Joan M
02-11-2012, 03:44 PM
Here's a "flash update" of recent changes to the NCCN's guidelines for treating breast cancer, as well as a link to the patient guidelines. In order to see the physician guidelines that correspond to the pages in the update below, you will have to register to log into the NCCN's website.
The guidelines start on page 58:
http://www.nccn.com/files/cancer-guidelines/breast/index.html#/1/
Some of the flash update below does not apply to HER2+ patients.
Flash Update Sent January 30, 2012
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer. These NCCN Guidelines® are currently available as Version 1.2012.
Invasive Breast Cancer
Work-up of recurrent disease or initial work-up for Stage IV disease
A footnote was added for clarification stating "False negative ER and/or PR determinations occur, and there may be discordance between the ER and/or PR determination between the primary and metastatic tumor(s). Therefore, endocrine therapy with its low attendant toxicity may be considered in patients with non-visceral or asymptomatic visceral tumors, especially in patients with clinical characteristics predicting for a hormone receptor positive tumor (eg, long disease free interval, limited sites of recurrence, indolent disease, or older age)." (page: BINV-16)
Under systemic adjuvant therapy
For patients with hormone receptor positive, HER2 negative disease ( pT1, pT2, or pT3 and pNmi (< 2 mm axillary node metastasis), with microinvasive or < 0.5 cm tumors, adjuvant chemotherapy along with endocrine therapy was added as a category 2B option (page: BINV-6). Previously endocrine therapy (category 2B) was the only option listed for these patients.
The duration of adjuvant for endocrine therapy in both premenopausal and postmenopausal women was revised (page: BINV-J).
Under systemic treatment of recurrent or stage IV disease
In postmenopausal patients with hormone-positive disease, with no prior endocrine therapy within the past year, and with a plan to undergo aromatase inhibitor therapy (page: BINV-18), a new footnote was added stating "A single study (S0226) in women with hormone receptor-positive breast cancer and no prior chemotherapy, biological therapy, or endocrine therapy for metastatic disease demonstrated that the addition of fulvestrant to anastrozole resulted in prolongation of time to progression (Hazard rate for recurrence 0.80; 95% CI 0.68 - 0.94; stratified log-rank P = 0.007) and improvement in overall survival (Hazard rate 0.81; 95% CI 0.65- 1.00; stratified log-rank P = 0.049). Subset analysis suggested that patients without prior adjuvant tamoxifen and more than 10 years since diagnosis experienced the greatest benefit. A study of similar design (FACT) demonstrated no advantage in time to progression with the addition of fulvestrant to anastrozole (Hazard rate 0.99; 95% CI 0.81-1.20; P = 0.91)."
Surgical axillary staging for I, IIA, IIB and lllA T3, N1, M0 (page: BINV- D) the following was added:
For patients clinically node positive at time of diagnosis and found to be FNA or core biopsy positive, axillary dissection level l/ll.
Principles of Monitoring Metastatic Disease is new to the Guidelines (page: BINV-M).
On the page listing subsequent endocrine therapy for patients (page: BINV-N), a new footnote was added stating "A single study (BOLERO-2) in women with hormone receptor-positive, HER2-negative metastatic breast cancer and prior therapy with a nonsteroidal aromatase inhibitor demonstrated improvement in time to progression with the addition of everolimus (an mTOR inhibitor) to exemestane (Hazard rate 0.44; 95% CI 0.36-0.53; log-rank P = <1 x 10-16) and with increase in toxicity. No survival analysis is available. A randomized study using the mTOR inhibitor temsirolimus in combination with endocrine therapy did not demonstrate any improvement in outcome. Consider the addition of everolimus to exemestane in women who fulfill the eligibility criteria of BOLERO-2."
Breast Cancer During Pregnancy
The footnote ‘c' was modified to include that the "use of paclitaxel weekly administration after the first trimester is acceptable if clinically indicated by disease status".
Discussion section was updated to reflect the changes in the algorithm.
***********
Joan
The guidelines start on page 58:
http://www.nccn.com/files/cancer-guidelines/breast/index.html#/1/
Some of the flash update below does not apply to HER2+ patients.
Flash Update Sent January 30, 2012
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer. These NCCN Guidelines® are currently available as Version 1.2012.
Invasive Breast Cancer
Work-up of recurrent disease or initial work-up for Stage IV disease
A footnote was added for clarification stating "False negative ER and/or PR determinations occur, and there may be discordance between the ER and/or PR determination between the primary and metastatic tumor(s). Therefore, endocrine therapy with its low attendant toxicity may be considered in patients with non-visceral or asymptomatic visceral tumors, especially in patients with clinical characteristics predicting for a hormone receptor positive tumor (eg, long disease free interval, limited sites of recurrence, indolent disease, or older age)." (page: BINV-16)
Under systemic adjuvant therapy
For patients with hormone receptor positive, HER2 negative disease ( pT1, pT2, or pT3 and pNmi (< 2 mm axillary node metastasis), with microinvasive or < 0.5 cm tumors, adjuvant chemotherapy along with endocrine therapy was added as a category 2B option (page: BINV-6). Previously endocrine therapy (category 2B) was the only option listed for these patients.
The duration of adjuvant for endocrine therapy in both premenopausal and postmenopausal women was revised (page: BINV-J).
Under systemic treatment of recurrent or stage IV disease
In postmenopausal patients with hormone-positive disease, with no prior endocrine therapy within the past year, and with a plan to undergo aromatase inhibitor therapy (page: BINV-18), a new footnote was added stating "A single study (S0226) in women with hormone receptor-positive breast cancer and no prior chemotherapy, biological therapy, or endocrine therapy for metastatic disease demonstrated that the addition of fulvestrant to anastrozole resulted in prolongation of time to progression (Hazard rate for recurrence 0.80; 95% CI 0.68 - 0.94; stratified log-rank P = 0.007) and improvement in overall survival (Hazard rate 0.81; 95% CI 0.65- 1.00; stratified log-rank P = 0.049). Subset analysis suggested that patients without prior adjuvant tamoxifen and more than 10 years since diagnosis experienced the greatest benefit. A study of similar design (FACT) demonstrated no advantage in time to progression with the addition of fulvestrant to anastrozole (Hazard rate 0.99; 95% CI 0.81-1.20; P = 0.91)."
Surgical axillary staging for I, IIA, IIB and lllA T3, N1, M0 (page: BINV- D) the following was added:
For patients clinically node positive at time of diagnosis and found to be FNA or core biopsy positive, axillary dissection level l/ll.
Principles of Monitoring Metastatic Disease is new to the Guidelines (page: BINV-M).
On the page listing subsequent endocrine therapy for patients (page: BINV-N), a new footnote was added stating "A single study (BOLERO-2) in women with hormone receptor-positive, HER2-negative metastatic breast cancer and prior therapy with a nonsteroidal aromatase inhibitor demonstrated improvement in time to progression with the addition of everolimus (an mTOR inhibitor) to exemestane (Hazard rate 0.44; 95% CI 0.36-0.53; log-rank P = <1 x 10-16) and with increase in toxicity. No survival analysis is available. A randomized study using the mTOR inhibitor temsirolimus in combination with endocrine therapy did not demonstrate any improvement in outcome. Consider the addition of everolimus to exemestane in women who fulfill the eligibility criteria of BOLERO-2."
Breast Cancer During Pregnancy
The footnote ‘c' was modified to include that the "use of paclitaxel weekly administration after the first trimester is acceptable if clinically indicated by disease status".
Discussion section was updated to reflect the changes in the algorithm.
***********
Joan