Allen S. Lichter, MD
At the 2015 ASCO Annual Meeting, the much heralded CancerLinQ big data system for helping oncologists more clearly understand treatment patterns and options was offered for demonstration in advance of its rollout.
In a press conference, Allen S. Lichter, MD, chief executive officer of ASCO, said that once fully up and running, CancerLinQ would provide data that was “logical, compelling, and searchable,” and would, eventually, become an indispensable tool, enabling doctors to improve quality and understand how they are performing in comparison with others across the health industry. “Physicians will say ‘I cannot practice without this,’” he predicted.
CancerLinQ has four chief capabilities: continual performance tracking for comparison with clinical quality measures; trend evaluation based on anonymous patient data; patient cohort identification based on shared characteristics; and individual patient timeline construction based on treatments, side effects, and outcomes.
ASCO aims to have 15 practices using CancerLinQ before the end of the year. Twelve practices across the country have already signed up to share data through the system. They range in size from six practitioners to NCI comprehensive centers. With 15 practices, CancerLinQ is expected to have around a half million patient records, Lichter said.
“CancerLinQ will soon become a reality for trailblazing oncology practices, and their patients will see its impact right away,” ASCO President Peter Paul Yu, MD, said in a statement.
“Our vision for CancerLinQ is ambitious—it is for every patient’s experience to contribute to the most compassionate, effective, and sustainable cancer care possible,” Yu said. “This first version offers a glimpse at the potential for big data to make cancer care better and more seamless. But it’s just a taste of the future, in which every patient’s care will be guided by up-to-the-minute science and data-driven insights.”
Giving examples of system capability, Lichter said CancerLinQ can provide “longitudinal” perspectives on individual patient cases, enabling doctors, for example, to very quickly find out how a patient within their own practice was treated months earlier, something that might otherwise have involved “a great deal of time flipping through charts, a page at a time.”
Similarly, patient status can quickly be plotted within a map of care guidelines so that doctors can know whether or not a patient falls within the “window of opportunity” for certain treatments. Practices will also be able to drill down into their own experience with patients and determine whether their findings are at odds with what other practices have encountered, Lichter said.
“Most quality programs are tests,” Lichter said. “What we’re trying to do is say everybody ought to get 100%—not do a ‘gotcha’ moment but do a ‘help ya’ moment. If you can move this patient along you will achieve 100% compliance.”
CancerLinQ will also provide physicians with “real-time” comparisons of their performance against that of other doctors, Lichter said. In addition, physicians can query the database to gain insight into treatments that may or may not work, Lichter said, citing the hypothetical case of a 70-year-old patient with neutropenia, the danger that represents, and the dilemma over the type of chemotherapy to use.
A prototype of CancerLinQ was established in 2013, when ASCO announced it had begun creating a depository of breast cancer information involving a variety of data from different sources. Too much information on cancer patients was locked away in unconnected servers and paper files, depriving physicians of valuable insight into the nature of cancer and its treatment, ASCO said at the time.
CancerLinQ was also touted as a prototype for the big data projects that are entering the mainstream of medicine. Data from 100,000 breast cancer patients who were treated at cancer centers around the United States were gathered. The CancerLinQ system was designed to accept data in multiple formats on a real-time basis, overcoming the hurdle of inconsistent health data standards. The data that was collected ranged from genomic profiles to lab tests and even physicians’ notes.
Another feature of the system was its capability to provide feedback for physicians’ performance based on 10 quality measures from ASCO’s Quality Oncology Practice Initiative (QOPI), a tool for care assessment and quality improvement.
Participating practices include MedStar Washington Hospital Center, Washington Cancer Institute, Washington, DC; Marin Cancer Care, California; Montgomery Cancer Center, Alabama; New England Cancer Specialists, Maine; INOVA Medical Group, Virginia; Medical Oncology Hematology Consultants, Delaware; Southwest Centers for Cancer Care, Massachusetts; Zangmeister Center, Ohio; Michiana Hematology Oncology, Indiana; Space Coast Cancer Center, Florida; Cancer Treatment Centers of America, Arizona; and Catholic Health Initiatives, Colorado.
