Mario E. Lacouture, MDAssociate AttendingDepartment of MedicineMemorial Sloan-Kettering Cancer CenterNew York, New York
EGFR Inhibitor–Related Dermatologic Toxicities: Applying MASCC Guidelines in Prevention and Treatment
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Faculty
Mario E. Lacouture, MD Associate AttendingDepartment of MedicineMemorial Sloan-Kettering Cancer CenterNew York, New York
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Faculty Disclosures
Mario E. Lacouture, MD, has disclosed that he has received consulting fees from Advanced Cell Technology, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Genzyme, GlaxoSmithKline, ImClone, Lilly, Onyx, OSI, Pfizer, Roche, and Wyeth.
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Thymidylate Synthase
Grb2
Ras
Sos
Raf
Mek
Erk
Targeting Tumors
Survival, proliferation,
invasion/motility
EGFR
TGFα
Roberts PJ, et al. Oncogene. 2007;26:3291-3310. Montagut C, et al. Cancer Letters. 2009;283:125-134.
EGFR overexpressed
– CRC: 27% to 77%; pancreatic: 30% to 50%; lung: 40% to 80%; NSCLC: 14% to 91%
EGFR mutated
– NSCLC: 10%; glioblastoma: 20%
Ras mutated
– Pancreatic: 90%; papillary thyroid: 60%; colon: 50%; NSCLC: 30%
Raf mutated
– Melanoma: 70%; papillary thyroid: 50%; colon: 10%
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And Targeting the Skin
1.6 million people diagnosed each yr
– Prior to therapy, 45.1% with skin findings (N = 700)
– Tinea pedis/onychomycosis, xerosis, pruritus, pyoderma
Consequences of dermatologic conditions
– Psychosocial impact
– Financial burden
– Physical health
– Anticancer treatment disruptionKiliç A, et al. Int J Dermatol. 2007;46:1055-1060. Lacouture ME. Nat Rev Cancer. 2006;6:803-812.
Eye/eyelashabnormalities
Periungual/nail
alterations
Hair loss
Papulopustularrash
Xerosis/pruritus
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EGFR in Skin
EGFR is constitutively expressed in the epidermis, follicle, sebaceous, eccrine glands, dendritic APCs
EGFR inhibition leads to negative effects in skin – Apoptosis, inflammation, atrophy, telangiectasias, ↓ photoprotection
EGFR
Lacouture ME. Nat Rev Cancer. 2006;6:803-812. Busam KJ, et al. Br J Dermatol. 2001;144:1169-1176.
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Timing of EGFR Inhibitor–Associated Dermatologic Toxicities
Van Cutsem E. Oncologist. 2006;11:1010-1017. Lacouture ME, et al. J Clin Oncol. 2010;28:1351-1357.Scope A, et al. J Clin Oncol. 2007;25:5390-5396.
Wk of EGFR-Targeted Therapy
Acne-like rash Postinflammatory effects
Dry skin
FissureParonychia
1 2 3 4 5 6 7 8 9
Pruritus
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Prevention and Treatment of EGFR Inhibitor–Assoc. Dermatologic ToxicitiesLevels of Evidence
Level I evidence is reserved for meta-analyses of randomized controlled trials or randomized trials with high power
Level II evidence includes randomized trials with lower power
Level III evidence includes nonrandomized trials, such as cohort or case-controlled series
Level IV evidence includes descriptive and case studies
Level V evidence includes case reports and clinical examples
Recommendation Grades
Grade A is reserved for level I evidence or consistent findings from multiples studies of level II, III, or IV evidence
Grade B is for level II, III, or IV evidence with generally consistent findings
Grade C is similar to grade B but with inconsistencies
Grade D implies little or no evidence
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
EGFR Inhibitor–Induced Rash Red papulopustules[1]
– Pruritus, tenderness in 62% Erlotinib 150 mg QD[2]
– All grade: 75%
– Grade 3: 9% Cetuximab[3]
– All grade: 85%
– Grade 3: 10% Panitumumab[4]
– All grade: 90%
– Grade 3: 16% Lapatinib[5]
– All grade: 27%
– Grade 3: 1%
1. Lacouture ME, et al. Br J Dermatol. 2006;155:852-854.2. Shepherd FA, et al. N Engl J Med. 2005; 353:123-132.3. Rosell R, et al. Ann Oncol. 2008;19:362-369.4. Van Cutsem E, et al. J Clin Oncol. 2007;25:1658-1664.5. Geyer CE, et al. N Engl J Med. 2006;355:2733-2743.
