So mom has been taking the Crizotinib targeted therapy drug for about 2 weeks and she was done with her last (round 6) intravenous chemo therapy of Avastin, Alimta, and Carboplatin combination about a month ago now. She was feeling pretty bad after round 6, but it wasn't as bad as what I hear from other survivors who had very difficult chemo treatments. She still has her hair, she has back pain, her blood pressure has elevated, and she has been really tired and worn out. All this aside, she has been looking like she feels better and she does have a lot more energy. We will get the results of how the targeted therapy drug crizotinib is doing in about 2 and half weeks. Just keep praying that it is working! She is strong and continues the good fight!!!
Okay, so now that I've written all that I can tell you all that mom had a wonderful weekend with girlfriends. They took her out for some window shopping, people watching, awesome lunch and dinner, and even took in a show!! Mom said she felt like she had walked 10 miles and it shows that she is very happy to have had that energy! She had a great weekend and is in a really good mood. She is rather tired today though. So I made her some chicken pot pie. It was good. I am just really glad that she had such a great time with her friends!!!
Next week she will be leaving to visit Michael, Annie, and her grandchildren. I am soooo happy that she has this opportunity to go visit. It has been really difficult for her emotionally not see or be around her youngest son, his wife and grandchildren. The boys, William and Charlie are 3 and almost 5, are such a joy and she loves doting on them. I am just so happy that she will be spending Thanksgiving with them! We all have so much to be thankful for and we thank all of you for your continued support!
God Bless!
Sunday, November 20, 2011
More info on the Avastin chemo drug-This is the news release from the FDA
The FDA results from the clinical trials are a little different from the company website info, but here is the press release info from the FDA to shed a little more light on the chemo drug Avastin. Remember that they removed the drug for its complications in regards to breast cancer. My mom has Non Small Cell Lung cancer (NSCL), and this drug is still being used in regards to that. She has finished the 6 rounds of chemo and is now using a different type of chemo. It is pill form called crizotinib and it is used for targeted therapy. Mom had positive results from the genetic marker testing. Info is posted on this blog. She did have some of the side effects from the Avastin that are listed in this press release during the chemo and we will have to wait and see how these symptoms will change after being done with the 6 rounds of chemo and the change to this new targeted therapy drug.
-Vanessa
FDA Commissioner announces Avastin decision
Drug not shown to be safe and effective in breast cancer patients
Drug not shown to be safe and effective in breast cancer patients
FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.
Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).
“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” Dr. Hamburg said. “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”
Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.
Today’s decision, outlined in Dr Hamburg’s 69-page opinion, involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin’s product labeling.
Dr. Hamburg’s decision is based on an extensive record, which includes thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing held in June, 2011.
Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.
After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.
FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.
Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, 2011, included recommendations from the FDA's Oncologic Drugs Advisory Committee (ODAC), voting 6-0 in favor of withdrawing approval of Avastin’s breast cancer indication. After the hearing, the public docket remained open until Aug. 4, 2011. (In an earlier meeting of the ODAC, that committee had voted 12-1 in favor of the removal of the breast cancer indication from the Avastin label).
“FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval,” Dr. Hamburg said. “I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”
For more information:
News about Avastin- Mom took the Avastin for the 6 rounds of chemo
The FDA has recalled Avastin in its use for metastatic breast cancer. It is still used for non small cell lung cancer in combination with carboplatin. It looks like the biggest worry with Avastin, in its use on nscl cancer, is the low white cell count. I'm glad that mom made it through the chemo and she seems to be doing well on the crizontinib. We won't know until next month when we get more scans done and see whats going on inside. She still has pain in her back, but she is looking great and looks like she is feeling better. She still gets worn out, but she recovers fast.
