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第三次 臺灣晚期攝護腺癌專家共識

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(1)

Topic 4.

Management of castration-sensitive/naive 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)

In men with non-metastatic disease and confirmed rising PSA (post-local therapy +/- salvage local RT), (PSA fail without radiographic progression), do you recommend starting ADT?

Survey Panelists St.Gallen

210 55%

39%

6%

41

44 39%

59%

2%

0 50

22%

66%

12%

1 Responders

1. Yes, in the majority of patients

2. In a minority of selected patients e.g. PSA ≥4ng/ml and rising with doubling time less than 6 months or PSA ≥20ng/ml (STAMPEDE inclusion criteria)

3. No, I only recommend ADT after detection of metastatic disease

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

175 55%

39%

5%

96 49%

43%

7%

95 54%

40%

6%

46 64%

31%

5%

30 40%

52%

8%

30 38%

48%

14%

Q4-1

第一階段問卷中,有55%回覆醫師主張對大多數患者於post-local therapy +/- salvage local RT後,confirmed rising PSA立即給予 androgen deprivation therapy (ADT)。但是國 外專家,與第二階段現場投票的國內專家,傾向ADT只給予少部分具高風險的M0 rising PSA (曾接受過RP or RT之後BCR,biochemical recurrence only) 患者 (即STAMPEDE inclusion criteria: PSADT<6 months or PSA≥20 ng/ml)。

•評論分析:

(3)

對於”Rising PSA” only after RT or after RP ± RT,台灣的與會專家達成下列共識:

1.“Post-surgery biochemical recurrence (BCR)”定義為:Three successive PSA rise > 0.2 ng/mL, single PSA>0.4 ng/mL, or use of second therapy for PSA>0.1 ng/mL。

2. Radiotherapy (RT) 後BCR定義為: “Any PSA increase > 2 ng/mL higher than nadir” as the “RTOG-ASTRO Phoenix Consensus” suggested.

3. Bone scan and CT should be performed only for patients with PSA>10 ng/mL, or PSA doubling time (PSA-DT) < 6 months, or PSA velocity > 0.5 ng/mL/mo, as the EAU guide lines recommended.

4. Initial consideration for salvage treatment vs ADT monotherapy depends on the life expectancy, PSA-DT, Gleason score and LN status.

5. Salvage ADT + RT is standard of care for local or regional recurrence.

6. Selective use of PSMA-PET to detect oligometastasis before salvage lymph node dissection or RT is recommended.

7. ADT monotherapy is an option for men with rising PSA post-surgery and salvage RT, when RT is contraindicated, patients with pN+ disease, PSA-DT<6 months, or PSA> 1 ng/mL.

8. Immediate ADT compared to delayed ADT prolongs overall survival in patients with long life expectancy, PSA >4 ng/ml, PSA-DT <12 month (TOAD study).

9. ADT should be avoided in men with low risk, slow progressive disease.

10. Intermittent ADT can be an option for select patients.

(4)

Q4-2

Do you still believe upfront combined androgen blockade (not short term usage of antiandrogen to prevent disease flare up) will benefit patients with metastatic castration-sensitive/naive prostate cancer (mCNPC)?

A. Upfront CAB treatment in mCNPC (Q4-2, 3, 9)

Survey URO RO MO High Vol Senior UO

N 175 46 30 96 95 30

Survey Panelists 196

38%

3%

2%

13%

9%

3%

9%

23%

56 41

15%

35%

50%

44 23%

0 2%

7%

2%

0

18%

48%

0 Responders

1. Yes, in the majority of patients

2. Only for patients with initial PSA > 20 ng/mL 3. Only for patients with Gleason score ≧ 8 or with Gleason grade 5

4.Only for patients with high metastatic burden (as definition in CHAARTED trial)

5. Only for patients with PSA > 20 and Gleason score ≧ 8 or with Gleason grade 5

6. Only for patients with PSA > 20 ng/mL and high metastatic burden

7. Only for patients with PSA > 20 , Gleason score ≧8, and high metastatic burden

8. No

Non-responder, abstain, unqualified to answer

St.Gallen (2015)

