1. New Way to Assess Treatment for Metastatic Disease

http://www.breastcancer.org/cell_search_mets.html

New Test Offers Faster Way to Assess Treatment for Metastatic Breast Cancer

M. Cristofanilli et al., New England Journal of Medicine, August 19, 2004

In recent years, great advances have been made in treating metastatic breast cancer. More treatments are available now than ever before, and many more women are able to live for years with metastatic disease.

Yet with so many treatment options, it's sometimes hard to know which one to choose, and whether to continue with what you're on or switch to something else. How well is the treatment working to stop or slow down the cancer? Does the treatment cause side effects that are draining your quality of life? The bottom line is always this: Do the benefits outweigh the side effects?

To get answers to these questions, women with metastatic breast cancer typically have to wait two or three months after starting a new treatment. Only then can doctors order the tests (blood work, x-rays, scans, etc.) that will show whether the cancer has improved, stayed the same, or progressed.

If you could learn more quickly how effective your treatment is, you could make better treatment decisions. If the treatment is working, you'd stick with it. If it's not doing the job, you could stop the current therapy and try another treatment that might work better.

Switching sooner rather than later might boost the chances that the new treatment would be more successful. And if you're bothered by the side effects of a treatment, knowing right away that it's working might make it easier to tolerate. Or, if a test showed the treatment wasn't working, you could feel more at peace with the decision to stop it.

A new test called CellSearch can show how well a treatment for metastatic disease is working just three to four weeks after the treatment begins. The test counts how many cancer cells are in a sample of your blood before treatment and a few weeks after you start taking it. If the number stays the same or goes up after treatment, then the treatment probably isn't working. If the number goes down, the treatment is probably doing a good job slowing down the cancer.

It's important to note that cancer cells can sometimes be detected in the bloodstream even in women before surgery, whose tests show only cancer in the breast with or without lymph node involvement. Cancer cells circulating in the blood may be harmless if they are unable to grow and just die off. Or the cancer cells may be able to land elsewhere in the body, form a metastatic deposit, grow, and cause problems. In women with metastatic disease, there is a higher chance that cancer cells can be found in the blood.

The new CellSearch test offers hope that women with metastatic breast cancer will be able to decide more quickly whether or not to continue with a particular treatment, depending on how well it is working for them. But researchers need to do more studies with larger numbers of women with metastatic breast disease—as well as women with early-stage breast cancer—to determine how accurate CellSearch, and other tests like it, are.

The U.S. Food and Drug Administration approved the CellSearch test in January 2004. But it still isn't widely available. If you're interested, talk to your doctor about enrolling in a clinical trial for this or other systems that can help you find the best treatments for YOU. You might also consider joining the BCMETS mailing list. This is a large international email discussion list on which women with metastatic breast cancer and their partners discuss treatment and offer support. Another place to find friendship and support is the breastcancer.org Discussion Boards.

And stay tuned to breastcancer.org for more news of emerging research in this important area.

http://www.breastcancer.org/cell_search_mets.html

Posted at 3:06PM on Mar 22nd 2007 by Theo de Chaumont-Quitry

2. CellSearch(TM) System Cleared For Monitoring Metastatic Breast Cancer
16 Dec 2006

Veridex, a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch(TM) System to be used as an aid in the monitoring of metastatic breast cancer.

The CellSearch(TM) System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch(TM) System, in conjunction with other clinical methods for monitoring breast cancer, can help inform physicians' treatment decisions.

"The clearance of the CellSearch(TM) System as a routine monitoring diagnostic tool validates its efficacy as a critical part of the resources used to manage patients with metastatic breast cancer," said Mark Myslinski, General Manager, Veridex, LLC. "With the CellSearch(TM) test, oncologists can clearly and consistently monitor the number of circulating tumor cells present in a patient's blood, an indication of disease progression."

The CellSearch(TM) System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools. The presence and number of CTCs in the blood provides valuable information to physicians for developing individual management programs for patients with metastatic breast cancer. The system's sensitivity, specificity and reproducibility allow for more rapid observation of CTCs as early as the first cycle of treatment helping to evaluate disease progression sooner.

