Season for rare lymphomas: new drug approved for CTCL

BY ELIZABETH WHITTINGTON | NOVEMBER 10, 2009

This must be the season for drug approvals for rare lymphomas--an early Christmas gift to many patients suffering from a rare blood cancer.

Folotyn (pralatrexate), which was approved in September for peripheral T-cell lymphoma came less than one month after an advisory committee recommended its approval. This time, it's patients with cutaneous T-cell lymphoma, a group of rare non-Hodgkin lymphomas that affect the skin, that are the recipients of a new treatment option.

CTCL is often mistaken at first for a rash and can cause itchy, red disfiguring patches. Current treatments for CTCL can include chemotherapy, radiation, or topical therapies. A new treatment, Istodax (romidepsin) was approved on November 5 for CTCL patients who have progressed on at least one prior therapy.

The Istodax approval was based on two studies that looked at a total of 167 CTCL patients who had either one or two prior therapies. The studies did not have a comparison arm. The overall response rate was about 34 percent with 6 percent of patients experiencing a complete response--a total remission from their cancer. The median length of response rate was 15 months (range of 1 to 20-plus months) in one study and 11 months (range of 1 to 66-plus months) in the second. Common side effects seen in the studies included nausea, fatigue, infection, and anemia.

Istodax is a histone deacetylase (HDAC) inhibitor, a class of drugs that works by helping the cell to package its DNA correctly around proteins called histones, by either unwinding genes that control cell growth or constricting those that invite unchecked cell division. You can read more about HDAC inhibitors, including other treatments in this drug class, in our feature on epigenetics, "Medicine's New Epicenter? Epigenetics" from our Winter 2008 issue.

Patients want honesty, compassion from their doctor

BY ELIZABETH WHITTINGTON | NOVEMBER 4, 2009

Not exactly news to cancer patients, but results released today found that what patients want most out of their oncologist is honesty and compassion.

The study results were released at the annual meeting of ASTRO (American Society for Radiation Oncology), the professional organization of radiation oncologists (read abstract). And while most of the presentations during ASTRO focused on treatment, symptom management, and long-term effects, the study also showcased the medical community's desire to improve behavior and relationships to better impact treatment and quality of life.

The study involved more than 500 prostate, breast, and lung cancer patients at the University of Pittsburgh Cancer Institute's Department of Radiation Oncology. Patients completed surveys about their preferences of their radiation oncologist--during the initial consultation, halfway during radiation treatment, and at the end of treatment.

After the initial consultation, half of the patients' doctors reviewed the first survey, and possibly adjusted their behavior to meet the needs and desires of their patients. So, what did patients want most from their radiation oncologist? Most wanted to be called by their first name. And almost all (95 percent) wanted their oncologist to just be honest with them. Another interesting finding was that more than a third of female patients want to have their hands held during important office visits.

Patients were asked to take a satisfaction survey after treatment was completed, which showed satisfaction was very high and not significantly affected by whether the physician knew the patient's preferences.

This study may reinforce what patients have known for years, but the medical community is just now addressing--the importance of a strong patient-doctor relationship. Researchers hope the study will encourage oncologists to work on their patient relationships, which will ultimately improve patient care.

To read more on patient-doctor relationships, read CURE's article, "Power to the Patient."

New smart phone application tracks cancer meds and side effects

BY ELIZABETH WHITTINGTON | OCTOBER 21, 2009

We do it when we drive, when we're at work, when we're suppose to be listening to something important ... I'm sure we do it when we're getting chemo or waiting for the oncologist--talking on the phone, texting, using those many smart phone apps that make our lives so much easier (or at least less mundane).

Ours is a plugged-in world and it was only a matter of time before smart phone applications began to be developed for cancer patients.

This month, Merck launched a free iPhone application called iChemoDiary, which serves as an interactive health diary to help patients and caregivers record chemo schedules, note medication and treatment plans, and log side effects as they happen (feel like vomiting two hours after chemo? Whip out your phone and make it official).

You can also log your temperature and severity of certain side effects. The only thing it appears to lack is the ability to write in side effects that aren't included in the application. (Although the main side effects are included--pain, nausea, fatigue, diarrhea, rash, lack of appetite, neuropathy, and constipation--there may be other side effects you may want to make note of).

