PROFILE AND TREATMENT OUTCOME OF LARYNGEAL CANCER PATIENTS ATTENDED AT ORCI FROM 2008 TO 2011

Laryngeal cancer is the cancer of the cells found in the larynx. The new cases diagnosed annually have significant geographical variation. Laryngeal cancer is more common to male compared female and more in low social economic class. It is more prevalent in elderly people and the glottis area is the most common site. The high risk factors associated with laryngeal cancer include smoking cigarette, excessive alcohol consumption especially spirits, squamous cell carcinoma is by far the commonest histological type and the symptoms include hoarseness of voices, sore throat, painful swallowing and change in voice quality or enlarged neck nodes. In early stages, laryngeal cancer can be treated by surgery or radiotherapy and combination of radiotherapy and chemotherapy in late stages of the disease. Objective of the study: The aimed to describe the disease profile of the patient with laryngeal cancer attended at ocean road cancer institute, Tanzania from 2008to 2011. Methodology: The study was hospital based cross-sectional study and it was conducted at ocean road cancer institute targeting included all patients with laryngeal cancer from 2008 to 2011, whose baseline characteristics were determined before beginning of treatment and at least one follow up visit and excluded all subjects whose records were not available. sociodermographic characteristics, disease and treatment profiles were clearly documented. Results: 72 patients were included in a study, 86.1% were males and 13.9% were females. The youngest patient was 35 years and the oldest patient had 84 years with mean age 58.1 years, where by 59.7% of the patients included in the study had primary education and below. 64.4% had history of both alcohol consumption and cigarette smoking prior to disease development and the glottis area was common disease site by 66.7% with squamous cell carcinoma the most histological type by 98.6%. Majority had advanced disease stage III and IV with 73.6% of all patients included in the study where by the combination chemoradiation was common treatment modality.

To my precious wife Juliet Mlaki for her love, hardworking and dedication to our family.
To our lovely child Frank, for the joy he bring into our life.
ORCI was mid age males with low level of education, presented with late stage disease and they were treated by combination chemoradiation which offered symptomatic relief.
The proportion of patients attaining complete remission following treatment was low and this is probably due to late disease presentation.
Health education, change of behavior campaigns towards cigarette smoking and alcohol consumption and improvement of health infrastructures are needed to reduce the disease development and improve its diagnosis and treatment.   (3). Countries with the highest incidence of laryngeal cancer includes Hungary were the incidence is 181.9; Belgium 152.4 and USA were the incidence is 142.6 per 100,000 according to data obtained from IARC (4).
In Tanzania Laryngeal cancer is more common in male compared to female with a ratio of almost 5:1 (6) and it is more prevalent in among lower socio-economic class in which it is diagnosed at more advanced stages and the frequency of the disease increased along with age in both sexes (7) In most recent studies shows glottic tumors forms the majority and subglottic tumors comprising only a few per cent of all laryngeal malignancies while some earlier studies indicate supraglottic dominance (9, 10). Tumors arising from different regions of the larynx probably have different risk factors and show considerable difference in clinical behavior and prognosis (8,9).Usually supraglottic cancers present with sore throat, painful swallowing, referred ear pain, change in voice quality or enlarged neck nodes.
Early vocal cord cancers are usually detected because of hoarseness of voice. Cancers arising in the subglottic area commonly involve the vocal cords and symptoms usually relate to contiguous spread.
Squamous cell carcinoma is by far the most common histological type, comprising 95% of laryngeal cancers. Other rare type of cancer arises from the other types of cells within the larynx including adenocarcinoma. The exact reason why a cell becomes cancerous is unclear. It is thought that something damages or alters certain genes in the cell, which make these cells abnormal and multiply out of control.
There are certain risk factors that increases the chances of laryngeal cancer development including: agemore common in older people over 60 years, smoking habit, excessive alcohol consumption, poor diet especially a diet lacking certain vitamins and minerals, long term exposure to certain chemicals, fumes or pollutant may irritate the larynx and Human Papilloma Virus (HPV) has been shown in some studies to be associated with cancer of the larynx.
For smokers, the risk of the developing laryngeal cancer decreases after the cessation of smoking but remains elevated even years later when compared to that of nonsmokers.
The risk of second tumor is enhanced in a patient who has had a single cancer and continues to smoke and drink alcoholic beverages and the likelihood of a cure for the initial cancer, by any modality, is highly diminished.
The treatment advised for each case depends on various factors such as the exact site of the primary tumor in the larynx, the stage of the cancer, the grade of the cancerous cells and the general health of the patient. Although most early lesions can be cured by either radiation therapy or surgery, radiation therapy may be reasonable to preserve the voice, leaving surgery for salvage. Locally advanced lesions, especially those with large clinically involved lymph nodes, are poorly controlled with surgery, radiation therapy, or combined modality treatment. Distant metastases are also common, even if the primary tumor is controlled.
Patients treated for laryngeal cancers are at the highest risk of recurrence in the first 2 to 3 years. Recurrences after 5 years are rare and usually represent new primary malignancies. Close, regular follow-up is crucial to maximize the chance for salvage.
Careful clinical examination and repetition of any abnormal staging study are included in follow-up, along with attention to any treatment-related toxic effect or complication The survival rates for laryngeal cancer depends on the stage that the condition is diagnosed. Around 1 in 4 people with stage four laryngeal cancer will live at least five years after diagnosis (7) (19).

