Survival Rate of Esophageal Cancer Patients with Intra-Luminal Brachytherapy - Thesis Example

Sur Lecturer Retroanalyses nonrandomized study over X period of time for esophageal cancer patient which compares two treatment options: intra-luminal brachytherapy alone vs. intra-luminal brachytherapy treatment combined with chemotherapy Introduction This chapter seeks to present the proposal of the research study. In the proposal, the paper will attempt to discuss the research problem which is the survival rate of esophageal cancer patients with intra-luminal brachytherapy alone and when chemotherapy is added to the intra-luminal brachytherapy. The study that this proposal seeks to perform is on the overall survival rate for esophageal cancer patients’ improvement when chemotherapy is added as a concurrent treatment to intra-luminal brachytherapy compared to the survival rate when intra-luminal brachytherapy is used as treatment alone. From this study, we hope to establish whether there is improvement of the dysphagia free-survival as well as overall survival rate with chemotherapy combined with intra-luminal brachytherapy or intra-luminal brachytherapy alone or not. On the other hand, the research also hopes to illustrate the ability to tolerate treatment, toxicity, patterns, and complications such as strictures, ulcerations, tracheoesophageal fistulae, of reoccurrence. Esophageal cancer is a very devastating disease. And therefore this proposed study is obviously necessary and is of necessity in order to determine the effectiveness for both treatment strategies in palliation of dysphagia, the quality of life for both treatment strategies, and to determine the incidence of complications for both treatment strategies. The severity of esophageal cancer forms the problem statement of the study. Problem statement The research problem is based on the severity of esophageal cancer. This condition often leads to death due to its severity. Although radical surgery has proved to be the most successful treatment of this sever disease, majority of the patients are not, at the time of diagnosis, operable. For such kind of patients, a choice for palliation or cure is provided by the external beam radiotherapy without or with concurrent chemotherapy. In addition, intra-luminal brachytherapy has been suggested for patients with an advanced esophageal cancer as a method of increasing local control. For example, in a study conducted by Gasper et al. (1997), about 49 patients who had inoperable esophageal cancer received treatment with a combined intra-luminal brachytherapy and external chemotherapy in the Central Hospital of the University of Turku. The intra-luminal brachytherapy could be as well performed without any technical difficulties with any major complications seen. In most cases, 20 out of 49 patients (41% of the patients) the symptoms could be immediately relieved and the disease progression delayed. There is a chance of 30% and 18% of one and two year rate of survival respectively (Gaspar et al. 130). The patients who remain alive after two years are termed as long term survivors. Therefore intra-luminal brachytherapy is an efficient and safe treatment modality that provides a potential mechanism of cure to selected esophageal cancer patients. It is hence evident that esophageal cancer patients need treatment and therefore the proposed study is necessary. In another study that proves the need of this proposed research study, an experimental study and a clinical test involving 30 patients with endoscopic proven and locally advanced squamous cell esophageal cancer, 29 of these patients were given high rate of intraluminal dose brachytherapy sessions of 8Gy in one week, and the remaining patient only got one session. After a month of following the patients, it was found out that the outcome involved symptoms control, quality of life: regurgitation, dysphagia, chest or back pain, odynophagia, and the general survival. There was a noted statistical improvement in quality of life after 4 months. Although pain, regurgitation and odynophagia were lower during this 4 month follow up, there was a general median rate of survival from death of 165 days. We can therefore conclude that high rate of intraluminal dose brachytherapy of advanced esophageal cancer with a two outpatient procedures has proven successful in accomplishing the principle objective of patients to improve the quality of life and reduce dysphagia as well as increase the survival rate. This obviously illustrates the necessity of the proposed study. It is also important to note that esophageal cancer may be cured in some patients even though the treatment is very protracted. It decreases the quality of the life of the victim and is often lethal in several cases. The idyllic treatment of esophageal cancer is actually debatable. In fact, some defendants of surgical treatment have argued that resection is the only modality treatment to provide curative intent; however, the defendant of non surgical approach have claimed that esophageal cancer is particularly incurable and that esophagectomy pose a prohibitive index of mortality. Overall aims of the research study Generally, the research study seeks to discuss the overall survival rate for esophageal cancer patients’ improvement when chemotherapy