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  1. Eastman, Peggy

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For the second year in a row, ASCO has chosen immunotherapy as the most important advance in treating patients with cancer. The society's new report cites progress with immune checkpoint inhibitors as especially effective in extending the lives of cancer patients with different cancers, many of whom had few other treatment options that worked for them (J Clin Oncol 2017; doi: 10.1200/JCO.2016.71.5292).

  
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The new report was released at a briefing on Capitol Hill in Washington, D.C., just days before World Cancer Day was marked Feb. 4. This is the 12th year ASCO released its progress report on clinical cancer advances.

 

ASCO refers to progress with immunotherapy in 2017 as immunotherapy 2.0, a term indicating how the field has proven itself over the past few years and matured since its sketchy beginnings 100 years ago.

 

"This year's advance is next-generation immunotherapy," said ASCO Chief Medical Officer Richard L. Schilsky, MD, describing immunotherapy 2.0 as "the hottest area in oncology." In a wide-ranging introduction to the new report, Schilsky noted that once scientists in the field of cancer immunotherapy were considered to be on the fringe, but now they are hailed as cutting-edge researchers who are saving lives.

 

"The new breakthroughs are really exceptional-things we could not have imagined decades ago," he said. "A diagnosis of cancer is no longer as grim as it used to be."

 

ASCO President Daniel F. Hayes, MD, Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center, Ann Arbor, agreed. "In less than a decade, immunotherapy has gone from being considered a promising theoretical treatment to one that has become a standard of care that is helping extend or improve the lives of thousands of patients," he said in a statement accompanying the release of the new report.

 

Schilsky noted that a targeted therapy generally works on one specific cancer type, while immunotherapies, when they are effective, seem to work across almost every cancer type. When patients do benefit, he said, "It can be a long-lived benefit."

 

The new report notes that over the past year, the FDA approved five new uses for immune checkpoint inhibitors: lung cancer, head and neck cancer, bladder cancer, kidney cancer, and Hodgkin lymphoma. The approval of atezolizumab for bladder cancer in May 2016 represents the first new treatment for that cancer in more than 30 years.

 

Bladder cancer survivor Susan Corcoran, who spoke at the briefing, said she owes her life to participation in a clinical trial of atezolizumab. Schilsky said the next phase in the field of immunotherapy will be to identify the reasons why some patients, like Corcoran, benefit from this treatment approach and some do not. According to the new report, fewer than half of patients selected for immunotherapy actually benefit.

 

Funding Needs Continue

The need for strong federal support of cancer research was a major theme at the Capitol Hill briefing. Schilsky said that every single advance featured in the new ASCO report could be tied in some way back to the foundational support of federal funding of research - especially for the NIH and NCI. While the NIH received a major budget increase in 2016, its budget, when adjusted for inflation, remains below pre-recession levels. ASCO is requesting that for fiscal year (FY) 2017 Congress appropriate at least $34.1 billion for the NIH, including at least $5.6 billion for the NCI. ASCO is also requesting Congress maintain support for the Cancer Moonshot funds authorized in the 21st Century Cures Act legislation signed into law by then-President Obama, and ensure appropriations for the Moonshot are included in the FY 2018 budget and beyond.

 

In addition to immunotherapy, the new ASCO report cites advances in cancer risk, prevention, and screening (including the identification of additional genes linked to ovarian cancer risk); targeted (precision) therapy; the use of big data, such as ASCO's CancerLinQ; combined modality therapy; chemotherapy; patient care, including the incorporation of self-reported symptoms; and tumor biology, including the finding that melanoma develops through successive genetic changes. Taken together, notes the new report, progress against cancer has resulted in a 23 percent decline in the U.S. cancer death rate since a peak in 1991; the approval of more than 90 cancer drugs approved by the FDA since 2006; increased 5-year survival (two out of three people with cancer live at least 5 years after diagnosis); and the fact that there are some 14.5 million cancer survivors, up from 11.4 million in 2006.

 

At the briefing, Jan C. Buckner, MD, Chair of the Department of Oncology and Professor of Oncology at the Mayo Clinic in Rochester, Minn., described how federal funding of combined modality therapy has led to longer lives for patients with grade 2 gliomas. Grade 2 gliomas are rare, accounting for about 5-10 percent of brain tumors, but they tend to occur in younger people, said Buckner.

