Current role of chemotherapy in hormone-naïve...
-
Upload
trinhkhanh -
Category
Documents
-
view
218 -
download
3
Transcript of Current role of chemotherapy in hormone-naïve...
![Page 1: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/1.jpg)
Current role of chemotherapy in hormone-naïve patients
Elena Castro
Spanish National Cancer Research Centre
Lugano, 17 October 2017
![Page 2: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/2.jpg)
Siegel, Ca Cancer J Clin,2017
Buzzoni, Eur Urol, 2015
-Aprox 15-20% of new PrCa diagnosis present with advanced disease:
- 4-5% distant metastasis EU, USA
- Prevalence of metastasis at diagnosis varies geographically, depending
on screening programs, access to health system, etc
- 80-75% patients with metastatic disease will present it after recurrence
following treatment for localized disease.
Local DIsease
M0
Metastatic
Disease
M1
Recurrence
M1
CPRC_M1
CPRC_M1
20%
80%
![Page 3: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/3.jpg)
-ADT may induce biochemical and clinical responses in 90% of patients
- After 24-36 months progression to Castration Resistance Prostate Cancer ocurrs
-ADT may induce adaptation of hormone-sensitive cells and/or selection of AR-
independent clones
Hellerstdet, CA Cancer J Clin, 2002
Zong, Nat Rev Urol, 2013
![Page 4: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/4.jpg)
Metastatic
No Chemo
ECOG ≤2
n=1006
Docetaxel 75mg/m2 q3w +
Prednisone 5 mg /12h
Mitoxantrone 12mg/m2 q3w +
Prednisone 5 mg /12h
Docetaxel 30 mg/m2 1w +
Prednisone 5 mg /12h
Study end points:• Primary: OS• Secondary: Pain reduction, QoL, ≥50% decline, tumour response
Improved OS (18.9m vs 16.5 m, p<0.001)≥ 50% PSA decline (45% vs 32 %, p<0.001)
Reduction in pain: 35 % vs 22 % (p=0.01)
QoL:22% vs 13% (p=0.009)
DocetaxelTAX-327
Tannock, NEJM, 2004
N=335
N=334
N=337
![Page 5: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/5.jpg)
Would the adition of docetaxel to ADT for M1 hormone-sensitive
PrCa delay the progression to mCRPC and improve survival?
![Page 6: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/6.jpg)
M1 HSPC
Stratification
- Previous TT
-Glass risk group-Apendicular vs axial disese
-Performance status
-PSA < or > 65ng/dL
-Gleason <or >8
Docetaxel 75mg/m2 q3w
(No prednisone) up to 9 cycles
+
ADT
ADT alone
Study end points:• Primary: OS• Secondary: Clinical and PSA Progression Free Survival
GETUG 15 study
Gravis, Lancet Oncol, 2013
N=193
N=192
Median OS: 58.4 vs 52.2 months, p=0.955)
3y OS: 64.2% vs 62.9%
72% de novo M1 Median follow-up: 50 months
Median 8 cycles
![Page 7: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/7.jpg)
bPFS: 22.9 vs 12.9, HR 0.72, p=0.005 cPFS: 20.5 vs 15.4, HR 0.75, p=0.015
![Page 8: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/8.jpg)
M1 HSPC
Stratification-Low vs High volume
- Age <70 vs >70 yrs
-MAB <30 vs >30 days
-SER prevention
-Adjuvant ADT <12
vs<12 months
Docetaxel 75mg/m2 q3w
(No prednisone) up to 6 cycles
+
ADT
ADT alone
Study end points:• Primary: OS• Secondary: Time to CRPC and to clinical progression
CHAARTED study
Seeney,NEJMl, 2015
N=397
N=393
ADT allowed up to 120 days prior to randomization
Median follow-up: 28.9 months
73% de novo M1
27% recurrent disease
Improved OS: 57.6 vs 44 months (HR 0.61, p<0.001)
cPFS: 33 vs 19.8 monts (HR, 0.49 p<0.001)
Time to CRPC: 20.2 vs 11.7 months (HR
0.56,p<0.001)
![Page 9: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/9.jpg)
ADT + docetaxel was beneficial in all subgroups
Seeney,NEJMl, 2015
![Page 10: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/10.jpg)
STAMPEDE: Docetaxel +Pred + ADT vs ADT
Recruitment: Oct-2005 to Mar-2013 Patients: 1184 SOC
592 SOC+DocP
Allocation ratio:2:1
Courtesy of Dr Sydes
![Page 11: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/11.jpg)
STAMPEDE
SOC (ADT+/-RT)
N=1184
Study end points:• Primary: OS• Secondary: PFS
61% M1 and 39% M0
Median follow-up: 43 months
Docetaxel 75mg/m2 q3w + Prednisone 5mg/12h
up to 6 cycles + SOC
N=592
Metastasis at presentation
OS: 60 vs 45 months
(HR 0.76, p=0.005)
OS: 81 vs 71 months, (HR 0.78, p=0.006)
SOC+DOC
SOC
![Page 12: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/12.jpg)
![Page 13: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/13.jpg)
Sweeney,NEJMl, 2015
Do all patients benefit the same?
