Category Archives: Cancer medicine (Oncology)

Nivolumab in Melanoma—Progress but not a cure

A study at the annual ASCO (American Society of Clinical Oncology meetings report a 31% partial remission rate in malignant melanoma with the immune modulator nivolumab.   31% of patients responded to this drug showing a 1/3 decrease in size of the tumor masses and 1 complete remission.

31% is a minority of patients but this rate of response far exceeds the 5-10% rate of other agents used in melanoma.  Yes I said 5-10%.

This is not a cure but there is clear progress evident with this new drug.  Whether this will be sustained remissions with a significant survival benefit, as appears likely, remains to be fully proven.

Medicynical Note:  The cost of this new agent will be interesting to track.  An unaffordable drug has the same impact as the sound generated by a tree falling in the woods.

High Cancer Drug Costs: Unsustainable and Unconscionable

High cancer drug costs have finally gotten the attention they deserve from cancer doctors.  They don’t understand the reason for the high costs.

Prices for cancer drugs have been part of the debate over health care costs for several years — and recently led to a public protest from doctors at a major cancer center in New York. But the decision by so many specialists, from more than 15 countries on five continents, to join the effort is a sign that doctors, who are on the front lines of caring for patients, are now taking a more active role in resisting high prices. In this case, some of the specialists even include researchers with close ties to the pharmaceutical industry.

And:

Gleevec entered the market in 2001 at a price of about $30,000 a year in the United States, the doctors wrote. Since then, the price has tripled, it said, even as Gleevec has faced competition from five newer drugs. And those drugs are even more expensive.

The prices have been the subject of intense debate elsewhere as well. The Supreme Court in India ruled recently that the drug could not be patented, clearing the way for use of far less expensive generic alternatives.

Read the article for more.

Medicynical Note:  The article emphasizes the cost inflation of the most successful of the new targeted agents.  As noted above since it’s introduction Gleevac has tripled in cost.  It is the most profitable drug marketed by Novartis.  Oh yes you remember Novartis the company that in the news the past few days for bribing doctors and pharmacists, yes that “ethical” company Novartis.

What’s not discussed in the article is that many of these super expensive drugs do very little to improve patient outcomes (i.e. patients don’ t live longer) but still cost in the range of $100,000/year.

As Marcia Angell observed 10 years or so ago, in today’s medical business it’s your money or life or in the case of drugs that don’t work, both.

Prostate Cancer Radiation: Proton beam costs twice as much, twice as good? NO

A recent retrospective study looked at outcomes in prostate cancer treated with Proton radiotherapy (PRT)  vs intensity-modulated radiotherapy (IMRT).

And the results:

We identified 27,647 men; 553 (2%) received PRT and 27,094 (98%) received IMRT. Patients receiving PRT were younger, healthier, and from more affluent areas than patients receiving IMRT. Median Medicare reimbursement was $32,428 for PRT and $18,575 for IMRT. Although PRT was associated with a statistically significant reduction in genitourinary toxicity at 6 months compared with IMRT (5.9% vs 9.5%; odds ratio [OR] = 0.60, 95% confidence interval [CI] = 0.38 to 0.96, P = .03), at 12 months post-treatment there was no difference in genitourinary toxicity (18.8% vs 17.5%; OR = 1.08, 95% CI = 0.76 to 1.54, P = .66). There was no statistically significant difference in gastrointestinal or other toxicity at 6 months or 12 months post-treatment.

Medicynical Note:  There is a build it and they will come mentality in medicine that applies to new approaches that are costly and have little benefit.  In this case Proton Beam radiotherapy has a word of mouth that it is less “toxic”,  fostered in part by institutions that invested in this prohibitively expensive equipment. 

It appears, however, that the benefits of this modality are overstated, as often is the case with medical “advances,” and that the nearly 100% additional expense of proton beam treatment  is not justified in prostate cancer.

And When a Medicine (Revlimid) “Works” It’s Unaffordable: $132,000/year, $534/pill

Poignant piece in the NY Times magazine that highlights some of the flaws in our unsustainable health care non-system.  This paragraph outlines the problem

After making more than 70 phone calls to 16 organizations over the past few weeks, I’m still not totally sure what I will owe for my Revlimid, a derivative of thalidomide that is keeping my multiple myeloma in check. The drug is extremely expensive — about $11,000 retail for a four-week supply, $132,000 a year, $524 a pill. Time Warner, my former employer, has covered me for years under its Supplementary Medicare Program, a plan for retirees that included a special Writers Guild benefit capping my out-of-pocket prescription costs at $1,000 a year. That out-of-pocket limit is scheduled to expire on Jan. 1. So what will my Revlimid cost me next year?