According to the American Cancer Society, breast cancer claims approximately 40,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic breast cancer occurs when tumor cells spread to other locations in the body and grow. Although there are many options for the treatment of metastatic breast cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch(TM) System helps physicians to predict if treatment is effective at any time during therapy through its ability to locate one circulating tumor cell in the 40 billion cells contained in a 7.5 ml sample of blood - an achievement no other diagnostic approach has been able to accomplish.

The CellSearch(TM) System was cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer.

About Veridex

Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch(TM) assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch(TM) assays that use molecular technology to diagnose, stage and more accurately characterize tumors. http://www.veridex.com

Veridex
http://www.veridex.com

Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=59187

Posted at 4:56PM on Mar 22nd 2007 by Theo de Chaumont-Quitry

3. A more recent post, no I don't work for JNJ, but my good friends dealing with MBC have benefited greatly from using CellSearch to make treatment decisions and to know their cancer status both pre- and post-chemo to assure better progression-free survival and a better quality of life.
---------------------------------

CELLSEARCHTM SYSTEM CLEARED FOR MONITORING METASTATIC BREAST CANCER

WARREN, N.J., Dec. 15, 2006 – Veridex, a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic breast cancer.

The CellSearch™ System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System, in conjunction with other clinical methods for monitoring breast cancer, can help inform physicians’ treatment decisions.

“The clearance of the CellSearch™ System as a routine monitoring diagnostic tool validates its efficacy as a critical part of the resources used to manage patients with metastatic breast cancer,” said Mark Myslinski, General Manager, Veridex LLC. “With the CellSearch™ test, oncologists can clearly and consistently monitor the number of circulating tumor cells present in a patient’s blood, an indication of disease progression.”

The CellSearch™ System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools. The presence and number of these CTCs in blood provides valuable information to physicians for developing individual management programs for patients with metastatic breast cancer. The system’s sensitivity, specificity and reproducibility allow for more rapid observation of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner.

According to the American Cancer Society, breast cancer claims approximately 40,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic breast cancer occurs when tumor cells spread to other locations in the body and grow. Although there are many options for the treatment of metastatic breast cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch™ System helps physicians to predict if treatment is effective at any time during therapy through its ability to locate one circulating tumor cell in the 40 billion cells contained in a 7.5 ml sample of blood – an achievement no other diagnostic approach has been able to accomplish.

The CellSearchTM System was cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer.
Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors.

Posted at 8:44PM on Mar 22nd 2007 by Theo de Chaumont-Quitry

4. First-in-Class Test Can Predict Progression-Free and Overall Survival of Patients with Metastatic Breast Cancer

Simple blood test may help doctors make critical treatment decisions earlier

WARREN, N.J., Aug. 18 (HSMN NewsFeed) -- Veridex, LLC, a Johnson & Johnson company, today announced that The New England Journal of Medicine (351; 781-791, 2004, August 19) published the results of a prospective study showing that the number of circulating tumor cells (CTCs) in 7.5mL of blood taken from women with metastatic breast cancer can predict progression-free and overall survival. CTCs are cancer cells that detach from solid tumors and enter the bloodstream. Knowing the number of CTCs in the blood may pave the way for oncologists to make critical decisions about patients' treatment earlier than previously possible.

The multi-institutional, double-blind trial used the Veridex CellSearch(TM) System, a diagnostic technology that is the first of its class to automate the detection and enumeration of CTCs. The CellSearch(TM) System was cleared according to the FDA "de novo" classification process whereby the test was first determined to be safe and effective, then listed with the U.S. Federal Register as a new device. It is expected to become commercially available in the fall of 2004.

The study enrolled 177 metastatic breast cancer patients who were about to either start initial therapy or change to a new course of therapy. Patients were tested for a CTC count before therapy, and then again at the first follow-up approximately three to four weeks later. Patients with five or more CTCs per 7.5mL (the equivalent of one blood draw) ultimately had significantly shorter progression-free survival and overall survival than patients with fewer than five CTCs. Further, the percentage of patients with more than 5 CTCs was reduced from 49 percent (87 women) to just 30 percent (49 women) at first follow up -- an indication that a number of patients responded to therapy.

