First-ever targeted roadmap outlines steps to end childhood TB deaths

1 October 2013 | Washington - The deaths of more than 74 000 children from tuberculosis (TB) could be prevented each year through measures outlined in the first ever action plan developed specifically on TB and children.

The "Roadmap for childhood TB: towards zero deaths", launched today by global TB leaders ¹ in Washington D.C., estimates that US$ 120 million per year could have a major impact on saving tens of thousands of children’s lives from TB, including among children infected with both TB and HIV.

Every day, more than 200 children under the age of 15 die needlessly from TB – a disease that is preventable and curable. WHO estimates that as many as 1 in 10 TB cases globally (6 to 10% of all TB cases) are among this age group, but that the number could be even higher because many children are simply undiagnosed. The new roadmap builds on the latest knowledge of the disease and identifies clear actions to prevent these child deaths.

“Any child who dies from TB is one child too many,” says Dr Mario Raviglione, Director, Global Tuberculosis Programme at WHO. “TB is preventable and treatable, and this roadmap focuses on immediate actions governments and partners can take to stop children dying.”

The launch of the first roadmap on TB and children follows increasing awareness on the urgent need to address the issue. Under the child survival movement’s banner of A Promise Renewed, more than 175 countries signed a pledge in June 2012, vowing to redouble efforts to stop children from dying of preventable diseases, including tuberculosis.

A small price tag to halt a global disease

The US$ 120 million a year in new funding for addressing TB in children from governments and donors includes US$ 40 million for HIV antiretroviral therapy and preventive therapy (to prevent active TB disease) for children co-infected with TB and HIV.

The funds will also go towards improving detection, developing better medicines for children and integrating TB treatment into existing maternal and child health programmes. Getting more paediatric health professionals to actively screen for TB with better tools, i.e. drugs, diagnostics and vaccines, will help capture the full scope of the epidemic and reach more children with life-saving treatment sooner.

“Far too many children with tuberculosis are not getting the treatment they need,” says Nicholas Alipui, Director of Programmes for UNICEF. “Most of these children live in the poorest, most vulnerable households. It is wrong that any children should die for want of a simple, affordable cure, especially where there are community-based options to deliver life-saving interventions.”

Ten actions to save young lives

The "Roadmap for childhood TB: towards zero deaths" recommends ten actions at national and global levels:

• include the needs of children and adolescents in research, policy development and clinical practices;
• collect and report better data, including preventive measures;
• develop training and reference materials on childhood TB for health workers;
• foster local expertise and leadership among child health workers at all levels of health systems;
• use critical intervention strategies, such as intensive case finding, contact tracing and preventive therapy; implement policies enabling early diagnosis; and ensure there is an uninterrupted supply of high-quality anti-TB medicines for children;
• engage key stakeholders and establish effective communication and collaboration between the health sector and other sectors that address the social determinants of health and access to care;
• develop integrated family- and community-centred strategies to provide comprehensive and effective services at the community level;
• address research gaps in the following areas: epidemiology, fundamental research, the development of new tools (such as diagnostics, medicines and vaccines); and address gaps in operational research and research looking at health systems and services;
• close all funding gaps for childhood TB;
• form coalitions and partnerships to study and evaluate the best strategies for preventing and managing childhood TB, and for improving tools used for diagnosis and treatment.

“If a small child can summon the bravery to complete a six-month TB treatment, the global community must be similarly brave in its ambitions to defeat the epidemic,” says Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership. “To get to zero TB deaths, we must focus on the most vulnerable groups and children are the most vulnerable of all. The steps outlined in this roadmap are simple and low-cost. We owe it to the children of the world to put this plan into action.”

Bringing childhood TB into the mainstream

As more attention has focused on the need to address child TB, experts have sought to broaden the net and involve organizations and agencies beyond the national TB programmes that have contact with children. As much as possible, the roadmap recommends that TB services for children be mainstreamed into existing children’s health services, and more responsibility and accountability be given to primary care providers.

“By scaling up existing tools and investing in improved approaches for the future, we can turn the tide on this hidden epidemic. But we must put these tools in the hands of front-line health care workers and use every opportunity to identify children at risk for TB,” says Dr Tom Kenyon, Director of the Center for Global Health at the U.S. Centers for Disease Control and Prevention. “We must ensure systems are in place to serve children through existing health, community, and child-centred services.”

Moving to this type of family-centred or community-centred approach, however, will require effective collaboration and joint planning among TB control programmes, maternal and child health services, and HIV services.

