St.Gallen乳癌初期治療に関する コンセンサスカンファレンス International Consensus Conference on Primary Treatment of Breast Cancer 2013

速報！パネリスト投票結果 2013. 3.24
一部不明なところもあり、誤りがありましたらお知らせ下さい。

Surgery of the Primary　　　　　　　　　　　　　　　　　　　Abstention: 分からない

	設　問	Yes	No	Abstention
When considering breast conserving surgery the following factors are contraindications
1	Young age (<35 yr) Absolute
%		6.3	89.6	4.2
2	Young age (<35 yr) Relative
%		30.4	60.9	8.7
3	Young age (<40 yr) Absolute
%		4.3	93.5	2.2
4	Young age (<40 yr) Relative
%		9.1	88.6	2.3
5	Extensive or diffuse microcalcification Absolute
%		19.1	74.5	6.4
6	Extensive or diffuse microcalcification Relative
%		69.6	15.2	15.2
7	Multi-focal disease Absolute
%		6.7	88.9	4.4
8	Multi-focal disease Relative
%		42.6	53.2	4.3
9	Multi-centric disease Absolute
%		30.4	65.2	4.3
10	Multi-centric disease Relative
%		76.9	15.4	7.7
11	Tumor close to nipple Absolute
%		0	95.9	4.1
12	Tumor close to nipple Relative
%		42.6	53.2	4.3
13	Extensive vascular invasion Absolute
%		6.5	91.3	2.2
14	Extensive vascular invasion Relative
%		26.2	69.0	4.8
15	Extens. intraductal component Absolute
%		2.1	95.7	2.1
16	Extens. intraductal component Relative
%		34.1	63.3	2.0
17	Lobular hstology Absolute
%		4.8	92.9	2.4
18	Lobular hstology Relative
%		6.7	91.1	2.2
19	Family history
%		4.1	95.9	0.0
20	BRCA1 positivity
%		54.3	43.5	2.2
21	BRCA2 positivity
%		51.1	46.8	2.1
22	Involved margins after repeated excisions (including DCIS)
%		95.9	2.0	2.0
23	Unfavourable biology on gene expression/sequencing
%		6.3	93.8	0.0
24	Contraindications to breast irradiation that should follow breast conserving surgery
%		93.8	4.2	2.1
Is skin-nipple sparing mastectomy an acceptable treatment without RT?
%		66.7	21.4	11.9
ONLY if margin toward nipple is tumour-free and immediate reconstruction planned
%		55.3	15.8	28.9
Should MRI be routine for patients with newly diagnosed disease (to assist decision on BCS)?
%		10.2	89.8	0.0
In women undergoing breast conserving surgery the minimum appropriate surgical margin is
1	No ink on invasive tumor?
%		72.9	20.8	6.3
2	1 mm clearance (invasive)?
%		48.1	25.9	25.9
3	3 mm clearance (invasive)?
%		7.7	30.8	61.5
4	5 mm clearance (invasive)?
%		4.7	9.3	86.0
5	Dependent on tumor biology?
%		18.4	77.6	4.1
6	2mm clearance (DCIS)?
%		41.5	53.7	4.9

Surgery of the Axilla

	設　問	Yes	No	Abstention
In patients with macrometastases in 1-2 sentinel nodes, completion axillary dissection can safely be omitted following:
1	Mastectomy (no radiotherapy planned)
%		4.3	91.3	4.3
2	Mastectomy (radiotherapy planned)
%		31.9	50.0	10.9
3	Conservative resection and radiotherapy
%		72.7	20.5	6.8
In patients with macrometastases in 1-2 sentinel nodes, completion axillary dissection should be omitted following:
1	Clinical N1 ?
%		87.5	8.3	4.2
2	3 or more positive SLNs ?
%		95.1	4.9	0.0
3	Nodal status (eg. N 4+) needed for chemotherapy choice ?
%		59.1	38.6	2.3