"The results showed the presence of circulating tumor cells to be the strongest independent predictor of progression-free and overall survival," said lead author Massimo Cristofanilli, M.D., Associate Professor in the Department of Breast Medical Oncology at The University of Texas M. D. Anderson Cancer Center in Houston.

While CTCs have been documented since 1869, and discussed in over 1,500 publications, the technology has not been available until now to fully understand their value.

"For the first time, oncologists now have a powerful diagnostic tool, designed for mainstream clinical practice, that automates and standardizes the collection and detection of CTCs," said Robert T. McCormack, Ph.D., general manager, cellular diagnostics, Veridex. "The CellSearch(TM) System addresses a significant unmet need by providing more accurate information -- earlier than ever before possible -- to enable more informed treatment decisions. It is important to note that the CellSearch(TM) test is not for use with early breast cancer or for screening purposes."

Currently patients go through several rounds of treatment before it is known whether or not the therapy is working. According to Daniel F. Hayes, M.D., Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center and the study's senior author, "One of the most problematic aspects of managing cancer is determining the fine lines dividing an effective course of therapy from one that is futile. The CellSearch(TM) System may significantly advance our ability to more accurately define those lines and more effectively manage cancer therapy; we are planning further studies to precisely define the role of monitoring CTCs in women with metastatic disease."

Immunicon Corp. of Huntingdon Valley, PA, developed the CellSearch(TM) System under a Development, License and Supply Agreement with Veridex.

Veridex, LLC

Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complimentary product lines: CellSearch(TM) assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch(TM) assays that use molecular technology to diagnose, stage and more accurately characterize tumors. http://www.veridex.com

Posted at 8:44PM on Mar 22nd 2007 by Theo de Chaumont-Quitry

5. Looking at reactions to a technology/product that can help, another lister posted this about Elizabeth Edward's health.

------------------------------------------
Immunicon's Cell Search [marketed by J&J's Veridex unit] would have been an ideal way to monitor her treatment.

If anyone knows how to contact her, it might be worthwhile to let her and her doctors know about CellSearch. Of course, is she is being treated by Oncologists who can't get their heads out of their backsides, it might not make a difference.

Posted at 8:45PM on Mar 22nd 2007 by Theo de Chaumont-Quitry

6. Results of using the CellSearch system indicate that monitoring of circulating tumor cells can contribute to the understanding of tumor-blood interactions and may provide a valuable tool for therapy monitoring in solid tumors like breast cancer. With cells being alive in circulation, it may mean that a patient would need additional treatment.

It was such a technique that German investigators from Friedrich-Schiller University in Jena were able to quantify ciculating tumor cells in a study of neoadjuvant chemotherapy with three different paclitaxel (taxol) containing regimens, which showed as the tumor collapses (a clinical response, not cure), it produces the greatest release of circulating tumor cells. The study had not looked at any other combination regimens.

These ciculating tumor cells can detach from solid tumors and enter the blood stream, thus beginning the process of metastasis, the most life-threatening aspect of cancer. To metastasize, or spread cancer to other sites in the body, circulating tumor cells travel through the blood and can take root in another tissue or organ (the lungs, bones, liver, adrenals, and even the brain).

In the study, according to Katharina Pachmann, M.D., professor of experimental oncology and hematology, breast cancer patients undergoing neoadjuvant chemotherapy gave blood samples in which epithelial antigen-positive cells were isolated. Such cells are detected in most breast cancer patients but are rarely found in normal subjects. The investigators measured the levels of cirulating tumor cells before and during primary chemotherapy with several different cytotoxic agents.

Paclitaxel (taxol) produced the greatest degree of tumor shrinkage but also the greatest release of circulating tumor cells. In three different paclitaxel-containing regimens, circulating cell numbers massively increased, whereas tumor size decreased. It may indeed give clinical response (tumor shrinkage), sometimes impressive, however, these are mostly short-lived and relapses after a response to taxanes (taxol) are often dramatic.

