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 This is an original JCO publication from 2016. Please visit the JCO website to access the full article.


Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update


 Authors

Abram Recht, Elizabeth A. Comen, Richard E. Fine, Gini F. Fleming, Patricia H. Hardenbergh, Alice Y. Ho, Clifford A. Hudis, E. Shelley Hwang, Jeffrey J. Kirshner, Monica Morrow, Kilian E. Salerno, George W. Sledge Jr, Lawrence J. Solin, Patricia A. Spears, Timothy J. Whelan, Mark R. Somerfield, and Stephen B. Edge

THE BOTTOM LINE

Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update

Guideline Questions and Target Populations

• Is postmastectomy radiotherapy (PMRT) indicated in patients with T1-2 tumors with one to three positive axillary lymph nodes who undergo axillary lymph node dissection (ALND)?

• Is PMRT indicated in patients with T1-2 tumors and a positive sentinel node biopsy (SNB) who do not undergo completion ALND?

• Is PMRT indicated in patients presenting with clinical stage I or II cancers who have received neoadjuvant systemic therapy (NAST)?

• Should regional nodal irradiation (RNI) include the internal mammary (IMNs) and/or supraclavicular-axillary apical nodes when PMRT is used in patients with T1-2 tumors with one to three positive axillary nodes?

Target Audience

Medical oncologists, pathologists, surgeons, oncology nurses, patients, and caregivers

Clinical Question 1

Is PMRT indicated in patients with T1-2 tumors with one to three positive axillary lymph nodes who undergo ALND?

Recommendations

Recommendation 1a. The panel unanimously agreed that the available evidence shows that PMRT reduces the risks of locoregional failure (LRF), any recurrence, and breast cancer mortality for patients with T1-2 breast cancer and one to three positive lymph nodes. However, some subsets of these patients are likely to have such a low risk of LRF that the absolute benefit of PMRT is outweighed by its potential toxicities. In addition, the acceptable ratio of benefit to toxicity varies among patients and physicians. Thus, the decision to recommend PMRT or not requires a great deal of clinical judgment. The panel agreed clinicians making such recommendations for individual patients should consider factors that may decrease the risk of LRF, attenuate the benefit of reduced breast cancer–specific mortality, and/or increase the risk of complications resulting from PMRT. These factors include: patient characteristics (age > 40 to 45 years, limited life expectancy because of older age or comorbidities, or coexisting conditions that might increase the risk of complications), pathologic findings associated with a lower tumor burden (eg, T1 tumor size, absence of lymphovascular invasion, presence of only a single positive node and/or small size of nodal metastases, or substantial response to NAST), and biologic characteristics of the cancer associated with better outcomes and survival and/or greater effectiveness of systemic therapy (eg, low tumor grade or strong hormonal sensitivity; type: informal consensus; evidence quality: intermediate; strength of recommendation: moderate). There are several risk-adaptive models that physicians may find useful in explaining the benefits of PMRT during shared decision making with patients. However, the panel found insufficient evidence to endorse any specific model or to unambiguously define specific patient subgroups to which PMRT should not be administered (type: no recommendation; evidence quality: low; strength of recommendation: weak). Further research is needed on how to accurately estimate individuals’ risk of LRF and hence their potential reductions in LRF and breast cancer mortality.

Recommendation 1b. The decision to use PMRT should be made in a multidisciplinary fashion through discussion among providers from all treating disciplines early in a patient’s treatment course (soon after surgery or before or soon after the initiation of systemic therapy), either in the context of a formal tumor board or by referral (type: informal consensus; evidence quality: insufficient; strength of recommendation: strong).

Recommendation 1c. Decision making must fully involve the patient, whose values as to what constitutes sufficient benefit and how to weigh the risk of complications against this in light of the best information the treating physicians can provide regarding PMRT in her situation must be respected and incorporated into the final treatment choice (type: informal consensus; evidence quality: insufficient; strength of recommendation: strong).

