ASCO 2010 NEWS

Investigational Drug May Help Improve Survival In Patients With Advanced Breast Cancer.

The Wall Street Journal (6/7, Dooren, subscription required) reports that eribulin, a chemotherapy drug being developed by Eisai Co. Ltd., may help improve survival in patients with advanced breast cancer, according to a study scheduled to be presented at the American Society of Clinical Oncology's annual meeting.

The Los Angeles Times (6/6, Maugh) "Booster Shots" blog reported that investigators "studied 762 women who had failed at least two courses of chemotherapy for breast cancer, and as many as five." Participants "were randomized so that two-thirds received infusions of the drug and the rest received the best treatment their physician thought appropriate." The researchers found that "the median survival for those receiving eribulin was 13.12 months, compared with a median of 10.65 months for those receiving other treatments."

Bloomberg News (6/7, Pettypiece) reports that the drug "contains a synthetic form of a substance first isolated from a marine sponge in 1992, according to Eisai." Eisai "is also investigating whether its medicine can help patients with prostate and lung cancers." Bloomberg adds, "The Food and Drug Administration will decide whether to approve eribulin by Sept. 30...Eisai said last week."

MedPage Today (6/6, Phend) reported, "Eribulin represents a new class of microtubulin inhibitors, which Twelves described as attacking the scaffolding by which cells divide, but at a different point than the taxanes, vinca alkyloids, and other existing microtubulin inhibitors."

Reuters (6/7, Fox) reported that in a telephone interview, ASCO president Dr. Douglas Blayney said, "This is potentially practice changing." HealthDay (6/6, Gardner) and AFP (6/7) also covered the story.
Ipilimumab Nearly Doubles Number Of Late-Stage Melanoma Patients Surviving One Year.

USA Today (6/7, Szabo) reports that, "in a study of two novel treatments -- a therapeutic vaccine called gp100 and an immune stimulator called ipilimumab -- ipilimumab nearly doubled the number of patients surviving one year, found a study presented Saturday at the American Society of Clinical Oncology" meeting and published online by the New England Journal of Medicine. Approximately "25% of those given the vaccine lived one year, compared with 46% of those on ipilimumab," a drug developed by Bristol-Myers Squibb Co.

In a trial of "676 patients with advanced melanoma who had failed to benefit from two treatments currently available, interleukin-2 or dacarbazine," Bloomberg News (6/5, Pettypiece) reported, "ipilimumab kept about a quarter of patients battling late-stage melanoma alive for two years -- about twice the proportion with current therapies." Those patients who took "ipilimumab alone lived an average of 10.1 months, according to the study, almost four months longer than those given the gp100 vaccine."

The AP (6/7, Marchione) reports that ipilimumab "works by helping the immune system fight tumors. The federal Food and Drug Administration has pledged a quick review, and doctors think the drug could be available by the end of this year."

The Chicago Sun-Times (6/5, Thomas) reported, "Metastatic melanoma has become increasingly common in the United States over the past three decades, and death rates are rising faster than with other cancers." Although "ipilimumab isn't a cure for skin cancer, 'this is a huge event in advanced melanoma, where there just are not a lot of good things to do, and the things we do are pretty toxic,' said Dr. Allen Lichter, chief executive officer of the American Society of Clinical Oncology."

MedPage Today (6/5, Phend) reported that "grade 3 or 4 immune-related adverse events occurred in 10% to 15% of ipilimumab-treated patients, compared with 3.0% on gp100 alone. Some, generally mild, adverse effects persisted up to the two-year follow-up point." Notably, "seven of the 14 deaths in the study were associated with immune-related adverse events."

The Wall Street Journal (6/6, Loftus, subscription required), Medscape (6/5, Mulcahy), Reuters (6/57, Steenhuysen), Dow Jones Newswire (6/5, Loftus, subscription required), HealthDay (6/5, Gardner), and AFP (6/6) also covered the story.
Avastin May Extend Progression-Free Survival In Ovarian Cancer Patients.

The Los Angeles Times (6/7, Maugh) reports that "the cancer drug Avastin [bevacizumab] extends progression-free survival by 39% in ovarian cancer patients." This "study, reported Sunday at a Chicago meeting of the American Society of Clinical Oncology, is also the first to use the drug as first-line therapy for ovarian cancer."