Even if one or more chemotherapy regimen is identified as being likely to work on a particular cancer, has the science advanced to tell us whether application of the chosen chemotherapy regimen will not cause other changes that also cause cancer to later return and perhaps be even harder to treat? Is it a case of chemotherapy being bad, in cases where it apparently works? Traditional chemotherapy is mutagenic (changes in form), you might kill off a whole lot of cancer, only to cause a mutation in the remaining cancer, such that the remaining cancer behaves in a more agressive fashion.

This study tells us that much more work needs to be done, and oncologists need to adapt treatment to the patient. There are hundreds of chemotherapeutic agents, all of which have approximately the same probability of working. The tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing individual properties of each patient's cancer.

(Oncol News Int'l, Vol 14, #5, May '05)

Posted at 8:47PM on Mar 22nd 2007 by Gregory D. Pawelski

7. Please tell Mrs. Edwards I too had a recurrence, though not metastatic. That was 30 years ago! I am still well, working and just turned 64. Wearing a wig can be just fine as you don't have to worry about how your hair looks! I had a husband, 3 children and a full time job. I send my support to her and she is most welcome to contact me for any support I can offer.

Posted at 10:35PM on Mar 22nd 2007 by Gwen

8. CellSearch(TM) System Cleared For Monitoring Metastatic Breast Cancer
16 Dec 2006

Veridex, a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch(TM) System to be used as an aid in the monitoring of metastatic breast cancer.

The CellSearch(TM) System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch(TM) System, in conjunction with other clinical methods for monitoring breast cancer, can help inform physicians' treatment decisions.

"The clearance of the CellSearch(TM) System as a routine monitoring diagnostic tool validates its efficacy as a critical part of the resources used to manage patients with metastatic breast cancer," said Mark Myslinski, General Manager, Veridex, LLC. "With the CellSearch(TM) test, oncologists can clearly and consistently monitor the number of circulating tumor cells present in a patient's blood, an indication of disease progression."

The CellSearch(TM) System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools. The presence and number of CTCs in the blood provides valuable information to physicians for developing individual management programs for patients with metastatic breast cancer. The system's sensitivity, specificity and reproducibility allow for more rapid observation of CTCs as early as the first cycle of treatment helping to evaluate disease progression sooner.

According to the American Cancer Society, breast cancer claims approximately 40,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic breast cancer occurs when tumor cells spread to other locations in the body and grow. Although there are many options for the treatment of metastatic breast cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch(TM) System helps physicians to predict if treatment is effective at any time during therapy through its ability to locate one circulating tumor cell in the 40 billion cells contained in a 7.5 ml sample of blood - an achievement no other diagnostic approach has been able to accomplish.

The CellSearch(TM) System was cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer.

About Veridex

Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch(TM) assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch(TM) assays that use molecular technology to diagnose, stage and more accurately characterize tumors. http://www.veridex.com

Veridex
http://www.veridex.com

Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=59187

Posted at 10:49AM on Mar 23rd 2007 by Theo de Chaumont-Quitry

9. Taxol reduces circulating tumor cells. It doesn't increase them.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8765198&dopt=Abstract

This whole idea of the prognostic value of circulating cells must be taken with a large grain of salt as indicated in this study:

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1514320

It's far too early to jump on this train.

Posted at 7:32PM on Mar 23rd 2007 by hchcec

10. Wow! 1995! That's what happens when you chase one abstract/paper after another abstract/paper. You get = one abstract/paper after another abstract/paper (and in mice).

In addition to the Pachmann, et al study above, (2005) which showed that in three different taxol-containing regimens, circulating cell numbers massively increased, it has been frequently observed that patients with breast cancer treated with a taxane-containing chemotherapy regimen, either in the adjuvant setting or in the metastatic setting, presented with CNS involvement as the only evidence of disease progression, according to another study. This one even more recent (2006).