 

In a clinical trial funded primarily by the NCI, patients with grade 2 gliomas were randomized to receive either radiation therapy alone or radiation therapy followed by PCV (procarbazine, CCNU, and vincristine) chemotherapy. Those treated in the combination therapy arm-radiation and chemotherapy-had a median survival of 13.3 years, compared to 7.8 years for those treated with radiation therapy alone. At 10 years, the cancer worsened in only 21 percent of patients in the combination treatment arm, compared with 51 percent of those treated with radiation therapy alone. The standard of care for high-risk, low-grade gliomas now includes PCV chemotherapy in combination with radiation.

 

This trial, which did not use new pharmaceuticals, shows researchers can continue to make progress with combinations of therapies "that have been around for a long time," emphasized Buckner, who specializes in research on cancers of the brain and nervous system. He noted that without federal funding, the trial would never have been done-because pharmaceutical companies would have lacked the incentive to fund it.

 

Looking to the future, the new ASCO report cites liquid biopsies and expanded targeted therapy options for ovarian cancer as promising avenues for progress against cancer. In 2016, researchers reported the PARP inhibitor niraparib is effective in a broad range of patients with advanced, recurrent ovarian cancer. In a large randomized clinical trial of niraparib or placebo, niraparib slowed cancer growth in all groups, but it was most effective in patients with BRCA mutations.

 

Forward Thinking

While passage of the 21st Century Cures Act and the Cancer Moonshot initiative led by former Vice President Joe Biden spurred a reinvigorated attack against cancer, Rep. David Price (D-NC) -who spoke at the Capitol Hill briefing-warned that it may be difficult with the new administration to secure the federal funding for cancer research ASCO recommends. "You're here at a critical time," he said. "The trouble is we're in a budget environment that's going to make it hard to deliver on what you need," said Price, who serves on the House Appropriations Committee. "I'm very, very worried that we will get a sequestration-level budget from the new administration...we have a lot of work to do," added Price, a vocal supporter of increased funding for the NIH and affordable health care for all.

 

Rep. David Joyce (R-OH), who spoke at the briefing as well, pledged his support for increased funding for cancer research. Citing the success of the U.S. investment in space research, Joyce-who also serves on the House Appropriations Committee-said investing in science and technology makes economic sense and is good for the country. He said he wants to make sure NIH can keep up the pace of discovery, stating, "I'm convinced we have the ability to do it."

 

Asked by Oncology Times if he is concerned that repeal of the Affordable Care Act (ACA) -a campaign promise of President Trump-would hurt cancer patients and impede progress against cancer, Schilsky said, "There's a direct relationship between having insurance and having the best possible outcomes." He said ASCO has not taken a position on repeal of the ACA, but it has released a list of seven essential principles for patient-centered health care reform (see Table).

 

The American Society for Radiation Oncology (ASTRO) has also released a set of principles for patient-centered healthcare reform. ASTRO calls on health reformers to prohibit cost-shifting to cancer patients and providers to cover uncompensated or underfunded care, and to provide access to specialty care, provider choice, and the full range of services that cancer patients need.

 

Peggy Eastman is a contributing writer.

 

Essential Principles for Patient-Centered Health Care Reform

 

1. All Americans should have access to affordable and sufficient health care coverage regardless of income or health status. The current ban on pre-existing condition limitations, elimination of annual and lifetime coverage caps, and maintenance of guaranteed renewability should be preserved.

 

2. Any efforts to reform the health care system at national or local levels should ensure that individuals with health insurance can continue to have affordable coverage without interruption.

 

3. All individuals with cancer should have insurance that guarantees access to high-quality care by a cancer specialist delivered in a timely manner.

 

4. Policymakers should protect cancer prevention and screening services, preserving the "no co-pay" access to cancer screening that currently exists.

 

5. All patients should have access to clinical trials, and insurance coverage should not be a barrier to participation in clinical trials.

 

6. Current efforts to improve health care through value-based reform strategies should be continued, and such strategies should be designed in a patient-centered way.

 

7. Health care reform efforts should engage patients and providers to gain their ideas and suggestions in order to avoid unintended consequences during implementation.