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
1. Lacouture ME, et al. Br J Dermatol. 2006;155:852-854.2. Shepherd FA, et al. N Engl J Med. 2005; 353:123-132.3. Rosell R, et al. Ann Oncol. 2008;19:362-369.4. Van Cutsem E, et al. J Clin Oncol. 2007;25:1658-1664.5. Geyer CE, et al. N Engl J Med. 2006;355:2733-2743.
EGFR Inhibitor–Induced Rash Red papulopustules[1]
– Pruritus, tenderness in 62% Erlotinib 150 mg QD[2]
– All grade: 75%
– Grade 3: 9% Cetuximab[3]
– All grade: 85%
– Grade 3: 10% Panitumumab[4]
– All grade: 90%
– Grade 3: 16% Lapatinib[5]
– All grade: 27%
– Grade 3: 1%
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QoL[1] Cost[2]
Impact of EGFR Inhibitor Dermatologic Toxicities on QoL and Cost
Survey of 58 patients with Skindex-16
Top domain: emotions (P < .05)
Inverse corr age-emotions (r = -0.26; P = .03)
Mean cost/pt: $2788
Med
ian
Ove
rall
Ski
nd
ex-1
6 S
core
NCI-CTCAE v3.0 Papulopustular Rash Grade
100
40
80
60
20
01 2 3
Drugs
Clinic Visits
Lab Tests
Procedures
1. Joshi SS, et al. Cancer. 2010;116:3916-3923. 2. Borovicka JH, et al. ASCO 2010. Abstract 3569.
Avg
. Co
st/P
t fo
r M
anag
emen
t o
f E
GF
R
Inh
ibit
or
Der
mat
olo
gic
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xici
ties
($) 1497
862
338
91
0
200
400
600
800
1000
1200
1400
1600
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Impact of EGFR Inhibitor Skin Toxicity on Oncologists Survey of 110 oncology practices, 51 questions on EGFR
inhibitor rash
Per
cen
tag
e o
f R
esp
on
der
s w
ho
Ob
serv
e In
dic
ated
Ras
h
Gra
de
in >
50%
of
Pat
ien
ts
Wit
h R
ash
Dose reduction: 60%Dose interruption: 76%
Drug discontinuation: 32%
Boone SL, et al. Oncology. 2007;72:152-159.
Rash CTCAE Grade
Grade 1 Grade 2 Grade 3 Grade 4
40
30
20
10
0
39
34
4 3
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Vincenzi 2006[1]
P = .06
Saltz 2004[2]
P = .02
Hecht 2007[3]
HR: 0.72; 95% CI: 0.54-0.97 Grade 0-1Grade 2-4
Grades 0-2Grade 3
Grade 0Grade 3
Median OS (Mos)0 5 10
Cetuximab
Cetuximab
Panitumumab
Ras
h G
rad
e
Correlation: Rash and Survival/Response in CRC
1. Vincenzi B, et al. Br J Cancer. 2006;94:792-797. 2. Saltz LB, et al. J Clin Oncol. 2004;22:1201-1208. 3. Hecht JR, et al. Cancer. 2007;110:980-988.
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Tazarotene and Minocycline for Rash Prevention
Cetuximab therapy for CRC
2 mos
Total lesion count each side of face
Randomize
Daily Placebo
(N = 24)
0.05% tazarotene cream daily to left
half of face(n = 12)
0.05% tazarotene cream daily to right
half of face(n = 12)
Minocycline 100 mg/day
(N = 24)
0.05% tazarotene cream daily to left
half of face(n = 12)
0.05% tazarotene cream daily to right
half of face(n = 12)
18 Analyzed 17 Analyzed
Scope A, et al. J Clin Oncol. 2007;25:5390-5396.
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Minocycline for Rash Prevention: Total Lesion Counts
Prophylaxis with minocycline results in decreased severity of rash in first mo of cetuximab therapy
There was no difference with tazarotene treatment
Scope A, et al. J Clin Oncol. 2007;25:5390-5396.
7
6
5
4
3
2
1
0
Lo
g-T
ota
l Les
ion
Co
un
t
Study Wk1 2 4 8
MinocyclinePlacebo
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Lacouture ME, et al. J Clin Oncol. 2010;28:1351-1357.
