Thyroid Cancer Fight

I was diagnosed with thyroid cancer in Nov., 1999. Surgery and radioactive iodine followed. In Dec., 2006, I found a lump in my neck that turned cancerous. Shortly thereafter, it was found to have metastasized throughout my body and to be untreatable and inoperable. I started a clinical trial with Sutent (sunitinib) since Apr., 2007. In Nov., 2013, the tumors began growing again and I was removed from the Sutent Clinical Trial. I started a clinical trial taking of CEDIRANIB on 04/09/14.

Wednesday, November 27, 2013

Link to Thyroid Cancer in Humans May be Found in Cats - PawNation

LINK TO THYROID CANCER IN HUMANS MAY BE FOUND IN CATS

Tuesday, November 26, 2013

Brose Sheds Light on Targeted Therapies in Thyroid Cancer

Brose Sheds Light on Targeted Therapies in Thyroid Cancer:

'via Blog this'

FDA Expands Nexavar Label to Treat Late-Stage Thyroid Cancer

FDA Expands Nexavar Label to Treat Late-Stage Thyroid Cancer:

By Ross Bonander, Sun, November 24, 2013

The US Food and Drug Administration issued a statement saying it has expanded the approved uses of the drug Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.

Differentiated thyroid cancer

is the most common type of thyroid cancer; the National Cancer Institute's SEER statistics estimate that each year about 60,220 Americans will be diagnosed with thyroid cancer, and 1,850 will die from the disease.

Nexavar works by inhibiting multiple proteins in cancer cells, thereby limiting cancer cell growth and division.

The FDA initially approved Nexavar for the treatment of advanced kidney cancer in 2005. Two years later it expanded the drug’s label to treat unresectable liver cancer. Nexavar's new approved use is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer

that no longer responds to radioactive iodine treatment.

Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research:

Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies. Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases.

A clinical trial involving 417 participants with locally recurrent or metastatic, progressive differentiated thyroid cancer that did not respond to radioactive iodine treatment established the drug's safety and effectiveness. The findings demonstrated that Nexavar could increase progression free survival (the length of time patients lived without the cancer progressing) by 41 percent. Half of patients receiving Nexavar lived without cancer progression for at least 10.8 months compared to at least 5.8 months for participants receiving a placebo.

Source: FDA

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Early Results Show Promise for Anti-PD-1 Antibody MK-3475 in NSCLC

Silas Inman

Published Online: Wednesday, October 2, 2013

The investigational immunotherapy MK-3475 has demonstrated an objective response rate (ORR) of up to 24% in patients with previously treated non-small cell lung cancer (NSCLC), according to interim results from a phase Ib expansion study. A new nonproprietary generic name for MK-3475 (previously known as lambrolizumab) is currently under review by the United States Adopted Names Council.

MK-3475, a monoclonal IgG4 antibody, is in a class of agents that target PD-1, an inhibitory T-cell co-receptor. It is thought that interactions between PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression. Additionally, preclinical evidence has supported this mechanism’s role in the development of lung cancer.

The preliminary safety and efficacy data, including progression-free survival (PFS) and overall survival (OS), will be reported on October 29 at the 2013 World Conference on Lung Cancer.

“We look forward to further discussion of the data following its presentation at the conference,” said Eric H. Rubin, MD, the vice president of Oncology at Merck Research Laboratories, the company developing the drug, in a statement.

In the trial, 38 patients with squamous and nonsquamous NSCLC who had received two prior systemic regimens were treated with MK-3475 at 10 mg/kg every three weeks. The median age of patients on the trial was 63 years old. Forty-two percent of patients had an ECOG performance status of zero and 10% of patients had stable, previously treated brain metastases. Additionally, tumor PD-L1 expression was assessed prior to treatment.

According to an abstract published in advance of the meeting, imaging reports were examined every 9 weeks using immune-related response criteria (irRC). In the preliminary findings, ORR was calculated using both confirmed and unconfirmed responses. According to investigator-assessed irRC, ORR was 24%. However, an independent central review using RECIST v1.1 criteria found an ORR of 21%. At a median 9-month follow-up, the median duration of response had not been reached. PD-L1 expression was found to be a statistically significant predictor of response.

