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Monday, August 31, 2015

With CHARLES FUCHS, MD, MPH, of Dana-Farber Cancer Institute and Harvard Medical School



Another win for java in the should-you/shouldn’t-you debate. New data showed that patients with colon cancer who drank four or more cups of coffee a day were less likely to have their cancers recur or to die compared with patients with colon cancer who did not regularly drink coffee, according to a study now published online ahead of print (JCO 2015 doi: 10.1200/JCO.2015.61.5062).


Previous studies have shown that diet and lifestyle do influence an individual’s risk for developing colon cancer, said the study’s corresponding author Charles Fuchs, MD, MPH, Director of the Gastrointestinal Cancer Center and Institute Physician at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “But it’s a bit of an inference to conclude that those studies necessarily inform how patients with colon cancer would do with any particular diet modification.


“So we decided to prospectively look at diet and lifestyle, and as it relates to cancer risk, get the same data for a population of patients being treated for cancer to see which diet and lifestyle choices might influence the ultimate outcome from their cancer.”


And as Fuchs and his colleagues hypothesized, similar to how coffee has been shown to play a role in colon cancer risk, it also appears to play a role in outcomes for patients who have been diagnosed with colon cancer.


The researchers analyzed data from a cohort of 953 patients with stage III colon cancer from the National Cancer Institute-sponsored Cancer and Leukemia Group B 89803 for which patients prospectively completed food frequency questionnaires four months after surgery (at which point they were receiving chemotherapy) and six months after completion of chemotherapy. Compared to patients who drank no coffee, patients who reported consuming four cups or more of caffeinated coffee per day had a 45 percent reduction in risk for cancer recurrence and a 46 percent reduction in risk of death from any cause. The researchers adjusted risk for sugar-sweetened beverage intake and glycemic load, which their previous work had showed also play a role in outcomes for patients with colon cancer.


The researchers also compared the effects of caffeinated coffee versus decaffeinated coffee and found that when analyzing decaffeinated coffee consumption alone, there was no link to improved outcomes. While those findings might mean that caffeinated coffee yields a benefit in terms of colon cancer outcomes that decaffeinated coffee does not have—it also might be the case that the low number of decaffeinated coffee drinkers in the study was inadequate to statistically show a benefit.


The bottom line, Fuchs said: “Patients who were regular caffeinated coffee drinkers had a significant improvement in their outcomes—namely a lower risk of cancer recurrence and a better survival.”


Why? Here’s what he told OT in a phone interview.


1. You said it was an “inference” that the diet and lifestyle choices that influence colon cancer risk would also influence colon cancer outcomes—why did you suspect there might be a connection?

“CALGB 89803 started in order to collect dietary information in this population of stage III colon cancer patients. We found over time that a number of factors do influence outcomes for these patients—namely that patients who are obese and who are sedentary do worse, and patients who avoid exercise and exercise regularly have better outcomes. And in this cohort of patients [for which coffee consumption was followed], we also found that consumption of sugar sweetened beverages was associated with worse outcomes; and having a high glycemic load diet was associated with worse outcomes.


“Many of these factors seemed to be risk factors for the development of type 2 diabetes—obesity, sedentary lifestyle, high glycemic load diet, high consumption of sugar sweetened beverages. And what’s curious is that other research has shown that people who have a history of type 2 diabetes actually do worse from colon cancer. So we wanted to look and see whether factors that influence diabetes risk could influence outcomes for patients with colon cancer.


“And coffee has—relatively consistently—been a factor associated with lowering the glycemic risk of type 2 diabetes—so that was the motivation to look at coffee consumption.”


2. So what is the mechanism for coffee having this protective effect?

“We suspect that given that we’re now consistently finding the risk factors for diabetes having a similar modifying risk on outcomes for these patients with colon cancer, we are at least hypothesizing that the ability of coffee to improve outcomes may be through that pathway.


“At a mechanistic level how is it doing that? We don’t know yet. What component of coffee might be contributing to the benefit? We don’t know. And what pathway is it influencing in colon cancer that might improve outcomes?


“I think those are very important questions. Not only does it give you better insight into the nature of the causality, but it also gives you potential clues toward better treatments. We believe that these pathways—referred to as energy-balance pathways or the pathways that relate to diabetes and glucose metabolism—are relevant. And if we understand what the target of these ‘interventions’ (in this case coffee) is in the cancer cells, then potentially we could even come up with a more sophisticated and targeted approach that might benefit these patients even more beyond these lifestyle habits.”


3. So, based on these findings, what is the message to practicing oncologists about whether or not patients with colon cancer should drink coffee?

