Influenza epidemics occur every year in the United States, typically beginning in the late

fall or winter and concluding during the spring.1 During the 2006—2007 season, influenza

circulated at epidemic levels for about 14 weeks and peaked during February, the month

most frequently associated with peak activity over the past 31 influenza seasons.1,2 According

to estimates from the Centers for Disease Control and Prevention (CDC), influenza has

caused roughly 36,000 deaths and 226,000 hospitalizations annually.3,4 However, the rate

of flu varies each year based on viral virulence and duration of circulation. Complications,

hospitalizations, and death are most common in patients aged =65 years.5,6 In recent years,

there has been a growing recognition among oncologists and other cancer care professionals

of the importance of vaccination against influenza in patients with cancer.

For most people with cancer, vaccination for influenza is not only safe, but also a crucial part

of staying as healthy as possible. Owing to their weakened immune system, patients with cancer

are at high risk for infection with flu and pneumonia viruses, which can be lethal in these individuals.

Yearly flu and pneumonia shots often prevent infection entirely and can lessen the severity

Influenza viruses are divided into three types, designated A, B, and C. Influenza types A and

B are responsible for epidemics of respiratory illness that occur almost every winter and are

often associated with increased rates for hospitalization

and death. Influenza type C differs from types A and B in some important ways.

Type C infection usually causes either a very mild respiratory illness or no symptoms at all;

it does not cause epidemics and does not have the severe public health impact that influenza

types A and B do. Efforts to control the impact of influenza are aimed at types A and B.

Influenza type A viruses are divided into subtypes based on differences in two viral proteins

called the hemagglutinin (H) and the neuraminidase (N). The current subtypes of influenza A

are designated A(H1N1) and A(H3N2). Influenza A(H1N1), A(H3N2), and influenza B strains are

included in each year’s influenza vaccine. In the years since its emergence, type A(H3N2) epidemics

have caused more than 400,000 deaths in the United States alone, and more than 90% of 

these deaths have occur-red among people age 65 and older.

Influenza type A viruses undergo two kinds of changes. One is a series of mutations that

occur over time and cause a gradual change in the virus. This is called antigenic “drift.” This

constant changing enables the virus to evade the immune system of its host, so that people

are susceptible to influenza virus infection throughout life. This process works as follows:

A person infected with influenza virus develops antibody against that virus; as the virus

changes, the “older” antibody no longer recognizes the “newer” virus, and reinfection can occur.

The older antibody can, however, provide partial protection against re-infection.

The other kind of change is an abrupt change in the hemagglutinin and/or the neuraminidase

proteins. This is called antigenic “shift.” In this case, a new subtype of the virus suddenly

emerges. Type A viruses undergo both kinds of changes; influenza type B viruses change only

by the more gradual process of antigenic drift.

CDC Recommendations For Influenza Vaccination

Influenza vaccination is the most effective method for preventing influenza virus infection

and its complications, which may be severe The CDC updated its recommendations

regarding who should receive influenza vaccination in 2008.1,7 Current recommendations 

regarding annual vaccination in children/adolescents and adults are summarized in Table 1

and Table 2, respectively. It is important to note that patients with cancer may fall into several

In 2008, the Advisory Committee on Immunization Practices (ACIP) of the CDC expandedits 

recommendations for influenza vaccination for school-aged children.1,7 The ACIP-CDC

now recommends that all children aged six months to 18 years receive annual influenza

vaccination, beginning in 2008 if feasible, but beginning no later than during the 2009—2010

Since influenza viruses undergo frequent antigenic change, persons recommended for

vaccination must receive an annual vaccination against the viruses known to be in circulation

According to the CDC,1 trivalent influenza vaccine may be used for any person aged

=6 months, including those with high-risk conditions. The 2008—2009 trivalent vaccine

virus strains are A/Brisbane/59/2007 (H1N1)-like, A/Brisbane/10/2007 (H3N2)-like,

and B/Florida/4/2006-like antigens.1 Live, attenuated-virus vaccine is currently approved

only for healthy, nonpregnant persons aged 5—49 years.

According to the CDC, less than 30% of patients with high-risk conditions, including cancer, 

were vaccinated against flu in 2005.8 Table 3 shows flu vaccination coverage levels in persons

with high-risk conditions, including cancer, by age. Data shown in the table were derived

from the National Health Interview Survey and National Immunization Survey, US, 2005.