(5)

第一階段問卷中,有38%醫師主張對多數mCNPC患者給予combined androgen block- ade (CAB),23%醫師則不使用。這結果和2015年St. Gallen consensus差異極大。目前 的臨床證據與國際Guidelines都指出,使用CAB對於患者的overall survival 沒有顯著改 善。只有Akaza et al在Cancer 2009的報導中指出,使用CAB with bicalutamide對於日本 族群有OS的幫助。但由於日本使用bicalutamid的劑量和其他國家不同(80 mg/d),國內 與會專家認為此研究證據強度不夠。討論後,48%與會專家不主張對mCNPC患者使用 upfront CAB,然而還是有23%與會專家,在第二階段投票,主張該用在大多數的病人。

Tombal et al在2017 Nature Review指出,LATITUDE (Fizazi et al., NEJM 2017) 及 STAMPEDE (James et al., NEJM 2017) trials中,ADT加上upfront abiraterone在mCNPC,

是一種新形態的CAB。這一種新型的AR targeted agents除了提供mCNPC的病人完全的 androgen blockade,也非常顯著的增加OS和延緩rPFS。在此同時,許多大型的mCNPC 研究也正在進行中,例如: ENZAMET (ADT+enzalutamide vs. ADT+ first-generation antiandrogen)和ARCHES (ADT+enzalutamide vs ADT+placebo),我們應該等待其研究結 果發表,讓病患接受更好的治療組合和選項。

•評論分析:

(6)

Q4-3

If you decided to adopt upfront combined androgen blockade for mCNPC patients, what is the optimal duration of usage of antiandrogen?

Survey Panelists 175

29%

35%

30%

2%

2%

3%

36 40

19 5%

74%

16%

5%

0%

0%

23 0 Responders

1. life-long

2. Till PSA declined to a stable level 3. Till progress to CRPC

4. 1 years 5. 2 years 6. 3 years

7. Abstain (including never use combined androgen blockade) Non-responder, unqualified to answer

Survey URO RO MO High Vol Senior UO

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

175 31%

39%

23%

2%

2%

2%

96 24%

46%

25%

1%

1%

1%

95 26%

36%

35%

0%

1%

1%

46 24%

21%

48%

0%

3%

3%

30 24%

29%

43%

0%

0%

5%

30 12%

64%

24%

0%

0%

0%

贊同使用CAB的與會專家中,有74%認為當PSA下降至某一穩定數值時,即可停用CAB。

•評論分析:

(7)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4 Option 5 Option 6 Option 7 Option 8

175 49%

8%

3%

3%

35%

2%

0%

0%

46 62%

3%

3%

0%

31%

0%

0%

0%

30 42%

13%

13%

0%

33%

0%

0%

0%

96 53%

8%

2%

1%

33%

2%

0%

0%

95 52%

12%

1%

3%

29%

3%

0%

0%

30 62%

7%

3%

0%

24%

3%

0%

0%

Q4-9

What kind of hormone therapy do you recommend in the majority of men presenting with high-volume metastatic castration-sensitive/naive prostate cancer?

Survey Panelists St.Gallen

197 50%

8%

5%

2%

34%

2%

0 0 54

39 62%

15%

5%

0

18%

0 0 0 4 51

68%

6%

10%

2%

14%

0 0 0 0

Responders

1. Continuous ADT by LHRH agonist alone (± short course first generation AR antagonist)

2. Continuous ADT by LHRH antagonist alone 3. Start with LHRH antagonist and switch to LHRH agonist in the course of treatment

4. ADT by Orchiectomy alone

5. Continuous combined ADT (LHRH agonist or antagonist or orchiectomy plus ongoing first generation AR antagonist)

6. Any form of intermittent ADT 7. Bicalutamide 150mg monotherapy 8. Enzalutamide monotherapy

Non-responder, abstain, unqualified to answer

(8)

