Annals of Oncology

Annals of Oncology Advance Access originally published online on September 7, 2005
Annals of Oncology 2005 16(10):1569-1583; doi:10.1093/annonc/mdi326

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© 2005 European Society for Medical Oncology

Review

Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005

A. Goldhirsch^1,2,*, J. H. Glick³, R. D. Gelber⁴, A. S. Coates⁵, B. Thürlimann⁶, H.-J. Senn⁷ and Panel Members

¹ International Breast Cancer Study Group, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; ² European Institute of Oncology, Milan, Italy; ³ Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA; ⁴ Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA; ⁵ The Cancer Council Australia and University of Sydney, Sydney, NSW, Australia; ⁶ Division of Gynecologic Oncology, Kantonsspital, St Gallen, Switzerland; ⁷ Zentrum für Tumordiagnostik und Prävention, Silberturm, Grossacker, St Gallen, Switzerland

^* Correspondence to: Dr A. Goldhirsch, International Breast Cancer Study Group, European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy. E-mail: aron.goldhirsch{at}ibcsg.org

	Abstract

Top Abstract St Gallen 2005: news... Panel recommendations and... Systemic treatment regimens Radiation therapy Specific aspects of treatments Commentary Appendix References

 
The ninth St Gallen (Switzerland) expert consensus meeting in January 2005 made a fundamental change in the algorithm for selection of adjuvant systemic therapy for early breast cancer. Rather than the earlier approach commencing with risk assessment, the Panel affirmed that the first consideration was endocrine responsiveness. Three categories were acknowledged: endocrine responsive, endocrine non-responsive and tumors of uncertain endocrine responsiveness. The three categories were further divided according to menopausal status. Only then did the Panel divide patients into low-, intermediate- and high-risk categories. It agreed that axillary lymph node involvement did not automatically define high risk. Intermediate risk included both node-negative disease (if some features of the primary tumor indicated elevated risk) and patients with one to three involved lymph nodes without additional high-risk features such as HER2/neu gene overexpression. The Panel recommended that patients be offered chemotherapy for endocrine non-responsive disease; endocrine therapy as the primary therapy for endocrine responsive disease, adding chemotherapy for some intermediate- and all high-risk groups in this category; and both chemotherapy and endocrine therapy for all patients in the uncertain endocrine response category except those in the low-risk group.

	St Gallen 2005: news and progress

Top Abstract St Gallen 2005: news... Panel recommendations and... Systemic treatment regimens Radiation therapy Specific aspects of treatments Commentary Appendix References

 
Since 1978, St Gallen (Switzerland) conferences have consistently focused on reaching expert consensus on the implications of evidence for patient treatment selection [1]. The ninth such meeting, in January 2005, attracted 4166 participants from 78 countries. Highlights reported here reflect information that has emerged since the last such meeting in 2003.

A Consensus Panel of experts (see Appendix), developed a series of guidelines and recommendations for selection of adjuvant systemic treatments in specific patient populations, modifying its previous guidelines and recommendations [1] based on the new evidence that has emerged since 2003. The declaration of consensus was based on best available evidence as presented at the St Gallen and other recent meetings and reflected by votes recorded at the Panel session. The manuscript was subsequently reviewed by all members of the Panel, and by other opinion leaders as acknowledged. The new treatment recommendations stress endocrine responsiveness and modify risk classification, since prognosis per se is now less of an issue influencing treatment choice.

This report concentrates on new aspects. Its recommendations are evidence-based to the extent possible, so recent evidence is critical, as summarized in Table 1. Breast cancer mortality is decreasing in many countries, despite a rising incidence. Care for patients with breast cancer is essentially multidisciplinary, and there is an important general trend to more selective interventions to minimize acute and late toxicity without compromising efficacy. Just as limited surgery allows conservation of the breast and unaffected lymph nodes and limited radiation therapy is being studied, so appropriate adjuvant systemic therapy involves choosing treatments tailored to individual patients according to assessment of endocrine responsiveness. This last aspect is perhaps the most important innovation for the 2005 conference.

View this table: [in this window] [in a new window]   Table 1. Recent research findings presented at the 9th International Conference on Primary Therapy of Early Breast Cancer and their implications for patient care

 
Endocrine responsiveness
Three disease responsiveness categories were defined:

(i) Endocrine responsive: the cells express steroid hormone receptors (diagnosed with proper immunohistological or biochemical methods) and for which it is probable that endocrine therapies are effective in improving disease-free and overall survival.

