ADVANCES IN PROSTATE CANCER

In advanced prostate cancer TREAT FIRST LINE WITH PROVENGE TO EXTEND SURVIVAL

Prescribing Information

PROVENGE extends median survival beyond 2 years in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer PROVENGE reduced the risk of death by 22.5% vs the control group (P=0.032)¹

Overall Survival Benefits of PROVENGE1,2

Data originally published in The New England Journal of Medicine: Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422. Average time to subsequent therapy with docetaxel in the IMPACT trial was approximately 1 year.¹

PROVENGE provides a sustained survival benefit and a durable immune response PROVENGE provided a survival benefit every year studied³

Overall Survival Benefit for PROVENGE3

*(Percent PROVENGE-percent control)/percent control.

Percentage of Patients Alive: ITT Population (95% CI)3 1 year 2 years 3 years 4 years PROVENGE 81.1% (76.9, 85.3) n=274 52.1% (46.4, 57.7) n=129 31.7% (25.7, 37.8) n=49 20.5% (14.0, 26.9) n=14 Control 72.4% (65.6, 79.1) n=123 41.2% (33.5, 49.9) n=55 23.0% (15.5, 30.5) n=19 16.0% (8.5, 23.4) n=4

ITT=intent-to-treat.

PROVENGE provided a durable immune response²

•  A sustained immune response to PROVENGE was seen out to 26 weeks in the pivotal study (the last time point measured)

PROVENGE provides a safety profile you and your patients can manage

Only 1.5% of patients treated with PROVENGE in the pivotal trial discontinued treatment due to adverse events²

The most common adverse events reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache²

INDICATION PROVENGE® (sipuleucel-T) is approved by the FDA as an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases. In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. The most common adverse events (incidence ≥ 15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Please see the Full Prescribing Information.

Visit www.PROVENGE.com to learn more about treating advanced prostate cancer

REFERENCES

1. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422. 2. PROVENGE [package insert]. Dendreon Corporation; June 2011. 3. Data on file. Dendreon Corporation.

©2012 Dendreon Corporation. All rights reserved. P-A-10.12-281.00

IT IS A CIVIL RIGHT ISSUE, CURE OF CANCER FOR VULNERABLE POPULATION.

We have found an El Paso Chapter of the NAACP.  We at CRBCM have understood that the field is not leveled given the limited funds available.  Larger organizations will crush us and lead us to oblivion.  But we will fight until the enemies relent!  They have built futile barriers and discriminatory processes to shield us away from participation, they have put propaganda to cast doubt in the community while they are ripping the goods!  What they are afraid of is the competition in this race for the cure!  What they don't know  is that they cannot deny the facts that some people are more vulnerable to cancers, and that huge institutions gobbling up all the resources do not necessarily you in mind as a priority.  Do not believe that someone else will think of you as a priority.  The proof is in the pudding!  EL PASO HAS BEEN FORGOTTEN.  CPRIT SENT LESS THEN 1 PERCENT OF CLOSE TO A BILLION DOLLARS TO EL PASO WHICH IS THE 6TH LARGEST CITY IN TEXAS! AND IT IS NOT BECAUSE EL PASO DID NOT ASK FOR THE MONEY.   GRANT APPLICATIONS ARE BEING SYSTEMATICALLY REJECTED AT THE HEST OF SO-CALLED REVIEWERS WHO ARE UNIVERSITY BIASED REPRESENTATIVES!  OTHER APPLICATIONS ARE "ADMINISTRATIVELY WITHDRAWN" WITHOUT ANY REVIEW!  They call a party, but El Paso is not allowed to dance and show how good it is really.  Not even a chance to be reviewed!

They claim we have been removed from the competition because the Coalition did not have a product to be produced!  What is services to our community?  Under the survivorship program well detailed in our plan, most of the services are reimbursed by the federal government. This will assure survival and revenues for El Paso.  No, in their mind, services are not a product. They prefer gambling away money in research that will yield less 10-20% possible return in 10-15 years.  At the pace of progress,  most of these research RESULTS will be old by then.  Changes need to be implemented today to yield results in the near future.  Lifestyle need modifications today for a better Texas tomorrow.   If we agree that close to 3000 African women are dying yearly  from a breast cancer that could be prevented, when do you prefer having a solution? Now or in 10 years?  At CRBCM we believe that denying people participation in a race for the cure, is a civil right issue.  We call to the senses of our leaders to take positive steps to reduce politics!

Greed has entered the fray. Universities are shaping and packaging their products to fit funding requirements.
Since the old CPRIT was avidly gobbling up companies located outside Texas, old patents/research products developed in Texas, are quickly being sold to outside Companies so that CPRIT money is relocating these old patents to Texas!  and believe this, this has been funded reportedly! And funded 5 times the millions it was originally sold by the TEXAS university!  Do not tease me because I have the facts!  CPRIT now has been renovated, the new CPRIT will not let itself untangled in politics, at least we believe and hope!

