Optimizing Nursing Management of Patients Receiving Novel Therapies for Advanced NSCLC - PowerPoint Presentation

Slide1

Optimizing Nursing Management of Patients Receiving Novel Therapies for Advanced NSCLC

Beth

Eaby

-Sandy, MSN, CRNP, OCN

®

Nurse Practitioner

Abramson

Cancer Center of the University of Pennsylvania

Slide2

Disclosure of Conflicts of Interest

Beth

Eaby

-Sandy, MSN, CRNP,

O

CN

®

discloses she was a member of the advisory board of Boehringer Ingelheim and a member of the speakers’ bureau of Genentech in the last 12 months. She is currently a member of the speakers’ bureau of Lilly.

Slide3

NSCLC: Scope of the Problem

Estimated New Cancer Cases in 2013

Prostate: 238,590 (28%)

Lung/Bronchus: 118,080 (14%

)

Colon/Rectum: 73,680 (9%)

Breast: 226,870 (29%)

Lung/Bronchus: 110,110 (14%

)Colon/Rectum: 69,140 (9%)

ACS, 2013.

Slide4

PERSPECTIVE

Lung/Bronchus Deaths = 159,480

Breast, Prostate, Colon/Rectum, and Pancreatic Deaths = 158,630

NSCLC: Scope of the Problem

Estimated New Cancer Cases in 2013

Prostate

: 238,590 (28%

)

Lung/Bronchus: 118,080 (14%)Colon/Rectum: 73,680 (9%)

Breast

: 226,870 (29%

)

Lung/Bronchus: 110,110 (14%

)

Colon/Rectum: 69,140 (9%)

ACS, 2013.

Slide5

Lung Cancer Stages and Survival

SEER Data, 2003-2009.

Slide6

NSCLC: Breakdown by Subtype

Squamous (30-35%)

Usually more centralized

More frequently associated with significant cough and hemoptysis

Eaby

-Sandy, 2011.

Slide7

NSCLC: Breakdown by Subtype

Nonsquamous (65%)

Adenocarcinoma (40%)

Most common type of

NSCLC

Most common type in

nonsmokersLarge cell carcinoma (15%)Mixed or NOS (10%)NOS = not otherwise specified.Eaby-Sandy, 2011.

Slide8

NSCLC: Why Does Histology Matter?

In past, all NSCLC patients treated the same

Data have shown that the

use of certain

agents

in certain histologies results in improved survival and response rates

Histology may predict the presence of biomarkersSafety parameters of certain treatments depend on histologyNCCN, 2013.

Slide9

NSCLC: Breakdown of Biomarkers

Hirsch, 2012.

Slide10

NCCN,

2013

;

Langer

et al, 2010.

EGFR

Transmembrane

receptor

Detectable in about 80-85% of patients

Level of expression varies widely

Mutations in this domain (10-15% of

pts

) result in activation of the tyrosine kinase domain with significantly better response to erlotinib or gefitinib

Mutations: highest incidence in never smokers, adenocarcinoma, women, and patients with Asian ethnicity

KRAS

25% of North American population

Associated with smoking and resistance to tyrosine kinase inhibitors

KRAS mutations associated with shorter survival

Therapy with drugs other than erlotinib should be considered first

EML4-ALK

Incidence of EML4-ALK translocation: 2-7%

Estimated prevalence of EML4-ALK in lung cancer: 6,000 pts/

yr

US; up to 40,000 pts/

yr globallyMost EML4-ALK fusion events observed in lung adenocarcinoma specimens vs squamous or small cell histologiesEML4-ALK rarely coexists with EGFR, HER2, or KRAS mutations, indicating it is a distinct disease subtypeMolecular Abnormalities in NSCLC With Current Implications

Slide11

Why Do Biomarkers Matter?