Central Nervous System (CNS) relapses are common among breast cancer patients treated with a taxane-based chemotherapy regimen. In this study it was possible to confirm the initial clinical observation that breast cancer patients who receive a taxane-containing chemotherapy regimen have a significantly higher incidence of CNS metastases compared with that of patients treated with a nontaxane-containing regimen.

The reasons for the association between treatment of breast cancer with a taxane-containing chemotherapy regimen and an increased incidence of CNS involvement was that taxanes are very lipophilic, their concentration in the CNS is very low after their intravenous administration. Taxanes are unable to penetrate the intact blood-brain barrier, the concentration of radiolabeled taxol in the cerebrospinal fluid is found to be significantly lower than in other organs, and thus undetectable in the brain, in the spinal cord or in any other site of the CNS. The detection of cytokeratin 19 (CK-19) and of mRNA-positive circulating tumor cells (CTC's) in the peripheral blood and the bone marrow of patients with breast cancer is correlated with increased incidence of relapse.

(Breast Cancer Res. 2006;8(4)2006 BioMed Central, Ltd.)

Posted at 9:42PM on Mar 23rd 2007 by Gregory D. Pawelski

11. Pawelski, above makes the mistake that any first year epidemiology student should not make, i.e. correlation does not equal causation. It took awhile to find the Pachmann paper but the author states that "These cells seeded into the circulation may be the origin of the recurrences seen after taxol treatment."

"MAY BE"

No evidence at all. Merely a conjecture. The author could present no evidence and has not done so since the original article was published years ago.

Secondly, the statement that CNS relapses occur from taxanes lacks evidence. And here you will see why Pachmann was wrong:

Look at this study:
http://www.medscape.com/viewarticle/543766_4

It states:

1. Taxanes are highly effective in breast cancer and they prolong the survival of patients with advanced disease.

2.It is also well known that CNS involvement is more frequent in the late stages of the disease.

3.The increase in survival and the prolonged period of advanced disease is correlated with the increased frequency of CNS relapse.

4.[The] difference in the incidence of CNS relapse between patients with breast cancer and other solid tumors could be explained by the higher efficacy of the taxanes in breast cancer which is associated with increased survival in comparison with other solid tumors.

Taxanes do not emerge as an independent predictive factor for CNS metastases. So, it's very evident that CNS metastases occur because patients lived longer.

Correlation definitely does not equal causation.

Be careful what you read on the internet.

Do the research yourself.

It will pay off.

Posted at 11:55PM on Mar 23rd 2007 by hchcec

12. To the reader, as you may know, personal experiences should be viewed with caution. The reader knows only what the poster posts and one case certainly does not make for evidence.

I read Mr. Pawelski's web site. He leaves one with the impression that chemotherapy kills, not cancer. I hear this from the alternative medicine and New Age community all the time. Yet, there was, and is in 2007, no clear indication that taxanes "feverishly" increase cancer cells that then "wreak havoc." One must look warily at those who use words like "could explain" in a post.

Pawelski states, "The fact that they are there, and TAXANES FEVERISHLY INCREASE THEM, is disconcerting." This has already been addressed in my above post, yet there is a persistence here, for whatever reason.

These are highly charged words from someone who does not interpret the data the way the scientists do and no good scientist would ever use emotionally charged words like this to make a point.

It is one thing to state that taxanes and other chemotherapies may not affect overall survival. It is quite another to say that they increase mortality as he continues to do.

I recommend you be diligent in your research when individuals like this post to blogs. Do the same when people like myself post.

And, do as I do. If it sounds emotional, call them on it. Probe. Ask for real evidence, not personal, emotional getting-it-off-your-chest information, but the real thing.

I'm sure I'll get a response to this post, but I think I've answered the taxane charge. Until there is any convincing evidence, not some opinion, I think we've tossed this one around enough.

Good health to you, to those of you on taxanes.

Posted at 9:31AM on Mar 24th 2007 by hchcec

13. hchcec reminded me of a so-called oncologist at our local community hospital, who thought he had to give my wife a fifth infusion of chemotherapy into her ommaya reservoir, when after each of the prior three infusions the cytology from withdrawn CNS fluid was negative in every case. His reasoning? I read a paper once. Then I asked if he wanted to do this without any bloodwork being done. He looked up, then looked at me, and said, "never mind."