The CancerLinQ platform will be powered by big data technology called HANA, offered by SAP, a global software developer. The HANA software can manipulate the data that are collected in a number of ways. All data are stored in main memory, which enhances the speed to analyze the data and can provide the real-time insight that a busy oncologist needs when he or she is seeing a patient. In addition, HANA can collect and adjust data that are collected from multiple sources (ie, different community oncology practices).
Over time, further development and input will come from physicians, patients and experts in relevant disciplines that include quality improvement, health outcomes, epidemiology, and health IT. ASCO will continue to maintain control over the data, services, and products, including decision support tools and analyses. SAP will provide engineering and technical support to continue to enrich CancerLinQ’s versatility.
- See more at: http://www.onclive.com/conference-coverage/asco-2015/ASCO-Provides-Early-Look-at-CancerLinQ-Big-Data-Initiative-#sthash.OUkslCuf.dpuf
martes, 2 de junio de 2015
Nivolumab in Lung Cancer Shows 'Unprecedented' Survival
Medscape Medical News from the
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting
Medscape Medical News > Conference News
Nivolumab in Lung Cancer Shows 'Unprecedented' Survival
Zosia Chustecka
May 29, 2015
CHICAGO, IL — The immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb) has beaten chemotherapy in another subset of patients with lung cancer in the second phase 3 trial to show an improvement in survival compared with docetaxel.
The results were hailed as practice-changing here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.
Nivolumab is the new standard of care in patients with previously treated squamous nonsmall cell lung cancer (NSCLC), declared Roy Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center in New Haven, Connecticut, who acted as discussant for the study. Overall survival was significantly improved, and nivolumab showed significantly less toxicity than docetaxel, he said.
"We now need to move this to frontline therapy in lung cancer," Dr Herbst said.
The latest results come from the CheckMate 057 study, Results released today from the CheckMate 057 study, conducted in 582 patients with advanced nonsquamous NSCLCnonsmall cell lung cancer (NSCLC) who who had progressed on platinum-doublet chemotherapy, . The overall results show that treatment with nivolumab extended median overall survival by 3 months compared with docetaxel (12.2 vs 9.4 months; hazard ratio, 0.73; P = .00155).
However, a subset of patients with high levels of expression of programmed death ligand 1 (PDL-1) showed even great benefit; here the median overall survival was 17.2 to 19.4 months. This is unprecedented in this type of patient population, commented lead author Luis Paz-Ares MD, PhD, from the Hospital Universitario Virgen Del Roccio in Seville, Spain. Usually, patients who are treated with second-line docetaxel have a median overall survival of 8 to 10.4 months, he added.
He noted that although the responses and survival were much lower in the patients who had low PDL-1 expression, some of these patients did respond, so this biomarker is useful as a positive predictor of patients who are likely to respond, but not so useful as a negative predictor of those who are unlikely to respond.
In his discussion of the results, Dr Herbst said the PDL-I biomarker is not yet ready for clinical use.
Response rates were higher in the nivolumab group compared with in the docetaxel group (19.2% vs 12.4%). Responses also lasted significantly longer in the nivolumab group (17.1 vs 5.6 months, on average).
Dr Paz-Ares said he was hopeful that longer follow-up will show that the responses to immunotherapy in lung cancer are long-lasting, as they have shown to be in melanoma.
Already Approved for NSCLC
This is the second phase 3 trial to show a survival benefit with nivolumab. The other was CheckMate 017, which was conducted in patients with advanced squamous NSCLC. This trial has already resulted in the approval of nivolumab for squamous NSCLC in the United States; this indication was also recently recommended for approval in Europe.
These latest results should result in an approval for the nonsquamous subset of NSCLC as well, predicts Dr Paz-Ares. He noted that nonsquamous subset is the larger of the two, accounting for around 60% of all patients with lung cancer, whereas the squamous subset accounts for some 25%. The remainder is made up of SCLC, he commented, which is a different disease.
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting
Medscape Medical News > Conference News
Nivolumab in Lung Cancer Shows 'Unprecedented' Survival
Zosia Chustecka
May 29, 2015
CHICAGO, IL — The immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb) has beaten chemotherapy in another subset of patients with lung cancer in the second phase 3 trial to show an improvement in survival compared with docetaxel.