(ii) Endocrine response uncertain: some expression of steroid hormone receptors either quantitatively low or qualitatively insufficient to indicate a substantial chance for response to endocrine therapies alone, thus suggesting the need for chemotherapy. The exact boundary between ‘endocrine responsive’ and ‘endocrine response uncertain’ is undecided, and may well be different in different clinical settings (e.g. according to number of involved axillary lymph nodes or menopausal status).

(iii) Endocrine non-responsive: cells have no detectable expression of steroid hormone receptors.

The value of this primary classification is that endocrine therapies may be offered alone to selected patients with clearly endocrine responsive disease, while chemotherapy alone is offered to patients with endocrine non-responsive disease. The newly defined category of uncertain endocrine responsiveness is suited to combinations of chemotherapy and endocrine therapy.

Features indicative of uncertainty of endocrine responsiveness include low levels of steroid hormone receptor immunoreactivity (usually considered as <10% of cells positive), lack of progesterone receptors (PgR) [irrespective of the expression of estrogen receptors (ER)], features suggesting potential resistance to particular endocrine therapies (e.g. HER2/neu overexpression and tamoxifen), a high number of involved lymph nodes, high tumor levels of urokinase-type plasminogen activator/plasminogen activator inhibitor type 1 (uPA/PAI-1) [91] and increased proliferation markers. Since any detectable steroid hormone receptor indicates some degree of endocrine responsiveness, such patients should receive endocrine therapy, but the doubtful adequacy of such treatment alone suggests a need also for adjuvant chemotherapy.

As biological understanding of factors influencing treatment response improves, it is likely that the language used to describe various aspects of discussion on treatment choice will evolve. Currently, the terms endocrine responsive, uncertain endocrine response (see text), and endocrine non-responsive refer to the groups of tumors that are responsive to endocrine therapies alone, chemotherapy and endocrine therapy combinations, and chemotherapy alone, respectively. Endocrine responsiveness may not in future be the most precise way to describe the continuum of therapeutic targets against which new biological agents are effective.

 

Research findings summarized in Table 1 bring together and interpret recent data, and lead to re-interpretion of some older observations according to newer hypotheses (generated by clinical observations). While much useful information will come from new technologies, there is also a valuable resource of information in data from current and past studies. Subset analysis is extremely helpful as we try to tailor treatment to individual patients. Such analysis is statistically proper provided sufficient numbers of patients are available and provided hypotheses generated in one dataset can be independently confirmed [92]. An important finding from this approach was the large benefit of chemotherapy alone for postmenopausal women with endocrine non-responsive disease [93], which was confirmed by an analysis of patients with ER-poor tumors enrolled in randomized trials unconfounded by tamoxifen [information derived from the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) Overview] [82]. Retrospective, exploratory analysis of the SWOG 8814/Intergroup 0100 trial similarly indicated little additional benefit from CAF (cyclophosphamide, adriamycin and 5-fluorouracil) chemotherapy among patients with high ER levels who also received tamoxifen [78, 94, 95], in contrast to the benefit of CAF in sequence with tamoxifen in patients with low and intermediate levels of ER expression. Similarly, although more intensive chemotherapy (compared with a less intensive ‘standard’) is reproducibly more effective across trials in cohorts of patients with endocrine non-responsive disease, this effect is almost imperceptible in the cohorts with endocrine responsive disease [81].

Risk categories
Nodal status remains the most important feature for defining risk category. Node-negative status, including sentinel node negative, was accepted overwhelmingly to be the major condition defining low risk [96]. Although nodal micrometastases were prognostically relevant in several studies [31, 32], the Panel considered that neither they nor isolated tumor cells in lymph nodes should influence risk allocation and treatment choice. Involvement of four or more nodes in the axilla by itself indicated high risk, but patients with one to three nodes involved required significant HER2/neu overexpression or amplification [58] to be included in the high-risk group, with other patients with one to three nodes included in the intermediate-risk category. The reproducibility of HER2/neu testing was recognized as a significant methodological problem [97], but was not directly addressed by the Panel. Fluorescence in situ hybridization (FISH) testing was viewed as more reliable if HER2/neu was to dictate risk group or treatment choice.

Tumors larger than 2 cm (measured as the invasive component on the pathological specimen), indicated intermediate- or high-risk allocation, even in the absence of other adverse prognostic features. The risk allocation of tumors below 1 cm in size and negative nodes remained controversial. Some but not all Panel members viewed all such patients as having an excellent prognosis regardless of any additional feature (i.e. despite high-grade histology or the absence of steroid hormone receptor expression) [98]. Recent observations indicate that treatment choice for patients with very small tumors (but not including microinvasive disease) should be based upon endocrine responsiveness [99].