放射線治療：　Conversed Breast Irradiation

	設　問	Yes	No	A
1	Is there a group not requiring RT as part of BCT?
%		59.2	30.6	10.2
2	Should <<short course>> RT (e.g. <40 Gy in 15 fractions) be offered as a standard?
%		72.2	11.1	16.7
3	Is <<short course>> RT as above a option if boost is also planned?
%		78.8	4.4	17.8
Following breast conserving surgery, partial breast irradiation may be used:
1	As the definitive irradiation, without external beam therapy (ASTRO/ESTRO group?
%		36.2	40.4	23.4
2	Only in the absence of adverse tumor pathology?
%		49.0	22.4	28.6

放射線治療：　After Mx

	設　問	Yes	No	A
Should post Mx RT be standard for patient with
1	N+ = 4 ?
%		95.3	2.3	2.3
2	N+ 1 to 3 ?
%		29.8	63.8	6.4
3	N+ 1 to 3 with adverse pathology
%		61.7	31.9	6.4
4	N+ 1 to 3 at young age (<40 yr) ?
%		55.1	40.8	4.1
5	pN1 after axillary dissection but <8 node examined ?
%		6.5	89.1	4.3
6	Positive sentinel node biopsy but no axillary dissection ?
%		63.8	25.5	10.6
7	Young age (<40 yr) regardless of nodes ?
%		10.0	86.0	4.0
8	Adverse pathology regardless of nodes ?
	･ Grade 3
%		4.1	91.8	4.1
	･ Lymphovascular invasion
%		18.8	77.1	4.1
	･ HER2
%		4.1	93.9	2.0
	･ Triple negative
%		2.2	95.7	2.2
	･ T>5cm regardless of nodes?
%		67.3	28.7	4.1
	･ Positive deep/radial margins?
%		82.2	11.1	6.7

放射線治療：

	設　問	Yes	No	A
Nodal areas requiring irradiation should:
1	Include SCF in all irraadiated patients?
%		32.7	53.1	14.3
2	Include axilla in all irradiated patients?
%		6.8	81.8	11.4
3	Include IMN in all irraadiated patients?
%		10.9	69.6	19.6
4	Be influenced by response to neoadjuvant therapy?
%		33.3	55.6	11.1
5	Be influenced by the intrinsic subtype of the tumor?
%		16.7	77.1	6.3

Pathology:

	設　問	Yes	No	A
For practical pruposes, distinction between 'Luminal A' and 'Luminal B' (Her2 Neg) tumors can be:
1	made by ER, PR alone?
%		6.1	91.8	2.0
2	made by ER, PR and Ki-67?
%		72.9	27.1	0.0
3	made with grade 3 as a substitute for high Ki-67?
%		36.0	64.0	0.0
4	only safely determined by molecular diagnosis?
%		34.0	60.0	6.0
5	only safely determined by laboratories participating in quality assurance programs?
%		88.9	8.9	2.2

Pathology：　HER2

	設　問	Yes	No	A
In the determination of HER2 status for anti-HER2 treatment purposes, do we need to know:
1	Heterogeneity of overexpression of HER2?
%		23.9	71.7	4.3
2	Polysomy 17
%		10.6	71.7	4.3
For treatment decisions do we also need to know
1	Concomitant estrogen receptor expression status?
%		40.5	59.5	0.0
2	Degree of tumor proliferation?
%		10.4	89.6	0.0

Pathology: Subtypes

	設　問	Yes	No	A
1	Intrinsic subtypes may influence whether or not chemotherapy is used in the adjuvant regimes?
%		88.9	6.7	4.4
2	If yes, multi-gene expression array profiling is required for subtype definition?
%		22.0	70.0	8.0
3	Yes, but clinicopathologic definition of 'subtype' (e.g. St Gallen 2011) is sufficient for this prupose?
%		53.1	38.8	8.2
4	Choice of cytotoxic therapy regimen should be influenced by intrinsic subtype?
%		27.7	68.1	4.3

