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(1)

Topic 3.

‘‘Oligometastatic’’ prostate cancer

第三次

臺灣晚期攝護腺癌專家共識

3 rd Taiwan Advanced Prostate

Cancer Consensus

(2)

Q3-1

A clinically meaningful definition of oligometastatic prostate cancer thatinfluences treatment decision (local treatment of all lesions +/- systemic therapy) includes:

A. Definition of oligometastatic prostate cancer (Q3-1~3)

Survey Panelists 215

60%

17%

13%

10%

36 48

65%

10%

15%

10%

3

39

90%

5%

5%

0 0 Responders

1. Only patients with a limited number of bone and/or lymph nodes metastases that can be treated with local therapy

2. Only patients with a limited number of lymph node metastases that can be treated with local therapy 3. A limited number of any metastases (including visceral) 4. I do not believe oligometastatic prostate cancer exists as a clinically meaningful entity

Non-responder, abstain, unqualified to answer

St.Gallen

54

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

96 66%

16%

11%

7%

95 56%

18%

13%

13%

175 59%

19%

12%

11%

46 68%

9%

20%

2%

30 54%

23%

8%

15%

30 70%

13%

13%

Option 4 3%

(3)

Q3-2

What is your cut-off for the number of metastases to consider a patient as oligometastatic?

Survey Panelists St.Gallen

201 47%

42%

11%

20 30

39 15%

77%

8%

0 0 44

14%

66%

20%

7 1 Responders

1.≤2 metastases 2. ≤3 metastases 3. ≤5 metastases

4. Abstain (including I do not believe that oligometastatic prostate cancer is a clinically meaningful entity) Non-responder, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

96 53%

39%

8%

95 40%

47%

13%

175 56%

36%

9%

46 28%

51%

21%

30 35%

61%

4%

30 37%

50%

13%

(4)

Do you recommend that a biopsy is taken from an oligometastatic lesion for diagnostic purposes (if feasible)? (no previous prostate treatment)

Survey Panelists St.Gallen

210 40%

48%

11%

14 27

37 11%

89%

0%

0 0 50

34%

52%

14%

2 0 Responders

1. Yes, in the majority of patients 2. In minority of selected patients 3. No

4. Abstain (including I do not believe that oligometastatic prostate cancer is a clinicallymeaningful entity) Non-responder, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

Hellman and Weichselbaum在1995提出“oligometastasis (寡轉移)”這個名詞,來定義一 種臨床上僅有少數偵測到的轉移病灶的疾病狀態。至今文獻中尚無正式數字來作“少數”

的切點。國內外專家多數定義 ≤3 個病灶為寡轉移。

目前定義與確診寡轉移,主要依賴影像學,但是傳統的影像學技術 (CT、bone scan)對於 偵測轉移的敏感度不夠。mpMRI (multi-parametric MRI) 較適合偵測Local recurrence after definitive local therapy。Pelvic nodal disease較適合使用敏感度較高的 PET/CT (either PSMA or F-choline PET)。Choline PET 和whole body MRI 比傳統的bone scan更可以看到細 微的骨轉移。(Maura et al., Eur Urol 2016; Barchetti et al., Biomed Res Int 2014)

與會專家達成以下共識:

1.“Oligometastasis (寡轉移)”定義:≤3 bone and/or lymph nodes metastases (excluding viscera metastasis) that can be treated with local therapy.

2. 對於無法確定是否轉移的病灶,若實務可行建議切片。

3. 在報告寡轉移時,應該包括以下內容:

(1) 是前列腺局部治療後遠端轉移,還是新診斷就有轉移 (De novo)?

(2) 寡轉移的數目及位置?

(3) 是仍然hormone-sensitive,還是已經castration-resistant?

•評論分析:

96 46%

45%

10%

95 38%

48%

15%

175 39%

46%

14%

46 45%

48%

7%

30 38%

58%

4%

30 41%

52%

7%

56

Q3-3

(5)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4 Option 5 Option 6 Option 7

96 13%

6%

11%

34%

27%

6%

4%

95 13%

4%

14%

38%

24%

5%

4%

175 17%

6%

12%

32%

23%

6%

4%

46 0%

0%

5%

51%

35%

0%

9%

30 12%

0%

12%

28%

36%

8%

4%

30 7%

7%

14%

45%

24%

0%

3%

Q3-4

Which treatment do you recommend in men with newly-diagnosed oligometastatic prostate cancer with an untreated primary?

