BY JON GARINN | JULY 3, 2014
On July 3, the Food and Drug Administration (FDA) granted accelerated approval to Beleodaq (belinostat) for treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the third drug that has been approved since 2009 for treating patients with this rare form of lymphoma. Folotyn (pralatrexate) and Istodax (romidepsin) were approved for use in this same patient population in 2009 and 2011, respectively. PTCL is a fast-growing immune system cancer affecting the T cells.
More than 70,000 Americans are expected to receive a diagnosis of non-Hodgkin lymphoma this year, and 10 to 15 percent of those cases will be PTCL, according to the National Cancer Institute.
The FDA based its decision on a single arm clinical trial of 120 participants who had received at least one prior treatment. Participants received the experimental drug until they experienced disease progression or an unacceptable toxicity. The overall response rate (meaning the percentage of participants who experienced either a complete or partial response to the treatment) was 25.8 percent, with a median response duration time of 8.4 months.
Side effects included nausea, fatigue, fever, low red blood cells and vomiting. A small number of participants (less than 2 percent) experienced serious side effects, including pneumonia, infection, thrombocytopenia and organ failure.
To receive full approval from the FDA, the manufacturer must continue to evaluate Beleodaq's effectiveness in further clinical trials.
Beleodaq is also being studied in other cancer types, including liver, ovarian and non-small cell lung.RELATED POSTS
BY GUEST BLOGGER | MAY 6, 2014
Raise your hand if you're a cancer survivor. If you're reading this, you probably have an intimate relationship with the green-eyed monster, whether it's you or your loved one.
During my first breast cancer diagnosis, I focused on the light at the end of the tunnel. I remember counting down weeks for recovering from surgery or chemotherapy, thinking it was the number of weeks until I got my old life back.
You veterans are smiling right now; because once you've had cancer, your "old life" doesn't exist anymore. But hey, I was only 29 – I didn't know that yet!
Now I am a 34-year old wife and mom living with metastatic breast cancer. I receive my day-to-day treatment in Dallas where I live, but I travel to MD Anderson in Houston every three months for a PET scan and reevaluation. We manage to make a family event of our trips to Houston, enjoying two nights in a hotel and exploring new restaurants. This trip, Chris and I left our son with his grandparents so we could also celebrate our five-year wedding anniversary with a nice Galveston hotel and a fancy dinner (without a nacho-throwing toddler!)
In the two years since I was deemed incurable, I have tried to focus on living my life rather than the fear of it being taken away. Most days two-year-old Henry keeps me too busy to have idle hands and mind, but there are times even my "Pollyanna" mom can't help me ignore those dark thoughts.
This would be one of those times.
Today the fun is over. We have checked out of our nice hotel, and are on our way to the cancer center. In a few hours, I will receive the verdict of yesterday's scan. It all boils down to one simple, yet very complicated question: IS THE MEDICINE WORKING?
My last scan said NO. So in the five months since, I started a new drug regimen, had a laparoscopic hysterectomy, had a brief hospital stay with pneumonia (supposedly not related to my cancer), and tweaked my dosage on multiple occasions to try and keep the crazy new side effects at bay. We also celebrated Henry's second birthday, my 34th birthday, traveled to Pensacola and Phoenix, and lived through a complete kitchen renovation. HA!
When I write it all out...I am pretty much painting the picture of a crazy person! But remember what I said about idle hands and mind? I do like to keep busy.
Last night as I lay in bed, I kept running through my checklist of new aches, pains and irritations and guessing whether they are attributed to the cancer, the medicine or the germs Henry brings home from Mother's Day Out. My itchy hands and annoying mouth sores are side effects, but is my cough from last month's cold or swollen lymph nodes? Is my trouble sleeping a side effect or just a touch of anxiety? What about my recurring headache? Medicine or cancer in my skull?
If it's not a good scan, we will switch medicines again, and I will get a whole new list of side effects to manage. I will also cross one more off the very finite list of drugs available for my kind of cancer. At last count, I was one drug away from the chemo chair. (And darn it, my summer hair highlights look great!) But Pollyanna reminds me of what my doctors all say - new drugs are coming down the pipeline.