| Friday, Nov 18, 2011 |
FDA Commissioner Announces Final Decision on Avastin for Metastatic Breast Cancer |
South San Francisco, Calif. -- November 18, 2011 --
Information for Doctors and Patients
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com. Avastin is approved for first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa. BOXED WARNINGS and Additional Important Safety Information People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including: Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (2.4 percent to 0.3 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs. Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin. Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing. Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs. In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people. Avastin could cause a woman?s ovaries to stop working and may impair her ability to have children. Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin. Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother. First-line Metastatic Colorectal Cancer In the first-line metastatic colorectal cancer trial, the most common severe to life-threatening side effects that increased by two percent or more in people who received Avastin plus IFL chemotherapy vs. IFL alone were weakness (10 percent vs. 7 percent), abdominal pain (8 percent vs. 5 percent), pain (8 percent vs. 5 percent), high blood pressure (12 percent vs. 2 percent), blood clots in the veins of the body (9 percent vs. 5 percent), blood clots inside the abdomen (3 percent vs. 1 percent), a brief loss of consciousness (3 percent vs. 1 percent), diarrhea (34 percent vs. 25 percent), constipation (4 percent vs. 2 percent), reduced white blood cell counts (37 percent vs. 31 percent), and reduced white blood cell counts that may increase the chance of infection (21 percent vs. 14 percent). Second-line Metastatic Colorectal Cancer In the second-line metastatic colorectal cancer trial, the most common severe to life-threatening and fatal side effects that increased by two percent or more in people who received Avastin plus FOLFOX4 chemotherapy vs. FOLFOX4 alone were diarrhea (18 percent vs. 13 percent), nausea (12 percent vs. 5 percent), vomiting (11 percent vs. 4 percent), dehydration (10 percent vs. 5 percent), blockage of the bowel (4 percent vs. 1 percent), numbness and tingling in fingers and toes (17 percent vs. 9 percent), nervous system disturbances (5 percent vs. 3 percent), tiredness (19 percent vs. 13 percent), abdominal pain (8 percent vs. 5 percent), headache (3 percent vs. 0 percent), high blood pressure (9 percent vs. 2 percent), and severe bleeding (5 percent vs. 1 percent). First-line Advanced Non-Squamous Non-Small Cell Lung Cancer In the non-small cell lung cancer trial, the most common life-threatening to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group were reduced white blood cell counts (27 percent vs. 17 percent), tiredness (16 percent vs. 13 percent), high blood pressure (8 percent vs. 0.7 percent), infection without reduced white blood cell counts (7 percent vs. 3 percent), blood clots in the veins of the body (5 percent vs. 3 percent), fever with reduced white blood cell counts (5 percent vs. 2 percent), inflammation of the lungs (5 percent vs. 3 percent), infection with severe or life-threatening reduced white blood cell counts (4 percent vs. 2 percent), low sodium levels in the blood that could lead to seizure or coma (4 percent vs. 1 percent), headache (3 percent vs. 1 percent), and too much protein in the urine (3 percent vs. 0 percent). Metastatic Kidney Cancer In the metastatic kidney cancer trial, the most common severe to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group included tiredness (13 percent vs. 8 percent), weakness (10 percent vs. 7 percent), too much protein in the urine (7 percent vs. 0 percent), high blood pressure (6 percent vs. 1 percent), and severe bleeding (3 percent vs. 0.3 percent). For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com. About Genentech Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. |
Monday, November 7, 2011
FYI on clinical studies and survival rate. Believe she is healing!
The Lancet Oncology, Volume 12, Issue 11, Pages 1004 - 1012, October 2011
doi:10.1016/S1470-2045(11)70232-7
Cite or Link Using DOI
Cite or Link Using DOIEffect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis
Dr Alice T Shaw MD a 
,
, Summary
Background
ALK gene rearrangement defines a new molecular subtype of non-small-cell lung cancer (NSCLC). In a recent phase 1 clinical trial, the ALK tyrosine-kinase inhibitor (TKI) crizotinib showed marked antitumour activity in patients with advanced, ALK-positive NSCLC. To assess whether crizotinib affects overall survival in these patients, we did a retrospective study comparing survival outcomes in crizotinib-treated patients in the trial and crizotinib-naive controls screened during the same time period.
Methods
We examined overall survival in patients with advanced, ALK-positive NSCLC who enrolled in the phase 1 clinical trial of crizotinib, focusing on the cohort of 82 patients who had enrolled through Feb 10, 2010. For comparators, we identified 36 ALK-positive patients from trial sites who were not given crizotinib (ALK-positive controls), 67 patients without ALK rearrangement but positive for EGFR mutation, and 253 wild-type patients lacking either ALK rearrangement or EGFR mutation. To assess differences in overall survival, we assessed subsets of clinically comparable ALK-positive and ALK-negative patients.
Findings
Among 82 ALK-positive patients who were given crizotinib, median overall survival from initiation of crizotinib has not been reached (95% CI 17 months to not reached); 1-year overall survival was 74% (95% CI 63—82), and 2-year overall survival was 54% (40—66). Overall survival did not differ based on age, sex, smoking history, or ethnic origin. Survival in 30 ALK-positive patients who were given crizotinib in the second-line or third-line setting was significantly longer than in 23 ALK-positive controls given any second-line therapy (median overall survival not reached [95% CI 14 months to not reached] vs 6 months [4—17], 1-year overall survival 70% [95% CI 50—83] vs 44% [23—64], and 2-year overall survival 55% [33—72] vs 12% [2—30]; hazard ratio 0·36, 95% CI 0·17—0·75; p=0·004). Survival in 56 crizotinib-treated, ALK-positive patients was similar to that in 63 ALK-negative, EGFR-positive patients given EGFR TKI therapy (median overall survival not reached [95% CI 17 months to not reached] vs 24 months [15—34], 1-year overall survival 71% [95% CI 58—81] vs 74% [61—83], and 2-year overall survival 57% [40—71] vs 52% [38—65]; p=0·786), whereas survival in 36 crizotinib-naive, ALK-positive controls was similar to that in 253 wild-type controls (median overall survival 20 months [95% CI 13—26] vs 15 months [13—17]; p=0·244).