Multi-gene Signatures

	設　問	Yes	No	A
Would you ask for one of the multigene signatures (after clinicopathological assessment):
1	in nearly all cases independently of the 'intrinsic subtype'?
%		0.0	97.6	2.4
2	in nearly all ER and/or PgR positive' (HER2-neg) cases?
%		20.8	79.2	0.0
3	in nearly all 'Luminal B' (HER2-neg) but not 'Luminal A' cases?
%		44.4	51.1	4.4
4	in N-neg. ER positive' (HER2-neg) cases?
%		56.8	43.2	0.0
5	in N-pos. ER positive' (HER2-neg) cases?
%		22.2	77.8	0.0
In an endocrine-responsive* cohort: *i.e. any expression of ER and/or PgR
1	Does 21 gene RS predict Chemotherapy (ChT) response?
%		78.0	12.0	10.0
2	Does PAM-50 predict ChT response?
%		29.5	40.9	29.5
3	Does 70 gene signature predict ChT response?
%		25.0	54.2	20.8
4	Does EPClin predict ChT response?
%		10.6	57.4	31.9
In an endocrine-responsive cohort*, selection of patients who might forego chemotherapy can be partially based on: *i.e. any expression of ER and/or PgR
1	21 gene RS
%		88.1	7.1	4.8
2	PAM-50
%		28.6	50.0	21.4
3	70 gene signature
%		40.4	44.7	14.9
4	EPClin
%		21.7	50.0	28.3

Molecular Diagnosis

	設　問	Yes	No	A
In an endocrine-responsive cohort*, molecular diagnostics can be omitted if: *i.e. any expression of ER and/or PgR
1	Chemotherapy would not be given anyway because:
	・ T size ≦ 1 cm ?
%		83.9	12.9	3.2
2	Chemotherapy would be given anyway because:
	・ T size (e.g. >5 cm)
%		37.0	60.9	2.2
	・ Inflammatory BC ?
%		93.8	4.2	2.1
	・ 1 - 3 nodes + ?
%		26.3	71.1	2.6
	・ ≧ 4 nodes + ?
%		91.5	6.4	2.1
	・ Grade 3 ?
%		30.6	65.3	4.1
	・ Low ER% (e.g. 5%)
%		55.8	44.2	0.0
	・ Yougn age (e.g. <35)
%		24.4	75.6	0.0

Stroma

	設　問	Yes	No	A
Pathological features of the stroma which should influence therapy choice in routine clinical practice include:
1	Immunocyte infiltration?
%		11.4	74.3	14.3
2	Microvascular density?
%		9.5	88.1	2.4
3	Stromal p16 staining?
%		0.0	97.7	2.3

Endocrine Therapies:

	設　問	Yes	No	A
Establishing Standards for Premenopausal
1	Tam alone as default?
%		83.3	16.7	0.0
2	Tamoxifen duration should be extended to 10 years in patients remaining premenopausal?
%		88.9	8.9	2.2
3	Ovarian function suppression (OFS) should be added to Tam:
	- In all patients
%		14.9	80.9	4.3
	- In the young (e.g. <40 yr)
%		40.9	50.0	9.1
4	OFS alone (without tamoxifen)?
%		24.0	70.0	6.0
5	AI + OFS is a valid option in case of contraindicated tam?
%		85.1	8.5	6.4
6	AI + OFS is a valid option in all patients?
%		6.3	87.5	6.3
7	Can some patients be adequately treated with tamoxifen alone?
%		93.6	6.4	0.0
8	If an AI, need it be started upfront in all patients?
%		47.5	50.0	2.5
9	If an AI, need it be started upfront in high risk?
%		87.2	10.6	2.1
10	Can upfront AI be replaced with TAM after 2 yr?
%		68.1	29.8	2.1
11	Can upfront AI be replaced with TAM after 2 yr?
	・ node-pisitive disease?
%		57.8	17.8	24.4
	・ node-negative disease?
%		25.5	66.0	8.5
12	If so, does the prior endocrine therapy matter?
	・ Should extended AI beyond 5 years be given after 5 years adjuvant tamoxifen?
%		83.3	11.9	4.8
	・ Should extended AI beyond 5 years be given after 5 years endocrine therapy switching from tamoxifen to an AI?
%		73.3	11.9	15.6
	・ Should extended AI beyond 5 years be given after 5 years adjuvant AI?
%		35.6	40.0	24.4
13	If AI is unavailable or not tolerated, (so that patient has switched to tamoxifen), should tamoxifen be continued beyond 5 years?
%		78.0	8.0	14.0
14	Should extended tamoxifen beyond 5 years be given after 5 years adjuvant AI?
%		51.1	28.9	20.0
15	Should extended tamoxifen beyond 5 years be given after 10 years adjuvant AI?
%		31.4	48.6	20.0