The results of a survey presented on October 27, 2007 at the 49th annual meeting of the

American Society for Therapeutic Radiation and Oncology (ASTRO) in Los Angeles (Poster

2641) highlight the poor flu vaccination coverage in patients with cancer specifically.9 About

a third of patients who responded to an anonymous survey said they had not had a flu vaccination,

according to Neha Vapiwala, MD, University of Pennsylvania, Philadelphia, PA, and

one of the authors of the presented study. The survey was completed by 214 consecutive

cancer outpatients at the University of Pennsylvania from August 2006 to January

2007. Ninety-eight percent of the questionnaires were complete and usable for analysis.

This was the first performed to evaluate whether patients with cancer are compliant

with national vaccination guidelines. Patients who reported not receiving flu vaccine were

asked further questions about the reasons why they didn’t receive it.

Key findings from the study were as follows:

• Thirty percent of patients said they had never

had the flu vaccine, and another 9% said they

• About 60% of unvaccinated patients said they

• Among patients aged 50 and older—i.e., those

recommended for a flu shot—33% had never

• Among patients who got their shots, 66% said

they heard about the vaccines from a health

care provider other than one providing cancer

care. Only ten% of patients were told about flu

Dr. Vapiwala reiterated, “Despite being seen by many clinicians for their cancer care, only one

in ten patients who actually got vaccinations said the shots had been recommended by their

When asked about potential reasons for the suboptimal flu vaccination in patients with cancer,

Dr. Vapiwala explained, “It’s a communications gap. Oncologists tend to assume that vaccinations

are being handled by the primary care provider, while the primary care physician may

assume the opposite. It’s not clear to patients and it’s not clear to physicians necessarily who

Articles

During the 2006–2007 season, influenza
circulated at epidemic levels for about 14
weeks and peaked during February, the month
most frequently associated with peak activity
over the past 31 influenza seasons.

Flu Vaccination in Patients with Cancer

Women in Malaysia diagnosed with metastatic breast cancer don’t prepare for life with a serious chronic disease. They prepare for death.

“Cancer is cancer,” Dr. Ednin Hamzah, technical advisor of the Malaysian Breast Cancer Association says. “Cancer is death.” With only about 40 oncologists in the entire country (32 of them in capital city Kuala Lumpur), about 60% of the women diagnosed with breast cancer have advanced metastatic disease. Many will die from it. “Access to care is completely irrelevant to many patients,” he says. “You just can’t get it.”

As a result, the goals of these women are different. “Most women with MBC are not really concerned with the disease,” he says. “They’re more concerned with day-to-day issues like pain and symptom control and keeping their family together, which is highly important to many of them.”

Breast cancer in general is not openly discussed in Malaysia, but this may be changing. When Malaysia’s well-liked former first lady, Endon Mahmood Ambak, died of MBC in 2005, “the whole country mourned the loss of this wonderful woman, and many of my patients expressed relief,” Dr. Hamzah says. “They said, you know, it’s okay to talk about it because even the most powerful woman in the country couldn’t beat this.”

As in Malaysia and other developing countries, Mexican women with MBC suffer from lack of access to medical care. Many Mexican women, according to some breast cancer advocates familiar with the country, live far away from hospitals and doctors. If they do manage to see a doctor, they are often faced with language and literacy barriers.

At first blush, one might think clinical trials would be a perfect fi t for women living in developing or underserved countries like Mexico who can’t afford medical care and who may benefi t from an on-site hospital stay. Unfortunately, that’s not the case. Doctors are reportedly hesitant to get involved in clinical trials because they fear further stretching of their budgets and staff. Having more patients in clinical trials means more patients in the hospital, more frequent follow-up visits, and more of a drain on already scarce resources.

Providing patients with take-home support materials written in a woman’s native language and in understandable terms, something taken for granted in Westernized countries, might be a way to start easing the burden on Mexican doctors and make them more receptive to getting involved, some advocates suggest.

Brazilian women with MBC encounter similar barriers. “There are two kinds of people in Brazil,” says Vitoria Herzberg of the Brazilian Cancer Association. “The twenty percent who have access to private insurance and the other 80%, who use our public health system; this major group is so politically uncultivated and unaware of their rights as citizens that when we do give them information, they are not able to assimilate it.”

Cultural differences affecting the way healthcare professionals and others reach out to women with early and metastatic breast cancer also exist within “Westernized” countries, even in the United States. Though women here may have routine access to the Internet, libraries, community clinics and informational booklets, some channels are more effective at reaching them than others.

Black and Hispanic women here, advocates observe, are often better reached through churches and female leaders within them. Some Black women in the United States, Dr. Marisa C. Weiss, president and founder of Breastcancer.org discovered, are especially wary of entering clinical trials because of atrocious historical ‘experiments’ on Blacks in the U.S., such as the infamous 40-year ‘Tuskegee Experiment’ involving hundreds of Black men diagnosed with syphilis who went untreated for decades. “Trusting their doctor is critically important,” she said.