is added as a concurrent treatment to intra-luminal brachytherapy compared to intra-luminal brachytherapy alone. In addition, the proposed study seeks to ascertain the improvement of the dysphagia free-survival as well as overall survival rate in esophageal cancer treatment with intra-luminal brachytherapy alone and when chemotherapy is added to the treatment. As part of the proposed study, the research will also illustrate the ability to tolerate treatment, toxicity, patterns, and complications such as strictures, ulcerations, trachea-esophageal fistulae, of reoccurrence. In summary, the overall aims of the research study include: 1. To analyze and compare survival rate for patients with esophageal cancer patient receiving either a combination of High-Dose Intra-luminla Brachytherapy with chemotherapy OR high-Dose Rate Intr-luminal Brachytherapy alone 2. To determine the effectiveness for both treatment strategies in palliation of dysphagia 3. To determine the quality of life for both treatment strategies 4. To determine the incidence of complications for both treatment strategies Background and significance of the study Studies have ascertained that patients with locally advanced or recurrent esophageal cancer have indicated poor prognosis. Dysphagia relief is normally the goal of any further treatment. In order to alleviate dysphagia, several methods of treatment including prosthetic intubation, external beam irradiation, laser re-canalization, dilatation, and intraluminal brachytherapy can be used among diagnosed patients with esophageal cancer. For example, in a study involving 11 patients, 3 newly diagnosed patients and 8 with recurrent tumor, were treated using a low dose intraluminal brachytherapy (Barcat et al. 717). Dysphagia relief was achieved in 9 patients. All these 9 patients were able to swallow a semi-solid food diet until the last follow up. Although there was a minimal toxicity, the rate of survival was poor, with a median of 3 months survival. This clearly indicates that intraluminal brachytherapy has various advantages compared to other methods of palliation, most especially in recurrent tumors in which there exists normal tissue tolerance making re-treatment very difficult. The intra-luminal brachytherapy low dose rate take about 1 to 2 days to deliver, it is also very effective with very little morbidity. It achieves a relatively durable palliation. On the other hand, in unresectable esophageal cancer, the boost by brachytherapy after concurrent chemo radiation is feasible in patients with good and performance score of Karnofsky and is associated with acceptable toxicities. However, there is still a need for the standardization of schedules of the intra-luminal brachytherapy with protocols of chemo radiation. It is therefore important to carry out the proposed study in order to ascertain the mentioned aims of the research. The use of just radical external radiation is proven to result into just 6%, 5 year, rate of survival. This leaves 80% of the patients failing locally. Due to a 3 year rate of survival, there has been a significant consideration of concomitant chemo radiation as the standard approach for the unresectable esophageal cancer treatment. In spite of these improved results, the local and regional control of esophageal cancer is still very poor, in fact 48% of the patients fail locally only. Therefore, further improvement of esophageal cancer lies in the increment of biological response with the use of combined treatment modality optimally, that is intra-luminal brachytherapy after a chemo radiation or just radiation only. Due to the rapid dose fall of and ability of intra-luminal brachytherapy to deliver a high dose to esophageal cancer, intra-luminal brachytherapy is used for local boost (Bhatt et al. 370). Due to the limited time of treatment, ease of administration, better compliance by the patient and high dose rate brachytherapy is preferred mostly. Because of the adverse events incidental with certain dose schedules, the dose per fraction and dose fraction in high dose rate brachytherapy of the esophageal cancer has remained an issue of great concern. Thus, this research study has been conducted to make certain that the overall survival rate for esophageal cancer patients improves when chemotherapy is added as a concurrent treatment to intraluminal brachytherapy. Due to the study, it will also ascertain the improvement of the dysphagia free-survival as well as overall survival with chemotherapy or not. On the other hand, the paper will also illustrate the ability to tolerate treatment, toxicity, patterns, and complications such as strictures, ulcerations, tracheoesophageal fistulae, of reoccurrence. This shows the significance of the proposed study as well as what it is likely to improve among esophageal cancer patients. We can hence conclude that, this proposed study will bring attention to the treatment modalities that increase the rate of patient survival, such as the proposed intra-luminal brachytherapy and when chemotherapy in added to intra-luminal brachytherapy. Therefore this research paper will be looking into chemotherapy as a necessary addition to the intra-luminal brachytherapy treatment in order to increase the rate of survival among esophageal cancer patients. This research study is