化学療法：　基礎問題

	設　問	Yes	No	A
化学療法を考慮すべき因子は：
1	組織学的悪性度３の腫瘍？
%		84.4	13.3	2.2
2	Ki-67 high
%		75.5	14.3	10.2
3	低ホルモン受容体 ?
%		81.6	12.2	6.1
4	HER2陽性？
%		91.9	8.2	0.0
5	トリプルネガティブ？
%		98.0	0.0	2.0
6	High 21 gene RS (e.g. >25)?
%		93.9	4.1	2.0
7	70 gene High-Risk?
%		63.3	30.6	6.1
8	Any positive node?
%		32.7	67.3	0.0
9	>3 positive nodes?
%		93.9	6.1	0.0
10	Lymphovascular invasion?
%		32.0	64.0	4.0
11	Young age (e.g. <35 yr)?
%		46.0	54.0	0.0

化学療法：　Luminal A

	設　問	Yes	No	A
1	Is Luminal A phenotype less responsive to chemotherapy?
%		83.3	10.4	6.3
2	Is less intensive chemotherapy such as AC4 or CMF6 or TC4 adequate if chemotherapy is considered in Luminal A disease?
%		61.7	25.5	12.8
3	Should chemotherapy be added for high risk (based on tumour volume)?
%		60.0	22.9	17.1

化学療法：　Luminal B

	設　問	Yes	No	A
1	Is Luminal B subtype by itself sufficient to prescribe chemotherapy?
%		61.2	38.8	0.0
2	Is Ki-67 useful in defining Luminal B subtype?
%		72.9	20.8	6.3
3	If Ki-67 is used, which threshold should be used for defining Luminal B subtype:
	・ ≧14% ?
%		23.9	37.0	39.1
	・ ≧20% ?
%		29.5	13.6	56.8
	・ ≧25% ?
%		13.3	6.7	80.0
4	If given, the ChT regimen should contain anthracyclines rather than CMF?
%		70.5	18.2	11.4
5	Should the regimen contain taxanes?
%		56.5	26.1	17.4
6	Should chemotheapy extend for at least 6 courses?
%		50.0	34.8	15.2
7	Should dose-dense ChT be preferred when chemotherapy is indicated?
%		19.1	68.1	12.8
8	Is there a chemotherapy regimen known to be preferred for HER2-positive phenotype?
%		36.4	61.4	2.3

化学療法：　HER2-positive

	設　問	Yes	No	A
1	Need the chemotherapy regimen for HER2-positive disease contain anthracyclines?
%		68.0	22.0	10.0
2	Need the chemotherapy regimen for HER2-positive disease contain taxanes?
%		93.2	4.5	2.3

化学療法：　basal-like

	設　問	Yes	No	A
1	Should the ChT regimen for <<basal-like>> (TNBC ductal) phenotype contain anthracyclines and taxames?
%		87.0	6.5	6.5
2	Should the ChT regimen for <<basal-like>> phenotype stress alkylating agents (not merely AC)?
%		30.0	47.5	22.5
3	Should the ChT regimen for <<basal-like>> phenotype contain Platinum?
%		14.6	68.8	16.7
4	Should dose-dense ChT requiring growth factor support be preferred?
%		38.3	48.9	12.8