If it is a good scan, I get to breathe a little easier this summer, at least until I'm back here for my next round of scanxiety.
I approach today cautiously optimistic. I am hopeful for good news, but prepare myself for dealing with whatever may come. We'll spend the sobering four-hour drive back to Dallas wrapping our heads around it all and remembering to focus on how truly lucky we are, despite our challenges. Because there is an awesome little guy at home, impatiently waiting to see us.
And like me, you'll just have to wait for the results. Here we go...
Carrie Corey was diagnosed with stage 2 breast cancer at age 29 and with a stage 4 recurrence in 2012 at the age of 31. She is a wife and new mom living in Dallas, and will be reporting frequently on her cancer experiences.RELATED POSTS
BY LINDSAY RAY | APRIL 30, 2014
On April 29, the Food and Drug Administration (FDA) granted accelerated approval to Zykadia (ceritinib) to treat patients with a subtype of advanced non-small cell lung cancer (NSCLC).
Zykadia inhibits the mutated protein anaplastic lymphoma kinase (ALK), which is caused by an abnormality in the ALK gene and can promote abnormal cell growth. This abnormality is present in 3-7 percent of patients with NSCLC. Zykadia is specifically approved to treat patients with this abnormality who no longer respond to Xalkori (crizotinib), which is also approved to treat ALK-positive NSCLC patients.
Xalkori was the first drug approved for ALK-positive lung tumors and has since become a standard of care for this patient population. However, once patients become resistant to the drug, there has been no other approved therapy to offer them until now.
Zykadia's safety and effectiveness were established in a trial of 163 participants with Xalkori-resistant, ALK-positive NSCLC. All participants received Zykadia, and about half of the participants had their tumors shrink, a result that lasted for a median of approximately seven months.
This decision comes four months before the review deadline. The accelerated approval review process allows patients earlier access to promising drugs while the manufacturer conducts confirmation trials. Zykadia was also given a breakthrough therapy designation, which is also designated to speed promising therapies through the review process, and is the fourth drug to be approved with this designation. (You can read more about this new designation here.)
Common side effects are mostly gastrointestinal, including diarrhea, abdominal pain, nausea and vomiting. Increased liver and pancreatic enzymes and glucose levels might also occur.
For more information, visit Zykadia.com or call 888-669-6682.
And for more information on lung cancer and genetic abnormalities, read CURE's Spring 2014 feature "Research Reveals New Frontiers in Lung Cancer."RELATED POSTS
BY LINDSAY RAY | APRIL 22, 2014
On Monday, April 21, the Food and Drug Administration approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or cancer where the esophagus meets the stomach (gastroesophageal junction adenocarcinoma). This approval includes patients with inoperable cancers and those with metastatic disease after treatment with platinum- or fluoropyrimidine-based chemotherapy.
Cyramza is a type of drug known as an angiogenesis inhibitor, which means it blocks the tumor's blood supply.
This past October, the therapy was given priority review status (meaning the FDA would make a decision within six months) after promising clinical trial results and because it met an unfilled need. This approval makes Cyramza the first approved single-agent treatment for stomach cancer after it has progressed following initial therapy.
The FDA based the approval on results from the REGARD trial, an international, phase 3 study in which 355 previously treated patients with either stomach cancer or gastroesophageal junction adenocarcinoma were randomly assigned to receive either Cyramza or best supportive care. Treatment with Cyramza improved median overall survival by 1.4 months compared with those receiving placebo.
Earlier this year, data from another study pointed to further benefits of Cyramza therapy. The phase 3 RAINBOW trial looked at adding Cyramza to paclitaxel when treating these diseases after prior therapy. The combination extended median overall survival to 9.63 months compared with 7.36 months for patients who received paclitaxel plus placebo. Furthermore, the combination of Cyramza and paclitaxel also prolonged progression-free survival: 4.4 months compared with 2.86 months.
Common side effects of Cyramza include diarrhea and high blood pressure.
For more information, call 800-545-5979.RELATED POSTS
BY ELIZABETH WHITTINGTON | MARCH 21, 2014
One of the stories out of the ASCO Genitourinary Cancers Symposium earlier this year was that patients with metastatic kidney cancer may benefit from surgery in addition to biological treatments.