PFS with standard chemotherapy regimens in NSCLC:

Pemetrexed/cisplatin: 5 months

Paclitaxel/carboplatin/bevacizumab: 6 months

PFS with EGFR mutated NSCLC receiving EGFR targeted therapy:

Gefitinib: 9.5 months

Erlotinib: 9.7 monthsAfatinib: 11.0 monthsPFS with ALK-positive NSCLC receiving ALK inhibitor:Crizotinib: 9.7 monthsPFS = progression-free survival.Camidge et al, 2012; Yang, Shih et al, 2012;

Rosell et al, 2012; Fukuoka et al, 2011; Scagliotti et al, 2008; Sandler et al, 2006.

Slide12

Patient Factors in Treatment Planning

Patient ECOG PS

PS is a predictor of survival/tolerating chemotherapy

PS 0/1 patients tolerate chemotherapy best

PS 2 patients can potentially benefit, even from doublet chemotherapy; however, toxicity must be monitored closely

Comorbidities

Diabetes, heart diseaseRenal diseaseECOG PS = Eastern Cooperative Oncology Group performance status.Rodriguez & Lilenbaum, 2008.

Slide13

Patient Factors in Treatment Planning

Patient goals for treatment

Quality-of-life issue (eg, hair loss)

Advanced directives

Demographics

Social support

Involve social workerCounseling servicesNutrition servicesFinancial issues

Slide14

Evolving Supportive Care P

aradigms

Early palliative care leads to increase in OS in

patients with metastatic NSCLC

Increased quality of life, less depressive symptoms

Improved understanding of diagnosis

1/3 patients at diagnosis thought they had curable diseaseLess likely to receive chemotherapy near end of lifeOS = overall survival.Temel et al, 2011; Temel et al, 2010.

Slide15

Case Study: First-Line Treatment

Slide16

Mrs. JF: History

68-year-old woman, presented 1 month ago with pain in her lower back

Initial management with NSAIDs somewhat helpful; however, the pain persisted

and an

x-ray of the lower spine was ordered

X-ray did not show bone abnormality but revealed a right lung mass at the right lung base

Further imaging with PET/CT revealed a right lung mass, mediastinal lymphadenopathy, bone metastases in the lumbar spine, and liver metastasesX-rays are often negativeNSAIDs = nonsteroidal antiinflammatory drugs;

PET/CT = positron emission tomography/computed tomography.

Slide17

Mrs. JF: Diagnostic Evaluation

Treating physician referred patient to pulmonologist for a bronchoscopy with biopsy

Mediastinal lymph node was positive for NSCLC, adenocarcinoma histology

MRI scan of the brain negative for metastatic disease

Baseline labs within normal limits

Baseline PS 1

What factors important in treatment planning?MRI = magnetic resonance imaging.

Slide18

Mrs. JF: Treatment Considerations

Bronchoscopy yielded core biopsy, able to perform KRAS, EGFR, ALK, and ROS testing. All were negative.

Patient has a 45-pack-year smoking history, currently trying to quit

Patient has hypertension (controlled with medication), hypercholesterolemia, and chronic obstructive pulmonary disease

No significant weight loss, no hemoptysis

Understands incurable, no advanced directive, would like to “fight”

Slide19

Mrs. JF: Treatment Selection

Standard chemotherapy in biomarker-negative patient appropriate therapy

Numerous options available for chemotherapy

Platinum based chemotherapy appropriate given good PS

Is hair loss an issue?

Does she want to enroll in a clinical trial?

NCCN, 2013.

Slide20

Mrs. JF: Treatment Selection

Cisplatin versus

c

arboplatin? In US

,

often use carboplatin in frontline therapy

What drug to pair with carboplatin? Toxicity?PemetrexedPaclitaxelDocetaxelnab-paclitaxelGemcitabineVinorelbine

Slide21

ECOG 1594:

All

Platinum Doublets Essentially

Equal

1,207 patients, stage IIIB/IV (15/85%),

PS 0-2

Median age 63; male/female: 64/36%

q3w

AUC=6 mg/mL/min D1225 mg/m2/3h D1

Carboplatin

Paclitaxel

q3w

75 mg/m

2

D1

75 mg/m

2

D1

Cisplatin

Docetaxel

q4w

100 mg/m

2

D11 g/m2 D1,8,15CisplatinGemcitabineq3w75 mg/m2 D2135 mg/m2

/24hCisplatinPaclitaxelRANDOMIZEAUC = area under the curve.Schiller et al, 2002.