The New York Times (6/7, A15, Pollack) reports that the "trial involved 1,873 women with newly diagnosed Stage 3 or Stage 4 ovarian cancer who had undergone surgery to remove as much cancer as possible." Participants "received either standard chemotherapy and a placebo, standard chemotherapy and Avastin, or standard chemotherapy and Avastin followed by as many as 10 months of Avastin by itself." The researchers found that, "for those who got the extended Avastin treatment, it took a median of 14.1 months for the cancer to start worsening, compared with 10.3 months for those who received only standard chemotherapy and the placebo."

USA Today (6/7, Szabo) reports, however, that "a short course of Avastin and chemotherapy didn't appear to offer any benefit, says study author Robert Burger of the Gynecologic Oncology Group." While previous research has "shown that Avastin can help fight relapsed ovarian cancer, this is the first" study "to show it also combats newly diagnosed disease, Burger says."

The Wall Street Journal (6/7, Dooren, subscription required), Bloomberg News (6/6, Waters), the London Times (6/7, Rose), the UK's Daily Mail (6/7, Macrae), Reuters (6/7, Beasley), and MedPage Today (6/6, Smith) also covered the story.
Data Suggest Two Drugs May Be Better Than Gleevec For Patients With Newly Diagnosed CML.

The Wall Street Journal (6/7, Loftus, subscription required) reports that research presented at the American Society of Clinical Oncology meeting and published online in the New England Journal of Medicine suggests that Bristol-Myers Squibb Co.'s Sprycel (dasatinib) and Novartis's Tasigna (nilotinib) may be better than Novartis AG's Gleevec (imatinib) for patients with newly diagnosed chronic myeloid leukemia.

HealthDay (6/5, Reinberg) reported that in one study, "after a year, 77 percent of the patients receiving Sprycel had a complete cytogenetic response, compared with 66 percent of the patients receiving Gleevec." In the other study, "after one year, more patients -- about 80 percent of those receiving Tasigna -- had a complete cytogenetic response, compared with 65 percent of the patients receiving Gleevec." MedPage Today (6/5, Phend) and the Houston Chronicle (6/7, Ackerman) also covered the story.
Experimental Drug Appears To Shrink Tumors In Lung Cancer Patients With Certain Genetic Variations.

The New York Times (6/6, A16, Pollack) reported that researchers were able to significantly shrink "tumors...in a majority of patients with advanced lung cancer marked by a specific genetic abnormality," according to a study "featured Sunday at the main session of the annual meeting of the American Society of Clinical Oncology."

The Wall Street Journal (6/5, Loftus, subscription required) reported that Pfizer scientists believed crizotinib would inhibit a particular enzyme that is known to feed tumors and have some sort of nil effect on anaplastic lymphoma kinase (ALK), which also appears to promote malignant growth. But, according to a 2007 paper, fusion of a gene and the ALK gene contributed to the development of lung cancer.

In the current study, researchers found that "crizotinib, shrank tumors in 64% of patients with advanced lung cancer and kept 90% of cancers in check," USA Today (6/6, Szabo) reported. Apparently, "crizotinib blocks a genetic abnormality found most often in non-smokers, caused when two normal genes fuse together to form a new, cancer-causing gene, called EML4-ALK."

Responses to "crizotinib have lasted up to 15 months so far, and the drug has been rushed into late-stage testing," but it's "way too soon to declare success," the AP (6/5, Marchione) reported. HealthDay (6/5, Gardner) and Bloomberg News (6/6, Pettypiece) also covered the story.
Erbitux Provides No Benefit Among Patients With Early-Stage Colon Cancer.

The Los Angeles Times (6/6, Maugh) "Booster Shots" blog reported, "For the second time in a year, researchers have found that a drug that has proved useful in treating advanced colon cancer provides no benefit in the early stages of the disease."

Speaking during the American Society of Clinical Oncology meeting, researchers explained that they recruited 1,864 patients whose cancer had spread to close lymph nodes, Dow Jones Newswire (6/6, Dooren, subscription required) reported. All participants also carried a normal KRAS gene. Nearly half of the subjects were treated with FOLFOX, while the remaining patients were treated with Erbitux [cetuximab] and chemotherapy. Some three years later, investigators found that 72% of the latter group survived without disease recurrence, compared with the 75% of those who only received chemotherapy.