對於high volume mCNPC患者使用hormone therapy,第一階段問卷中有50%醫師主張單獨 使用ADT,34%則主張採用CAB。第一階段與會專家中,有62%主張單獨使用ADT,支 持CAB的只有18%。

與會專家共識為:

1. CAB may be associated with 3~5% overall survival advantage when cyproterone acetate are excluded from analysis.

2. We should wait for results of ENZAMET (ADT+enzalutamide vs. ADT+ other antiandrogen) and ARCHES (ADT+enzalutamide vs ADT+placebo) studies to comment if enzalutamide has a life-prolonging effect in men with mCNPC similar with abiraterone.

•評論分析:

(9)

Q4-4

Survey Panelists 209

57%

11%

22%

11%

42

44 36%

16%

11%

36%

0 Responders

1. Yes, in all patients 2. No, only PSA

3. No, only PSA + testosterone

4. No, only PSA + testosterone + Alk-P

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

175 51%

13%

25%

11%

46 62%

8%

18%

13%

30 84%

4%

8%

4%

96 52%

15%

19%

13%

95 45%

12%

29%

14%

30 52%

10%

17%

Option 4 21%

B. Monitoring patients during ADT (Q4-4~7)

Do you agree with the statement that “Baseline blood tests including (not limited to) PSA, testosterone, Alk-P, LDH, should be performed in every man with mCNPC before starting ADT?

第一階段問卷中有57%醫師在開始ADT前,會常規檢測 PSA、testosterone、Alk-P及LDH。

與會專家中有討論到,LDH在攝護腺癌預後所扮演角色不明確。但 Radium 223 pivotal trial中,LDH level是一個prognostic indicator (Parkers et al., NEJM 2013)。經討論後投 票,72%與會專家會常規檢測PSA、testosterone及Alk-P,但是其中仍只有半數會檢測 LDH。

•評論分析:

(10)

How often do you think PSA should be followed in mCNPC patients after starting ADT?

Survey Panelists Responders

1. Monthly or every 3 months till PSA stabilized and change to every 3 months thereafter

2. Monthly or every 3 months till PSA stabilized and change to every 6 months thereafter

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2

175 77%

23%

46 84%

16%

30 88%

12%

80%第一階段醫師和86%第二階段專家,認同在ADT開始時,應每一至三個月測量一次 PSA,直至穩定,之後則是每三個月追蹤一次。

•評論分析:

96 86%

14%

95 80%

20%

30 100%

0%

Q4-5

211 80%

20%

40

44 86%

14%

0

(11)

How often do you think testosterone should be followed in mCNPC patients after starting ADT?

Survey Panelists Responders

1. Monthly or every 3 months till PSA stabilized and then stop until confirmed PSA rising or symptom suggesting disease progression developed

2. No necessary for regular follow up unless confirmed PSA rising or symptom suggesting disease progression developed

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2

175 45%

55%

46 46%

54%

30 28%

72%

43%第一階段醫師會在ADT開始後,每一至三個月測量一次testosterone level,直至PSA 穩定,然而86%與會專家認為,在ADT治療中,實在無需定期追蹤testosterone,除非 PSA上升或症狀懷疑progression。

•評論分析:

96 40%

60%

95 38%

62%

30 45%

55%

Q4-6

207

43%

57%

44

43

14%

86%

0

(12)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

175 7%

16%

16%

61%

46 2%

12%

10%

76%

30 8%

24%

4%

64%

96 2%

19%

7%

72%

95 4%

15%

11%

70%

30 3%

17%

7%

Option 4 72%

至於bone scan的追蹤時機,64%的第一階段醫師和89%的第二階段與會專家,都認為 只有在confirmed PSA rising 或 symptoms suggesting disease progression時才需要做 bone scan。

•評論分析:

How often do you think bone scan should be followed in mCNPC patients after starting ADT?

