1. CHAARTED: QoL Analysis of Docetaxel + ADT in Metastatic Hormone-Sensitive Prostate Cancer
CCO Independent Conference Coverage* of the 2016 ASCO Annual Meeting, June 3-7, 2016
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
ADT, androgen deprivation therapy; QoL, quality of life.
This activity is supported by educational grants from Amgen, Ariad, Bayer Healthcare Pharmaceuticals, Celgene Corporation, Genentech, Incyte, Merck, and Taiho Pharmaceuticals.

2. CHAARTED: Docetaxel + ADT in mHSPC
Docetaxel first agent to provide survival benefit in mHSPC
Significant toxicity associated with docetaxel
QoL is an important factor in understanding full clinical benefit of a therapeutic option
CHAARTED trial: ADT + docetaxel in hormone-naive mHSPC
Docetaxel + ADT significantly prolonged OS over ADT alone ( vs 44.0 mos; HR: 0.61; P = .0003)[1]
Analysis includes pt-reported outcomes (QoL, disease-related and treatment-related symptoms) from CHAARTED trial[2]
ADT, androgen deprivation therapy; mHSPC, metastatic hormone-sensitive prostate cancer; QoL, quality of life.
1. Sweeney CJ et al. N Engl J Med. 2015; 373: Patrick-Miller LJ, et al. ASCO Abstract 5004.
Slide credit: clinicaloptions.com

3. CHAARTED: Study Design for Pt-Reported Outcomes
Randomized phase IIIb trial
QoL analysis in ITT population
Primary endpoint: overall QoL (FACT-P)
Secondary endpoints: disease-related symptoms (BPI), treatment-related symptoms (FACIT-F, FACT-T)
Stratified by extent of mets (high vs low); age (≥ 70 vs < 70 yrs); ECOG PS (0-1 vs 2); CAB > 30 days (yes vs no); SRE prevention (yes vs no), prior adjuvant ADT (≤ 12 vs > 12 mos)
ADT + Docetaxel
75 mg/m2 Q3W up to 6 cycles
(n = 397)
ADT alone
(n = 393)
Metastatic hormone-sensitive prostate cancer with elevated PSA, ECOG PS 0-2, no prior docetaxel
(N = 790)
Evaluate QoL at baseline,
3, 6, 9, 12 mos
ADT, androgen deprivation therapy; BPI, Brief Pain Inventory; ECOG, Eastern Cooperative Oncology Group; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FACT-P, Functional Assessment of Cancer Therapy-Prostate; FACT-T, Functional Assessment of Cancer Therapy-Taxane; ITT, intent to treat; QoL, quality of life; PS, performance status; PSA, prostate-specific antigen; SRE, skeletal-related event;
Slide credit: clinicaloptions.com
Patrick-Miller LJ, et al. ASCO Abstract 5004.

4. CHAARTED: Pt Characteristics
Baseline characteristics well balanced between treatment arms
Characteristic, %
ADT + Docetaxel
(n = 397)
ADT alone
(n = 393)
Median age, yrs (range)
64 (36-88)
63 (39-91)
White, %
88.9
88.5
ECOG PS 0, %
69.8
69.4
High volume of metastasis, %
66.2
63.6
No prior localized therapy, %
72.8
73.0
Median time from ADT start to randomization, mos (range)
1.2 (0-3.9)
1.3 (0-3.9)
ADT, androgen deprivation therapy; ECOG, Eastern Cooperative Oncology Group; PS, performance status.
Baseline characteristics not reported
Slide credit: clinicaloptions.com
Patrick-Miller LJ, et al. ASCO Abstract 5004.

5. CHAARTED: Pt-Reported Outcomes
Overall QoL with early docetaxel + ADT worse than ADT alone at 3 mos, superior at 12 mos
Treatment-associated symptoms show early worsening with docetaxel + ADT vs ADT alone followed by rebound
Disease-associated symptoms (pain) similar between arms
Emotional well-being, prostate cancer–specific concerns reported better with docetaxel + ADT vs ADT alone throughout treatment
QoL Difference Between Docetaxel + ADT and ADT Alone
Estimate SE
P Value
Baseline
-1.00
1.28
.43
3 mos
-3.09
1.32
.02
6 mos
0.90
1.34
.50
9 mos
0.29
1.37
.84
12 mos
2.85
1.39
.04
ADT, androgen deprivation therapy; QoL, quality of life; SE, standard error.
Slide credit: clinicaloptions.com
Patrick-Miller LJ, et al. ASCO Abstract 5004.

6. CHAARTED: Conclusions From Pt-Reported Outcomes
Larger decline of QoL measures (FACT-P, FACT-T, FACIT-F) in first 3 mos of docetaxel + ADT vs ADT alone[1]
However, by 12 mos, return to baseline and to significantly higher FACT-P scores with docetaxel + ADT vs ADT alone[1]
No long-term negative impact on QoL with docetaxel + ADT[1]
Investigators suggest improvement in QoL at 12 mos and prolonged survival with docetaxel + ADT vs ADT alone, indicates a clinically meaningful benefit of early docetaxel with ADT[1,2]
ADT, androgen deprivation therapy; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FACT-P, Functional Assessment of Cancer Therapy-Prostate; FACT-T, Functional Assessment of Cancer Therapy-Taxane;QoL, quality of life.
1. Patrick-Miller LJ, et al. ASCO Abstract 5004.
2. Sweeney CJ et al. N Engl J Med. 2015; 373:
Slide credit: clinicaloptions.com

7. Go Online for More CCO Coverage of ASCO 2016!
Short slideset summaries of all the key data
Additional CME-certified analyses with expert faculty commentary on all the key studies in:
Breast, genitourinary, and lung cancers
Hematologic malignancies
Immunotherapy
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