Lung cancer screening: appropriate pa0ent selec0on and informed decision making

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1 Lung cancer screening: appropriate pa0ent selec0on and informed decision making William C. Black, MD Department of Radiology Norris Cancer Center Geisel School of Medicine at Dartmouth Dartmouth- Hitchcock Medical Center

2 Outline Background lung cancer screening Recent policy developments Implementa0on at DHMC

3 Lung Cancer Facts Leading cause of cancer death 224,210 new cases in ,260 deaths in % 5- year survival smoking causes > 80% American Cancer Society.

4 Mayo Clinic Project Screened (CXR + SC) Control (Usual) Subjects 1 4,618 4,593 Incident cases % resectable % five-year survival Lung cancer deaths Relative risk 2 (95%CI) 1.06 ( ) 1 91 prevalent cases excluded before randomization 2 based on cumulative lung cancer mortality at eleven year Fontana et al. Cancer 1991;67:

5 Hamartoma PA

6 SPN 4-10mm

7 NLST Study Design Prospec0ve randomized trial 53,454 high risk 1:1 randomiza0on LDCT: CXR 3 annual screens Primary endpoint: lung cancer mortality Aberle et al. Radiology 2011

8 NLST: Eligibility No symptoms of lung cancer Ages >=30 pack- yr history of smoking No prior lung cancer Medically fit for surgery NLST Research Team. Radiology 2011

9 Stage of Lung Cancers Diagnosed by NLST arm. Cancer Stage Low- dose CT N=1060 Chest X- Ray N=941 Number Percent Number Percent IA IB II III IV Total* Aberle et al. N Engl J Med 2011

10 Cumula0ve Numbers of Lung Cancers and of Deaths from Lung Cancer X X X The Na=onal Lung Screening Trial Research Team. N Engl J Med DOI: /NEJMoa

11 Through Jan 15, 2009 Lung Cancer Mortality Low- dose CT Aberle et al. N Engl J Med CXR Person- years 144, ,368 Lung cancer deaths Lung cancer mortality rate (per 100,000) Rela0ve risk reduc0on (%) % CI, 6.8 to 26.7 P = 0.004

12 All Cause Mortality Low- dose CT CXR Person- years Not Reported Not Reported All deaths 1,877 2,000 All cause mortality (per 100,000) 1,303 1,395 Rela0ve risk reduc0on (%) % CI, 1.2 to 13.6 P = 0.02 Through Dec 31, 2009 Aberle et al. N Engl J Med

13 Absolute Risk Reduc0on of Lung Cancer Death = 425/26, /26,455 = per 1,000 Aberle et al. N Engl J Med

14 Number Needed to Screen to Prevent One Lung Cancer Death NNS = 1/ARR = 1/ = 320 Aberle et al. N Engl J Med

15 Harms of CT screening for Lung Cancer False- posi0ve screening results Overdiagnosis Radia0on exposure

16 False- Posi0ve CT Screening Results 27% during first round of screening 37% during all three rounds of screening Most common follow- up was a single low- dose CT < 7% of false posi0ve par0cipants had invasive procedure Aberle et al. N Engl J Med, 2011

17 Overdiagnosis More lung cancers in low- dose CT than CXR: 1089 vs % of the CT screen detected lung cancers overdiagnosed Rates of overdiagnosis much higher for in situ and minimally invasive tumors than other NSCLC, 49% vs 3% Patz et al. JAMA intern Med, 2013

18 Radia0on Exposure Effec0ve dose low- dose CT 1.4 msv Effec0ve dose standard chest CT 7 msv Effec0ve dose natural background 3.1 msv CT screening for lung cancer would prevent 20 0mes more lung cancer deaths than it would cause Benefit/risk least favorable for younger women with fewer pack- years Larke et al. AJR, 2011

19 NLST Summary RCT of 53,454 high risk 20% lung cancer mortality reduction 7% all cause mortality reduction Cumulative False Positive Rate 37% Modest degree of overdiagnosis Aberle et al. N Engl J Med, 2011

20 USPSTF Recommenda0on The USPSTF recommends annual screening for lung cancer with low- dose computed tomography in adults ages 55 to 80 years who have a 30 pack- year smoking history and currently smoke or have quit within the past 15 years. Moyer VA. Ann Intern Med. 2013

21 USPSTF Recommenda0on Screening should be discon0nued once a person has not smoked for 15 years or develops a health problem that substan0ally limits life expectancy or the ability or willingness to have cura0ve lung surgery. Grade B recommenda0on Moyer VA. Ann Intern Med. 2013

22 USPSTF Other Considera0ons Smoking cessa0on Shared decision making Standardiza0on of low- dose CT screening and follow- up Development of registry Moyer VA. Ann Intern Med. 2013

23 MEDCAC Voted low confidence in April 2014 Major concerns: Who would be screened? How and for how long would they be screened? Proficiency of screening center?

