Metastatic Non-Small Cell Lung CancerFor tumors with epidermal growth factor receptor
(EGFR) exon 19 deletions or exon 21
substitution mutations

Approaches to the management of metastatic non-small cell lung cancer (mNSCLC) are evolving through a better understanding of key driver mutations that can play a major role in the development and progression of NSCLC; therefore it is important to perform biomarker testing. Let’s look at two possible journeys.

Indication and Usage

GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.

Metastatic Non-Small Cell Lung CancerFor tumors with epidermal growth factor receptor
(EGFR) exon 19 deletions or exon 21
substitution mutations
Paul H.*
EGFR exon 19 deletion
(Del 19)

*Not an actual patient.

Rebecca T.*
EGFR exon 21 substitution
(L858R)

*Not an actual patient.

*Not an actual patient.
Metastatic Non-Small Cell Lung
Cancer Patient: Rebecca T.
History and initial evaluation
  • 52-year-old real estate agent
  • Loves adventurous cooking, traveling, and writing
  • Tobacco status: current smoker (12 pack-years)
  • Lung abnormalities detected in routine shoulder x-ray
Rebecca’s goal is to
publish a travel cookbook.
Metastatic Non-Small Cell
Lung Cancer Patient: Paul H.
History and presenting symptoms
  • 64-year-old retired police detective
  • Married 39 years
  • Active golfer
  • Tobacco status: quit smoking at age 59 (40 pack-years)
  • Persistent cough, shortness of breath
Paul’s goal is to celebrate his
40th wedding anniversary with his family.
Rebecca T.* EGFR exon 21 substitution (L858R) *Not an actual patient.

Comorbid conditions and medications

  • Gastroesophageal reflux disease: taking esomeprazole magnesium, a proton pump inhibitor (PPI)
  • Hyperlipidemia: taking atorvastatin, a cytochrome P450-metabolized HMG-CoA* reductase inhibitor (statin)

Initial workup conducted by Rebecca’s oncologist

  • CT scan shows multiple bilateral nodules in the lungs, visceral pleura, and lymph nodes

Diagnosis

  • Biopsy confirms adenocarcinoma of the lung
  • Stage IV; Eastern Cooperative Oncology Group Performance Status: 0
*3-hydroxy-3-methyl-glutaryl-co-enzyme-A.

NCCN guidelines1 recommend EGFR and ALK testing as part of broad molecular profiling for patients with metastatic adenocarcinoma NSCLC.

Rebecca’s biomarker testing report

  • Rebecca’s oncologist performed an FDA-approved biomarker test, which detected EGFR exon 21 substitution (L858R) mutations in Rebecca’s tumor specimens

In the United States, approximately 15% of patients have adenocarcinomas that harbor EGFR-activating mutations.2,3

GILOTRIF tablets are indicated as first-line treatment of patients with mNSCLC whose tumors have EGFR L858R substitution mutations as detected by an FDA-approved test.4 GILOTRIF has a Category 1 NCCN recommendation for the first-line treatment of patients with EGFR mutation-positive (M+) Stage IV NSCLC.1

FOR THE FIRST-LINE TREATMENT OF mNSCLC WITH EGFR L858R MUTATIONS

GILOTRIF tablets: Approved treatment option for patients with L858R mutations4,5

Median overall survival (OS) in LUX-Lung 3
L858R mutation populationa,b
  • GILOTRIF
    (40 mg orally once daily; n=91)
  • Pemetrexed/cisplatin
    (500 mg/m2/75 mg/m2 every
    3 weeks, up to 6 cycles; n=47)
27.6 months
40.3 months
HR: 1.30 (95% CI, 0.80-2.11)
HR: 1.30 (95% CI, 0.80-2.11)
Overall survival (%)
Time of overall survival (OS) (months)

FOR THE FIRST-LINE TREATMENT OF mNSCLC WITH L858R EGFR MUTATIONS

GILOTRIF tablets: Approved treatment option with proven PFS for patients with L858R mutations4,6,7

Primary endpoint: Median PFS for L858R (exon 21) mutations (n=138)4,6,7
HR: 0.73 (95% CI, 0.46-1.17)
Time (months)
GILOTRIF Pemetrexed/cisplatin

Efficacy information in uncommon mutations (n=37)4

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.