All grade adverse events (AEs) occurred in 50% of patients treated with MK-3475, with the most common AEs being fatigue, rash, and pruritus. Additionally, 1 patient developed drug-related grade 3 pulmonary edema.

“These early data in lung cancer patients were the basis for Merck’s decision to rapidly advance MK-3475 into a Phase II/III clinical trial in NSCLC," remarked Rubin in a statement announcing the presentation of these results.

A phase II/III study is currently recruiting and plans to enroll 920 PD-L1-positive patients with NSCLC who have experienced disease progression after platinum-containing systemic therapy. The study will compare a low and high dose of intravenous MK-3475 with docetaxel at 75 mg/m², every 3 weeks. The primary endpoints for both portions of the study are OS, PFS, the number of patients experiencing an adverse event, and the number of patients that discontinue treatment.

Merck recently announced that the company plans to restructure their operations to place more emphasis on potential growth opportunities, such as its anti-PD-1 immunotherapy program. In conjunction with this, the company announced the formation of a new unit focused solely on the development of MK-3475.

In April, MK-3475 received a Breakthrough Therapy designation from the FDA as a treatment for patients with melanoma after promising results from a small single-arm study. The agent is also being explored in a variety of clinical trials as a treatment for patients with bladder cancer, colorectal cancer, head and neck cancer, and triple-negative breast cancer.

Garon EB, Balmanoukian A, Hamid O, et al. Preliminary clinical safety and activity of MK-3475 monotherapy for the treatment of previously treated patients with non-small cell lung cancer (NSCLC). To be presented at: 15th World Conference on Lung Cancer; October 27-October 30, 2013; Sydney, Australia. Abstract 2416.

- See more at: http://www.onclive.com/web-exclusives/Early-Results-Show-Promise-for-MK-3475-in-NSCLC#sthash.d1fDKdyD.dpuf

Dad Pleading for Unapproved Cancer Drug Dies - Yahoo

Dad Pleading for Unapproved Cancer Drug Dies

By SYDNEY LUPKIN | Good Morning America – 2 hours 55 minutes ago

Nick Auden, the 41-year-old Denver man who had been pleading with drug companies for one last chance to beat his terminalcancer, has died.

"He never stopped fighting and never stopped believing he would conquer this absolutely horrendous disease," Auden's wife, Amy Auden, said in a statement following his death on Nov. 22 at home.

Read more about skin cancer on our topics page.

Auden, a father of three, was admitted into a clinical trial to get what he called a "wonder drug" to treat his stage 4 melanoma over the summer, but hours later, he suffered a complication and was immediately disqualified from the trial. What's more, the drug companies that make the drug wouldn't allow him to take it on his own.

So after lying awake at 3 a.m., Amy started "Save Locky's Dad," an online petition and campaign named for Auden's oldest son, 7-year-old Locky. The goal was to get the companies to him the drug under "compassionate use" or "expanded access" programs, which allow still unapproved drugs to be used outside clinical trials.

They gathered more than 520,000 Change.org signatures, but the drug companies wouldn't budge. Two drug companies -- Merck and Bristol-Myers Squibb -- make versions of the so-called anti-PD-1 drug, which teaches the immune system to attack cancer, but they both declined to provide it to Auden outside a clinical trial. Bristol-Myers Squibb cited safety concerns, and Merck said it just didn't have enough of the drug to give it to him.

Auden's story started in March 2010, when he had a cancerous mole removed. Although it put him at risk for more skin cancer, he continued to live an active life, running, biking and hiking.

But in September 2011, Auden said his doctors sat him down and told him the cancer had returned and had spread throughout his body. The official diagnosis was stage 4 melanoma.

"Some people survive, 90-odd percent don't," he said. "There's no doubt that was tough news. I had trouble not being emotional about it every time I thought of the concept of not being there to watch the kids grow up."