Clinical Question 2

Is PMRT indicated in patients with T1-2 tumors and a positive SNB who do not undergo completion ALND?

Recommendation

For patients with clinical T1-2 tumors with clinically negative nodes, SNB is now generally performed at the time of mastectomy, with omission of ALND if the nodes are negative. ALND has generally been performed if the nodes are positive, but there is increasing controversy about whether this is always necessary, especially if there is limited disease in the affected nodes. The panel recognizes that some clinicians omit axillary dissection with one or two positive sentinel nodes in patients treated with mastectomy. This practice is primarily based on extrapolation of data from randomized trials of patients treated exclusively or predominantly with breastconserving surgery and whole-breast irradiation or breast plus axillary irradiation. In such cases where clinicians and patients elect to omit axillary dissection, the panel recommends that these patients receive PMRTonly if there is already sufficient information to justify its use without needing to know that additional axillary nodes are involved (type: informal consensus; evidence quality: weak; strength of recommendation: moderate).

Clinical Question 3

Is PMRT indicated in patients presenting with clinical stage I or II cancers who have received NAST?

Recommendation

Patients with axillary nodal involvement that persists after NAST (eg, less than a complete pathologic response) should receive PMRT. Observational data suggest a low risk of locoregional recurrence for patients who have clinically negative nodes and receive NAST or who have a complete pathologic response in the lymph nodes with NAST. However, there is currently insufficient evidence to recommend whether PMRT should be administered or can be routinely omitted in these groups. The panel recommends entering eligible patients in clinical trials that examine this question (type: informal consensus; evidence quality: low; strength of recommendation: weak).

Clinical Question 4

Should RNI include both the IMNs and supraclavicular-axillary apical nodes when PMRT is used in patients with T1-2 tumors with one to three positive axillary nodes?

Recommendation

The panel recommends treatment generally be administered to both the IMNs and the supraclavicular-axillary apical nodes in addition to the chest wall or reconstructed breast when PMRT is used for patients with positive axillary lymph nodes. There may be subgroups that will experience limited, if any, benefits from treating both these nodal areas compared with treating only one or perhaps treating only the chest wall or reconstructed breast. There is insufficient evidence at this time to define such subgroups in detail. Additional research is needed to identify them (type: informal consensus; evidence quality: intermediate; strength of recommendation: moderate).

More information, including a Data Supplement, a Methodology Supplement, slide sets, and clinical tools and resources, is available at www.asco.org/pmrt-guideline and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net.

The American Society of Clinical Oncology believes that cancer clinical trials are vital to inform medical decisions and improve cancer care and that all patients should have the opportunity to participate.

SUMMARY OF RECOMMENDATIONS

Clinical QuestionRecommendationEvidence Rating
Is PMRT indicated in patients with T1-2 tumors with one to three positive axillary lymph nodes who have axillary lymph node dissection?The Panel unanimously agreed that the available evidence shows that PMRT reduces the risks of LRF, any recurrence, and breast cancer mortality for patients with T1-2 breast cancer with 1-3 positive axillary nodes

Type: Evidence-based

Evidence quality: High

Strength of recommendation: Strong

However, some subsets of these patients are likely to have such a low risk of LRF that the absolute benefit of PMRT is outweighed by its potential toxicities

Type: Evidence-based

Evidence quality: Intermediate

Strength of recommendation: Strong

In addition, the acceptable ratio of benefit to toxicity varies among patients and physicians. Thus, the decision to recommend PMRT or not requires a great deal of clinical judgement. The Panel agreed clinicians making such recommendations for an individual patient should consider factors that may decrease the risk of LRF, attenuate the benefit of reduced breast cancer-specific mortality, and/or increase the risks of complications from PMRT. These factors include: patient characteristics (age older than 40-45 years, limited life expectancy due to older age or comorbidities, coexisting conditions that might increase the risk of complications); pathologic findings associated with a lower tumor burden (T1 tumor size, the absence of lymphovascular invasion, the presence of only a single positive node and/or small size of nodal metastases, or substantial response to NAST); and biologic characteristics of the cancer associated with better outcomes and survival and/or greater effectiveness of systemic therapy (e.g. low tumor grade, strongly hormonally sensitive)