We will continue our planned talk with the local chapter of the NAACP, because it is a CIVIL RIGHTS' issue to protect women from a disease they could be saved from today!

APPROACHES TO CANCER CURE!

As we are moving forward to cancer cure, one realizes several facts

1.  Translational research reveals to us that Medical science is too much compartmentalized.
- Our biologists focus on giving us Molecular basis, chemistry basis to various organelles and even smaller molecules important in the patho-physiology, homeostasis, metabolism at cell level.
- Our Biotech and /or pharmaceutical companies focus on taking this information and developing localized therapeutic targets.  They operate under significant stress to be first and patented!
- Clinical researcher take these  target therapy into clinical trials
- Our Medical Oncologists await the results of clinical trial to use the drug and formulate patterns of treatments based on experience on broader population (Phase IV post market tracking).

At each step, necessary check and balances occur, but it is also true that information is lost, diluted or missed.  This slows down translational research results' implementation. An integrated approach will allow for faster pace of implementation.  We need a TRANSLATIONAL  ONCOLOGY CLINIC WHERE ALL GROUPS WILL SIT TOGETHER AND PRIORITIZE THE THINGS TO DO!

2. Cure is not going to be the same for every cancer.   The reason is in some cancers there are DRIVER Oncogenes, in others, there are DRIVER Pathways.  At least so far, evidence seems to suggest that the success in targeting steps in pathways seems more promising in hematologic malignancies then in treatment of solid tumors.  This impression may change as we move forward.  We are now seeing response rates of 70+ percent in lung cancer when the right driver oncogene is disabled.  This is new!

3. One of the major clinical differences between a basal cell cancer of the skin and  Melanoma is in their ability to spread and multiply.  And one cannot talk about multiplication without looking at events in the Podosomes where actin, paxillin, cortactin and integrin B are main events.  We are reviewing the literature to see what has been accomplished with these potential targets!  Many pathways start in the Podosome and a whole lot of Enzymes are also here!

4. ACTIN (closely liked to 2nd law) is the core of the cell Cytoskeleton and the nervous system of the cell.
What types of Microfilaments/Microtubule/Actin exist,  can some anti-Actin work better than others...? Its relationship with metabolism and physiology of CA++/Calmodulin?  This is important stuff for Brain tumors!
We are working hard at CRBCM!

GOOD TO COME BACK TO EL PASO, ALREADY AT WORK
A FEW PATIENTS READY FOR CONSULTATIONS AND FOLLOW-UP ON SATURDAY AFTERNOON!  PEOPLE WANT TO SEE THEIR DR PRIOR TO VISITING FAMILY IN JUAREZ, MEXICO FOR CHRISTMAS CELEBRATION.  MY DESK FULL OF INCOMING JOURNALS!
TOMORROW ON CALL ROTATION AT PHYSICIANS HOSPITAL STARTING 7:00 am.  FEELS GOOD TO STAY BUSY.   NEED TO PUT TOGETHER STRATEGY OF CRBCM ACTIVITY.  FIRST WRITE TO THE PRESIDENT OF NAACP TO REQUEST A LETTER OF RECOMMENDATION.

• 

  www.naacp.org/pages/naacp-history

  NAACP: 100 Years of History W.E.B. DuBois | Charles Hamilton Houston | Oscar Micheaux | Harry T. and Harriette Moore | Martin Luther King, Jr. | Rosa Parks | …

• National Association for the Advancement of Colored People .

  WE ARE A COALITION AND WILL FIGHT FOR OUR CAUSE TO THE END!  WE BELIEVE THE CAUSE IS RIGHT AND WILL SAVE LIVES.  IT IS JUST SAD TO FIGHT HUMAN BELIEFS FIRST, DISTRACTING US FROM  CANCER, OUR ULTIMATE ENEMY.  THE MD ANDERSON BOUGHT 35 MORE ACRES TO EXPAND IN THE WEST PART OF HOUSTON (TO START A NEW CANCER CENTER)...AND THE CRBCM IS NOT ALLOWED TO START ITS FIGHT IN EL PASO?  IT'S A NIGHTMARE, WE ARE FIGHTING INVISIBLE NEGATIVE FORCES POLITICAL AND OTHERWISE.  I THANK YOU FOR YOUR CONTINUOUS SUPPORT!  SOMEONE WROTE A FEW DAYS BACK ABOUT THE HISTORY OF THE MD ANDERSON.  BELIEVE IT STARTED BY THE DETERMINATION OF ONE SINGLE PHYSICIAN YEARS AGO!