Similar efficacy for all doublets

Slide22

Importance of Histology

Overall Survival for Pemetrexed/Cisplatin Versus

Gemcitabine/Cisplatin in First-Line Adenocarcinoma Patients

CI = confidence interval.

Scagliotti

et al, 2008;

Scagliotti & Novello, 2003.

Median OS (months)

(95% CI)

12.6

(10.7-13.6)

10.9

(10.2-11.9)

Pemetrexed/

Cisplatin

(n=436)

Gemcitabine/

Cisplatin

(n=411)

Slide23

What About Bevacizumab?

Targeted therapy that can be added to chemotherapy in metastatic NSCLC

Eligibility criteria and warnings:

Nonsquamous histology only

No history hemoptysis (

postprocedure

ok?)No recent history of arterial thrombotic eventNo uncontrolled hypertensionNephrotic syndrome (proteinuria ≥3.5gm)No surgery within 28 daysGastrointestinal perforationNon-gastrointestinal fistula formationReversible posterior leukoencephalopathy syndromeInfusion reactionsOvarian failure

Avastin® prescribing information, 2013.

Slide24

E4599 Trial: Bevacizumab + PC Versus PC Alone

in

First-Line Nonsquamous

NSCLC

Median OS with Bevacizumab + PC was

12.3

months vs 10.3 months for PC alone (P=0.013)PC = paclitaxel + carboplatin.

Sandler et al, 2006; Sandler et al, 2011.

1-year survival:

51% vs 44%

2-year survival:

23% vs 15%

Slide25

PointBreak Trial: Can Regimens Be Combined?

Randomized, open-label, phase III superiority study conducted in US

Pemetrexed 500 mg/m

2

; carboplatin AUC 6; bevacizumab 15 mg/kg

Paclitaxel 200 mg/m

2; carboplatin AUC 6; bevacizumab 15 mg/kg Induction Phase Maintenance Phase q21d, 4 cycles q21d until PD

Inclusion:

No prior systemic therapy for lung cancer

PS 0/1

Stage IIIB-IV

nonsquamous

NSCLC

Stable treated brain metastasized

Exclusion:

Peripheral neuropathy ≥grade 1

Uncontrolled pleural effusions

Pemetrexed

+ Carboplatin

+

Bevacizumab

Pemetrexed

+ Bevacizumab

Paclitaxel

+ Carboplatin+ BevacizumabBevacizumab 450 Patients Each

q21d= every 21 days; PD = progressive disease.

Patel et al, 2012.

R

1:1

Slide26

PointBreak Trial: OS Did Not Differ Between

Treatment

Arms

PointBreak: KM OS From Randomization (ITT)

ITT = intent to

treat; KM = Kaplan

-Meier.Patel et al, 2012.

Slide27

Which Regimen to Choose for First-Line Treatment?

Discuss toxicity profiles of different regimens

Take histology into account

Give patients autonomy to decide

Do they want treatment?

If so, which regimen’s toxicity profile is right for them?

Comorbidities? Diabetes? Coronary artery disease? Renal insufficiency?

Slide28

Maintenance Therapy

If no disease progression after first-line chemotherapy, continue the chemotherapy and/or targeted agent?

We know that in NSCLC continuing platinum chemotherapy past 4 to 6 cycles does not improve survival, just increases toxicity

However, three drugs have shown improvement in PFS in the maintenance setting

NCCN, 2013.

