Lung Cancer: 2015 - aaimedicine.org€¦ · Cancer Statistics 2015 Primary Site New Cases (no.)...
Transcript of Lung Cancer: 2015 - aaimedicine.org€¦ · Cancer Statistics 2015 Primary Site New Cases (no.)...
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James R. Jett, MD
National Jewish Health
Denver, Colorado
Lung Cancer: 2015
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James Jett MD
I have no potential conflicts of interest related to this lecture.
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Cancer Statistics 2015Lung Cancer
New
Cases
Deaths
(no.)
Cancer
Deaths (%)
Men 115,610 86,380 28
Women 105,590
(48%)
71,660 28
Total 221,200 158,050
American Cancer Society, Cancer Statistics; 2015
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Cancer Statistics 2015
kk k
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Cancer Statistics 2015
Primary
Site
New
Cases
(no.)
Deaths
(no.)
1975-
1977
2004-
2010
Lung 221,200 158,040 12 18
Colorectal 132,700 49,700 51 65
Breast 234,190 40,730 75 91
Pancreas 48,960 40,560 3 7
Prostate 220,800 27,540 68 >99
American Cancer Society, Cancer Statistics; 2015
5-Year Survival
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Deaths Due to Cigarette Smoking (2011)for 12 Smoking-Related Cancers in USA
Total
Deaths
Smoking
Attributed Percent
Larynx 3,728 2,856 77%
Lung 156,855 125,799 80%
Oral Cavity & Pharynx 8,576 4,032 47%
Esophagus 14,404 7,307 51%
Urinary Bladder 14,997 6,724 45%
Total (all 12 cancers) 345,962 167,805 48%
Amer Can Society JAMA, pub online June 15, 2015
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Stage groups according to TNM descriptor and subgroups.
Chest;2009;136:260-271
©2009 by American College of Chest Physicians
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Focus of this Lecture
• Current Status of Innovative Treatments of Lung Cancer
• Impact on Survival
• Update on Lung Cancer Screening
• Solitary Pulmonary Nodule followupand risk of cancer.
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Survival With Stage IV NSCLC:First Line Therapies
1980 No Treatment 4-5 Months
1990 Platinum Doublets 9 Months
2000 Platinum Doublets ±Bevacizumab 12 Months
2010 EGFR Sensitizing Mutations 24 Months
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13
ECOG 1594: Time to Progression
Schiller JH, et al. N Engl J Med. 2002;346:92-98.
1.0
0.8
0.6
0.4
0.2
0
10 15 25
Months
0 5 20 30
Cisplatin/Paclitaxel
Cisplatin/Gemcitabine
Cisplatin/Docetaxel
Carboplatin/Paclitaxel
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Traditional
Molecular Testing for NSCLC - 2012
Adenocarcinoma
Squamous
Large Cell
Unknown
FGFR1
Amp
EGFRvIII
PI3KCA
EGFR TK
DDR2
BRAF
AKT
VEGFRHER2
EPHA/B
PDGFR
FGFR
INSR
PI3K
MAPK
KRAS
EGFR
ALK
Unknown
Adenocarcinoma
Squamous Cell Ca
RET
Adapted from W. Pao and N Girard, Lancet Oncol, 2011
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Driver Mutations
• “Driver mutations” confer growth advantage and are causal to cancer development versus “passenger” mutation which are biologically neutral with no growth advantage
• These mutations occur in genes that encode signal proteins critical for cellular proliferation and survival
• Most “driver mutations” have been identified in adenocarcinomas.