STEPP Study: Preemptive vs Reactive Skin Toxicity Treatment in Metastatic CRC Open‑label phase II study
Prophylactic skin treatment regimen administered Wks 1-6 (beginning Day 1)
– Skin moisturizer
– Sunscreen (PABA free, SPF ≥ 15, UVA/UVB protection)
– Topical steroid (1% hydrocortisone cream)
– Doxycycline 100 mg BID
Per investigator discretion, reactive skin treatment administered anytime during Wks 1-6
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STEPP: Dermatologic Toxicities
0
5
10
15
20
25
Dermatitis Acneiform Pruritus Pustular Rash Paronychia
Prophylactic skin treatment
Reactive skin treatment
Gra
de
3 T
oxi
cit
y (
%)
Prophylactic (n = 48)
Reactive (n = 47)
Patients with grade 2 or higher skin toxicity, n (%) 14 (29) 29 (62)
OR (95% CI) 0.3 (0.1-0.6)
Lacouture ME, et al. J Clin Oncol. 2010;28:1351-1357.
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Case 1
The patient is a 48-yr-old man with colorectal cancer that is EGFR positive and KRAS wild type. You opt to initiate treatment with cetuximab plus irinotecan
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A. Topical hydrocortisone 1% cream with sunscreen and moisturizer twice daily
B. Topical tazarotene 0.05% cream daily
C. Systemic tetracycline
D. Systemic minocycline or doxycycline
Based on the MASCC guidelines, which of the following strategies do you recommend for this pt to prevent acneiform rash during the first 1-6 wks of cetuximab therapy?
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
A. Topical hydrocortisone 1% cream with sunscreen and moisturizer twice daily (level II, grade C)
B. Topical tazarotene 0.05% cream daily
C. Systemic tetracycline
D. Systemic minocycline or doxycycline (level II, grade A)
– Doxycycline is preferred in patients with renal impairment
– Minocycline is less photosensitizing and thus preferred in areas that have a high UV index
Based on the MASCC guidelines, which of the following strategies do you recommend for this pt to prevent acneiform rash during the first 1-6 wks of cetuximab therapy?
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Acneiform Rash Management RecommendationsPreventive Recommended Not
RecommendedLevel of
EvidenceRecommend-ation Grades
Comments
TopicalHydrocortisone 1% cream with moisturizer, sunscreen twice
daily
Pimecrolimus 1% cream
Tazarotene 0.05% cream
Sunscreen as single agent
II* C
Systemic Minocycline 100 mg/day Doxycycline 100 mg BID
Tetracycline 500 mg BID
II* A Doxycycline is preferred in patients
with renal impairment; minocycline is less photosensitizing
Treatment Recommend Not Recommended
Level of Evidence
Recommend-ation Grades
Comments
TopicalAlclometasone 0.05% cream
Fluocinonide 0.05% cream BIDClindamycin 1%
Vitamin K1 cream
IV* C
Systemic Doxycycline 100 mg BID Minocycline 100 mg/day Isotretinoin at low doses
(20-30 mg/day)
Acitretin IV* C Photosensitizing agents
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.
*EGFR inhibitor study.
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Additional Dermatological Toxicities to EGFR Inhibitors: Xerosis Patients receiving EGFR inhibitors
> 6 mos (n = 16)
– Range on therapy (6-27 mos)
– Cutaneous toxicities in 100%
– Dose mod in 37.5%
Symptom, n (%) Any Grade
Xerosis 16 (100)
Paronychia 9 (56)
Alopecia 6/12 (50)
Hair Modifications 14 (87.5)
Xerotic Dermatitis
Fissures
Lacouture ME, et al. Br J Dermatol. 2006;155:852-854. Mitchell EP, et al. Oncology (Williston Park). 2007;21(11 suppl 5):4-9. Osio A, et al. Br J Dermatol. 2009;161:515-521.