 Lifestyle measures (FROM THE BRITISH HYPERTENSION GUIDELINES)

• Maintain normal weight for adults (body mass index 20-25 kg/m²)
• Reduce salt intake to < 100 mmol/day (< 6g NaCl or <2.4 g Na⁺/day)
• Limit alcohol consumption to ≤ 3 units/day for men and ≤ 2 units/day for women
• Engage in regular aerobic physical exercise (brisk walking rather than weightlifting) for ≥ 30 minutes per day, ideally on most of days of the week but at least on three days of the week
• Consume at least five portions/day of fresh fruit and vegetables
• Reduce the intake of total and saturated fat
  ============================================
  FOR BREAST CANCER PATIENTS, REDUCING CARBOHYDRATE INCREASES DISEASE FREE PROGRESSION MEANING ONCE YOU HAVE COMPLETED PRIMARY TREATMENT, YOU STAY FREE OF DISEASE LONGER IF YOU TAKE LESS CARBOHYDRATES.  THIS HAS BEEN VALIDATED!

MORE INSIGHT IN THE SECOND LAW:  PLEASE READ

Authors: Rhonda M. Perciavalle, Joseph T. OpfermanSee Affiliations

Summary

BCL-2 molecules are regulators of programmed cell death Defects in this pathway contribute to human diseases. One family member, MCL-1, is unique because its expression is tightly regulated and it is essential for promoting the survival of a myriad of cellular lineages. Additionally, MCL-1 promotes the maintenance of normal mitochondrial morphology and energy production. Dissection of these functions revealed recently that they depend on separate mitochondrial sublocalizations. MCL-1's antiapoptotic activity is restricted to the outer mitochondrial membrane (OMM), whereas its function in mitochondrial physiology requires localization to the matrix. These findings provide an attractive model for how MCL-1's diverse functions may contribute to normal cell homeostasis and function. MCL-1 is highly amplified in human cancer, suggesting that these functions may contribute to malignant cell growth and evasion of apoptosis.

Keywords

apoptosis; MCL-1; homeostasis; mitochondrial function; cancer; development

===================================
THIS IS A SUMMARY OF AN ARTICLE FROM "TRENDS IN CELL BIOLOGY".
FOR MORE INFORMATION, PLEASE GO TO THE SOURCE.
WE ARE TRACKING SUPPORTIVE MATERIAL THAT REENFORCES OUR ASSUMPTIONS!
OUR ASSUMPTIONS STILL ARE THAT MEDICATIONS THAT AFFECT THE ACTINIC SCAFFOLDING  (MICROTUBULE/MICROFILAMENT) BYPASS THE Bcl-2 RESISTANCE.
HOW MUCH AUTOPHAGY PLAYS INTO THIS IS STILL TO BE DETERMINED.  AUTOPHAGY IS MEANT TO BE FOR CANCER SURVIVAL GLOBALLY AS A RESPONSE TO STRESS ON THE CANCER CELL.  BUT THERE COMES A POINT WHEN IT IS DETRIMENTAL AND LEADS TO NON CASPASE CELL DEATH.  OTHERS HAVE CALLED THIS (RIGHT OR WRONGLY) "NECROSIS".

MISSION ACCOMPLISHED IN HOUSTON
TIME FOR  CRBCM TO GO BACK TO EL PASO FOR CHRISTMAS WITH FAMILY!

Today is a big day for CRBCM, we have completed our comittments in Houston.  It has been challenging.  But with every step comes the hope that at the end of this struggle, the CRBCM will prevail in its mission.  We will see things through.
Today was a big day as the CRBCM was acknowledged by leaders of our community in letters and phone calls.  We thank Senator Jane Nelson for taking the time to write to us.  She will never realize the full breadth of the significance of her letter for the life of the CRBCM!  We also thank investigators who called us to have our take on the business at CPRIT.   We believe at CRBCM that CPRIT will rise to the challenge and bring the cure to a reality.  We believe history will be made by CPRIT because it must.  Too much is at stake.  And the CPRIT initiative is the right answer to the challenge of Cancer.

Today is a big day because CPRIT is back on its feet.  We, the CRBCM, join others to congratulate Mr Wayne Roberts amd Mr Billy Hamilton who will bring new wind and trust to CPRIT.   While we celebrate their appointments, the CRBCM will remind them that El Paso needs to be given a chance to participate.  While it is true that we cannot compete with the MD Anderson or Rice University.  It is not right nor appropriate that at each round of CPRIT grants, the same players win all the time!  I really doubt that those who fought for CPRIT intended this great institution to be solely a University funding source.  Otherwise they would have called it so.  When one look at the Constitution, what the founding fathers thought is a huge argument.  We believe that the founding fathers of CPRIT who are all alive can speak today so that the future of CPRIT can be better understood now and in history!