Type: Informal Consensus

Evidence quality: Intermediate

Strength of recommendation: Moderate

There are several risk-adaptive models, which physicians may find useful in explaining the benefits of PMRT during shared decision-making with patients. However, the Panel found insufficient evidence to endorse any specific model or to unambiguously define specific patient subgroups for whom PMRT should not be given

Type: No recommendation

Evidence quality: Low

Strength of recommendation: Weak

Further research is needed on how to accurately estimate individuals' risk of LRF and hence their potential reductions in LRF and breast cancer mortality.
The decision to use PMRT should be made in a multidisciplinary fashion by discussion among providers from all treating disciplines early in the patient's treatment course (soon after surgery or prior to or soon after the initiation of systemic therapy), either in the context of a formal tumor board or by referral.

Type: Informal consensus

Evidence quality: Insufficient

Strength of recommendation: Strong

Decision-making must fully involve the patient, whose values as to what constitute sufficient benefits and how to weigh the risks of complications against these in light of the best information the treating physicians can provide as to those of PMRT in their situation must be respected and incorporated into the final treatment choice.

Type: Informal consensus

Evidence quality: Insufficient

Strength of recommendation: Strong

Is PMRT indicated in patients with T1-2 tumors and a positive sentinel node biopsy who do not undergo completion axillary lymph node dissection?For patients with clinical T1-2 tumors with clinically negative nodes sentinel node biopsy (SNB) is now generally performed at the time of mastectomy with omission of ALND if the nodes are negative. ALND has generally been performed if the nodes are positive, but there is increasing controversy about whether this is always necessary, especially if there is limited disease in the affected nodes. The Panel recognizes that some clinicians omit axillary dissection with 1 or 2 positive sentinel nodes in patients treated by mastectomy. This practice is primarily based on extrapolation of data from randomized trials of patients treated exclusively or predominantly with breastconserving surgery and whole breast irradiation or breast plus axillary irradiation. In such cases where clinicians and patients elect to omit axillary dissection, the Panel recommends that these patients receive PMRT only if there is already sufficient information to justify its use without needing to know that additional axillary nodes are involved.

Type: Informal consensus

Evidence quality: Weak

Strength of recommendation: Moderate

Is PMRT indicated in patients with clinical Stage I or II cancers who have received neoadjuvant systemic therapy?Patients with axillary nodal involvement that persists following NAST (e.g. less that a complete pathological response) should receive PMRT. Observational data suggest a low risk of local-regional recurrence for patients who have clinically negative nodes and receive NAST or who have a complete pathological response in the lymph nodes with NAST. However, there is currently insufficient evidence to recommend whether PMRT should be given or can be routinely omitted in these groups. The Panel recommends entering eligible patients into clinical trials that examine this question.

Type: Informal consensus

Evidence quality: Low

Strength of recommendation: Weak

Should RNI include both the internal mammary and supraclavicularaxillary apical nodes when PMRT is used in patients with T1-2 tumors with one to three positive axillary nodes?The Panel recommends treatment generally be given to both the internal mammary nodes and the supraclavicular-axillary apical nodes in addition to the chest wall or reconstructed breast when PMRT is used for patients with positive axillary lymph nodes. There may be subgroups that will have limited, if any, benefits from treating both these nodal areas compared to treating only one of them or, perhaps, treating only the chest wall or reconstructed breast. There is insufficient evidence at this time to define such subgroups in detail. Additional research is needed to identify them.

Type: Informal consensus

Evidence quality: Intermediate

Strength of recommendation: Moderate




ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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