Adjuvant Chemotherapy in Older Adults with Lung Cancer · Ajeet Gajra MD FACP Upstate Cancer...
Transcript of Adjuvant Chemotherapy in Older Adults with Lung Cancer · Ajeet Gajra MD FACP Upstate Cancer...
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Adjuvant Chemotherapy in Older Adults with Lung Cancer
Ajeet Gajra MD FACP
Upstate Cancer Center,
SUNY Upstate Medical University
Syracuse, NY
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Introduction: Early Stage NSCLC • More older adults safely undergo surgery given improved
surgical techniques and peri-operative care
• Cisplatin-based adjuvant chemotherapy (ACT) is standard of care in early stage resected NSCLC though no trials specific to older adults
• The evidence is limited to:– Sub-group analyses of studies in age-unselected populations– Retrospective analyses from population databases
• It is challenging to administer cisplatin to older adults
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Adjuvant Chemotherapy in Older Adults with NSCLC: Questions
1. What proportion of older adults receive surgery for stage I-IIIA NSCLC?
2. What is the representation of elderly in ACT trials?(IALT, JBR, ANITA and CALGB 9633/ LACE)
Example of database studies: SEER, Ontario, VA
3. Decision making in the clinic
4. Is carboplatin as good as cisplatin?
5. Is some chemotherapy better than none i.e. chemotherapy dose?
7. Can Geriatric Assessment help?
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Surgical Treatment of Early Stage NSCLC
The Impact of Age
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Surgical Treatment of NSCLC in Older Adults
• How often are older adults offered curative
surgery compared to younger patients?
• Is the Overall Survival the same amongst
older adults treated with curative surgery as
younger patients?
• What about lung cancer specific survival?
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Surgical Treatment in the Elderly:SEER review of > 14000 adults
Overalln 14,555
< 65n 5057
65-74n 6073
≥75n 3425
p value
Treated with
Curative Surgery (%)
92 86 70 < .0001
Median Survival
(mo)
71 47 28 < .0001
Adapted from Mery et al. Chest 2005
Overall Survival Lung cancer Related Survival
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Early Stage Lung Cancer: Surgical Treatment
Overall Mortality H.R. Lung Ca related Mortality H.R.
Age 65-74 years 1.38 1.23
Age ≥ 75 years 1.82 1.56
Overalln 10,923
66-69 yn 1408
70-74 yn 2055
75-79 yn 1907
≥ 80 yn 1161
Treated with
Lobectomy (%)
60 73 68 61 41
Recent Results
Adapted from Shrivani et al. Intl J Rad Onc Biol Phys 2012
Adapted from Mery et al. Chest 2005
Thus, older adults are less likely to be offered curative surgery for
early stage NSCLC.
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“But my surgeon said they got it all so why do I need chemo…?”
“….but they even got the lymph nodes that the cancer traveled to!”
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“Surgeons can cut out everything
except cause.”
Herbert M. Shelton
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Adjuvant Chemotherapy in Stage I-III NSCLC
Data from Prospective Randomized Clinical Trials
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Outcomes in Clinical Trials
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“Positive” Phase III Trials
ANITA IALT JBR.10 All Cis CALGB9633
Total patients 840 1867 482 4584 344
Age 65-69: n
(%)
170 (20) 328 (18) 84 (17) 901 (20 ) NA
Age > 70: n (%) 64 (8) 168 (9) 71 (15) 414 (9) 72 (21)
Upper Age limit 75 75 None - None
Stage IB-IIIA I-III IB-II I- IIIA IB
PS 0-2 0-2 0,1 NA 0, 1
Cisplatin
Planned Dose
(mg/sqm)
400 300-400 400 150-400 None;
Cb AUC6
OS increase at
5 years (%)
8.6 4.1 15 5.4 None
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Lung Adjuvant Cisplatin Evaluation (LACE)
• 5 trials - 4,584 patients
• Median follow-up: 5.1 years
• OS HR 0.89 [0.82-0.96], p= .005
Stage IA HR 1.40 [0.95, 2.06]
Stage IB HR 0.93 [0.78, 1.10]
Stage II/III HR 0.83 [0.73, 0.95]
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““As to diseases, make a habit of two things —to help, or at least, to do no harm…”
Hippocrates
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Toxicity of Adjuvant Chemotherapy
Stage N Chemotherapy Grade 3/4 Neutropenia
Therapy related mortality
ALPI I-IIIA 1 209 C + Mito/Vds 28% 0.5%
BLT I – III 381 C + Etop/Vinca 40% 3%
IALT I – III 1 867 C + Etop/Vinca 18% (G4) 0.8%