The results were hailed as practice-changing here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.
Nivolumab is the new standard of care in patients with previously treated squamous nonsmall cell lung cancer (NSCLC), declared Roy Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center in New Haven, Connecticut, who acted as discussant for the study. Overall survival was significantly improved, and nivolumab showed significantly less toxicity than docetaxel, he said.
"We now need to move this to frontline therapy in lung cancer," Dr Herbst said.
The latest results come from the CheckMate 057 study, Results released today from the CheckMate 057 study, conducted in 582 patients with advanced nonsquamous NSCLCnonsmall cell lung cancer (NSCLC) who who had progressed on platinum-doublet chemotherapy, . The overall results show that treatment with nivolumab extended median overall survival by 3 months compared with docetaxel (12.2 vs 9.4 months; hazard ratio, 0.73; P = .00155).
However, a subset of patients with high levels of expression of programmed death ligand 1 (PDL-1) showed even great benefit; here the median overall survival was 17.2 to 19.4 months. This is unprecedented in this type of patient population, commented lead author Luis Paz-Ares MD, PhD, from the Hospital Universitario Virgen Del Roccio in Seville, Spain. Usually, patients who are treated with second-line docetaxel have a median overall survival of 8 to 10.4 months, he added.
He noted that although the responses and survival were much lower in the patients who had low PDL-1 expression, some of these patients did respond, so this biomarker is useful as a positive predictor of patients who are likely to respond, but not so useful as a negative predictor of those who are unlikely to respond.
In his discussion of the results, Dr Herbst said the PDL-I biomarker is not yet ready for clinical use.
Response rates were higher in the nivolumab group compared with in the docetaxel group (19.2% vs 12.4%). Responses also lasted significantly longer in the nivolumab group (17.1 vs 5.6 months, on average).
Dr Paz-Ares said he was hopeful that longer follow-up will show that the responses to immunotherapy in lung cancer are long-lasting, as they have shown to be in melanoma.
Already Approved for NSCLC
This is the second phase 3 trial to show a survival benefit with nivolumab. The other was CheckMate 017, which was conducted in patients with advanced squamous NSCLC. This trial has already resulted in the approval of nivolumab for squamous NSCLC in the United States; this indication was also recently recommended for approval in Europe.
These latest results should result in an approval for the nonsquamous subset of NSCLC as well, predicts Dr Paz-Ares. He noted that nonsquamous subset is the larger of the two, accounting for around 60% of all patients with lung cancer, whereas the squamous subset accounts for some 25%. The remainder is made up of SCLC, he commented, which is a different disease.
New Immunotherapy Costing $1 Million a Year
Medscape Medical News from the
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting
Medscape Medical News > Conference News
New Immunotherapy Costing $1 Million a Year
Gooder Than Gold
Zosia Chustecka
June 01, 2015
CHICAGO — One of the new immunotherapies would cost more than $1 million per patient per year at the higher dose currently being studied in many different cancer types, an expert has warned.
"This is unsustainable.... We must acknowledge that there must be some upper limit to how much we can, as a society, afford to pay to treat each patient with cancer," said Leonard Saltz, MD, from Memorial Sloan Kettering Cancer Center, New York City.
Dr Saltz was speaking at an extra session entitled Perspective on Value conducted at the end of the plenary session here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. He has been vocal in the past about the high cost of cancer therapies, and he even managed to get one company to lower its price when his center's team refused to use it.
In his talk, Dr Saltz focused on a plenary presentation that showed dramatic results for the combination of two immuotherapies together, ipilimumab (Yervoy, Bristol-Myers Squibb Company) and nivolumab (Opdivo, Bristol-Myers Squibb Company) in metastatic melanoma. The results "are truly, truly remarkable for a disease that 5 years ago we thought that was basically untreatable," he said.
"As a researcher, I am deeply gratified to see how basic research has been elegantly translated to useful drugs that are benefiting patients today, and as a clinician, I want to have these drugs and others like them available for my patients," he said. "But as someone who worries about making cancer care available to everyone and minimizing disparities, I have a major problem with this ― these drugs cost too much."
Dr Saltz discussed the difference between value and benefit and that in assessing the value of any therapy, downsides such as toxicity have to be taken into account, as does the cost of the drug.