HIGH volume disease
-Visceral metastasis or
-≥ 4 bone metastasis with ≥1 beyond vertebral bodies and pelvis
![Page 14: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/14.jpg)
CHAARTED_update ESMO 2016
-Benefit on OS in High Volume
- Low Volume: Benefit on time to CRPC: 31 months (ADT+Doce) vs 27monts (ADT),
p=0.03
![Page 15: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/15.jpg)
OS High Volume Disease
(48%)
OS Low Burden Disease
- 20% reduction in the risk of death in the HVD group (No significant)
- Patients with LVD did not benefit form early docetaxel.
GETUG-AFU15 post hoc analysis
![Page 16: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/16.jpg)
Puente, Ther Adv Me Oncol, 2017
![Page 17: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/17.jpg)
METAANALYSIS M1
2993 patients included
-Addition of Docetaxel to ADT improved OS.
-HR 0.77 and 9% absolute improvement in survival at 4 years.
-Addition of Docetaxel to ADT improved PFS.
-HR 0.64 and 15% absolute reduction in failure at 4 years.
Vale, Lancet Oncol, 2016
Overall Survival PFS
![Page 18: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/18.jpg)
METAANALYSIS M0
2121patients included
-Addition of Docetaxel to ADT did not improved OS.
-HR 0.87, p=0.218.
-Addition of Docetaxel to ADT improved PFS.
-HR 0.70 and 8% absolute reduction in failure at 4 years.
Overall Survival PFS
![Page 19: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/19.jpg)
CONCLUSIONS
-Addition of Docetaxel to ADT should be considered standard of care for M1 Hormone-
Sensitive Prostate Cancer.
- Further evidence on the impact of Docetaxel in survival is needed to recomend the
addition of docetaxel to ADT for M0 patients
![Page 20: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/20.jpg)
The addition of abiraterone acetate to ADT significantly increases OS and rPFS in M1 HSPC
LATITUD trial
Fizazi, NEJM, 2017
![Page 21: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/21.jpg)
Slide 30
Presented By Nicholas James at 2017 ASCO Annual Meeting
![Page 22: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/22.jpg)
OK…….SO WHAT SHOULD WE USE?
