Practical Grading System for Evaluating Cisplatin ...€¦ · Dept of Audiology. Article: Chang,...
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Practical Grading System for Evaluating Cisplatin Ototoxicity in Children
K30 Journal Article ReviewDenise Nicholson, Au.D., Ph.D. candidateSenior AudiologistDept of Audiology
Article: Chang, K.W. & Chinosornvatana, N. (2010). Practical Grading System
for Evaluating Cisplatin Ototoxicity in Children. Journal of Clinical Oncology, 28 (10), 1788-1795.
Background Article Clinical applications/future research
Background
Cisplatin is used in the treatment of several childhood malignancies.
Improvement in long-term survival has made the monitoring of long-term side effects more important.
Nephrotoxicity and high frequency hearing loss are the most notable adverse effects of cisplatin in children
Brock et. al (1991)
Audiometry Types of hearing loss◦ Conductive (CHL)- a hearing loss resulting from
something affecting the outer or middle ear.◦ Possible causes include:
Cerumen impaction Serous otitis media Tumor
◦ Sensorineural (SNHL)- A permanent type of hearing loss that may be congenital, due to inner ear or auditory nerve damage, and may be the result of noise exposure, genetics, or ototoxic medications.
May affect certain frequencies more than others May cause distorted sound quality Severity can range from mild to profound May be late onset, stable, or progressive in nature
◦ Mixed – Combination of CHL and SNHL
Implications of HFHL in Children
Unable to hear certain speech sounds
Distortion Speech
understanding in noise
phonics (reading)
Normal Hearing and Degrees of HL
http://helpkidshear.org/resources/starter/degrees.htm
Difficulties Testing Children Age dependent test
procedures Bedside audiograms◦ Background noise◦ Not up to the task
Limited attention span Sedated ABRs & other
objective measures can be utilized
Chang & Chinosornvatana (2010)
Purpose:◦ Present a new ototoxicity grading system,
with clearly defined audiometric criteria.◦ Validation of the grading system Correspondence to audiology treatment
recommendations Compared with currently utilized Common
Terminology Criteria for Adverse Events (CTCAE)
CTCAE Pediatric Grading Scale Based on 1,2,3,4,6, & 8 kHz Grade 1◦ Threshold shift >20dB at 8kHZ in at least 1 ear
Grade 2◦ Threshold shift >20dB at 4kHz and above in at least 1 ear
Grade 3◦ HL sufficient to indicate therapeutic intervention including
hearing aids◦ Threshold shift >20dB at 3kHz and above in at least 1 ear◦ Speech and language svcs indicated
Grade 4◦ Audiologic indication of cochlear implant◦ Speech and language svcs indicated
Brock Pediatric Grading Scale
Bilateral Hearing Loss Grade
< 40 dB at all frequencies 0
≥ 40 dB at 8kHz only 1
≥ 40 dB at 4kHz and above 2
≥ 40 dB at 2kHz and above 3
≥ 40 dB at 1kHz and above 4
Brock et. al (1991)
Patients 134 pediatric patients Received cisplatin or carboplatin◦ Audiologic evaluation performed during 105
(70.5%) of 149 treatment courses◦ 90 had audiograms measured after @ least one
dose of cisplatin or carboplatin◦ 81 received cisplatin, of which, 67 received
cisplatin as their only primary ototoxicchemotherapeutic agent◦ 14 – cisplatin & carboplatin◦ 9 – carboplatin only
Methods
Retrospective chart review◦ Audiologic ◦ Demographic◦ clinical
computerized patient charting database was used to collect:◦ Treatment course data◦ Process measures◦ Audiologist recommendations
Audiologist Recommendations
Hearing Aid◦ Makes certain sounds louder◦ Programming is based on individual’s freq
specific hearing thresholds◦ Limitations Output (especially in the high freqs)
FM system◦ Ideal for children with minimal hearing loss◦ Most often used in classroom setting only
Audiologic Grading
Serial behavioral audiograms (ear specific in all but 7 patients)
Audiograms were graded in a blinded manner (w/out knowledge of tx regimen or clinical hx)
All audiograms assigned CTCAE, Brock, & Chang grades.
Audiologic Grading Continued
CTCAE subjective criteria were not used in order to keep the grading blinded◦ HL at 25-90 dB was averaged at 3 contiguous
frequencies
Chang grading scale – modified version of Brock scale◦ Meant to incorporate functional deficits
caused by HL < 40dB
Chang vs Brock
Chang 2b, Brock 0, CTCAE 3
Data Analysis Linear regression◦ Used to test the relationship between
audiogram-based ototoxicity grades and the following factors: Delivery volume Mannitol usage Dextrose usage Tx length Cumulative and daily cisplatin dosage Patient age patient body-surface area (BSA)
Data Analysis continued
One-tailed, two-sample Mann-Whitney U test was used to assess mannitol usage, comorbidity, radiotherapy coadministration, and metastatic status.
Pearson x squared values were used to test the interaction btwn audiogram-based ototoxicity grades and the final recommendations made by audiologists
Results
No significant difference in mean grade among the different diagnoses (P=.357), using univariate analysis of variance.
Patients with higher Chang grades had higher chance of requiring a HA or FM system
Results: Demographics & Clinical Characteristics
Results continued
Results continued
Results continued
Take home message
Both the Chang and CTCAE grades from audiogram scoring were significantly related to the audiologists’ recommendations (FM or HA use)
Chang scale was more specific than the CTCAE scale
Patients receiving combination radiation therapy, lower BSA, and patients with metastatic disease had higher grades
Limitations of the Study
Retrospective analysis Ear specific data not available on each
patient More treatment options besides FM
systems and hearing aids Audiologist recommendations are based
on various factors Uneven comparison groups
Clinical Considerations/Use
Audiologist can report a grade versus a lengthy descriptive analysis
Promotes interspecialty communication re: ototoxic clinical effects
Modifications to tx protocols when applicable
Helps with counseling families/patients Grading system is practical and easy to
interpret
Future research Prospective analysis Use of a specific audiology test protocol◦ Test high frequencies only, interfrequencies
Establish specific audiology recommendations based on objective data
More balanced groups Mannitol – possible otoprotectant?◦ Randomized controlled study