Notably, the "finding is the latest of at least three studies that have narrowed the scope of a drug that was the first of its kind for colon cancer when approved in 2004," Bloomberg News (6/6, Randall) reported. HealthDay (6/6, Gardner) also covered the story.
Drug Shows Promise In Treating Drug-Resistant Medulloblastomas.

AFP (6/7) reports that "an experimental drug," currently called GDC-0449, "has shown promise in treating" drug-resistant medulloblastomas, "a small study unveiled at the annual American Society of Clinical Oncology conference showed."

HealthDay (6/5, Gardner) reported that "the drug...interrupts the 'sonic hedgehog' pathway, which has been implicated in a number of other cancers; it is involved in 20 percent of cases of children with medulloblastoma." GDC-0449 "has already been shown to have some effectiveness in adults with medulloblastoma that has recurred, as well as with basal cell carcinoma, a type of skin cancer."

MedPage Today (6/6, Phend) reported that "the 13 children with refractory medulloblastoma included in the proof-of-principle study tolerated the drug...with no grade 4 toxicity or any of the dental or bone growth problems that were considered a risk based on animal studies." Researchers reported that "of the two children confirmed to have activation of the hedgehog pathway in their tumor, one progressed after roughly six months of daily oral therapy and the other remains in the study without progression after 391 days of follow-up."

Reuters (6/6, Beasley) reports that, according to the study's lead investigator, "less than five percent of these children survive if they fail primary treatment."

Medscape (6/6, Chustecka) reported that "there are now plans for a phase 2 trial in children (up to 22 years of age) with recurrent medulloblastomas, but only in those who show activation of the sonic hedgehog pathway."
Delivering One Dose Of Radiation To Breast Tumor's Former Site Effectively Prevents Recurrence.

The Chicago Tribune (6/5, Shelton) reported, "Delivering one dose of radiation to the area where a breast tumor was removed is as effective at preventing recurrence as treating the whole breast with radiation for weeks," according to a study appearing in The Lancet paper and presented during the American Society of Clinical Oncology meeting.

The San Francisco Chronicle (6/5, A1, Allday) reported on its front page, "About 15 percent of the women who got the targeted therapy ended up also getting the extended therapy because of hospital protocols." Investigators eventually noted that "there were six recurrences of cancer in the targeted therapy group and five recurrences in the extended therapy group." In addition, "both groups...reported about the same number of complications from radiation, including infections; breakdown of the skin, or delayed healing in the area that was treated; and pain in the breast or nearby areas."

Yet, "the single dose during surgery avoids potential damage to organs such as the heart, lung, and esophagus, which can occur during radiation to the whole breast," BBC News (6/5) reported. HealthDay (6/5, Dotinga) and MedPage Today (6/5, Smith) also covered the story.
New Findings Highlight Cancer's Complexity.

The Wall Street Journal (6/7, Winslow, Loftus, subscription required) reports on some of the research presented at the American Society of Clinical Oncology meeting. Some of the new findings highlight the complexity of the disease. The Journal quotes George Sledge, MD, newly elected president of ASCO, as saying, "Cancer is like cable television." Sledge adds, "Thirty years ago you had three channels. Now you have 500."
Adding Radiation To Standard Hormone Treatments Prolongs Survival In Locally Advanced Prostate Cancer.

The AP (6/5, Marchione) reported, "Doctors are reporting a key advance in treating men with cancer that has started to spread beyond the prostate: survival is significantly better if radiation is added to standard hormone treatments." Researchers found that "74 percent of men receiving both" radiation and standard hormone treatments "were alive versus 66 percent of the others." In fact, "those on both treatments lived an average of six months longer than those given just hormones."

HealthDay (6/6, Gardner) reported that study author Dr. Padraig Warde said that "radiation treatments should be part of the treatment package for this group of patients," during the annual American Society of Clinical Oncology meeting. AFP (6/6) also covered the story.
Denosumab Trumps Zometa In Delaying Fractures In Men Whose Prostate Cancer Spread To Their Bones.