El Paso is relatively poor compared to most grant receiving CPRIT Cities.  The CRBCM believes that a minimum investment in EL Paso will have a larger impact in people's life today!  El Paso is the 6th largest City in Texas but less than 1% of CPRIT investment reached us!  However one cuts this, it cannot be right!   Even Biotech Companies relocating to Texas are all pouring into Dallas and Houston.  Why?  El Paso is the safest City in the United States.  Their families will be safe! 

At CRBCM, times are hard as we are not yet allowed to participate. We have by now submitted 5 projects to CPRIT.  2 have been  turned down.  3 are still pending.  CPRIT policies provide an appeal process.  We will submit to this process to challenge it and test it.  We know our chances are slim but the system requires to be tested.  The CRBCM has a vision and a mission to complete to save lives!  We believe in the mission, we will keep THE DREAM ALIVE  in this Lone Star State, and in these United States of America.  God bless America, God bless us all in this Christmas Time!  The fight is on!

Medscape Medical News > Oncology

Major Advances in Clinical Cancer Research in 2012

Zosia Chustecka

 

Drug & Reference Information

• Childhood Cancer Epidemiology
• Neoadjuvant Androgen Deprivation Therapy in Prostate Cancer
• Chemoprevention Strategies in Head and Neck Cancer

A list of 17 major advances in clinical cancer research, considered to be practice-changing, has been issued by the American Society of Clinical Oncology (ASCO) in its annual report, entitled Clinical Cancer Advances 2012.
The report, which covers the period from October 2011 to September 2012, also highlights 70 "notable advances" that are promising but not immediately applicable to practice.
"Consistent, significant achievements are being made in oncology care with novel therapeutics, even in malignancies that have previously had few treatment options, as well as in defining factors that will predict response to treatment. ASCO's report distils the most significant of these advances that [will affect] the lives of cancer patients today," said Bruce Roth, MD, coexecutive editor of the report.
The 17 major advances considered to be practice-changing are listed below; the top 5 were identified as such by ACSO; the others follow in no particular order.

• Everolimus ( Afinitor) in hormone-receptor positive breast cancer. Everolimus, an mTOR inhibitor used in the treatment of renal cell cancer, was approved for use in combination with exemestane ( Aromasin) for women with hormone-positive breast cancer that has spread despite initial treatment with an aromatase inhibitor. This indication was based on results from the 724-patient BOLERO-2 trial, which was halted early because of the benefit observed. The combination of everolimus plus exemestane increased the median time to disease progression to 10.6 months, compared with 4.1 months with exemestane alone ( N Engl J Med. 2012;366:520-529).
  

• T-DM1 in HER2-positive metastatic breast cancer. T-DM1, which is currently awaiting approval by the US Food and Drug Administration (FDA), consists of the anti- HER2 antibody trastuzumab ( Herceptin) linked to the cytotoxic emansine. "We've taught an old friend a new trick — we're using [trastuzumab] as a delivery vehicle," said one expert. In the pivotal EMILIA trial of 991 women with HER2-positive metastatic breast cancer who had stopped responding to trastuzumab, T-DM1 improved survival, compared with the current standard treatment of capecitabine ( Xeloda) and lapatinib ( Tykerb) ( N Engl J Med. 2012;367:1783-1791). After 2 years, the median survival rates were 65.4% with T-DM1 and 47.5% with the standard combination.
  

• Preoperative chemo and radiation for esophageal cancers. A phase 3 trial of 366 patients with cancer of the esophagus or gastroesophageal junction showed that preoperative treatment with chemotherapy (carboplatin and paclitaxel) plus radiation, followed by surgery, yielded substantial benefits, compared with surgery alone ( N Engl J Med. 2012;366:2074-2084). Patients who had preoperative treatment survived for twice as long (median overall survival, 49 vs 24 months), and 29% had a complete remission.
  

• Screening with flexible sigmoidoscopy reduces colorectal cancer deaths. A large American study, involving 154,000 patients with a median follow-up of 11.9 years, showed a significant decrease in the incidence of colorectal cancer (reduced by 21%) and death (26%) ( N Engl J Med. 2012;366;2345-2357). This study, hailed as a landmark trial, confirmed benefits seen in previous British and Italian studies, and has prompted much discussion about how flexible sigmoidoscopy compares with colonoscopy, the preferred screening method in the United States.
  

• Enzalutamide ( Xtandi) for late-stage prostate cancer. Enzalutamide was approved by the FDA in August for use in men with metastatic castration-resistant prostate cancer previously treated with docetaxel after the ARRIRM trial of 1199 men was stopped early because it showed a survival benefit. Median overall survival was 18.4 months with enzalutamide and 13.6 months with placebo ( N Engl J Med. 2012:367:1187-1197). It is predicted that this first-in-its-class drug will be a "game-changer" in prostate cancer.
  

