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(1)

空格結果≧75%(達到St. Gallen共識)標示黃底紅字;空格結果≧50%標示紅字。

Topic 5.

Management of castration-resistant prostate cancer (CRPC)

第三次

臺灣晚期攝護腺癌專家共識

3 rd Taiwan Advanced Prostate

Cancer Consensus

(2)

A. 1st Line treatment for chemo-native mCRPC (Q5-1~2)

Q5-1

What is your preferred first-line mCRPC treatment option in the majority of asymptomatic or minimally symptomatic men who did NOT receive Docetaxel in the castration-sensi- tive/naive setting (i.e.no early chemo)?

Survey URO RO MO High Vol Senior UO

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

175 74%

1%

18%

1%

1%

6%

46 86%

0%

14%

0%

0%

0%

30 85%

0%

15%

0%

0%

0%

96 85%

0%

12%

0%

0%

4%

51 86%

0 6%

0 0 8%

0 0

95 81%

0%

14%

0%

0%

4%

30 90%

0%

7%

0%

0%

3%

Survey Panelists 183

77%

1%

17%

1%

1%

- 4%

68

39 100%

0 0 0 0 - 0 0

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Docetaxel

4. Platinum based chemotherapy 5. Radium-223

6.Sipuleucel-T

7. No preferred option

Non-responder, abstain, unqualified to answer

St.Gallen

(3)

Q5-2

What is your preferred first-line mCRPC treatment option in the majority of symptomatic men who did NOT receive Docetaxel in the castration- sensitive / naive setting (i.e.no early chemo)?

Survey URO RO MO High Vol Senior UO

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

175 48%

1%

47%

1%

1%

2%

46 55%

0%

41%

0%

0%

5%

30 37%

0%

63%

0%

0%

0%

96 54%

1%

43%

0%

0%

3%

50 52%

0 46%

0 0 0 2%

0

95 58%

1%

38%

0%

0%

3%

30 59%

0%

41%

0%

0%

0%

Survey Panelists 187

47%

1%

49%

1%

1%

- 2%

64

40 40%

0 57.5%

0 2.5%

- 0 0

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Docetaxel

4. Platinum based chemotherapy 5. Radium-223

6.Sipuleucel-T

7. No preferred option

Non-responder, abstain, unqualified to answer

對於第一線治療asymptomatic or minimally symptomatic的chemo-naïve mCRPC 病患,國 內外的專家皆一致有共識的選擇novel AR targeted agents (abiraterone or enzalutamide)。

但是對於治療symptomatic 的病患,國內外的專家約一半選擇docetaxel,一半選擇 Abi/Enza。由於現今台灣健保規定,Abi/Enza僅給付在無症狀或是輕度症狀的pre-chemo mCRPC病人。因此超過半數的國內專家選擇docetaxel為第一線治療symptomatic的病人。

在國際治療指引中(2017 AUA, EAU),對於asymptomatic or minimally symptomatic的標 準療法,為novel AR targeted agents or chemotherapy。但是對於symptomatic and poor performance的病人,novel AR targeted agents也同為治療選項之一。

•評論分析:

St.Gallen

(4)

B. 1st Line treatment for upfront-chemo treated mCRPC (Q5-3~6)

Q5-3

What is your preferred first-line mCRPC treatmentoption in the majority of asymptomatic or minimally symptomatic men who DID receive Docetaxel in the castration-sensitive/naive setting (i.e. had early chemo)?

Survey URO RO MO High Vol Senior UO

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

175 89%

2%

4%

0%

0%

4%

46 95%

0%

5%

0%

0%

0%

30 93%

4%

4%

0%

0%

0%

96 94%

1%

3%

0%

0%

3%

95 93%

1%

1%

0%

0%

4%

30 97%

3%

0%

0%

0%

0%

Survey Panelists 182

90%

2%

4%

0 0 - 3%

69

40 100%

0 0 0 0 - 0 0

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Docetaxel

4. Platinum based chemotherapy 5. Radium-223

6.Sipuleucel-T

7. No preferred option

Non-responder, abstain, unqualified to answer

St.Gallen 49 90%

2%

2%

0 0 6%

0 0

(5)

Q5-4

What is your preferred first-line mCRPC treatment option in the majority of symptomatic men who DID receive Docetaxel in the castration- sensitive / naive setting (i.e. had early chemo)?