Bloomberg News (6/6, Waters, Randall) reported that investigators have found that "Amgen Inc.'s bone-strengthening drug denosumab delayed fractures and complications longer than Novartis AG's Zometa [zoledronic acid] in men whose prostate cancer had spread to their bones." In fact, according to data presented during the American Society of Clinical Oncology meeting, "men with the malignancy taking denosumab went an average of 20.7 months before they had their first bone complication, compared with the 17.1 months for Zometa users."

Meanwhile, Reuters (6/6, Beasley) reported, another phase III trial involving 1,960 UK patients with newly diagnosed multiple myeloma revealed that Zometa improved survival and reduced the incidence of bone-related issues. Specifically, patients who took the drug, alongside chemotherapy, experienced a 16% reduction in the mortality risk, compared to those who took an older drug. The Wall Street Journal (6/5, Dooren, subscription required) and Dow Jones Newswire (6/5, subscription required) also covered the story.

Battery-Powered Helmet May Benefit Patients With Brain Tumors.

Bloomberg News (6/5, Randall) reported that a "helmet, powered by a six-pound battery pack," may benefit patients with brain tumors, according to a study presented at the annual meeting of the American Society of Clinical Oncology. Researchers found that the helmet "helped patients with recurrent tumors live 7.8 months, compared with a median 6.1 months for patients given the best available chemotherapies or Roche AG's Avastin." Bloomberg added that "the electric fields resonate at a frequency designed to do no harm to healthy brain tissue."
Abraxane May Help Shrink Tumors In Lung Cancer Patients.

Bloomberg News (6/6, Gibson) reported, "Abraxis BioScience Inc.'s Abraxane helped doctors do a better job of shrinking tumors in lung cancer patients, especially those with a hard-to-treat type, a company-sponsored study found." In fact, "using Abraxane in combination with carboplatin, a standard chemotherapy, shrank the tumors in 33 percent of patients getting the drugs, compared with 25 percent when Bristol-Myers Squibb Co.'s Taxol was added to carboplatin, according to data released...at a Chicago meeting of the American Society of Clinical Oncology." Notably, the company "plans to seek US regulatory clearance for the drug's use in lung cancer," and the current "study is the third and final round of testing required for approval."
Adding Everolimus To Herceptin May Benefit Some Patients With Metastatic Breast Cancer.

MedPage Today (6/6, Susman) reported that "adding the targeted agent everolimus (Afinitor) to therapy for women with metastatic breast cancer resistant to trastuzumab (Herceptin) results in clinical benefit for more than a third of patients," according to a study presented at the annual meeting of the American Society of Clinical Oncology. Altogether, "seven of 47 of these advanced cancer patients achieved an objective partial response to therapy and another nine patients had stable disease for at least 24 weeks."
Patients With Cancer Of The Oropharynx May Do Better If Tumor Is HPV-Positive.

MedPage Today (6/5, Smith) reported that "patients with cancer of the oropharynx did significantly better if their tumor showed markers of human papillomavirus (HPV)," according to a study presented at the annual meeting of the American Society of Clinical Oncology. Investigators found, "in a retrospective analysis of patients in a large chemotherapy trial," that "those with HPV-positive tumors had a five-year survival rate of 79% regardless of the type of treatment." The researchers found that patients "whose tumors were HPV-negative had a five-year survival rate of just 31% -- a difference that was statistically significant."
Selenium May Not Prevent Recurrence Among NSCLC Patients.

Medscape (6/5, Mulcahy) reported, "The vast majority of lung cancer patients do not benefit from selenium, according to the results of a major study presented...at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting."

Researchers examined "more than 1,500 stage 1 (early) non-small cell lung cancer patients who had survived their initial bout with the disease," HealthDay (6/5) reported. After surgery, all "remained cancer-free for a minimum of six months post-treatment. Half the patients were placed on a regimen of 200 micrograms of selenium, while the other half took a placebo."

