People living with and beyond who experience ototoxicity as a result of chemotherapy

Quality of Life

Cancer

Hearing Loss, Sensorineural

Tinnitus, Subjective

Late Effect

High frequency audiometry

Questionnaire on quality of life (Short Form 36 Item- SF-36)

Short-Form 36-Item Questionnaire (SF-36)

Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)

Hearing handicap inventory for adults/elderly (HHIA/HHIE)

Questionnaire on Tinnitus (Tinnitus Handicap Inventory)

Tinnitus handicap inventory (THI)

University of Nottingham

Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors

Long-term Ototoxicity in Cancer Survivors Treated With Chemotherapy and the Impact on Quality of Life

Questionnaire on quality of life, scale between 0-100 with 0 being bad quality of life and 100 being good

Questionnaire on hearing loss scale from 0-100, 0 being no handicap and 100 being a big handicap

Questionnaire on Tinnitus from 0-100, 0 being no handicap and 100 being a bit handicap

Data will be anonymised and made confidential, statistical analysis will be performed before data is shared.

National Institute for Health Research, United Kingdom

International Stem Cell Forum

Subjects will receive lapatinib for 10 days prior to surgery for vestibular schwannoma resection.

Control subjects will not receive any intervention prior to surgery for vestibular schwannoma resection.

Subjects received lapatinib for 1500 mg by mouth daily for 10 days prior to surgery for vestibular schwannoma resection

Lapatinib

Control subjects did not receive any intervention prior to surgery for vestibular schwannoma resection

Control

Total

Sex: Female, Male

Region of Enrollment

KPS is a physician-reported outcome measuring an individual's functional impairment. Scores range from 0% (death) to 100% (normal no complaints; no evidence of disease).
Specific to these results, 70% represents an ability to care for self; unable to carry on normal activity or to do active work, and 90% represents an ability to carry on normal activity; minor signs or symptoms of disease.

Karnofsky Performance Status (KPS)

Patients with a diagnosis of NF2

Steady-state plasma concentrations of lapatinib (ng/mL) at time of surgery, 10-13 days from starting drug.

Subjects received lapatinib 1500 mg by mouth for 10 days prior to surgery for vestibular schwannoma resection

Median Steady-state Lapatinib Plasma Concentrations at the Time of Surgical Resection

Count of tissue samples with lapatinib concentration >3uM

Subjects will receive lapatinib for 10 days prior to surgery for vestibular schwannoma resection.
lapatinib: 1500 mg lapatinib by mouth per day for 10 days

To Assess Whether Lapatinib Can Reach a Minimum Tumor Concentration Level of >3uM in VS After Oral Dosing.

Assessed number of samples with high expression of phospho-ErbB2 in tissue at time of surgery

Control subjects will not receive any intervention prior to surgery for vestibular schwannoma resection. Control subjects donate tissue at the time of surgery.

Assess the Level of ErbB2 Phosphorylation in VS.

Assess Markers of Tumor Proliferation and Cell Death in VS After Exposure to Lapatinib.

A comparison in the median lapatinib concentration (ng/g) in vestibular schwannomas associated with neurofibromatosis type 2 and sporadic vestibular schwannomas

Participants with vestibular schwannomas associated with a diagnosis of neurofibromatosis type 2

NF2 Associated VS

Participants with sporadic vestibular schwannomas (i.e. not associated with a diagnosis of neurofibromatosis type 2)

Sporadic VS

Explore the Difference in the Concentration of Lapatinib Achieved in NF2-related Versus Idiopathic VS.

Due to the sample sizes, a comparison between sporadic and NF2-related vestibular schwannomas could not be made. Instead we report the mutational status.

Seven participants had successful NF2 gene mutation analysis via exon scanning and MLPA.

Participants With Tissue Available for Gene Mutation Analysis

Perform NF2 Gene Mutation Analysis Via Exon Scanning and MLPA as Well as Protein Expression in All VS and Explore Differences Between Sporadic and NF2 Related VS.

Subjects received lapatinib 1500 mg by mouth for 10 days prior to surgery for vestibular schwannoma resection.

Control subjects did not receive any intervention prior to surgery for vestibular schwannoma resection.

Overall Study

Jaishri Blakeley

Control subjects will not receive any intervention prior to surgery for vestibular schwannoma resection. Control subjects donate tissue at the time of surgery. AEs were not collected in this group as there was no study intervention (i.e. they did not take the drug).

Vestibular Schwannoma

Neurofibromatosis 2

Acoustic Neuroma

Auditory Tumor

1500 mg lapatinib by mouth per day for 10 days

lapatinib

House Reserach Institute

Johns Hopkins Hospital

Massachusetts General Hospital

Washington University Medical Center

New York University Medical Center

Weil Cornell Medical College, New York Presbyterian Hospital

Ohio State University Medical Center

Concentration and Activity of Lapatinib in Vestibular Schwannomas

Exploration and Estimation of Intratumoral Concentration and Activity of Lapatinib in Vivo in Vestibular Schwannomas

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

The Children's Tumor Foundation

GlaxoSmithKline

New York University

Ohio State University

House Research Institute

Washington University School of Medicine

Weill Medical College of Cornell University

325mg ASA OD during course of chemotherapy

Hearing Loss

Ototoxicity

325mg ASA OD for the duration of the cisplatin

hearing loss/breast neoplasms

Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors

Concentration and Activity of Lapatinib in Vestibular Schwannomas

Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

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