Cisplatin-associated ototoxicity: perspectives from a single institution cervical cancer cohort and implications for developing a locally responsive monitoring programme in a public healthcare setting.

BACKGROUND: Ototoxicity monitoring is uncommon in South Africa, despite the increased use of ototoxic medication to manage the burden of disease in the country. The successful implementation of such a protocol requires cognisance of contextual realities and multiple dimensions for consideration from both patients and service providers. As part of an ongoing cohort study on cisplatin-associated ototoxicity and efforts to better inform the implementation of such programmes, the perspectives of cervical cancer patients and healthcare workers towards ototoxicity monitoring were assessed. METHODS: This concurrent-triangulation mixed-methods study was conducted at a tertiary hospital in South Africa. Self-reported questionnaires from patients (n = 80) and healthcare personnel comprising clinicians, oncology nurses, pharmacists, and radiotherapists (n = 32), results of audiological evaluations, researcher field notes, and estimated patient and service provider costs contributed to data for this study. Data analysis included descriptive statistics, comparison of test characteristics and deductive thematic analysis. RESULTS: The ototoxicity monitoring programme was positively received by the participants, with 90.6% of healthcare personnel and 89% of patients reporting it to be beneficial. The clinicians (76.6%) were identified as the main providers of information on the effects of chemotherapy medication and made the necessary referrals for audiological evaluation. The approximate cost of setting up such a programme included purchase of equipment (US56 700) and the appointment of an audiologist (US 26 250). The approximate costs to patients included transport costs (US$ 38) and the loss of income for the day (US 60), calculated at the minimum wage per hour, if employed. Creative appointment scheduling, easy facility access and detailed locally comprehensible couselling improved patient compliance to the programme. Whilst the sequential use of American Speech-Language-Hearing Association (ASHA) and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria aided in an evidence-informed approach to aural rehabilitation, DPOAEs and speech discrimination displayed low sensitivity (range 1.45% - 22.39%) but high specificity (range 77.78% - 100%) when identifying ototoxic change. CONCLUSION: This novel study, through a 'real-world' experience, has revealed that an ototoxicity monitoring programme is feasible in South Africa, through meaningful engagements with- and considerations from- patients and service providers regarding planning, delineation of responsibilities and cost implications. The findings can potentially serve as a roadmap for other limited resource environments.

Feasibility and first results of a prospective cohort study to investigate cisplatin-associated ototoxicity amongst cancer patients in South Africa.

BACKGROUND: Cervical cancer, one of the most common cancers affecting females in South Africa, commonly requires a cisplatin-based-treatment regimen, which has been associated with ototoxic side effects. However, cisplatin-associated ototoxicity is largely under-reported in South Africa, despite its impact of hearing loss having serious overt ramifications on the quality of life of these patients. Hence, a prospective cohort study was undertaken to assess the audiological changes in female cervical cancer patients receiving cisplatin therapy. OBJECTIVE: To present details of the feasibility study and initial results on hearing patterns in cervical cancer patients receiving cisplatin chemotherapy. . METHODS: Fifty cervical cancer patients commencing with cisplatin chemotherapy underwent audiological assessments at a hospital in South Africa at various time intervals. Assessments included case history, otoscopic examination, immittance audiometry, pure tone audiometry (including high-frequency audiometry), speech audiometry, and distortion product otoacoustic emission testing. Data analysis involved the use of descriptive statistics and the Cochran-Armitage trend test for a linear trend in proportions. RESULTS: Fifty participants, aged between 32 and 79 years (Mean: 53 years; SD = 11.00), were recruited. Clinical findings revealed an incidence of 100% ototoxic hearing loss at the one-month post-treatment, i.e., 98%  after three cycles of cisplatin and 2%  at one-month post-chemotherapy. Sensorineural hearing loss and high-frequency tinnitus were most common. Deterioration in hearing thresholds was more evident in the extended high-frequency range, with the number of "no-responses," from 11,200 Hz to 20,000 Hz, increasing with each successive audiological evaluation. This study further indicated that recruitment and follow-up of study participants within a limited resource setting are possible. However, cognizance must be given to a multidisciplinary approach and constant engagement with participants through regular contact either telephonically or via a short-message-system. CONCLUSION: Exposure to cisplatin treatment contributed to hearing loss in females with cervical cancer, highlighting the need for ototoxicity monitoring during chemotherapy treatments. Furthermore, the results indicate that it is possible to conduct prospective cohort studies, using a multidisciplinary approach in limited-resource environments with appropriate planning and training strategies, as this study was able to achieve its aim successfully.

Baseline audiological profiling of South African females with cervical cancer: an important attribute for assessing cisplatin-associated ototoxicity.

