friday poster discussion - physicians' education...
Post on 28-Feb-2021
1 Views
Preview:
TRANSCRIPT
Friday Poster Discussion
Heather Wakelee, MD
Stanford University
Stanford Cancer Institute
Posters
• DR. STEINER- PREVALENCE AND IMPACT OF
HYPOGONADISM IN CANCER PATIENTS WITH MUSCLE
WASTING IN A PHASE IIB ENOBOSARM TRIAL
• DR. STEINER- EFFECT OF ENOBOSARM ON PHYSICAL
FUNCTION IN CANCER PATIENTS WITH < OR ≥5% WEIGHT
LOSS IN A PHASE IIB TRIAL
• DR. MAGASI- UNDERSTANDING NON-SMALL CELL LUNG
CANCER FROM THE PATIENT'S PERSPECTIVE: FROM
DISEASE DEFINING SYMPTOMS TO ITS IMPACT ON QUALITY
OF LIFE
• DR. SIO- IMPACT OF PULMONARY FUNCTION AND BODY
HABITUS ON PATIENT IMMOBILIZATION FOR UPPER LUNG
TUMORS USING STEREOTACTIC BODY RADIOTHERAPY
50% of patients with cancer have muscle wasting
Loss of skeletal muscle and physical decline
GTX-024 (Enobosarm) selective androgen receptor modulator
Potential to reduce muscle wasting
Used lean body mass and stair climb power as measurement of efficacy
Randomized 159 pts to oral drug versus placebo (61 w/ NSCLC)
Previously reported on the stair climb power (WCLC 2011)
Posters today with data on :
Hypogonadism
Physical Function w/wo 5% weight loss
Muscle wasting in cancer patients is a
significant unmet medical need
Bruera E. 1997. BMJ 315(7117):1219-22; Prado CM, et al. 2009. Clin Cancer Res 15(8):2920-6; Antoun S. 2010. Ann Oncol Epub
Ahead of Print; Ryan JL. 2007. Oncologist 12(Suppl 1):22-34; Baracos VE. 2010. Am J Clin Nutr 91(4):1133S-7S; Baracos VE.
2001; Cancer 92(6 Suppl):1669-77.
Modified from Dodson WCLC 2011
Phase IIb clinical trial in cancer patients with muscle wasting
16 week, randomized, double blind, placebo controlled trial
Dodson WCLC 2011
• 1 endpoint: total lean body mass (LBM) by dual energy x-ray absorptiometry (DXA)
• 2nd endpoints: physical function as measured by stair climb power +time, QoL
• Additional analysis: OS assessed by >8% or ≤8% weight loss
GTx-024 improved physical function
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) QoL measure
correlated with physical function
Dodson WCLC 2011
Hypogonadism poster
• Hypogonadism is associated with weight loss and poor
outcomes in cancer patients
• Up to 50% of men w/ adv cancer are hypogonadal
• Pts (n=159; 61 NSCLC) were randomized to
enobosarm or placebo for 16 weeks
• Report on incidence and impact of hypogonadism
(T<300 ng/dL)
Hypogonadism poster
• Baseline testosterone levels were available for 93/103 men
• 60% of males were hypogonadal at randomization
• Distribution of hypogonadism was similar across cancers
• Hypogonadal men were less likely to complete the study
• Baseline T was correlated with weight loss (r=0.32, P=0.002)
– hypogonadal men had greater loss in previous six months (median, -9.5%).
• Baseline physical function (stair climb power) was higher among
eugonadal versus hypogonadal males
– 174 watts vs 147 watts; P=0.02
• Enobosarm significantly improved physical function regardless of
baseline gonadal status
– eugonadal:12%, P=0.044; hypogonadal:17%, P=0.006
Enobosarm physical function changes
•
P=0.044 P=0.006
Hypogonadal Eugonadal
2nd Enobosarm poster
• 103 evaluable subjects had physical function (stair climb) assessed
at baseline and week 16
• 24% had lost <5% weight in previous 6 months
• Distribution of weight loss was similar across genders
• Subjects with <5% weight loss were more likely ECOG=0
• Subjects with ≥5% weight loss had worse physical function at
baseline compared to those with <5% loss.