Preference for Regimen

	設　問	Yes	No	A
Are there reasons other than tumor characteristics to prefer specific chemotherapy regimens?
%		72.7	21.2	6.1
1	Women desiring fertility preservation?
%		76.2	19.0	4.8
2	Avoiding alopecia?
%		56.5	41.3	2.2
3	Co-morbidities?
%		100.0	0.0	0.0
4	Age of patient?
%		64.0	34.0	2.0
5	Intrinsic subtype?
%		37.8	53.3	2.0
6	BRCA carriers?
%		20.8	72.9	6.3
Age --- chemotherapy change ?
%		60.0	37.1	2.9

Anti-HER2 Therapies

	設　問	Yes	No	A
Minimum T size (invasive diameter) requiring trastuzumab:
%		10mm 10.0	5mm 72.5	Any 17.5
Chemotherapy Preference for Regimen
1	Trastuzumab if given should be concurrent with taxane?
%		87.2	8.5	4.3
2	Trastuzumab if given should be concurrent with anthracycline?
%		14.3	85.7	0.0
3	Trastuzumab (+/- endocrine therapy) may be if ChT contra-indicated?
	・ ER positive
%		75.0	25.0	0.0
	・ ER negative
%		85.0	15.0	0.0
4	Preferred duration of trastuzumab if given:
	・ 1 yr
%		100.0	0.0	0.0

術前全身療法 Neo-Adjuvant Systemic Therapy

	設　問	Yes	No	A
Chemotherapy
1	Should the only aim of neoadjuvant chemotherapy be to facilitate subsequent local therapies?
%		50.9	45.3	3.8
2	After pCR to neoadjuvant chemotherapy, subsequent adjuvant chemotherapy: Should be given?
%		4.1	95.9	0.0
3	After failure to achieve pCR with neoadjuvant chemotherapy, subsequent adjuvant chemotherapy: Should be given?
%		10.0	82.5	7.5
4	After failure to achieve pCR with neoadjuvant chemotherapy, after surgery complete adjuvant chemotherapy: Should be given?
%		79.2	10.4	10.4
5	After failure to achieve pCR with neoadjuvant chemotherapy, after surgery complete adjuvant chemotherapy: Should be given?
%		62.2	26.7	11.1
HER2-Positive Disease
1	Should neoadjuvant regimens for HER2-positive disease contain anti-HER2 drug(s)?
%		95.9	0.0	4.1
2	Should dual HER2-targeting be recommended in the preoperative setting for HER2-positive disease?
%		37.1	54.3	8.6
Endocrine Therapy
1	Is neoadjuvant endocrine therapy alone a reasonable option for postmenopausal patients with highly endocrine-responsive disease (e.g. strongly positive receptors, low proliferation)?
%		93.8	2.1	4.2
2	If yes, for which duration (choose one)?
%		3-4 months	4-8 months	Maximal response
%		11.1	26.7	62.2

ビスフォスフォネート　Bisphosphonate

	設　問	Yes	No	A
1	Is zoledronic acid, given every 6 months during adjuvant endocrine therapy, indicated to improve DFS?
%		22.5	70.0	7.5
2	In premonopausal patients receiving LHRH plus TAM?
%		6.7	86.7	6.7
3	In postmonopausal patients?
%		34.0	61.7	4.3
3	Should adjuvant denosumab substitute for zoledronic acid?
%		2.2	84.4	13.3

Follow up

	設　問	Yes	No	A
Follow up After Early Breast Cancer
1	Should all patients have regular follow-up with their srgeon/oncologist after completing their treatment? (excluding long-term endocrine therapy)?
%		70.4	25.9	3.7
2	Is regular follow-up supervised by a nurse specialist in person or by telephone an acceptable follow-up option?
%		59.1	34.1	6.8
3	Is regular follow-up supervised by a nurse specialist in person?
%		77.3	15.9	6.8
4	Is regular follow-up supervised by telephone an acceptable follow-up option?
%		22.9	64.6	12.5
5	Should patients have any form of routine imaging apart from mammography as part of their follw-up?
%		14.9	78.7	6.4