Educating men about their risk of breast cancer is even more daunting. Although a relatively small number of men (2,000) in the United States are diagnosed with breast cancer each year,

it has usually metastasized beyond treatment by the time it is discovered, simply because it is considered “a woman’s disease” and a breast lump is likely to be ignored.

Canada is a vast country with 10 large, distinctly different provinces and three territories. Not all of them speak the same language, and many present severe travel challenges. This has prevented the delivery of a consistent message to residents about breast cancer in all of its stages.

Whether in Malaysia, or Africa, or South America, or any of the countries considered “Westernized”, advocates agree women with metastatic breast cancer will pay more attention to a message delivered by someone who reminds them of themselves. As Ms. Knox of Europa Donna says: “We need to make sure we have an Italian in Italy, a Romanian in Romania, and so forth. Sending people from one country to the next is not going to be as effective. People need to see someone from their own culture and background who’s willing to stand up and speak.”

Breast cancer in general is not openly discussed in Malaysia, but this may be changing. 

Metastatic Breast Cancer Worldwide: Different Languages, Different Views, Different Goals

As a peer-to-peer organization, Breast Cancer Network of Strength (formerly known as Y-ME National Breast Cancer Organization) is always looking for different ways to meet the needs of women with breast cancer who are seeking information about their disease and living with it, no matter what stage they’re in. Women with MBC certainly want to gain more information about their disease. With that in mind, we began seeking ways to really try to meet those needs. 

We asked women with metastatic breast cancer to participate in a survey we conducted in 2007. The main purpose of the survey was to identify and prioritize the unmet medical, educational, and psychosocial needs of women with this disease. This online survey was posted on our website and promoted in our e-newsletter, Peer to Peer. Only people who stated they have had a medical diagnosis of metastic breast cancer could answer all the survey questions.

The number of women who responded to our 16-question survey delighted us. A total of 733 women answered. Clearly, we knew right then and there we had struck a chord with this all-too-silent community of women dealing with this stage of breast cancer.

One of the first things we asked these women is where they were getting medical information and personal support as far as their lives as a person with MBC. Not surprisingly, many said their family members were their main support. Perhaps a bit more interesting to us, however, was that while 42% of these women sought educational information about their disease from their doctors, almost as many (39%) turned to the Internet for this information.

I wish there was more support for MBC in the area of mental health, economics, treatment options, clinical trials and addressing mood and emotions.

We also asked women how they felt, overall, about the treatment options available to women like themselves— women with MBC—including their awareness of clinical trials. Again, the survey revealed some surprising insights. Well over one-quarter of those surveyed (36%) told us they did not feel there were many treatment options available to them; 41% said the treatment options that were discussed were not clear to them. Even more signifi cantly, 73% of the respondents said they were not informed of, let alone offered entry into, a clinical trial when they were told their cancer had metastasized.

Clearly, this survey not only exposed some serious gaps in how we, as breast cancer professionals, interact with women with metastatic breast cancer, but also offered some clues on how to close those gaps straight from the women themselves. We learned how women obtain information about their disease; up to 86% of our respondents indicated better use of Web-based educational and support materials would be most helpful to them, because the Web is really where they look. There is need for more information about treatment options and defi nitely about clinical trials—this includes a need for physicians to be better educated about clinical trials, as well.

But our work isn’t done just by letting women know clinical trials are an option they can consider when deciding which tools to use against metastatic breast cancer. Women whom I’ve spoken to personally have expressed several reasons why they may be wary of entering clinical trials. Some of the reasons are so basic that we, as advocates in this area, may have never even thought they would be a question in a potential enrollee’s mind.

For example, one question I’ve heard from metastatic breast cancer patients is this: what is the purpose of the clinical trial? They really want to know. Pharmaceutical companies may think they’re already doing that, but it’s clear not everybody comes to the information with the same kind of background and education.

Think about it: you’re diagnosed with breast cancer, you’re scared to death, and you don’t know what to do. Suddenly, you’re thrown into a whole new world with a whole new language—even if you have had cancer before. Now you’re being told it has metastasized. Although I myself am a breast cancer survivor, I am not a metastatic patient. Even with that, and the fact that I am a staff member of a well-known breast cancer advocacy group, I did not know what “first-line treatment” and “second-line treatment” meant until it was explained to me. It made me realize that, if I were diagnosed with metastatic breast cancer tomorrow, I’d have a lot of learning to do. There’s a great deal of information out there, but I’m not sure if even I understand it. If I were trying to educate myself about clinical trials, or my doctor was telling me about clinical trials, I would need confi dence that I have a good handle on the language of clinical trials in order to make an informed decision about whether to enter one or not.