  • Median PFS: 2.8 months with GILOTRIF vs 9.9 months with pemetrexed/cisplatin (HR: 1.89; 95% CI, 0.84-4.28)4,8
  • Median OS: 15.9 months with GILOTRIF vs 40.8 months with pemetrexed/cisplatin (HR: 2.35; 95% CI, 0.96-6.11)4,7

GILOTRIF has an NCCN Category 1 recommendation for first-line treatment of mNSCLC in patients with Del 19 or L858R mutations.1

Adverse reactions in LUX-Lung 3, the pivotal study for GILOTRIF6

Adverse reactions reported in LUX-Lung 3 in ≥10% of GILOTRIF-treated patients4

Adverse reaction GILOTRIF (n=229) Pemetrexed/cisplatin (n=111)
All grades, % Grade 3a, % All grades, % Grade 3a, %
Gastrointestinal disorders
Diarrhea 96 15 23 2
Stomatitisb 71 9 15 1
Cheilitis 12 0 1 0
Skin and subcutaneous tissue disorders
Rash/acneiform dermatitisc 90 16 11 0
Pruritus 21 0 1 0
Dry skin 31 0 2 0
Infections
Paronychiad 58 11 0 0
Cystitis 13 1 5 0
Respiratory, thoracic, and mediastinal disorders
Epistaxis 17 0 2 1
Rhinorrhea 11 0 6 0
Investigations
Weight decreased 17 1 14 1
General disorders and administration site conditions
Pyrexia 12 0 6 0
Eye disorders
Conjunctivitis 11 0 3 0
Adverse reaction GILOTRIF
(n=229)
All grades, % Grade 3a, %
Gastrointestinal disorders
Diarrhea 96 15
Stomatitisb 71 9
Cheilitis 12 0
Skin and subcutaneous tissue disorders
Rash/acneiform dermatitisc 90 16
Pruritus 21 0
Dry skin 31 0
Infections
Paronychiad 58 11
Cystitis 13 1
Respiratory, thoracic, and mediastinal disorders
Epistaxis 17 0
Rhinorrhea 11 0
Investigations
Weight decreased 17 1
General disorders and administration site conditions
Pyrexia 12 0
Eye disorders
Conjunctivitis 11 0
Adverse reaction Pemetrexed/cisplatin
(n=111)
All grades, % Grade 3a, %
Gastrointestinal disorders
Diarrhea 23 2
Stomatitisb 15 1
Cheilitis 1 0
Skin and subcutaneous tissue disorders
Rash/acneiform dermatitisc 11 0
Pruritus 1 0
Dry skin 2 0
Infections
Paronychiad 0 0
Cystitis 5 0
Respiratory, thoracic, and mediastinal disorders
Epistaxis 2 1
Rhinorrhea 6 0
Investigations
Weight decreased 14 1
General disorders and administration site conditions
Pyrexia 6 0
Eye disorders
Conjunctivitis 3 0
Other clinically important adverse reactions observed in patients treated with GILOTRIF include decreased appetite (29%), nausea (25%), and vomiting (23%).4

aNone of the adverse reactions in this table except stomatitis (1 patient on GILOTRIF [0.4%]) were grade 4 in severity.

bIncludes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration.

cIncludes acne, acne pustular, dermatitis, acneiform dermatitis, dermatosis, drug eruption, erythema, exfoliative rash, folliculitis, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin disorder, skin erosion, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.

dIncludes paronychia, nail infection, nail bed infection.

Serious adverse reactions in LUX-Lung 34

Adverse reaction GILOTRIF
Diarrhea 6.6%
Vomiting 4.8%
Dyspnea 1.7%
Fatigue 1.7%
Hypokalemia 1.7%
  • Serious adverse reactions were reported in 29% of patients treated with GILOTRIF
  • Fatal adverse reactions in GILOTRIF-treated patients included pulmonary toxicity/interstitial lung disease-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%)
  • More GILOTRIF-treated patients (2.2%; n=5) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all less than grade 3) than chemotherapy-treated patients (0.9%)
  • Pancreatitis has been reported during postmarketing use of GILOTRIF. The frequency and causal relationship of pancreatitis to GILOTRIF has not been established

Schedule a 2-week check-in with Rebecca

Rebecca was started on GILOTRIF 40 mg

  • GILOTRIF was effective for patients like Rebecca in the LUX-Lung 3 study; there are no known drug interactions with her PPI or hyperlipidemia medications4