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Driver Mutations and Amplification
EGFR
ALK
ROS
KRAS
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L858R +: 4 weeks of erlotinib therapy
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CT scans of 2/26/14 & 7/2/14
ALK Fusion on Crizotinib
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Changes in Last 5-10 Years
•Sensitizing somatic mutations in adenocarcinoma: EGFR, ALK, ROS-1
•EGFR (T790M) inhibitors
– Rociletinib; AZD 9291
•Second line ALK inhibitors
– Ceritinib; Alectinib
•Immune Check-Point Inhibitors with Anti-PD1 or Anti-PDL1 Inhibitors
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Randomized Trials of EGFR TKI vs CT in 1st Line Rx
Study ORR PFS (mo) HR OS
EURTAC 58% vs 15% 9.7 vs 5.2 0.37 ND
OPTIMAL 83% vs 36% 13.1 vs 4.6 0.16 ND
NEJ 002 74% vs 31% 10.8 vs 5.4 0.30 ND
WJTOG 3405 62% vs 31% 9.2 vs 6.3 0.49 ND
IPASS 71% vs 47% 9.5 vs 5.5 0.19 ND
LUX LUNG 3 56% vs 23% 11.1 vs 6.9 0.58 ND
LUX LUNG 6 67% vs 23% 11.0 vs 5.6 NR NR
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The relative frequencies of the various mechanisms of acquired resistance.
Yu H A et al. Clin Cancer Res 2013;19:2240-2247
©2013 by American Association for Cancer Research
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AZD9291 in EGFR Resistant NSCLC
Janne, et al. NEJM 2015; 372:1689
• All patients had sensitizing mutations and progression on EGFR TKIs
• 127 Patients with EGFR T790M Mutations
– RR of 61% (52-70)
• 61 Patients Without T790M Mutations
– RR of 21% (12-34)
• Median PFS of 9.6 Months in T790M Positive
– PFS of 2.8 months in T79OM negative
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Janne, et al. NEJM 2015; 372:1689
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Janne, et al. NEJM 2015; 372:1689
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Before and 14 days after start of crizotinib in ALK mutation
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Rociletinib in EGFR Mutated NSCLC
Sequist et al. NEJM 2015;372:1700
• Tumor biopsy was mandatory and T790M positivity had to be confirmed in Phase II
• 172 patients screened
– Genotyping possible in 148 (86%)
– 78 (53%) had T790M mutation
• Majority of testing failures due to Insufficient Tumor Tissue in Biopsy Sample
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•Tumor cells release free DNA into the blood
•Blood sample can identify both genetic and epigenetic aberrations of cancers
•Systematically track genomic changes
Nature Rev Clin Oncol 2013; 10:472-484
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Nature Rev Clin Oncol 2013; 10:472-484
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How Do PD-L1 Blockade and PD-1 Blockade Differ?
Freeman & Sharpe, Nat Immun 2012; 13 (113) Presented by: Natasha Leighl at ASCO Annual 13 Meeting
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MPDL3280A (Anti-PDL1) Inhibits the Binding of PD-L1 to PD-1 and B7.1
Blocking PD-L1 restores T-cell activity, resulting in tumor regression in preclinical model.
Binding to PD-L1 leaves PD-1/PD-L2 interaction intact and may enhance efficacy and safety.