The vocabulary question leads into another concern women have shared with me about how participating in a clinical trial may affect their lives, and/or the lives of their caretakers and family, and how much contact they’ll have with the investigators running the trial. They say, ‘Linda, I’m looking at a clinical trial, and I’m thinking about going into it, but I’ve got lots of questions. How will my participation affect my quality of life? What are the anticipated side effects? Who can answer these questions for me, and will they give me “real” answers?’ I think if pharmaceutical companies and clinical trial investigators anticipated these questions and had answers, it would say a lot to potential enrollees.

Finally, and perhaps I’m taking my peer-to-peer support to another level, but I think we also have to address the isolation often felt by metastatic breast cancer patients at the clinical trial level, too. I’m thinking about one woman in particular who I spoke with who said she’d really like to be able to talk with somebody else in the clinical trial with her, or even get information about somebody like her to compare experiences with. So maybe some kind of “matching” ability, the ability to connect clinical trial participants with someone who is also participating in it, depending on what stage they are at, may be something we as health care professionals should look into.

All of these points seem to underscore one signifi cant thing that we as professionals who work with women with metastatic breast cancer can do. We can start to take the negative energy and conceptions we’ve gotten from women and begin to reframe them into much more positive, proactive, and hopeful answers for them in the future.

Breast Cancer Network of Strength is always looking for different ways to meet the needs of women with breast cancer.

Why Weï¿½re Not Reaching Women With Metastatic Breast Cancer and How We Can Change That

The purpose of this Priority Report is to raise awareness of metastatic breast cancer (MBC), identify some of the obstacles women living with this disease face, and understand how we as a community can address the unique informational and support needs of these women. The narrative is told primarily by individuals involved with the support of women with MBC.

Little did former First Lady Betty Ford, wife of the late President Gerald Ford, know she would start a revolution of sorts by discussing breast cancer so openly and frankly in public back in 1974.

By speaking forthrightly about her disease and her subsequent radical mastectomy, Mrs. Ford, who turned 90 in April, hoped to raise awareness about the disease and the importance of breast exams, and put a face on what was once a woman’s disease, spoken about in hushed, embarrassed tones. Seventeen years later, Mrs. Ford’s efforts had evolved into one of the most successful brand symbols of all time: the pink ribbon. Although many ribbons of various shapes and sizes had existed before—from yellow ribbons tied on trees in support of soldiers overseas to red ribbons on the lapels of celebrities against AIDS in the late 1990s&mdash; pink ribbons replaced pink visors at the 1991 annual Susan G. Komen “Race for the Cure,” and a movement began. Today, the pink ribbon’s symbol and color are still a successful representation of the fi ght against breast cancer.

After more than one-quarter century of the pink ribbon movement, however, some wish the pink ribbon would lengthen its reach and wrap itself around more women and families whose lives have been changed by breast cancer, namely, those with MBC.

Breast cancer remains the leading cause of cancer death among women worldwide—close to 500,000 women will die of the disease annually, and an estimated 1.3 million new cases will be diagnosed internationally.

 In the US, an estimated 182,460 new cases of breast cancer are expected to occur among women in 2008,2 and 30% of these cases will eventually develop into metastatic disease.

Yet despite these numbers, some women with MBC say they feel invisible compared to women with less advanced forms of breast cancer.

“When we are remembered, we are recognized as losing the battle,” one patient with MBC poignantly says. “We are what the pink ribbon crowd wants to forget, because we are the painful reminders of what can happen.”

Feelings of isolation can become particularly intense in October (Breast Cancer Awareness Month in some countries). Women with MBC say the media prefers to cover “happy endings,” stories of women detecting breast cancer early, having the tumor removed, and going on their way. They may be right.

“Every October, the pink ribbons come out, and every October, women with metastatic disease are not spoken about in a very tailored or personalized manner,” said Elyse Caplan, MA, Education Director of Living Beyond Breast Cancer (LBBC), 

a patient advocacy organization headquartered in Haverford, Pennsylvania. Women with MBC want information and resources that speak to the challenges of their stage of disease. Why is it so hard, they wonder, to find survival statistics? What are their clinical trial options? How do they navigate an often confusing and conflicting sea of information?

Breast cancer professionals from all disciplines are trying to answer these questions, starting with the basics: identifying the needs and wants of women with MBC; developing ways for those most closely involved with these women (doctors, nurses, caregivers) to meet those needs and wants; conveying information more cohesively to both medical professionals and patients; and changing the perception of clinical trials—from one of a “last chance” to one of an additional tool in living with the disease.

In 2006, LBBC conducted a U.S.-based “Needs Assessment Survey,” which concentrated on learning the needs of women with MBC with a focus on how the women gathered information and how they applied it to their lives.

 Ms. Caplan expressed surprise at the number of women who responded to the survey and believes it spoke volumes about the subject.