Rebecca’s 2-week check-in visit

  • Reports persistent mild diarrhea
  • Reduced appetite
  • Papular eruptions on upper arm, but little itching

The onset of diarrhea and skin reaction often occurs within the first 2 weeks of GILOTRIF initiation.7

Rebecca’s follow-up visit

Rebecca’s CT scan confirms disease control
(tumor shrinkage noted)

She continues on GILOTRIF 40 mg

Her diarrhea reduced to occasional grade 1 (mild)
with loperamide and dietary modifications

Rash successfully treated with topical steroid cream

She reported stomatitis at 3 months that was treated with a mouth rinse and diet modifications

Rebecca presents her doctor with a signed
copy of her new cookbook.

Conclusions: How the journey begins could determine how far they go

First-line OS and PFS in Del 19, and PFS in L858R1,4
NCCN Category 1 recommendation
GILOTRIF has an NCCN Category 1 recommendation for first-line treatment of mNSCLC patients with Del 19 or L858R mutations1

Patient counseling
tips for your staff

  • Educate patients that adverse events are expected with GILOTRIF4
  • Discuss proactive measures such as diet modification and skin protection9
  • Advise patients to call your office immediately if they experience diarrhea or rash
  • Review other potential adverse events and treatment strategies
An established safety profile based on data from more than 4200 patients in clinical trials4
40-mg, once-daily dosing4
The recommended dose of GILOTRIF in patients with severe renal impairment (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) is 30 mg orally, once daily
Schedule a 2-week check-in with your patients after the start of therapy
Solutions Plus®: Access and clinical support solutions for patients
www.bisolutionsplus.com or call a Patient Care Advocate at 1-877-814-3915 from 8:00am to 8:00pm ET
Dedicated GILOTRIF team at Accredo® 1-844-569-2837 from 8:30am to 7:00pm ET
Accredo is a registered trademark.

References

  • National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines). Non-small cell lung cancer (Version 4.2016). https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed September 26, 2016.
  • Bernicker E. Biomarker testing in non-small cell lung cancer. Arch Pathol Lab Med. 2015;139:448-450.
  • Lee CK, Wu YL, Ding PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol. 2015;33(17):1958-1965.
  • Gilotrif® (afatinib) tablets Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2016.
  • Yang JC-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-151.
  • Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-3334.
  • Data on file. Boehringer Ingelheim. CTR.
  • Data on file. Boehringer Ingelheim. Other mutations PFS table.
  • Hirsh V. Managing treatment-related adverse events associated with EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer. Curr Oncol. 2011;18(3):126-138.
Paul H.* EGFR exon 19 deletion (Del 19) *Not an actual patient.

Comorbid conditions and medications

  • Epilepsy: taking carbamazepine, a P-glycoprotein (P-gp) inducer
  • Hypertension: taking nifedipine, a cytochrome P450-metabolized calcium-channel blocker
  • Gastroesophageal reflux disease: taking esomeprazole magnesium, a proton pump inhibitor (PPI)

Initial workup conducted by Paul’s oncologist

  • Chest x-ray detects abnormalities
  • MRI scan confirms multiple lesions

Diagnosis

  • Needle biopsy confirms diagnosis of adenocarcinoma of the lung
  • Stage IV; Eastern Cooperative Oncology Group Performance Status: 1
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People who answered YES 23%
People who answered NO 32%

NCCN guidelines1 recommend EGFR and ALK testing as part of broad molecular profiling for patients with metastatic adenocarcinoma NSCLC.

Paul’s biomarker testing report

  • Paul’s oncologist performed an FDA-approved biomarker test, which detected EGFR exon 19 deletion mutations in Paul’s tumor specimens

In the United States, approximately 15% of patients have adenocarcinomas that harbor EGFR-activating mutations.2,3 In the LUX-Lung 3 study, GILOTRIF was shown to have significantly improved progression-free survival (PFS) compared with pemetrexed/cisplatin in patients with EGFR exon 19 deletions.4-6

GILOTRIF tablets are indicated as first-line treatment of patients with mNSCLC whose tumors have EGFR exon 19 deletions as detected by an FDA-approved test.4 GILOTRIF has a Category 1 NCCN recommendation for the first-line treatment of patients with EGFR mutation-positive (M+) Stage IV NSCLC.1