• Lenalidomide ( Revlimid ) maintenance in multiple myeloma. The finding that lenalidomide delays relapse after stem cell transplantation comes from 2 placebo-controlled phase 3 trials. In the first study ( N Engl J Med. 2012;366:1782-1791), conducted in 615 patients younger than 65 years, the disease returned after 41 months with lenalidomide and after 23 months with placebo; after 4 years of follow-up, more than 70% of patients were alive in both groups. In the second study ( N Engl J Med. 2012;366:1759-1769), conducted in 460 patients younger than 71 years, median time to progression was 46 months with lenalidomide and 27 months with placebo. Lenalidomide also increased overall survival (35 deaths in the lenalidomide group and 53 in the placebo group). However, lenalidomide was associated with more adverse events and a higher incidence of second cancers than placebo (7%–8% vs 3%–4%), the report notes.
  

• Pertuzumab ( Perjeta) in HER2-positive metastatic breast cancer. Pertuzumab is an anti- HER2 antibody that was approved in June in the United States and just cleared for approval in Europe. The CLEOPATRA trial showed that adding pertuzumab to the combination of trastuzumab plus docetaxel in the initial treatment of HER2-postive breast cancer can overcome or delay the resistance that develops to trastuzumab when it is used alone. In the 808 women, the median time to progression was 18.5 months when pertuzumab was added to the initial treatment,and 12.4 months when it was not ( N Engl J Med. 2012;366:109-119).
  

• Regorafenib ( Stivarga) in metastatic colorectal cancer. This multitargeted drug was approved by the FDA in September, after the CORRECT trial showed that regorafenib extended overall survival in patients with metastatic colorectal cancer whose disease had progressed after all approved standard therapies. Median overall survival was 6.4 months with regorafenib and 5.0 months with best supportive care. These results were presented at the Gastrointestinal Cancers Symposium in January, and so far the data are available only in abstract form ( J Clin Oncol. 2012;30(4 Suppl): abstract LBA385).
  

• Bevacizumab ( Avastin) in recurrent ovarian cancer. Women with ovarian cancer who progress after platinum-based chemotherapy are then treated nonplatinum-containing chemotherapy, such as pegylated liposomal doxorubicin, topotecan, and weekly paclitaxel. The AURELIA trial of 361 women who had received up to 2 previous treatment regimens showed that median time to disease progression was better with bevacizumab plus this chemotherapy than with chemotherapy alone (6.7 vs 3.4 months). These results were presented at the 2012 ASCO annual meeting, and so far are available only in abstract form ( J Clin Oncol. 2012:30:30(15 Suppl): abstract LBA5002).
  

• Cabozantinib ( Cometriq) in medullary thyroid cancer. This drug was approved by the FDA in November on the basis of the pivotal EXAM trial of 330 patients with progressive, inoperable, metastatic, or locally advanced disease, and tumors that were actively growing. The results showed that cabozantinib improved time to disease progression over placebo (11.2 vs 4.0 months). In addition, tumor shrinkage was seen in 26% of patients in the cabozantinib group, compared with 0% in the placebo group, and these responses lasted a median of 14.6 months. These results have been presented at meetings and are available only in abstract form ( J Clin Oncol 2012:30:(15 Suppl): abstract 5508). Cabozantinib is also being studied in other cancer types, and "unprecedented" results were recently reported in advanced prostate cancer.
  

• Carboplatin and pemetrexed combination in nonsmall-cell lung cancer (NSCLC). Patients with NSCLC who have a performance score of 2 (capable of caring for themselves, but not carrying out work activities) are currently treated with a single chemotherapy, but a new study suggests they might live longer if they are treated with a 2-drug combination. This represents a "paradigm shift in the standard care for advanced NSCLC," and underscores the importance of not undertreating this patient population, according to the ASCO report. The 205-patient study showed that the combination of carboplatin plus pemetrexed increased median overall survival to 9.1 months, compared with 5.6 months for pemetrexed alone. In addition, tumor shrinkage was seen in 24% of patients in the combination group and in 10% of the monotherapy group ( J Clin Oncol 2012;30(15 Suppl): abstract 7506).
  

• Vismodegib ( Erivedge) for basal cell carcinoma. Basal cell carcinoma is the most common form of skin cancer, and vismodegib is the first drug approved by the FDA for the treatment of advanced disease that has metastasized or relapsed after treatment with surgery, or for patients who are not candidates for surgery or radiation. Two studies showing efficacy ( N Engl J Med. 2012;366: 2171-2179, 2180-2188) were accompanied by an editorial ( N Engl J Med. 2012;366:2225-2226) declaring that vismodegib is "the greatest advance in therapy yet." One of the studies ( N Engl J Med. 2012;366:2180-2188) involved 41 patients with basal cell nevus syndrome, which can lead to hundreds or thousands of lesions. During treatment with vismodegib, no tumors progressed and in some patients, all tumors regressed. However, more than half of the patients receiving vismodegib had to stop treatment because of adverse events (including loss of taste, muscle crams, weight loss, and hair loss), according to the ASCO report. It highlights the fact that vismodegib has a novel mechanism of action — blocking the Hedgehog signaling pathway — and that the drug is being investigated in other cancer types, including colorectal, stomach, and pancreatic cancers.
  