“The findings do require confirmation. This is one study—it has a fair number of patients and it’s prospective in its design—in that we collected the information on diet and lifestyle before we knew anything about the individual outcomes for patients. But you want to see a confirmatory study; and we are in the process of planning that.


“Right now for patients who have been recently diagnosed with colon cancer and they enjoy coffee—I would say, don’t stop drinking it. This study suggests there may be a genuine benefit. If someone says, I hate the stuff, I would say, then don’t drink it.


“As it is stated in the paper, regular exercise, avoiding obesity, avoiding a high glycemic load diet, avoiding sugar-sweetened beverages, and avoiding an excessive Western diet all also seem to contribute to a meaningful benefit. So I wouldn’t tell somebody to start drinking coffee if that’s not something they’re inclined to do.”

Monday, August 17, 2015

With J. Lee Westmaas, PhD, Director of Tobacco Control Research at the American Cancer Society



Clinicians should take advantage of any opportunity to help patients stop smoking, said J. Lee Westmaas, PhD, Director of Tobacco Control at the American Cancer Society. That disclaimer aside, his new research found that any time after a cancer diagnosis could be a particularly effective time to get the message across to a smoker, he explained in a phone interview about the findings. The study showed that both two- and four-year quit rates were higher for patients diagnosed with cancer, compared with a group of patients who were not diagnosed with cancer (JCO 2015;33:1647-1652).


“It didn’t matter what stage the cancer was, the type of cancer, how much they smoked, or when they started smoking,” Westmaas said.


The researchers used data from ACS’s Cancer Prevention Study-II Nutrition Cohort (which included both men and women, the majority of whom were 50 and older). For the 772 smokers in the cohort who were diagnosed with cancer (for which data was available on smoking status for a minimum of four years), 31.3 percent quit within two years of their cancer diagnosis, compared with 19 percent for the 11,410 smokers in the cohort who were not diagnosed with cancer. Similarly, 43 percent of those diagnosed with a cancer quit smoking within four years of their diagnosis, compared with 33.8 percent for the smokers not diagnosed with cancer. And smokers who quit in the first two years after a cancer diagnosis were less likely to resume smoking compared to the smokers who had not been diagnosed with cancer—12.4 percent of the two-year quitters who had cancer resumed smoking within four years versus 15.4 percent of the two-year quitters who had not had cancer.


“It seems to be that cancer diagnosis may have triggered [for the smokers] some thinking about health behaviors that they may need to change, or perhaps they may have thought of smoking as having a link to their cancer even though it was not a smoking related cancer,” Westmaas explained.


This study excluded patients from the group with cancers of the lung, head and neck, esophagus, or any metastatic or advanced cancer.


“We eliminated those cancers, not because they were smoking-related cancers, but because they probably would limit a person’s ability to smoke,” Westmaas said. “We were really trying to answer the question—was diagnosis a trigger for quitting? Whereas with those other cancers or advanced cancer, because of the symptoms and side effects, you almost have to quit.”


So how should these findings change practice? Here’s what Westmaas said.


1. What’s the key message about these findings that all practicing oncologists should be aware of?

“Oncologists should always ask patients about smoking and try to provide as many resources for the patient as possible—even for long-term survivors. And oncologists should provide follow up support, checking in with patients to ask whether they are smoking or not.


“This research showed that smokers who are diagnosed with cancer regardless of cancer stage, how much they smoked, or when they started smoking, quit at much higher rates than those who were not diagnosed with cancer.


“But, I think that some oncologists are not addressing smoking with their cancer survivors.”


2. What makes the topic a difficult one for oncologists to address?

“Some oncologists may be afraid to bring it up to some of their patients. Doctors may think their patients are already going through a lot—to have them quit smoking would be another stressor that we don’t want to be responsible for incurring.


“It’s true that dealing with a cancer is stressful and some survivors might look at smoking as a way of relieving that stress. But studies consistently show that when people quit smoking their stress levels go down. So, in that regard training would be important.


“And the other issue is connecting both patients who smoke and the clinicians taking care of them with the resources that are available, like the 1-800-QUIT-NOW free tobacco cessation counseling phone line, which is available to any member of the public; or websites like (the National Cancer Institute website with cessation resources). And there are various pharmacotherapies for smoking cessation that cancer survivors may also benefit from.


“I think many smokers don’t even know about the resources that are out there—and some physicians might not be aware of them either. Getting that knowledge out there is important.”