Survey Panelists 214

6%

16%

14%

64%

37

44 0 2%

9%

89%

0 Responders

1. Every 3 months 2. Every 6 months 3. Every year

4. Only when confirmed PSA rising or symptom suggesting disease progression developed

Non-responder, abstain, unqualified to answer

Q4-7

(13)

Which testosterone level is most appropriate on ADT?

St. Gallen Panelists 50

54%

36%

10%

44 32%

68%

0 Responders

1.<50 ng/dL 2.<20 ng/dL

Abstain (including other threshold)

Q 4.7-1

Testosterone castration level是EAU Guideline按照當時leuprolide registration trial訂下 的標準 (<50 ng/dL)。54%的第一階段醫師主張testosterone level降至<50 ng/dL即足夠,

但多數(68%)第二階段專家則主張應該降至< 20 ng/dL。此外,我們觀察到有趣的現象,

從2015年St Gallen第一次共識會議,到2017第二次共識會議,國外專家選擇Testosterone castration level < 20 ng/dL的人,增加了3倍 (from 12% to 36%)。同期間,國內專家選 擇< 20 ng/dL的人數,也從57%增加到68%。這顯現國內外專家逐漸傾向將Testosterone castration level降低。最近研究報導顯示,testosterone level < 20 ng/dL也許對延緩病程 到CRPC是有幫助的 (Klotz et al., JCO 2015)。

•評論分析:

(14)

What is your preferred next management option in a patient on GnRH agonist with rising PSA in case a non-castrate testosterone level is confirmed and LH is suppressed?

St. Gallen Panelists 50

14%

20%

36%

26%

4%

44 16%

48%

25%

11%

- Responders

1. Change to orchiectomy

2. Change to alternative GnRH agonist 3. Change to GnRH antagonist

4. Add first generation AR antagonist Abstain (including other option)

Q 4.7-2

當患者在接受GnRH agonist治療中,發生PSA上升而testosterone 無法達成castrate level 時,應採取何種後續治療,大家意見相當分歧。與會專家中,48%認為可以改用其他的 GnRH agonist。高雄榮總提供自身經驗認為有部分患者由 Leuplin® (11.25 mg leuprore- lin acetate) 轉換成 Eligard® (22.5 mg leuprorelin acetate) 時,可以讓PSA下降。

95%與會專家達成以下共識:

1. Baseline blood tests including, but not limited to PSA, testosterone, and Alk-P, should be performed in every man with mCNPC (castration naïve prostate cancer) before starting ADT.

2. PSA level should be checked every 1 to 3 months till PSA stabilizes and every 3 months thereafter.

3. The optimal testosterone castration level is < 20 ng/dL. However, it may not be necessary to monitor serum testosterone levels regularly during long term ADT treatment for mCNPC unless there are confirmed PSA rising or symptoms suggesting disease progression.

4. Following up bone scan during long term ADT treatment for mCNPC is indicated only when there are confirmed PSA rising or symptoms suggesting disease progression.

•評論分析:

(15)

When is the suitable time to discuss the option about intermittent androgen deprivation therapy (iADT) in men with metastatic castration-naïve prostate cancer under ADT?

Q4-8

Survey URO RO MO High Vol Senior UO

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

175 8%

15%

26%

6%

15%

30%

46 5%

15%

30%

0%

10%

40%

30 26%

21%

16%

0%

26%

11%

96 10%

13%

19%

6%

15%

38%

95 9%

22%

24%

3%

9%

34%

30 4%

19%

30%

0%

7%

41%

Survey Panelists 206

8%

12%

20%

3%

12%

22%

22%

45

42 0 5%

36%

7%

10%

33%

7%

1

Responders

1. When PSA nadir < 4 ng/ml and lasted for > 6 months 2. When PSA nadir < 1 ng/ml and lasted for > 6 months 3. When PSA nadir < 0.1 ng/ml and lasted for > 6 months 4. When PSA nadir < 4 ng/ml and lasted for > 12 months 5. When PSA nadir < 1 ng/ml and lasted for > 12 months 6. When PSA nadir < 0.1 ng/ml and lasted for > 12 months 7. Abstain (including never discuss option of iADT)