While tumor (histological or nuclear) grade was accepted as useful for risk allocation, quantitative Ki67 expression was not. Other tumor features (Table 1) were not viewed by the panelists as sufficiently established to guide responsiveness or prognosis.

Gene expression profiling studies of several types were reviewed (Table 1). The Panel overwhelmingly endorsed the need for further prospective studies of gene profiling both for prognostic estimation, and especially to aid treatment choice. Such trials are being discussed and hopefully will soon be activated [33, 100].

The Panel modified classification of risk, defining three categories: low-, intermediate- and high-risk groups (Table 2). Risk is a continuum, so distinction between risk categories is inevitably arbitrary and indeed less important now that endocrine responsiveness is the primary consideration in treatment choice. The new risk groups departed from the traditional node-positive/node-negative boundary, by including some patients with node-negative, low-grade disease but with features conferring a worse prognosis and patients with one to three involved axillary lymph nodes but no other adverse features in an intermediate-risk group (Table 2).

View this table: [in this window] [in a new window]   Table 2. Definition of risk categories for patients with operated breast cancer

 
The Panel added two features not previously accepted as sufficiently reliable to define risk category. The first was overexpession or amplification of the HER2/neu gene. Despite issues related to reproducibility of immunohistochemistry staining or FISH testing for HER2/neu, it was felt that HER2/neu status should be regarded as useful for patient care, with overexpression indicating a worsened prognosis [101]. Overexpressed or amplified HER2/neu may also have predictive value. It may indicate a lower probability of response to tamoxifen [21] and perhaps suggest treatment with taxanes or anthracyclines [102], rather than CMF (cyclophosphamide, methotrexate and 5-fluorouracil).

The second new adverse prognostic feature was peritumoral vessel invasion [103–105], especially lymphovascular invasion [106]. This proved somewhat controversial, but was accepted by the majority of panelists for patients with node-negative disease [107]. Its value in patients with one or few positive axillary lymph nodes was considered uncertain, and insufficient at the present time to influence the hierarchical risk allocation (e.g. a patient with one positive axillary node, no HER2/neu overexpression should remain in the intermediate-risk category despite peritumoral vascular invasion).

Several instruments are available to help estimate the risk of breast cancer-related events and the reduction of these risks by given therapies, as well as their costs in terms of side-effects [108, 109]. Adjuvant! On line was independently validated by Olivotto et al. [110] and provides simplified (average) estimates for various clinical scenarios allowing graphical presentation of risks and benefits during consultations. The appeal of these instruments lies in their simplified and averaged format, but this is also their major drawback.

The historical evolution of thinking about risk and responsiveness may be summarized as follows: in 2001 multiple categories of risk were based upon nodal status (three risk categories for node-negative and a fourth for the node-positive group); 2003 added endocrine responsiveness to define both risk and treatment choice leading to only two categories of risk for node-negative disease plus one for node-positive; in 2005 endocrine responsiveness is removed from determination of risk since it is the primary factor determining treatment choice (Table 3). The 2005 edition defines three risk categories including a group merging higher risk node-negative disease and lower risk node-positive disease into an intermediate-risk group ‘across nodal status’.

View this table: [in this window] [in a new window]   Table 3. Choice of treatment modalities 2005 (see text)

 

	Panel recommendations and guidelines

Top Abstract St Gallen 2005: news... Panel recommendations and... Systemic treatment regimens Radiation therapy Specific aspects of treatments Commentary Appendix References

 
This section and Tables 3 and 4 summarize the recommendations and guidelines for post-operative adjuvant systemic therapies of early breast cancer as updated by the International Consensus Panel during the St Gallen Conference, 2005. The Panel emphasized that these guidelines are based on evidence from clinical trials demonstrating that various adjuvant therapies can reduce the risk of relapse and increase survival duration, and include expert interpretation of the implications of this evidence for clinical decision making. Clinical trial evidence applies only on average for a patient population. Selection of treatment for an individual typically involves attempts to relate clinical trial findings to specific subgroups, despite the uncertainties inherent in this step.

View this table: [in this window] [in a new window]   Table 4. Adjuvant systemic treatment regimens for patients with operable breast cancera

 
Patient preferences will frequently influence treatment choice. A thorough discussion of the potential benefits and risks of each therapeutic option is required for each patient. Therefore, these recommendations are not intended as prescriptive for all patients, since circumstances, attitudes toward treatment and availability of resources may vary both among individuals and across health care systems in different parts of the world.

Emerging evidence on postoperative radiation therapy, preoperative systemic therapy, biological therapies, choice, timing and duration of endocrine treatments and chemotherapy regimen are also described within sections of Table 1.