What's so neat about this application is that patients can e-mail a daily or weekly report to themselves to print off and give to their medical team. No more carrying around your cancer notebook everywhere or trying to remember when that funny rash appeared.

This is, by far, the most comprehensive and useful application yet to make it to the market. Another, called TouchOut Cancer, developed by a cancer survivor and released earlier this year, gives up-to-date cancer news from various organizations, such as the Leukemia & Lymphoma Society, I'm Too Young for This Cancer Foundation, and The Cancer Schmancer Movement.

Here are a few other applications that might make your cancer journey a little less stressful (or at least a little more entertaining):

1. Social networking applications like Twitter and Facebook have made it vogue to let the world know you're sitting in the infusion room ready for your dose of the "red devil" (aka: Adriamycin) or that you're feeling down and really need some instant words of encouragement.

2. Loopt, which acts similar to a GPS, is an application that can show where you or your friends are at a particular moment. Kind of creepy, but if you're chilling in Waiting Room 1 for your radiation, it might be cool to find out a Loopt acquaintance is in Waiting Room 2. A new app just out this week called Loopt Mix introduces you to nearby people that you may have something in common with, and allows you to message back and forth. (It doesn't show exact locations, but proximity--little less creepy).

3. Bump, which gained fame as being the iPhone's billionth application downloaded, makes exchanging contact information a breeze. Need to know your oncology nurse's e-mail, cell, and work address? Both of you can open the Bump application, do the Obama fist bump, and voila!

4. The Kidney Cancer Association created an application that mirrors information on their website, but also offers a trivia quiz, podcasts, and video.

So, do you use any smart phone applications to keep you occupied at the clinic? Please share!

Second vaccine to prevent cervical cancer approved by FDA

BY ELIZABETH WHITTINGTON | OCTOBER 16, 2009

Today, Cervarix became the second cervical cancer vaccine approved in the U.S. The FDA decided the vaccine, which is administered in three injections for females age 10 to 25, was safe and effective. It is recommended women receive the vaccine before becoming sexually active, which can exposed them to human papillomavirus (HPV), a virus linked to cervical cancer and other diseases.

In clinical studies, Cervarix was found to be 93 percent effective in preventing pre-cancers associated with HPV types 16 and 18, which cause about 70-75 percent of cervical cancers. Cervarix may also protect against types 31 and 45, which account for another 10 percent.

Because there are more than 100 types of HPV--15 of which have been associated with cancer--the vaccine does not offer full protection from cervical cancer, and women vaccinated are recommended to continue cervical cancer screening.

In a phase II study in which more than 1,000 women age 15 to 25 were vaccinated with either three doses of Cervarix or placebo, the vaccine showed protection for more than five years and demonstrated 100 percent efficacy in precancers caused by types 16 and 18, as well as 68 percent efficacy against cervical precancerous lesions and 38 percent benefit against abnormal Pap tests, regardless of HPV type. Side effects reported in studies of the vaccine include pain, redness, and swelling at the site of the injection, as well as headache, fatigue, and weakness.

Cervarix has been playing a game of catch-up to to Gardasil, which was initially approved in 2006 for prevention of cervical cancer in females ages 9 to 26 and has also been approved for vulvar and vaginal cancers and genital warts. Gardasil's maker has filed for additional indications for boys ages 9 to 26, because the virus can also cause genital warts in males (as well as penile and anal cancers), and for women older than 26. And although the two vaccines both protect against cervical pre-cancers and cancers associated with HPV types 16 and 18, studies have shown Gardasil also protects against types 6 and 11.

It's not known whether competition between the two vaccines may help bring down costs. Merck's Gardasil typically runs about $360 for all three shots, but is usually covered by insurance, while GSK officials say pricing information for Cervarix will be released in the next week or so. But whether one is more effective than the other is not known. While one study has shown Cervarix produces a higher immune response against the virus than Gardasil, no head-to-head studies have been conducted.

Update: The FDA also announced today that the agency approved Gardasil for boys age 9 to 26 to prevent genital warts.

Should you be concerned about the H1N1 virus?

BY ELIZABETH WHITTINGTON | OCTOBER 9, 2009

The H1N1 virus, or swine flu, has steadily swept across the country, and is considered widespread in 27 U.S. states now (view the CDC's interactive map).