Non-responder, unqualified to answer

會議中有74%專家認為可以和患者討論 intermittent ADT (iADT) 的可行性,69%與會專 家認為當PSA下降至< 0.1 ng/mL以下,且持續足夠長的時間時,可以考慮轉換成iADT,

然而下降持續時間,應維持6個月(15位專家),還是12個月(14位專家),則無法達成共 識。

•評論分析:

(16)

Q4-10

Survey Panelists 187

56%

16%

12%

14%

2%

64

42 76%

0 12%

10%

2%

1 Responders

1. Yes, in the majority of patients 2. Only for young patients

3. Only for patients whose PSA level did not drop low enough after 2 months of ADT

4. Only for young and PSA level did not drop low enough after 2 months of ADT

5. No

Non-responder, abstain, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

175 63%

11%

10%

14%

46 32%

32%

24%

12%

30 44%

28%

12%

16%

96 66%

9%

9%

17%

95 61%

14%

11%

14%

30 68%

11%

4%

Option 4 18%

C. Upfront Treatment in mCNPC (chemo/abiraterone) (Q4-10~17)

St.Gallen 50 96%

4%

-

- - -

For men who are suitable for chemotherapy: Do you recommend Docetaxel in addition to ADT in men with de novo metastatic castration-sensitive/naive prostate cancer and high volume disease as defined by CHAARTED (visceral metastases and/or ≥4 bone lesions with ≥1 beyond vertebral bodies and pelvis)?

(17)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4 Option 5

Q4-13

Survey Panelists 181

61%

13%

13%

11%

2%

70

44 80%

0 9%

7%

5%

Responders

1. Yes, in the majority of patients 2. Only for young patients

3. Only for patients whose PSA level did not drop low enough after 2 months of ADT

4. Only for young and PSA level did not drop low enough after 2 months of ADT

5. No

Non-responder, abstain, unqualified to answer

175 64%

7%

14%

11%

3%

46 46%

29%

8%

17%

0%

30 56%

28%

12%

4%

0%

96 62%

9%

16%

11%

2%

95 55%

12%

16%

14%

3%

30 68%

11%

11%

11%

0%

St.Gallen 50 74%

24%

2%

Do you recommend Docetaxel in addition to ADT in with metastatic castration- sensitive/naive disease relapsing after prior treatment for localized prostate cancer and with high volume disease as per CHAARTED (visceral metastases and/or ≥4 bone lesions with ≥1 beyond vertebral bodies and pelvis)?

(18)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

Q4-12

Survey Panelists 178

20%

39%

42%

73

43 2%

58%

40%

1 Responders

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

Non-responder, abstain, unqualified to answer

175 24%

31%

46%

46 9%

65%

26%

30 8%

58%

33%

96 16%

33%

51%

95 14%

39%

46%

30 3%

52%

45%

St.Gallen 52 29%

65%

6%

Do you recommend Docetaxel in addition to ADT in men with de novo metastatic castration-sensitive/naive and low-volume disease as per CHAARTED (no visceral metastases and <4 bone lesions and only confined to axial skeleton)?

(19)

Survey

自從2014年發表CHAARTED study以來,許多國內外專家都已經漸漸接受且開始使用 upfront chemo in mCNPC (HSPC),特別是針對具有high-volume mets的病人(Sweeny et al., NEJM 2015)。雖然CHARRTED updated analysis (Sweeney et al. ESMO 2016) 指出,

upfront docetaxel + ADT只有用在de novo high-volume mCNPC才有OS benefit,在prima- ry definitive treatment failure之後,發生mets者,似乎沒有OS benefit。但與會專家仍主 張,只要是high-volume mets都建議使用upfront docetaxel + ADT (chemohormonal therapy)。