Slide29

E4599 Trial:

Bevacizumab

+ PC Versus PC Alone in

First-Line Nonsquamous NSCLC

Paclitaxel 200 mg/m

2

+ carboplatin AUC=6q3w x 6(no crossover permitted)(n=444)

Bev 15 mg/kg Solution for IV infusionq3w + PC x 6(n=434)

Bev 15 mg/kg IVq3w until disease progression or unacceptable toxicity

Stratified by

Disease stage

Degree of weight loss

Prior radiotherapy

Measurable disease

Primary

end point

OS

Secondary

end points

Response rate,

PFS, toxicity

q3w = every 3 weeks

; IV =

intravenously. Sandler et al, 2006.

First-line treatment of patients with stage IIIB and malignant pleural effusion, stage IV, or recurrent NSCLC (N=878)Continued until progression or unacceptable toxicity

Slide30

Maintenance Pemetrexed

Both studies showed improvement in OS when either switching or continuing on with

maintenance

p

emetrexed after first-line induction platinum-based chemotherapy.

Ciuleanu

et al, 2009; Paz-Ares et al, 2012.

Slide31

PointBreak Trial: Data

Did Not

Favor Either

Maintenance Regimen

Randomized, open-label, phase III superiority study conducted in US

Pemetrexed 500 mg/m

2; carboplatin AUC 6; bevacizumab 15 mg/kgPaclitaxel 200 mg/m2; carboplatin AUC 6; bevacizumab 15 mg/kg Induction Phase Maintenance Phase q21d, 4

cycles q21d until PD

Inclusion:

No prior systemic therapy for lung cancer

PS 0/1

Stage IIIB-IV

nonsquamous

NSCLC

Stable treated brain metastasized

Exclusion:

Peripheral neuropathy ≥grade 1

Uncontrolled pleural effusions

Pemetrexed

+ Carboplatin

+

Bevacizumab

Pemetrexed

+ Bevacizumab

Paclitaxel+ Carboplatin+ BevacizumabBevacizumab 450 Patients Each

Patel et al, 2012.

R

1:1

Slide32

SATURN Trial: Erlotinib Maintenance

IHC =

immunohistochemistry.

Cappuzzo

et al, 2010

.

PD

PD

Mandatory

tumor sampling

4 cycles of

first-line

platinum-based doublet

Chemotherapy-

naive

, advanced NSCLC

N

=

1,949

Non-PD

n

=889

Erlotinib

150 mg/

dn=438Placebon=451SATURN included patients with the following tumor types:Squamous cell carcinomaNonsquamous cell carcinoma (adenocarcinoma, large cell, other)Coprimary end points:PFS in all patients

PFS in patients with EGFR IHC-positive

tumors

Secondary end

points:

OS in all patients and those with EGFR IHC-positive tumors

OS and PFS in EGFR IHC-negative tumors

Safety

Slide33

SATURN Trial: Erlotinib Maintenance

0 3 6 9 12 15 18 21 24 27 30 33 36

12.0 months

median OS

11.0 months

median OS

OS rates

in

the

SATURN

ITT population

at milestone

19% reduction in risk of death

HR = hazard ratio.

Cappuzzo

et al, 2010

.

Time (months)

Overall Survival

Probability

1.0

0.8

0.60.40.20

Erlotinib (n=438)Placebo (n=451)OS in a broad ITT populationHR=0.81 95% CI:0.70-0.95; P=0.0088Median 12.0 months with erlotinib vs 11.0 months with placebo

Slide34

Maintenance Treatment Conclusions

Again, there are options, just like first-line chemotherapy choice

Do patients want a break or wish to continue?

Toxicity profile

Pemetrexed is chemotherapy: potential for lowering of blood counts, requires vitamin supplementation

Bevacizumab and

erlotinib are targeted agents, with the potential for hypertension/cardiac toxicity, rashCost? Should this be an issue?Insurance coverage/denials?

Slide35

Case Study: Biomarker-Positive Patient

Slide36

Ms. LT: History

47-year-old woman who had a cough for

2 months. Antibiotics and antihistamines did not improve her symptoms.