24 ACR LungRADS Standardize repor0ng Reduce confusion Facilitate outcome monitoring Reduce posi0vity rate from 28% to 11% 1 1 Mckee et al. J Am Coll Radiol 2014

25 ACR Screening Center Designa0on Eligibility requirements Smoking cessa0on CT specifica0ons Structured repor0ng Follow- up system

26 Cost Effec0veness Analysis Comparison: LDCT, CXR, No Screen Health effects: LYs and QALYs Costs: $US (reference 2009) Perspec0ve: Societal Time horizon: Within- trial and life0me Discount rate: 3% Gold et al. Cost- effec0veness in health and medicine

27 Base Case Results STRATEGY $ QALYs $ QALYs $/QALY LDCT 3, , ,000 CXR 1, DOM DOM NO SCR 1, Black et al. NEJM 2014.

28 Age years Asymptoma0c >= 30 pack- years CMS Pa0ent Eligibility Current or quit <= 15 years order from physician or qualified non- physician prac00oner during SDM visit

29 CMS SDM Visit Determina0on of beneficiary eligibility SDM including the use of one or more decision aids Counseling on adherence and willingness dx and rx Counseling on smoking abs0nence or cessa0on If appropriate, the furnishing of a wri@en order for LDCT screening

30 Date of birth CMS Order Actual pack - year smoking history (number) Smoking status and number of years since quivng Statement that the beneficiary is asymptoma0c Na0onal Provider Iden0fier (NPI) of the ordering prac00oner

31 CMS Reading Radiologist Board cer0fica0on or eligibility ABR Documented training in DR and radia0on safety Interpreta0on >= 300 chest CTs in the past 3 years Documented CME in accordance with ACR Furnish lung cancer screening with LDCT in approved radiology imaging facility

32 CMS Imaging Facility CT dose index 3.0 mgy for standard size pa0ents U0lizes standardized repor0ng system Makes available smoking cessa0on interven0ons for current smokers Collects and submits data to a CMS- approved registry for each LDCT lung cancer screening exam

33 CMS Registry 83 data elements (48 required) Facility (2) Pa0ent info (13) Exam (18) Follow- up (15)

34 One DH: Lung Cancer Screening Program Provider Brochure Pa0ent Brochure Decision aids for shared decision making CT screening telephone access line edh order entry process (fax order sheet) Smoking cessa0on counseling Standardized repor0ng (LungRADS) Follow- up and communica0on with referring clinicians

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38 edh Order Entry edh name: CT Chest Screening Lung Cancer edh order code: IMG4556 Eligibility Criteria: 1. Willing and able to undergo lung cancer treatment 2. No symptoms or signs of lung cancer or respiratory infec0on in past 12 weeks 3. Minimum of 30 pack- years of smoking 4. If former smoker, quit within 15 years 5. Age years 6. No hx of lung cancer ever or other cancer with metasta0c poten0al in last 5 years The pa0ent should have no severe comorbidi0es that would preclude cura0ve treatment

39 edh order request 2/26/15

40 Fax order request drax 3/5/15

41 Treatments for Lung Cancer Surgery - lobectomy or wedge resec0on Stereotac0c Radia0on (within 1 week) Conven0onal radia0on (several weeks) Radiofrequency abla0on Chemotherapy

42 Payment Considera0ons Full coverage by private insurance since Jan 1, Private insurance should cover evalua0on and treatment of findings, but these may be subject to deduc0bles and co- payments. CMS will cover retroac0vely to Feb 5, 2015 with data submission to approved registry and other requirements

43 Summary NLST showed 20% reduc0on in lung cancer mortality USPSTF recommends CT screening to select pa0ents Full coverage by private insurance since Jan 1, 2015 CMS decision memo Feb 5, 2015 DH high standard for CT screening, eligibility criteria, informed decision making and thorough pa0ent follow- up

44 References 1. Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al. Reduced lung- cancer mortality with low- dose computed tomographic screening. N Engl J Med Aug 4;365(5): PubMed PMID: Aberle DR, Berg CD, Black WC, Church TR, Fagerstrom RM, Galen B, et al. The Na0onal Lung Screening Trial: overview and study design. Radiology Jan;258(1): PubMed PMID: Black WC, Gareen IF, Soneji SS, et al. Cost- effec0veness of CT screening in the Na0onal Lung Screening Trial. N Engl J Med Nov 6;371(19): PubMed PMID: Fontana RS, Sanderson DR, Woolner LB, Taylor WF, Miller WE, Muhm JR, et al. Screening for lung cancer. A cri0que of the Mayo Lung Project. Cancer Feb 15;67(4 Suppl): PubMed PMID:

45 References (cont) 5. Larke FJ, Kruger RL, Cagnon CH, Flynn MJ, Gray MM, Wu X, et al. Es0mated radia0on dose associated with low- dose chest CT of average- size par0cipants in the Na0onal Lung Screening Trial. AJR American journal of roentgenology Nov;197(5): PubMed PMID: McKee BJ, Regis SM, McKee AB, Flacke S, Wald C. Performance of ACR Lung- RADS in a Clinical CT Lung Screening Program. Journal of the American College of Radiology : JACR Moyer VA. Screening for Lung Cancer: U.S. Preven0ve Services Task Force Recommenda0on Statement. Annals of internal medicine Dec 31. PubMed PMID: Patz EF, Jr., Pinsky P, Gatsonis C, Sicks JD, Kramer BS, Tammemagi MC, et al. Overdiagnosis in low- dose computed tomography screening for lung cancer. JAMA internal medicine Feb 1;174(2): PubMed PMID:

46 Learning module for CME credit hitchcock.org/ac0vity/ /detail.aspx