不管是第一階段問卷調查或現場與會專家都認為,high-volume mCNPC 病患應接受 chemohormonal therapy。若是low-volume disease則僅限於少數selected patients需要接 受chemohormonal therapy。在台灣醫師心目中,primary definitive treatment failure之後 發生的mCNPC,比de novo mCNPC 更需要接受chemohormonal therapy。

•評論分析:

URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

Q4-15

Survey Panelists 183

23%

37%

40%

68

44 7%

71%

22%

- Responders

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

Non-responder, abstain, unqualified to answer

175 26%

30%

43%

46 14%

59%

27%

30 16%

52%

32%

96 14%

36%

49%

95 19%

39%

42%

30 7%

48%

45%

St.Gallen 52 19%

54%

25%

2%

Do you recommend Docetaxel in addition to ADT in with metastatic castration- sensitive/naive disease relapsing after prior treatment for localized prostate cancer and with low-volume disease as per CHAARTED (no visceral metastases and <4 bone lesions and only confined to axial skeleton)?

(20)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

175 49%

31%

5%

15%

46 0%

30%

10%

60%

30 52%

32%

0%

16%

96 49%

32%

5%

14%

95 33%

41%

10%

16%

30 48%

26%

11%

Option 4 15%

If you use chemo-hormonal therapy in men with castration-sensitive/naive disease which chemotherapy regimen do you recommend for the majority of patients?

Survey Panelists St.Gallen

145 46%

31%

5%

18%

36 70

35 49%

23%

3%

26%

4 5 49

96%

4%

0 0 1 1 Responders

1. 75 mg/m2 q3w * 6 cycles (450 mg/15wks) 2. 60 mg/m2 q3w * 6 cycles (360 mg/15wks) 3. 60 mg/m2 q2w * 8 cycles (480 mg/14 wks) 4. 50 mg/m2 q2w * 9 cycles (450 mg/16 wks) 5. Abstain (including I do not use chemo-hormonal therapy)

Non-responder, unqualified to answer

Q4-16

(21)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3

175 29%

51%

5%

15%

46 54%

23%

8%

15%

30 28%

48%

4%

20%

96 22%

57%

4%

16%

95 20%

55%

4%

20%

30 22%

59%

7%

Option 4 11%

How long after starting ADT do you recommend starting Docetaxel in men where you plan to add Docetaxel to ADT?

Survey Panelists St.Gallen

140 31%

48%

5%

16%

44 67

43 14%

81%

5%

0 1 50

20%

58%

18%

4%

0 2 Responders

1. Within 2 to 4 weeks after starting ADT 2. Within 3 months after starting ADT 3. Within 4 months after starting ADT 4. Within 6 months after starting ADT

5. Abstain (including I do not use chemo-hormonal therapy)

Non-responder, unqualified to answer

Q4-17

對於在mCNPC的病患使用docetaxel的劑量,國內專家覺得標準劑量 (75 mg/m2 q3w) 對 於台灣病人的負擔較重,大多數台灣醫師會減低docetaxel的劑量,或是使用alternative regiment (50 mg/m2 q2w),將劑量降低並增加cycle數。使病人接受的總劑量與標準劑量 相同。但是目前對於調整劑量或改變regiment的upfront chemo treatment,並沒有任何證 據顯示其對於OS的差別。

CHAARTED trial並沒有亞洲族群的病患加入。所以無法知道,對於亞洲族群的效果。香 港在2015-2016年間,收錄了32名mCNPC病患(96% with high volume)接受CHARRTED的 標準劑量與療程。結果顯示,對於香港病患,upfront chemo 對於減緩PSA progression 和

•評論分析:

(22)

大部分與會專家同意以下敘述:

1. Based on CHAARATED and STAMPEDE trials, upfront docetaxel + ADT is recommended for chemo-fit patients with high volume, metastatic castration- sensitive/naive prostate cancer (mCNPC).