	Systemic treatment regimens

Top Abstract St Gallen 2005: news... Panel recommendations and... Systemic treatment regimens Radiation therapy Specific aspects of treatments Commentary Appendix References

 
Choice of modalities
Treatment allocation follows considerations related to endocrine responsiveness, which are summarized in Table 3. Patients with tumors that express some level of steroid hormone receptors but with characteristics indicating a potential clinically relevant (slight to substantial) benefit from adding chemotherapy to endocrine therapy were defined as having an uncertain degree of endocrine responsiveness. While such patients should receive endocrine therapy, adding four to six courses of chemotherapy to the adjuvant program was viewed as appropriate. The endocrine components of these therapies should be tailored according to menopausal status.

Low-risk group
In the low-risk category there are by definition no endocrine non-responsive cancers. Patients with endocrine responsive low-risk disease should be offered an endocrine treatment according to menopausal status (Table 3). If endocrine treatment is contra-indicated (e.g. known intolerance, co-morbid condition) or rejected, the alternative of no adjuvant systemic treatment is a reasonable option.

Intermediate-risk group
Intermediate-risk (Table 3) includes patients with endocrine responsive disease for whom endocrine therapy alone is reasonable, as well as patients with endocrine non-responsive disease for whom chemotherapy alone is indicated. Between these extremes, some patients with endocrine responsive disease or disease of uncertain endocrine responsiveness should receive chemotherapy in addition to endocrine treatment. Experimental and clinical experience has shown that tamoxifen, and probably other selective estrogen receptor modulators (e.g. toremifene), should not be administered concurrently with chemotherapy, especially for patients in whom the disease is of uncertain endocrine responsiveness [78, 113]. It is not known whether concurrent use of chemotherapy and other types of endocrine therapies (e.g. GnRH analog for premenopausal patients) should be similarly avoided, though concurrent treatment works well in advanced disease [111] and in the preoperative treatment setting [112].

High-risk group
Most patients in the high-risk group (Table 3) are likely to receive chemotherapy unless it is contraindicated (owing to a co-morbid condition) or rejected by patient preference. Elderly patients at high risk of relapse and without significant co-morbidity should be offered chemotherapy. EBCTCG Overview analyses for the ER-poor cohort in trials not confounded by tamoxifen show that the benefits of adjuvant chemotherapy are substantial and unrelated to age in such patients. Elderly patients with co-morbidities, but with a sufficiently long life expectancy, require difficult individualized decisions about adjuvant systemic therapy outside clinical trials.

Endocrine therapies for premenopausal women
Published EBCTCG Overview results indicated a beneficial effect of tamoxifen [114] and of ovarian ablation [115], the latter only in trials without chemotherapy [116]. Ovarian ablation and tamoxifen yielded results similar to those obtained with chemotherapy, while the need for both modalities in women with endocrine responsive disease remains unclear [117].

The 2005 Panel again viewed tamoxifen as a standard adjuvant treatment for premenopausal women with endocrine responsive disease who have an indication for endocrine therapy alone. Ovarian function suppression (OFS) was accepted as an alternative where tamoxifen was contraindicated [118]. While admitting the lack of conclusive data favoring the combination of tamoxifen plus ovarian function suppression, this was accepted as reasonable for very young patients, especially in intermediate- and high-risk groups, and for premenopausal patients of any age at high risk, especially if chemotherapy did not induce OFS. The lack of evidence on the combination of OFS and tamoxifen in patients with intermediate risk and those for whom endocrine therapy alone is prescribed emphasizes the strategic importance of the ongoing trials such as SOFT and TEXT [75]. The Panel was reluctant to recommend the use of aromatase inhibitors plus GnRH analog for premenopausal patients outside clinical trials, although the majority accepted the combination as an option for women with contraindications to adjuvant tamoxifen especially for those with node-positive disease. Tamoxifen should be avoided in pregnancy owing to its teratogencity [119].

Optimal duration of ovarian function suppression is unknown. Patients with tumors overexpressing HER2/neu [120] may benefit if the entire period of tamoxifen were covered with a GnRH analog.

Most panelists agreed that tamoxifen should be given sequentially after adjuvant chemotherapy, but timing of OFS in relation to chemotherapy was less clearly defined. Sequential use of any indicated chemotherapy before OFS allows assessment of chemotherapy-induced amenorrhea [121].

Patients who received adjuvant tamoxifen when they were premenopausal for node positive, endocrine responsive disease, might consider later continuation of the adjuvant endocrine treatment with letrozole if they become postmenopausal in the interim. Almost 14% of the patients in the MA-17 trial were premenopausal at diagnosis and postmenopausal before randomization [122].

