare for 20-pack-year smokers or 40-pack-year smokers. in our society.” And it’s not clear that rounds of annual screening The panel members didn’t define a target populationwould improve the outcome, modelers say (The Cancer that would be subjected to low-dose spiral CT scanning,Letter, Nov. 26, 2010). even as they called for an “A” rating from USPSTF. Henschke has argued that NLST amounts to Mulshine said the benefits of CT screening extendvindication of her own results. beyond finding early-stage tumors in current and former “I would say that the NLST showing a 20 percent smokers, the populations in I-ELCAP and NLST, andmortality reduction after three years of screening and may be applied anyone at risk for cardiovascular diseasefive years of follow-up is tremendous,” Henschke, now or chronic obstructive pulmonary disease.a professor at Mt. Sinai School of Medicine and Arizona “And so, predictably, if this goes forward with aState University, said at the May 9 meeting. B or with an A from the U.S. Preventive Services Task But Henschke said true results of the intervention Force, we will have a challenge of this screening beingcould be even better than they appear: disseminated nationally, if that’s in fact their declaration, “It’s comparing it with chest X-ray, and chest across a very heterogeneous healthcare system,” saidX-ray does have a benefit. So it would be even more if it Mulshine.had compared CT with no screening—and it would have “Claudia and others have shown that spiral CT,been even more if there were more rounds of screening. looking at calcification of the vascular tree of the heartSo every year, an additional round of screening for 10 is a very powerful risk marker. More powerful thanyears would probably show higher reduction.” cholesterol,” he said. “Three major smoking-related This would more than double the drop in mortality diseases—lung disease, heart disease, and COPD,rates, she said. which account for every other premature death in our “What people have to understand is that that society—are all detected by early spiral CT.”mortality reduction of 20 percent is a population figure,”she said. “So if you only focus—and I looked at some Changing the Standard of Caretheoretical curves, what I think those curves will look “For years, a line of resistance that you ran intolike when they’re published—that if you looked on an was, yes, you might identify nodules early, and someannual basis it would have been as much as almost 50 of those nodules it was argued are not going to be lungpercent reduction, even after three rounds of screening. cancer, but were going to subject patients to surgery “While I always say I’m a researcher, not a and other treatment unnecessarily,” panel moderatorpublic policy person…I think that it will get an ‘A’ Susan Dentzer, editor-in-chief of Health Affairs, askedrecommendation. Whether it will is another question,” Henschke. “Talk about what progress you’ve made onsaid Henschke. refuting that argument, and how specifically a continuum James Mulshine, associate provost for research of very careful scrutiny of the nodules can lead toand vice president of Rush University Translational effective care and not to inappropriate care.”Sciences Consortium, also said that the NLST finding “As CT scans get better all of us will have aof 20 percent mortality reduction may understate the nodule,” replied Henschke. “So what distinguishestrue benefit. lung cancer from those other nodules? Well lung cancer “It may be that the 20 percent benefit may be the has certain growth rates, it’s fairly well known whatfloor and not the ceiling of what can be obtained through those growth rates are and everyone’s in the processspiral CT screening,” said Mulshine, a panel member. of developing technology that will allow very careful He described the outcome of these studies as assessment of that growth.a “teachable moment” and a challenge for the U.S. “Today, we have a low-dose CT scan, and if takenhealth care system, which he said would have difficulty in the same way and taken at the same place—that’s whyproviding CT screening for such a large population. the process and where you get it done is so important— “Anybody who looks at this fact set understands you can differentiate very well in a relatively short timethat there are challenges,” Mulshine said. “But those what is a cancer and what is not.challenges are systematic ones that if we take on lung “There will be unnecessary harms related to The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 3
  4. 4. spiral CT screening,” Mulshine said. “And this is very “Shame on Us”problematic because we have scarce resources and While under a spotlight of professional criticismswe’re talking about people’s lives, and we do not want and questions, both the panel and moderator appearedto intervene in such a way that we undermine people’s defiant.health, but we improve it.” “You have suffered the slings and arrows of How would national CT screening be paid for? amazing criticism and opposition to get there, but now “It’s probably not premature to start a dialogue of we see it finally scientifically validated to the satisfactionwhether or not there shouldn’t be any sort of user fee on of even some of the lung cancer experts who challengedthe product that would underwrite a national system of you along your way,” said Dentzer to Henschke.screening