“Much to our surprise, even though we did pare it down to only 64 questions, it still took about 40 minutes to complete,” said Ms. Caplan. “We had expected about 200 respondents; we had well over 600 (online). So that proved my personal point that, if you ask women with MBC what they want, they will take the time to tell you.” The responses, according to Ms. Caplan, are testaments to “isolation, feeling alone, and the need to have their voices heard.”

Virtually all of the women surveyed placed great value on access to information related to the treatment of MBC, such as side-effect and symptom management, stated Ms. Caplan. To them, information means support and established control in coping with their disease. This also included a desire to know about clinical trials available to treat their disease. Some 84% of the women said they thought information about clinical trials was “important,” yet less than half (39%) sought information on them.

Additionally, many who completed the LBBC survey said they didn’t know where to fi nd information about MBC educational programs either in the community or on the Internet. Those who did, cobbled their information together from a variety of sources like books, brochures, handouts, government websites, and articles from medical journals. “Here we have women who highly value information about MBC, but they can’t find it,” Ms. Caplan said. “This is striking, because demographically the survey respondents generally had higher levels of education. So, you’ve got knowledge-seeking women not knowing where to go. We need to do better.”

Along with this desire to have more accessible information about their disease, women with MBC who participated in the LBBC survey shed insight on another potential hurdle in information access—reaching women at the right time. More than one-half (56%) said they are most likely to seek information when they are experiencing discomfort and side effects from their disease, but less than one-half (44%) do so when they feel worried or sad.

This would seem to strongly indicate a need for information providers— doctors, advocates, and other healthcare information providers&mdash;to try to predict not only the kind of information women with MBC are likely to seek, but when and where they are likely to seek it.

Reaching the right women at the right time is challenging. Most professionals acknowledge that large, well-funded campaigns like the Susan G. Komen for the Cure (formerly known as Susan G. Komen Foundation’s Race for the Cure) and the Avon Walk for Breast Cancer have gone a long way toward raising awareness about breast cancer in general, removing the taboo of discussing it, and urging women to be more vigilant about their own health. The next step, however, needs to be to tailor awareness and information to women who are at different stages of breast cancer, including those with advanced disease. 

“The initial launch of the pink ribbon campaign [raised] awareness of the disease and [gave] it a face,” said Pat Kelly of the Campaign to Control Cancer in Canada. “But now there’s a second phase of the campaign, and that is to recognize that this is a chronic disease and there are transcendent issues around clinical trials and patient navigation that would be appropriate for women at any stage. We’re not just asking people to give money, or wear a ribbon— we’ve got a little bit more for them to do in terms of accrual to clinical trials and systematic improvements in ensuring access to [patient] quality care.”

“I’ve been a MBC survivor for eight years, but breast cancer policy discussions all seem to focus on finding a cure,” said Lilla Romeo of the Metastatic Breast Cancer Network, based in New York City. “That would be wonderful, but we also want to hear more talk about extending lives, because anyone with MBC has gone beyond finding a cure. We need to know about drugs that will extend our lives—that is what every single person with MBC is seeking.”

Facing this reality makes women with MBC more interested in quality of life issues when deciding whether to enroll in potentially life-extending trials. When looking at a clinical trial, a patient is likely to ask many questions that pertain to quality of life and side effects. 

The medical community, advocacy groups, clinical trial coordinators, and corporations that provide the funding for outreach must work together to answer these types of questions. New ways to identify and bridge these gaps are getting attention, and many of them involve taking advantage of the Web and other emerging media—like interactive video chat and social networking websites—and offline resources to give women information when they need it and want it. Dr. Marisa C. Weiss, president and founder of Breastcancer.org and a practicing oncologist in the Philadelphia area for over 20 years, said the Web has become an essential 24/7 resource for many women with MBC. “There are relatively few support groups for women with MBC, but at breastcancer.org there are thousands of conversations going on in community discussion boards, day and night, all around the world. That online connection ends up being the most common source of support groups for women with MBC.”

Navigating the Journey from Many Directions 

A cancer navigator assists patients and their families throughout the entire cancer care continuum, including directing patients to resources for diagnosis, treatment, and recovery.

Navigation programs also offer support to meet each person’s specific needs. “A woman who has just been told her breast cancer has returned or has metastasized wants information that speaks to her phase of this experience,” said Ms. Caplan. 

Navigators will become even more important as cancer care becomes more and more personalized, according to Dr. Weiss. “When we talk about the world of breast cancer, we realize how many different groups there are within that one term. Particularly women with metastatic disease— each one is an individual.”