Survey URO RO MO High Vol Senior UO

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

175 73%

12%

9%

1%

3%

2%

46 82%

9%

9%

0%

0%

0%

30 78%

7%

15%

0%

0%

0%

96 79%

9%

10%

0%

1%

1%

95 80%

11%

5%

1%

0%

3%

30 76%

10%

10%

0%

3%

0%

Survey Panelists 184

75%

11%

10%

1%

2%

- 2%

67

40 97.5%

2.5%

0 0 0 - 0 0

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Docetaxel

4. Platinum based chemotherapy 5. Radium-223

6.Sipuleucel-T

7. No preferred option

Non-responder, abstain, unqualified to answer

St.Gallen 48 73%

19%

6%

0 2%

0 0 0

(6)

Q5-5

What is your preferred first-line mCRPC treatment option in the majority of asymptomatic or minimally symptomatic men who received chemo-hormonal therapy and who progressed within ≤6 months after completion of Docetaxel in the castration-sensitive/naive setting?

Survey URO RO MO High Vol Senior UO

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

175 89%

5%

3%

0%

0%

3%

46 100%

0%

0%

0%

0%

0%

30 93%

4%

0%

0%

4%

0%

96 91%

5%

3%

0%

0%

1%

95 90%

7%

1%

0%

0%

1%

30 97%

0%

3%

0%

0%

0%

Survey Panelists 176

90%

5%

2%

0 1%

- 2%

75

40 90%

7.5%

0 0 2.5%

- 0 0

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Docetaxel

4. Platinum based chemotherapy 5. Radium-223

6.Sipuleucel-T

7. No preferred option

Non-responder, abstain, unqualified to answer

St.Gallen 47

77%

17%

2%

2%

0 0 2%

0

(7)

Q5-6

What is your preferred first-line mCRPC treatment option in the majority of symptomatic men who received chemo-hormonal therapy and who progressed within ≤6 months after completion of Docetaxel in the castration-sensitive/ naive setting?

Survey URO RO MO High Vol Senior UO

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

175 69%

19%

4%

1%

4%

3%

46 76%

6%

12%

0%

0%

6%

30 74%

11%

4%

7%

4%

0%

96 69%

19%

5%

0%

4%

3%

95 73%

15%

3%

0%

4%

4%

30 68%

18%

4%

0%

7%

4%

Survey Panelists 174

71%

17%

5%

2%

3%

- 3%

77

40 65%

27.5%

0 0 7.5%

- 0 0

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Docetaxel

4. Platinum based chemotherapy 5. Radium-223

6.Sipuleucel-T

7. No preferred option

Non-responder, abstain, unqualified to answer

St.Gallen 49

57%

27%

0 4%

8%

2%

2%

0

從2015 CHAAETED與2016 STAMPEDE studies發表後,國內外許多醫師已接受了high-volume mHSPC的病患,接受upfront-chemo (6 cycles) 的治療觀念。當這些接受過upfront-chemo 的病人開始progress,進入mCRPC,接下來的治療選項,則是一個未解的問題。目前在 討論這些病人sequential treatment的文獻並不多。

在GETUG 15病人progression以後,後線治療的分析中指出,對於已接受過upfront chemo 的病人,接受novel AR targeted agents (Abi/Enza)治療的PSA response (84%)較docetaxel rechallenge的效果好(55%)。或許考慮轉換不同機轉的治療,對於已接受upfront chemo 的病人效益較好(Lavaud et al. 2017 Eur Urol)。

•評論分析:

(8)

國內外專家也有相同的共識,對於不論是asymptomatic, minimally symptomatic or symp- tomatic,或是progression within ≤ 6 months的病人,多數醫師選擇Abi/Enza為下一線的 治療選項。大約30%的國內外專家,會選擇cabazitaxel使用在symptomatic且progression within ≤6 months惡性程度較高的病人。

(9)

Survey Panelists St.Gallen

Responders

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

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

Q5-7

If you have to choose between Abiraterone and Enzalutamide what is your preferred first-line choice for men with mCRPC with no contraindication to either drug?

184 46%

21%

34%

67

30 22.5%

12.5%

65%

0 49

37%

24%

39%

2

175 46%

20%

35%

46 48%

24%

29%

30 44%

22%

33%

96 46%

17%

37%

95 52%

19%

29%

30 38%

10%

52%

C. 1

st

Line treatment for mCRPC (Q5-7~9)

多數醫師對於名Abiraterone or Enzalutamide並沒有preference。多數醫師建議需要依據 病人可能發生的副作用來作選擇。目前一個正在進行的Phase 2 trial (NCT02125357), head to head 的比較使用這兩種藥物在treatment naïve mCRPC的病患上。在2017 ASCO發 表的部份結果顯示,time to progression並沒有顯著差別 (p=0.266, Chi et al., ASCO 2017), 最後的結果還要等後續的發表。

•評論分析:

(10)

Survey Panelists St.Gallen

Responders

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

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

Q5-8

In men with mCRPC who are asymptomatic and have rising PSA on Abiraterone plus Prednisone/Prednisolone, do you recommend a steroid switch to Dexamethasone?