Endocrine therapies for postmenopausal women
Several trials comparing aromatase inhibitors either versus standard tamoxifen or versus placebo after completion of about 5 years of tamoxifen have reported results during the past 2 years. The ATAC trial results indicated that 5 years of anastrozole increased disease-free though not overall survival compared with tamoxifen [66]. Joint, muscle and bone pain, especially bone fractures, were more frequent with anastrozole, while gynecological and vascular events were more frequent with tamoxifen. In the BIG 1-98 trial, letrozole was shown to improve disease-free survival, especially systemic disease-free survival [67], as compared with tamoxifen. Cardio- and cerebro-vascular events, as well as bone fractures, were more frequent with letrozole, while gynecological and venous thromboembolic complications were more frequent with tamoxifen.

Five trials have examined a switch to an aromatase inhibitor after 2–3 years of adjuvant tamoxifen compared with continuing tamoxifen alone to complete 5 years. The first trial (380 patients) tested low-dose aminogluthethimide and resulted in comparable event-free survival, but longer overall survival [123]. In an Italian trial (426 patients), switch to anastrozole after 2 years of tamoxifen yielded a significant reduction in recurrences [124]. A joint analysis combined an Austrian and a German trial (total of 3123 patients) of anastrozole treatment after 2 years of tamoxifen. The group treated with anastrozole had significantly improved relapse-free survival compared with continuing on tamoxifen, regardless of nodal status [69]. IES, the largest such trial (4742 patients), tested switch to the aromatase inhibitor exemestane after 2–3 years of tamoxifen. There was a significant improvement of disease-free survival, but not survival within the first 30 months of follow-up [68]. The MA-17 trial compared letrozole with placebo after completion of about 5 years of tamoxifen in 5157 women. Letrozole improved disease-free and overall survival in patients with node-positive disease at diagnosis. Patients with node-negative disease at diagnosis experienced improved disease-free but not overall survival compared with placebo [122].

The ASCO Technology Assessment report recently recommended that ‘optimal adjuvant hormonal therapy for a postmenopausal woman with receptor-positive breast cancer should include an aromatase inhibitor either as initial therapy or after treatment with tamoxifen. Of course, women with breast cancer and their physicians must weigh the risks and benefits of all therapeutic options’ [72]. Is tamoxifen alone still an acceptable therapy? Cost and side-effects are important issues when choosing a treatment for an individual patient. Adjuvant tamoxifen has a long-lasting (‘carry-over’) benefit well beyond 5 years after its cessation, while no information is available on similar long-term follow up of patients after aromatase inhibitor therapy. Treatment with aromatase inhibitors compared with tamoxifen is associated with a decreased risk of endometrial cancer and thromboembolic events, but with increased cardiovascular events as well as bone fractures, muscle and osteoarticular pain. Knowledge of long-term side-effects of aromatase inhibitors is much less extensive than that for tamoxifen, an issue of concern for several panelists.

In summary, recent trials support several options for postmenopausal women who require endocrine therapy, while lacking evidence to choose between them: (i) an aromatase inhibitor (anastrozole, letrozole) alone for 5 years; (ii) tamoxifen for 2–3 years followed by an aromatase inhibitor (exemestane, anastrozole) to complete 5 years of therapy; or (iii) switch to an aromatase inhibitor (letrozole) after completing 5 years of tamoxifen. (iv) Finally, selected patients at low risk or with co-morbid musculo-skeletal or cardiovascular risk factors may be considered suitable for tamoxifen alone, and this may be the only option available on economic grounds in many cases [125, 126].

An additional area of uncertainty was whether adjuvant chemotherapy should be given concurrently with aromatase inhibitors. The majority of the panelists supported sequential use, but data directly addressing this question are lacking.

Chemotherapy regimens
The Panel recognized several types and levels of chemotherapy regimens, but acknowledged the possibility that the higher the degree of endocrine responsiveness, the lower the likely benefit from adding chemotherapy. For patients with endocrine responsive high-risk disease, chemotherapy in addition to endocrine therapy was considered indicated by most panelists. In such cases, however, the more intensive regimens (i.e. adding taxanes to the regimen or using a dose-dense schedule) may not be more effective than ‘basic’, once every 3 weeks anthracycline-based regimens like AC (doxorubicin or epirubicin plus cyclophosphamide), FEC₁₀₀ (5-fluorouracil, epirubicin 100 mg/m² and cyclophosphamide) or CAF (Table 1). The degree of perceived benefit led to the various categories of chemotherapy displayed in Table 4.

