【medical-news】【资讯翻译】HER2阳性乳腺癌可从低毒性方案中获益
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翻译时请参照版规 【版务】科技动态版版规及加分细则（ 2014-02-21 更新）
HER2-Positive Breast Cancer Patients WithSmall Tumors Benefit From Low-Toxicity Regimen
http://www.ascopost.com/issues/march-1,-2014/her2-positive-breast-cancer-patients-with-small-tumors-benefit-from-low-toxicity-regimen.aspx
There may be a benefit for treating smallHER2-positive tumors—a breast cancer subset for whom treatment recommendationshave not been established but for whom there is still risk of recurrence—andthis can be done with little toxicity, according to a multicenter studypresented at the 2013 San Antonio Breast Cancer Symposium.1
“Smaller, HER2-positive, node-negative breast cancers are thought tohave a sufficiently high chance of recurring that many doctors have offeredpatients a combination of chemotherapy and trastuzumab [Herceptin] to reducethat risk,” said senior author Eric P. Winer, MD, Chief of the Division ofWomen’s Cancers in the Susan F. Smith Center for Women’s Cancers at Dana-FarberCancer Institute, Boston. “But, as this approach had not been tested in manywomen with smaller tumors, we have lacked a standard approach to preventingrecurrence in this group.”
That may be largely because previousstudies of chemotherapy plus anti-HER2 treatment for node-negative patientshave included few subjects with tumors measuring < 2 cm and virtually nonewith tumors ≤ 1 cm, a group for whom treatment has been debated. The findings ofthe current study offer, for the first time, a set of standard treatmentguidelines for recurrence prevention in this group of patients, according toDr. Winer.
APT Trial
The Adjuvant Paclitaxel and Trastuzumab(APT) study of 406 women with HER2-positive, node-negative tumors ≤ 3 cm waspresented at the San Antonio Breast Cancer Symposium by Sara M. Tolaney, MD,MPH, a medical oncologist at Dana-Farber Cancer Institute, who explained theneed to balance risks and benefits in a group of patients who will likelyderive a small absolute treatment benefit.
“In balancing the risks and benefits of treatment, the development ofregimens with lower degrees of toxicity is particularly important for thispatient population,” she said.
The investigators, therefore, designed amore tolerable chemotherapy regimen than is often given. Patients received onlypaclitaxel at 80 mg/m2 plus trastuzumab at 2 mg/kg weekly for 12 weeks,followed by 9 months of trastuzumab alone at 6 mg/kg every 3 weeks. The studywas a nonrandomized prospective trial to define the outcomes in a uniformlytreated cohort based on the fact that “a prospective randomized trial oftrastuzumab-based therapy is likely not feasible,” Dr. Tolaney said.
Key Findings
After a median follow-up of 3.6 years, only10 of 406 patients experienced a recurrence or death, accounting for 2.5% ofthe population. There were only four local/regional recurrences (0.9%).
Study patients developed three newcontralateral primary breast cancers (0.7%), all HER2-negative, and two distantrecurrences (0.5%). Disease-free survival at 3 years was 98.7% (P < .0001).By hormone receptor status, disease-free survival rates were 98.5% inreceptor-positive patients and 99.2% in receptor-negative patients.
The recurrence-free survival rate (invasivelocoregional recurrence, distant recurrence, death from breast cancer) was99.2%, Dr. Tolaney reported.
Few adverse events were noted. Only twopatients (0.5%) developed symptomatic congestive heart failure, and both casesresolved after discontinuation of trastuzumab. Asymptomatic declines inleft-ventricular ejection fraction were observed in 13 patients (3.2%), and 11patients were able to resume trastuzumab after a treatment interruption.
Dr. Tolaney acknowledged that the study haslimitations. It was a single-arm, nonrandomized trial, and about 20% ofenrolled patients had T1a tumors that already have a very favorable prognosis.Also, two-thirds had hormone receptor–positive tumors, and this may beassociated with late recurrences.
Nevertheless, she suggested that paclitaxelplus trastuzumab can be considered “a reasonable and appealing approach for themajority of patients with stage I HER2-positive breast cancer.”
Practice-Changing Results
Dr. Winer suggested that the results werepractice-changing. For this population, the paclitaxel/trastuzumab doublet“should be considered one of the standard strategies for recurrenceprevention,” he said.
“This doesn’t mean that every single patient with node-negativeHER2-positive disease has to be treated with trastuzumab and chemotherapy, andthere are patients with T1a tumors who almost certainly should not be treatedsystemically,” he said in an interview with The ASCO Post.
The T1a population accounted for 20% ofsubjects, while 9% had relatively large T2 tumors. “This was not just apopulation of patients with tumors less than 1 cm, and in spite of that, theoutcome was very favorable,” he noted.
“We think that for most women with stage I HER2-positive breastcancer, trastuzumab plus paclitaxel is an entirely reasonable, and certainlyappealing, regimen because of its low-toxicity profile,” he maintained.