Navigators also help patients understand their diagnosis. Many groups of breast cancer advocates, health care professionals, and others have the information they seek about their care decisions—but how do women know which group to go to? To quote one advocate: “Patients have enough to deal with getting through the ‘day to day.’ They shouldn’t have to work hard to access the information they need.”

What if each group talked to each other and worked together to increase support and access to information that could reduce anxiety for women with MBC and, hopefully, help them continue with their “everyday” lives? Greater efforts to synchronize and streamline that information— whether from the Internet or elsewhere—could go a long way to make information easier to get to. It is reported that 73% of women with MBC seek disease information on a daily or weekly basis,

 and 86% said better use of Web-based educational and support materials would be helpful.

Collaboration, not duplication or competition on the Web, is getting more attention from smaller breast cancer groups. With each group struggling for limited resources, “best practices” are being sought and copied in a spirit of cooperation. “Several years ago we created a section on our website on MBC,” says Jackie Manthorne, Executive Director of the Canadian Breast Cancer Network, based in Ottawa, Ontario. “It is quite highly used, and I know that other organizations in Canada have done the same thing. I think we need to grow these and I think we need to share information. We’ve always said ‘take what you want, just don’t create our site over again.’”

Not everyone is “online” these days, but those who are possess different levels of Internet literacy. Some information is written for medical professionals, some for patients, and some for a little of both. 

“Many women in the metastatic population are older... and do not use the Internet as much as many of us who are sitting here today,” said Ms. Romeo. One possible solution: a printed guidebook for use on and off the Internet, including where to fi nd information about enrolling in clinical trials. Some medical centers and pharmaceutical companies have already developed “navigation” tools that people without Internet access can obtain, “like a one-on-one coach” whether online or off.

“One of the greatest sources of information besides the Internet is nurses,” said Pat Spicer, Breast Cancer Program Coordinator for Cancer Care, based in Woodbury, New York. “When we send out information, they are the ones who are the most active in handing out our pamphlets and promoting our programs. We need them to be a greater part of this, because they’re really good at it.”

One-on-one interaction with health care professionals, including nurses, varies greatly, however, because—like their patients—nurses possess different levels of knowledge or may be affected by the particular culture of their office. Access does not always equal accessibility, according to one MBC survivor.

Ms. Romeo, who has been receiving chemotherapy for eight years to treat her MBC (with only an 8-month break in between) speaks from experience: “I live in New York City, so there’s no problem with access. Still, the doctor has about 15 minutes to see you, and as you’re walking out the door you remember you didn’t ask him this or he didn’t answer that. But you know that while you’re sitting in the infusion room for the one hour, two hours, five hours, depending on what treatment you’re on, there will be plenty of time to ask the nurses those questions.”

Ms. Caplan, who was diagnosed with early stage breast cancer, agrees. “I was diagnosed with breast cancer 16 years ago...my oncologist spent 45 minutes with me. That doesn’t happen today. It hasn’t happened for years. The nurses who administer treatment are the ones who are face-to-face with you for longer periods of time.” 

Even within one country or province, the information chain can vary greatly. For example, breast cancer networks in several Canadian provinces have created breast cancer kits that are given out to the newly diagnosed by family doctors, oncologists, or pathologists. In addition, patient navigators working in some provincial breast screening programs, cancer centers or hospitals automatically contact newly diagnosed women to communicate what resources are available to her while navigating her treatment plan. “It isn’t the patient who actually must find out about the navigator,” said Ms. Manthorne. “The navigator automatically finds out about the patient.”

The telephone is still an effective way to reach and teach women with MBC what their options are. In fact, the telephone becomes a particularly important tool of communication—if not the only tool&mdash;for many women with MBC who do not live in Westernized nations.

“There were more than 1,600 people listening in on the last educational call we did,” said Ms. Spicer. “Those calls extend all over the world...we’ve had people from Thailand, from Africa, and from the more developed countries. Women gather in groups to listen on one phone occasionally.” Phone “support groups” can also be a valid alternative to women in Westernized countries as well, simply because they may not feel well enough to leave home.

If reaching and teaching women with MBC about the disease and their treatment options is a challenge, enrolling them in clinical trials is even more so. This problem has been studied by leading cancer researchers for several years now, and the cancer community is seeking ways to encourage people, including those with MBC, to enroll in trials to test potentially life-extending treatments.

There are several points of disconnect between the importance of clinical trials and patient participation. According to a study published in the Journal of Clinical Oncology, a majority of cancer patients say they are receptive to the idea of enrolling in clinical trials, yet only 2%—4% actually do so.

One reason may be because patients are not aware of them. Many physicians—who are in the best position to recommend patients for enrollment—say they support clinical trials. Yet, a patient survey found 85% of patients were unaware clinical trials were even an option for them.

