BY MELISSA WEBER | APRIL 29, 2010
After decades of research, the first vaccine to treat cancer has won approval from the Food and Drug Administration. In a milestone decision, the FDA today approved Provenge (sipuleucel-T) for men with metastatic prostate cancer that is resistant to hormonal therapy.
Provenge uses the patient's own immune cells to activate the body's immune response to seek out and destroy cancer cells. (View an illustration of how Provenge works.)
This was the second try for Provenge, after the FDA chose not to approve the vaccine in 2007, despite a unanimous vote in favor of approval by a panel that advises the FDA. Dendreon, the maker of Provenge, later submitted more data.
According to the FDA, the approval was based on results from a phase 3 trial showing Provenge extended overall survival by 4.1 months in men with metastatic hormone-refractory prostate cancer. The median overall survival--meaning some patients lived a longer period of time, and some lived shorter--reached 25.8 months for patients receiving Provenge, compared with 21.7 months for those not receiving the vaccine. Common side effects of Provenge include chills, fever, and headaches during the intravenous administration.
Dendreon has not announced how much the vaccine will cost.
Check out "Getting Personal" from the Spring 2010 issue of CURE for more about Provenge and other vaccines to treat cancer.RELATED POSTS
BY MELISSA WEBER | APRIL 17, 2010
Patients with advanced non-small cell lung cancer now have the option of receiving a targeted drug immediately after chemotherapy--before the disease worsens.
Late Friday, the Food and Drug Administration approved Tarceva (erlotinib) as maintenance therapy for patients with locally advanced or metastatic lung cancer that has not progressed after first-line chemotherapy. Until now, the approved use of Tarceva had been limited to advanced lung cancer that grew or spread after chemotherapy. (Check out "Lung Overdue" from the Spring 2010 issue.)
Surprisingly, the approval came despite an FDA advisory panel's almost unanimous vote last December against the new use. The panel's main concern was the minimal benefit shown in the SATURN study, which served as the basis for the approval.
In the trial, nearly 900 patients with advanced non-small cell lung cancer received four cycles of first-line platinum-based chemotherapy. Patients were then split into two groups: one received placebo, and the other received maintenance Tarceva. For patients on Tarceva, median progression-free survival (the time before the cancer progressed) reached 12.3 weeks, compared with 11.1 weeks for patients taking placebo. The Tarceva group lived only slightly longer, with median overall survival reaching 12 months for patients on Tarceva versus 11 months for those on placebo. The most common side effects of Tarceva included rash and diarrhea.
Tarceva, also approved for advanced pancreatic cancer, is an oral drug that inhibits the EGFR signaling pathway inside a cancer cell. OSI Pharmaceuticals, the maker of Tarceva, is investigating the drug as a first-line treatment in lung cancer patients with an EGFR mutation, as treatment after surgery for non-small cell lung cancer, and for treating ovarian cancer and liver cancer, the company said in a statement.
Check out our lung cancer page for more.RELATED POSTS
BY MELISSA WEBER | MARCH 17, 2010
With spring break upon us and summer vacation not too far behind, you're likely making plans for your next family getaway. Whether it's a day trip to a nearby amusement park or a week at the beach, traveling can be complicated when you have a child with cancer. But if you plan ahead, you can help keep your child safe while making sure they don't miss out on any of the fun.
Parents of patients at St. Jude Children's Research Hospital and the patient and family education department at St. Jude have compiled the following list of tips for traveling with a child who has cancer:
• Carry the names, addresses, and phone numbers of emergency contacts.
• Carry your insurance information (medical and pharmacy).
• Carry the name, phone number, and e-mail address of your child's doctor.
• Identify a children's hospital or other reliable health care facility near your destination. Your child's doctor may be able to offer suggestions.
• Bring your child's face mask. Wearing a face mask is not always comfortable for your child, but it is essential for helping keep germs away.
• Carry small bottles of alcohol-based hand cleaner so you and your child can clean your hands often.
• If your child has a central venous line, be sure to bring all the supplies needed to keep up with the cleaning schedule.
• Before traveling, make an organized chart or list of medicines that you will need to give your child and note when you should give them.
• Keep medicines in the original, childproof containers.
• If traveling by car, do not store medicines in the glove compartment or trunk of your car. These areas can become hot and humid, which can alter how well some medicines work.
• Keep all medicines with you in a carry-on bag when traveling by train, plane, or bus. Your child may need a dose during travel. If your luggage gets lost, you could be without the medicine for several days.