Recent references describe current use of chemotherapy in clinical practice. Less intensive regimens like AC or classical CMF [127, 128] are typically used for node-negative disease, while more intensive regimens such as AC or A followed by CMF [129], Canadian CEF [130], the CAF regimen [131, 132], dose-dense cyclophosphamide, doxorubicin and paclitaxel [133], FEC₁₀₀ followed by docetaxel [134], tailored FEC [135], FEC₁₀₀ [136] and TAC (docetaxel, doxorubicin, cyclophosphamide) [137] are more frequently offered to patients with node-positive disease. These have been shown in comparative trials to yield superior results, though at the cost of greater complexity, cost or toxicity.

For patients with endocrine responsive disease and an indication for chemotherapy, treatment with four courses of AC was considered to be appropriate. Most panelists did not support taxane-containing treatments in this population regardless of their nodal status.

The Panel favored anthracycline-containing regimens for patients with endocrine non-responsive disease and intermediate risk. Duration was controversial, with roughly equal Panel support for 4 or 6 months for patients with node-negative disease. Six courses of 3 or 4 weeks duration were clearly favored for patients at higher range of risk of relapse. Most but not all Panel members agreed that chemotherapy should start within 3–4 weeks from operation for patients with endocrine non-responsive disease [138]. Taxanes were supported for patients at higher risk. Most Panel members did not advocate dose-dense regimens even for patients with endocrine non-responsive disease notwithstanding results from one large study [133]. Panel members could not agree on the use of hematopoietic growth factors to avoid dose reduction or delay.

	Radiation therapy

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The Panel members reviewed recent changes in practice related to the developments described in Table 1. Radiation therapy, whether after breast conservation or mastectomy, should follow chemotherapy. Concurrent chemotherapy and radiation therapy might be feasible with CMF, perhaps requiring alteration to the schedule or dose of radiation [139, 140]. Concurrent radiation with anthracycline-based regimes or taxanes is not recommended since it increases the risk of symptomatic radiation-induced damage to normal tissue. Tamoxifen and radiotherapy can be given concurrently without significant altered efficacy or increased toxicity [141, 142].

Radiation therapy may not be necessary after conservative surgery in selected elderly patients (over 70 years) with small endocrine responsive cancer whose tumor excision was complete and who receive tamoxifen, although long-term follow up is not yet available [143, 144]. Thus, for example, an 80-year-old patient with significant co-morbid conditions and a small endocrine responsive breast cancer, endocrine therapy alone following proper local tumor excision is appropriate. However, for a healthy 70 year old patient (with life expectancy that might exceed 15 years), radiation therapy to the conserved breast might be preferred.

Radiotherapy variations
A boost may be particularly useful in premenopausal patients [145]. Accelerated partial breast irradiation (APBI) lacks data from phase III trials. Outside trials, the Panel recommended that APBI should be limited to defined patient groups (e.g. older age, low or intermediate risk, negative margins) with informed consent on lack of data on long-term outcome [55].

Although shorter radiotherapy fractionation schemes are popular due to logistical and patient convenience [146], data are lacking on long-term efficacy and toxicity.

Indications for radiation therapy after mastectomy are unchanged from previous St Gallen Meeting highlights [1], although computed tomography scan-based simulation, especially for left-sided cancers, may ensure that the heart is not included in the radiation fields [1, 147, 148].

	Specific aspects of treatments

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Patient preferences and quality of life considerations
Quality of life during treatment is important, but not the dominant factor for patients with operable breast cancer since the adverse effects of treatments are transient [149, 150]. Patients' preferences assessed post hoc were found to support this attitude [151, 152]. Long-term effects may be important. Special considerations may apply to underserved minority groups, younger women, elderly women, those in difficult relationships or who are rendered prematurely menopausal by adjuvant chemotherapy [153]. Endocrine-related symptoms usually worsened initially and recovered partially during 2 years [1].

	Commentary

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The Panel tried to apply answers derived from randomized clinical trials. Trials are usually designed to test the value of one or more treatments in a defined group, but tailoring treatment for an individual patient requires an additional step. Extrapolation of information from clinical trials, focusing upon patterns of response of different subpopulations, yielded important answers for several groups, especially contrasting those with endocrine responsive and endocrine non-responsive disease. Panel members were convinced that increased participation in clinical trials would increase knowledge about the disease and improve patient care [154]. International trial cooperation should be focused on questions relevant for patient care and biological principles, rather than regulatory requirements for the marketing of a new drug. Substudies focusing on safety, quality of life and subjective side-effects, and on economic and personal costs should be routinely incorporated in cooperative group trials.

Definition of appropriate niches for tailored research is perhaps the key achievement of this St Gallen Conference. Such an approach brings clinical research closer to the individual patient. Women with breast cancer deserve no less.