And while the virus has primarily stricken young adults, those individuals at high risk for flu complications, which include the elderly and immunocompromised patients, should still consider getting vaccinated.

I had a chance to talk with Dr. Michael Boeckh, a member of the Vaccine and Infectious Disease Institute at Fred Hutchinson Cancer Research Center, last week on how the flu may affect cancer patients and he provided some valuable insight.

Boeckh suggests that there are certain individuals who are recommended to get the vaccine--namely those actively receiving chemotherapy or who are taking immunosuppressive drugs after a stem cell transplantation. Patients in this category who contract the flu, he says, could potentially have their treatment delayed or have other complications. "They are actually in a pretty high tier," he says, along with young children, pregnant women, and individuals with asthma, HIV, diabetes, lung disease, and cardiovascular disease. However, he suggests that most patients, regardless of treatment, be vaccinated.

"Except those who are very close to transplantation, they should all be vaccinated," Boeckh says. And while patients who have undergone a stem cell transplant within the past six months should not get the vaccine, he says it's important that family members and caregivers be vaccinated to reduce transmission of the virus.

For longterm survivors, Boeckh recommends they talk with their physician. Although the virus is least likely to affect people over 65 years of age, survivors may have other underlying conditions that may favor vaccination that would put them in a high tier (including those conditions listed above).

It's also suggested that patients who may have low immunity due to chemotherapy or transplantation receive the inactivated vaccine shot over the nasal mist, which uses a mild, but live, form of the virus. Unfortunately, the first batch of vaccines to be distributed, which began yesterday, is the nasal mist version. The shot version is expected to be widely distributed by mid-month.

And don't forget about the seasonal flu, Boeckh cautions. Individuals should be vaccinated for both the swine flu and seasonal flu.

"This first week of October, the predominant strain circulating, by far, is the swine flu, but that may change at any time," he says. "There is no reason to believe the seasonal flu will not come up. Typically, it's not even here this early. It's just about to start in a normal year."

Tips from the CDC:

To avoid getting the H1N1 flu:

Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.

Avoid touching your eyes, nose, and mouth. Germs spread this way.

Try to avoid close contact with sick people.

Follow public health advice regarding school closures, avoiding crowds, and other measures to keep our distance from each other to lessen the spread of flu.

To avoid spreading the flu:

Stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone without the use of a fever-reducing medicine.)

Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.

Ask about antiviral drugs, which can make illness milder and shorten the time you are sick. They may also prevent serious flu complications. Antiviral drugs are not sold over-the-counter and are different from antibiotics.

For treatment, antiviral drugs work best if started within the first two days of symptoms.

FDA advisory panel unanimously recommends new kidney cancer drug

BY ELIZABETH WHITTINGTON | OCTOBER 6, 2009

Update [Oct. 20]: Pazopanib gets FDA approval. Read more...

There is probably no other cancer that has seen such breakthroughs in the past five years than kidney cancer. Less than a decade ago, patients with advanced renal cell carcinoma were treated with biological therapies, including interferon and interleukin, with few results. But in the past five years, there have been five drugs approved for the cancer--Sutent, Nexavar, Avastin, Torisel, and Afinitor.

Yesterday, the Oncologic Drugs Advisory Committee, a panel that reports to the Food and Drug Administration on whether a cancer drug should be approved or not, unanimously gave its recommendation for pazopanib. The panel said the drug appeared to be effective and its side effects were no more severe than other recently approved kidney cancer drugs.

The drug may also be a better alternative to some patients unable to tolerate the side effects of pazopanib's competitors. While studies show that pazopanib had a lower risk of rash and fatigue than with other kidney cancer drugs, some patients did develop diarrhea, hypertension, and nausea. The risk of severe liver injury, although rare, has also been noted.

Pazopanib, recently given a brand name of Votrient, was highlighted at this year's American Society of Clinical Oncology annual meeting where a phase III study compared the drug to placebo. Results showed the median progression-free survival in all patients more than doubled from 4.2 months with placebo to 9.2 months on pazopanib. (Newly diagnosed patients had improved PFS from 2.8 months to 11.1 months, while patients with prior biological treatment improved from 4.2 months to 7.4 months on the drug.)

Because there are so many kidney cancer drugs on the market now, some question whether pazopanib should be approved based on a placebo study. A phase III trial looking at the drug versus Sutent--the standard treatment for advanced kidney cancer--in locally advanced or metastatic RCC is currently ongoing. ODAC recommended the study be completed and that side effects continue to be monitored.