Reference
![Page 23: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/23.jpg)
STAMPEDE: SOC+AAP vs SOC+DocP
-Evidence about whether to
give both is pending
-566 patients randomised
contemporaneously to either
research arm:
ESMO2017
Patients: 189 SOC+DocP
377 SOC+AAP
Recruitment: Nov2011-Mar2013
Courtesy of Matt Sydes. ESMO 2017
![Page 24: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/24.jpg)
Populations in each comparison
SOC+DocP vs SOC+AAP
M1 60%
Age 66 yr median
PSA 56 ng/ml median
Accrue Nov-2011 to Mar-2013
Freeze Mar-2017
SOC+DocP vs SOC
M1 61%
Age 65 yr median
PSA 68 ng/ml median
Accrue Oct-2005 to Mar-2013
Freeze May-2015
SOC+AAP vs SOC
M1 52%
Age 67 yr median
PSA 53 ng/ml median
Accrue Nov-2011 to Jan-2014
Freeze Mar-2017
Courtesy of Matt Sydes. ESMO 2017
![Page 25: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/25.jpg)
HR (95%CI) P-valInteractn
test
All 1.16 (0.82 to 1.65) 0.40
M0 1.51 (0.58 to 3.93) 0.400.69
M1 1.13 (0.77 to 1.66) 0.53
Key:HR<1 favours SOC+AAPHR>1 favours SOC+DocP
Interactn = test for interaction (heterogeneity of treatment effect)
SOC+DocP SOC+AAP
Events Pts Events Pts
All 44 189 105 377
M0 6 74 16 150
M1 38 115 89 227
SOC+AAP
SOC+DocP
Overall Survival
Courtesy of Matt Sydes. ESMO 2017
![Page 26: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/26.jpg)
Cause-specific survival
Sub-HR
(95%CI)P-val
All 1.02 (0.70 to 1.49) 0.92
Status SOC+DocP SOC+AAP
N % N %
Alive 145 77% 272 72%
Dead 44 23% 105 28%
PCa Death 40 21% 86 23%
Other cause 4 2% 19 5%
Competing risks approach
SOC+DocP death: 91% PCa and 9% otherSOC+AAP deaths: 82% PCa and 18% other
Key:HR<1 favours SOC+AAPHR>1 favours SOC+DocP
Courtesy of Matt Sydes. ESMO 2017
![Page 27: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/27.jpg)
PSA Failure-free survival
HR (95%CI) P-valInteractn
test
All 0.51 (0.39 to 0.67) <0.001
M0 0.34 (0.16 to 0.69) 0.0030.17
M1 0.56 (0.42 to 0.75) <0.001
SOC+AAP
SOC+DocP
Key:HR<1 favours SOC+AAPHR>1 favours SOC+DocP
Interactn = test for interaction (heterogeneity of treatment effect)
SOC+DocP SOC+AAP
Events Pts Events Pts
All 97 189 122 377
M0 18 74 13 150
M1 79 115 109 227
Courtesy of Matt Sydes. ESMO 2017
![Page 28: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/28.jpg)
Progression-free survival
HR (95%CI) P-valInteractn
test
All 0.65 (0.48 to 0.88) 0.005
M0 0.42 (0.17 to 1.05) 0.060.32
M1 0.69 (0.50 to 0.95) 0.02
Key:HR<1 favours SOC+AAPHR>1 favours SOC+DocP
Interactn = test for interaction (heterogeneity of treatment effect)
SOC+DocP SOC+AAP
Events Pts Events Pts
All 72 189 103 377
M0 10 74 9 150
M1 62 115 94 227
SOC+AAP
SOC+DocP
PFS = FFS ignoring PSA failure Courtesy of Matt Sydes. ESMO 2017
![Page 29: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/29.jpg)
Metastatic progression-free survival
HR (95%CI) P-val
Interactn
test
All 0.77 (0.57 to 1.03) 0.08
M0 0.91 (0.42 to 2.01) 0.820.74
M1 0.76 (0.55 to 1.04) 0.09
Key:HR<1 favours SOC+AAPHR>1 favours SOC+DocP
Interactn = test for interaction (heterogeneity of treatment effect)
SOC+DocP SOC+AAP
Events Pts Events Pts
All 71 189 118 377
M0 10 74 18 150
M1 61 115 100 227
SOC+AAP
SOC+DocP
MPFS = new or progression of metastases
![Page 30: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/30.jpg)
Symptomatic skeletal events
HR (95%CI) P-valInteractn
test
All 0.83 (0.55 to 1.25) 0.38
M0 1.28 (0.24 to 6.67) 0.770.65
M1 0.82 (0.53 to 1.25) 0.35
SOC+AAP
SOC+DocP
Key:HR<1 favours SOC+AAPHR>1 favours SOC+DocP
Interactn = test for interaction (heterogeneity of treatment effect)
