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L’algoritmo terapeutico nel carcinoma della prostata metastatico sensibile alla castrazione

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N OVITÀ IN TEMA DI NEOPLASIA DELLA P ROSTATA

L’ ALGORITMO TERAPEUTICO NEL CARCINOMA DELLA PROSTATA METASTATICO SENSIBILE ALLA

CASTRAZIONE

Raffaele Ratta

S.S. Oncologia Medica Genitourinaria

(2)

Outline

1. Clinical case 2. Chemotherapy 3. Hormone therapy 4. Trials ongoing

AIOM Giovani 2018 Raffaele Ratta

(3)

• Metastatic hormone-sensitive prostate cancer incidence is:

- ≈ 3% in US and rising;

- ≈ 6% across Europe

- ≈ 4-10% in Latin America - ≈ 60% in Asia-Pacific

• Historically, androgen deprivation therapy (ADT) has been the standard of care

• Most men with metastases progress to mCRPC largely driven by reactivation of AR signaling

AIOM Giovani 2018 Raffaele Ratta

Background

Weiner AG et al. Prostate Cancer Prostatic Dis. 2016 Buzzoni C et al. Eur Urol. 2015

Chen R et al. Asian J Urol. 2014 Ito K et al. Nat Rev Urol. 2014 Nardi AC et al. Int Braz J Urol. 2012 Yamaoka M et al. Clin Cancer Res. 2010

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AIOM Giovani 2018 Raffaele Ratta

Let’s start from clinics!

68 yo man

Comorbidities:

• Type II Diabetes Mellitus

• Obesity

May 2017: PSA 129 ng/mL

14/06/17 Bone scan: negative

19/06/17 Prostatic biopsy: adenocarcinoma, Gleason Score 4+4=8

11/07/17 CT scan (T/A): multiple lung secondary lesions

(5)

AIOM Giovani 2018 Raffaele Ratta 07/2017 Start LHRHa q 28 + bicalutamide 50 mg/die (for 1

month)

26/09/2017 PSA 8 ng/mL (vs 129) Main characteristics of my patient:

• Newly diagnosed metastatic prostate cancer

• Gleason score 8

• Lung secondary lesions

09/10/2017-22/01/2018 Docetaxel 75 mg/mq q21 + prednisone 5 mg bid (6 cycles)

04/12/2017 PSA 1.4 ng/mL 09/02/2018 PSA 1.35 ng/mL

12/03/2018 CT scan

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AIOM Giovani 2018 Raffaele Ratta

Lung PR

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AIOM Giovani 2018 Raffaele Ratta

From clinics to literature…

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GETUG-AFU 15: biochemical PFS and rPFS for ADT+docetaxel but no significant OS benefit

Gravis G. et al Eur Urol. 2016

AIOM Giovani 2018 Raffaele Ratta

Low Volume

High Volume

Subsequent retrospective analysis:

(9)

Gravis G. et al Eur Urol. 2016

AIOM Giovani 2018 Raffaele Ratta

HIGH VOLUME: presence of visceral metastases or ≥4 bone

lesions with ≥1 beyond the vertebral bodies and pelvis

(10)

Gravis G. et al Eur Urol. 2016

AIOM Giovani 2018 Raffaele Ratta

High Volume

Low Volume

(11)

Gravis G. et al Eur Urol. 2016

AIOM Giovani 2018 Raffaele Ratta

High Volume de novo metastatic pts

Low Volume de novo metastatic pts

(12)

Gravis G. et al Eur Urol. 2016

AIOM Giovani 2018 Raffaele Ratta

High Volume pts with prior local therapy

Low Volume pts with prior local therapy

(13)

AIOM Giovani 2018 Raffaele Ratta

James ND. et al. Lancet 2016

(14)

AIOM Giovani 2018 Raffaele Ratta

James ND. et al. Lancet 2016

No stratification by extent of metastatic disease

(15)

AIOM Giovani 2018 Raffaele Ratta

James ND. et al. Lancet 2016

(16)

AIOM Giovani 2018 Raffaele Ratta

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AIOM Giovani 2018 Raffaele Ratta

Fizazi K et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017.