centers,” said Healton. “That type of a system And if the program fails to go national, “shame oncould be built on around 20 cents per pack.” us as a country for not taking the steps to put together Panel members said screening protocols could be a system that all of these folks have said might work,”tested in a demonstration project within the Veterans said Dentzer.Administration. Healton said political action would be required to Dentzer asked Barbara Campling, of Thomas change the standard of care.Jefferson University Hospital, to talk about the VA’s “I continue to be one of Claudia’s patients in herelectronic health records system, which Dentzer trial, because I know that the odds that I will developdescribed as “light years ahead of our health care non- cancer are high and I would prefer to continue to live,”system,” and could provide “marvelous opportunities said Healton. “So we are at a turning point, we should befor identifying a portion of the population that could watching very carefully what happens. And if somethingbenefit from CT screening.” untoward happens, we should rise up, and in the name “Anybody that goes to the VA is required to have of all of those who are dying of, and will die in thea smoking history taken," said Campling. "You can’t future of lung cancer…we have to make sure that doesgo on in the record without recording that information, not happen.”So you could immediately identify everybody at the VAwho would be eligible for screening. And my guess is “Screening is a Process”that that’s going to be a majority of people that go to Responding to criticism that could lead tothe VA that will be eligible.” retraction of her papers, Henschke said her registry But whether this pilot project had a definite future approach is valid.at the VA, Campling did not know. “People should set up screening programs as “I can’t get a definite answer on that, but I can tell a study and pool the data, that way we continuouslyyou what I think is going on. I have no access to any improve the process,” she said. “We’ve developed ainside information, so I’m going to tell you what I think collaboration of 60 institutions around the world whois probably going on in the VA,” she said. contribute their data prospectively, they’ve all signed “I think that they are probably planning to consent forms.implement it. I think they will probably wait until “And that has enabled us to keep up with the statethe results of the [National Lung Screening Trial] are of the art. When you go to a program for CT screening,published, or available for all to see before they actually or any screening, you want to go to a program that ismake an announcement about how they’re going to do the state of the art, that uses the latest equipment, theit. But I think they will do it. And I think that they will latest surgery, the latest biopsies—and also looks at thedo a much better job of it than in the private sector,” ancillary things.Campling said. “And this is because they have got a "We’ve found that, for example, that low-dosereally outstanding record for cancer prevention and CT scan gives us a lot of information about the risk ofcancer screening. cardiovascular disease, which is also associated with “I predict that when they do this, veterans will smoking and emphysema.benefit more than any other group. Because it has been "And as we learn more and more we will be ableshown that veterans have a higher incidence of smoking, to individualize the risk of those different diseases.they have a higher incidence of lung cancer, the people “Screening is a process that will continue forever.who do smoke tend to smoke more. These are the It’s going to be a continuously evolving process that getsexact kind of people you want to target for screening better and better. And we will be better able to defineprograms,” she said. those risks. Who should get those CT scans as well, and The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 4
  5. 5. we will be able to integrate biomarkers or any genetic prevention, enhancing the U.S. economy and globalinformation we have.” competitiveness, and advancing translational science. In her remarks, Henschke said the true benefit of For his first example, he showed that NIH research,screening far exceeds the NLST results. over the past 10 years, has dramatically lowered the “Screening is something that even as a smoker or cost of sequencing a single human genome—from $100a former smoker you continue for a long time. We don’t million in 2001, to about $10,000 today, and possiblyhave any good idea yet on when that endpoint is, but to as little as $1,000 in the next few years.you remain vulnerable for the rest of your life,” said That will open the feasibility of providingHenschke. “So we say that if you have a life expectancy personalized therapies to many more patients, heof 10 years, consider getting screened. But we don’t have said. It has greatly lowered the cost of doing science,the data on that. We say screening finds it five years specifically making The Cancer Genome Atlas possible.earlier, and then you should have another five years that “My colleague Harold Varmus and others areyou’ll enjoy because of the fact that you had your lung analyzing the DNA of tumors of hundreds of patientscancer taken out earlier. to identify comprehensively the genetic mutations “That’s really a lot of data still needs to