157 55%

25%

19%

94

37 76%

22%

3%

2 48

37%

35%

26%

1

175 61%

22%

17%

46 50%

36%

14%

30 33%

37%

30%

96 57%

21%

21%

95 61%

20%

20%

30 54%

25%

21%

有許多Phase 2 trial是比較glucocorticoid monotherapy對於mCRPC病人的治療,已發現 dexamethasone在PSAresponse上,比prednisolone要好 (Nayayanan et al., Nar Rev Urol 2015)。

近幾年有文獻發表,關於steroid switch from prednisolone to dexamethasone在已使用 abiraterone的病患上,似乎可以更進一步控制tumor burden and PSA response (Lorente et al., Br J Cancer 2014)。國內外專家多數也知道這種steroid switch的方式。但是目前並 沒有足夠證據,證明用Dexamethasone對於mCRPC病患的OS有不同的影響。台灣的健保 有限制按照abiraterone藥物仿單使用prednisone or prednisolone 5 mg BID。

•評論分析:

(11)

Q5-9

For Docetaxel chemotherapy which regimen do you recommend in the majority of men with mCRPC?

Survey URO RO MO High Vol Senior UO

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

175 41%

21%

5%

14%

1%

1%

17%

46 4%

11%

2%

11%

0%

0%

71%

30 46%

21%

0%

18%

11%

0%

4%

96 38%

28%

2%

17%

2%

2%

10%

49 86%

- - 10%

4%

0 1 0

95 25%

24%

6%

13%

2%

1%

29%

30 28%

34%

7%

28%

0%

3%

0%

Survey Panelists 165

46%

26%

5%

19%

3%

1%

58 28

29 38%

17%

10%

31%

0 3%

10 0

Responders

1. 3-weekly Docetaxel (75mg/m2) 2. 3-weekly Docetaxel (60mg/m2) 3. 2-weekly Docetaxel (60mg/m2) 4. 2-weekly Docetaxel (50mg/m2) 5. 1-weekly Docetaxel (30-35mg/m2) 6. Other Docetaxel regimen

7. I do not prescribe docetaxel by myself Non-responder, abstain

對由於西方人對於化療劑量的耐受性似乎比東方人好。不論在治療mHSPC或mCPRC,

國外專家都會使用標準劑量 (75 mg/m2 q3w)。在台灣,化療的劑量會因病人的耐受度 和年齡會有比較多的調整。近四成的與會專家表示,mCRPC病人使用化學治療,一開 始會使用接近full dose 75-70 mg/m2 q3w。之後再依照病人的狀況或是副作用做調整,

劑量改成50~60 mg/m2 q3w 或不同的regimen 50 mg/m2 q2w。

在場專家分享臨床經驗表示。使用50 mg/m2 q2w的病患,time to response比較慢一點,

但hematology & bone marrow方面的AE確實比較少。

•評論分析:

St.Gallen

(12)

Q5-10

What is your preferred second-line mCRPC treatment option in the majority of men with asymptomatic mCRPC who had progressive diseaseas best response to first-line Abiraterone or Enzalutamide? (i.e. 沒有用過upfront chemo, initial resistance)

D. 2

nd

line treatment for after Abi/Enza treated mCRPC (Q5-10~13)

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5

175 61%

32%

1%

2%

5%

46 53%

47%

0%

0%

0%

30 26%

67%

0%

4%

4%

96 52%

42%

1%

1%

4%

95 63%

31%

0%

1%

4%

30 45%

52%

3%

0%

0%

Survey Panelists 188

51%

36%

1%

2%

4%

6%

63

39 23%

77%

0 0 0 0 1

Responders

1. Abiraterone or Enzalutamide (depending which has already been used)

2. Taxane 3. Radium-223 4. Sipuleucel-T

5. No preferred option

6. Abstain (including other treatment option) Non-responder, unqualified to answer

St.Gallen 51 14%

70%

4%

6%

6%

0 0

(13)