PROBLEM STATEMENT
Laryngeal cancers usually develop in the sixth and seventh decades of life and it is more common in male compared to female and people with low socioeconomic status but nowadays the trend has changed and there is an increase in number of young and female patients who develop laryngeal cancer compared to previous years. The changes observed is highly attributed by change in lifestyle toward western, lack of awareness on disease risk factors that increase the chances of disease development.
Despite the advancement in the treatment of laryngeal cancer, the disease presents a challenge in its management due to the occurrence near vital structures. Diagnosis and screening is difficult in the early stages due to hidden nature of the lesions often resulting in late clinical presentation making the treatment outcome to be poor.
Unfortunately, in Tanzania there is no any scientific study that has assessed disease profile and the outcome after treatment of laryngeal cancer in a population.

RATIONALE
It has been found that in less developed countries like Tanzania the total number of laryngeal cancer patients increases yearly while their survival rate of the after one year decreases, this is much contributed by poor knowledge of the disease, poor lifestyle, lack of skilled medical personnel to diagnose the disease at early stages and lack of proper facilities in diagnosis and treatment of the disease properly.
There is no scientific research which has been done at ORCI to show how sociodemographic characteristics is related to disease, the profile of the disease and the treatment outcome in diagnosed patients for the past 3 years and this study is expected to find the relation between sociodemographic characteristics and the disease, disease profile and treatment outcome of the patients attended and treated at ORCI for the past 3 years , so that proper arrangement of treatment, diagnostic tools and in improvement of disease knowledge and proper delivery of treatment and therefore improve the outcome after treatment.

RESEARCH QUESTION
What is the profile of Laryngeal cancer patients attending at ORCI from 2008 to 2011 and their outcome after treatment? Laryngeal cancer patients brought to ORCI are treated either by radiotherapy and chemotherapy and most of them are brought in advanced stages.

Study participants Target population: All patients with diagnosis of laryngeal cancer in Tanzania.
Accessible population: All patients referred to ORCI for treatment with diagnosis of laryngeal cancer.
Study population: All patients with laryngeal cancer who fulfill the eligibility criteria.

Inclusion criteria
The study included all patients referred to ORCI with diagnosis of laryngeal cancer from January 2008 to December 2011, and whose baseline characteristics were determined before beginning of the therapy and had at least 1 follow-up visit.

Exclusion criteria
The study excluded subjects whose records were not available.

Sampling procedure
All patients who attended ORCI between 1 st January 2008 and 31 st December 2011 with a diagnosis of laryngeal cancer were identified from the central hospital register.
Hospital case-notes were retrieved for each patient. Details pertinent to patient demographics, diagnosis, disease severity and laterality, treatment, and outcome, were recorded.

