FDA approves first vaccine to treat cancer

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.

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• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Tarceva approved for new use in lung cancer

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.

• More trail mix
• When the cancer comes back
• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Rituxan approved for most common type of leukemia

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.

• More trail mix
• When the cancer comes back
• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

New test available that predicts risk of colon cancer recurrence

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.

• More trail mix
• When the cancer comes back
• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Curetoday.com's most-read articles and blogs of 2009

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

1. The Vitamin D Difference

2. The Good Cancer?

3. The Internal Flame

4. Trying Something New

5. Targeting the Triple Threat

6. Battling Cancer Again

7. The Final Journey

8. Reining in Renal Cancer

9. Under the Sheets

10. Fatigue-Fighting Foods

Top 10 Blogs

1. PARP inhibitors create buzz at ASCO (June 8)

2. Tips for managing the financial cost of caregiving (June 24)

3. Finally, good news for triple negative breast cancer patients! (June 9)

4. "So You Think You Can Dance" shows breast cancer struggle through art (July 24)

5. Study shows how to prevent rash from EGFR inhibitors (June 1)

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)

9. Jonathan White is a fraud -- and other strange things (July 22)

10. Ductal carcinoma in situ: Is it cancer (September 29)

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• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Is Treanda a better mate to Rituxan than CHOP?

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.

• More trail mix
• When the cancer comes back
• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

More frequent dose of Rituxan fails to show benefit

BY MELISSA WEBER | DECEMBER 7, 2009

The standard schedule of giving Rituxan every three weeks, as opposed to every two weeks, is still the best option for older patients with diffuse large B-cell lymphoma, according to research presented today at ASH's annual meeting.

Early analysis of a phase 3 French study found that giving eight cycles of Rituxan plus CHOP chemotherapy every 14 days, compared with the standard of every 21 days, resulted in no clinical benefit for patients. Plus, the more frequent schedule caused more blood-related side effects, requiring more red blood cell and platelet transfusions and a higher number of hospitalizations.

The final analysis of data should be available in 2010, researchers said, but currently, the two-year overall survival stands at 67 percent for patients treated every 14 days compared with 70 percent for patients treated every 21 days.

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• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Four drugs may be better than three in older myeloma patients

BY MELISSA WEBER | DECEMBER 6, 2009

A four-drug combo with Velcade (bortezomib) followed by maintenance therapy resulted in better response rates and less neuropathy compared with the standard three-drug Velcade combo in newly diagnosed multiple myeloma patients who are over age 65.

The phase 3 study, presented today at the annual meeting of the American Society of Hematology, compared a combination of Velcade, melphalan, prednisone, and thalidomide (VMPT) followed by a maintenance regimen of Velcade and thalidomide versus the current standard of care--Velcade, melphalan, and prednisone (VMP). The intensity of both VMPT and VMP was reduced from nine six-week cycles to nine five-week cycles, with Velcade given weekly.

While roughly one-quarter (24 percent) of patients in the VMP arm had complete disappearance of cancer, known as a complete response, 38 percent of patients on VMPT had a complete response. Plus, for 60 percent of VMPT patients, the cancer had not progressed after three years, compared with 42 percent of VMP patients. Investigators said longer follow-up is needed to assess overall survival.

The weekly infusion of Velcade (as opposed to twice a week) resulted in a significantly reduced incidence of peripheral neuropathy, a debilitating side effect that affects the nerves, without affecting response or progression-free survival. Researchers noted a higher incidence of neutropenia and heart complications in the VMPT arm.

A Spanish study presented at the meeting also looked at different Velcade combinations in older myeloma patients. Although each trial used a different approach, both used four drugs in the end. You can read about that study in CURE's Winter issue, which drops in a couple weeks, or sign up for one of our blood cancer e-newsletters to get the latest news from ASH.

• More trail mix
• When the cancer comes back
• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Online tool helps narrow down treatment options for breast cancer

BY MELISSA WEBER | NOVEMBER 19, 2009

My Breast Cancer Coach is pretty straightforward: Answer a handful of questions about your type of breast cancer and in return you get a personalized report of treatment options to talk over with your doctor.

The online tool has been available for over a year, but it recently re-launched with some new features, including information for stage 0 patients, a podcast series, and a "Get Answers" page that offers Q&As with experts.

Created by the nonprofits Breastcancer.org and Breast Cancer Network of Strength as well as the life science company Genomic Health (it markets the Oncotype DX breast cancer test), My Breast Cancer Coach also offers a glossary and a list of questions to ask your doctor.

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• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology

Want to know the top cancer advances for 2009?