Before targeted therapies, patients with metastatic renal cell carcinoma were treated with surgery and interferon. With the advent of targeted therapy, it's unknown whether surgery is still beneficial. The retrospective study examined patients treated with a targeted agent--most patients were treated with Sutent (sunitinib) or Nexavar (sorafenib). Because the study was not a randomized prospective study, patients chose whether to proceed with surgery, and about 60 percent elected to undergo a nephrectomy (surgical removal of the kidney). You can read the abstract here.
Patients who had surgery lived longer than patients who did not have surgery (20.6 months versus 9.5 months). However, because those who elected to have surgery were in better health, researchers had to adjust the data, which ultimately came out to a 40 percent survival benefit. This effect was apparent in patients who had longer life expectancy and good prognostic factors. Researchers noted that patients who had poor prognostic factors, such as low blood counts, did not appear to benefit from surgery.
Daniel Yick Chin Heng, presenting author of the study, said these results confirm a previous, but much smaller, study. "Cytoreductive nephrectomy may extend overall survival; however, not all patients should have it," he said. "Patients with a longer estimated survival can potentially stand to gain a lot more benefit from cytoreductive nephrectomy." Two phase 3 randomized studies will, hopefully, answer more questions in which patients would benefit from surgery.RELATED POSTS
BY GUEST BLOGGER | FEBRUARY 26, 2014
Since my diagnosis in 1994 of a rare, incurable condition--medullary thyroid carcinoma--I've searched for an effective treatment. After three neck operations and chemotherapy did little to check my cancer's spread, I entered a drug trial at Fletcher Allen Health Care in Vermont. The oncologist running the experiment was Dr. Steven Grunberg, who took me under his wing. Despite my aggressive disease, he reassured me with quiet confidence. We're going to help you stick around, he said.
Today, thanks to Dr. Grunberg and his staff, I'm still here. But Dr. Grunberg isn't. He died of lung cancer in September. It's a painful irony I'm still sorting through.
By the time I found Dr. Grunberg five years ago, my cancer had spread to my lungs. I was growing desperate. In my mid-40s, with many things yet to accomplish in life, I researched experimental treatments and exchanged information with other sufferers of my rare disease through the Thyroid Cancer Survivors' Association.
One day I clicked to the clinical trials page of the National Institutes of Health, and learned of a novel drug being tested against my specific condition. The drug, then called Zactima, is a tyrosine kinase inhibitor. Basically it works to block proteins that tell tumors to grow.
Vermont's Fletcher Allen Health Care was among the study sites. One weekday morning I drove three hours from my Clifton Park, N.Y., home to Burlington, Vt., to meet Dr. Grunberg and get the ball rolling. Though untested drugs can be risky, he quickly earned my trust. A thick-haired man who spoke in quiet intelligent bursts, he'd keep a close eye on me, monitoring my status through bloodwork and scans. He spoke frankly of possible side effects, which included skin and intestinal problems. There was another concern. Two-thirds of study participants were supplied with the drug--but one-third received a placebo. Neither doctor nor patient knew which one patients had. I could be left without a life preserver.
By my next appointment, three months later, my levels of calcitonin--a hormone stimulated by my cancer--crashed to 10,000 from over 100,000 before the trial. It was apparent I was among the lucky two-thirds of patients. The drug was working!
Dr. Grunberg wasn't one to show a lot of emotion with me, but he shared an enthusiastic smile when he told me the good news. I immediately called my wife to tell her, and drove back to New York that afternoon, my heart singing with hope for my future.
Over the next five years I visited Fletcher Allen every three months. I came to refill my prescription of once-a-day Zactima pills, undergo CT scans and bloodwork -- and to feel supported by Dr. Grunberg and his staff of nurses and researchers. I remember pricking my ears to catch every morsel of what Dr. Grunberg was saying. He was a steadfast presence, and when he examined my neck and chest for recurrence, I was in sure hands.
He was more than a doctor to me. As a theater buff, he took an active interest in my writing, and spoke to me of his daughter's creative pursuits. I emailed him several of my short stories, and he always took time to send me a complimentary email back. I considered him a friend.