• Pazopanib ( Votrient) for soft tissue sarcoma. Pazopanib is already marketed for the treatment of renal cell carcinoma, but this year it was approved in the United States and in Europe for use in the treatment of patients with advanced soft tissue sarcomas (excluding adipocytic sarcomas and gastrointestinal stromal tumors) who have received previous chemotherapy. The PALETTE trial of 369 such patients showed an increase in the median time to disease progression with pazopanib, compared with placebo (4.6 vs 1.6 months), although median overall survival times were similar (12.5 vs 10.7 months) ( Lancet. 2012;379:1879-1886). Although this led to questions about benefit, experts treating sarcoma feel it offers an important new option for their patients. This is the first positive trial and the first new drug in sarcoma for decades, according to the ASCO report.
  

• Olanzapine ( Zyprexa) for chemo-induced nausea and vomiting. Olanzapine, marketed as an antipsychotic drug, was shown to be an effective rescue medication for patients who were suffering from breakthrough chemotherapy-induced nausea and vomiting (CINV), despite having received standard prophylactic treatment. In 80 of 205 patients who developed breakthrough CINV, olanzapine significantly outperformed the conventional antinausea drug metoclopramide. More patients in the olanzapine group than in the metoclopramide group reported no vomiting (71% vs 32%) and no nausea (67% vs 24%). The study was presented at the 2012 ASCO annual meeting, and so far is available only in abstract form ( J Clin Oncol. 2012;30(15 Suppl): abstract 9064).
  

• Duloxetine ( Cymbalta) for chemo-induced peripheral neuropathy. Duloxetine is marketed as an antidepressant but is also approved for use in painful diabetic peripheral neuropathy. In a phase 3 trial, it was shown to be useful in alleviating pain from chemotherapy-induced peripheral neuropathy (CIPN). The trial involved 231 cancer patients who had been treated with oxaliplatin or paclitaxel and had developed CIPN, and duloxetine was associated with a greater average decrease in the pain score than placebo. These results are also available only in abstract form ( J Clin Oncol 2012;30(15 Suppl): abstract CRA9013).
  

• Factors in elderly patients that increase chemotherapy risks. Few clinical trials are conducted specifically in the elderly, so deciding on cancer treatment in an elderly patient is difficult, the ASCO report notes. A trial published this year identified factors that are important to consider when deciding whether an elderly patient should undergo chemotherapy, and explained how they affect the risk for fatality after initiating chemotherapy ( J Clin Oncol. 2012;30:1829-1834). A baseline abbreviated comprehensive geriatric assessment was carried out on 348 patients older than 70 years who were scheduled for initial chemotherapy for various cancers; advanced disease, low nutritional assessment score, and poor mobility predicted early death (in less than 6 months) after beginning chemotherapy.
  

• Predicting risk for chemo adverse effects in elderly patients. Another trial in elderly patients proposed a predictive model to identify those at elevated risk for adverse effects from chemotherapy ( J Clin Oncol. 2011;29:3457-3465). The trial involved 500 patients 59 to 91 years of age with a variety of cancers who underwent detailed assessment of tumor characteristics, laboratory tests, and geriatric status (including function, comorbidity, cognition, physiological state, social activity/support, and nutrition), and were then observed going through 1 round of chemotherapy. On the basis of responses, the researchers developed a scoring system and risk-stratification model that identify older adults at low, intermediate, and high risk for adverse events from chemotherapy.
  