“If we can shift TB diagnosis and treatment out of specialised programmes and into other existing maternal and child health activities, we automatically gain reach and scale,” says Jose Luis Castro, Interim Executive Director of the International Union Against Tuberculosis and Lung Disease. “Combining that scale with investment in tools and medicine would save tens of thousands of lives.”

“By integrating critical child TB interventions into community health services, we will contribute to the global goal of ending preventable child deaths,” says Katie Taylor, Deputy Assistant Administrator, Bureau for Global Health, USAID. “The next step will require investment and engagement at all levels, including families, frontline health workers, and community leaders. The Roadmap equips all involved with the tools needed to fight childhood TB. As a result, children will receive the quality and comprehensive care they deserve close to home.”

"Current diagnostics, toxic drugs and inadequate drug formulations are insufficient to respond to the needs of children with TB,” says Colleen Daniels, Director TB/HIV at Treatment Action Group (TAG). “New tools will be a crucial part of addressing TB in children and current investments are minimal at best. Much more investment and commitment to childhood TB is urgently needed now".

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¹ World Health Organization (WHO), Stop TB Partnership, the International Union Against Tuberculosis and Lung Disease (The Union), UNICEF, U.S. Centers for Disease Control and Prevention (CDC), United States Agency for International Development (USAID) and Treatment Action Group (TAG).

About the Global TB Programme, WHO

The Global TB Programme at WHO guides global action for a world free of TB by advancing universal access to TB prevention, care and control; framing the response to threats through norms, standards and strategy; technically supporting Member States; monitoring the burden and response; and promoting innovation. WHO is the directing and coordinating authority for health within the United Nations system.

About the Stop TB Partnership

The Stop TB Partnership is leading the way to a world without tuberculosis, a disease that is curable but still kills three people every minute. Its partners are a collective force that is transforming the fight against TB in more than 100 countries. They include international and technical organizations, government programmes, research and funding agencies, foundations, NGOs, civil society and community groups and the private sector.

About the International Union Against Tuberculosis and Lung Disease

The mission of the International Union Against Tuberculosis and Lung Disease (The Union) is to bring innovation, expertise, solutions and support to address health challenges in low- and middle-income populations. With nearly 15 000 members and subscribers from 150 countries, The Union has its headquarters in Paris and offices in the Africa, Asia Pacific, Europe, Latin America, North America and South-East Asia regions. Its scientific departments focus on tuberculosis and HIV, lung health and non-communications diseases, tobacco control and research.

About UNICEF and A Promise Renewed

UNICEF works in more than 190 countries and territories to help children survive and thrive, from early childhood through adolescence. The world’s largest provider of vaccines for developing countries, UNICEF supports child health and nutrition, good water and sanitation, quality basic education for all boys and girls, and the protection of children from violence, exploitation, and AIDS. UNICEF is hosting the secretariat of A Promise Renewed, a global movement that seeks through action and advocacy to accelerate reductions in preventable maternal, newborn and child deaths. The movement emerged from the Child Survival Call to Action, a high-level forum convened in June 2012 by the Governments of Ethiopia, India and the United States, in collaboration with UNICEF, to examine ways to spur progress on child survival and advance the goals of Every Woman Every Child, a strategy launched by United Nations Secretary-General Ban Ki-moon to mobilize and intensify global action to improve the health of women and children everywhere. Over 175 governments have signed a pledge vowing to redouble efforts to stop women and children from dying of preventable causes. Hundreds of civil society organizations, including Save the Children, have signed their own pledges of support for this global effort.

About U.S. Centers for Disease Control and Prevention

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

About the United States Agency for International Development

The American people, through the US Agency for International Development (USAID), have provided economic and social development, as well as humanitarian assistance, worldwide for more than 50 years. USAID’s programs in global health represent the commitment and determination of the US government to partner with countries to prevent suffering, save lives, and create a brighter future for families throughout the world. USAID’s Bureau for Global Health is contributing to President Obama’s goal of eliminating extreme poverty by working to end preventable child deaths and realize an AIDS-free generation.

About the Treatment Action Group

Treatment Action Group (TAG) is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS. TAG works to ensure that all people with HIV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end AIDS.

