A WEARABLE medical device that delivers electrical fields through the scalp helped to extend the survival of patients with lethal brain tumors, according to data presented Sunday.
In a study involving major medical centers in the United States and abroad, the novel treatment was used to administer alternating, low-intensity "tumor-treating fields" to newly diagnosed glioblastoma patients who also were getting chemotherapy. Such electrical fields may block the division of cancer cells and cause their demise, according to Roger Stupp, the study's lead investigator and a neuro-oncologist at the Northwestern University Feinberg School of Medicine.
Stupp, who has worked on the device for several years, acknowledged that it has prompted considerable skepticism from some experts in the field. Although the new data have not yet been peer-reviewed, he said he believes the results "firmly establish the survival benefit."
The study, presented at the annual meeting of the American Association for Cancer Research in Washington, D.C., involved 695 adult patients who were enrolled between July 2009 and November 2014. It found that the median survival for patients who were randomly assigned to use the device while getting the chemo drug temozolomide lived a median of 21 months compared with 16 months for those assigned to receive chemo without the device.
"I think this is fascinating, but the improvement is still quite modest," said George Demetri, an oncologist at the Dana-Farber Cancer Institute who was on the AACR committee that accepted and highlighted the abstract. Exploring non-drug therapies is important given that glioblastoma patients survive, on average, less than 15 months following their diagnosis. "I'm in favor of any incremental benefit" for such a lethal disease, Demetri said.
Some critics - and even some supporters - have said Stupp should have designed the trial so that one group of patients would have gotten a placebo in the form of a device without any electrical current. Doing so, they noted, would have ensured that the reported benefit was valid. Stupp counters that such a sham device would have been impractical since patients would have known the difference because of the warming sensation the actual treatment causes on the scalp.
Two prominent brain-cancer specialists declined to discuss the study, signaling that they remain dubious.
The technology, called Optune, is manufactured by Novocure Inc. Interim results for the first 315 patients enrolled in the study, which were published in 2015 in JAMA, prompted an independent data and safety monitoring committee to recommend that the trial be ended early so that all patients could get the device if they wanted. The latest data show that the two-year survival rate for the full group of patients was 43 percent for those using the device while getting temozolomide, compared with 31 percent for those only receiving chemo. The five-year rate was 13 percent vs. 5 percent.
Optune has several components. The device has a generator that can be plugged into an electrical outlet or powered by a battery. It produces an electrical field that is conveyed via wires to four adhesive patches taped in place on a patient's shaved scalp. Each patch has an array of nine electrode discs. The electrical field being delivered changes direction rapidly, which Stupp speculates disrupts the rapidly dividing cancer cells but does not affect healthy cells.
The device was initially approved by the Food and Drug Administration in 2011 to treat patients with glioblastoma that had returned after chemotherapy. In 2015, the agency approved the treatment for newly diagnosed patients who also were getting temozolomide, based on the interim data of the second trial. At the time, the FDA noted that the treatment wasn't a cure but seemed to increase survival by several months.
Researchers still aren't exactly sure how the device works. "It was a controversial approach," said Patrick Wen, director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute, who has not been involved in the trial. But he predicted that skepticism will begin to wane given the new "positive" data. Tumor-treating fields now are in early-stage testing for ovarian and pancreatic cancers.
Jessica Morris of Brooklyn was diagnosed with glioblastoma a year ago after having a seizure while hiking with friends. The 53-year-old public relations executive, who has gone through surgery, radiation, chemotherapy and immunotherapy, began using Optune in May. Its manufacturer recommends that it be worn at least 18 hours a day. Morris typically adds on several hours.
Morris said she replaces the patches and shaves her head a few times a week. Because those arrays "look a bit weird," she wears a scarf. She said she has had no effects other than feeling her head get a bit warm from the electrical fields. She hopes to extend her remission as long as possible and then look for an appropriate clinical trial.
Trial investigator Andrew Lassman, the chief of neuro-oncology at Columbia University, first heard about the device some years ago. He remembers thinking, "What is this thing, is it a joke?" Now he believes the approach is here to stay - "I don't think it's sci-fi," he said - and calls the results "pretty good" even though the improvements are "incremental, not curative."