Chest x-ray revealed multiple small masses in bilateral lungs and pleural effusion, confirmed by CT; PET/CT revealed no other disease outside of chest

MRI scan of brain negative for metastatic disease

Slide37

Ms. LT: Diagnostic Evaluation

Pleural fluid positive for adenocarcinoma histology; however, not enough for molecular analysis

Bronchoscopy/

endobronchial

ultrasound performed; able to biopsy

mediastinal lymph node to get more tissue

Molecular testing revealed an exon 19 deletion EGFR mutationPatient is a never smoker with no significant medical history or comorbidities

Slide38

EGFR-Positive NSCLC:

CT

Chest Scan at Diagnosis

Image courtesy of Beth

Eaby

-Sandy, MSN, CRNP, OCN

®

Slide39

Ms. LT: Treatment Considerations

Chemotherapy versus targeted therapy in first-line treatment?

How long did it take to receive the molecular testing results?

Toxicity profiles, how do they differ?

Current approved EGFR tyrosine kinase inhibitors: gefitinib (no longer approved in US), erlotinib, and afatinib

Slide40

EURTAC Trial

First-Line Erlotinib Versus Chemotherapy in EGFR Mutation-Positive NSCLC Patients

Rosell

et al, 2012.

Slide41

Another EGFR Inhibitor

Afatinib

Irreversible pan-EGFR/HER inhibitorA

pproved

in July

2013 for first-line treatment of EGFR

mutation-positive metastatic NSCLCDose is 40 mg daily, orallyYang, Shih et al, 2012.

Slide42

Primary End Point: PFS

Independent

review

‒

All Randomly Assigned Patients

Progression-Free

Survival (probability)1.0

0.80.6

0.4

0.2

0.0

Number at risk

Afatinib 230 180 151 120 77 50 31 10 3 0

Cis/Pem 115 72 41 21 11 7 3 2 0 0

Progression-Free

S

urvival (months)

0 3 6 9 12 15 18 21 24 27

Afatinib

n=230

Cis/pem

n=115

PFS event,

n (%)

152 (66)

69 (60)

Median PFS (months)

11.1

6.9

HR

(95% CI)

0.58

(0.43–0.78)

P

=0.0004

47%

22%

Yang, Schuler et al, 2012; Yang, Shih et al, 2012.

Slide43

Ms. LT: Treatment Selection

The patient is treated with

erlotinib, first line

Dose is 150 mg daily on an empty stomach

Most common toxicities in erlotinib arm:

Papulopustular rash: 80% (grade 3= 13%)

Diarrhea: 57% (grade 3=5%)Fatigue: 57% (grade 3=6%)Anorexia 31% (grade 3=0%)Rosell et al, 2012.

Slide44

Incidence and Severity of Rash

Drug

All Rash Incidence

Grade 3/4 Incidence

Cetuximab

89%

(70% in FLEX trial)

12%

(10% in FLEX trial)

Erlotinib

75%

9%

Gefitinib

Rash: 43%

Acne: 25%

0%

(only reported ≥5%)

0%

Panitumumab

89%

12%

Afatinib

89%

16%

Erbitux

®

prescribing information, 2013

;

Tarceva

®

prescribing information,

2010;

Iressa

®

prescribing information,

2010;

Vectibix

®

prescribing information, 2013;

Yang, Shih et al, 2012.

Slide45

Strategies to Prevent Dermatologic Toxicities: Pre-Emptive

STEPP in metastatic

colorectal

cancer patients who received

panitumumab

-containing regimens

95 total patients:Significant improvement in EGFR rash and quality of life with pre-emptive doxycycline and topical hydrocortisone cream.At 6 weeks, grade ≥2 skin toxicities were reduced by more than 50% in the pre-emptive armSTEPP = Skin Toxicity Evaluation Protocol With Panitumumab.

Lacouture et al, 2010.

