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Patients Against Lymphoma

 

Advocacy > Recipe for Progress

Last update: 03/19/2014

TOPICS

In the News | Treatments | Improving Drug Development and Assessment |
 The Essential Role of the NCI

The treatments we have are often effective but not good enough.  We continue to lose those we love.  We continue to suffer through painful and toxic therapies. And our society suffers as patients with lymphoma become less productive and less able to earn a living and make contributions to their communities. 

Concerning current treatments for lymphoma, we believe that the gap between what is and what's possible has never been wider. So we dedicate this page to listing the abundant opportunities for success, and to remind all of the urgent need to seize them.

In the News

*  Medscape, free login required:
Time for 'Smaller and Smarter' Clinical Trials, Says ASCO http://bit.ly/1otMIHn

In many cases, however, targeted agents are being developed without a complete understanding of the drug's target and without a companion diagnostic tool to help in the selection of appropriate patients, he and his colleagues point out.

To address that issue, the working groups recommend that trial sponsors establish comprehensive biospecimen banks, with informed consent from patients, so that investigators can "ask scientific questions before and after trials are completed" that will facilitate the discovery and validation of biomarkers.

 


Treatments

There is an urgent need to develop and clinically test new treatments that:

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Have greater specificity, more potency, and less toxicity;

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Can overcome bulky disease;

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Can selectively kill indolent lymphoma cells, that are not in cell cycle;

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Can induce and enhance active immunity - the way we naturally fight disease;

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Combine targeted therapies that may complement each other in order to minimize toxicity and prevent tumor escape; 

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Rationally selected to match the differences in the disease by using genetic and metabolic profiling; 
(please review information about the National Biospecimen Network an innovative blueprint for progress)

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Are less toxic, thus allowing patients with indolent lymphomas to safely receive treatment early and more regularly;

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Can be safely combined with existing treatments in order to cure indolent lymphomas, and more patients with aggressive disease.

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Address the role of the microenvironment:

(1) Altering the host environment in ways that silence or inhibit pro-survival signals concurrent with standard therapies.

(2) Focusing, and expanding immune surveillance against tumors.

(3) Turning off signals and inhibiting cells that contribute to drug resistance, depressed immunity and escape from immunity.

(4) Targeting tumors in ways that minimize damage to immunity, or that might enhance it. 

(5) Sequencing therapies in ways that restore positive elements of the microenvironment in order to consolidate the response to treatments. 

  
  


Improving Drug Development and Assessment:

bullet Identify and validate biomarkers that predict prognosis and response to specific therapies -

So therapy can be tailored to meet the needs of patients who can have lymphomas with unique underlying biology.
 
bullet Evaluate better ways to assess response, such as for detection of minimal residual disease.
 
bullet Ensure that there are sufficient incentives for pharmaceutical companies to take the financial risks to 
develop and test therapies for cancer.  
 
bullet Consider reducing incentives to develop "me-too" drugs for conditions that 
are not life-threatening.
 
bullet Ensure that the FDA considers factors such as lower toxicity and improvements in the quality of life benefits in the 
assessment of new therapies.
 
bullet Encourage drug sponsors to properly account for and measure toxicities and quality of life in 
clinical trials.
 
bullet Increase patient participation in clinical trials - an essential ingredient:
 
bullet Encourage drug sponsor to consult with informed patients and treating physicians 
to help design clinical studies that are in harmony with patients survival goals.
 
bullet Educate the communities' doctors and patients about what studies are available, and which show promise for specific treatment settings.
 
bullet Encourage treating physicians to discuss all appropriate therapies, including investigational therapies, 
during treatment consults.
 
bullet Ensure that tests associated with clinical trials are covered by government and / or insurance.
  
bullet Provide, when possible, predictive tests to determine who is more likely to benefit from an 
investigational therapy and/or a standard therapy used as a pretreatment in studies.
  

bullet Encourage drug sponsors to test investigational bio- and immune-based therapies earlier in the course 
of the disease, when they are more likely to provide benefit - especially for indolent lymphomas.
 