• It might be helpful to carry a note from your child's doctor that explains what medicines your child takes. With increased security at airports, you might find that security officers are more concerned about what you have in your bags, especially certain medical supplies, such as syringes.
• Bring more of your child's medicines and medical supplies than you think you will need, just in case your stay becomes longer than planned.
• Carry an empty, wide-mouth plastic container with a tight-fitting lid. You never know when your child will feel sick to his stomach.
• A change of clothes will be helpful if your child has been nauseated or has diarrhea.
• If you are heading to a warm climate, keep in mind that certain medicines could make your child's skin more sensitive. Know which medicines might make skin more sensitive to sunlight. Apply sunscreen with an SPF of 30 or more.
Find more on CURE's childhood cancer page.RELATED POSTS
BY MELISSA WEBER | MARCH 3, 2010
With its first update in almost a decade, the American Cancer Society today released revised guidelines for prostate cancer screening. Although some recommendations haven't changed--most notably, they still don't support routine screening for prostate cancer--the society is offering some new advice.
For men who choose to be screened, the revamped guidelines recommend annual screening for those with a PSA (prostate-specific antigen) level of 2.5 ng/ml or higher, but screening can be stretched to every two years for men whose PSA is under 2.5 ng/ml. Once the PSA level hits 4.0 ng/ml, the society recommends further evaluation or biopsy. For levels that fall between 2.5 ng/mL and 4.0 ng/mL, doctors should assess individual risk before deciding how to proceed.
The society put greater emphasis on shared decision-making, offering physicians specific suggestions, such as use of decision aids (check out the ACS decision aid), to help facilitate conversations with patients about the risks and benefits of screening. (Read about the cancer screening debate in "Life Preserver?" from the Fall 2009 issue.)
The controversy surrounding PSA screening again ignited a year ago when two studies were reported in The New England Journal of Medicine. One study found the test saved lives, while the other found it didn't. (Check out our coverage of the research.) These conflicting findings are what led the ACS to focus attention on informed decision-making in the new guidelines.
The guidelines also acknowledge the limits of digital rectal exams, stating that screening can be performed using PSA with or without the digital rectal exam.
As for community-based prostate cancer screening programs, the society discourages men from participating in programs unless they provide appropriate counseling and follow-up care to men with abnormal screening results. "Availability of follow-up care must not be an afterthought. Unless these program elements are in place, community-based screening should not be initiated," the guidelines say.
Read the complete guidelines in CA: A Cancer Journal for Clinicians.RELATED POSTS
BY MELISSA WEBER | FEBRUARY 19, 2010
Last night, the Food and Drug Administration announced its approval of Rituxan (rituximab) in combination with fludarabine and cyclophosphamide (FC) for the treatment of CD20-positive chronic lymphocytic leukemia. The combination can be given to CLL patients who have not received previous treatment as well as those whose cancer has not responded to other drugs.
The agency based its decision on two phase 3 studies. The first trial showed progression-free survival--the amount of time patients lived without the disease getting worse--was eight months longer (39.8 months versus 31.5 months) in patients who received Rituxan plus FC compared with patients who received FC alone. In the second study, patients on the Rituxan combo lived five months longer without disease progression than patients receiving chemotherapy alone (26.7 months versus 21.7 months).
Already approved for non-Hodgkin lymphoma, Rituxan is a monoclonal antibody that works by targeting the CD20 protein that is found at high levels on cancerous B cells. Side effects of the drug can include fever, chills, headache, and, rarely, infusion reactions (Rituxan is administered intravenously).
About 16,000 people in the U.S. are diagnosed with CLL each year, making it the most common type of adult leukemia.
Rituxan becomes the third drug approved for CLL in the past two years. The FDA gave the green light to Arzerra (ofatumumab) last October for patients whose cancer stopped responding to other forms of chemotherapy, and Treanda (bendamustine) received the FDA's OK in March 2008 for patients who had not received prior treatment.
Watch for our feature on CLL in CURE's Summer issue, which drops in June. And for more, visit our leukemia page.RELATED POSTS
BY MELISSA WEBER | JANUARY 26, 2010
Instead of American Idol or So You Think You Can Dance, young musicians and dancers with cancer now have a competition of their own.
Vital Options has launched Surviving Idol: Young Adults with Cancer Expressing Themselves in support of National Young Adult Cancer Awareness Week, which takes place the first week of April. Cancer survivors between ages 17 and 40 can compete in the global talent contest in any of three categories: vocal, instrumental, and dance.