• Significant improvement in physical function was observed in
enobosarm subjects regardless of baseline weight loss (<5%,
P=0.002, ≥5%, P<0.001) while placebo subjects failed to improve.
Enobosarm Adverse events
•
Physical Function by Wt Loss
• Baseline
% change from baseline
N = 39 (<5%); N = 119 (>5%)
< 5% wt loss
n=10(NS), N=15 p.002
>5% wt loss
N= 27 NS; n=51 p<.001
Understanding Non-Small Cell Lung cancer from the Patient’s Perspective: From disease defining symptoms to its impact on health-
related quality of life
By
Susan Magasi, PhD1, Rajiv Mallick, PhD2, Beatriz Menendez, BA1, David Cella,
PhD1
1 Northwestern University, 2Daiichi Sankyo Inc.
Background
• Among patients with advanced (NSCLC), reducing or delaying deterioration of symptoms can be a meaningful treatment outcome.
• As new cancer therapies are developed, it is important to evaluate their clinical benefit based not only on survival outcomes but also on the symptoms and concerns important and relevant to patients.
• Prior to assessing treatment benefit in terms of patient-reported outcome scales in clinical trials in NSCLC, it is important to document that the scales reflect key symptoms experienced by people with NSCLC.
• The purpose of this study was to characterize pulmonary symptoms among patients receiving first line treatment for advanced NSCLC.
Methods
Semi-Structured Interviews
• Patient interviews involved open-elicitation and direct probing about NSCLC symptoms and experiences.
Content Analysis
• Descriptive coding of verbatim transcripts in Atlas-ti was undertaken.
• Excerpts were assigned sub-codes representing symptom impacts experiences and later collapsed into broad symptom codes.
Results
• Participants described a broad range of issues related to their lung cancer, including symptom experiences (both disease-defining and generalized), treatment attributed effects, and functional and emotional impacts of the disease.
• 32% of the participants (8/25) indicated that either they had no pulmonary symptoms or that their pulmonary symptoms had abated since treatment.
Results: Most frequently reported symptoms
Results – Conceptual model of patient reported impact of NSCLC and its treatment
Conclusions
• Given the reported diversity of symptoms from disease defining symptoms like cough and shortness of breath to distal impacts like emotional tolls, a global symptom index such as the NCCN-FACT, FACT-L, or EORTC-QLQ-LC-13 can provide comprehensive content coverage of the most key symptoms.
• Our conceptual measurement model distinguished disease related symptoms, proximal disease impacts, treatment effects, and distal impacts on health-related quality of life, and can enable practitioners and regulators to monitor therapeutic interventions (e.g. pharmacological and psychosocial) with greater specificity.
Prevalence of Symptoms in Adv Cancer Walsh et al. The symptoms of advanced cancer: relationship to age, gender and performance status in 1000
patients. Support Care Cancer (2000) 8: 175-179
Symptom % Symptom %
Pain 84% Depression 41%
Fatigue 69% Cough 38%
Weakness 66% Nausea 36%
Anorexia 66% Edema 28%
Xerostomia 57% Taste Change 28%
Constipation 52% Hoarseness 24%
Early Satiety 51% Anxiety 24%
Dyspnea 50% Vomiting 23%
Weight loss 50% Confusion 21%
Sleep problems 49%
Slide courtesy Kavitha Ramchandran
Impact of Pulmonary Function and Body Habitus on Patient Immobilization for Upper
Lung Tumors Using Stereotactic Body Radiotherapy (SBRT)
Sio TT, Brown LC, Blanchard MJ, Jensen
AR, Ma DJ, Fong de los Santos LE, Park
SS, Olivier KR Department of Radiation Oncology, Rochester, MN
Introduction
• Stereotactic body radiation therapy
(SBRT) offer excellent local control for
small lung tumors
• However, many factors can affect patient
setup and tumor localization
Objectives
• To evaluate the influence of patient’s
pulmonary function and body habitus on
setup and reproducibility for upper lung
tumors as treated by SBRT
What is Stereotactic Ablative Radiotherapy (SABR)?