Sample size
The sample size for laryngeal cancer was calculated using a single proportion formula: From the formula the minimum number of patients with laryngeal cancer to be recruited in the study was found to be 76 Study variables The outcome variables were:

Data collection
Research assistants under the supervision of the principal investigator use data extraction forms to retrieve data from patient's records stored in manual files and or files on computer. The data extraction forms were capture demographic characteristics, severity of disease, treatment modalities and outcome of treatment and other variables of interest.

Data Management
The data extraction forms were carefully reviewed for completeness and consistency. In case of missing or inconsistent data was checked the patient periodical records or medical registers while ensuring utmost confidentiality of patient records and identity.

Statistical analysis
The data analysis was done using the SPSS version 21 for windows.

Quality control
The data obtained was coded, edited and cleaned before any statistical analysis was carried out on the data. Additional internal documentations such as variable and value labels were added and any necessary additional variables were created through algebraic or logical expressions. Study research assistants were trained before the start of the study.
Data capture sheet will be pre-tested to improve consistency. Data was double entered to control for errors.

ETHICAL CONSIDERATIONS
Ethical clearance to conduct the study was obtained from MUHAS Ethical Committee.
In addition ORCI was asked to allow a researcher to access the medical sites and files of patients with laryngeal cancer between Jan 2008 and Dec 2011.

RESULTS
Information required was obtained from hospital registry and patients files. After excluding the patients whose information didn't fulfil the selection criteria, only 72 patients were included in the study and data extraction and analysis was performed and the results of socio-demographic characteristics and disease profile are presented below. There were more male than female, with ratio of 6.2:1, with majority of the patients, 56.9% at the age of less than 60 years which is the most economic and active group with the mean age of 58.71 years. 58.3% of the patients had primary school education, 30.6% attends secondary school and only 9.7% had post-secondary school education.  There was no any patient presented with disease at subglottic area. The squamous cell carcinoma was found to be the common histological presentation 98.6% compared to adenocarcinoma which was in about 1.4 % of all patients with laryngeal carcinoma attended at ORCI from 2008 to 2011.   Surgery followed by chemotherapy and EBRT 5 6.9 Surgery followed by EBRT 1 1.4 Radiotherapy alone 2 2.8

Total 72 100
Combination of chemotherapy and radiotherapy was the most common treatment modality, 88.9% combination of surgery followed by chemotherapy and radiotherapy was 6.9%, surgery followed by radiotherapy was 1.4% and radiotherapy alone was 2.8%.  Disease stage and treatment modality shows association with treatment outcome with p <0.0001 and 0.014 respectively, but there were no any association between treatment outcome and sex, age or level of education of the patient.

STRENGTH AND LIMITATION STRENGTH
This was a hospital based cross-sectional study in which the author was involved in data collection and personally entered and analyzed the data in order to assure authenticity and completeness of data collected as well as the results obtained.

LIMITATIONS
Being a hospital based retrospective study, some important information's in a files was missing due to improper filling of patients particulars.

CONCLUSION
Most of the patients attended at ORCI are male with the age between 30 to 60 years and with low socioeconomic status. They present with late stage of the disease and squamous cell carcinoma is the most common histopathology where they receive chemoradiation treatment which offered symptomatic relief to our patients.
However the proportion of our patient attaining complete disease remission following treatment in our set up is very low. This may be due to late disease presentation observed in our patients which end up receiving palliative treatment.

RECOMMENDATIONS
1. More effort from the government and all other stakeholders are required in order to prevent/reduce the occurrence of laryngeal cancer, by reducing/stop cigarette smoking and alcohol consumption.
2. Health education, income capacity buildup and improvement of health infrastructures are necessary in order to overcome late disease presentation.
3. Further studies to assess incidence and prevalence of laryngeal cancer with respect to socio-demographic characteristics.

29.
Findings of diagnostic investigation done in question 9