Auden's wife was pregnant with the couple's third child when doctors told her husband that his median life expectancy was between six and nine months. He survived more than two years with the help of radiation and other experimental treatments, but time was running out.

When he learned about the anti-PD-1 drugs and their ability to treat melanoma, he got excited. Studies of Merck's version of the drug found that 38 percent of participants in a clinical trial for patients with melanoma saw tumors shrink. Of those who took the highest doses of the drug, 52 percent experienced tumor shrinkage.

Dr. Jedd Wolchok, an oncologist who has not met or treated Auden but has corresponded with him through email, told ABCNews.com that immune cells typically don't attack cancer in a meaningful way because of a kind of natural brake function called PD-1. But the new anti-PD-1 drugs cancel out that brake and allow the immune cells to attack the cancer.

Although there are currently no anti-PD-1 drugs in "compassionate use" trials -- trials for individuals who don't qualify for clinical trials but still want the drug -- Wolchok said there was chance the drug could offer Auden long-term benefits.

"This kind of medicine is not the kind of medicine that if it works, it works for a few weeks and stops working," said Wolchok, a melanoma specialist at Memorial Sloan-Kettering Cancer Center in New York. "If medications like this work, they tend to benefit people for months or years. Some people might even be 'cured.'"

Auden said he was told that in order to be accepted into a clinical trial for the anti-PD-1 drug, he would need to have either no brain tumors or brain tumors that were at least no longer growing. Wolchok explained that the drug had the potential to cause brain swelling in people with existing brain disease.

Since Auden had brain tumors, he and his oncologist, who declined to be interviewed for this story, worked to stabilize the tumors using a combination of drugs and other therapies. After months of monitoring his brain scans, Auden got good news in July: His tumors had not grown, and he qualified for the Merck trial.

They high-fived in the doctor's office.

But hours later, Auden experienced abdominal pain and sent his doctor a message. The doctor said to go straight to an emergency room, because there was a possibility he had a perforated intestine.

"Sure enough, I did," Auden said. "That instantly disqualifies you for the trial."

Auden's wife, of course, had other plans, hatched during those sleepless nights at 3 a.m.

Maybe Auden could become an individual case study under compassionate use rules, which give people access to experimental drugs even if they don't fit into clinical trials, she said she thought.

"I could not sleep," Amy Auden told ABCNews.com. "I was lying awake at night thinking, I can't just lie here and do nothing."

"Save Locky's Dad" launched in September.

"I want my dad to get the PD-1 drug because then I can do the things I like to do with him all the time," Locky says in a video on the "Save Locky's Dad" website, flashing a smile that's missing two front teeth between shots of the two playing Frisbee.

But by October, the companies still hadn't granted Auden access to the drug, and he needed surgery to remove two tumors that had grown in his brain since the site's launch.

"His oncologist says he must have the drug now to survive," his wife, Amy Auden, told ABCNews.com in an email that week. "The tumors do not stop growing throughout this process."

The FDA gave Merck's drug "breakthrough therapy" status in April, allowing the pharmaceutical company to speed up clinical trials in the hopes of approving it, and making it more widely available, sooner, according to company filings.

But that meant it would need to increase its supply of the drug for the ramped-up clinical trials, which Merck spokesman Steven Cragle said was no easy feat. Because the drug is made from mammalian cells, it takes time to literally grow the supply in a lab. As such, Merck only has enough for the clinical trials.

"Nature is working against us," Cragle said. "It's hard to conceptualize why we can't just 'bake a bigger loaf of bread,' so to speak."

He added that Merck is working to make enough of the drug to develop an expanded access program -- which would benefit patients like Auden, who don't fit into clinical trials -- but there's no timeline for it yet.

"Not everyone has as short a window as I," Auden said in October. "Why can't they supply me now rather than me missing by a couple of months? Imagine Amy explaining that to the kids ..."

Although Auden was the highest profile patient seeking the anti-PD-1 drug outside of a clinical trial, he was not the only one, Cragle said.

In a statement on the "Save Locky's Dad" website following Auden's death, the family declared "this mission is not over."