• Highly focused radiation concentrated on small
tumors – low dose to surrounding tissue
• Highly dose intensive – Single or few treatments,
high biologically effective dose
• Highly accurate & precise delivery – image
guidance, immobilization, and other technologies
to ensure accuracy
• AKA: SBRT, SRT, radiosurgery (SRS),
extracranial stereotactic radioablation (ESR)
B Loo / Stanford
Thoracic SABR
Conventional vs. SABR dose distribution
B Loo / Stanford
SABR outcomes (n=64)
0.0
0.2
0.4
0.6
0.8
1.0
0 1 2 3 4 5
Years Since Registration
P
r
o
b
a
b
i
l
i
t
y
76.0% @ 3y (95% CI: 63.3% - 84.8%) expected: 80%@3y
Overall Survival Rate
Y Nagata / JCOG 0403 / ASTRO 2010
Methods
• April 2008 to November 2011
• Prospective SBRT database (Mayo Clinic)
• 89 patients receiving SBRT to upper lung
• Two immobilization techniques: BodyFIX (left), and
S-frame with shoulders (right)
Methods (continued)
• Shifts from initial couch measured by serial
cone-beam CT (CBCT) analyzed
• Institutional tolerance of 3-D CBCT-based
shifts for treatment was 2, 2, 4 mm; shifts
exceeding these limits needed re-imaging
• Calculated Couch shifts, compared as square
root of sum of squares in x, y, z-directions,
• Gating or breathing control was not employed
Results – Patient characteristics
• Median f/u: 8.7 months
• Median age: 71.8 years
• 64 NSCLC, 29 metastatic tumors
• Lesion sizes were: <1 cm (15%), 1.1-2 cm
(50%), 2.1-3 cm (25%), and >3 cm (10%)
• 21 central and 72 peripheral tumors
• Dose schemes: 4800/4 (cGy/fraction, 28%), 5000/5
(24%) and 5400/3 (46%)
Results – Pulmonary function
• 68 (76%) patients were past or current smokers, 59
(66%) with clinically significant COPD (13 oxygen-
dependent)
• Larger total lung capacity (TLC, suggesting air trapping
in COPD patients) was related to larger setup
difference in first couch shifts (p<0.040)
• Larger TLC (p<0.0001) and residual volume (RV,
p<0.0039) were correlated with increased number of
required couch shifts per SBRT fraction, independent of
immobilization choice
Results – Body habitus
• 28 (31%) patients were obese (BMI>30)
• Increased patient weight was related to
more setup uncertainty
• Increased body mass index were directly
related to larger averaged couch shift
errors by CBCT
Results – Local control
• For all pts, 2 and 3-yr local control (LC)
rates were 94% and 81%, respectively
• There is no difference in LC by patient’s
age, PFT function, body habitus, COPD
or smoking status, though tumors larger
than 2cm had poorer LC in the final
multivariate analysis (Log-rank p<0.0058)
Conclusions
• Patients with obese habitus and
advanced emphysema experienced more
SBRT setup uncertainty by CBCT
• However, their outcome and probability
for local tumor control remained excellent
when compared to their counterparts in
the same cohort
Posters Conclusions
• HYPOGONADISM IS COMMON AND IS LINKED TO WEIGHT
LOSS AND MUSCLE WASTING
• ENOBOSARM SHOWS PROMISE FOR OVERCOMING MUSCLE
WASTING IN PATIENTS REGARDLESS OF PRIOR WT LOSS
• BETTER TOOLS IN DEVELOPMENT TO ASSESS PATIENT
SYMPTOMS
• SBRT CAN BE GIVEN SAFELY AND EFFECTIVELY TO OBESE
PATIENTS AND THOSE WITH COPD
top related