3. In an accompanying editorial about your research, Stephanie R. Land, PhD, and Pamela M. Marcus, PhD, both at NCI, wrote that your research raises the question of whether the smoking cessation rates would also be higher after patients undergo cancer screening (JCO 2015;33:1631-1632). The hypothesis seems intriguing based on—as they note in the editorial—the rapid expansion of low-dose computed tomography screening for lung cancer, the U.S. Preventive Services Task Force’s recommendation that high-risk individuals undergo screening, and the Centers for Medicare and Medicaid Services’ decision to provide Medicare coverage for lung cancer screening. Based on your findings and conclusions about the best time for smoking cessation interventions—what do you think about their hypothesis?

“Any chance that physicians have to convey the message that your health will be improved if you quit smoking should be acted on. And cancer screening, I think, is also a teachable moment, because patients who are getting screened for a cancer are presumably showing some interest in their health—so it very well may be that cancer screening is a teachable moment for asking about smoking and providing patient resources for the smoker who is being screened.


“In the case of lung cancer screening, there is some evidence suggesting that screening for lung cancer doesn’t change smokers’ risk perceptions—regardless of whether the screening was positive or negative. There was a recent small qualitative study suggesting that smokers may be interpreting the screening test (computed low-dose tomography) as showing that they won’t get lung cancer, or that the test “protects” them (JAMA Int Med doi:10.1001/jamainternmed.2015.3558). And if this is happening, I think it becomes even more important to use any screening as a ‘teachable moment’ and provide smokers with all of the tools that could potentially help them quit.”

Tuesday, July 21, 2015

With Carlo Gambacorti-Passerini, MD, of University of Milano Bicocca


“Imatinib mesylate changed the prognosis for chronic myeloid leukemia (CML) so dramatically that patients with newly diagnosed CML starting treatment with imatinib now have a normal life expectancy, compared with the historical median survival of 2 to 3 years. In addition to its outstanding therapeutic activity, imatinib possesses a remarkably safe profile.”


So writes Carlo Gambacorti-Passerini, MD, Professor of Hematology and Director of the Clinical Research Unit at the University of Milano Bicocca—with coauthor Rocco Piazza, MD, PhD, also of the University of Milano-Bicocca—in a recent “Viewpoint” editorial in JAMA Oncology (2015;1:143-144).


In a phone interview Gambacorti-Passerini noted that the article is particularly timely given that generic imatinib is set to be available in the U.S. in 2016—which will make the drug available to patients in the U.S. at a fraction of the cost of the branded product (Gleevec, manufactured by Novatis). Generic versions of imatinib have been available in Canada and South Korea since 2013, costing 10 to 25 percent of the branded product.


The coauthors succinctly summarize the argument why imatinib should remain the first choice for first-line treatment for patients with newly diagnosed CML, as well as why second- and third-generation tyrosine kinase inhibitors (TKIs)—developed primarily for second- and third-line use—are best suited for that purpose.


“Bosutinib monohydrate, dasatinib, nilotinib, and ponatinib hydrochloride constitute a set of formidable ‘spare wheels’ for patients whose imatinib treatment fails, giving a viable option to more than 50 percent of them,” the article states. But the Gambacorti-Passerini and Piazza go on to explain why the evidence does not quite support those drugs as a replacement for imatinib.


“If obtaining ‘faster and deeper’ responses using second-generation TKIs does not convert into a better prognosis, then this phenomenon should not dictate a change in therapy by itself,” they write, adding: “The safety profiles of these drugs are also a matter of debate.”


Gambacorti-Passerini summed up the bottom line from the editorial for OT, and commented on his recent work that suggest there is a subset of CML patients who can safely discontinue TKI treatment, published online ahead of print (Amer J Hem DOI: 10.1002/ajh.24120).


1. What is your key message about imatinib?

“Imatinib is definitely the safest inhibitor around in terms of long-term toxicity—and as active as any other TKI in the setting of first-line use. So, in my opinion, there is no scientific, clinical reason for using second-generation TKIs as frontline treatment. Imatinib remains, as the title indicates, the first-line TKI of choice for treating newly-diagnosed CML patients. And we need to in every object way try not to be biased for economic reasons.


“Other hematologists have different opinions on the topic, which is quite hot—as one can imagine.”


2. What would you say are the key points about the findings you recently published on safely discontinuing imatinib treatment for some patients with CML?

“Number one, imatinib can be safely discontinued in real-world scenarios [in some patients], assuming that close monitoring is guaranteed.


“Number two, the risk of relapse is linked to both the age of the patient and the result of the digital PCR test—being old lowers the risk of relapse.