obviously significant and needed in order to improve the quality of life of such patients. This paper has therefore detailed a proposal of the research paper that needs to be carried out in order to ascertain the improvement of rate of survival among esophageal cancer patients, the quality of life of such patients, to determine the incidence of complications for both the treatment strategies and to compare their effectiveness in increasing the rate of survival. The proposed study is hence significant and needs to be conducted. In addition, the significance of the study can be ascertained by the aim of the study to ascertain the improvement of the dysphagia free-survival as well as overall survival with chemotherapy, and to illustrate the existing literature on the ability to tolerate treatment, toxicity, patterns, and complications such as strictures, ulcerations, trachea-esophageal fistulae, of reoccurrence. Research questions 1. What is the survival rate for patients with esophageal cancer receiving either a combination of High Dose Rate Intra-luminal Brachytherapy with chemotherapy or high-Dose Rate Intra-luminal Brachytherapy alone? 2. How effective are the treatment strategies (a combination of High-Dose Intra-luminal Brachytherapy with chemotherapy or high-Dose Rate Intra-luminal Brachytherapy alone) in palliation of dysphagia? 3. What is the quality of life of patients for both treatment strategies? 4. What is the incidence of complications for both treatment strategies? Hypotheses of the study Alternative hypotheses 1. There is an increased survival rate in esophageal cancer patients receiving a combination of High Dose Intra-luminal Brachytherapy with chemotherapy compared to those receiving High Dose Rate Intra-luminal Brachytherapy alone. 2. There is an improved quality of life of esophageal cancer patients receiving a combination of High Dose Intra-luminal Brachytherapy with chemotherapy compared to those receiving High Dose Rate Intra-luminal Brachytherapy alone. Null hypotheses 1. There is no increment in survival rate in esophageal cancer patients receiving a combination of High Dose Intra-luminal Brachytherapy with chemotherapy compared to those receiving High Dose Rate Intra-luminal Brachytherapy alone. 2. There is no improvement in quality of life of esophageal cancer patients receiving a combination of High Dose Intra-luminal Brachytherapy with chemotherapy compared to those receiving High Dose Rate Intra-luminal Brachytherapy alone. Methods This is a retrospective study of patients of esophageal cancer treated between 2005 through 2011. Patients will be considered eligible for this proposed study if they have squamous cell carcinomas of thoracic esophagus (esophageal cancer). ### patients with stage…esophageal cancer was treated with High Dose Intra-luminal brachytherapy with or without chemotherapy. Intra-luminal brachytherapy was used in ### patients and chemotherapy was added in ## patients. Initially, patients will be treated with High Dose Rate Intra-luminal Brachytherapy without chemotherapy. At a later stage, a concurrent chemotherapy will be added to the treatment with High Dose Rate Intra-luminal Brachytherapy. Patients will be treated after a concurrent chemotherapy with two different High Dose Rate Brachytherapy schedules. The data will hence be tabulated for analysis to compare the rate of survival in esophageal cancer patients receiving either a combination of High Dose Rate Intra-luminal Brachytherapy with chemotherapy or high-Dose Rate Intra-luminal Brachytherapy alone. Analysis strategy A statistical analysis will be performed using a Statistical Package for Social Sciences (SPSS) software, version 16.0. Survival analysis and actuarial probabilities will be calculated and compared for both the treatment strategies (a combination of High Dose Rate Intra-luminal Brachytherapy with chemotherapy or high-Dose Rate Intra-luminal Brachytherapy alone). Patients will be analyzed retrospectively and the distribution of patients across the radiation schedules will be determined. All the patients who will be included in the analysis will have to undergo an evaluation in order to assess the stage of the disease. The characteristics of the patients and the tumor will also be determined and shown. These patients will be evaluated clinically for dysphagia at intervals of 1, 2, 3, 6, and 12 months. Limitations/ Implications The proposed study although significant and is likely to bring an effect on the rate of survival of esophageal cancer patients receiving either a combination of High Dose Rate Intra-luminal Brachytherapy with chemotherapy or High-Dose Rate Intra-luminal Brachytherapy alone, is associated with various limitations and implications. The first limitation of this study would be based on the stage of the disease. Some patients may not respond to the treatment to the recommended optimal intra-luminal brachytherapy dose fractions that may be used in the study. Some esophageal cancer patients also prefer surgery to chemotherapy as stated in the previous literature review. During the clinical evaluation of patients, some patients may not report for dysphagia evaluation intervals. The proposed study is also limited by the number of patients covered in the study. 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