Progress in Clinical Cancer Research

2012 New Drug Approvals

From Medscape Oncology

Cancer Beats All Other Fields for 2012 New Drug Approvals 1. Axitinib (Inlyta, Pfizer) Drug monograph on Medscape Reference FDA Approves Axitinib for Advanced Renal Cell Cancer Medscape News, January 30, 2012 2. Vismodegib (Erivedge, Genentech) Drug monograph on Medscape Reference FDA Approves Vismodegib for Advanced Basal Cell Carcinoma Medscape News, January 30, 2012 3. Pertuzumab (Perjeta, Roche) Drug monograph on Medscape Reference Pertuzumab Approved for HER2 Breast Cancer Medscape News, June 11, 2012 4. Carfilzomib (Kyprolis, Onyx Pharmaceuticals) Drug monograph on Medscape Reference Carfilzomib Receives FDA Nod for Multiple Myeloma Medscape News, July 20, 2012 5. Ziv-aflibercept (Zaltrap) Drug monograph on Medscape Reference Aflibercept Approved for Colorectal Cancer in the US Medscape News, August 3, 2012 6. Enzalutamide (Xtandi, Astellas/Medivation) Drug monograph on Medscape Reference Enzalutamide Gets FDA Nod for Late-Stage Prostate Cancer Medscape News, August 31, 2012 7. Bosutinib (Bosulif, Pfizer) Drug monograph on Medscape Reference A 4th Option for CML: FDA Grants Approval for Bosutinib Medscape News, September 4, 2012 8. Regorafenib (Stivarga, Bayer) Drug monograph on Medscape Reference FDA Approves Regorafenib for Metastatic Colorectal Cancer Medscape News, September 27, 2012 9. Omacetaxine mepesuccinate (Synribo, Teva Pharmaceuticals) Drug monograph on Medscape Reference FDA Approves New Drug for Chronic Myelogenous Leukemia Medscape News, October 26, 2012 10. Cabozantinib (Cometriq, Exelixis) Drug monograph on Medscape Reference FDA Approves Cabozantinib for Medullary Thyroid Cancer Medscape News, November 29, 2012 11. Ponatinib (lclusig, Ariad) Drug monograph on Medscape Reference FDA Approves Ponatinib for Rare Leukemias Medscape News, December 14, 2012 Other Approvals The FDA approved another 3 agents for use in cancer patients this year, either for supportive care or for imaging. 1. Glucarpidase (Voraxaze, BTG International) Drug monograph on Medscape Reference FDA Approves Glucarpidase to Reduce Toxic Methotrexate Levels Medscape News, January 17, 2012 2. Tbo-filgrastim (TevaGrastim, Teva Pharma) - a biosimilar to Neupogen, Amgen Drug monograph on Medscape Reference FDA Approves Tbo-Filgrastim for Neutropenia Medscape News, August 29, 2012 3. FDA Approves PET Imaging Agent for Prostate Cancer Medscape News, September 12, 2012

New interim Leaders for CPRIT

Press Releases

• For Immediate Release
  December 21, 2012 - AUSTIN, TX
• For more information, contact
  Ellen Read (512) 305-8483

CPRIT SELECTS TWO SEASONED EXECUTIVES TO LEAD THE AGENCY FORWARD
Institute appoints Wayne Roberts and Billy Hamilton to leadership roles.

The Cancer Prevention and Research Institute of Texas (CPRIT) today announced the appointment of Wayne Roberts to be Interim Executive Director of the agency. Roberts will serve in this capacity until a permanent Executive Director can be hired. Mansour also announced that former Texas Deputy Comptroller Billy Hamilton has agreed to serve as a senior advisor to the CPRIT Executive Director and CPRIT Oversight Committee.
"I am excited about the appointment of our new interim executive director," said Jimmy Mansour, Chairman of the Oversight Committee, CPRIT's governing body. "Wayne has strong leadership capabilities, as well as a background and experience in state government that will be invaluable to the institute as we move forward."
Roberts served as associate vice president for public policy at The University of Texas Health Science Center at Houston from November 2008 to December 2012. He is a member of the State Pension Review Board, which oversees all Texas public retirement systems; state and local, to ensure they are actuarially sound and comply with state law. His background is heavily weighted towards public finance and budget, especially with respect to public higher education.
Mr. Hamilton works as a private consultant, specializing in issues related to tax, fiscal policy and related issues. Prior to January 2007, he served as Chief Deputy Comptroller of Public Accounts of Texas, where he managed a staff of over 2,800 employees and worked on issues ranging from the rising cost of healthcare to financing Texas' public education system.
"Restoring public confidence in CPRIT is critical, and I believe having two recognized leaders like Wayne and Billy assuming leadership roles will go a long way toward improving the institute's management and restoring confidence in its operations," Mansour said.
About CPRIT
Texas voters overwhelmingly approved a constitutional amendment in 2007 establishing CPRIT and authorizing the state to issue $3 billion in bonds to fund groundbreaking cancer research and prevention programs and services in Texas. CPRIT's goal is to expedite innovation and commercialization in the area of cancer research and to enhance access to evidence-based prevention programs and services throughout the state. CPRIT accepts applications and awards grants for a wide variety of cancer-related research and for the delivery of cancer prevention programs and services by public and private entities located in Texas. More information about CPRIT is available on its website, www.cprit.state.tx.us.

Re: CPRIT Funding for independent research

Alternate ID Sen. Jane Nelson <Jane.Nelson@senate.state.tx.us>	2:14 PM (16 hours ago)
to me

Dear Mutombo:

Thank you for contacting me regarding the ongoing challenges at the Cancer Prevention and Research Institute of Texas (CPRIT).  I appreciate this opportunity to correspond.