Slide46

MASCC

Rash

Prevention and

Treatment

Guidelines

Preventive

(Weeks 1-6,8 of EGFR Inhibitor initiation)

Recommend

Not Recommended

Level of Evidence

Recommendation Grades

Comments

Topical

Hydrocortisone 1% cream with

moisturizer and sunscreen BID

Pimecrolimus

1% cream

Tazarotene

0.05% cream

Sunscreen as single agent

II

a

C

Doxycycline is preferred in patients with renal impairment. Minocycline is less photosensitizing.SystemicMinocycline 100 mg dailyDoxycyline 100 mg BIDTetracycline 550 mg BIDIIaATopicalAlclometasone 0.05% creamFluocinonide 0.05% cream BIDClindamycin 1%Vitamin K1 Cream

IV

a

C

Fluocinonide

0.05% cream BID should not be used on the face for more than 2 weeks at a time.

Systemic

Doxycycline

100 mg BID

Minocycline

100 mg daily

Isotretinoin

at low doses (20-30 mg/d)

Acitretin

IV

a

C

Isotretinoin

is photosensitizing and can cause

xerosis

. Monitor lipids and liver enzymes with retinoids.

a

EGFR

inhibitor study. MASCC = Multinational Association of Supportive Care in Cancer. BID = twice daily.

Lacouture

et al, 2011.

Slide47

Mild Rash

Image courtesy of Beth

Eaby

-Sandy, MSN, CRNP, OCN

®

Slide48

Moderate Rash

Image courtesy of Beth

Eaby

-Sandy, MSN, CRNP, OCN

®

Slide49

Severe Rash

Image courtesy of Beth

Eaby

-Sandy, MSN, CRNP, OCN

®

Slide50

Other Cutaneous Toxicities

Alopecia/scalp rash

Paronychia

Hypertrichosis

Fissures

Images courtesy of Beth

Eaby

-Sandy, MSN, CRNP, OCN®

Slide51

Case Study: Older Adult With NSCLC

Slide52

Mr. PD: History

Patient is an 80-year-old fit man who developed increased shortness of breath and cough during the past 6 months, though hemoptysis is what led him to the emergency department

CT scan of the chest reveals a large, central lung mass as well as adrenal metastases

He is a lifelong cigarette smoker, 1 pack per day

CT-guided needle biopsy reveals squamous cell NSCLC

Slide53

Mr. PD: Diagnostic Evaluation

Brain MRI scan shows a single brain metastasis 1.5 cm, for which he undergoes stereotactic brain radiation

Patient presents to oncology office to decide about treatment options for his cancer

Patient has a supportive wife and daughter; he still plays golf once a week and bridge with his friends on Wednesday nights

Slide54

Incidence of NSCLC in the US by Age at Diagnosis

Langer et al, 2010; SEER Data

1975-2002.

Slide55

Mr. PD: Treatment Considerations

Chemotherapy has survival advantage over best supportive care for the fit elderly

Patient would like to maintain ability to play golf and bridge and spend time with grandchildren

Chemotherapy with platinum-based doublet is an option for him

What can we give him that can maintain quality of life and yet give him chance for increased survival? Famil

y

wants him to pursue treatment.NCCN, 2013.

Slide56

IFCT-

0501:

Weekly PC Doublet Superior to

Single

-Agent Chemotherapy

Overall survival (ITT)

MST = median survival time.Quoix et al, 2011.

Slide57

Which Treatment Regimen to Use?

Toxicity was similar in both arms

Weekly paclitaxel/carboplatin a reasonable treatment option for elderly patients based on 2011 trial data

More recent study examined weekly

nab

-paclitaxel/carboplatin

versus paclitaxel/carboplatin every 3 weeksQuoix et al, 2011.

Slide58

0.75

Probability of Survival

0.50

0.00

3

0

95% Cl:0.388-0.875

HR=0.583

10.4 months

19.9 months

P

=0.009

9

6

15

18

21

24

12

0.25

1.00

nab

-PC (n=74)

sb

-PC (n=82)

Kaplan

-Meier Curve of Overall Survival in Patients

≥70 Years

In elderly patients, a

nonsignificant

trend toward improved PFS (8.0 vs 6.8 months;

HR=0.687; 95% CI:0.420-1.123;

P

=0.134)

A significant improvement in

OS was

observed with

nab

-PC vs

sb

-PC

In patients <70 years of age, there was no difference in PFS or OS

nab

-Paclitaxel in Elderly Patients

sb

-PC = subcutaneous paclitaxel.

