Seniors face steep drug costs as Congress stalls on capping Medicare out-of-pockets
Seniors face steep drug costs as Congress stalls on capping Medicare out-of-pockets
Sharon Clark is able to get her life-sustaining cancer drug, Pomalyst—priced at more than $18,000 for a 28-day supply—only because of the generosity of patient assistance foundations.
Clark, 57, a former insurance agent who lives in Bixby, Okla., had to stop working in 2015 and go on Social Security disability and Medicare after being diagnosed with multiple myeloma, a blood cancer. Without the…
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Riveting survival stories from the early clinical trials of Gleevec
Medicine had never seen anything like it before, Brian Druker, M.D., recalled. “These are people who’d been told to get their affairs in order. And now their blood counts are normal,” the director of the OHSU Knight Cancer Institute told Stat News reporter Bob Tedeschi.“But here’s the problem: When can you celebrate? I felt a little bit like walking on eggshells, because it’s like, OK, is this going to be a flash in the pan, or is this going to last? And there’s only one way to find out: wait and see.”
Druker didn’t know it yet, but the experimental compound STI571, now known as Gleevec, would transform the outlook for people diagnosed with chronic myeloid leukemia. A disease with a three- to five-year life expectancy became, for most patients, a chronic, long-term condition managed with a daily pill.
Tedeschi collected a riveting oral history of the early clinical trials of Gleevec starting in 1998, and how Druker and three of his longest-surviving patients remember the drug that changed their lives.
When Doralee Mortensen was diagnosed with CML in 1991, she looked up survival data that showed she had an 80 percent chance of dying in two years. After 70 bone marrow biopsies, she had dreams of being cured but couldn’t allow herself to believe them:
When they’re drilling through the bone, all you hear is the sound. You don’t feel anything. But when they draw it out, it’s like a dentist hitting a nerve.
It was November 2002 when they called me. They left a voicemail, that I was down to 1 percent abnormal cells. That I would survive. It was – it was – [crying]. Sorry. So I called everybody that I knew. By then I had a man in my life — we’ve since married. We celebrated over lunch.
I felt — I can say this — everybody I’d known had died. All the clinics I’d been to, all the waiting rooms I’d been in, all those people had died. So many had children, young children. One fellow who’d just been married and had a baby and he didn’t survive. I was in a meditation group for terminal patients and I’m the only one in that room of 10 people that’s still alive. And some of it is survivor guilt. Why me?
Obviously, I’m very thankful and feeling very lucky, but it was just so many people had died.
You just kind of think, “I’ve got to live for them.”
You can read the full the oral history online at Stat News. It includes recollections from Doug Jensen (now age 83; diagnosed in 1997) and Judy Orem (now age 73; diagnosed in December 1995).
Photo: (Left to right) Judy Orem, Doug Jenson and Dori Mortensen were diagnosed with chronic myeloid leukemia in the 1990s, when few survived more than five years. They were among the earliest participants in clinical trials of Gleevec. (Stat News/Meg Roussos)
Years of life expectancy at age 55 for people diagnosed with CML compared with the general population, from the work of Bower et al. (OHSU/Joe Rojas-Burke)
The cancer drug that “changed everything”
It transformed the outlook for people diagnosed with chronic myeloid leukemia. A disease with a three- to five-year life expectancy became, for most patients, a chronic, long-term condition managed with a daily pill.
And this week, researchers published the outcomes of people treated for more than 10 years with the drug imatinib (Gleevec), ushered from lab to clinical success by Brian Druker, M.D., director of the OHSU Knight Cancer Institute. The findings stand as a testament to the idea that understanding the earliest drivers of cancer formation can lead to less toxic and more effective treatments.
Estimated overall survival at 10 years was 83 percent among patients receiving first-line imatinib treatment, Druker and co-authors reported in the New England Journal of Medicine. Many of the recorded deaths of people in the imatinib group were unrelated to CML. Among 134 patients with cytogenetic assessments at 10 years, 92 percent had a complete cytogenetic response, that is, they had no measurable sign of the chromosome alteration that causes CML.
No surprising toxic effects emerged with long-term use. A total of 51 of 551 patients (9 percent) receiving first-line therapy with imatinib had a serious adverse event. The frequency of adverse events was highest during the first year of treatment and declined over time.
Among the patients in the clinical trial who had been randomly assigned to receive interferon alfa plus cytarabine, nearly two-thirds crossed over to imatinib, typically because of disease progression, lack or loss of response, or unacceptable side effects from the older treatment. The high rate of crossover makes it impossible to compare overall survival directly, but the available data indicate a 26 percent lower risk of death with first-line imatinib therapy than with interferon alfa plus cytarabine, Druker and co-authors said.
Imatinib is a tyrosine kinase inhibitor that specifically targets a mutant protein, BCR-ABL1, that is a driver of malignant transformation in CML. Second- and third-generation TKIs have continued to improve outcomes by providing effective therapy when CML develops resistance to imatinib. With the advent of these drugs, life expectancy in patients with chronic myeloid leukemia climbed to a level almost equal to that of the general population.
Imatinib treatment has also allowed for the successful stopping of therapy in a subset of patients who achieve deep remission. Druker and co-authors estimated that approximately 10 percent of imatinib-treated patients might be able to achieve a stable treatment-free remission. They said second-generation agents may enable an even larger proportion of patients to be eligible to attempt treatment-free remission.
Other cancers haven’t been as amenable to the targeted therapy approach because the genetic alterations driving them are more complex than the BCR-ABL1 mutation that underlies CML. Solid tumors, for instance, tend to quickly develop resistance to targeted therapies by diverting to alternative metabolic and signaling pathways.
Nevertheless, the imatinib experience has “fundamentally altered the field of oncology,” in the words of Dan L. Longo, M.D., a deputy editor of the New England Journal of Medicine. While none of the new targeted therapies appears to cure a majority of patients, and many hurdles remain, he said, “The future of oncology is more hopeful now.”
Citations
Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia by Andreas Hochhaus, Brian J. Druker and others, NEJM (March 9, 2017)
Imatinib Changed Everything by Dan L. Longo, NEJM (March 9, 2017)
Life Expectancy of Patients With Chronic Myeloid Leukemia Approaches the Life Expectancy of the General Population, by Hannah Bower, Magnus Björkholm, Paul W. Dickman, Martin Höglund, Paul C. Lambert and Therese M.-L. Andersson, Journal of Clinical Oncology, June 20, 2016.
É possível que estejamos domando a leucemia, uma assassina de centenas de milhares, inclusive de crianças. Uma pesquisa revela que mais de 80% dos pacientes que sofriam de CML (chronic myelogenous leucemia) continuavam vivos depois de onze anos de tratamento com imatinib (Gleevec). Nessa pesquisa, quatro em cinco dos pacientes originalmente alocados para o grupo imatinib tiveram uma resposta…
É possível que estejamos domando a leucemia, uma assassina de centenas de milhares, inclusive de crianças. Uma pesquisa revela que mais de 80% dos pacientes que sofriam de CML (chronic myelogenous leucemia) continuavam vivos depois de onze anos de tratamento com imatinib (Gleevec). Nessa pesquisa, quatro em cinco dos pacientes originalmente alocados para o grupo imatinib tiveram uma resposta…