Drs. V. Valero and G.N. Hortobagyi, in an editorial published in the March 15, 2003 issue of the Journal of Clinical Oncology stated that review of all the large, prospective, randomized trials published comparing taxane-based chemotherapy regimens, concluded that none of these regimens have increased either complete response rates or overall survival.

These ciculating tumor cells could explain the lack of overall survival advantage for unsuccessful or even partially successful treatment. If anything, the surviving cells would be more disregulated and therefore tougher and more aggressive, and since they no longer have to compete with the less aggressive and easier to kill cells for nutrients, all of the now even more rapidly expanding clone of tough-guy cells would be more likely to invade, metastasize, and generally wreak havoc. The fact that they are there, and taxanes feverishly increase them, is disconcerting.

Posted at 9:33AM on Mar 24th 2007 by Gregory D. Pawelski

14. The so-called scientific community gets angry at being given information that challenges their entrenched position or they deny that opposing facts are valid. They think what they believe is the truth. Established beliefs are defended with our very lives. Upton Sinclair asserted that you can't convince a man to know something that his income depends on him not acknowledging. Albert Einstein stated that the significant problems we face cannot be solved by the same level of thinking that created them. Perhaps hchcec's significant-other shouldn't be so entrenched?

Posted at 11:41AM on Mar 24th 2007 by Gregory D. Pawelski

15. You've all made some interesting points. I am currently on docetaxol. Last treatment Apr 5.
Here in this part of Canada the protocol for E+
node+ adjuvant chemotherapy is FEC100 3x q3W and
docetaxol 3x q3w. They say my stage is curable:)
Maybe and maybe not. It would be helpful if someone would address any causative factors because if my tumour suppressor gene has gone for coffee and not returned, who's to say we can't create another tumour just like it.

I was terrified of chemo because of the damage it can do. Injecting a carcinogen and mutagen in my
veins and being terribly ill for months does not
induce a feeling of moving towards health in my
mind at least. Esp when one of the drugs can actually make your skin sizzle. What am I doing??
I wish there had been another way than using this barbaric system, but I didn't find one and time was ticking. Adjuvantonline gave me a 70% chance of recurrence.

I believe firmly that what this stuff doesn't kill, it only makes stronger as too often we hear of a recurrence or mets that is substantially more
aggressive than the original cancer. If it took them 7-10yrs to grow, we would all get by the 5yr. mark.

I am concerned about this comment: The fact that they are there, and taxanes feverishly increase them, is disconcerting.

This wouldn't surprise me one bit, what annoys me
is that I didn't see any of that info when I was researching the chemo's.

At any rate it's been interesting reading the bantering of the posters and very thought provoking.

Thank you
jan

Posted at 10:40PM on Mar 25th 2007 by jan

16. ONGOING Clinical Trial - Trial Examines Value of Circulating Cancer Cells in Advanced Cancer, see
http://www.cancer.gov/clinicaltrials/SWOG-S0500

or @ Living Beyond Breast Cancer website
http://www.lbbc.org/clinical-trial-detail.asp?section_tag=A&id=40

By Mary Alice Hartsock, LBBC Staff

Phase III trial will study whether using CellSearch test can help doctors determine more quickly whether a woman’s advanced breast cancer is responding to chemotherapy treatment

Trial Starts: 10/1/2006

Sponsored By: National Cancer Institute

A new clinical trial from the National Cancer Institute will study whether women with advanced (metastatic) breast cancer with elevated levels of circulating tumor cells (CTCs) after their first chemotherapy treatment can live longer by changing to a different chemotherapy regimen immediately rather than waiting until their disease progresses.

The Phase III trial, called Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy or SWOG-S0500, may help women affected by advanced breast cancer and their doctors to more quickly determine the most effective course of treatment.

Why Is This Trial Important?

A new test called CellSearch measures the number of circulating tumor cells in a sample of blood.

