An Alternative Cisplatin based Induction Chemotherapy dosing Regimen in Advanced Esophageal Epithelial Cancers: A Single Arm Cross Sectional Study

Vivek, R S (2010) An Alternative Cisplatin based Induction Chemotherapy dosing Regimen in Advanced Esophageal Epithelial Cancers: A Single Arm Cross Sectional Study. Masters thesis, Madras Medical College, Chennai.


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INTRODUCTION: Esophageal cancer is unique among the gastrointestinal tract malignancies because it embodies two distinct histopathologic types, squamous cell carcinoma and adenocarcinoma. In 2008, an estimated 16,470 people in the United States were told that they have esophageal carcinoma1. During the same year, an estimated 14,280 people died of this disease1. This high rate of mortality occurs even though the esophagus is in a relatively accessible location and the use of screening endoscopy is widespread. One reason for the high mortality is the difficulty in properly identifying and treating early lesions. Which type of cancer occurs in a given patient or predominates in a given geographic area depends on many variables, including individual lifestyle, socioeconomic pressures, and environmental factors. The United States, along with many other Western countries, has witnessed in recent decades a profound increase in incidence rates of adenocarcinoma, whereas squamous cell carcinoma continues to predominate worldwide. AIM OF THE STUDY: This trial is designed to determine if the treatment arm under consideration is promising enough to be pursued in a phase II study. 1. To determine the feasibility of treatment delivery, patient tolerance, and acute toxicities. 2. To describe the response (including dysphagia relief) on completion of the test chemotherapy schedule. SUBJECTS AND METHODS: PATIENT SELECTION: (Note: As per NCI (National Cancer Institute), USA guidelines, exceptions to eligibility are not permitted) Conditions for Patient Eligibility: 1. Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or esophageal-gastric junction within 12 weeks prior to registration. • Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible. • Patients with cervical esophageal carcinoma are eligible. • Patients with non-regional adenopathy and distant metastasis are eligible. 2. Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, M1b based upon the following minimum diagnostic work-up: • History/physical examination within 6 weeks prior to registration. • Chest/Whole Abdominal CT within 6 weeks prior to registration. • ECG within 6 weeks of study entry. • Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be able to document histologic subtype) within 12 weeks of study entry. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to check for fistula. (NOTE: Any images from endoscopic procedures up to the time of progression must be kept in the patient’s confidential study file.) 3. Zubrod/ECOG performance status 0-2. 4. Age ≥ 18. 5. CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3. • Platelets ≥ 100,000 cells/mm3. • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.). 6. Additional laboratory studies obtained within 2 weeks prior to registration on study: • Creatinine ≤ 1.5 mg/dl, • Bilirubin ≤ 1.5 x upper limit of normal, • AST ≤ 3 x upper limit of normal, • Serum pregnancy test for women of childbearing potential. 7. Patient’s total intake (oral/enteral) must be ≥ 1500 kCal/day. 8. Patient must provide study-specific informed consent prior to study entry. 9. Women of childbearing potential and male participants must practice adequate contraception. CONCLUSIONS: In conclusion, we have identified that; 1. One course of dose intense cisplatin based chemotherapy preceding the standard treatment is a feasible inpatient induction treatment regimen for patients with locally advanced and metastatic esophageal carcinomas, and has an acceptable toxicity profile. 2. One course of dose intense cisplatin based induction chemotherapy is an active regimen in esophageal Squamous cell Carcinomas and Adenocarcinomas. In light of the high rates of dysphagia relief and clinical activity that is comparable to conventional chemotherapy, we believe that this is an effective chemotherapy regimen as an inpatient induction therapy. 3. This regimen should be considered in larger phase-II clinical studies evaluating induction therapy for a similar group of patients.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Alternative Cisplatin ; Induction Chemotherapy dosing Regimen ; Advanced Esophageal Epithelial Cancers ; Single Arm Cross Sectional Study.
Subjects: MEDICAL > Medical Oncology
Depositing User: Kambaraman B
Date Deposited: 09 May 2018 17:25
Last Modified: 09 May 2018 17:25

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