bullet Watch & wait should not be routine.  Periods of stable disease provide an important 
opportunity to test immune-based therapies and other more targeted therapies with safer toxicity profiles.
We must encourage drug sponsors, patients, and treating physicians to use this opportunity:
 
bullet Better immune competence
bullet Less tumor burden
bullet Less prior exposure to immune-suppressing or toxic treatments
bullet Potential to improve quality of life
bullet Potential to learn without precluding the use of standard treatments

The Essential Role of the National Cancer Institute (NCI):

bullet Ensure that funding of cancer research becomes a national priority.
 
bullet Encourage all cancer groups to work cooperatively in this effort.
 
bullet Encourage the NCI to carry out its promise to conduct translational research in order to validate 
and clinically test promising new therapeutics. 
 
bullet Ensure that gene-profiling technologies are fully funded and applied as quickly as possible.  
 
We support the following rationale:
 
bullet Enables scientist to more rapidly identify the gene expressions that distinguish normal from 
malignant cells and assist in the "development of molecularly targeted therapies that have specificity 
and potency for defined cancer types."
   
bullet Enables scientists to link clinical behavior (how aggressive or indolent the cancer is likely to be) 
to gene expression, and thus better advise patients about treatment selection and timing. 
(Currently, the variable clinical course of patients given the same diagnosis stems, in part, from 
the underlying molecular diversity among their tumors.)
  
bullet Enables identification of viral factors that may be present and may contribute to causing, 
promoting, or maintaining malignant behavior of lymphoma cells.
  
bullet Enables scientists to discover how genes function in immune cells and apply that knowledge to 
the treatment of numerous diseases. 
 
bullet Enables retrospective testing to genetic expression with individual responses to treatments. 
 
The potential benefits will enable researchers and/or doctors to:
 
bullet select treatments that are far more likely to benefit the patients
bullet spare patients from the side effects of ineffective treatments
bullet identify patients in need of experimental approaches to treatment
bullet reduce health costs by enabling rational treatment selection, instead of by wasteful trial and error
bullet identify genes in tumors that lead to treatment resistance
bullet select patients most likely to benefit from investigational drugs in clinical trials

“Presently we are overlooking effective treatments for some people, while administering ineffective and toxic treatments to others based on studies conducted with ill-defined aggregates of patients.”  – DF.  

 

bullet Enable testing of multiple samples from the same patient, in order to:
 
bullet identify changes to gene expression and other tumor characteristics in response to 
treatments and over time.
bullet identify changes to gene expression and other tumor characteristics that correlate to refractory
disease, or transformation to aggressive disease, or the lack thereof.
   
bullet Enable identification of tumor-associated antigens that can form the basis for therapeutic 
cancer vaccines.
   
bullet Enable discovery of cells in the lymphoid microenvironment that may be promoting or inhibiting 
lymphomas.

   
bullet Enable production of patient-specific therapeutics, such as cancer vaccines or therapeutic antibodies.
 
bullet Consider providing financial incentives to managers that bring new therapeutics to cancer patients, 
and to scientist who make key discoveries to make this possible. 
 
 
bullet Encourage clinical studies of the many promising therapeutics and adjuvants that are not of 
commercial interest, such as:
 
bullet Combinations and sequences of agents that may complement one another.  
  
bullet Immune-based strategies that have low toxicity on patients with indolent lymphomas.
 
bullet Natural compounds that have potential in combination with chemotherapies, such as fish oil and melatonin.
bullet Last, but NOT least:

Design compassionate use protocols in advance - anticipating the needs of patients who fail standard therapies, and are ineligible for clinical trials - so we can give patients every reasonable chance to survive, and also test new concepts in a timely manner.

 

 
Disclaimer:  The information on Lymphomation.org is not intended to be a substitute for 
professional medical advice or to replace your relationship with a physician.
For all medical concerns,  you should always consult your doctor. 
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