Socinski

et al, 2013.

Months

Slide59

Populations That Benefited Most

North America

Elderly (age ≥70)

Squamous histology

Socinski

et al, 2013.

Slide60

n

ab

-PC

sb-PC

C2

BL

FACT Subscore: Mean Baseline Score or Mean Change

From Baseline

C3

C4

C5

C6

C7

C8

Final

Peripheral Neuropathy

C2

BL

C3

C4

C5

C6

C7

C8

Final

Pain in Hands/Feet

FACT Subscore: Mean Baseline Score or Mean Change from Baseline

FACT-Taxane Results in Patients ≥70 Years

Socinski

et al, 2013.

Neuropathy in Elderly Patients in

nab

-Paclitaxel Study

Slide61

Management of CIPN

Complicating

comorbidities

, are they under control?

Assessment: FACT-Taxane?

DTRs

? Vibration testing? Neurological consult for electromyography?Several studies evaluating agents such as nortriptyline, amitriptyline, gabapentin, and lamotrigine have not shown a benefit, though these agents are often used in clinical practiceDuloxetine is the only agent shown to diminish CIPN in a phase III trial

DTRs = deep tendon reflexes; CIPN = chemotherapy-induced peripheral neuropathy.Eaby-Sandy, 2013.

Slide62

Patient Education Challenges

Explaining targeted therapy versus chemotherapy

Adherence to oral therapies

Cost, Medicare “donut hole”

Over-adherence vs under-adherence

Increased clinic visitsPhone call support

Logging, pillboxesEducation on side-effect managementNeuss et al, 2013.

Slide63

Key Takeaways

Treatment strategies for advanced NSCLC continue to evolve: maintenance, more aggressive treatment for elderly patients

Toxicity profiles can vary significantly depending on selected agent(s)

Oncology nurses play an important role in monitoring for and managing toxicities, as well as providing patient education

Slide64

References

Alimta

®

(

pemetrexed) prescribing information (2012). Eli Lilly and Company.

American Cancer Society (2013). American Cancer Society: Cancer facts & figures 2013. Atlanta.

Avastin® (bevacizumab) prescribing information (2013). Genentech USA, Inc. Camidge DR, Bang YJ, Kwak EL, et al (2012). Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol, 13(10):1011-1019.Cappuzzo F, Ciuleanu T, Stelmakh L, et al (2010). Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicenter, randomized, placebo-controlled phase 3 study. Lancet

, 11(6):521-529.Capuzzo F, Marchetti A, Skokan M, et al (2009). Increased MET gene copy number negatively affects survival of surgically resected non-small-cell lung cancer patients. J Clin Oncol, 27(10):1667-1674

.Ciuleanu T, Brodowicz T, Zielinski C, et al (2009). Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet, 374(9699):1432-1440.

Eaby

-Sandy B (2011).

Cancer Nursing:

Principals and Practice

. Jones and Bartlett Publishers. Sudbury, Massachusetts.

Eaby

-Sandy B, Ko A, Renschler

et al (2013).

Efficacy and toxicity profile of

nab

-paclitaxel in patients with advanced

non-small

cell lung cancer (NSCLC): nursing implications and management strategies

. Poster presented at Oncology Nursing Society 38th Congress in Washington, DC

.Erbitux® (cetuximab) prescribing information (2013). New York, NY: ImClone Systems, Inc and Princeton, NJ: Bristol-Myers Squibb Co.Fukuoka M, Wu YL, Thongprasert S, et al (2011). Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol, 29(21):2866-2874.

Slide65

References

Hirsch

FR (2012). Recent advances in biomarker research in lung cancer with special reference to new targeted therapies. Presented at: 13th International Lung Cancer Congress; July 19-22, 2012; Huntington Beach, CA.