	Appendix

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Members of the Panel are listed below. All had a significant input to the discussion and manuscript. Professor Alan S. Coates was unable to attend the conference, but had a major impact on the planning of the meeting and on the final manuscript. Professor Martine Piccart also was unable to attend, but maintained a significant input and was represented by a senior member of her institution.

Kathy S. Albain MD, Loyola University Medical Center, Cardinal Bernardin Cancer Center, Marywood, IL 60153, USA.

Jonas Bergh MD, Department of Oncology, Radiumhemmet, Karolinska Institute and Hospital 17176 Stockholm, Sweden.

Monica Castiglione-Gertsch MD, International Breast Cancer Study Group Coordinating Center, Effingerstrasse 40, 3008 Bern, Switzerland.

Alan S. Coates MD, The Cancer Council Australia and University of Sydney, GPO Box 4708, Sydney, NSW 2001 Australia (absent).

Alberto Costa MD, Department of Breast Surgery, Fondazione S. Maugeri, Via A. Ferrata 8, 27100 Pavia, Italy.

Jack Cuzick PhD, Cancer Research, UK Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary College, University of London, Charterhouse Square, London EC1M 6BQ, UK.

Nancy Davidson MD, Sidney Kimmel Cancer Center of Johns Hopkins, 1650 Orleans Street, Room 409, Baltimore, MD 21231-1000, USA.

John F. Forbes MD, Department of Surgical Oncology, University of Newcastle, Locked Bag 7, Hunter Region Mail Centre, NSW 2310, Australia.

Richard D. Gelber PhD, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA.

Paul Goss MD, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA.

Jay Harris MD, Department of Radiation Oncology, Dana Farber Cancer Institute, Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA.

John H. Glick MD, Abramson Cancer Center of the University of Pennsylvania Cancer Center, 16 Penn Tower, 3400 Spruce Street, Philadelphia PA 19104-4283, USA (Chairman).

Aron Goldhirsch MD, International Breast Cancer Study Group, Oncology Institute of Southern Switzerland, 6903 Lugano, Switzerland, and European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy (Chairman).

Anthony Howell MD, CRC, Department of Medical Oncology, Christie Hospital, NHS Trust, Wilmslow Road, Manchester M20 4BX, UK.

James N. Ingle MD, Mayo Clinic, 200 First Street S.W., Rochester, MN 55905, USA.

Raimund Jakesz MD, University of Vienna, Department of General Surgery, Waehringer Guertel 18–20, 1090 Wien, Austria.

Jacek Jassem MD Medical University of Gdansk, Department of Oncology & Radiotherapy, Debinki Street 7, 80-211 Gdansk, Poland.

Manfred Kaufmann MD, Department of Gynecology and Obstetrics, Goethe University, Theodor Stern Kai 7, 60596 Frankfurt am Main, Germany.

Miguel Martin MD, Servicio de Oncologia Medica, Hospital Universitario San Carlos, Cindad Universitaria s/n, 28040 Madrid, Spain.

Louis Mauriac MD, Institute Bergonié, 229, Cours d'Argonne, 33076 Bordeaux, France.

Monica Morrow MD, Lynn Sage Comprehensive Breast Center, Northwestern Memorial Hospital, 251 East Huron Street, Galter 13-174, Chicago, IL 60611, USA.

Henning T. Mouridsen MD, Department of Oncology 5074, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark.

Moise Namer MD, Centre Antoine Lacassagne, 33 Av. Valombrose, 06189 Nice Cedex, France.

Martine J. Piccart-Gebhart MD, PhD, Department of Chemotherapy, Institut Jules Bordet, Rue Héger-Bordet 1, 1000 Brussels, Belgium (substituted by Dominique de Valeriola MD, Medical Director, Institut Jules Bordet, Rue Héger-Bordet 1, 1000 Brussels, Belgium).

Kurt Possinger MD, Universitätsklinikum Charite, Onkologie/Hämatologie, Schumannstrasse 20–21, 10098 Berlin, Germany.

Kathleen Pritchard MD, Toronto-Sunnybrook Regional Cancer Center, Head Clinical Trials & Epidemiology, 2075 Bayview Avenue, Toronto, ON M4N 3M5, Canada.

Emiel JT Rutgers MD, The Netherlands Cancer Institute, Department of Surgery, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.

Beat Thürlimann MD, Medizinische Onkologie, Haus 06, Kantonsspital St Gallen, 9007 St Gallen, Switzerland.

Giuseppe Viale MD, Department of Pathology, European Institute of Oncology and University of Milan, Via Ripamonti 435, 20141 Milan, Italy.