Q5-11

What is your preferred second-line mCRPC treatment option in the majority of men with symptomatic mCRPC who had progressive disease as best response to first-line Abiraterone or Enzalutamide? (i.e. initial resistance)

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5

175 36%

55%

3%

0%

6%

46 32%

58%

5%

0%

5%

30 15%

78%

4%

0%

4%

96 32%

63%

3%

0%

3%

95 39%

51%

1%

0%

9%

30 21%

76%

0%

0%

3%

Survey Panelists 187

30%

55%

3%

0 5%

7%

64

39 0 95%

5%

0 0 0 1

Responders

1. Abiraterone or Enzalutamide (depending which has already been used)

2. Taxane 3. Radium-223 4. Sipuleucel-T

5. No preferred option

6. Abstain (including other treatment option) Non-responder, unqualified to answer

St.Gallen 50

0 96%

4%

0 0 0 0

在Abi/Enza pivotal trials, COU-AA-301 and AFFIRM中,約有25-30%的病人對於novel AR targeted agents有primary resistance。對於這類病患,國內外專家都有共識選擇docetaxel 為第二線的治療方式。少數的專家會考慮使用Radium-223。

現在有許多genomic analysis 對於mCRPC的病人做研究分析,發現其他的gene mutation markers也許可以為之後的treatment resistance的病患,提供personized treatment治療,例 如:BRCA2/ATM, TP53 or PI3K mutation。

•評論分析:

(14)

Q5-12

What is your preferred second-line mCRPC treatment option in the majority of men with asymptomatic mCRPC and secondary (acquired) resistance (initial response followed by progression) after use of first-line Abiraterone or Enzalutamide?

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5

175 48%

44%

2%

1%

6%

46 60%

35%

0%

0%

5%

30 37%

56%

4%

0%

4%

96 49%

45%

1%

1%

3%

95 58%

35%

2%

2%

5%

30 46%

50%

4%

0%

0%

Survey Panelists 186

44%

41%

2%

1%

5%

8%

65

38 47%

53%

0 0 0 0 1

Responders

1. Abiraterone or Enzalutamide (depending which has already been used)

2. Taxane 3. Radium-223 4. Sipuleucel-T

5. No preferred option

6. Abstain (including other treatment option) Non-responder, unqualified to answer

St.Gallen 51 27%

57%

10%

4%

2%

0 0

(15)

Q5-13

What is your preferred second-line mCRPC treatment option in the majority of men with symptomatic mCRPC and secondary (acquired) resistance (initial response followed by progression) after use of first-line Abiraterone or Enzalutamide?

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5

175 30%

58%

4%

0%

8%

46 37%

58%

0%

0%

5%

30 19%

70%

4%

0%

7%

96 25%

65%

4%

0%

6%

95 32%

54%

3%

0%

11%

30 17%

76%

3%

0%

3%

Survey Panelists 186

27%

55%

3%

0 7%

8%

65

39 10%

87%

3%

0 0 0 1

Responders

1. Abiraterone or Enzalutamide (depending which has already been used)

2. Taxane 3. Radium-223 4. Sipuleucel-T

5. No preferred option

6. Abstain (including other treatment option) Non-responder, unqualified to answer

St.Gallen 51

0 90%

8%

0 2%

0 0

若是對於已接受過novel AR targeted agents (Abi/Enza)治療後,再次disease progression 且asymptomatic的病人,約半數的國內外專家會選擇taxane類藥物治療。另外半數專 家會Abi/Enza互換使用,延長使用novel AR targeted agents的時間。若是病人已經是 symptomatic,國內外專家會一致選擇使用taxane來做為第二線治療。與會專家建議,

若病人真的是bone only disease和symptomatic,Radium-223是化療外的另一個選項。

•評論分析:

(16)

Q5-14

What is your preferred second-line mCRPC treatment option in the majority of asymptom- atic/minimally symptomatic men, progressing on or after Docetaxel for mCRPC? (without prior Abiraterone or Enzalutamide)

E. 2

nd

or 3rd Line treatment for post chemotherapy mCRPC (Q5-14~15)

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5

175 88%

5%

0%

1%

6%

46 95%

0%

0%

0%

5%

30 89%

0%

4%

4%

4%

96 95%

1%

0%

1%

3%

95 88%

4%

0%

1%

6%

30 90%

3%

0%

0%

7%

Survey Panelists 187

83%

4%

1%

1%

5%

6%

64

38 100%

0 0 0 0 0 1

Responders

1. Abiraterone or Enzalutamide 2. Cabazitaxel

3. Radium-223 4. Sipuleucel-T

5. No preferred option

6. Abstain (including other treatment option) Non-responder, unqualified to answer

St.Gallen 51 92%

6%

2%

0 0 0 0

(17)