FOR THE FIRST-LINE TREATMENT OF EGFR M+ mNSCLC VS CHEMOTHERAPY

GILOTRIF tablets: Only agent with proven overall survival (OS) in patients with Del 19 mutations3,4,7

Median OS in LUX-Lung 3
Del 19 mutation populationa,b
  • GILOTRIF
    (40 mg orally once daily; n=112)
  • Pemetrexed/cisplatin
    (500 mg/m2/75 mg/m2 every
    3 weeks, up to 6 cycles; n=57)
45% reduction
in risk of death
21.1 months
33.3 months
HR: 0.55 (95% CI, 0.36-0.79)
HR: 0.55 (95% CI, 0.36-0.79)
Overall survival (%)
Time of overall survival (months)

FOR THE FIRST-LINE TREATMENT OF EGFR M+ mNSCLC VS CHEMOTHERAPY

GILOTRIF: Treatment option with proven PFS for patients with Del 19 mutations4-6

Primary endpoint: Median PFS for Del 19 mutations (n=170)4-6
HR: 0.28 (95% CI, 0.18-0.44)
Time (months)
GILOTRIF Pemetrexed/cisplatin

Efficacy information in uncommon mutations (n=37)4

Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.

  • Median PFS: 2.8 months with GILOTRIF vs 9.9 months with pemetrexed/cisplatin (HR: 1.89; 95% CI, 0.84-4.28)4,8
  • Median OS: 15.9 months with GILOTRIF vs 40.8 months with pemetrexed/cisplatin (HR: 2.35; 95% CI, 0.96-6.11)4,6

GILOTRIF has an NCCN Category 1 recommendation for first-line treatment of mNSCLC in patients with Del 19 or L858R mutations.1

Adverse reactions in LUX-Lung 3, the pivotal study for GILOTRIF5

Adverse reactions reported in LUX-Lung 3 in ≥10% of GILOTRIF-treated patients4

Adverse reaction GILOTRIF (n=229) Pemetrexed/cisplatin (n=111)
All grades, % Grade 3a, % All grades, % Grade 3a, %
Gastrointestinal disorders
Diarrhea 96 15 23 2
Stomatitisb 71 9 15 1
Cheilitis 12 0 1 0
Skin and subcutaneous tissue disorders
Rash/acneiform dermatitisc 90 16 11 0
Pruritus 21 0 1 0
Dry skin 31 0 2 0
Infections
Paronychiad 58 11 0 0
Cystitis 13 1 5 0
Respiratory, thoracic, and mediastinal disorders
Epistaxis 17 0 2 1
Rhinorrhea 11 0 6 0
Investigations
Weight decreased 17 1 14 1
General disorders and administration site conditions
Pyrexia 12 0 6 0
Eye disorders
Conjunctivitis 11 0 3 0
Adverse reaction GILOTRIF
(n=229)
All grades, % Grade 3a, %
Gastrointestinal disorders
Diarrhea 96 15
Stomatitisb 71 9
Cheilitis 12 0
Skin and subcutaneous tissue disorders
Rash/acneiform dermatitisc 90 16
Pruritus 21 0
Dry skin 31 0
Infections
Paronychiad 58 11
Cystitis 13 1
Respiratory, thoracic, and mediastinal disorders
Epistaxis 17 0
Rhinorrhea 11 0
Investigations
Weight decreased 17 1
General disorders and administration site conditions
Pyrexia 12 0
Eye disorders
Conjunctivitis 11 0
Adverse reaction Pemetrexed/cisplatin
(n=111)
All grades, % Grade 3a, %
Gastrointestinal disorders
Diarrhea 23 2
Stomatitisb 15 1
Cheilitis 1 0
Skin and subcutaneous tissue disorders
Rash/acneiform dermatitisc 11 0
Pruritus 1 0
Dry skin 2 0
Infections
Paronychiad 0 0
Cystitis 5 0
Respiratory, thoracic, and mediastinal disorders
Epistaxis 2 1
Rhinorrhea 6 0
Investigations
Weight decreased 14 1
General disorders and administration site conditions
Pyrexia 6 0
Eye disorders
Conjunctivitis 3 0
Other clinically important adverse reactions observed in patients treated with GILOTRIF include decreased appetite (29%), nausea (25%), and vomiting (23%).4

aNone of the adverse reactions in this table except stomatitis (1 patient on GILOTRIF [0.4%]) were grade 4 in severity.

bIncludes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration.

cIncludes acne, acne pustular, dermatitis, acneiform dermatitis, dermatosis, drug eruption, erythema, exfoliative rash, folliculitis, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin disorder, skin erosion, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.

dIncludes paronychia, nail infection, nail bed infection.