“And third, even for patients who did not relapse and for the most part show at least some PCR positivity after discontinuation [of imatinib], this positivity does not seem to be growing as you would expect from leukemic cells.


“So our study suggests the patient who is at the lower risk of relapse is the patient who is older (approximately 45 and older) with a negative digital PCR.”


3. Are the findings conclusive enough to suggest clinicians should change practice for these patients?

“As for any study, these data need to be confirmed. Though our study is one of the biggest studies performed so far. We had 112 patients enrolled in the study.”

Tuesday, May 05, 2015


With DOUGLAS LOWY, MD, NCI Acting Director



Douglas Lowy, MD, became Acting Director of the National Cancer Institute on April 1 after serving as NCI’s Deputy Director since July 2010. The NCI’s previous Director, Harold Varmus, MD, stepped down from the role to become the Lewis Thomas University Professor of Medicine at Weill Cornell Medical College (OT 4/10/15 issue). Lowy is also a member of the National Academy of Sciences, as well as the Institutes of Medicine of the NAS.


“We are fortunate to have a scientist of such stature stepping into the role of Acting Director of the NCI,” National Institutes of Health Director Francis S. Collins, MD, PhD, said in a news release. “Dr. Lowy possesses not only a sharp intellect, deep knowledge of science, and proven leadership experience, but he takes a warm and humane approach to all things. He is superbly positioned to lead the NCI at a time of exceptional progress in cancer research.”


Lowy has more than four decades of experience as a cancer researcher under his belt. He received the National Medal of Technology and Innovation from President Obama in 2014 for his work on the biology of papillomavirus and the regulation of normal and neoplastic growth that led to the development of the human papillomavirus vaccine. His laboratory was involved in the initial development, characterization, and clinical testing of the preventive virus-like particle-based HPV vaccines that are now used in the three FDA-approved HPV vaccines.


Lowy is also involved in research that focuses on cancer genes, including investigating the DLC1 tumor suppressor, which encodes a Rho-GAP that is down-regulated in a variety of cancers, leading to the high Rho activity seen in many advanced cancers. His research has identified key scaffold functions for DLC1, including protein-protein interactions and phosphorylations, which contribute to the regulation of its activity and its role as a tumor suppressor.


In a phone interview in April, Lowy spoke to OT about the current fiscal climate at the NCI now and what’s ahead for the Institute, as well as for his own research.


1. The NCI has seen a particularly tight fiscal climate in recent years. How does this affect your new job?

“Our budget has been flat or reduced for close to 10 years. And the budget this year is more than $150 million lower than it was five years ago.


“That is a challenge because there are enormous opportunities in cancer research to make progress from the most applied research to the most basic research—and everything in between. So, we run out of money long before we run out of good ideas to test. It is challenging to try to make the strategic decisions [that need to be made] when there are so many competing meritorious opportunities. But that’s basically what we need to do.


“One way we are trying to help researchers be able to feel more confident and comfortable with their funding situation is the Outstanding Investigator Award. Instead of being for five years, as are most of our major grants, this award is for seven years and it’s for a larger amount of money than most of our research awards. It gives the recipient the opportunity, we hope, to be able to take risks and to test important problems that otherwise might be more difficult for them to do because of the funding situation and continually needing to apply for grants.


“Also, the President’s budget for the 2016 fiscal year proposes a 2.9 percent increase for the NCI; and if that proposed budget is passed it will be easier for us to do more.


“And I certainly will advocate for that.”


2. What are the biggest opportunities for the NCI in terms of areas of research to pursue?

“I see four deep opportunities. One is the Precision Medicine Initiative, which has been proposed for fiscal year 2016 as part of the President’s budget proposal. That initiative aims to change the paradigm for more patients to better understand the molecular abnormalities in their cancer and better tailor treatments to those molecular abnormalities. The initiative has several components—adult cancer clinical trials, pediatric cancer clinical trials, an effort to overcome targeted drug resistance, and the building of a knowledge system to support precision medicine.


“Another important area is cancer prevention and screening. Many of the same principles can be applied, in terms of what we understand about the causes of cancer and how cancer comes about, to enable us to be more strategic and more effective in our interventions for cancer prevention and cancer screening.


“And we also have a serious problem with cancer health disparities. It’s very important for us to try to understand where these disparities are—we need to understand the biological role, the lifestyle role, and the role of health care access and utilization. And we need to understand how those [factors] come together to lead to imbalances, and what can be done to reduce these imbalances to improve outcomes for all populations.


“And we want to strongly support basic research—because many of the breakthroughs that will help us in the years ahead will come from that basic research.”