NCIC-JBR10 IB – IIB 482 C + Vrb 73% 0.8%
ANITA IB – III A 840 C + Vrb 85% 2%
LACE-
Metaanalysis*
IB - IIIA 1 190 Cisplatin-based 37% 0.9%
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Adjuvant Trials in NSCLC: Summary
• No trials specific to older adults to date
• Older adults are under-represented in existing trials
– JBR.10- 15%
– LACE – 9%
• Older adults may be at significant risk of chemotherapy toxicity
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Limitations of Available Data
Trial Median Age
(2 arms)
Pts PS2
IALT 59 7
BR.10 61 0
CALGB 9633 61-62 1
ANITA 59 3
US Population 70 34-48%*
• How can the results of trials conducted in younger, healthier patients be applied to older, sicker patients in our clinics?
What is the evidence specific to older adults?
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In the absence of PRCTs specific to older adults
Post-hoc Subset Analyses
JBR.10
LACE
Population Database studies
SEER
VA Cancer Registry
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Subset Analysis by Age: JBR.10Overall Survival
Age > 65 Age ≤ 65
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JBR.10: Disease Specific Survival
Age > 65 Age ≤ 65
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JBR.10 Subset Analysis
• Elderly had worse PS
• No significant
differences in overall
grade III/IV toxicity
• Elderly patients
received significantly
less chemotherapy
• More elderly patients
refused treatment
Age
≤ 65
Age
>65
p
Vb 53 40 .0004
Cis 72 56 .001
Chemotherapy Dose Intensity mg/m2/week
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Pooled analysis of Elderly in Adjuvant Trials
• No differences in severe toxicity rates were observed.
• Older patients received significantly lower first and total
cisplatin doses, and fewer chemotherapy cycles (P < .0001)
• Older patients derived benefit from ACT but had competing
causes for mortality
Age Groups <65 65-69 70+ P
N (total 2390) 1654 491 245 -
% 70 21 9 -
H.R. (OS) - With chemo 0.86 1.01 0.90 .29
H.R. (EFS) 0.82 0.90 0.87 .42
Non-Lung Ca Deaths (%) 12 19 22 <.0001
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Population Database Studies
SEER Database
Veterans Administration Cancer Registry
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Population Database Analyses: SEER (Age > 65)
• Observational cohort study of 3324 patients with resected stages II-IIIA lung NSCLC
• Only 21% received platinum based ACT
• ACT assoc with improved OS: H.R. 0.78-0.81
• ACT not beneficial age ≥ 80: HR 1.32-1.46
• ACT was associated with:– Increased odds of SAEs: O.R. 2.0
– Increased likelihood of hospital admission (13 vs. 7%)
– A 3.1% risk of death within 12 weeks
Wisnivesky et al BMJ 2011
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Population Study: Veterans Administration
Williams C, et al, Cancer 2014
3
10
2224
39 40
17
47 46
0
10
20
30
40
50
60
70
80
90
100
IB II III
% R
ecei
vin
g A
C
Stage
AC use among patients with Stages IB-III
surgically resected NSCLC, by time period
2001-20032004-20052006-2008
(N=1674) (N=2482)
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The Role of Carboplatin- VA Study
0
10
20
30
40
50
60
70
80
90
100
01 02 03 04 05 06 07 08
% R
ecei
vin
g p
lati
nu
m-b
ased
AC
Year
Proportion of patients receiving
carboplatin vs cisplatin, by year
CARBO
CIS
Ganti AK, et al, ASCO 2013
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Type of adjuvant chemotherapy by age (VA Study)
Ganti et al, ASCO 2013
0
10
20
30
40
50
60
70
80
90
100
Carboplatin Cisplatin Non platinum
< 70 Years
≥ 70 Years
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VA Study: Impact of Chemotherapy on OS
Ganti et al, ASCO 2013
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SEER Database: Type of Chemotherapy
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Conclusions by authors:
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Chemotherapy dose
• Even though older adults tolerate and receive lower doses, they still derive benefit
• Need to develop definitive guidelines for chemotherapy dose modification in older adults
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Decision-making in the Clinic
• Communication is key
• Consider medical, psychological, and social issues: – Pain, impaired breathing, or fatigue from thoracotomy. – Debility due to smoking-related illness– Depression – Lung cancer related social stigma– Nicotine withdrawal – Social support- family, friends, caregivers.