The drug kept my condition at bay, and as a result of the trial was approved as Caprelsa by the Food and Drug Administration for use against my cancer. Today thousands of patients like me can now benefit from work by Dr. Grunberg and other study researchers.
The last time I saw Dr. Grunberg was this past spring. I noticed no difference in his manner toward me. He seemed healthy, energetic--his hair as thick and dark as ever. He gave zero hint he had cancer, let alone terminal cancer, even as he treated mine. He betrayed nothing. But when I visited Fletcher Allen again in summer I received the odd news he'd taken a leave. I asked for elaboration but the staff was oddly quiet. It wasn't until I visited again this fall when his staff told me Dr. Grunberg had died of lung cancer.
I was stunned. But he didn't seem sick, I insisted. He kept working right up until the end. That's when it hit me: he didn't want his patients to know their doctor was dying of the same condition they hoped to beat. Dr. Grunberg didn't want them to lose hope, even as his own situation grew hopeless. My sense of betrayal at not being told sooner melted away into gratitude. His silence was admirably selfless. The world--my world--is poorer without him.
When I revisit Fletcher Allen for my next appointment in January, I'll see another oncologist who has replaced Dr. Grunberg on the trial I'd entered. She's a smart, caring doctor, and I recognize signs of selflessness in her as well, because I now have a standard against which to measure people's worth. Because Dr. Grunberg gave me a new lease on life, even as his own lease expired.
David Kalish is a survivor of medullary thyroid carcinoma and the author of the comedic novel, The Opposite of Everything, which inspired this essay and will be published this spring. You can read more at davidkalishwriter.com.RELATED POSTS
BY GUEST BLOGGER | FEBRUARY 24, 2014
Most any diagnosis of cancer is filled with worry and bad thoughts, but when the cancer diagnosis comes with the words that it's a rare cancer, the words are more than devastating, they're horrifying and nerve-racking.
How rare, what's the prognosis, why me, what did I do, what can be done and what are my odds or chances on recurrence and dying?
At least that was my reaction when I was told in 2007 that the tumor behind my right eye was adenoid cystic carcinoma; the more difficult part was the pronouncement by the oncologist that the cancer was incurable and fatal. "You will certainly die because of the cancer."
Wow, could it have been told in a gentler way, without the windows closed and dark curtains drawn all around?
After the surgeons and oncologist left, I took a half hour to myself and cried, uncontrollably. I needed that time to understand the magnitude of what had been said to me, and then I straightened up, took a deep breath, looked around and realized I was still alive and the cancer was just a disease like any other disease. All I had to do was find out more about the cancer and try to live life as best as possible.
The problem was gathering information about adenoid cystic carcinoma is that there's such scant information out there. Plus, what information is out there is sometimes so outdated and wrong.
For example, how many people are diagnosed each year with ACC, is it 1,200 or 1,500 or a lesser number? And what are the survival rates in terms of years? Different sites, different information. I wondered should I just pick my own numbers.
The other problem was finding an oncologist who had at least some experience with this type of cancer. The first one put it very bluntly, "30 years as an oncologist and you're my first ACC patient; I can't help you."
The second oncologist put it more mildly, "I know nothing about your cancer. I'm flying blind and learning as we go along. You probably know more about this cancer than I do."
My third and current oncologist hasn't said what he knows about this cancer, which I guess is good. During a visit, I did ask him if he's treating me like any other cancer patient, wondering if this cancer is different than other cancers.
It sure looks as though he's treating my cancer like any other cancer, with the standard six months between tests and check-ups.
I did pick five years as the starting number for survival rates; that sounded good but by 2012, a new tumor had been found pushing against the brain. It actually started growing in 2011 but it was missed, even with the MRI and contrast.
My oncologist gave me the bad news, there's nothing that can be done, surgery is out because the tumor had grown around a major blood vessel. If we tried surgery, I would die on the table. Oh, not good.
Chemotherapy has never been and was not an option with ACC because the cancer is so relentless.