Serious adverse reactions in LUX-Lung 34

Adverse reaction GILOTRIF
Diarrhea 6.6%
Vomiting 4.8%
Dyspnea 1.7%
Fatigue 1.7%
Hypokalemia 1.7%
  • Serious adverse reactions were reported in 29% of patients treated with GILOTRIF
  • Fatal adverse reactions in GILOTRIF-treated patients included pulmonary toxicity/interstitial lung disease-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%)
  • More GILOTRIF-treated patients (2.2%; n=5) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all less than grade 3) than chemotherapy-treated patients (0.9%)
  • Pancreatitis has been reported during postmarketing use of GILOTRIF. The frequency and causal relationship of pancreatitis to GILOTRIF has not been established

Schedule a 2-week check-in with Paul

Paul was started on GILOTRIF 40 mg

  • GILOTRIF was effective for patients like Paul in the LUX-Lung 3 study; it should not affect the metabolism of his hypertension medication4
  • Paul was closely monitored for drug interactions between GILOTRIF and carbamazepine, a P-gp inducer
  • There are no known drug interactions with his PPI4

Paul’s 2-week check-in visit

  • Reports persistent worsening diarrhea despite taking antidiarrheal medication
  • Grade 3 diarrhea of approximately 8 stools per day
  • Maculopapular rash on upper arms, chest, and back, with itching

The onset of diarrhea and skin reaction often occurs within the first 2 weeks of GILOTRIF initiation.6

Managing Paul’s diarrhea

  • Paul’s GILOTRIF was paused for 10 days, then restarted at 30 mg, using the GILOTRIF Dose Exchange™ program

Paul’s follow-up visit

Paul’s CT scan confirms disease control, no new lesions detected

He continues on GILOTRIF 30 mg per day

His diarrhea reduced to occasional grade 1 (mild)

Rash successfully treated with oral antibiotics and topical therapies

Paul’s children and grandchildren are planning a
40th wedding anniversary party.

Conclusions: How the journey begins could determine how far they go

First-line OS and PFS in Del 19, and PFS in L858R1,4
NCCN Category 1 recommendation
GILOTRIF has an NCCN Category 1 recommendation for first-line treatment of mNSCLC patients with Del 19 or L858R mutations1

Patient counseling
tips for your staff

  • Educate patients that adverse events are expected with GILOTRIF4
  • Discuss proactive measures such as diet modification and skin protection9
  • Advise patients to call your office immediately if they experience diarrhea or rash
  • Review other potential adverse events and treatment strategies
  • Inform patients that dose modifications were common in LUX-Lung 34
An established safety profile based on data from more than 4200 patients in clinical trials4
40-mg, once-daily dosing4
The recommended dose of GILOTRIF in patients with severe renal impairment (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) is 30 mg orally, once daily
Schedule a 2-week check-in with your patients after the start of therapy
Solutions Plus®: Access and clinical support solutions for patients
www.bisolutionsplus.com or call a Patient Care Advocate at 1-877-814-3915 from 8:00am to 8:00pm ET
Dedicated GILOTRIF team at Accredo® 1-844-569-2837 from 8:30am to 7:00pm ET
Accredo is a registered trademark.

References

  • National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines). Non-small cell lung cancer (Version 4.2016). https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed September 26, 2016.
  • Bernicker E. Biomarker testing in non-small cell lung cancer. Arch Pathol Lab Med. 2015;139:448-450.
  • Lee CK, Wu YL, Ding PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol. 2015;33(17):1958-1965.
  • Gilotrif® (afatinib) tablets Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2016.
  • Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-3334.
  • Data on file. Boehringer Ingelheim. CTR.
  • Yang JC-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-151.
  • Data on file. Boehringer Ingelheim. Other mutations PFS table.
  • Hirsh V. Managing treatment-related adverse events associated with EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer. Curr Oncol. 2011;18(3):126-138.
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Metastatic Non-Small Cell Lung Cancer