 This seems to indicate a large communication gap between doctors who are aware of trials and the patients who would like to be made aware of them.

“One of the things I hear is that doctors don’t explain clearly what the trial is about,” said Ms. Spicer. “Their doctors say ‘Here, take this consent form home, read it, sign it, and bring it back to me.’” Change is beginning, however. One European-based MBC support group, for example, is developing a DVD for patients enrolling in an especially complicated trial, complete with a written consent form.

Women with MBC can get information about clinical trials on their own, from such websites as clinicaltrials.gov, the clinical trials page of the 

, and others, but the presentation of information varies greatly and can confuse and overwhelm even highly educated women. Women who do successfully uncover and decipher information about clinical trials may still have misgivings about enrollment.

Clinical trials, especially for cancer, still have an air of a “last resort” choice for many people. Potential enrollees are also concerned about being placed in the placebo arm (or, as in the case of cancer, only receiving the “standard” care and not the investigative treatment or becoming a “guinea pig”), according to studies from 

and others.8 Overwhelmingly long and confusing consent forms or difficulty with physical access to the trial site can also prevent even the most motivated women from enrolling.

In the U.S., there are currently an estimated 56 Phase 3 studies that are open and enrolling women with stage 4 breast cancer, and some 30,000 patients are needed to fi ll them.

Addressing the gaps and disconnects is one thing, but convincing women with MBC that their participation in clinical trials is worth their precious time is another. One advocate sums it up in three simple words: “Extend my life,” Ms. Romeo said. “That’s the message women want to hear about clinical trials for MBC, but many of these trials have too many limitations for entry. Your expectation of hope is raised, and then you discover that if you’ve been through eight types of chemotherapy, or even just three, you don’t qualify for any trials.”

Care must be taken, advised Ms. Kelly, to have other options ready for those women who don’t qualify for clinical trial entry and to make sure these options are clearly and sincerely conveyed to them. “Rejection is really a tough issue when you have advanced disease.”

The lack of clinical trial participants is affecting research as well. The Center for Information & Study on Clinical Research Participation, located in Dedham, Massachusetts, estimates that if enrollment in clinical trials increased by just 10%, most could be completed in one year instead of three years or more.

The quicker a drug can be determined efficacious or dropped, the faster resources can be released to pursue more studies.

The good news is that people involved with patients who have MBC—from health care professionals to support groups and patients themselves—are not only recognizing the barriers women with MBC face, but they have many ideas on how to break them down and make these women feel more in control of their destinies.

One of the first orders of business, MBC advocates say, is to establish a unique presence among people battling cancer and among patients with MBC in particular. This means putting a “face” on the disease in both a literal and figurative sense. Elizabeth Edwards (wife of former presidential candidate John Edwards) has been public about her battle with MBC, and serves as one example of how a person can lead a productive life with the disease. It also means getting the attention and financial support of large corporate foundations and political leaders who have already demonstrated their commitment to breast cancer awareness through the pink ribbon campaigns, marathons, and other initiatives.

“They [corporations] are not going to listen if we just have a meeting and sit around a table,” said Donna Sheehan of Willow Breast Cancer Support in Canada. “They want to see that something is happening. They need to see there’s a movement, that something is starting, and they’ll have no choice but to jump on.” This would be easier, she said, if a position statement existed among advocacy groups that is general and broad but clearly points to the need to consider the issue of MBC.

Such a statement must bring new awareness of MBC to groups who may not have previously been as involved or invested in it. Care must be taken to convey that, while a diagnosis of MBC does not mean a near-term death, it is still a serious, incurable condition. The message must be one of realistic hope for women with MBC but at the same time not strike fear into the hearts of those with earlier or less-serious forms of breast cancer.

Changing how information on MBC is delivered is another way, advocates say, to elevate awareness of the disease in the general population and specifically reach women with MBC. Using both new and traditional ways of communicating this information, including education about clinical trials, is key, as is a unified statement of purpose.

“A consensus guideline with specific targets—inclusive of both patients and professionals, nurses, grassroots organizations, Komen and all of us involved in raising awareness about breast cancer—is needed,” said Ms. Kelly. “[We need to raise] awareness specifically about the need for a full range of standards and guidelines for the treatment and care of MBC. Once consensus has been reached, we need to have a broad-based communication venue among ourselves to let everyone know what the consensus is.”

When it comes to one-on-one recruitment for clinical trials, even the most powerful consensus statement will not draw women with MBC in. For this part of the equation, a push/pull strategy must be in place—a “pull” from the professionals on the front lines, and a “push” from the patients.

“One of the biggest drivers of clinical trial enrollment is the patients themselves,” says Dr. Weiss. “Women have to ask for them and may even have to be pushy and speak up about enrollment when they think about what is at stake.”