An earlier study of 123 women with advanced breast cancer published in the Journal of Clinical Oncology (2006 ASCO Annual Meeting Proceedings Part 1, Vol. 24, No 18S: 615) suggested that the presence of CTCs may help doctors determine the aggressiveness of a woman’s cancer. For example, a blood sample that contains fewer than five CTCs may indicate a cancer that will be slower to spread; a blood sample with five or more CTCs may suggest a cancer more likely to progress quickly.

Many women affected by advanced breast cancer undergo first-line, or initial, chemotherapy to treat their cancers. In most cases, women with advanced disease receive a treatment until the cancer grows (as seen by the doctor on physical exam or using imaging tests) or until the side effects impact their quality of life. Researchers hope that by measuring the CTC count before a woman begins treatment and following it over time, they may be able to determine whether the treatment is working before symptoms of progression appear.

Goals of the CTC Trial

This purpose of this trial is to determine the value of CTCs and to see whether information gathered from the CellSearch test may give doctors more information about the aggressiveness of a cancer.

The trial also will establish the value of regularly measuring CTC levels and will evaluate the degree to which women with and without elevated CTC levels experience treatment side effects.

Structure of the Trial

This phase III trial will compare the effectiveness of choosing a course of chemotherapy based on CTC levels to the standard treatment strategy of selecting a course of chemotherapy based on disease progression.

Women who enter this trial must be receiving chemotherapy for the first time for advanced breast cancer. Before the first course of chemotherapy, doctors will measure the baseline (starting) CTC levels of a 7.5ml sample of each participant’s blood. The participants will then be divided into groups based on their results. All participants with fewer than five CTCs will be assigned to group one. Participants with five or more CTCs will have their blood levels analyzed three weeks later, after their first course of chemotherapy, and be assigned to either groups two or three:

Group 1 participants will have fewer than five CTCs at the start of the trial and a low risk of early progression. They will continue to receive regular chemotherapy treatment.

Group 2 participants will have fewer than five CTCs after completing one course of chemotherapy and a moderate risk of early progression. Their CTC levels will have decreased during treatment. They will continue to receive their current chemotherapy without change.

Group 3 participants will have a CTC level greater than five with a high risk of early progression. They will be divided based on HER-2/neu status and disease type (metastasis to the bone versus measurable metastasis to other areas of the body) and will be randomly assigned to one of two treatment arms:

Arm 1 participants will continue to receive their current chemotherapy (the standard treatment).

Arm 2 participants will receive a new chemotherapy (the treatment under study).

This trial is partially randomized because only Group 3 participants are randomly assigned to certain treatments. Randomization ensures that doctors analyze results objectively and do not let their predictions influence conclusions.

Participants from groups two and three will undergo blood collection throughout and at the conclusion of chemotherapy. In addition to the CellSearch test, researchers also will test each participant’s blood sample using CA 15-3, a test measuring how well invasive breast cancers respond to treatment, and CEA (carcinoembryonic antigen), a test that measures the amount of certain protein in the blood.

Can I Participate in this Trial?

The researchers seek 500 participants for this trial. They will be followed five years after completion of their treatment. You may be able to participate in this trial if you have been diagnosed with advanced breast cancer, are female and:

* You are planning to receive first-line chemotherapy for advanced disease
* Your HER-2/neu status has been determined
* Your disease is not leptomenigeal, meaning that it has not spread to tissues that cover the brain and spinal cord
* If you have brain metastasis, your disease has not changed in extent or severity for at least 90 days after completion of your last treatment
* You have not had another non-breast cancer within the past five years, except for certain skin cancers
* You are not pregnant or nursing

You may be eligible to participate if you have had prior hormonal therapy, bisphosphonate therapy, trastuzumab (brand name: Herceptin), bevacizumab or other hormonal therapies for metastatic disease. You must be one year since prior adjuvant chemotherapy. You must be recovered from surgery and two weeks out of minor surgery or four weeks out of major surgery.

Read more about the advanced breast cancer clinical trial, here
http://www.cancer.gov/clinicaltrials/SWOG-S0500

Posted at 1:48PM on Apr 5th 2007 by Theo de Chaumont-Quitry