be associated with specific cancers,” said Collins. “Thisgenerated on that count, but at the moment you have approach will lead to a new generation of targetedto do it every year. And perhaps we’ll get better. For therapies.”some people we only do it every two years or every Sen. Tom Harkin (D-Iowa), chairman of the Senatethree years. That’s research that still needs to be done.” Appropriations Subcommittee on Labor, HHS, and Education, noted that the NIH Human Genome Project Appropriations 2011: was an example of some of the best investments theCollins, Varmus Emphasize government can make.Returns on Investment in NIH “The federal government spent $3.8 billion on(Continued from page 1) this historic initiative,” Harkin said. “That’s a lot ofinstitutes’ lowest rate ever. money. But the return on investment is staggering. That “In FY ’10, we funded approximately 9,300 research translated into an economic output of $796research grants,” said Collins. “The success rate in FY billion between 1988 and 2010. And we’ll be seeing’10 came out at just about 20 percent. With the FY ’11 benefits from the Human Genome Project for manybudget now in front of us, now that it’s been decided, more decades to come.”we won’t do that well.” According to a report from United for Medical “But for every one grant that you can fund, how Research, an umbrella group pf health organizations,many are unfunded?” asked Sen. Barbara Mikulski NIH funding supported 488,000 jobs in 2010 alone,(D-Md.). producing $68 billion in new economic activity. NIH “It would be five out of the six,” responded Collins. funding supported over 71,000 jobs in California, over“If you have six grants in front of you, you’re going to 34,000 in Massachusetts, over 33,000 in New York, andfund one of them and five are going to go begging.” 31,000 in Texas. Collins was joined by NCI Director Harold Also, over the past 15 years, cancer mortality ratesVarmus, National Institute of Allergy and Infectious dropped 13.5 percent for women and 21.2 percent forDiseases Director Anthony Fauci, National Institute men, saving an estimated 750,000 lives, Collins wroteof Diabetes, Digestive and Kidney Diseases Director in his testimony.Griffin Rodgers, and National Heart, Lung and BloodInstitute Acting Director Susan Shurin. They were asked several questions about the how INSTITUTIONAL SUBSCRIPTIONSthe U.S. competes with foreign countries in biomedical allow everyone in your organization to readresearch, and senators requested an update on plans for The Cancer Letter and The Clinical Cancer Letterthe new National Center for Advancing TranslationalSciences. Find subscription plans by clicking Join Now at: Collins described four major points, accentuating http://www.cancerletter.com/all of the positives—and all of the money—thatinvestment in the NIH can offer, through acceleratingdiscovery through technology, applying science to The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 5
  6. 6. “Let me just cite a couple of figures,” Collins said. to say that about the genome project. So I decided that“If you look, for instance, at heart disease…we’ve seen we could, and we should, because this is the best waya 60 percent drop in mortality from heart attack [in the to move the science forward.past] 40 years. The cost of that, in terms of the research “We needed, of course, to communicate with ourthat led to those advances is about $3.70 per American, communities and constituencies, and as we figured outper year. It’s the cost of a latte—and not even a grande how to do this shifting right down to every employee,latte.” we had to be sure we had that right. We are at the point “And if you add up the economic benefits that have now where we believe we have that together. It needsresulted from increased longevity, that have occurred to be reviewed by the HHS and OMB experts. We hopebetween 1970 and 2000, I am told credible economists to get that to you, Senator, in the fairly near future,believe that adds up to $91 trillion,” he said. certainly within the next few weeks, and hopefully very “Each time the frequency of cancer goes down by few weeks,” said Collins.one percent, economists say that saves our country $500billion,” he said. “And that’s actually happening each Why are there no more Gleevecs?year. The return is enormous.” “In 2001, Gleevec was on the cover of all our “I’m not surprised by that,” said Sen. Jerry Moran national news magazines,” said Harkin. “They talked(R-Kan.). “It would be very helpful to have that—I don’t about it being the magic bullet, heralding in a new agelike the word soundbite, but that phrase that says, ‘For in the war against cancer. For the first time we had aevery dollar spent, here’s what we’re able to save,’ in drug that specifically targeted a lung cancer gene. It tookotherwise spending on healthcare.” this deadly blood disease, turned it into a chronic but “This is such an example of public service and survivable condition. We were told that Gleevec was thewhy government matters,” said Sen. Sherrod Brown future. We talked about it in our committee hearings at(D-Ohio). “And when I hear some of the know-nothings, that time. But that was 10 years ago. We haven’t hadthat hold jobs like we hold, say that the government any other Gleevecs. What happened? How come nois broke, and that government can’t function, and more Gleevecs?”that government doesn’t