James N et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017.

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AIOM Giovani 2018 Raffaele Ratta

Fizazi K et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

High-risk defined as meeting at least 2 of 3 high-risk criteria:

• Gleason score of ≥ 8

• Presence of ≥ 3 lesions on bone scan

• Presence of measurable visceral lesion

(19)

AIOM Giovani 2018 Raffaele Ratta

Fizazi K et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(20)

AIOM Giovani 2018 Raffaele Ratta

Fizazi K et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(21)

AIOM Giovani 2018 Raffaele Ratta

Fizazi K et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(22)

AIOM Giovani 2018 Raffaele Ratta

Fizazi K et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(23)

AIOM Giovani 2018 Raffaele Ratta

James ND et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(24)

AIOM Giovani 2018 Raffaele Ratta

James ND et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(25)

AIOM Giovani 2018 Raffaele Ratta

James ND et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(26)

AIOM Giovani 2018 Raffaele Ratta

James ND et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

(27)

AIOM Giovani 2018 Raffaele Ratta

James ND et al. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017, NEJM 2017

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What is better for hormone-sensitive patients starting ADT?

Doc or Abi???

AIOM Giovani 2018 Raffaele Ratta

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Comparing Overall Survival Across Studies

Small E. Presented at 2017 ASCO Annual Meeting. Chicago, IL, USA: June 2-6, 2017.

*Estimated from KM plots

Overlay of LATITUDE KM Plot on CHAARTED (High Volume) KM Plot

AIOM Giovani 2018 Raffaele Ratta

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AIOM Giovani 2018 Raffaele Ratta ABI

DOC

(31)

AIOM Giovani 2018 Raffaele Ratta

Sydes M et al. 2017 ESMO Annual Meeting

This is not a true randomized trial (only a part)

(32)

AIOM Giovani 2018 Raffaele Ratta

Sartor O, NEJM 2018

Trials ongoing

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AIOM Giovani 2018 Raffaele Ratta Main characteristics of my patient:

• Newly diagnosed metastatic prostate cancer

• Gleason score 8

• Lung secondary lesions

LATITUDE trial: High-risk defined as meeting at least 2 of 3 high-risk criteria:

• Gleason score of ≥ 8

• Presence of ≥ 3 lesions on bone scan

• Presence of measurable visceral lesion

CHARTEED trial: High-volume disease defined as:

• presence of visceral metastases or

• ≥4 bone lesions with ≥1 beyond the vertebral bodies and pelvis

Let’s summarize

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Toxicity profiles

AIOM Giovani 2018 Raffaele Ratta

Disease burden (high volume vs low volume)

Disease risk (high vs low) Patient’s characteristics (age, comorbidities) Symptoms

Cost-effectiveness Long term steroids?

Availability

Patient’s preference

(35)

AIOM Giovani 2018 Raffaele Ratta

The results of LATITUDE and STAMPEDE trials will change our clinical practice?

Not yet….soon!

(36)

Take home messages

• Docetaxel and Abiraterone improve survival in hormone-sensitive newly diagnosed patients with metastatic high volume disease

• Docetaxel should be considered for routine practice in suitable men with newly-diagnosed high volume metastatic disease

• Patients’ selection will be fundamental

• Treatments should be tailored on patients’ characteristics

AIOM Giovani 2018 Raffaele Ratta

(37)

Take home messages

• Docetaxel and Abiraterone improve survival in hormone naïve newly diagnosed patients with metastatic high volume disease

• Docetaxel should be considered for routine practice in suitable men with newly-diagnosed high volume metastatic disease

• Patients’ selection is fundamental

• Treatments should be tailored on patients’ characteristics

AIOM Giovani 2018 Raffaele Ratta

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Grazie per l’attenzione

raffaele.ratta@istitutotumori.mi.it

Riferimenti

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