Presented below are updates in Oncology Pharmaceutical and clinical research-
Experimental Drug Appears To Shrink Tumors In Lung Cancer Patients With A Certain Genetic Variation.
Lung cancer is one of the "hardest cancers to treat," but scientists in South Korea "have made progress in taming" one form. In fact, using a "focused approach," the researchers were able to significantly shrink "tumors...in a majority of patients with advanced lung cancer marked by a specific genetic abnormality." Although the "clinical trial was small (just 82 people, with no control group), the results were considered so striking for such sick patients that the study" was "featured Sunday at the main session of the annual meeting of the American Society of Clinical Oncology."
The scientists stumbled upon the finding somewhat unexpectedly. Apparently, 15 years ago, 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. Research from Japan changed that opinion. According to a 2007 paper, fusion of a gene and the ALK gene contributed to the development of lung cancer.
The breakthrough, sent the current study authors "scrambling to find lung cancer patients to add to the study and four months later they started testing the drug in lung cancer." The team in South Korea eventually recruited 76 individuals and found that "crizotinib, shrank tumors in 64% of patients with advanced lung cancer and kept 90% of cancers in check." 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. About 7,500 of the 219,440 Americans diagnosed with lung cancer each year have this cancer gene." And, "because the cancer gene isn't found in healthy cells, crizotinib causes fewer serious side effects than chemo, which can lower patients' blood counts and lead to life-threatening infections."
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. Still, many leading cancer specialists, who normally don't get excited until a drug proves effective in large studies against existing treatments, said the researchers, crizotinib was promising. We didn't even know this [the fusion gene] could cause lung cancer in 2006, and now we're moving to phase 3 trials and likely pretty quick approval of this drug." Dr. Karen Reckamp, of the City of Hope Cancer Center, added, "So, although it's only four percent of patients, it's still a good proportion and it will affect many lives in a significant and positive way."
Investigational Drug May Help Improve Survival In Patients With Advanced Breast Cancer.
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. 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." 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.
Avastin May Extend Progression-Free Survival In Ovarian Cancer Patients.
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 "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." 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."
Data Suggest Two Drugs May Be Better Than Gleevec For Patients With Newly Diagnosed CML.
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. The two drugs are currently given to patients who become resistant to Gleevec.
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." Dasatinib and nilotinib are both more potent inhibitors of the BCR-ABL kinase and less susceptible to the resistance-conferring mutations in this domain than imatinib."
Drug Shows Promise In Treating Drug-Resistant Medulloblastomas.
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. 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."
Ipilimumab Nearly Doubles Number Of Late-Stage Melanoma Patients Surviving One Year.
An experimental immune therapy may provide a new way to fight advanced melanoma." Specifically, "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. 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." Further, 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." While the drug was given to late-stage melanoma patients in its clinical trials, "doctors hope the drug can provide more benefit if given earlier in the course of the disease and to less sick patients."
The Chicago Sun-Times 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." .
Erbitux Provides No Benefit Among Patients With Early-Stage Colon Cancer.
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. It is well known that "cancer drugs are typically tested first in the most advanced cases for ethical reasons, but the assumption has always been that a drug that works for advanced disease should work even better when the tumor is of a smaller, more manageable size." The new work by Mayo Clinic researchers, however, "turns that assumption on its head."
Speaking during the American Society of Clinical Oncology meeting, the team explained that they began their study by recruiting 1,864 patients whose cancer had spread to close lymph nodes. 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.
Study author Dr. Steven Alberts explained that the study "also indicates that disease in earlier stages may be different than diseases in later stages.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”.
Adding Everolimus To Herceptin May Benefit Some Patients With Metastatic Breast Cancer.
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."
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