contribute anything, and that “I wouldn’t characterize it quite that way. Gleevecgovernment doesn’t create jobs. I think primarily of what remains the poster child for targeted therapy,” saidNIH does and what you contribute to public health and Varmus. “Just to give you a brief update, it’s used notto the wealth of our country.” only for the treatment of chronic myeloid leukemia, but it’s used for the treatment of several other diseasesAn update on NCATS in which potential targets for the drug are mutated, and The subcommittee asked for an update on the that includes gastro-intestinal stromal tumors, a numberprogress of NIH’s plan to shift its centers to make room of other blood diseases, and indeed a few other casesfor the new translational research center that NIH hopes in which certain genes are known to be mutated, as theto open at the beginning of the next fiscal year. result of the sequenced genomes of those cancers. “We’ve not received a budget amendment of “Moreover it’s recently been challenged thatspecific structure details on NCATS, a program you want we can deal with drug resistance, a common problemto implement by October 1. How can the committee in cancer therapy, by using drugs closely related tosupport a program that does not yet exist in budget Gleevec, but not identical to it, and to treat patients thatdocuments?” asked Sen. Richard Shelby (R-Ala.), the become resistant to Gleevec.subcommittee’s ranking member. “When will we receive “Secondly, it’s been shown recently that a personsome more details… do you have a timeline? in their 40’s or 50’s that developed that leukemia now “I had certainly hoped that by the time of this have normal life expectancy, which was previouslyhearing, we would have been able to provide the details five years. That’s a dramatic change. That shows theabout the budgetary consequences of setting up this efficacy of Gleevec has been sustained over the past tenexciting new center,” said Collins. years nationally. There are a number of other targeted “Rather than putting this off until FY ’13—which therapies. They tend to work quite well initially, but thenI thought would really have wasted an opportunity—we their tumors become resistant to therapy.decided we would try to move as quickly as possible. “Let me give you a couple of examples. OneAlthough some people said, ‘Hey this is the government! happens to involve my own work on lung cancer, inYou can’t possibly do that by October!’ Well, they used which a significant percentage, perhaps 10 percent of The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 6
  7. 7. cancers, have mutations in specific genes against which that feels if you’re a post-doctoral fellow in the middlewe have effective inhibitors. But generally speaking, of an experiment that you’ve been working on for twowithin a year or so, on average, patients become resistant to three weeks, and has a couple of weeks to go, andto those drugs. We don’t have good therapies to counter you’re being told, ‘I’m sorry, you’re not allowed tothe tumors that are resistant. come to work tomorrow if the government shuts down.’ “Recently, in the case of a disease called metastatic “It did have a very significant effect. Peoplemelanoma, it’s been found as recently as seven or eight were quite shaken up by that. I think people are, in theyears ago that about 60 percent of those cancers have a aftermath of that, feeling a little uncertain about what it’smutation in a specific gene in which we have an inhibitor like to work in this environment. And we’re hoping thatthat has been developed. we won’t face that again. But, again, I think everybody “It’s extremely effective in inducing remissions in understands these are terribly, terribly difficult timesa fairly non-toxic way. There are two drugs that do this, for our country.”and they are likely to soon be approved by the FDA.They don’t cause persistent regressions, but there’s Varmus’s Testimonyevery reason to hope that, with additional drugs to help Varmus’s testimony focused on the budget requestcounter the drug resistance. for the next fiscal year, an update on scientific work “I will say that we’ve had a number of other being done at NCI, information on the reorganization oftargeted therapies, they’ve not in general been quite as the adult clinical trials cooperative groups, and anotherdramatic as Gleevec, but most of us who are working look at NCI’s Provocative Questions initiative.in this area are quite optimistic about a number of new The text of Varmus’s testimony follows:drugs, some of which I haven’t mentioned that are inthe pipeline.” Mr. Chairman and Members of the Committee: “This is about as important as Gleevec. This attacks I am pleased to present the President’s Fiscalmetastatic melanoma in later stages,” said Harkin. Year (FY) 2012 Budget request for the National Cancer “Correct,” said Varmus. “We are quite optimistic Institute (NCI) of the National Institutes of Healththat after many years of trying to manipulate the immune (NIH). The FY 2012 request includes $5,196,136,000system that we have some various handles on how for NCI, which reflects an increase of $141,899,000the immune system works that we can use in cancer over the comparable FY 2011 level of $5,054,237,000.therapies.” We now know that cancer is a collection of diseases reflecting changes in a cell’s genetic makeup and thus itsThe Government