• The elderly, are more susceptible to the toxic adverse effects of chemotherapy.
• More likely to die of something other than lung cancer than a younger patient with similar stage disease
• What are their goals for themselves?
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“Isn’t it a bit unnerving that doctors
call what they do “practice”?”
George Carlin
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A GA-based approach
Can Geriatric Assessment help identify those at greatest risk of
chemotherapy toxicity?
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Ideal Tool to Risk Stratify
• Identification of vulnerable older adult
• To stratify by toxicity risk for cytotoxic therapy
• Outcomes depend on not just age but other
factors:
• Comorbidity,
• Physiologic function,
• Nutrition
• Functional status
• Social support
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Predictive Model (CARG)
Risk factors for Gr. 3-5 Toxicity OR (95% CI) Score
Age ≥73 yrs 1.8 (1.2-2.7) 2
GI/GU cancer 2.2 (1.4-3.3) 3
Standard dose 2.1 (1.3-3.5) 3
Poly-chemotherapy 1.8 (1.1-2.7) 2
Hemoglobin (male: <11, female: <10) 2.2 (1.1-4.3) 3
Creatinine Clearance (Jelliffe –ideal wt) <34 2.5 (1.2-5.6) 3
1 or more falls in last 6 months 2.3 (1.3-3.9) 3
Hearing impairment (fair or worse) 1.6 (1.0-2.6) 2
Limited in walking 1 block (MOS) 1.8 (1.1-3.1) 2
Assistance required in medication intake 1.4 (0.6-3.1) 1
Decreased social activity (MOS) 1.3 (0.9-2.0) 1
Possible score range: 0-25
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Model Performance:Prevalence of Toxicity by Score
Gra
de
3-5
To
xic
itie
s
Total ScoreN=39 N=64 N=123 N=36N=50N=161
0%
20%
40%
60%
80%
100%
0 to 4 5 6 to 8 9 to 11 12 to 13 ≥14
“Low” 27%(0 to 5)
31%21%
“Mid” 53%(6 to 11)
45%
63%
“High” 83%( ≥12)
76%
92%
ROC: 0.72
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MD-rated KPS vs. Model II
50% 51%
62%
0%
20%
40%
60%
80%
100%
90-100 80 ≤70
“Low” “High”“Mid”
Chi-square test
p<.0001
Chi-square test
p=0.17
27%
53%
83%
0%
20%
40%
60%
80%
100%
0-5 6-10 11-21
Low
Mid
High
Gra
de
3-5
To
xic
itie
s
Model II score
MD KPS
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Future Directions
• Use of GA to guide adjuvant treatment. – While the “fit elderly” may be offered the same therapies as
younger patients, for the vulnerable elderly, alternative treatment strategies need to be explored.
• Study the role of non-cisplatin based regimens in the older adults
• Lower dose and altered schedule of cisplatin
• Care of octagenerarians offers particular challenges. – No evidence thus far that ACT offers benefit.
– It is vital to discern the goals and expectations of the individual
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Conclusions
– Assess interest in adjuvant chemotherapy.
– While absolute improvement in OS is 5.4% based on
meta-analysis, the magnitude of benefit it is likely lower
for older adults.
– If the patient is interested and at low risk for
chemotherapy toxicity consider cisplatin based therapy.
– If the patient has contraindication to cisplatin, consider
carboplatin based therapy.
– Data do not support the use of adjuvant chemotherapy
in those over age 80 years.
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“The art of medicine consists of
amusing the patient while nature cures
the disease.”
― Voltaire
Thank You