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CLL Reseponse Criteria

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Criteria for response are based upon the Revised National Cancer

Institute-sponsored Working Group Guidelines for CLL:

1. Complete response CR) requires all of the following conditions to

be met for a period of at least two months:

-Decrease in peripheral blood lymphocyte count to less than 5000.

-Normal CBC as exhibited by:

neutrophil count > 1500, without the use of growth factors

hemoglobin > 11 gm/dL, untransfused (men and women)

platelet count > 100,000, untransfused

-Absence of lymphadenopathy, hepatomegaly, and splenomegaly on exam.

-Absence of constitutional symptoms.

-Bone marrow aspirate and biopsy which is normocellular for the age

of the patient with <30% of the cells being lymphocytes. Lymphoid

nodules should be absent from the bone marrow.

2. nodular PR (nPR): Patients who meet the above criteria but have

residual lymphoid nodules in their bone marrow are categorized as

nodular PRs.

3. Partial response (PR) is defined as any response less than a

complete response but still meeting the following criteria:

> 50% decrease in blood lymphocyte count from pre-treatment value.

> 50% reduction in the total size of lymph nodes on physical exam.

> 50% reduction in the size of the liver and / or spleen.

Additionally, patients must demonstrate one of the following:

Absolute neutrophil count > 1500 cells or 50% improvement

Hemoglobin > 11.0 gm/dL or 50% improvement

Platelet count > 100,000 /mL or 50% improvement

4. Progressive disease is characterized by one of the following:

> 50% increase in the sum of the products of at least two lymph node

masses on at least two consecutive examinations two weeks apart. At

least one node must be > 2 cm in size.

> Appearance of new palpable lymph nodes.

> 50% increase in the size of the liver and/or spleen or the

appearance of hepatomegaly and/or splenomegaly not present at

baseline.

> 50% increase in the absolute number of circulating lymphocytes to

at least 5000 cells.

Transformation to a more aggressive histology

5. Stable disease (SD): Patients who have not achieved a CR or PR,

and who have not met the criteria for progressive disease, will be

considered to have stable disease.

6. Patients meeting criteria for both partial response and

progressive disease will be characterized as having a mixed response.

Rick Furman, MD

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Dr. Furman Thank you for your very complete and understandable

response regarding remission. Pat-

-- In , " rrfman " <rrfurman@...> wrote:

>

> Criteria for response are based upon the Revised National Cancer

> Institute-sponsored Working Group Guidelines for CLL:

>

>

> 1. Complete response CR) requires all of the following conditions to

> be met for a period of at least two months:

> -Decrease in peripheral blood lymphocyte count to less than 5000.

> -Normal CBC as exhibited by:

> neutrophil count > 1500, without the use of growth factors

> hemoglobin > 11 gm/dL, untransfused (men and women)

> platelet count > 100,000, untransfused

> -Absence of lymphadenopathy, hepatomegaly, and splenomegaly on exam.

> -Absence of constitutional symptoms.

> -Bone marrow aspirate and biopsy which is normocellular for the age

> of the patient with <30% of the cells being lymphocytes. Lymphoid

> nodules should be absent from the bone marrow.

>

> 2. nodular PR (nPR): Patients who meet the above criteria but have

> residual lymphoid nodules in their bone marrow are categorized as

> nodular PRs.

>

> 3. Partial response (PR) is defined as any response less than a

> complete response but still meeting the following criteria:

> > 50% decrease in blood lymphocyte count from pre-treatment value.

> > 50% reduction in the total size of lymph nodes on physical exam.

> > 50% reduction in the size of the liver and / or spleen.

> Additionally, patients must demonstrate one of the following:

> Absolute neutrophil count > 1500 cells or 50% improvement

> Hemoglobin > 11.0 gm/dL or 50% improvement

> Platelet count > 100,000 /mL or 50% improvement

>

> 4. Progressive disease is characterized by one of the following:

> > 50% increase in the sum of the products of at least two lymph node

> masses on at least two consecutive examinations two weeks apart. At

> least one node must be > 2 cm in size.

> > Appearance of new palpable lymph nodes.

> > 50% increase in the size of the liver and/or spleen or the

> appearance of hepatomegaly and/or splenomegaly not present at

> baseline.

> > 50% increase in the absolute number of circulating lymphocytes to

> at least 5000 cells.

> Transformation to a more aggressive histology

>

> 5. Stable disease (SD): Patients who have not achieved a CR or PR,

> and who have not met the criteria for progressive disease, will be

> considered to have stable disease.

>

> 6. Patients meeting criteria for both partial response and

> progressive disease will be characterized as having a mixed response.

>

> Rick Furman, MD

>

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