He said that only 5 percent to 10 percent of his patients have opted to use the device. One reason is that it's impossible to hide: "For some patients, they'll say, 'I'm proud to display that I'm fighting this cancer.' But o thers say, 'I don't want anyone to know my business, I'd prefer to get an IV or a pill and be private.'"
At $21,000 a month, it's also costly. Standard Medicare doesn't cover it, and some other insurers are balking, as well. Novocure's vice president for financial and investor relations, Ashley Cordova, said the company has financial assistance programs in an effort to ensure that everyone prescribed the device can get it.
The Washington Post
Mon Apr 03 2017
Stupp, who has worked on the device for several years, acknowledged that it has prompted considerable skepticism from some experts in the field.
US plan to take over Gaza: Malaysia's stance on Palestine unchanged - PM
Datuk Seri Anwar Ibrahim says Malaysia's stance remains the same as that of other Islamic countries.
US freezes funding for security mission tackling Haiti's gangs
More than $13 million in US funding for an international security force helping fight armed gangs in Haiti has been frozen, the UN says.
Over 40,000 civil servants at high risk of mental health issues - Zaliha
A total of 44,901 civil servants were screened under Public Service Psychological Health Digital Profiling System, says Dr Zaliha Mustafa.
India's Modi takes 'holy dips' at Maha Kumbh, week after stampede killed dozens
Security personnel stood in the water nearby while thousands of people crowded the banks to watch the prime minister perform the rituals.
Philippine Congress endorses impeachment complaint against vice president
Vice President Sara Duterte would be the Philippines' second most senior official to face removal from office.
What is a sovereign wealth fund?
Sovereign wealth funds are investment vehicles owned by countries.
[COLUMNIST] Rising above Trump tariffs: How a resilient global economy outlasts US protectionism
The current alarm over Trumps tariff threats overlooks a key point: global markets are resilient and adaptable.
Khazanah reports RM5.1 billion operating profit for 2024
Khazanah records RM103.6 billion NAV in 2024, driven by strong domestic investments and strategic growth.
Washington, DC officials identify 66 of 67 victims of midair collision
Work continues by the US Army Corps of Engineers to remove the airplane wreckage from the Potomac River.
Government to further strengthen ASEAN's readiness in finalising DEFA
Malaysia is focusing on two main approaches to facilitate the DEFA negotiation, says Liew Chin Tong.
Trade war will not hinder Malaysia’s GDP growth for 2025 - Rafizi
The finance ministry has projected Malaysia's GDP to grow between 4.5 and 5.5 per cent in 2025.
Trump administration considers adding Shein, Temu to 'forced labor' list, Semafor reports
The move comes after China imposes targeted tariffs on US imports and warnings of possible sanctions against firms like Google.
Thailand to cut power to Myanmar border areas linked to scam centres
Evidence shows transnational crime syndicates in Myanmar's Tachileik, Myawaddy, Payathonzu, that are possible power cut targets.
Trump reimposes 'maximum pressure' on Iran, aims to drive oil exports to zero
Trump signs the presidential memorandum reimposing Washington's tough policy on Iran that was practiced throughout his first term.
FACTBOX: Trump proposes US takeover of Gaza
Here are some remarks that US President Donald Trump made and questions that he answered during a press conference.
Singapore passes law against foreign interference in race-based organisations
Under the Racial Harmony Bill, race-based groups must disclose foreign and anonymous donations, affiliations, and leadership.
Malaysia, Uzbekistan agree to elevate ties to strategic partnership
Malaysia and Uzbekistan noted active cooperation on key issues within international bodies, especially the UN and OIC.
Musk's dad says he arranged son's call with South African leader
Trump's post claiming South Africa is "confiscating land" and mistreating "certain classes" triggers sudden flurry of backdoor diplomacy.
Israel PM Netanyahu says peace with Saudi Arabia is achievable
I think peace between Israel and Saudi Arabia is not only feasible, I think it's going to happen, says Israeli PM Benjamin Netanyahu.
Trump says UN has to 'get its act together,' UN pushes back
US President Donald Trump criticises the United Nations as "not being well run".