SOC+DocP SOC+AAP
Events Pts Events Pts
All 36 189 63 377
M0 2 74 5 150
M1 34 115 58 227
![Page 31: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/31.jpg)
Exposure to relapse treatments after FFS event
Note:
• Randomisation: Nov-2011 to Jan-2013
• Data freeze: Feb-2017
Docetaxel started after FFS event AR-targeted therapy started after FFS event
SOC+AAP
SOC+DocP
FFS event FFS event
Note:
• Relapse treatments at investigators’ discretion
• Access to relapse treatments may depend on:
• Metastatic status at event
• Calendar year of event
• Suspect under reporting of third-line therapies and onwards
SOC+AAP
SOC+DocP
![Page 32: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/32.jpg)
Summary
Strong evidence favouring AAP
Toxicity profiles quite different and well known
Weak evidence favouring AAP
No good evidence of a difference
FavoursSOC+AAP
FavoursSOC+DocP
Hazard ratio
Metastatic progression-free
survival
Progression-free survival
PSA Failure-free survival
Symptomatic skeletal events
Cause-specific survival
Overall survival
Head-to-head data in 566 pts (Nov-2011 to Mar-2013)
Courtesy of Matt Sydes. ESMO 2017
![Page 33: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/33.jpg)
Safety population SOC+DocP SOC+AAP
Patients included in adverse event analysis 172 (91%) 373 (>99%)
Grade 1+ AE 172 (100%) 370 (99%)
Grade 3+ AE 86 (50%) 180 (48%)
Grade 3+ AEs by category (incl. expected AEs)
Endocrine disorder (incl. hot flashes, impotence) 15 (9%) 49 (13%)
Febrile neutropenia 29 (17%) 3 (1%)
Neutropenia 22 (13%) 4 (1%)
Musculoskeletal disorder: 9 (5%) 33 (9%)
Cardiovascular (incl. hypertension, MI, cardiac dysrhythmia): 6 (3%) 32 (9%)
Gastrointestinal disorder: 9 (5%) 28 (8%)
Hepatic disorder (incl. increased AST, increased ALT): 1 (1%) 32 (9%)
General disorder (incl. fatigue, oedema): 18 (10%) 21 (6%)
Respiratory disorder (incl. breathlessness): 12 (7%) 11 (3%)
Renal disorder 5 (3%) 20 (5%)
Lab abnormalities (incl. hypokalaemia): 9 (5%) 11 (3%)
Adverse events – worst toxicity ever
Courtesy of Matt Sydes. ESMO 2017
![Page 34: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/34.jpg)
1 year SOC+DocP SOC+AAP
Patients in safety dataset 136 323
Grade 3+ AE 15 (11%) 37 (11%)
2 years SOC+DocP SOC+AAP
Patients in safety dataset 104 271
Grade 3+ AE 11 (11%) 30 (11%)
Adverse events – prevalence at 1 year and 2 years
Safety dataset includes patients who::: started treatment:: with assessment in toxicity window :: without FFS event before window
Courtesy of Matt Sydes. ESMO 2017
![Page 35: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/35.jpg)
Wallis, Eur Urol, 2017
6067 patients included (1921 events)
- 1181 (19.5%) Docetaxel + ADT (391 events)
- 1557 (25.7%) Abiraterone +ADT (353 events)
- 3329 (54.9%) ADT alone (1177 events)
Docetaxel +ADT vs ADT
Pooled HR for OS
HR 0.75 (95%CI 0.55-0.72)
Abiraterone + ADT vs ADT
Pooled HR for OS
HR 0.75 (95%CI 0.55-0.72)
Indirect comparision of Abi + ADT vs Docetaxel + ADT shows no significant difference on OS
![Page 36: Current role of chemotherapy in hormone-naïve patientsoncologypro.esmo.org/content/download/122060/2310436/file/2017... · Current role of chemotherapy in hormone-naïve patients](https://reader034.fdocuments.us/reader034/viewer/2022051509/5ae0cab97f8b9a5a668e0c15/html5/thumbnails/36.jpg)
Choice of Abiraterone or Docetaxel may be driven by factors beyond survival outcomes:
- Treatment-associated side effects
- Physician – patient preferences
- Availability
- Cost