Interpretation
In patients with advanced, ALK-positive NSCLC, crizotinib therapy is associated with improved survival compared with that of crizotinib-naive controls. ALK rearrangement is not a favourable prognostic factor in advanced NSCLC.
Funding
Pfizer Inc, V Foundation for Cancer Research.
Crizotinib Approval For Lung Cancer Shows Our Miracles Aren't Getting Less Expensive
<a href="http://www.cancer.org/AboutUs/DrLensBlog/post/2011/08/30/Crizotinib-Approval-For-Lung-Cancer-Shows-Our-Miracles-Arent-Getting-Less-Expensive.aspx#.TriwwJFLLMs.blogger">Crizotinib Approval For Lung Cancer Shows Our Miracles Aren't Getting Less Expensive</a>Interesting article. The expense is overwhelming. Its crazy to see that mom's new targeted drug therapy for the pills alone costs $115,000 a year. We will do everything we can to continue to get her the best treatment and heal her. She will become No Evidence of Disease!!! It is God's will. On that note, I think we will need to organize a fundraiser for next year in the spring time while the weather is nice. One comment at the bottom of this article (posted before) tells of how the pills worked great for one's mom who was in the clinical trials. This is great news!
-Vanessa
-Vanessa
An excerpt from someone who's mother has taken crizotinib
"But when my mother was on Crizotinib, she had ZERO side effects. Yes, ZERO. Maybe during the first week she had some nausea/vomiting which can be taken care often easily by drugs or by eating a little food with crizotinib, but after first week it was gone. She had no side effects. I'd imagine some people had other side effects, but none even anywhere close to chemo. Could you name a single chemo drug for which there are people who claim zero side effects?
Not to mention that this drug can lead to better drugs in future.?
Not to mention that this drug can lead to better drugs in future.?
Mom's update. No results just yet on new drug. Give it some time and keep praying.
Well, mom has started the new drug and has been on it for about a week. She is not noticing improvement yet, but keep praying. She will get better!!! Before she started taking the medicine and after round 6 of chemo, she has been suffering from some pretty severe pain in the upper lung area of her back (behind the scapula). The pain is still the same so far. She is still working as much as she can and she gets wiped out by the end of the day. She is suffering from nausea (actually threw up today), but that is a big side effect of the new drug too. Hopefully she will start feeling better soon. Keep her in your prayers and thank you all.
More information on mom's new drug information. The previous posts are more detailed on the drug she is now taking. Please read them all to learn what she is going through.
More information on mom's new drug information. The previous posts are more detailed on the drug she is now taking. Please read them all to learn what she is going through.
New Lung Cancer Pill Highlights Improved Way of Treating Patients Aug. 30, 2011 — | go.com |
A new drug to combat a certain type of lung cancer is being hailed today as an "amazing development" by medical experts.
The drug crizotinib (Xalkori), manufactured by Pfizer and approved last week by the Food and Drug Administration, is intended for a small number of patients.
The twice-daily capsules are meant for patients with non-small cell lung cancer who have a unique gene known as an abnormal anaplastic lymphoma kinase(ALK). An ALK gene causes cancer growth and development.
Pfizer held a panel today to discuss the implications of the new drug.
"What we've seen from studies to date is that this pill does have significant activity," said Dr. Alice Shaw, a thoracic oncologist at Massachusetts General Hospital Cancer Center, who took part in crizotinib studies. "For about 60 percent of patients, they will have a significant shrinkage in their tumors and what the preliminary studies have also shown is that the median or average duration of response is on the order of 10 months."
Lung Cancer Drug Blocks Proteins
Crizotinib works by blocking the proteins produced by the ALK gene. The FDA also approved a diagnostic test by Abbott Laboratories that screens for the gene. Patients found to have the gene would be able to be prescribed the pill, although chemotherapy and radiation therapies would remain options.
The most common side effects, according to Medpage Today, reported in patients taking crizotinib were vision disorders, nausea and edema.
About 187,000, or 85 percent of the 220,000 lung cancer cases diagnosed yearly, are non-small cell lung cancer. Of those cases, less than 7 percent have the ALK gene.
Dr. David Carbone, a lung cancer specialist at Vanderbilt University, one of the sites that tested the drug, told The Associated Press that for those patients, crizotinib made a huge difference. "It's pretty exciting," he said.
"For many patients, this drug has been a lifesaver," Massachusetts General's Shaw told ABC News. "For many patients, they experienced a very immediate and significant relief in their symptoms, sometimes within the first week."
Dr. Roy S. Herbst, chief of medical oncology at Yale Cancer Center, said that crizotinib's FDA approval was a "pivotal milestone" in lung cancer treatment.
"It's another example of how we are using molecular medicine to effectively treat a subset of cancer patients," Herbst told ABC News via email.
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