3. You have a very noteworthy research career of your own. Are you able to continue with your own research while taking on these new leadership roles?

“Yes, I was able to continue doing research as Deputy Director, and I anticipate continuing my research activities [in the new role]. My degree of involvement was certainly not what it was when I did not have the responsibilities as Deputy Director, and my degree of involvement now will need to be even less, but that doesn’t mean that I won’t be involved.


“Research really is integral to what I do, and also to what the NIH does and to what the NCI does. And I think having first-hand experience of doing has benefits.


“Though if you are asking me: am I going to go to lab meetings when I should otherwise be testifying in front of Congress? I will be testifying in front of Congress.


“I’m very fortunate that the people that I work with in the lab are outstanding and extraordinarily supportive. I expect that I will continue [my research], as long as my site visits reports continue to be positive.”

Monday, April 27, 2015

With SANDRA SPOELSTRA, PHD, RN, Assistant Professor at Michigan State University College of Nursing



ORLANDO, Fla.—Oral anticancer agents are increasingly playing a growing role in oncology treatments, but the problem is that research consistently shows that patient adherence to those drug regimens is less than 80 percent, Sandra Spoelstra, PhD, RN, Assistant Professor at Michigan State University College of Nursing, said delivering the 2015 Victoria Mock New Investigator Award lecture here at the Oncology Nursing Society Annual Congress. “And we don’t know what the outcomes are for those agents if the recommended doses and schedules are not followed.”


ONS’s Victoria Mock New Investigator Award recognizes contributions of new investigators in building a scientific foundation for oncology nursing practice. Spoelstra’s work has focused on issues related to oral anti-cancer symptom and adherence management, including recent studies on: determining symptom severity from side effects of prescribed oral agents; patient preferences in regards to symptom management; and, most recently, a text message intervention for symptom management and adherence to oral agents.


Spoelstra presented two Podium Session Abstracts here at Congress on the topic—“Assessment and Measurement of Medication Adherence: ONS Putting Evidence Into Practice (PEP) Oral Anti-Cancer Agents” and “ONS PEP: Evidence-Based Interventions for Oral Anti-Cancer Agents.” Both studies evaluated current ONS PEP recommendations and will be published in the Clinical Journal of Oncology Nursing in June, Spoelstra said.


Why does she say mHealth is the solution? And why a text message intervention? Because people use cell phones in their daily lives—and making the intervention part of patients’ daily lives is key to a successful intervention, she explained.


In an interview after the lecture, Spoelstra shared these thoughts about why she says using mHealth to tackle the problems of oral drug symptom management and adherence is working—and why she is urging more nurses to publish their work on the topic.


1. Why would you say mHealth could play a major role in the solution to the problem of oral anti-cancer agent adherence and symptom management? Why has the text message intervention been successful?


“A lot of interventions are about trying to do something to patients—but the solutions need to be about helping patients do it for themselves. This is the lesson I’ve learned as a caregiver. I train all the people I care for to manage their own care. It’s about self-intervention. It’s a different approach—it comes from the person—it’s patient-centered.


“And that’s what the text message intervention is about. It engages patients to participate. And it delivers their care into their normal flow of activities of daily living. And attaching it to daily living—I think—is key.”


2. Based on your review of the current research, you talked about a need for more evidence? What are the gaps?


“We just finished our review of the evidence [for the ONS PEP resource] on medication adherence. We found that not a lot [of the interventions in the literature] were effective. That’s why I’m calling for people to publish their protocols so we understand what’s going on in trials. Maybe something worked, but it’s not widely disseminated. And I think a lot of projects start not with the person, but trying to fix the system.”


3. What do you mean by “trying to fix the system”? How does an intervention start with the person?


“Many interventions are focused on provision of patient education in traditional health care settings (i.e., hospitals or cancer clinics) and do not seem to focus on the individualized needs of cancer patients and how they can fit interventions naturally into their daily life.


“For example, often nurses tell patients take your pill at 9am, instead of asking, ‘What do you do once a day, that you can attach your medication taking to so that you can automatically remember to take your pill?’ This approach allows the patients to problem solve themselves, and to find a way to fit the pill taking into daily life successfully.


“All cancer patients and their caregivers need to understand how to conduct self-assessments—and be able to determine which symptoms they can self-manage and when they need to seek help from a clinician. This is what they need to do every day at home to be able to manage their cancer care.”

About this Blog

Sarah DiGiulio

SARAH DIGIULIO, Associate Editor of Oncology Times, asks oncology’s thought leaders for their perspectives and takes on the field’s current news and controversies.

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