Practical Grading System for Evaluating Cisplatin Ototoxicity in Children

Transcription

1 Practical Grading System for Evaluating Cisplatin Ototoxicity in Children K30 Journal Article Review Denise Nicholson, Au.D., Ph.D. candidate Senior Audiologist Dept of Audiology

2 Article: Chang, K.W. & Chinosornvatana, N. (2010). Practical Grading System for Evaluating Cisplatin Ototoxicity in Children. Journal of Clinical Oncology, 28 (10),

3 Background Article Clinical applications/future research

4 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)

5 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

6 Implications of HFHL in Children Unable to hear certain speech sounds Distortion Speech understanding in noise phonics (reading)

7 Normal Hearing and Degrees of HL

8 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

9 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)

10 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

11 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)

12 Patients 134 pediatric patients Received cisplatin or carboplatin Audiologic evaluation performed during 105 (70.5%) of 149 treatment courses 90 had audiograms measured least one dose of cisplatin or carboplatin 81 received cisplatin, of which, 67 received cisplatin as their only primary ototoxic chemotherapeutic agent 14 cisplatin & carboplatin 9 carboplatin only

13 Methods Retrospective chart review Audiologic Demographic clinical computerized patient charting database was used to collect: Treatment course data Process measures Audiologist recommendations

14 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

15 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.

16 Audiologic Grading Continued CTCAE subjective criteria were not used in order to keep the grading blinded HL at db was averaged at 3 contiguous frequencies Chang grading scale modified version of Brock scale Meant to incorporate functional deficits caused by HL < 40dB

17 Chang vs Brock

18 Chang 2b, Brock 0, CTCAE 3

19 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)

20 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 audiogrambased ototoxicity grades and the final recommendations made by audiologists

21 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

22 Results: Demographics & Clinical Characteristics

23 Results continued

24 Results continued

25 Results continued

26 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

27 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

28 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

29 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