Q5-15

What is your preferred third-line mCRPC treatment option in the majority of men with mCRPC, progressing on or after second-line Docetaxel for mCRPC AND prior treatment with Abiraterone or Enzalutamide? (abi/enz and docetaxel fail)

Survey URO RO MO High Vol Senior UO

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

175 37%

43%

4%

3%

2%

10%

46 61%

17%

6%

0%

0%

17%

30 38%

46%

0%

4%

0%

12%

96 39%

44%

3%

0%

0%

14%

95 48%

41%

0%

2%

0%

10%

30 30%

63%

4%

0%

0%

4%

Survey Panelists 181

36%

36%

3%

3%

1%

10%

10%

70

39 23%

69%

8%

0 0 0 0 1

Responders

1. Abiraterone or Enzalutamide(depending which has already been used)

2. Cabazitaxel 3. Radium-223

4. Platinum based chemotherapy 5. Sipuleucel-T

6. No preferred option

7. Abstain (including other treatment option) Non-responder, unqualified to answer

St.Gallen 51 8%

61%

15%

6%

0 8%

2%

0

若化療後的mCRPC病患,大多數專家們一致選擇Abi/Enza為下一線的治療選項,少數 的專家會考慮cabazitaxel。Abiraterone (COU-AA-301)和Enzalutamide (AFFIRM)已在各 自的pivotal study中,證明對於post chemo mCRPC病患的OS和radiographic PFS有顯著 助益。

•評論分析:

(18)

若是病患progress after chemo and Abi/Enza,在第三線治療的選擇,超過半數的國內外 專家,會選擇cabazitaxel。選擇後線的療法,要考慮藥物間是否有cross-resistance。在 文獻回顧中,cabazitaxel在三線治療時,不會被前線Abi/Enza 和docetaxel的治療影響。

對於能耐受cabazitaxel的病患,仍有很好的PSA response (Pezaro et al., Eur Urol. 2013)。

在第三線治療選項方面,對於特定gene mutations的病人,除了使用PARP inhibitors之 外,有些國外專家也覺得使用platinum-based chemotherapy會有幫助。所以針對很後線 治療的病人,做基因檢測或參加臨床試驗,也會有幫忙。另外,有些腫瘤有neuroendocrine differentiation,這類的病人應該要跳脫原來的治療架構,而是以最適合neuroendocrine differentiation的治療,如化學治療為主。

(19)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4

175 58%

21%

16%

6%

46 44%

31%

25%

0%

30 48%

15%

26%

11%

96 63%

17%

12%

8%

95 50%

25%

16%

9%

30 52%

17%

17%

14%

Q5-16

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations? Stable brain metastases

F. Treatment for mCRPC patients with comorbidity (Q5-16~21)

Brain metastasis很少發生在PC的病人上,但若是mCRPC病患同時有brain metastasis時,

大多數的專家都選擇使用abiraterone治療,而不是enzalutamide。在2015的一個case report中,brain mets的病患多具有一些CNS症狀 (headache, cognitive disorders, and seizures),case中使用不會通過BBB的abiraterone with RT (Craig et al., Curr Oncol 2015)。

2012 Caffo的文獻中指出,大部分的chemotherapy無法穿越BBB, 但是cabazitaxel 在brain model中是具有活性的,也許為治療PC 腦部轉移的一個治療選項 (Caffo et al., Future Oncol 2012)。

由於enzalutamide會通過BBB,所以國內與會專家有討論關於enzalutamide治療PC腦部轉 移的可能性。但是由於沒有study support,也不知道Enza確切到達腦中的濃度是否有達到 治療效果,與會專家還是建議使用RT局部治療轉移到腦部的腫瘤。

•評論分析:

Survey Panelists 163

55%

21%

18%

6%

64

39 82%

0 15%

3%

1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

St.Gallen 52 73%

6%

10%

11%

0

(20)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

175 61%

14%

22%

46 47%

20%

33%

30 63%

19%

19%

96 71%

10%

18%

95 56%

17%

24%

30 79%

3%

17%

Q5-17

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations? History of falls

Survey Panelists 171

60%

15%

23%

2%

80

39 85%

0 15%

0 1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

St.Gallen 51 94%

2%

4%

0 0

(21)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

175 61%

14%

22%

46 47%

20%

33%

30 63%

19%

19%

96 71%

10%

18%

95 56%

17%

24%

30 79%

3%

17%

Q5-18

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations? Baseline significant fatigue