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Nivolumab as Second Line Treatment in Squamous Cell Lung Cancer
Brahmer, et al. NEJM 2015;373:123
• 272 patients randomized to nivolumab3mg/kg every two weeks or docetaxel75mg/m2 Every Three Weeks
• MST 9 vs 6 months in favor of nivolumab
– HR 0.59 (41% lower risk death)
• One Year Survival 42% vs 24%
• Response Rate 20% vs 9%
• Grade ¾ Toxicity 7% vs 55%
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Brahmer et al NEJM 2015; 373:123-35
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Brahmer et al NEJM 2015; 373:123-35
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Survival with Nivolumab in
Previously Treated NSCLC
All Doses
(n=128)
3mg/kg
(n=37)
Median OS 9.9 mos 0
1 Year (%) 42 56
2 Year (%) 24 42
3 Year (%) 18 27
Gettinger et al. J Clin Oncol 2015; 33:2004
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Gettinger et al. J Clin Oncol 2015; 33:2004
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Gettinger et al. J Clin Oncol 2015; 33:2004
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Pembrolizumab Treatment
in Second Line NSCLC
•495 Patients Treated at Varying Doses and Schedules
•RR of 19%; DUR 12.5 mos; MST 12 mos
•With 50% Staining of Cells with PDL-1 (cancer and mononuclear inflammatory cells)
– RR 45%; PFS 6.3 mos; OS not reachedGaron et al. NEJM 2015: 372:2018-28
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Postow et al J Clin Oncol 2015; 33:1974-82
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Immunotherapy: Lung Cancer
• Nivolumab Has Been Approved for Second-Line Therapy for Non-Small Cell Lung Cancer
• Estimated Cost of $100,000/Year
$10,000 per treatment approximately
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•100 experts in CML drew attention to high prices of cancer drugs
• Lower the prices of cancer drugs to allow more patient to afford them
• Maintain sound long-term healthcare policies
Blood 2013: 121:4439
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Pricing of Oncology Drugs
“The Notion That Drug Prices
Are Linked to Anything
Coherent Like Value or
Benefit Has Been Debunked.”
Dr. Peter Back - MSKCC
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Drug Abacus.org
Research tool created at MSKCC to compare cost of 54 Oncology Drugs approved since 2001
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Screening and Nodule Evaluation
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Lung Cancer
•228,000 new cases in 2013
– 60% will be dead within one year
• Symptomatic lung cancer is advanced stage disease and not curable
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Lobar Collapse
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CP1066773-34
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National Lung Cancer
Screening Trial (NLST)
CP1066773-57
SmokerFormer smoker
30 pk yrAge 55-74
SmokerFormer smoker
30 pk yrAge 55-74
40,000PLCO40,000PLCO
10,000ACRIN10,000ACRIN
RandomizedRandomized
Low-dose fast spiral CTLow-dose fast spiral CT
CXRCXR
YearsYears
00 11 22
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Lung Cancer Mortality:October 2010
ARM
Lung
Cancer
Deaths
Lung
Cancer
Mortality per
100,000 PY
Reduction
in Lung
Cancer
Mortality
LDCT 356 247 20%
CXR 443 309
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True and False Positive Screens
Screen Results T0 T1 T2
Total Positive 7,193 6,902 4,052
Lung Cancer 270 (4%)
168 (2%)
211 (5%)
No Lung Cancer 96% 98% 95%
Low Dose CT
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Lung Cancer Stage I
•NELSON 64% (N Eng J Med)
•NLST 63%
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CP1066773-42
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CP1066773-43
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Predictive Value of LDCT
Nodule Size PPV%
≥4mm 3.8
4-6mm 0.5
7-10mm 1.7
11-20mm 11.9
21-30mm 29.7
>30mm 41.3
Hilar or Mediastinal Adenopathy 18.5
• Negative Predictive Value 99.9%NLST Team. NEJM 2013; 368:1980-91
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Two-Year Probability of Lung Cancer
by Nodule Size: NELSON
Horewig et al. Lancet Oncol 2014; Pub online Oct 2
Size in mm
2-Year
Probability
<4 0.6%
5 to <6 0.9%
6 to <7 0.4%
7 to <8 1.8% P=<.001
8 to <10 2.9% P=<.001
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Two-Year Probability of Lung Cancer
by Nodule Size: NELSON