For more information please contact:

Glenn Thomas
Communications Officer
WHO
Telephone: +41 22 791 3983
Mobile: +41 79 509 0677
E-mail: thomasg@who.int

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Targeted radiation therapy safe, effective treatment for elderly with pancreatic cancer

Sep. 24, 2013 — A highly targeted cancer radiation therapy may offer a safe and effective treatment option for elderly pancreatic cancer patients unable to undergo surgery or combined chemotherapy and radiation therapy, according to researchers at Henry Ford Hospital in Detroit.

Called stereotactic body radiotherapy (SBRT), the study finds patients lived, on average, six to seven months longer following treatment with minimal side-effects even when they had other severe comorbidities such as chronic obstructive pulmonary disease (COPD), heart disease and diabetes.

Two of the patients in the study lived nearly two years.

“Elderly individuals, those ages 75 and older, account for approximately 40 percent of patients diagnosed with pancreatic cancer,” says study lead author Raphael Yechieli, M.D., with the Department of Radiation Oncology at Henry Ford Hospital.

“These patients are too ill to receive any other treatment, but with stereotactic body radiotherapy we’re able to deliver a safe and effective treatment in two weeks that can provide them with a substantial quality of life with minimal side effects.”

The study was presented at the 55nd annual American Society for Radiation Oncology (ASTRO) meeting in Atlanta.

In 2013, there will be an estimated 45,220 new cases of pancreatic cancer, and approximately 38,460 will die from the disease, according to the National Cancer Institute. Risk factors for pancreatic cancer include smoking, diabetes, obesity, family history of the disease and pancreatitis. Most people diagnosed with the disease are older than 65.

Surgery is the only known cure for resectable pancreatic cancer, where the cancer is localized to the pancreas and hasn't spread. It is estimated that only 20 percent of pancreatic cancer patients have their tumors present with localized disease amendable to surgical removal.

A select number of those patients, however, are not candidates for surgery due to having other co-morbidities such as COPD, heart disease and diabetes. This leaves only chemotherapy and radiation, or a combination of the two, available for treatment.

But for a large portion of elderly patients with localized pancreatic cancer even chemotherapy and radiation therapy are not options.
The Henry Ford study looked to determine if SBRT – a method of giving radiation that can be highly targeted to the tumor, sparing the normal tissue around it – was a viable option for this group of patients. SBRT provides a higher dose of radiation, meaning patients have fewer treatments. In this case, treatment averaged two weeks.

The study included 20 patients with a median age of 83, all of whom were medically unable to tolerate surgery or combined chemo-radiation therapy. The majority of patients in the study (90 percent) received SBRT treatment at the time of diagnosis.

Seven patients reported side-effects from treatment: nausea, vomiting and fatigue.

Among the patients: 13 had a recurrence of cancer; nine had cancer spread from the original tumor to distant organs or distant lymph nodes.

Median overall survival was 6.7 months, and median recurrence-free survival was 8.1 months. At six months post-treatment, 61 percent of patients were alive; two patients in the study survived nearly two years.

“National trends tell us that very few patients over the age of 75 are getting any treatment at all for pancreatic cancer due to comorbidity risks,” notes Dr. Yechieli. “So we want to push the envelope to give them a treatment option that, while not a cure, is short, effective and safe, and has the potential to give them a good quality of life.”

The next step in this research, Dr. Yechieli says, is to closely follow patients after SBRT and get their direct feedback to measure post-treatment quality of life.

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First randomized trial of targeted cancer medicine in all tumor types

Sep. 11, 2013 — A further step along the road to the personalisation of cancer medicine, where treatment is based on the individual molecular characteristics of tumours rather than their primary site, will be presented at the 2013 European Cancer Congress (ECC2013), which starts on Friday 27 September in Amsterdam, The Netherlands.

Dr Christophe Le Tourneau, Head of the Phase I Programme at the Institut Curie, Paris, France, will tell the congress that the SHIVA trial is the first randomised trial to look at patient outcomes after treatments were chosen according to the individual molecular profiles of each person's tumour. It is also the first trial to do this for all tumour types. About 40% of all those taking part in the trial have molecular abnormalities that can be targeted by existing drugs, he will say.

To date, 320 patients from seven comprehensive cancer centres across France have been included in this phase II trial, of whom 60 have been randomised. In the standard arm, the patients received the chemotherapy they would have received if they had not been participating in the trial. All patients had recurrent or metastatic cancer that was unresponsive to standard treatment for their disease.