However, patients may not need to wait until the study is completed. The FDA is expected to make a decision on whether to approve the drug later this month.

Pazopanib, like some of the other approved kidney cancer drugs, including Sutent, is an antiangiogenic. These drugs inhibit the growth of new blood vessels that feed the tumor by targeting the vascular endothelial growth factor receptor. Other kidney cancer drugs, including Afinitor, on the other hand, target a protein called mTOR.

Robert Figlin, MD, interim director of City of Hope Comprehensive Cancer Center in Duarte, California, and director of the center's kidney cancer program, told CURE earlier this year that, in addition to the recent kidney cancer drug approvals, there may still be more on the horizon.

"We are already embarking on next-generation drugs," he says, including pazopanib, and another angiogenesis inhibitor, axitinib. "Both of these may have more activity than our currently available drugs." They might also have a better side effect profile, he says. "That's what we're looking for--better tolerance and more effectiveness."

And the increase in the number of treatment options for kidney cancer patients has an added benefit.

"This is a waterfall time for patients," he says. "The challenges for both doctors and patients are now how to choose the proper drugs, in what sequence, and whether or not to use them in combination."

For more on kidney cancer advancements, read "Reining in Renal Cancer" from the Summer 2009 issue of CURE.

Rare lymphoma receives a much-needed drug approval

BY ELIZABETH WHITTINGTON | SEPTEMBER 28, 2009

Folotyn (pralatrexate), a drug which made waves after results of a phase II trial were revealed at last year's American Society of Hematology meeting, was granted accelerated approval for peripheral T-cell lymphoma on Friday. (You can read more about the PROPEL study from CURE's 2008 ASH coverage).

The approval is a first for PTCL, a rare and aggressive type of lymphoma that does not have many treatment options. The FDA based its decision on an improved overall response rate with the drug. While progression-free survival or overall survival (common endpoints in clinical trials) have not yet been demonstrated in a study, the improvement in response rate was enough for the FDA to give a green light to Folotyn because of PTCL's aggressive nature and lack of successful treatments. Additional studies of the drug will be ongoing to further assess clinical benefit.

The drug's manufacturer, Allos, has established a patient assistance program to help with reimbursement issues once the drug is available, which is projected to be early October. Patients can learn more about ASAP (Allos Support for Assisting Patients) by calling 877-272-7102 or visiting www.getASAPinfo.com.

Would winning a pink Vespa help you raise awareness for Breast Cancer Awareness Month?

BY ELIZABETH WHITTINGTON | SEPTEMBER 23, 2009

In addition to the ribbons, visors, golf bags, and chip clips raising awareness of National Breast Cancer Month, you may also see a few pink Vespas next month.

More than a dozen organizations are offering limited edition pink Vespas to their Breast Cancer Awareness initiatives during October. In honor of its 15th annual National Breast Cancer Awareness Month campaign, "Stop Breast Cancer for Life: The Power of 15," Lifetime Network has partnered with Vespa USA to offer the scooters to various non-profits to help with their campaigns.

Here is a list of events and activities that feature the limited pink Vespas:

• Breast Cancer Network of Strength will host an event on October 6 at the Hard Rock Cafe in Chicago.

• BreastCancer.org will host an event in Philadelphia November 14 with Fuelthecure.net.

• The Breast Cancer Research Foundation's auction, which includes a pink Vespa LX 50, goes live on charitybuzz.com September 29 and ends October 22.

• Bright Pink will list its pink Vespa on eBay during the month of October with eBay's Giving Works.

• Cup with Love will conduct a raffle for a Vespa during October.

• Dr. Susan Love Research Foundation will launch a social media contest titled "How Would You Recruit an Army of Women?" through November to help mark the one-year anniversary of theLove/Avon Army of Women campaign.

• The Greater New York City Affiliate of Susan G. Komen for the Cure will offer the Vespa as a reward incentive to fundraisers who exceed their Komen NYC Race for the Cure pledge goals between September 14 and October 31.

• My Vision Foundation is offering a chance to win the pink Vespa LX 50 to donors who make a minimum $100 donation through October.

• Nueva Vida will conduct a raffle through October for a Vespa.