A panel of advocates and celebrities affected by cancer will select the finalists in each category, but in true Idol fashion, you vote for your favorites. The winners of Surviving Idol will be featured in an upcoming concert, with other plans in the works as well.
The site is still a work in progress, but they're already accepting entries at survivingidol.com.RELATED POSTS
BY MELISSA WEBER | JANUARY 21, 2010
Genomic Health announced today that its Oncotype DX colon cancer test to determine the risk of recurrence in patients with stage 2 colon cancer is now commercially available.
The colon cancer test looks at the activity of 12 genes in the patient's tumor to come up with a score that predicts how likely it is that the cancer will come back. It's this information that can help patients and doctors decide whether chemotherapy is needed after surgery.
Research will be presented this weekend at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium that suggests the test may have a potential role in stage 3 colon cancer, although further study is needed. And as we reported at last year's ASCO annual meeting, although the test successfully predicted recurrence, it did not predict which patients would benefit from chemotherapy.
A similar 21-gene test for early-stage breast cancer has been available since 2004, and Genomic Health is currently developing tests for prostate cancer, non-small cell lung cancer, kidney cancer, and melanoma.RELATED POSTS
BY MELISSA WEBER | JANUARY 20, 2010
Drew Carey really wants to give the Lance Armstrong Foundation a million bucks. Last fall, the actor and host of The Price Is Right said he would donate $1 million to LAF if his @DrewFromTV Twitter account reached a million followers before the ball dropped on New Year's Eve.
Then, in a tweet on December 30, he changed the rules: Follow him or LAF's @LIVESTRONG Twitter account and when the combined number of followers hits one million – regardless of the date – a check for as much is in the mail.
If you don't already have a Twitter account, you can sign up at twitter.com.RELATED POSTS
BY MELISSA WEBER | DECEMBER 31, 2009
So, which stories caught your eye during the past year? Based on the top 10 most popular articles and blogs on curetoday.com, you sampled a little bit of everything--nutrition, treatment, finances, end of life, and late effects.
We followed your clicks, and below are your faves in order of most viewed.
Top 10 Articles
Top 10 Blogs
1. PARP inhibitors create buzz at ASCO (June 8)
2. Tips for managing the financial cost of caregiving (June 24)
6. Should you be concerned about the H1N1 virus (October 9)
7. Would you date a cancer survivor? (July 20)
8. Cancer survivors sought for online study (September 10)
10. Ductal carcinoma in situ: Is it cancer (September 29)RELATED POSTS
BY MELISSA WEBER | DECEMBER 7, 2009
Treanda (bendamustine) may soon replace CHOP as the chemotherapy buddy to Rituxan (rituximab) for patients with advanced follicular, indolent, and mantle cell lymphoma who are getting first-line treatment, following research presented today at the American Society of Hematology's annual meeting.
A phase 3 German study, dubbed StiL (Study Group Indolent Lymphomas), compared the effectiveness and safety of Rituxan plus Treanda to Rituxan plus CHOP, a cocktail that includes cyclophosphamide, doxorubicin, vincristine, and prednisone. The Treanda study arm included 260 patients; the R-CHOP arm had 253 patients.
Rituxan plus Treanda outperformed the traditional R-CHOP regimen at almost every turn. Median progression-free survival (the amount of time the cancer did not progress) hit 54.9 months in the Treanda arm, compared with 34.8 months in the R-CHOP group, and 39.6 percent of patients receiving the Treanda combo had a complete remission (disappearance of all signs of cancer) versus 30 percent of those on R-CHOP. Plus, the R-CHOP arm resulted in a higher frequency of severe side effects, namely neutropenia (46.5 percent versus 10.7 percent) and leukocytopenia (38.2 percent versus 12.1 percent). There were also higher rates of hair loss, nerve damage, and inflammation in the mucous lining of the mouth in the R-CHOP group, although more patients on Treanda developed skin-related side effects.
Investigators said that because indolent lymphoma is such a long-term disease, extended follow-up is needed to determine overall survival. They also noted that although these results suggest Treanda is a better partner to Rituxan than CHOP in patients with indolent lymphomas, R-CHOP is still the standard of care for aggressive lymphomas.
Treanda has been used for decades in other countries, but it only just gained FDA approval last year for chronic lymphocytic leukemia and indolent (slow-growing) B-cell non-Hodgkin lymphoma. For more on lymphoma, check out "Trying Something New" from the Spring 2009 issue of CURE. And look for more breaking news from ASH in the Winter issue, which drops later this month.RELATED POSTS