It was almost as though the oncologist didn't have an answer; that he was at the end of the rope: and then, one last hope, radiation. But how much and how long, and would it be safe considering I had had radiation in the same general area in 2007; plus, this time there would be radiation to the brain. Thank God for Stanford.
Their recommendation, eight weeks of daily radiation and all will be good to go. Of course, with this cancer there is no good to go, ever.
On Jan. 2, news came that a growth had been found in the left lung; for now it's all observation and then a fine needle biopsy (I had that done for the eye in 2007, so no worries there).
What I've discovered in my cancer journey is that there is no ready-set information about adenoid cystic carcinoma. Yes, it is a rare cancer, and as such, there is little information out there on how to treat it and what to expect.
Also, there is little research being done leaving ACC patients to wonder why? Is it because this cancer affects so few? I know many ACC patients feel like we're the pariah, the black sheep of the family. I have noticed that ACC patients themselves have started their own websites for information on this cancer; only we understand what we're going through so it would stand to reason that we'd reach out to help each other.
We have several sites on Facebook, where we exchange information and often support each other as we fight this cancer; the sad part is so many new people are joining these sites and then there are the ones we say goodbye to...too often and too many. As for me, I am spending time with childhood cancer patients and helping raise funds for research.
Les Mahler is a journalist, copy editor, song writer, children's story writer, photographer, and an adenoid cystic cancer survivor since 2007. He's on his third fight against ACC.RELATED POSTS
BY GUEST BLOGGER | FEBRUARY 20, 2014
No, I'm not a celebrity – I'm a breast cancer patient.
For people living with metastatic disease, oftentimes medicine side effects are worse than the symptoms of the cancer itself, and such is the case for me today.
Two weeks ago I started taking a new drug (Afinitor) that studies have shown can dramatically increase patients' response time to my current medication (exemestane). As with any new drug, my medical team went over the side effects before writing the prescription; I admit I've somewhat started tuning that part out – it makes me feel like I'm watching a TV commercial for an erectile dysfunction drug. "Yuck!!! Who would want to take that?"
For me, when we're talking about LIFE-SAVING medicine, the benefit will almost always outweigh the negative side effects. I don't mean the debilitating side effects, I mean the manageable ones: I've lost my hair twice, I've had black fingernails, lost toenails....blah, blah, blah... diarrhea or constipation? Fatigue, aches and pains? You know the drill. If the drug works and gives me the quality of life to enjoy being a wife and a mom, I'm in. And so we start down the new path.
Now, when cancer drugs say you might get mouth sores or a rash, they don't mean an annoying cold sore or an itchy hand like "normal" folks might complain about. They mean painful, fire-breathing mouth sores and a rash that makes you want to scratch your skin off. While I don't have the rash on this one, I am not exaggerating about the mouth sores. The sore is inside my mouth, but my bottom lip is so swollen it looks like I was punched in the face.
When I dropped Henry off at school this morning, Chris was paranoid the teacher would think he is an abusive husband. It is HUGE. I am talking with a lisp, and I can't even sip my morning coffee without dribbling all down my shirt. Good times!
Like most aspects of cancer, there's also a mental battle going on here. My pride tells me I can do anything I want to do – that cancer doesn't have a hold on me. So I am determined to keep taking a good drug, even if it means dealing with some annoying side effects.
But I can hear the words of my oncologist's nurse, reminding me I can easily land myself in the hospital if side effects get out of control. Or worse, have to discontinue the medicine for good.
There's a thin line separating "deal with it" from "call your doctor."
Whereas last week I thought I could power-through, today I cried mercy. This morning's count was eight mouth sores, which makes me not want to eat, drink or talk! Darn it. I called my doctor, who gave me a few days off meds to let my mouth clear up with the help of some prescription goodies. Hopefully next week I can try it again.
I'm going to enjoy my weekend, pouty lip and all. Since I refuse to be a hermit, I will likely encounter strangers who ask what happened. There's no way to quickly explain how breast cancer caused my fat lip, so I need to come up with a better story or else I'll end up telling my life story to the checker at the grocery store. Right now I have three good options.
1. My two-year old Henry threw a ball and hit me in the face.
2. I just started taking a kick-boxing class.
3. You should see the other guy!
What do you think? Any suggestions?