Shutdown and NIH Morale programmed behavior. Sometimes the genetic changes “With all the talk of a shutdown, and during H.R. occur spontaneously or are inherited; sometimes they1—which had a cut to the NCI, which was stunning to are caused by environmental triggers, such as chemicalsme—what is the morale at NIH?” asked Mikulski. “Now in tobacco smoke, ultraviolet radiation from sunlight, orthat they’ve thought they might be sent home, and told viruses. While cancers constitute an incredibly diversethat they were non-essential and that the cuts might be and bewilderingly complex set of diseases, we have atcoming…and I must say that both the chairman and hand the methods to identify essentially all of the geneticthe ranking member were enormously supportive to changes in a cell and to use that knowledge to reworkminimize the disaster, but it was not a victory.” the landscape of cancer research and cancer care, from “I would say this was a difficult period to go basic science to prevention, diagnosis, and treatment.through,” said Collins. The funds in the President’s budget for NCI represent a “We were required, of course, in preparation for bold investment strategy critical for realizing that goal.what appeared to be a very high likelihood of shutdown, The emerging scientific landscape offers theto define how we would manage that. And that meant promise of significant advances for current and futuredefining which particular employees were considered cancer patients, and for preventing cancer so that manyessential—which were accepted, was the term that was never become cancer patients. And it offers scientistsused—and which were non-accepted. And, of course, at the National Cancer Institute—and in the thousandsthose that were involved in patient care or management of laboratories across the United States that receiveof animals couldn’t very well just not come to work. NCI support—the opportunity to increase the pace of “But others were told, ‘I’m sorry. If there’s a lifesaving discoveries dramatically.shutdown, you can’t come to work.’ Think about how In the past year alone, we have seen powerful The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 7
  8. 8. examples of how research dollars have translated into Cancer Treatmentconcrete advances against cancer through basic science, The potential therapeutic impact of basicprevention and early detection, and treatment. discoveries made by TCGA and other efforts in cancer genomics has been dramatically illustrated this yearBasic Science by the development of effective drugs against the In collaboration with NHGRI, the NCI is leading most deadly form of skin cancer, melanoma. Almost aThe Cancer Genome Atlas (TCGA), the largest and most decade ago, studies of cancer genomes first uncoveredcomprehensive analysis of the molecular basis of cancer a common mutation in a gene that encodes an enzymeever undertaken. TCGA aims to identify and catalog all of called BRAF. Last year, early stage clinical trials atthe relevant genetic alterations in many types of cancer. NCI-designated Cancer Centers of drugs targetedFor instance, building on their recent reclassification of against the mutant BRAF enzyme showed that mostglioblastoma multiforme (GBM), an aggressive form of melanomas with the relevant mutation regressedbrain cancer, this year TCGA investigators discovered dramatically. Although tumor regression generallythat about 10 percent of patients with one of the four lasted less than a year, NCI-supported investigators havesubtypes of GBM are younger at diagnosis and live already pinpointed some causes of resistance to BRAFlonger than patients with other subtypes of the disease, inhibitors, outlining a pathway to more sustained controlbut their tumors are unresponsive to current intensive of this lethal disease.therapies. The molecular profile of this subtype offers Another benefit of a prolonged and broad-basednew targets for developing drugs to treat this form of investment in cancer research has also been realized inthe disease more effectively. TCGA scientists are also the context of malignant melanoma this year, with thepreparing to publish similarly important findings about recent approval by the FDA of an antibody, ipilimumab,the major form of ovarian cancer in mid-2011 and are in which extends the lives of patients with metastaticthe midst of analyzing nearly 20 other types of cancer. melanoma. Ipilimumab stimulates the immune system to act against cancer by blocking natural inhibitorsPrevention and Early Detection of the immune response, an approach that would not NCI’s intensive efforts to study and reduce the be possible without a profound understanding of theuse of tobacco products have contributed to a sustained immune system and one that promises to harnessannual reduction in age-adjusted cancer mortality rates immunological tools against other cancers.over the past decade and more. But current and former These examples of NCI’s progress in understanding,heavy smokers remain at high risk of developing lethal treating, and detecting different forms of cancerlung cancers, which are the leading cause of cancer illustrate what can be achieved at an accelerated pacemortality. In late 2010, NCI announced initial results with sustained investments across the cancer researchfrom the National Lung Screening Trial, a large, spectrum, such as proposed under the