As the Senate sponsor of Proposition 15, which established CPRIT and authorized $3 billion over the next 10 years to fund cancer-fighting research and prevention efforts, I am deeply disappointed by lapses in the process designed to ensure transparency and fairness.  Investigations are ongoing into these disturbing revelations.  Individuals will be held accountable, and personnel changes are being made.  I am also developing legislation to strengthen governance of this important agency.

CPRIT's mission is too important to be de-railed by the mistakes of a few.  More importantly, CPRIT cannot succeed in its effort to fight cancer without the public's trust, and right now that trust is in serious jeopardy.  Please know that I will keep your thoughtful insights in mind as discussions continue about the future of CPRIT.

Very truly yours,

Senator Jane Nelson

====================================================
Our cry has been heard!
We thank senator Nelson for this letter,

STUDY OF GENETIC PREDISPOSITION TO CANCER.

Human genome has been uncovered, and laboratories can now give us our genomes quickly.  What took years to develop is now readily available.  Pretty soon we are all going to have a credit card/ID with our genome on it.  Already, scientists are working at studying the patterns of DNA as they relate to disease development.  It will soon become obligatory to write the patient's genome sequence to support the diagnosis doctors give to their patients before insurance will pay for the drug.
For Colon cancer, people will be swallowing disposable cameras to detect early masses.  Colonoscopies will be things of the past (it will be indicated just for biopsies of masses seen on cameras).  Hemocult test as we know it, will be replaced by gene detection on the stool sample.
Presence of Mismatch repair gene, APC gene, loss of 5q,18q,17q,8q (these numbers are not random, this is how cancer evolves from a normal cell to a cancer cell in Colon cancer).  If a stool sample gives you a 8q, you know pretty much this man or woman has more likely the cancer, based on the current model of colon cancer genetic evolution.
In families with many cancers, comparing sequences of genes of family members is now being further improved.  Who actually develops the cancer and who stays safe, is being mapped to see the differences that triggered cancer development (phylogenetics).  As we are uncovering DRIVER ONCOGENES, our treatment will be computer generated.  No one will be able to remember all the genes and their heterogeneous presentations.
We got to face this,  our future is to have a Gene Card for ID.  There is no Doctor who will know all the gene abnormalities, so the first thing you do when you enter the medical office is to hand over your gene card.  We put it in a READER and we have your disease, real, or tendencies and all potential treatments you may benefit from.  Drs will be there to hold your hand and give you some additional comforting advice.
Our infectious disease specialist will be giving a prescription  with the genes of the infectious agent spelled out, with the likely Antibiotic to give.   Science is moving forward, let's embrace it!

AMAZING GLYCOCALYX
CELL SUGAR COATING!

One of the wonders of the cell is its sugar coating.  Indeed this fine layer of mostly sugar component serves many functions to the cell.  From adhesion to other cells to providing signals to the surrounding milieu.  It is given to that sugar coating the responsibility to find the cell location in our tissues during global positioning in the embryo, sperm locating of the egg to fertilize, and recognition of bacteria passing by in the blood.
Glycocalyx, the sugar coat of the cell, plays a major role in cancer, it is one of the ways the immune system recognizes the early change of a normal cell to a cancer cell.  If changes in Glycocalyx are not striking enough to be noticed by our immune surveillance, cancer will be allowed to survive.  The other change of course involves the receptors on the cellular membranes.
How well our immune system detects the change depends on the status of that immune system, and how big of a change has occurred to the Glycocalyx as a result of malignant transformation.  Studying the changes in receptors and Glycocalyx can help us locate and selectively hit the cancer cell while sparing the normal cell.
Sugar coating glycocalyx !

WE NEED AN ETHICIST AT CPRIT!

1. TOBACCO WILL NOT STAY AWAY FROM A POOL OF MONEY SITTING IN TEXAS.
IT CAUSES CANCER, BUT WANTS THE MONEY CANCER PROVIDES AS A CAUSE.
THIS WAY YOU WIN BOTH WAYS!
2. BIO-ALLIANCE IS NOT STAFFED TO KEEP CPRIT FROM THIS KIND OF TROUBLE.
3. A TEXAS UNIVERSITY SELLS ITS PATENT TO A EUROPEAN COMPANY,  THAT COMPANY APPLIES FOR CPRIT RELOCATION FROM EUROPE, CPRIT PAYS 5 TIMES TO RELOCATE A PATENT THAT CAME FROM TEXAS!

WHY WOULD A CANCER PREVENTION ORGANIZATION FUND AN ORGANIZATION  CO-OWNED BY TOBACCO COMPANIES?

WE NEED AN ETHICIST AT CPRIT.