"Our goal is to have 200 randomised patients," says Dr Le Tourneau. "Although 40% of the 320 patients have a tumour for which targeted drugs are available, some are still on the chemotherapy that was started at the time of the biopsy and therefore we will have to randomise them later. Because we are looking for an effect in different kinds of tumours, we have ruled out the inclusion of any particular type of tumour if this brings the number of randomised patients with this type to over 20% of the total. We have also allowed the inclusion of patients with rare tumours."

Preliminary results of the feasibility study, to be presented at the congress, show that this approach works, the researchers say. The ultimate goal of the phase II trial is to see whether the selection of drugs that target the specific molecular profiles of tumours will improve outcomes for patients.

Once the first 100 patients were included, the researchers looked at the feasibility of a biopsy of a metastasis, since the molecular profile of the primary tumour, if tissue is available, may not be the same as that found in a metastasis. They also investigated the quality of available tumour samples, the proportion of the patients for which the necessary analyses could be undertaken, the proportion for which a molecular abnormality can be identified and for which a targeted therapy exists, and the timeframe needed to establish the tumour profile.

"Recent advances in diagnostics have enabled us to ascertain the molecular profile of tumours in a timeframe which is compatible with good clinical care, but we needed to verify this in our study," says Dr Le Tourneau.

Unlike conventional chemotherapy, molecular targeted agents only work in the presence of their targets. Side-effects are lessened and, in principle, efficacy heightened. One of the problems to date, however, is that such drugs have principally been developed based on the primary location and histology (cellular make-up) of the tumour. This has meant that many potentially promising targeted drugs have failed in early clinical trials simply because they have not induced a response in a sufficient number of patients.

"The history of breast cancer changed beyond recognition with the discovery of the role played by the ErB2/HER2 gene, which is amplified in up to 20% of breast cancers. And we now know that trastuzumab (Herceptin), one of the most widely-used targeted cancer therapies, which targets that gene, is effective in several tumour types and not just in breast when the ERBB2/HER2 gene is amplified or even mutated," says Dr Le Tourneau. "We also know that patient outcomes in the few trials to date where the choice of treatment is based on a molecular abnormality are better than those where the treatment is not matched to the abnormality. What was missing to date is a histology-independent randomised trial comparing molecular targeted treatment with conventional therapy, and this is why I decided to set up the SHIVA trial."

Even today, the researchers say, molecularly targeted therapy for cancer patients is initially prescribed according to the location of the primary tumour. At the end of the trial, analysis of progression-free survival will show whether this practice needs to be changed.

A positive finding would imply the need to make major changes in the way cancer drugs are developed and tested in patients. But this would represent a new and difficult challenge.

"At present we have no data on the efficacy of drugs in patients with the same molecular abnormality but different tumour types, and we also suspect that a treatment effect would not depend on the presence of a single molecular abnormality, but, more likely, on several. However, we believe that it is most likely that, in future, tumour location and histology will no longer be the primary criteria for the prescription of molecularly targeted agents; rather, tumour biology will be the deciding factor," says Dr Le Tourneau. "A positive result from our trial would be an important step forward on the road to personalised medicine."

Professor Cornelis van de Velde, President of ECCO, said: "This ground-breaking randomised trial is very exciting since this is the way to individualise therapy. We have already moved from empirical to stratified treatment, and now we can offer patients personalised treatment based on the understanding of the particular molecular profiles of their tumours in order to select drugs that target a specific profile. The means to determine the individual molecular profiles of tumours will be readily available at low cost in the years to come, and the integration of biopsy-based molecular profiles with individual patient characteristics will enable precision diagnosis to be translated into precision personalised therapies. ECCO will have an important role to play in ensuring the incorporation of molecular biology genetics into clinical multidisciplinary meetings."

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Calif. voters split on tax targeted by Big Tobacco

AppId is over the quota
AppId is over the quota

LOS ANGELES, Calif. (AP) — It's still too close to call the California initiative to raise the tax on tobacco products.

As of Wednesday morning, opposition to the increase leads by just over 1 percent, or about 64,000 votes, out of more than 3.8 million votes counted.

But there's an unknown number of ballots left to be tallied.

In California, even with all precincts reporting, there typically are many late-arriving early voting and absentee ballots not counted until after election day.

These ballots typically comprise up to 20 percent of all votes, meaning potentially hundreds of thousands of votes are still to be counted statewide.

The tobacco industry spent tens of millions of dollars on an ad campaign against imposing an additional $1-per-pack tax on cigarettes to fund cancer research. Cancer survivor Lance Armstrong led the effort to pass the tax hike.