Arne Wallgren MD, Sahlgrenska University Hospital, Department of Oncology, 413 45 Göteborg, Sweden.

William C. Wood MD, Department of Surgery, Emory University School of Medicine, 1364 Clifton Road, N.E. Atlanta, GA 30322, USA.

	Acknowledgements

 
The authors thank the Participants of the 9th International Conference on Primary Therapy of Early Breast Cancer for many useful remarks. They acknowledge substantial contribution of Dr. Marco Colleoni, Dr. Giuseppe Curigliano, Dr. Eric Winer, and Mrs. Shari Gelber. They also thank Professor Umberto Veronesi, Dr. Anne Hamilton, Dr. Franco Nolè, and Dr. Filippo de Braud for their thoughtful remarks. Partial support was provided by grant number CA-75362 from the United States National Cancer Institute. This work is dedicated to the memories of Joan Coates, Harold Frankel and Carlo Stucchi.

	Notes

 
Panel Members are listed in the Appendix.

	References

Top Abstract St Gallen 2005: news... Panel recommendations and... Systemic treatment regimens Radiation therapy Specific aspects of treatments Commentary Appendix References

 
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24. Osborne CK. Endocrine responsiveness: understanding how progesterone receptor can be used to select endocrine therapy. Breast 2005; 14 (Suppl): S5.

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56. Orecchia R. Intraoperative radiation therapy to the breast. Breast 2005; 14 (Suppl): S8.

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83. Aebi S. Special issues related to adjuvant therapy in very young women. Breast 2005; 14 (Suppl): S12.

84. Goldhirsch A, Gelber RD, Yothers G et al. Adjuvant therapy for very young women with breast cancer: need for tailored treatments. J Natl Cancer Inst Monogr 2001; 30: 44–51.[Medline]

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				M. M. Regan, G. Viale, M. G. Mastropasqua, E. Maiorano, R. Golouh, A. Carbone, B. Brown, M. Suurkula, G. Langman, L. Mazzucchelli, et al. Re-evaluating Adjuvant Breast Cancer Trials: Assessing Hormone Receptor Status by Immunohistochemical Versus Extraction Assays. J Natl Cancer Inst, November 1, 2006; 98(21): 1571 - 1581. [Abstract] [Full Text] [PDF]

				R Ponzone, F Montemurro, F Maggiorotto, C Robba, D Gregori, M. Jacomuzzi, F Kubatzki, D Marenco, A Dominguez, N Biglia, et al. Clinical outcome of adjuvant endocrine treatment according to PR and HER-2 status in early breast cancer Ann. Onc., November 1, 2006; 17(11): 1631 - 1636. [Abstract] [Full Text] [PDF]

				E. A. Perez Appraising Adjuvant Aromatase Inhibitor Therapy Oncologist, November 1, 2006; 11(10): 1058 - 1069. [Abstract] [Full Text] [PDF]

				X.-J. Ma, S. G. Hilsenbeck, W. Wang, L. Ding, D. C. Sgroi, R. A. Bender, C. K. Osborne, D. C. Allred, and M. G. Erlander The HOXB13:IL17BR Expression Index Is a Prognostic Factor in Early-Stage Breast Cancer J. Clin. Oncol., October 1, 2006; 24(28): 4611 - 4619. [Abstract] [Full Text] [PDF]

				F. Bertucci, D. Birnbaum, and A. Goncalves Proteomics of Breast Cancer: Principles and Potential Clinical Applications Mol. Cell. Proteomics, October 1, 2006; 5(10): 1772 - 1786. [Abstract] [Full Text] [PDF]

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				P. Urban, V. Vuaroqueaux, M. Labuhn, M. Delorenzi, P. Wirapati, E. Wight, H.-J. Senn, C. Benz, U. Eppenberger, and S. Eppenberger-Castori Increased Expression of Urokinase-Type Plasminogen Activator mRNA Determines Adverse Prognosis in ErbB2-Positive Primary Breast Cancer J. Clin. Oncol., September 10, 2006; 24(26): 4245 - 4253. [Abstract] [Full Text] [PDF]

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				A. Vocaturo, F. Novelli, M. Benevolo, G. Piperno, F. Marandino, A. M. Cianciulli, R. Merola, R. P. Donnorso, I. Sperduti, S. Buglioni, et al. Chromogenic In Situ Hybridization to Detect HER-2/neu Gene Amplification in Histological and ThinPrep(R)-Processed Breast Cancer Fine-Needle Aspirates: A Sensitive and Practical Method in the Trastuzumab Era Oncologist, September 1, 2006; 11(8): 878 - 886. [Abstract] [Full Text] [PDF]

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