BACKGROUND: Cisplatin is a popular antineoplastic agent used to treat cervical cancer in women from low and middle-income countries. Cisplatin treatment is associated with ototoxicity, often resulting in hearing loss. In light of this, it is crucial to conduct baseline audiological assessments prior to treatment initiation in order to evaluate the extent of cisplatin-associated-ototoxicity. Additionally, the identification of inherent risk factors and hearing patterns in specific patient cohorts is needed, especially in South Africa, a middle-income country characterized by the quadruple burden of disease (Human Immunodeficiency Virus (HIV), Tuberculosis (TB), Diabetes and Hypertension). METHODS: This study aimed to describe a profile of risk factors and hearing in a cohort of females with cervical cancer before cisplatin treatment commenced. A descriptive study design that included 82 cervical cancer patients, who underwent audiological evaluation prescribed for ototoxicity monitoring was conducted. RESULTS: All participants (n = 82) presented with risk factors (diabetes, hypertension, HIV, and antiretroviral therapy) for cisplatin ototoxicity and/or pre-existing sensorineural hearing loss. High-frequency tinnitus was the most common otological symptom experienced by 25 (31%) participants. Fifty-nine (72%) participants presented with normal hearing, twenty-two (27%) with a sensorineural hearing loss, and 36% were diagnosed with mild hearing loss. Abnormal Distortion Product Otoacoustic Emissions (DPOAE) findings were obtained bilaterally in two participants (2.4%), in the right ear only of another two (2.4%) participants and the left ear of three participants (3.7%). Most participants (94%) had excellent word recognition scores, demonstrating an excellent ability to recognize words within normal conversational levels under optimal listening conditions. Age was significantly associated with hearing loss at all thresholds. Among the co-morbidities, an HIV positive status significantly triggered hearing loss, especially at higher frequencies. CONCLUSION: This study demonstrated that South African females with cervical cancer present with various co-morbidities, which may predispose them to develop cisplatin-associated -ototoxic hearing loss. Identification of these co-morbidities and hearing loss is essential for the accurate monitoring of cisplatin toxicities. Appropriate management of these patients is pivotal to reduce the adverse effects that hearing impairment can have on an individual's quality of life and to facilitate informed decision-making regarding the commencement of cisplatin chemotherapy.

Perspectives and practices of ototoxicity monitoring.

BACKGROUND: Treatment of cancer with cisplatin can result in hearing loss. Given the increasing burden of cancer in Africa, appropriate and timely identification, intervention and management of hearing loss in affected patients is of paramount importance. OBJECTIVES: This study describes the perspectives and practices of healthcare professionals in relation to cisplatin-associated ototoxicity at an institution treating patients diagnosed with cancer. METHOD: A concurrent triangulation study design was used to collect quantitative data from seven oncologists, nine nurses and 13 pharmacists using self-administered questionnaires, and qualitative data from four audiologists through semi-structured interviews for this hospital-based study, conducted in South Africa. RESULTS: Levels of awareness of cisplatin-associated ototoxicity varied with only 33% of the nursing personnel being aware in comparison to the oncologists and pharmacists. Oncologists were identified as the main custodians for providing information to patients. Whilst 82% of the participants considered the audiologist to be part of the oncology team, there was no provision for ototoxicity monitoring in the chemotherapy protocols, nor any ototoxicity-monitoring programme in place. There was no evidence that knowledge of cisplatin-associated ototoxicity translated into an appropriate management strategy for such patients. CONCLUSION: Healthcare personnel overseeing the care and management of cancer patients need to improve their awareness of ototoxicity and refer timeously for audiological evaluation. Audiologists require greater awareness of monitoring programmes to appropriately implement and manage such programmes within a cancer platform and be part of a multidisciplinary team.

A Review of Cisplatin-Associated Ototoxicity.

Cisplatin, an effective antineoplastic drug used in the treatment of many cancers, has ototoxic potential, thus placing cancer patients, receiving this treatment, at risk of hearing loss. It is therefore important for health care professionals managing these patients to be aware of cisplatin's ototoxic properties and its clinical signs to identify patients at risk of developing a hearing impairment. Eighty-five English peer-reviewed articles and two books, from January 1975 to July 2015, were identified from PubMed, ScienceDirect, and EBSCOhost. An overview of cisplatin-associated ototoxicity, namely its clinical features, incidence rates, molecular and cellular mechanisms, and risk factors, is presented in this article. This review further highlights the importance of a team-based approach to complement an audiological monitoring program in reducing any further loss in the quality of life of affected patients, as there is currently no otoprotective agent routinely recommended for the prevention of cisplatin-associated ototoxicity.

Cisplatin-Associated Ototoxicity: A Review for the Health Professional.

Cisplatin is an effective drug used in the treatment of many cancers, yet its ototoxic potential places cancer patients, exposed to this drug, at risk of hearing loss, thus negatively impacting further on a patient's quality of life. It is paramount for health care practitioners managing such patients to be aware of cisplatin's ototoxic properties and the clinical signs to identify patients at risk of developing hearing loss. English peer-reviewed articles from January 1975 to July 2015 were assessed from PubMed, Science Direct, and Ebscohost. Seventy-nine articles and two books were identified for this review, using MeSH terms and keywords such as "ototoxicity", "cisplatin", "hearing loss", and "ototoxicity monitoring". This review provides an up-to-date overview of cisplatin-associated ototoxicity, namely, its clinical features, incidence rates, and molecular and cellular mechanisms and risk factors, to health care practitioners managing the patient with cancer, and highlights the need for a team-based approach to complement an audiological monitoring programme to mitigate any further loss in the quality of life of affected patients, as there is currently no otoprotective agent recommended routinely for the prevention of cisplatin-associated ototoxicity. It also sets the platform for effective dialogue towards policy formulation and strengthening of health systems in developing countries.