Dr. "Karp said the good news from the study was that in most cases, the curative therapy was just that -- there were only 216 second primaries (in 190 patients) including 84 new lung cancers in 83 patients," MedPage Today (6/6, Smith) reported. "But, analysis showed that the rate of overall second primary tumors was 3.66 per 100 person years of follow-up among patients in the placebo group, compared with 4.11 among those getting the selenium, Karp reported." Moreover, the "difference can't be explained by low adherence, since median compliance was 95%."
Older NSCLC Patients May Also Benefit From More Aggressive Chemotherapy.

MedPage Today (6/6, Phend) reported, "Older patients benefit from more aggressive chemotherapy in non-small cell lung cancer (NSCLC) similar to their younger counterparts," according to a study of 451 patients. "In a trial conducted specifically among those age 70 to 89, a paclitaxel (Taxol)-carboplatin doublet improved overall survival by nearly four months compared with single-agent cytotoxics." And, "this magnitude of improvement is at least as good as seen in a general population of NSCLC, Elisabeth Quoix, MD, of the University Hospital in Strasbourg, France, said at a press conference...at the American Society of Clinical Oncology meeting."

"ASCO President Dr. Douglas Blaney told CNN (6/5, Falco) this study is going to be practice-changing because it shows 'standard chemo is better than kinder, gentler chemo.'" Similarly, "Dr. Mark Kris, chief of thoracic oncology at Memorial-Sloan Kettering Hospital in New York and ASCO spokesman, told CNN the impact of this trial will be 'huge,'" considering the "average age of diagnosis for this type of lung cancer is 71." He went on to say that "'the message of this paper is really important,' because it encourages oncologists to look beyond their patient's chronological age and if the patient is fit enough, doctors should have the 'confidence to give the best treatment available to older adults with the anticipation of getting the same benefits and side effects.'"
Novel Antibody May Improve Head And Neck Cancer Outcomes.

MedPage Today (6/5, Smith) reported that "a novel antibody improved outcomes for patients with advanced and inoperable squamous cell carcinoma of the head and neck," according to a study presented at the annual meeting of the American Society of Clinical Oncology. Investigators found that, "combined with radiation or chemoradiation, the substance -- a fully humanized monoclonal antibody dubbed nimotuzumab -- significantly outperformed either modality alone in an open-label randomized trial." The researchers also found that "there was little serious toxicity -- such as debilitating skin rash -- attributed to the compound."
Retesting Patients With Metastatic Breast Cancer May Predict Trastuzumab-DM1 Effectiveness.

MedPage Today (6/5, Susman) reported, "Retesting patients with metastatic breast cancer to determine if their tumors overexpress HER2 could predict effectiveness of the experimental treatment trastuzumab-DM1 (T-DM1)," according to "a poster presentation at the annual meeting...of the American Society of Clinical Oncology." In one trial, "40.8% of patients who were found to have HER2-positive testing achieved an objective tumor response, compared with 20% of patients whose HER2 levels were normal." During a "second study, 33.8% of patients with HER2-positive tests responded, compared with 4.8% of the patients with normal HER2 expression."
Peretinoin Fails To Meet Expectations Among Patients With Recurrent Liver Cancer.

MedPage Today (6/6, Susman) reported, "Treatment of recurrent liver cancer with the experimental Vitamin A analog peretinoin failed to meet its primary endpoint in showing a progression-free survival benefit over placebo." In fact, according to data presented at the American Society of Clinical Oncology, "43.7% of patients on peretinoin had maintained progression-free survival after three years of therapy, compared with 29.3% of patients on placebo, but that difference failed to reach statistical significance." The research team from Japan did suggest, however, that "the drug may still have promise in hepatocellular carcinoma."
Bevacizumab Raises No New Safety Concerns Among Patients Undergoing Surgery For Gastric Cancers.

MedPage Today (6/5, Susman) reported, "Preliminary analyses find that the addition of bevacizumab (Avastin) does not appear to cause new safety concerns among patients undergoing surgery for gastric cancers." In fact, nearly "27% of the patients receiving the chemotherapy of epirubicin, cisplatin, and capecitabine (Xeloda) both before and after surgery experienced grade 3 neutropenia, compared with 25% of the patients who received the same chemotherapy regimen plus bevacizumab." Thus, UK researchers also pointed out during the American Society of Clinical Oncology meeting, there "was not a great difference in adverse events between those patients being treated with chemotherapy alone or those who were also receiving bevacizumab."