Two of the “five most important studies presented at ASCO this year,” according to session moderator Jyoti Patel, MD, incoming communications director for ASCO, involve drugs at opposite ends of the cost spectrum.
Sorafenib, one of the most expensive drugs in the anti-cancer arsenal, was shown to extend progression-free survival for patients with differentiated thyroid cancer that is resistant to standard radiation therapy.
On the flip side, researchers from the Tata Memorial Hospital in Mumbai, India, demonstrated that they could reduce cervical cancer mortality in that country by almost one-third through a community-based screening program administered by tenth-grade girls and using acetic acid, better known as vinegar, which costs a few dollars per gallon, retail.
Thanks to widespread use of the Pap smear, cervical cancer deaths are rare in the United States. But it is the leading cause of death among women in many developing countries, including India.
Fortunately, there is a simple and effective alternative screening method: VIA, short for visual inspection with acetic acid.
When vinegar is applied to the healthy cervix, nothing happens. When it is applied to a developing cervical cancer, it promptly turns the area white.
“There are abnormal blood vessels on the tumor surface,” explained study author Surendra Srinivas Shastri, MD, professor of preventive medicine at Tata. “The acetic acid coagulates proteins in the nucleus of those cells, giving them a white-ish appearance. It is very accurate. It takes about one minute. We give the women their results right away.”
The problem has been finding a low-cost way to perform such screening. The researchers trained teams of young women to perform the tests, going into low-income communities, such as the legendary slums of Mumbai, gaining the confidence of the women there and screening them every 24 months. Those who tested positive were provided free treatment.
This was not at all simple, Shastri reports.
“There were seven layers of community barriers,” he said, ranging from politicians to community leaders to schoolteachers, who are opinion leaders at the local levels. “It requires a lot of passion and commitment” but it proved remarkably effective.
In the 15-year study, involving 150,000 women, they reached an 89 percent compliance rate, “which is huge,” he said, and an 86 percent completion rate.
As a result they were able to prevent 31 percent of cervical cancer deaths. If extended to the whole country, they estimate, this could prevent 22,000 cervical cancer deaths each year and as many as 73,000 if extended to all developing countries.
Sorafenib may not compete with vinegar on cost-effectiveness measures, but it is being applied to a biologically more challenging task.
There has not been an effective new drug in four decades for radiation-resistant thyroid cancers, which kill about 1,800 people a year in the U.S.
A research team based at the University of Pennsylvania found that the drug could almost double progression-free survival. Overall survival data from the trial are “not yet mature,” the researchers report.
Ezra Cohen, MD, left, professor of medicine at the University of Chicago Medicine and discussant for this presentation at the annual meeting’s plenary session, congratulated the authors on completing the study.
“We do now have a therapy to offer these patients,” he said, but because of the trial design, we are “unlikely to see a benefit in overall survival.”
The critical issue now is who to treat. “Many patients are asymptomatic and the toxicity will impact quality of life,” he said.
It’s worth noting that sorafenib, originally developed as a multi-targeted agent against colon cancer, might never have made it to market were it not for an innovative phase-2 clinical trial designed and run by University of Chicago researchers.
In that trial, the drug, then known as Bay 43-9006, was not effective for colon cancer but emerged as a highly promising agent for renal cancer.
Two other reports at the Plenary Session focused on the angiogenesis inhibitor bevacizumab (Avastin).
Again, there were two sides of the story.
Adding the drug to two different chemotherapy regimens for advanced or refractory cervical cancer prolonged overall survival by about four months, from about 13 to 17 months.
Another study, in brain tumors, found no survival benefit from adding the drug to chemoradiation treatments for glioblastoma, where it also caused increased side effects.
The final study presented confirmed the benefits of giving breast cancer patients tamoxifen for at least ten years, rather than five.
It reduced breast cancer recurrence and death rates by 25 percent from post-treatment year ten onwards.