Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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RATIONALE In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between actual clinical outcome and TNM stages because it is an anatomy-based system in which functional factors are not concerned. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study. PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.

Detailed Description
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Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.

Official Title
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Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study

Conditions
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Nasopharyngeal Neoplasms, Blood Cell Count, Neoplasm Staging, Prognosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nasopharyngeal cancer patients diagnosed by pathology or cytology UICC/AJCC 2010 Stage T1-4 N0-3 M0 Male or female patients with age between 18 and 75 years old Karnofsky Performance Scores ≥ 60 Expected survival ≥ 3 months Without dysfunction of heart, lung, liver, kidney and hematopoiesis Exclusion Criteria: Karnofsky Performance Status Score < 70' Radiotherapy uncompleted (≥ 1 fraction missing) Distant metastases before or during radiotherapy Without weekly complete blood count during radiotherapy Application of colony stimulating factor such as erythropoietin Signs of infection before radiotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Risk Group<br>Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hb, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 1-4 called the low risk group. | |
| Intermediate Risk Group<br>Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 5-11 called the intermediate risk group. | |
| High Risk Group<br>Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 12-17 called the high risk group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival | The period until any event (death, local recurrence or distant metastasis) is detected. | 5 years after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year disease-free survival | The period until local recurrence or distant metastasis is detected. | 5 years after diagnosis | 
| 5-year recurrence-free survival | The period until local recurrence is detected. | 5 years after diagnosis | 
| 5-year distant-free survival | The period until distant metastasis is detected. | 5 years after diagnosis |