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Case 2
A 68-yr-old woman has been receiving maintenance erlotinib monotherapy for the treatment of metastatic non-small-cell lung cancer that responded to 4 cycles of first-line chemotherapy. Eight wks after initiating erlotinib, she presents with moderate xerosis on her back and shoulders
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Case 2: Moderate Xerosis
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Based on the MASCC guidelines, which of the following strategies do you recommend to treat this pt’s xerosis?A. Benzoyl peroxide
B. Fragrance-free, occlusive, emollient creams packaged in a jar/tub
C. Alcohol-based lotions that can be pumped
D. Topical retinoids
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Based on the MASCC guidelines, which of the following strategies do you recommend to treat this pt’s xerosis?A. Benzoyl peroxide
B. Fragrance-free, occlusive, emollient creams packaged in a jar/tub (level III, grade B)
C. Alcohol-based lotions that can be pumped
D. Topical retinoids
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Xerosis Management Recommendations
Preventive Recommended Not Recommended
Level of Evidence
Recommend-ation Grades
Comments
Topical Bathing techniques using bath oils or mild moisturizing soaps
and bathing in tepid waterRegular moisturizing creams
III B
Other Avoid extreme temperatures and direct sunlight
III* B
Treatment Recommended Not Recommended
Level of Evidence
Recommend-ation Grades
Comments
Topical (mild/moderate)
Emollient creams that are packaged in a jar/tub that lack fragrances or potential irritantsOcclusive emollients containing urea creams, colloidal oatmeal, and petroleum-based creams For scaly areas, ammonium lactate or lactic acid cream
Alcohol-containing
lotionsRetinoids or
benzoyl peroxide
III B More greasy creams for use on the limbs,
but caution use of greasy
creams on the face and chest
Topical (severe)
Medium- to high-potency steroid creams
III B
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.
*EGFR inhibitor study.
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Fissure Recommendations
Preventive Recommended Not Recommended
Level of Evidence
Recommendation Grades
Comments
Topical Wear protective footwear and avoid friction with fingertips, toes, and heels
III B
Treatment Recommended Not Recommended
Level of Evidence
Recommendation Grades
Comments
Topical Thick moisturizers or zinc oxide (13% to 40%) creams
Liquid glues or cyanoacrylate to seal cracks
Steroids or steroid tape, hydrocolloid dressings, topical antibiotics
Bleach soaks to prevent infection
Zinc oxide
III*† B Cream application
often impractical
*EGFR inhibitor study.†Non–EGFR inhibitor cancer treatment study.
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.
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Pruritus
Pruritus
– In 30% to 50%
– Decreased QoL
– Sleep deprivation
– Scratching and secondary infections
Haley AC, et al. Support Care Cancer. 2011;19:545-554.
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Preventive Recommended Not Recommended
Level of Evidence
Recommend-ation Grades
Comments
Topical Gentle skin care instructions IV*† D Consensus of experts
Systemic Steroids IV*† D Consensus of experts
Treatment Recommended Not Recommended
Level of Evidence
Recommend-ation Grades
Comments
Topical Menthol 0.5% pramoxine, 1% doxepin Medium- to high-potency steroids
(triamcinolone acetonide 0.025%;, desonide 0.05%, fluticasone propionate 0.05%, alclometasone 0.05%)
III† B Treat underlying condition first (rash, xerosis)
Topical Antihistamines,lidocaine
II† C These agents can become allergens and can be
absorbed systemically
Systemic Antihistamines† I‡ A Nonsedating first; some may need adjustment for
renal impairment
Systemic Aprepitant* V* D
Systemic Gabapentin/pregabalin* V*† D Recommended as second-line treatment only
if antihistamines fail
Systemic Doxepin V* D
Pruritus Recommendations
*EGFR inhibitor study.†Non–EGFR inhibitor noncancer treatment study.‡Non-EGFR inhibitor cancer treatment study.
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Symptom, n (%) Any Grade
Xerosis 16 (100)
Paronychia 9 (56)
Alopecia 6/12 (50)
Hair modifications 14 (87.5)
Additional Dermatologic Toxicities to EGFR Inhibitors: Paronychia Patients receiving EGFR inhibitors
> 6 mos (n = 16)
– Range on therapy (6-27 mos)
– Cutaneous toxicities in 100%
– Dose mod in 37.5%
Lacouture ME, et al. Br J Dermatol. 2006;155:852-854. Mitchell EP, et al. Oncology (Williston Park). 2007;21(11 suppl 5):4-9. Osio A, et al. Br J Dermatol. 2009;161:515-521.
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Case 3
A 40-yr-old woman has been receiving panitumumab for the treatment of colorectal cancer. After 4 mos, she developed paronychia and periungual granulation tissue in her fingernails, which limits self-care activities of daily living
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Case 3: Paronychia and Periungual Granulation Tissue
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Based on the MASCC guidelines, which of the following strategies do you recommend to treat this pt’s paronychia?