Medicynical note:  Anyone believing our non-system is the best in the world should need such drugs.  While  drug companies  spend a great deal to develop medications,  their costs are inflated and overstated.  Efficiency is simply not on their agenda.  Nor is patient well being, access or for that matter outcomes. 

It’s the money stupid!  Charging more than twice the median U.S. income for a single drug that patients in life-threatening situation, any single drug,  is simple blackmail.  It reflects an industry and economy gone mad.

Cabozantinib: A Miracle Cancer Drug without Survival Benefit

The FDA recently approved cabozantinib for use in medullary carcinoma.  What’s noteworthy about this drug is that it will likely be very expensive and that it does not, repeat does not improve the patients survival. 

Read the following for an extremely biased assessment of the drug’s efficacy: (likely from the drug companies PR info)

Below are some data showing Cometriq’s superiority over placebo:

  • Those on Cometriq survived 11.2 months (average) with no tumor growth
  • Patients in the placebo group survived 4 months (average) with no tumor growth
  • 27% of those in the placebo group experienced tumor reductions which lasted an average of almost 15 months
  • None of the participants in the placebo group experienced tumor reduction

What’s obscured in the above is that this drug results in 0 months increased longevity, that is, it had no effect on the longevity of the patients.

The ORR (overall remission rate:  Medicynical clarification) was significantly higher in the cabozantinib arm (27% versus 0%; p<0.0001) and all were partial responses.  The median response duration was 14.7 months (95% CI: 11.1, 19.3). No statistically significant difference in overall survival was observed between the treatment arms at the planned interim analysis and in an updated survival analysis requested by FDA.

Medicynical Note:  This is a new one for me.  Other new miracle agents often have limited efficacy with say two months median survival improvement.  But this is the first such drug being actively promoted, that I can recall, that has no survival benefit. 

Maybe this is yet another reason we spend more on health care than any other country in the world….by a wide margin. 

Cost Matters: Colon Cancer, Zaltrap (ziv-afibercept)

Sounds crazy, a drug (Zaltrap) costing $11,000/month, with little efficacy is being actively promoted to desperate patients.  A classic case of any promise of efficacy, no matter how small, or how expensive, being irresistible to those with dread diseases. 

What’s even more amazing this article makes the righteous argument that another drug costing only (sic) $5000/month (Avastin)  offering similar (in-)efficacy should be used in it’s stead. 

The “benefit” of these super expensive drugs is roughly the same,  a miniscule 1.4 months median survival.

Medicynical Note:  It’s good that Sloan Kettering finally seems to recognize the folly of a minimally effective agent costing so much.  The benefits, by the way,  are truly minimal.  When a drug offers a median benefit of 1.4 months it means that half the people got less than that benefit (at $11,000/month).  True, half did better but the same could be said of the conventional regimen or placebo with which it’s compared. 

Does 1.4 months median benefit justify the expenditure of over $60,000/year (more than the median or average income of families in our country) on a single drug?  And this expense doesn’t include doctor’s fees, lab costs or imaging expenses. 

Hopeful but Speculative Breast Cancer Gene Analysis

Nature this week published the report of on molecular portraits of breast cancer.  The study has received wide publicity as a major breakthrough, even in our local newspaper which features it as the lead story on page one.  (More a reflection of a low news weekend in a small town than the reality of the study)

As noted on the Genome Web site:  

  “This study has now provided a near complete framework for the genetic causes of breast cancer,” corresponding author Charles Perou, a genetics researcher with the University of North Carolina at Chapel Hill and the Lineberger Comprehensive Cancer Center, said in a statement, “which will significantly impact clinical medicine in the coming years as these genetic markers are evaluated as possible markers of therapeutic responsiveness.”

And:

“The biological finding of the four main breast cancer subtypes caused by different subsets of genetic and epigenetic abnormalities raises the hypothesis that much of the clinically observable plasticity and heterogeneity occurs within, and not across, these major biological subtypes of breast cancer,” Perou and his co-authors noted.

Medicynical Note:  This could be a major breakthrough in understanding the behavior of this group of  cancers.  Grouping these tumors by genetic defect also provides some hints at potentially effective treatments.  

It should be pointed out that all the potential “benefits” are  unproven.