"In the end, Nick's death beams a spotlight on a glaring need for change in compassionate access practices for life-saving drugs in late-stage investigational trials," they said in a statement. " More on this, when the time is right."

Thursday, November 14, 2013

Health: Promising Treatments For Advanced Thyroid Cancer « CBS Philly

Health: Promising Treatments For Advanced Thyroid Cancer « CBS Philly:

'via Blog this'

Monday, November 4, 2013

Penn Medicine researcher unveils findings on 2 new weapons against thyroid cancer

Penn Medicine researcher unveils findings on 2 new weapons against thyroid cancer

Sep 28, 2013 - 4:00:00 AM

The second study Brose will present during the European Cancer Congress focused on the subgroup of patients with papillary thyroid cancer (PTC), which is the most prevalent form of advanced thyroid cancer. About half of PTC patients harbor the BRAFV600E mutation, which is also present in melanomas that can be successfully treated with BRAF inhibitor drugs. In this phase II study, we took the BRAFV600E inhibitor, vemurafenib, and studied it in BRAF-mutated papillary thyroid cancer patients to see if there's an effect, Brose explained. Approximately 50 PTC patients with the BRAFV600E mutation were enrolled in the study, all with progressive disease that had failed to respond to radioactive iodine treatment. The patients were divided into two groups: one that had not received sorafenib or other similar kinase inhibitor, and one that had.

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By University of Pennsylvania School of Medicine, [RxPG] AMSTERDAM -- For many years, patients with advanced thyroid cancer faced bleak prospects and no viable treatment options. But now, building on recent discoveries about the genetics and cell signaling pathways of thyroid tumors, researchers are developing exciting new weapons against the disease, using kinase inhibitors that target tumor cell division and blood vessels. Two recent clinical trials led by a researcher from the Perelman School of Medicine at the University of Pennsylvania showcase the great promise of these new approaches. The work will be presented at the European Cancer Congress (ECCO 17 - ESMO 38 - ESTRO 32) in Amsterdam today.

The first study provides additional data from the phase III DECISION trial of the drug sorafenib, a kinase inhibitor already approved for treatment of kidney and liver cancer, which was presented as a plenary during the 2013 annual American Society of Clinical Oncology meeting. In the newly released findings, lead author Marcia Brose, MD, PhD, an assistant professor in the department of Otorhinolarlyngology: Head and Neck Surgery and the division of Hematology/Oncology in the Abramson Cancer Center, and her colleagues examined the effectiveness of sorafenib on thyroid cancers that harbor BRAF and RAS mutations. They previously reported that for patients who received sorafenib, progression free survival was 10.8 months vs. 5.8 months in the placebo arm. Of the 417 patients enrolled in the trial, 256 had tumors collected for genetic analysis. As they expected, the most common mutations were found in the BRAF and RAS genes. However, the analyses show that all groups, regardless of the presence of a BRAF and RAS mutation benefited from treatment with sorafenib.

Our results are important because they show that regardless of the presence of these two common genetic changes, the group that was treated with sorafenib did better than the placebo, Brose says. There was no subgroup that didn't appear to benefit from the intervention with the sorafenib. The use of sorafenib for the first line treatment for advanced differentiated thyroid cancer is now being evaluated for approval by the FDA, which would represent the first effective drug for advanced thyroid patients in more than 40 years.

The second study Brose will present during the European Cancer Congress focused on the subgroup of patients with papillary thyroid cancer (PTC), which is the most prevalent form of advanced thyroid cancer. About half of PTC patients harbor the BRAFV600E mutation, which is also present in melanomas that can be successfully treated with BRAF inhibitor drugs. In this phase II study, we took the BRAFV600E inhibitor, vemurafenib, and studied it in BRAF-mutated papillary thyroid cancer patients to see if there's an effect, Brose explained. Approximately 50 PTC patients with the BRAFV600E mutation were enrolled in the study, all with progressive disease that had failed to respond to radioactive iodine treatment. The patients were divided into two groups: one that had not received sorafenib or other similar kinase inhibitor, and one that had.