B. Treatment modality of oligometastasis (Q3-4~10)

Survey Panelists 213

13%

4%

10%

35%

27%

5%

5%

38 48

27%

8%

23%

33%

8%

NA

NA

3

39 0 0

0

92%

3%

3%

3%

0 Responders

1. Lifelong ADT ± Docetaxel

2. Radical local treatment of all lesions including the primary (surgery or RT) without ADT or Docetaxel 3. Radical local treatment of all lesions including the primary (surgery or RT) + ADT 6-12m ± Docetaxel 4. Radical local treatment of all lesions including the primary (surgery or RT) + ADT 24-36m ± Docetaxel 5. Radical local treatment of all lesions including the primary (surgery or RT) + lifelong ADT ± Docetaxel 6. Lifelong ADT+ abiraterone if meet LAITITUDE inclusion criteria

7. Radical local treatment of all lesions including the primary (surgery or RT) + Lifelong ADT+ abiraterone acetate Non-responder, abstain, unqualified to answer Non-responder, abstain, unqualified to answer

St.Gallen

(6)

58

If you recommend radical local treatment plus ADT in men with newly-diagnosed oligometastatic prostate cancer and an untreated primary do you recommend adding Docetaxel?

Survey Panelists St.Gallen

190 24%

35%

41%

23 38

38 5%

63%

32%

1 0 39

28%

38%

33%

11 1 Responders

1. Yes, in the majority of patients 2. In minority of selected patients 3. No

4. Abstain (including I do not recommend radical local treatment plus ADT)

Non-responder, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

96 24%

34%

42%

95 21%

38%

42%

175 26%

39%

26%

46 13%

50%

37%

30 26%

48%

26%

30 23%

33%

43%

Q3-5

(7)

In men with newly-diagnosed oligometastatic prostate cancer and an untreated primary what do you recommend for treatment of the primary?

Survey Panelists St.Gallen

197 10%

45%

42%

4%

27 27

40 2.5%

30%

67.5%

0%

0 0 42

21%

45%

31%

2%

10 0 Responders

1. Radical prostatectomy (RP) 2. Radiation therapy (RT) 3. Either RT or RP

4. Other

5. Abstain (including I do not recommend radical local treatment of the primary)

Non-responder, unqualified to answer

•評論分析:

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

96 11%

39%

43%

6%

95 12%

46%

37%

5%

175 14%

34%

47%

5%

46 0%

77%

23%

0%

30 5%

41%

55%

0%

30 14%

28%

55%

Option 4 3%

Q3-7

72% St. Gallen專家和95%台灣與會專家有共識的主張,新診斷的oligometastatic pros- tate cancer 可考慮對原發和所有轉移病灶做radical local treatment。台灣與會專家均主 張除了radical local treatment還應給予36個月以上的ADT,這比St. Gallen專家主張的 ADT治療時間長。

若以三個以下的骨骼或淋巴轉移來定義“oligometastasis”,則符合CHARRTED trial中 所定義的low-volume disease。Sweeny在2016 ESMO的CHARRTED updates中,顯示 upfront chemo對於low-volume disease沒有顯著的助益(OS: HR=1.04)。因此,63% 與會 專家主張只有selected patients需要加上docetaxel來治療。

在2004-2012的Retrospective analysis studies發現metastatic或clinical lymph node posi- tive 攝護腺癌患者若接受primary lesion 局部治療,(如radical prostatectomy or radiation therapy ) 可延長overall survival。(Rusthoven et al., JCO 2016)

Heidenreich et al (2015 J Urol) 一篇小型的case control study 發現對於 minimal osseous

(8)

60

If you recommend radical local treatment plus ADT in men with newly- diagnosed oligometa- static prostate cancer and an untreated primary do you recommend adding abiraterone acetate?

Survey Panelists 185

24%

35%

41%

23 43

35 6%

80%

14%

1 2 Responders

1. Yes, in the majority of patients 2. In minority of selected patients 3. No

4. Abstain (including I do not recommend radical local treatment plus ADT)

Non-responder, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

96 15%

35%

50%

95 23%

33%

43%

175 20%

33%

48%

46 32%

44%

24%

30 39%

35%

26%

30 10%

37%

53%

Q3-6

LATITUDE trial中只收錄high-risk的mHSPC病人接受upfront abiraterone的治療 (High-risk: ≥3 bone mets, GS≥8, visceral mets, 3項符合2 項)。但是在STAMPDED G arm (James et al 2017 NEJM)中,病患有包含M0 and non high-risk的病人。目前並沒有強力的證據在支持使用 abiraterone+prednisolone在oligometastatic PC patients.