Carrie Corey was diagnosed with stage 2 breast cancer at age 29 and with a stage 4 recurrence in 2012 at the age of 31. She is a wife and new mom living in Dallas, and will be reporting frequently on her cancer experiences.RELATED POSTS
BY ELIZABETH WHITTINGTON | DECEMBER 6, 2013
Pancreatic cancer, while hard to treat, is gaining awareness, research dollars and inspirational advocates. Learn more about how we're gaining on this aggressive cancer in the Winter issue of CURE.
You can also view an informational video based on the "Changing Course in Pancreatic Cancer" article below.RELATED POSTS
BY GUEST BLOGGER | DECEMBER 3, 2013
November was an exciting month for nurses conducting research in the area of cognitive changes related to cancer and cancer treatment.
Many of us were fortunate to attend the Oncology Nursing Society Connections conference in Dallas, where we had the opportunity to share research results and discuss future research projects dedicated to learning more about the cognitive changes that some cancer survivors experience. Additionally, the November issue of the Seminars in Oncology Nursing journal was devoted to "Cognitive Changes Associated with Cancer and Cancer Treatment."
"Chemobrain" and cognitive changes due to cancer and other related treatments pose a challenge to many survivors of cancer. Incidence estimates for cancer-related cognitive changes range from 75 to 90 percent of survivors at some point prior to, during or following treatment.
Around 25 percent of survivors struggle with long-term cognitive effects. Survivors describe the experience of these cognitive changes to include issues such as difficulty with word finding, misplacing things such as keys and cell phones, forgetting why they walked into a room, missing appointments and trouble multitasking. Results from neuro-psychologic tests have shown decreases in processing speed, memory and executive function (the ability to plan out and complete the steps necessary to accomplish a goal). All of these issues cause frustration and can decrease survivors' quality of life.
A great deal of research is being conducted to better understand the causes of these cognitive changes so that preventive strategies and interventions can be developed. Many different theories are being explored such as injury to neural progenitor cells (stem cells that give rise to mature brain cells), changes to DNA-repair genes, accelerated aging of the brain, and genetic pre-disposal to central nervous system injury. Results of studies that include the use of functional magnetic resonance imaging (MRI) and memory testing are demonstrating changes in brain volume and activation.
Additionally, exciting research is being conducted to explore interventions to reduce cognitive injury and/or improve cognitive function. Some interesting results are being seen in the areas of cognitive behavioral training and exercise.
Cognitive Behavioral Training includes exercises to assist with memory and processing speed as well as recommendations for strategies to accommodate for changes in cognitive function. Exercise studies to date have included yoga, Tai Chi, Qigong, aerobic exercise and resistance training. More research needs to be conducted to support the widespread use of these interventions, but these early results are encouraging. Additional results will be presented at the upcoming 2014 International Cancer and Cognition Task Force (ICCTF) Cancer and Cognition Conference to be held in Seattle next February. The Task Force is comprised of oncologists, radiologists, nurses, basic scientists and other disciplines all dedicated to finding solutions to the problem of cancer-related cognitive changes.
One study is currently being conducted to learn more about factors that may predict many of the symptoms associated with breast cancer prior to, during and following chemotherapy (including cognitive changes). Women with breast cancer are being asked to complete a confidential online questionnaire. If you or someone you know are newly diagnosed and have not yet received chemotherapy, or if chemotherapy was completed two or more years ago, please consider helping us learn more about predictive factors by completing the study questionnaire.
Jamie Myers, PhD, RN, AOCNS, is adjunct assistant professor at the University of Kansas School of Nursing and nurse researcher consultant for Carondelet Health in Kansas City. She also is the coordinator-elect for the Oncology Nursing Society Survivorship, Quality of Life, and Rehabilitation Special Interest Group.
To participate in the clinical study mentioned above, go to https://survey.kumc.edu/se.ashx?s=5A1E27D26B60E80F. Participants will be offered the opportunity to receive the study results. If you have questions about the study or would prefer to receive a hard copy questionnaire you can contact Jamie at firstname.lastname@example.org or 913-449-5996.RELATED POSTS