• Prevent Cancer Foundation will enter individuals who sign up for "Screen Your Boobs" alerts through October to win a pink Vespa.

• Young Survival Coalition is offering a chance to win a pink Vespa LX 50 to anyone who becomes a "fan" of the Young Survival Coalition's Facebook page by November 16.

And if you don't win one (or can't wait), you can also purchase one of the 1000 limited-edition pink scooters through Vespa USA.

Remembering Patrick Swayze

BY ELIZABETH WHITTINGTON | SEPTEMBER 16, 2009

The news of Patrick Swayze's death on Monday night was unexpected, but not shocking. Pancreatic cancer is such a horrible disease, with a five-year survival rate of only 5 percent. The fact that he was able to work throughout much of his treatment and lived for nearly two years after his diagnosis is a silver-lining to this sad ending.

Swayze's death will certainly put pancreatic cancer more on the public radar, something this rare, but deadly disease is often lacking--awareness and funding for research. The Pancreatic Action Network, the national non-profit organization dedicated to ending pancreatic cancer, noted that although more than 42,000 people will be diagnosed and more than 35,000 will die each year of the disease, it is still "the most under-funded among leading cancer killers with less than 2 percent of the National Cancer Institute's annual research budget--a figure far too low given the severity of the disease."

Swayze did much to raise awareness of the disease and fought for increased spending for cancer research. In February, he penned a piece in the Washington Post, "I'm Battling Cancer. How About Some Help, Congress?" where he made a case for increased cancer research funding for the National Institutes of Health as part of the economic stimulus package. And he appeared in the September 2008 TV event "Stand Up to Cancer," where he said: "I keep dreaming of a future, a future with a long and healthy life, a life not lived in the shadow of cancer, but in the light. ... I dream that the word `cure' will no longer be followed by the words 'it is impossible. ... The longer we do nothing, the more people will die.' "

Thank you, Patrick, for the memories and your legacy as a cancer survivor.

Another news headline touting a possible cure for cancer. Yawn.

BY ELIZABETH WHITTINGTON | SEPTEMBER 11, 2009

Breaking news this morning ... another headline with "cure" and "cancer."

With as much excitement as I could muster, I read the opening paragraph after first noting it was a press release passed along by a news agency. A company has developed a technology for killing cancer cells in the lab. No new drug, no clinical trial results, no drug approval. And no excitement or follow up by CURE.

Why?

Unfortunately, headlines and press releases like this come across our desks pretty frequently at CURE. We've become a little immune, you might say. Now, if that technology helped researchers develop a drug or treatment ... that could work against cancer cells ... in actual patients ... with tolerable side effects, then it's news to us. That's why CURE rarely reports on pre-clinical studies involving cancer cells or animals, even if the results seem miraculous. That's why we don't devote features to a new gene being discovered in a cancer cell line that could be targeted by an undeveloped, futuristic drug.

Anti-angiogenic drugs, such as Avastin and Nexavar, have been touted as breakthroughs because they target a specific pathway that tumors exploit to grow inside the body, and they have proven results against certain cancers--but no one would call them a "cure" for cancer, and they're not without their side effects. When the idea of angiogenesis was first realized in the 1960s by Judah Folkman, not many people took notice. Over several decades, drugs have been developed using this knowledge of angiogenesis, and large-scale trials have been conducted. Even Herceptin, another wonder drug, took decades and a few wrong turns to get from identifying a specific gene on a breast cancer cell to an approved drug that works in a minority of breast cancer patients (those with cancer that overexpress HER2).

Even when we do report on drugs that appear to work against a certain cancer in a clinical trial, later and larger trials may show the drug really doesn't benefit patients more than already approved drugs.

So, we can report on this new possibility of a cancer cure that--if it is that one in a million--may produce visible effects for patients in about 20 years ... if researchers work fast with few mistakes. And while drug development is speeding up (read our senior scientfic advisor Diane Gambill's blog on "PARP inhibitors prime example of acceleration in drug discovery"), it may take years for patients to reap the rewards of this new, possible cancer-curing technology.

So, CURE waits. We report on the breakthroughs and large-scale studies that excite oncologists who are in the field treating patients. We report on drug approvals that could affect thousands of patients the day a certain drug goes to market.

And if (or when) this new technology produces actual results for cancer patients, we'll make sure you know about it.