When the patients do speak up, Dr. Weiss said, the medical team should be ready with answers. “The number one item that will help in the accrual and recruiting process is for the physicians, the nurses, and whoever is going to really have the direct contact with the patients to be trained to do so properly so that information about clinical trials doesn’t come across with the wrong kind of impression,” said Dr. Weiss, who stated that professional lectures, continuing medical education and listening to patients are all ways community oncologists can stay on top of clinical trials just as well as any major medical university.

“I always like to stick to the facts to dispel myths and supply understandable, relevant information and facts to encourage people to participate in clinical trials,” she said. “These facts are then distributed through people, breast cancer organizations, and the media. [Also] the fact is people tend to do better on clinical trials than off. They have the opportunity to get better than average care. These types of facts are very encouraging and get the patient to drive the process by asking the doctor and making sure she gets good answers to her questions.”

If doctors do not have the time to tell each patient about clinical trials they may be eligible for, it is up to his or her support staff to deliver the information in person as well as provide comprehensive, easy-to-understand, take-home materials for patients to review when considering a clinical trial.

Speaking from experience, Susan Knox, Executive Director of Milan, Italy—based Europa Donna, the European Breast Cancer Coalition, agreed. “The physician will not have time, so in one of our programs we specified physicians had to have at least trained research nurses or research fellows on teams that would introduce material [on clinical trials] and initially explain it to patients with a nurse or the physician present.” This takes into account what most health care professionals and patients know: with their minds racing on a million different things, patients often can’t remember or absorb everything they need to know when they have the doctor sitting in front of them. Take-home materials reinforcing the information are essential.

Health care professionals, advocates, and patients agree: women with MBC face many challenges, both physically and mentally, which women with earlier forms of breast cancer do not. Furthermore, whereas breast cancer awareness is higher than it has ever been, women with MBC sometimes feel that they are not part of this group.

Things are starting to change, however, not just for patients with MBC, but for many patients with complex diseases who need guidance and support during their journey. The Patient Navigator, Outreach and Chronic Disease Prevention Act of 1995 allocated $25 million to help medical centers develop patient navigation programs for those with chronic illnesses, including those with MBC, and positive results are already emerging.

Funding and support is beginning to come from both pharmaceutical companies and other corporations that have taken early leadership roles in raising breast cancer awareness, including the Ralph Lauren Center for Cancer Care and Prevention in New York City.

Women with MBC want to concentrate their precious time and energy on maintaining their health, quality of life, and everyday living. Finding information on how to take control of their disease, including information about clinical trials, should not take up any more of their time than necessary. With creative collaboration between the medical and advocacy fields, there is more hope than ever that barriers will be become bridges to help women with MBC lead fuller, longer lives.

1. American Cancer Society. Accessed January 16, 2008.

2. American Cancer Society. Accessed May 19, 2008.

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4. Mayer M, Grober S. Silent Voices: Women with Advanced (Metastatic) Breast Cancer Share Their Needs and Preferences For Information, Support, and Practical Resources. Living Beyond Breast Cancer. Haverford, PA; 2006.

5. Kirk M. Identification and Prioritization of Unmet Medical, Educational and Psychosocial Needs in Patients With Metastatic Breast Cancer: Results of a Patient Study. Breast Cancer Network of Strength (formerly Y-ME National Breast Cancer Organization). Presented at the 30th Annual Meeting of the San Antonio Breast Cancer Symposium, San Antonio, TX, Dec 13-16, 2007.

6. Lara P, Higdon R, et al. Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment. J Clin Oncol. 2001;19:1728-1733.

7. Frank G. SoCRA SOURCE. February 2004. Accessed May 19, 2008.

8. Mills E, Seely D, et al. Barriers to Participation in Clinical Trials of Cancer: A Meta-analysis and Systematic Review of Patient- Reported Factors. Lancet Oncol. 2006;7:141-148.

9. Mayer M. The Challenge of Cancer Clinical Trials Recruitment: A Patient Perspective. Presented at the UICC World Cancer Congress, Washington, DC, July 8-12, 2006.

10. Data on file. Pfi zer Inc, New York, NY.

The purpose of this Priority Report is to raise awareness of metastatic breast cancer.

September 2008 - Supplement | Oncology & Biotech News

Flu Vaccination in Patients with Cancer

Metastatic Breast Cancer Worldwide: Different Languages, Different Views, Different Goals

Why Weï¿½re Not Reaching Women With Metastatic Breast Cancer and How We Can Change That

Bridging Gaps, Expanding Outreach: Identifying the Unmet Needs of Women Living with Metastatic Breast Cancer

Update on Pegfilgrastim (Neulasta)

Managing Oral Mucositis in Patients With Cancer