A. Clobetasol ointment daily
B. Obtain bacterial cultures
C. Cephalexin therapy for 10 days
D. Nail avulsion
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Based on the MASCC guidelines, which of the following strategies do you recommend to treat this pt’s paronychia?
A. Clobetasol ointment daily (level II, grade A)
B. Obtain bacterial cultures (level IV, grade D)
C. Cephalexin therapy for 10 days
D. Nail avulsion (level IV, grade D)
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Preventive Recommended Not Recommended Level of Evidence
Recommend-ation Grades
Comments
TopicalDilute bleach baths
Avoid irritantsII* A Recommend final
concentration of ~ 0.005%‡
Treatment Recommended Not Recommended Level of Evidence
Recommend-ation Grades
Comments
TopicalCorticosteroids
Calcineurin inhibitors
AntifungalsAntibiotics
II* A Recommend usage of ultrapotent topical steroids as first-line therapy given
cost and availability of these agents
Systemic TetracyclinesAntimicrobials:
reserved for culture proven infectionBiotin for brittle
nails
Empiric antibiotics, employed without
culturing lesional skinAntifungals
IV†/II*
III*
D/A
B
Other Silver nitrate chemical
cauterization wklyElectrodessication
Nail avulsion
IV* D Reserved for pyogenic granulomata;
consensus of experts
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.*Non-EGFR inhibitor noncancer treatment study. †EGFR inhibitor study. ‡Dilution: ~ 1/4-1/8 cup 6% bleach for 3-5 gal water.
Paronychia Management Recommendations
clinicaloptions.com/oncologyEGFR Inhibitor–Related Dermatologic Toxicities
Trichomegaly
Alopecia
Hirsutism
Corneal Erosion
Additional Dermatologic Toxicities With EGFR Inhibitors: Hair Changes Pts receiving therapy > 3 mos
– Scalp alopecia and hair curling
– Hirsutism on face
– Eyelash trichomegaly
Lacouture ME, et al. Br J Dermatol. 2006;155:852-854. Roe E, et al. J Am Acad Dermatol. 2006;55:429-437. Vano-Galvan S, et al. J Am Acad Dermatol. 2010;62:531-533. Kerob D, et al. Arch Dermatol. 2006;142:1656-1657. Foerster CG, et al. Cornea. 2008;27:612-614.
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Hair Changes Recommendations
Recommended Not Recommended
Level of Evidence
Recommend-ation Grades
Comments
Preventive hair loss
Topical For scarring alopecia, follow rash recommendations
Preventive interventions for nonscarring alopecia
V D
Systemic For scarring alopecia, follow rash recommendations
Preventive interventions for nonscarring alopecia
V D
Treatment for hair loss
Topical Nonscarring • Minoxidil 2%, 5% BID
Scarring • Class 1 steroid lotion,
shampoo, or foam• Antibiotic lotion
I*/II/III/IV† B/D Consensus of experts
Preventive increased hair
Patient education and support IV B Consensus of experts
Treatment for increased hair
Facial hypertrichosis
Eflornithine Lasers
Waxing, chemical depilatories
IV,† II* B Consensus of experts
Eyelash trichomegaly
Eyelash trimmings regularly IV B
*Non–EGFR inhibitor noncancer treatment study.†EGFR inhibitor study.
Lacouture ME, et al. Support Care Cancer. 2011;19:1079-1095.
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Eilers RE, et al. J Natl Cancer Inst. 2010;102:47-53. Hill A, et al. Am J Clin Oncol. 2004;27:361-363.
Enterococcal Cellulitis
Radiation Dermatitis ImpetigoDermatologic Infections With EGFR Inhibitors S aureus infection in grade 3/4 radiation
dermatitis EGFR inhibitor treated pts: 38% with
infections– Severe radiation dermatitis: 10/14
S aureus+
In oncology, SSTI may result in bacteremia
– Skin and mucosa entry in 64%; 16% mortality
Analysis conducted of 221 pts treated with EGFR inhibitors
– 38% with bacterial, viral, fungal
– Higher risk in leukopenic patients (P < .05)
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Conclusions
Skin toxicities during EGFR inhibitor therapy are amenable to study and treatment
Early/proactive approach toward toxicities is advisable
Characterization of dermatologic toxicities will increase in importance
– Adjuvant setting
– Dose escalation and combination studies
– Longer survival
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