2. Whether upfront docetaxel + ADT is necessary for patients with low volume mCNPC remained controversial.

3. Docetaxel should be added to ADT within 3 months of initiating ADT.

4. The recommended dosing schedule for docetaxel is 60~75 mg/m2 every 3 weeks or 50 mg/m2 every 2 weeks.

(23)

Survey URO RO MO High Vol Senior UO N

Option 1 Option 2 Option 3 Option 4 Option 5

175 50%

3%

24%

6%

17%

46 43%

14%

43%

0%

0%

30 58%

4%

33%

0%

4%

96 50%

6%

22%

3%

19%

95 40%

4%

31%

1%

22%

30 50%

7%

25%

4%

14%

Do you recommend abiraterone acetate in addition to ADT in men with de novo metastatic castration-sensitive/naive prostate cancer and high risk disease as defined by LATITUDE study?

Survey Panelists 167

50%

5%

28%

4%

13%

84

41 85%

2%

7%

2%

2%

3 Responders

1. Yes, in the majority of patients 2. Only for young patients

3. Only for patients whose PSA level did not drop low enough after 2 months of ADT

4. Only for young and PSA level did not drop low enough after 2 months of ADT

5. No

Non-responder, abstain, unqualified to answer

Q4-11

(24)

LATITUDE study (2017 NEJM) 建議,在新診斷的”high risk” mCNPC患者,使用early abiraterone + prednisolone (5 mg/day) + ADT,可以延長OS。High risk的定義為: 1) Glea-

•評論分析:

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3 Option 4 Option 5

175 54%

6%

19%

6%

15%

46 57%

14%

19%

10%

0%

30 63%

8%

21%

8%

0%

96 53%

7%

20%

7%

12%

95 42%

6%

25%

10%

16%

30 50%

11%

21%

7%

11%

Do you recommend abiraterone acetate in addition to ADT in men with metastatic castration- sensitive/naive disease relapsing after prior treatment for localized prostate cancer and high risk disease as defined by LATITUDE study?

Survey Panelists 169

56%

7%

20%

7%

11%

82

40 90%

0 2%

0 8%

3 Responders

1. Yes, in the majority of patients 2. Only for young patients

3. Only for patients whose PSA level did not drop low enough after 2 months of ADT

4. Only for young and PSA level did not drop low enough after 2 months of ADT

5. No

Non-responder, abstain, unqualified to answer

Q4-14

(25)

Q4-18

In men with de novo metastatic castration-sensitive/naive high-volume prostate cancer, who are not symptomatic from the primary, do you recommend treatment of the primary tumor in addition to systemic therapy?

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

Survey Panelists 203

24%

34%

42%

48

42 19%

36%

45%

1 Responders

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

Non-responder, abstain, unqualified to answer

175 22%

28%

50%

46 47%

39%

13%

30 4%

58%

38%

96 19%

29%

52%

95 19%

39%

42%

30 21%

31%

48%

St.Gallen 50 10%

38%

52%

-

(26)

Q4-19

與會專家認為對於de novo high-volume CNPC病患,除了systemic therapy之外,加上 primary (prostate) tumor的局部治療,對於患者OS不見得有助益,反而在 low-volume或 oligometastatic disease倒是值得考慮。與會專家一致同意局部治療以radiation therapy 為主。

•評論分析:

If you recommend treatment of the primary in this situation, what is your preferred treatment option in the majority of men?

Survey Panelists 203

83%

14%

3%

70 36

26 100%

0 0 18 1 Responders

1. Radiation therapy

2. Prostatectomy (if clinically operable cancer) 3. Other local treatment of the primary

4. Abstain (including “I do not recommend treatment of the primary in this situation”)

Non-responder, unqualified to answer

Survey URO RO MO High Vol Senior UO

N Option 1 Option 2 Option 3

175 76%

20%

5%

46 100%

0%

0%

30 80%

20%

0%

96 85%

12%

4%

95 82%

13%

5%

30 73%

18%

9%

St.Gallen 31 71%

26%

3%

21 -

參考文獻

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