Finding lessons in a failed pancreatic cancer clinical trial

chemoradiotherapy (1)

The LAP07 study, comparing chemoradiotherapy vs chemotherapy in patients with locally advanced pancreatic cancer, was stopped early for futility.

Nearly a third of people diagnosed with pancreatic adenocarcinoma have locally advanced tumors that cannot be removed by surgery. A longstanding and critical question for these patients is whether adding radiation to chemotherapy provides any benefit.

Alas, the answer appears to be no, according to the recently completed LAP07 study, which was stopped early when an interim analysis failed to demonstrate a benefit in overall survival. While disappointing, the finding fits with the emerging view that pancreatic cancer is a disease with a multitude of subtypes responding in diverse ways to therapy.

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First evidence that PD-1 antibody could help men with metastatic prostate cancer

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Restoring tumor-specific immunity is a treatment strategy that works well in melanoma and lung cancer patients. A new study is reviving hope that the approach also may help men with life-threatening prostate cancer.

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This is what a ‘game changing’ cancer therapy looks like

Gleevec structure - Structure of Gleevec bound to the kinase domain (1)Gleevec binds to the kinase domain of the mutant enzyme BCR-ABL1

 

Life expectancy in patients with chronic myeloid leukemia has soared to a level almost equal to that of the general population, according to a Swedish study quantifying the life-saving impact of Gleevec, the targeted therapy ushered from lab bench to clinical success by Brian Druker, M.D., director of the OHSU Knight Cancer Institute.

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Digging in to questions that matter for men with prostate cancer

Tom Beer at ASCO

Cancer researchers presented more than 5,200 study findings at the American Society of Clinical Oncology meeting in June. Amid the hubbub, Knight Cancer Institute Deputy Director Tom Beer, M.D., observed, “All of the progress that we see here at ASCO is largely the result of patients who are courageous enough to volunteer for clinical studies.”

With three expert colleagues at the meeting in Chicago, Beer led an online discussion digging in to questions that matter for men with prostate cancer: how shorter courses of radiation therapy can maintain effectiveness but reduce the burden on men with localized prostate cancer; how chemotherapy improves long-term quality of life and life expectancy in patients with advanced disease; how inherited genes may be driving a much larger share of aggressive prostate cancers than anyone assumed.

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Advancing a potential blood test for pancreatic cancer

immunoviaImmunovia’s “IMMray” technology uses an antibody microarray to detect the protein signature of pancreatic cancer in blood samples.

 

The Swedish biotech firm Immunovia reached another milestone with the OHSU Knight Cancer Institute in developing a blood test to speed the diagnosis of pancreatic cancer.

Immunovia’s antibody microarray correctly classified 96 percent of patients with stage I or II pancreatic ductal adenocarcinoma in a retrospective study using samples from North American pancreatic cancer patients. These results match those in a previous retrospective study using Scandinavian patient samples.

“We have data now from three different sets of specimens, and it all seems to support the same thing — that the assay is picking up cancer even down to stage I,” the Knight Cancer Institute’s Chris Corless, M.D., Ph.D., told GenomeWeb.

As it stands, less than one in ten cases of pancreatic cancer in the U.S. are diagnosed at the local stage and the relative survival rate – around six percent at five years – is by far the worst among major cancers.

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How shortcut clinical trials may be misleading oncologists

surrogate approvals (2)Among 55 cancer drugs recently approved on the basis of a surrogate endpoint, less than one-fifth have been shown to improve survival in follow-up clinical trials.

 

Fully two-thirds of new cancer drugs in recent years gained regulatory approval based on a so-called surrogate end point, such as tumor shrinkage, rather than a clinical end point directly measuring how patients feel, how well they function or how long they survive.

This shortcut strategy makes sense if the surrogate reliably predicts improvements in survival or quality of life. But that connection remains unknown for a surprisingly large share of surrogate-approved cancer drugs in the U.S., according to a study appearing this week in Mayo Clinic Proceedings.