Survey Panelists 171

60%

15%

23%

2%

80

39 85%

0 15%

0 1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

St.Gallen 52 88%

6%

6%

0 0

(22)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

175 21%

64%

14%

46 20%

60%

20%

30 19%

70%

11%

96 21%

70%

8%

95 23%

60%

16%

30 11%

75%

11%

Q5-19

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations? Diabetes mellitus requiring prescription drug therapy

Survey Panelists 170

21%

65%

14%

1%

81

39 8%

82%

10%

0 1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

St.Gallen 52 6%

84%

10%

0 0

(23)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4

175 14%

74%

6%

5%

46 13%

56%

19%

13%

30 26%

59%

15%

0%

96 13%

78%

8%

1%

95 14%

67%

12%

7%

30 14%

82%

0%

4%

對於同時具有其他的comorbidity的mCRPC病患,需要仔細考慮選擇合適的藥物給予病患。

對於容易跌倒,或平時就受疲倦症狀困擾者,依照藥物的AE profile,國內外專家一致 有共識的選擇使用abiraterone為治療的方式。

由於enzalutamide會進入BBB,在研究中有觀察到,老年人中有較高的跌倒比率(Enza 19.2% vs placebo 7.9%)和藥物造成的fatigue。與會專家分享使用經驗表示,加上使用 steroid對於Enza引起的fatigue有明顯改善。

關於mCRPC病患若有diabetes或是active liver dysfunction,國內外專家有較高比例選擇 使用enzalutamide。雖然在abiraterone的臨床試驗中,有15-17%的病人有使用diabetic drugs,但是專家們仍擔心steroid會讓血糖值較難控制。Abi/Enza 都要經過肝臟代謝,

藥物仿單中有提及使用abiraterone需要注意肝指數(ALT/AST),避免肝毒性的發生。

因此有liver dysfunction的病人,國內外專家傾向選擇使用enzalutamide治療。

•評論分析:

Q5-20

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations? Active liver dysfunction

Survey Panelists 168

16%

70%

9%

5%

83

39 8%

90%

3%

0 1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

St.Gallen 49 8%

66%

14%

12%

1

(24)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4

175 14%

70%

13%

3%

46 13%

60%

27%

0%

30 22%

48%

30%

0%

96 10%

74%

14%

1%

95 13%

64%

18%

4%

30 14%

79%

4%

4%

由於台灣的B、C型肝炎帶原者眾多,本題特地探討這群病人的用藥選擇。由於國外臨 床試驗中,有帶原但是non-active的病人,或是曾接受過治療的肝炎病人,只要肝功能 仍在Child-Pugh Class A/B,即可加入試驗接受治療。但現今並沒有此類病人的次分析 結果(COU-AA-301/302)。因考慮到對肝臟的負擔,國內專家約6成會選擇enzalutamide。

與會專家臨床經驗分享,由於考慮到台灣還是有相當比例的病人是HBV carriers。在給予 mCRPC化學治療前,都會測試HBV。若是在pre-chemo setting,會建議在給予藥物前測試 HBV。

•評論分析:

Q5-21

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations? Hepatitis B or C carrier

Survey Panelists 166

15%

66%

17%

2%

85

39 7.5%

61.5%

31%

0 1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

(25)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4

175 23%

14%

37%

26%

46 19%

13%

50%

19%

30 33%

15%

37%

15%

96 21%

10%

38%

31%

95 22%

9%

40%

29%

30 3%

7%

55%

34%

在治療pre-chemo asymptomatic and ADT <12 months的病患,大多數專家對於使用Abi 或Enza並無特別偏好。最重要還是要考慮病人的疾病的特徵,選擇適合病人的藥物。

•評論分析:

Q5-22

What is your preferred choice between Abiraterone and Enzalutamide at any time in the treatment sequence in men with mCRPC if all options are available in case of the following medical situations?

Asymptomatic men with a duration of response to ADT (no chemo-hormonal therapy) <12 months Survey

St.Gallen Panelists

164 24%

14%

38%

23%

87

38 13%

3%

71%

13%

1

Responders 1. Abiraterone 2. Enzalutamide

3. Either: No preferred choice

4. Neither: Alternative treatment option preferred Non-responder, abstain, unqualified to answer

52 6%

11%

56%

27%

0

參考文獻

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