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05-13-2005, 04:50 AM

Kaye,
I have been treated with Herceptin since August of 1999. This test currently should be used with other standard tests that measure progression although that may change in the future as more data is collected.

Less than 15 means that you are currently considered to be in remission.

A score higher than 15 means that you should be treated with Herceptin if you are currently not taking it. If you are currently taking Herceptin and your score is above 15, your onc should consider changing your treatment by using alternative combinations with or without Herceptin.

Below is an abstract which was presented at the 2004 SABCS meeting. More data may come out of ASCO this week.

Hugs
Christine

[6001] Clinical utility of circulating HER-2/neu in monitoring and prediction of progression-free survival in metastatic breast cancer patients undergoing trastuzumab-based therapy.

Esteva FJ, Cheli C, Fritsche HA, Fornier M, Slamon DJ, Thiel RP, Luftner D, Ghani F.. UT M. D. Anderson Cancer Center, Houston, TX; Bayer Healthcare, Tarrytown, NY; Memorial Sloan-Kettering Cancer Center, New York, NY; University of California Los Angeles, Los Angeles, CA; Thiel Consultants, Oxford, CT; Humboldt-Universitat, Berlin, Germany

The objective of this study was to determine the clinical utility of serum HER-2/neu in monitoring metastatic breast cancer patients undergoing trastuzumab-based therapy and to compare these results to those obtained using CA15-3. Additionally, we sought to determine whether early changes in serum HER-2/neu levels could be a predictor of progression-free survival (PFS). Patients and Methods: Patient sera were obtained retrospectively from 103 patients with HER-2/neu overexpressing metastatic breast cancer who were scheduled to be treated with trastuzumab, with or without additional therapies. Serum samples were taken prior to initiation of trastuzumab-based therapy, and at the time of clinical assessment over a 12-20 month period. Samples were tested using Bayer HER-2/neu and CA 15-3 ELISA assays.

Results: Concordance with clinical status in monitoring patients undergoing trastuzumab-based treatment using HER-2/neu and CA15-3 as single tests were 0.793 and 0.627, respectively and when the tests were used in combination concordance increased to 0.829. Baseline HER-2/neu levels were not predictive of PFS (p=0.12). However, progression-free- survival was significantly different in patients with >75% of baseline levels of HER-2/neu as compared to those with < 75% of baseline levels at 2-4 weeks after the start of therapy. The median PFS for those patients whose HER-2/neu value was less than 75% of baseline was 587 days. In the cohort with > 75% of baseline the median PFS was 260 days (p=0.035).

Conclusion: Serum HER-2/neu testing is clinically valuable in monitoring metastatic breast cancer patients undergoing trastuzumab-based treatment, and provides additional value over the commonly used CA 15-3 test. Futhermore, the percentage of baseline HER-2/neu levels in the early weeks after the start of therapy may be an early predictor of progression-free-survival.

Date: Saturday, December 11, 2004 07:00 AM
Session Info: Poster Session: Detection/Diagnosis: Circulating Markers (7:00 AM-9:00 AM)

05-13-2005, 04:50 AM	#5
Christine Guest Posts: n/a	Kaye, I have been treated with Herceptin since August of 1999. This test currently should be used with other standard tests that measure progression although that may change in the future as more data is collected. Less than 15 means that you are currently considered to be in remission. A score higher than 15 means that you should be treated with Herceptin if you are currently not taking it. If you are currently taking Herceptin and your score is above 15, your onc should consider changing your treatment by using alternative combinations with or without Herceptin. Below is an abstract which was presented at the 2004 SABCS meeting. More data may come out of ASCO this week. Hugs Christine [6001] Clinical utility of circulating HER-2/neu in monitoring and prediction of progression-free survival in metastatic breast cancer patients undergoing trastuzumab-based therapy. Esteva FJ, Cheli C, Fritsche HA, Fornier M, Slamon DJ, Thiel RP, Luftner D, Ghani F.. UT M. D. Anderson Cancer Center, Houston, TX; Bayer Healthcare, Tarrytown, NY; Memorial Sloan-Kettering Cancer Center, New York, NY; University of California Los Angeles, Los Angeles, CA; Thiel Consultants, Oxford, CT; Humboldt-Universitat, Berlin, Germany The objective of this study was to determine the clinical utility of serum HER-2/neu in monitoring metastatic breast cancer patients undergoing trastuzumab-based therapy and to compare these results to those obtained using CA15-3. Additionally, we sought to determine whether early changes in serum HER-2/neu levels could be a predictor of progression-free survival (PFS). Patients and Methods: Patient sera were obtained retrospectively from 103 patients with HER-2/neu overexpressing metastatic breast cancer who were scheduled to be treated with trastuzumab, with or without additional therapies. Serum samples were taken prior to initiation of trastuzumab-based therapy, and at the time of clinical assessment over a 12-20 month period. Samples were tested using Bayer HER-2/neu and CA 15-3 ELISA assays. Results: Concordance with clinical status in monitoring patients undergoing trastuzumab-based treatment using HER-2/neu and CA15-3 as single tests were 0.793 and 0.627, respectively and when the tests were used in combination concordance increased to 0.829. Baseline HER-2/neu levels were not predictive of PFS (p=0.12). However, progression-free- survival was significantly different in patients with >75% of baseline levels of HER-2/neu as compared to those with < 75% of baseline levels at 2-4 weeks after the start of therapy. The median PFS for those patients whose HER-2/neu value was less than 75% of baseline was 587 days. In the cohort with > 75% of baseline the median PFS was 260 days (p=0.035). Conclusion: Serum HER-2/neu testing is clinically valuable in monitoring metastatic breast cancer patients undergoing trastuzumab-based treatment, and provides additional value over the commonly used CA 15-3 test. Futhermore, the percentage of baseline HER-2/neu levels in the early weeks after the start of therapy may be an early predictor of progression-free-survival. Date: Saturday, December 11, 2004 07:00 AM Session Info: Poster Session: Detection/Diagnosis: Circulating Markers (7:00 AM-9:00 AM)