The authors analyzed cancer drug approvals by the Food and Drug Administration between January 1, 2009, and December 31, 2014. They found that 55 of 83 approvals were based on a surrogate end point. In 25 of the 55 surrogate approvals, the authors were unable to find any published research addressing whether the surrogate correlated with survival.

“How can you say it’s reasonably likely to predict true clinical efficacy if nobody has ever studied it?” says senior author Vinay Prasad, M.D., M.P.H., an OHSU Knight Cancer Institute hematologist-oncologist and assistant professor of medicine. “How can you say a surrogate is established when nobody can find a paper?”

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Ambiguous breast biopsies often “overinterpreted”

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Pathologists’ tendency to overinterpret breast biopsies may be contributing to the problem of breast cancer overdiagnosis.

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Engineering precision in cancer early detection

SE portraitSadik Esener, Ph.D., the engineer tapped to lead a major new cancer early detection program at the OHSU Knight Cancer Institute.

 

Medical science has come up with only a few ways to detect incipient cancers in healthy people. None of them can distinguish the aggressive, life-threatening cases from those that are unlikely to become lethal.

Researchers have spent decades, for instance, trying to develop a screening test for ovarian cancer. Most women with this cancer are diagnosed with advanced disease, when five-year survival is no more than about 40 percent. The largest-ever ovarian cancer screening study, published in December, failed to demonstrate a significant survival difference, while the screened population of women more than doubled their risk of unnecessary surgery.1

It’s a similar story for the cancers that claim the most lives: lung, breast and prostate cancer. The PSA screening test, for example, misses nearly 50 percent of high-grade prostate tumors while also driving a high rate of overdiagnosis. Some 20 to 40 percent of cases arising from PSA screening are tumors destined to never cause harm because they are slow growing or unable to metastasize.2

“It’s our view that this is one of the biggest unmet needs in cancer,” says Brian Druker, M.D., director of the OHSU Knight Cancer Institute.

Solving the problem will require unusually broad thinking and fresh perspectives. Perhaps it’s no surprise, then, that Druker and colleagues have chosen an electrical and computer engineer to lead a major new initiative on the precision early detection of life-threatening cancers. With $1 billion in hand from a record-breaking philanthropic campaign initiated by Nike co-founder Phil Knight and his wife Penny, the Knight Cancer Institute is creating a Center for Early Detection Research with plans to hire 250 to 300 researchers and a mission to transform how cancers are diagnosed.

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Long after chemotherapy, nerve damage may increase a woman’s risk of falling

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Years after completing treatment, nearly half of women cancer survivors continued to experience chemotherapy-induced peripheral neuropathy in a new study that tracked more than 500 survivors.

Those with neuropathy had worse physical functioning and a significantly higher risk of falls, the researchers reported this week at the American Society of Clinical Oncology Cancer Survivorship Symposium in San Francisco.

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How cancer screening may fail to save lives

Pap drawing

Vaginal cells drawn by George Papanicolaou, inventor of the pap smear. Credit: Wellcome Images

With the advent of mass screening by Pap smear, cervical cancer incidence and death rates declined by more than 60 percent in the U.S. between 1955 and 1992. It was a triumphant demonstration of the value of early detection.

But the model has never worked so well for other common cancers. Mammography, for example, fails to detect one in four tumors in younger women while also delivering many false-positive results. Less than 5 percent of positive initial findings prove to be cancer.

And believe it or not, we still don’t know for sure whether any cancer screening test saves lives. The evidence in favor of screening is based on fewer deaths due to the target cancer, not reductions in overall mortality, according to a critique published in the British Medical Journal calling for higher standards of evidence for cancer screening.

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Engineering precision in cancer early detection

Engineering precision in cancer early detection

Sadik Esener, Ph.D., is leading a new Center for Early Detection Research at the OHSU Knight Cancer Institute.