The APT study also “speaks to a largerpoint,” he said, “and that is the development of effective targeted therapiesprovides the opportunity not only to improve outcomes, but to back off toxicityby limiting some of the chemotherapy. The challenge now is to determine in whoma completely chemotherapy-free regimen might be a possibility.” ■
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新近参与本次活动的会员请查看： http://news.dxy.cn/bbs/topic/21537141
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翻译时请参照版规 【版务】科技动态版版规及加分细则（ 2014-02-21 更新）
HER2-Positive Breast Cancer Patients WithSmall Tumors Benefit From Low-Toxicity Regimen
http://www.ascopost.com/issues/march-1,-2014/her2-positive-breast-cancer-patients-with-small-tumors-benefit-from-low-toxicity-regimen.aspx
There may be a benefit for treating smallHER2-positive tumors—a breast cancer subset for whom treatment recommendationshave not been established but for whom there is still risk of recurrence—andthis can be done with little toxicity, according to a multicenter studypresented at the 2013 San Antonio Breast Cancer Symposium.1
“Smaller, HER2-positive, node-negative breast cancers are thought tohave a sufficiently high chance of recurring that many doctors have offeredpatients a combination of chemotherapy and trastuzumab [Herceptin] to reducethat risk,” said senior author Eric P. Winer, MD, Chief of the Division ofWomen’s Cancers in the Susan F. Smith Center for Women’s Cancers at Dana-FarberCancer Institute, Boston. “But, as this approach had not been tested in manywomen with smaller tumors, we have lacked a standard approach to preventingrecurrence in this group.”
That may be largely because previousstudies of chemotherapy plus anti-HER2 treatment for node-negative patientshave included few subjects with tumors measuring < 2 cm and virtually nonewith tumors ≤ 1 cm, a group for whom treatment has been debated. The findings ofthe current study offer, for the first time, a set of standard treatmentguidelines for recurrence prevention in this group of patients, according toDr. Winer.
APT Trial
The Adjuvant Paclitaxel and Trastuzumab(APT) study of 406 women with HER2-positive, node-negative tumors ≤ 3 cm waspresented at the San Antonio Breast Cancer Symposium by Sara M. Tolaney, MD,MPH, a medical oncologist at Dana-Farber Cancer Institute, who explained theneed to balance risks and benefits in a group of patients who will likelyderive a small absolute treatment benefit.
“In balancing the risks and benefits of treatment, the development ofregimens with lower degrees of toxicity is particularly important for thispatient population,” she said.
The investigators, therefore, designed amore tolerable chemotherapy regimen than is often given. Patients received onlypaclitaxel at 80 mg/m2 plus trastuzumab at 2 mg/kg weekly for 12 weeks,followed by 9 months of trastuzumab alone at 6 mg/kg every 3 weeks. The studywas a nonrandomized prospective trial to define the outcomes in a uniformlytreated cohort based on the fact that “a prospective randomized trial oftrastuzumab-based therapy is likely not feasible,” Dr. Tolaney said.
Key Findings
After a median follow-up of 3.6 years, only10 of 406 patients experienced a recurrence or death, accounting for 2.5% ofthe population. There were only four local/regional recurrences (0.9%).
Study patients developed three newcontralateral primary breast cancers (0.7%), all HER2-negative, and two distantrecurrences (0.5%). Disease-free survival at 3 years was 98.7% (P < .0001).By hormone receptor status, disease-free survival rates were 98.5% inreceptor-positive patients and 99.2% in receptor-negative patients.
The recurrence-free survival rate (invasivelocoregional recurrence, distant recurrence, death from breast cancer) was99.2%, Dr. Tolaney reported.
Few adverse events were noted. Only twopatients (0.5%) developed symptomatic congestive heart failure, and both casesresolved after discontinuation of trastuzumab. Asymptomatic declines inleft-ventricular ejection fraction were observed in 13 patients (3.2%), and 11patients were able to resume trastuzumab after a treatment interruption.
Dr. Tolaney acknowledged that the study haslimitations. It was a single-arm, nonrandomized trial, and about 20% ofenrolled patients had T1a tumors that already have a very favorable prognosis.Also, two-thirds had hormone receptor–positive tumors, and this may beassociated with late recurrences.
Nevertheless, she suggested that paclitaxelplus trastuzumab can be considered “a reasonable and appealing approach for themajority of patients with stage I HER2-positive breast cancer.”
Practice-Changing Results
Dr. Winer suggested that the results werepractice-changing. For this population, the paclitaxel/trastuzumab doublet“should be considered one of the standard strategies for recurrenceprevention,” he said.
“This doesn’t mean that every single patient with node-negativeHER2-positive disease has to be treated with trastuzumab and chemotherapy, andthere are patients with T1a tumors who almost certainly should not be treatedsystemically,” he said in an interview with The ASCO Post.
The T1a population accounted for 20% ofsubjects, while 9% had relatively large T2 tumors. “This was not just apopulation of patients with tumors less than 1 cm, and in spite of that, theoutcome was very favorable,” he noted.
“We think that for most women with stage I HER2-positive breastcancer, trastuzumab plus paclitaxel is an entirely reasonable, and certainlyappealing, regimen because of its low-toxicity profile,” he maintained.
The APT study also “speaks to a largerpoint,” he said, “and that is the development of effective targeted therapiesprovides the opportunity not only to improve outcomes, but to back off toxicityby limiting some of the chemotherapy. The challenge now is to determine in whoma completely chemotherapy-free regimen might be a possibility.” ■
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