President’s budget.multi-year randomized trial that enrolled more than While those perspectives are only beginning to inform53,000 subjects. Because early detection provides the the American public’s perception about cancer and itspotential to intervene at the earliest, most treatable treatment, the downward trajectory of cancer deaths –stages of disease, thus reducing potentially difficult to reported by NCI and its partners in March -- reflectstreat outcomes seen in more advanced disease, current real and sustained reductions over more than a decadeand former smokers who were screened with low-dose for numerous cancers, including the four most common:helical computed tomography were 20 percent less likely breast, colorectal, lung, and prostate. We have identifiedto die of lung cancer than were peers who received proteins and pathways that different cancers may havestandard chest x-rays. These results provide the first in common and represent targets for new drugs for theseclear demonstration that a screening procedure can be and many other cancers—since so often research in oneeffective in reducing mortality from lung cancer—a cancer creates potential benefits across others.finding that could save many lives among those at Additional progress against cancer also willgreatest risk. Over the course of the $240-million study, require building these research advances into clinicalNLST investigators collected samples of early and treatments and diagnostic tools for better patientadvanced lung cancers from enrolled subjects, and these care and by our many connections with public andspecimens will be invaluable for determining genetic private sector partners. The Institute’s investments inalterations that may be used to predict which tumors translational research are broad and deep, and willare likely to progress to an advanced stage. receive NCI’s full energies, recognizing that the publicly The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 8
  9. 9. announced proposal for reorganizing services that of the damage that occurs in the genome of a cancer cellsupport translational science in general could give NIH and how a cancer cell behaves in its local environmentadditional focus in this important area. as a result of those changes. With this better understanding of cancer andRevitalizing the Cancer Clinical Trials System recent technological advances in many fields, such For today’s new understandings of cancer biology as genomics, molecular biology, biochemistry, andto benefit cancer patients on a broad scale, they must computational sciences, progress has been made onbe coupled with a modernized system for conducting many fronts, and a portrait has emerged for severalcancer clinical trials. This system must enable clinical cancers.researchers across the nation to acquire tumor specimens With sustained and accelerated funding, andand conduct genetic tests on each patient, to efficiently NCI’s strong leadership in defining cancer researchanalyze molecular changes in those samples, to manage priorities, we can build upon today’s cancer advancesand secure vast quantities of genetic and clinical data, with provocative thinking by asking better questions.and to identify subsets of patients with tumors that To that end, NCI is asking researchers in variousdemonstrate changes in specific molecular pathways— disciplines to pose and articulate “provocativepathways that can be targeted by a new generation of questions” that can help guide the nation’s investmentcancer therapies. in cancer. Provocative questions may be built on older, As part of its effort to transform the cancer neglected observations that have never been adequatelyclinical trials system, NCI asked the Institute of explored, or on recent findings that are perplexing, or onMedicine (IOM) in 2009 to review the Clinical Trials problems that were traditionally thought to be intractableCooperative Group Program. This program involves but now might be vulnerable to attack with new methods.a national network of 14,000 investigators currently Many of these provocative questions are beingorganized into nine U.S. adult Cooperative Groups and asked–and answered – by young scientists who are earlyone pediatric cooperative group that conduct large- in their careers. The 2012 budget will support NCI’sscale cancer clinical trials at 3,100 sites across the U.S. commitment to ensuring that an equitable share of ourThe IOM report, issued in April 2010, noted that the research grants will go to the young men and women,current trials system—established a half-century ago— who are at the forefront of understanding cancer.is inefficient, cumbersome, under-funded, and overly We are now reaping the rewards of investments incomplex. Among a series of recommendations, the cancer research made over the past 40 years or more,report urged that the existing adult cooperative groups even as we stake out an investment strategy to realizebe consolidated into a smaller number of groups, each the potential we see so clearly for the future. Thewith greater individual capabilities and with new means public has benefitted from past generous Congressionalto function with the others in a more integrated manner. stewardship of biomedical research funding; cancer In December 2010, NCI announced its intent to research over the past four decades has provided thebegin consolidating the current