Nivolumab costs $28.78 per mg of drug, whereas ipilimumab costs $157.46 per mg.
"To put that into perspective, that's approximately 4000 times the cost of gold," he commented.
Cost of Immunotherapy Combo
Next, Dr Saltz calculated the cost of the combination of these two melanoma drugs for an average-size American patient; and here he digressed to note that with the current obesity epidemic, the average-size American now weighs 80 kg.
In the latest trial, the cost of using ipilimumab alone was $158,282 (for a median progress-free survival [PFS] of 2.9 months), the cost of nivolumab alone was $103,220 (for a PFS of 6.9 months), and the cost of the combination was $295,566 (PFS of 11.4 months, nearly four times that seen with ipilimumab alone, which is currently the standard of care). These results are predicted to lead to a sea change in the treatment of melanoma.
But how will patients afford these new therapies?
Patients on Medicare have a 20% co-pay, so for this combination of immunotherapies costing nearly $300,000, they would have pay $60,000 out of their own pocket for this treatment.
Expanding to Other Cancer Types
So far, the new immunotherapies are approved for use only in melanoma and lung cancer, but they are showing promise in many other cancer types, and experts believe that they will soon form the backbone of all cancer therapy.
Dr Saltz led the audience through a "thought experiment" that looked at a possible future scenario that could result from this research.
In the United States, there are 589,430 cancer deaths each year, and cancer deaths are ultimately due to metastatic disease, Dr Saltz commented. If all of these patients were to receive the immunotherapy combination (589,430 x $295,566), that would work out to more $174 billion per year, just for drugs to treat metastatic cancers for the first year only.
Dr Saltz discussed briefly the skyrocketing costs of new cancer drugs, which have already been reported extensively on Medscape Medical News, and he concluded, as have others, that "cancer drug prices are not related to the value of the drug" but that "rather, prices are based on what the market has come to bear and what the seller believes that the market will bear."
He then gave the alarming example of a drug that would cost more than $1 million.
The latest immunotherapy, pembrolizumab (Keytruda, Merck Sharp & Dohme Corp), was approved at the end of 2014 for use at a dose of 2 mg/kg for the treatment of melanoma. For this, it costs around $14,500 per month.
But a much higher dose of 10 mg/kg, pembrolizumab is now being used in clinical trials (featured in five abstracts presented at the ASCO meeting), and this higher dose works out to be $83,000 per month.
In calculating what the expense would be for a year, Dr Saltz dropped the weight of the hypothetical patient to 75 kg; for such a patient, pembrolizumab at the higher dose of 10 mg/kg (26 doses per year at $51.79 per mg) would cost $1,009,944 per patient per year.
"That is over $1 million per patient per year," he emphasized.
"This is unsustainable," he declared, and added the dictionary definition of the word: "not able to be maintained or supported in the future, especially without causing damage or depletion of resource."
Patients cannot afford these therapies. They cannot afford the co-pays, and, increasingly, they are not able to afford medical insurance.
"This year, the premium for a family insurance plan plus out-of-pocket healthcare costs will equal approximately half the average US household income," he noted.
"If we carry this to its illogical extreme, by 2028, 100% of household income would be needed to cover insurance premiums plus out-of-pocket costs."
Urgent discussion is needed on all this, he said, and "we must encourage (rather than suppress) discussion of value and cost in cancer care."
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. Presented May 31, 2015.
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting
Medscape Medical News > Conference News
New Immunotherapy Costing $1 Million a Year
Gooder Than Gold
Zosia Chustecka
June 01, 2015
CHICAGO — One of the new immunotherapies would cost more than $1 million per patient per year at the higher dose currently being studied in many different cancer types, an expert has warned.
"This is unsustainable.... We must acknowledge that there must be some upper limit to how much we can, as a society, afford to pay to treat each patient with cancer," said Leonard Saltz, MD, from Memorial Sloan Kettering Cancer Center, New York City.
Dr Saltz was speaking at an extra session entitled Perspective on Value conducted at the end of the plenary session here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. He has been vocal in the past about the high cost of cancer therapies, and he even managed to get one company to lower its price when his center's team refused to use it.