•評論分析:

(9)

What treatment do you recommend in the majority of asymptomatic men developing oligomet- astatic recurrent castration-sensitive/naive prostate cancer after local treatment of the primary with curative intent (+/- salvage radiation therapy)?

Q3-8

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5 Option 6 Option 7

96 24%

2%

6%

28%

21%

15%

4%

95 25%

3%

8%

30%

19%

11%

5%

175 29%

3%

5%

31%

13%

13%

6%

46 12%

0%

7%

40%

29%

2%

10%

30 8%

0%

8%

13%

33%

25%

13%

30 17%

3%

3%

33%

27%

13%

3%

Survey Panelists St.Gallen

207 23%

2%

6%

31%

18%

12%

8%

44

38 5%

0

3%

90%

3%

0 0 0 48

33%

13%

31%

19%

4%

NA NA 2

Responders

1. Lifelong ADT ± Docetaxel

2. Radical local treatment of all lesions (surgery or RT) without ADT or Docetaxel

3. Radical local treatment of all lesions (surgery or RT) + ADT 6-12m ± Docetaxel

4. Radical local treatment of all lesions (surgery or RT) + ADT 24-36m ± Docetaxel

5. Radical local treatment of lesions (surgery or RT) lifelong ADT ± Docetaxel

6. Lifelong ADT + abiraterone acetate

7. Radical local treatment of lesions (surgery or RT) lifelong ADT+ abiraterone acetate

Non-responder, abstain, unqualified to answer

(10)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

96 14%

17%

15%

54%

95 17%

17%

17%

59%

175 10%

27%

14%

49%

46 5%

14%

19%

62%

30 14%

14%

14%

57%

30 12%

24%

16%

Option 4 48%

62

What treatment do you recommend if you consider metastasis directed therapy in men with oligometastatic recurrent castration-sensitive/naive prostate cancer that is limited to lymph node metastases in the pelvis after local treatment with curative intent (± salvage radiation therapy)?

Q3-9

Survey Panelists St.Gallen

177 9%

23%

15%

53%

31

43

37 3%

19%

8%

70%

0

0 43

23%

19%

16%

42%

8

1

Responders

1. Salvage lymph node dissection

2. Salvage lymph node dissection + whole pelvis radiotherapy

3. Focal radiotherapy to the suspicious nodes

4. Whole pelvis radiotherapy ± boost to the suspicious nodes

5. Abstain (including I do not believe that the oligometastatic recurrent state is a clinically meaningful entity)

Non-responder, abstain, unqualified to answer

(11)

What treatment do you recommend in men with oligometastatic CRPC (Rising PSA on ADT and oligometastatic disease)?

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

175 50%

2%

17%

32%

46 7%

5%

20%

68%

30 46%

4%

13%

38%

96 43%

0%

20%

38%

95 40%

3%

21%

37%

30 48%

0%

21%

Option 4 31%

Survey Panelists St.Gallen

198 40%

3%

17%

40%

18 35

38 21%

3%

3%

74%

0 0 48

44%

2%

25%

29%

4 0

Responders

1. Standard of care (continue ADT and add additional systemic therapy)

2. Local treatment of all lesions and discontinue ADT 3. Local treatment of all lesions and continue ADT 4. Local treatment of all lesions and continue ADT and add additional systemic treatment for mCRPC 5. Abstain (including I do not believe that oligometastatic prostate cancer is a clinically meaningful entity in mCRPC) Non-responder, abstain, unqualified to answer

Q3-10

對於局部治療後發生oligometastasis的患者,國內專家有共識,先施行local salvage therapy。St. Gallen專家的討論共識中,建議應該藉助next generation imaging (如PSMA) 判斷可行性。然而這樣的意見,在台灣實務上是困難的。對於oligometastatic mCRPC患 者,除了標準CRPC治療外,可考慮對所有病灶施行局部治療。

絕大部分台灣與會專家,同意以下敘述:

For de novo oligometastatic disease:

1. Radical local treatment may improve disease-specific survival and local symptom control.

2. Either radical prostatectomy or radiotherapy will do, depends on patients’condition, patients’preference, local condition, physicians’capability and experience.

3. ADT should be used for 36 months or longer.

4. Adding docetaxel in select patients only.

•評論分析:

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