Horewig et al. Lancet Oncol 2014; Pub online Oct 2
Size in mm
2-Year
Probability
8 to <10 2.9%
10 to <15 11.1%
15 to <20 19.6%
20 to <30 25.0%
≥30 31.6%
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Lung Cancer Risk Prediction:PLCO Model
Tammemagi et al. NEJM 2013;368:728
Age
Education
Body Mass Index
Family History Lung Cancer
History of COPD
Race
Smoking Status (NS, F, C)
Smoking Intensity
Smoking Duration
Quit Time in Former Smokers
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Spread sheet calculator of Lung Cancer risk and Lung
Nodule Risk: Available online
http://www.brocku.ca/lung-cancer-risk-calculator
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ACR LungRADS®Category
Descriptor
Category
Descriptor
Primary
Category
Incomplete - 0
Negative No nodules & definitely benign nodules 1
Benign
Appearance or
Behavior
Nodules with a very low likelihood of
becoming a clinically active cancer due to
size or lack of growth2
Probably benign
Probably benign finding(s) - short term
follow up suggested; includes nodules with
a low likelihood of becoming a clinically
active cancer
3
SuspiciousFindings for which additional diagnostic
testing and/or tissue sampling is
recommended
4A
4B
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ACR LungRADS®
CategoryCategory
Descriptor
Categor
yFindings Management
Negative
No nodules
and definitely
benign
nodules
1no lung nodules
Continue
annual
screening
with
LDCT in 12
months
nodule(s) with specific calcifications:
complete, central, popcorn, concentric
rings and fat containing nodules
Benign
Appearanc
e or
Behavior
Nodules with a
very low
likelihood of
becoming a
clinically active
cancer due to
size or lack of
growth
2
solid nodule(s):
< 6 mm
new < 4 mm
part solid nodule(s):
< 6 mm total diameter on baseline
screening
non solid nodule(s) (GGN):
< 20 mm OR
≥ 20 mm and unchanged or slowly
growing
category 3 or 4 nodules unchanged for ≥ 3
months
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ACR LungRADS®
Category Category Descriptor Category Findings Management
Probably
Benign
Probably benign
finding(s) - short term
follow up suggested;
includes nodules with a
low likelihood of
becoming a clinically
active cancer
3
solid nodule(s):
6 month
LDCT
≥ 6 to < 8 mm at baseline
OR
new 4 mm to < 6 mm
part solid nodule(s)
≥ 6 mm total diameter
with
solid component < 6 mm
OR
new < 6 mm total
diameter
non solid nodule(s) (GGN) ≥
20 mm on baseline CT or new
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ACR LungRADS®Category Category Descriptor Category Findings Management
Suspiciou
s
Findings for
which additional
diagnostic testing
and/or tissue
sampling is
recommended
4A
solid nodule(s):
3 month
LDCT; PET/CT
may be used when
there is a ≥ 8 mm
solid component
≥ 8 to < 15 mm at baseline OR
growing < 8 mm OR
new 6 to < 8 mm
part solid nodule(s:
≥ 6 mm with solid component ≥ 6 mm to < 8
mm OR
with a new or growing < 4 mm solid
component
endobronchial nodule
4B
solid nodule(s)chest CT with or
without contrast,
PET/CT and/or
tissue sampling
depending on the
*probability of
malignancy and
comorbidities.
PET/CT may be
used when there is
a ≥ 8 mm solid
component.
≥ 15 mm OR
new or growing, and ≥ 8 mm
part solid nodule(s) with:
a solid component ≥ 8 mm OR
a new or growing ≥ 4 mm solid
component
4X
Category 3 or 4 nodules with additional features
or imaging findings that increases the suspicion
of malignancy
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Screening for Lung Cancer: US Preventive Services Task Force
•USPSTF recommends annual screening for lung cancer with LDCT in adults aged 55-80years
•30 pack year smoking history and currently smoke or have quit within the past 15 years
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74 page report with details on an approved screening program and center requirements
November 10, 2013CMS issues preliminary approval
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Must collect and submit data to CMS
Data Type
• Facility
• Radiologist
• Patient
• Ordering practitioner
• Demographics
• Indication
• Smoking history
• Scanner/radiation dose
• 4 more items on outcomes
Minimum data elements
• Identifier
• NPI
• Identifier
• NPI
• DOB, gender, race/ethnicity
• LC screening; no symptoms
• Current, former, yrs quit
• Manufacture/model/dose
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CP1081380-27