BY MELISSA WEBER | NOVEMBER 9, 2009

Each year, the American Society of Clinical Oncology releases a report that pinpoints the top advances in cancer treatment, prevention and screening. This year, ASCO identified 15 key advances in four areas. (The advances were not ranked.)

Here's a breakdown of the findings, provided by ASCO:

1. Advances in Personalized Medicine and Targeted Therapies

Multiple trials this year demonstrated that oncology is no longer "one size fits all" medicine. Rather, increased understanding of the biology of cancer is enabling researchers to develop highly targeted drugs and personalized treatment regimens for patients. Advances in this category include:

• The targeted drug trastuzumab (Herceptin), which has been successful against breast tumors that overexpress the HER2 protein, was found to improve survival for HER2+ gastric cancer. [We'll cover this topic in detail in the Winter issue of CURE, which drops in December.]

• Researchers identified the first effective immunotherapy for neuroblastoma – chimeric anti-GD2 antibody ch.14.18.

• For the first time in 30 years, a randomized trial identified a regimen – initial chemotherapy combined with the EGFR-targeted drug cetuximab (Erbitux) – that increases survival for people with metastatic head and neck cancer.

• Researchers identified a specific subset of patients with non-small cell lung cancer (NSCLC) who benefit from first-line treatment with the targeted drug gefitinib (Iressa). [Watch for our lung cancer feature in the Spring 2010 issue of CURE, which publishes in March.]

• The FDA approved new indications for targeted drugs to treat glioblastoma and advanced kidney cancer, both highly challenging forms of cancer. Bevacizumab (Avastin) was approved as a single agent for treatment of glioblastoma and when combined with interferon, for treatment of advanced kidney cancer. Additionally, everolimus (Afinitor) was approved for kidney cancer in patients whose disease has progressed despite treatment with other targeted drugs. [Read our kidney cancer coverage here.]

2. New Standards of Care

Results from several long-awaited clinical trials this year affirmed the superiority of certain treatment regimens for biliary, lung, and prostate cancers. These include:

• The first-ever standard of care for advanced biliary cancer (cancers of the gallbladder and bile ducts) – results from the largest clinical trial to date for this disease stage showed that combination gemcitabine (Gemzar) and cisplatin treatment increases survival and slows cancer progression, compared with gemcitabine treatment alone.

• Data from a late-stage trial reporting that maintenance therapy with pemetrexed (Alimta) extends survival for patients with nonsquamous forms of advanced NSCLC – a finding that establishes a new standard and gives patients a long-term, easily-administered treatment option with low toxicity. [Watch for our lung cancer feature in the Spring 2010 issue of CURE, which drops in March.]

• Practice-changing findings showing that radiation following prostatectomy improves survival and reduces risk of metastasis for men with early-stage prostate cancer.

3. Cancer Prevention and Screening

This year, findings from large trials shed new light on widely used cancer detection, monitoring and prevention tools. Major research advances in this category include:

• Interim results from two large trials showing that routine PSA testing has a minimal effect on reducing prostate cancer mortality – findings that add new insight to a long-time debate. [Read our coverage here.]

• A large trial showing that treating relapsed ovarian cancer based on rising levels of a protein in the blood called CA125 does not improve outcomes, compared with monitoring for physical symptoms of ovarian cancer relapse. These findings will help spare women from the anxiety and costs of frequent CA125 testing, as well as the toxicity of earlier treatment. [Read our coverage here.]

• Research suggesting that more women may benefit from HPV vaccination than previously thought, based on findings showing that Gardasil reduces the risk of HPV infection, cervical cancer and other HPV-related disease in women aged 25 to 45.

4. Large Trials Settle Key Debates in Colon, Breast Cancer Treatment

The results of two closely watched studies settled major debates in the treatment of colon and breast cancers. These include:

• In the first trial to examine bevacizumab in the adjuvant setting, researchers demonstrated that adjuvant bevacizumab treatment does not prevent colon cancer recurrence in patients who have undergone surgery for their disease. [Read our coverage here.]

• Standard three-drug chemotherapy is more effective and less toxic than single-drug treatment with capecitabine (Xeloda) in women age 65 and older undergoing adjuvant treatment for early-stage breast cancer. Researchers had thought that single-drug treatment may be more tolerable for older women, but this was not found to be the case.

The full report--plus reports from previous years--is available at www.cancer.net.

• More trail mix
• When the cancer comes back
• Two new drugs approved, one pulled from the pipeline
• Emerging treatment option for myeloma presented at hematology meeting
• The big news from the American Society of Hematology