nine adult cooperative evidence required to lower the incidence and mortalitygroups into four state-of-the-art entities that will design of many kinds of cancer, to improve the care of cancerand perform improved trials of cancer treatments, as patients, and to establish the new understanding ofwell as explore methods of cancer prevention and cancer that is now beginning to revolutionize controlearly detection, enhance the ability of the cooperative of cancer throughout the world.groups to assess the molecular characteristics of No matter what the fiscal climate, NCI will striveindividual patients’ tumors, and study quality-of-life to commit the resources necessary to bring about a newissues and rehabilitation during and after treatment. era of cancer research, diagnosis, prevention, treatment,The sole pediatric cooperative group was created by and survivorship.consolidating four pediatric cooperative groups almosta decade ago, and that group will not be affected by thecurrent consolidation effort. Follow us on Twitter: @TheCancerLetterProvocative Questions This has been a challenging and hopeful time forNCI to lead the nation’s cancer research program. Overthe past two decades researchers have unraveled some The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 9
  10. 10. NCI News: In the Cancer Centers:Varmus to be Keynote Speaker Columbia Recieves $1.35 MillionAt Lung Cancer Partnership Meeting From Komen and Conquer Cancer NCI DIRECTOR Harold Varmus will be COLUMBIA UNIVERSITY will receive a $1.35the keynote speaker at the National Lung Cancer million grant from the Conquer Cancer FoundationPartnership’s annual meeting in Chicago, June 3. and funded by Susan G. Komen for the Cure, to lead a Varmus will discuss the promise of the Scientific randomized trial of women receiving adjuvant hormoneRevolution, and how lung cancer researchers can therapy for breast cancer, as part of the foundation’scontribute. Improving Cancer Care Grant program. Panel discussions include: The National Lung To improve adherence to prescribed therapies, theScreening Trial: Ramifications and Challenges Moving women will receive text messages versus traditionalForward, debating screening guidelines, minimally follow-up care. The trial will also help establish ainvasive surgical procedures, and advances in biomarker methodology for testing other intervention techniquesdevelopment; and State of the Art in Lung Cancer to improve adherence in other cancers. The project isTreatment, discussing adaptive clinical trial designs, led by Alfred Neugut.the MET signaling pathway, EGFR inhibitors and “The Improving Cancer Care Grant providespalliative care. researchers with an opportunity to test real and practical The full agenda for the meeting can be found solutions that ultimately improve patient care,” saidhere: http://www.nationallungcancerpartnership.org/ Martin Murphy, chair of the foundation’s board ofdownloads/Events/annual_meeting/2011_annual_ directors.meeting_agenda.pdf The foundation gave out two awards as part of its Diversity in Oncology Initiative. The initiative consists NCI has elected new members to the steering of the Loan Repayment Program and the Medical Studentcommittee of the Public Affairs and Marketing Rotation, offering funding to physicians who commit toNetwork, a professional network of public affairs, practicing oncology in a medically underserved regionmarketing and communications officers at the nation’s of the United States for at least two years and to medicalleading cancer centers. The following members were students with an interest in oncology who self-identifyelected to two-year terms: as minorities. • Theresa DiNardo Brown, chief communications The Loan Repayment Program awardees include:officer, The Ohio State University Comprehensive Jason Brown, Yolanda G. Barco Oncology Institute;Cancer Center–James Cancer Hospital and Solove Waina Cheng, Lincoln Medical and Mental HealthResearch Institute Center; Sharyn Nan Lewin, Columbia University • Lynn Clark, communications manager, Medical Center; and Sarah Temkin, University ofUniversity of Colorado Cancer Center Maryland. • Alicia Jansen, associate vice president for The Medical Student Rotation awardees participatemarketing, MD Anderson Cancer Center in 8- to 10-week rotations in oncology with a mentor • Bill Schaller, director of media relations, Dana- oncologist who provides ongoing academic and careerFarber Cancer Institute support. Members of the network represent NCI-designated This year’s recipients are: Marcela Augustacomprehensive, clinical, basic and consortium cancer Azevedo, The Ohio State University; Mark Edmundcenters or academically based centers that are members Bernard, University of Pittsburgh; Christina Hunterof the Association of American Cancer Institutes. Chapman, University of Pennsylvania; Kristina The network meets each year in collaboration Lauren Demas, George Washington University;with a sister organization of cancer center fundraising Tiffany George, Meharry Medical College; Sheriofficers, the National Association of Cancer Center Jones, University of Medicine and Dentistry of NewDevelopment Officers. Jersey; Nicole Ashley Sample, The City College of New York; and Kimberly Michelle Thomas, The University of Texas. The Cancer Letter • May 13, 2011 Vol. 37 No. 19 • Page 10

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