In his talk, Dr Saltz focused on a plenary presentation that showed dramatic results for the combination of two immuotherapies together, ipilimumab (Yervoy, Bristol-Myers Squibb Company) and nivolumab (Opdivo, Bristol-Myers Squibb Company) in metastatic melanoma. The results "are truly, truly remarkable for a disease that 5 years ago we thought that was basically untreatable," he said.
"As a researcher, I am deeply gratified to see how basic research has been elegantly translated to useful drugs that are benefiting patients today, and as a clinician, I want to have these drugs and others like them available for my patients," he said. "But as someone who worries about making cancer care available to everyone and minimizing disparities, I have a major problem with this ― these drugs cost too much."
Dr Saltz discussed the difference between value and benefit and that in assessing the value of any therapy, downsides such as toxicity have to be taken into account, as does the cost of the drug.
Nivolumab costs $28.78 per mg of drug, whereas ipilimumab costs $157.46 per mg.
"To put that into perspective, that's approximately 4000 times the cost of gold," he commented.
Cost of Immunotherapy Combo
Next, Dr Saltz calculated the cost of the combination of these two melanoma drugs for an average-size American patient; and here he digressed to note that with the current obesity epidemic, the average-size American now weighs 80 kg.
In the latest trial, the cost of using ipilimumab alone was $158,282 (for a median progress-free survival [PFS] of 2.9 months), the cost of nivolumab alone was $103,220 (for a PFS of 6.9 months), and the cost of the combination was $295,566 (PFS of 11.4 months, nearly four times that seen with ipilimumab alone, which is currently the standard of care). These results are predicted to lead to a sea change in the treatment of melanoma.
But how will patients afford these new therapies?
Patients on Medicare have a 20% co-pay, so for this combination of immunotherapies costing nearly $300,000, they would have pay $60,000 out of their own pocket for this treatment.
Expanding to Other Cancer Types
So far, the new immunotherapies are approved for use only in melanoma and lung cancer, but they are showing promise in many other cancer types, and experts believe that they will soon form the backbone of all cancer therapy.
Dr Saltz led the audience through a "thought experiment" that looked at a possible future scenario that could result from this research.
In the United States, there are 589,430 cancer deaths each year, and cancer deaths are ultimately due to metastatic disease, Dr Saltz commented. If all of these patients were to receive the immunotherapy combination (589,430 x $295,566), that would work out to more $174 billion per year, just for drugs to treat metastatic cancers for the first year only.
Dr Saltz discussed briefly the skyrocketing costs of new cancer drugs, which have already been reported extensively on Medscape Medical News, and he concluded, as have others, that "cancer drug prices are not related to the value of the drug" but that "rather, prices are based on what the market has come to bear and what the seller believes that the market will bear."
He then gave the alarming example of a drug that would cost more than $1 million.
The latest immunotherapy, pembrolizumab (Keytruda, Merck Sharp & Dohme Corp), was approved at the end of 2014 for use at a dose of 2 mg/kg for the treatment of melanoma. For this, it costs around $14,500 per month.
But a much higher dose of 10 mg/kg, pembrolizumab is now being used in clinical trials (featured in five abstracts presented at the ASCO meeting), and this higher dose works out to be $83,000 per month.
In calculating what the expense would be for a year, Dr Saltz dropped the weight of the hypothetical patient to 75 kg; for such a patient, pembrolizumab at the higher dose of 10 mg/kg (26 doses per year at $51.79 per mg) would cost $1,009,944 per patient per year.
"That is over $1 million per patient per year," he emphasized.
"This is unsustainable," he declared, and added the dictionary definition of the word: "not able to be maintained or supported in the future, especially without causing damage or depletion of resource."
Patients cannot afford these therapies. They cannot afford the co-pays, and, increasingly, they are not able to afford medical insurance.
"This year, the premium for a family insurance plan plus out-of-pocket healthcare costs will equal approximately half the average US household income," he noted.
"If we carry this to its illogical extreme, by 2028, 100% of household income would be needed to cover insurance premiums plus out-of-pocket costs."
Urgent discussion is needed on all this, he said, and "we must encourage (rather than suppress) discussion of value and cost in cancer care."
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting. Presented May 31, 2015.
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