Iressa

®

(gefitinib) prescribing information (2010). Wilmington, DE: AstraZeneca Pharmaceuticals LP.Lacouture ME, Anadkat MJ, Bensadoun RJ, et al (2011). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer, 19(8):1079-1095.Lacouture ME, Mitchell EP, Piperdi B, et al (2010). Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin

Oncol, 28(8):1351-1357.Langer CJ, Besse B, Gualberto A, et al (2010). The evolving role of histology in the management of advanced non-small cell lung cancer. J Clin Oncol,

28(36):5311-5320.National Comprehensive Cancer Network (NCCN) (2013). Clinical practice guidelines in oncology. Non-small cell lung cancer. V.2.2013. Available at http://www.nccn.org.Neuss MN, Polovich M, McNiff K, et al (2013). 2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy. J

Oncol

Practice,

9(Suppl):5S-13S

.

Paz

-Ares L, de

Marinis F, Dediu M, et al (2012). Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3,

randomised

controlled trial.

Lancet

Oncol

,

13(3):247-255.

Slide66

References

Quoix

E,

Zalcman

G, Oster JP, et al (2011). Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501

randomised

, phase 3 trial. Lancet, 378(9796):1079-1088.Rodriguez E, Lilenbaum RC (2008). New treatment strategies in patients with advanced non-small-cell lung cancer and performance status 2. Clin Lung Cancer, 9(6):326-330. Rosell R, Carcereny E, Gervais R, et al (2012). Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre

, open-label, randomised phase 3 trial. Lancet Oncology, 13(3):239-246.Sandler A, Graham C, Baggstrom M, et al (2011). An open-label, multicenter, three-stage, phase II study of s-1 in combination with cisplatin as first-line therapy for patients with advanced non-small cell lung cancer. J Thoracic

Oncol, 6(8):1400-1406.Sandler A, Gray R, Perry MC, et al (2006). Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med, 355(24):2542-2550.Patel JD, Socinski

MA,

Garon

EB, et al (2012).

A randomized, open-label

,

phase

III, Label, Phase III, superiority study of pemetrexed (Pem) +

carboplatin (

Cb

) +

bevacizumab (

Bev)

followed

by

maintenance Pem + Bev versus paclitaxel (Pac) Cb + Bev followed by maintenance Bev in patients with sage IIIB or IV non-squamous non-cmall cell lung cancer (NS-NSCLC). Available at: http://www.thoracicsymposium.org/MeetingProgram/documents/PLPatel.pdf.Scagliotti GV, Novello S (2003). Pemetrexed and its emerging role in the treatment of thoracic malignancies. Expert Opin Investig Drugs, 12(5):853-863.

Slide67

References

Scagliotti

GV, Parikh P, von Pawel

J, et al (2008). Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage nonsmall-cell lung cancer

. J

Clin

Oncol, 20;26(21):3543-3551.Schiller JH, Harrington D, Belani CP, et al (2002). Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med, 346(2):92-98.Socinski MA, Langer CJ, Okamoto I, et al (2013). Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-smallvcell lung cancer.

Ann Oncol, 24(2):314-321.Tarceva® (erlotinib) [prescribing information] (2010). Melville, NY: OSI Pharmaceuticals, Inc.Temel JS, Greer JA,

Admane S, et al (2011). Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 29(17):2319-2326.Temel JS, Greer JA, Muzikansky

A, et al (2010). Early palliative care for patients with metastatic non-small cell lung cancer.

N

Engl

J Med,

363(8):733-742.

Vectibix

® (

panitumumab

) prescribing information] (2013). Thousand Oaks, CA: Amgen, Inc.

Yang JC, Schuler MH, Yamamoto N, et al (2012). LUX-Lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations.

J

Clin

Oncol

, 30(18 Suppl). Abstract LBA7500.Yang JC, Shih JY, Su WC, et al (2012). Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol, 13(5):539-548.