User:Heisenbergblack/sandbox

Introduction:
Intensification therapy is a is a cancer treatment method, which is done when the cancer is cured to kill the cancer cells left behind. This includes many practices such as radiation therapy, cell transplant or its treated with drugs to kill the cancer. It is also called consolidation therapy and post remission therapy. Intensification therapy has been proven useful for children’s as a positive outcome was received by the authorities. It was a 25-year investigation which was started in 1981, various methods had been use in the total procedure which include usage of drugs (medication), bone marrow analysis and more. The recent focus of clinical research has been on the topic of how could they possibly translate such remissions into cure for patients having this certain disease. The results were not hundred percent positive as many patients lost their lives during the therapy, it was obligatory for the patients to sign a consent and also get it signed by their parents as the procedure was risky. The patients who were initially treated with mitoxantrone and AZQ experienced bone marrow suspension Lastly the cost incurred was too much as it included medical cost, diagnosis, cost of drugs and much more, as the government was sponsoring a bigger part of the total cost.

Methods:
Intensification therapy consists various therapies such as induction therapy which includes vcr 1.5mg/m2 once a week and it lasts for four weeks. It was obligatory for all patients to perform a bone marrow analysis on the seventh day of the therapy, the results of bone marrow do not contribute to the final response of the patients. Patients who respite were directed to standard or increased postinduction therapy. The therapy period was two years for girls and three years for boys. Consent was another important factor which was essential to undertake by the patient himself and his family. All this process was monitored by specialists in the field. High dose chemotherapy was studied in 32 different patients based on their efficiency and toxicity. A group of ten patients was created who received a sum of three courses of induction therapy which includes vincristine(VCR) (1.5 mg X 2), ifosfamide (5 g/m2), and Adriamycin (Ad; Adria Laboratories, Columbus, Ohio) (60 mg/m2). The patients with tumour were required to undertake treatment, which consisted of irradiation, surgical excision or maybe a combination of both .One of the other important method was to calculate life expectancy of the patients which used to be calculated by the Kaplan meier procedure method and was achieved by peto’s method. There was a committee setup to look after this programme as a whole which was called the ‘Data Audit Committee’ who used to visit the participating institutions on regular basis. The data extracted from the patients were treated in a very confidential manner and is kept within high levels of privacy and protection, out of the 25 participating institutions any institution could get randomly reviewed. About the treatment method of chemotherapy in the whole process is that a different cycle was designed for that, which was 14 days long to make sure that the patients get enough time to recover their blood counts from any kind of toxicities. Many of the patients had to delay their cycle because of reasons such as thrombocytopenia followed by neutropenia or both together. Similarly, 8 patients started their radiation therapy at the beginning of the process, this had a direct effect on the duration of the chemotherapy. Sometimes chemo therapy dosage was decreased by the doctors to control the toxicity level in the patient’s body. Toxicity was another important factor in the whole process because it had caused many deaths of the patients. Chemotherapy also played a major role in calculating the dosage for the intensification therapy. The average dosage of intensification which was prescribed to the patients was 1.24, with a media of 1.27

Results:
Outcome of the therapy is based on a few different factors such as results according to the duration and results according to the intensity of the therapy. According to the intensity of the therapy, the patients who were receiving intensification therapy on SD=2.4% had a life expectancy of 81.2% out of five years, and the patients undertaking the therapy on SD=2.7% had a life expectancy of 71.7% out of five years. Many patients undertaking the therapy achieved unwanted results, which includes dead arms of twelve patients. It had been proven that unwanted results were caused by factors such as isolated marrow relapse. However, if we look at the results according to the duration of the therapy there is not much difference. Eighty-six deaths occurred in standard duration and seventy-eight deaths occurred in the longer duration After undertaking the therapy 41% of the patients achieved complete remission, 17% achieved partial remission, and none of them died during the time of the therapy. Patients using basal insulin were benefited as their usage decreased by 24% compared from year one to year three, this was a positive thing experienced by the patients regarding their overall health and financial burden. Results also include the response of the patients to the induction therapy. 72% of the patients who had undertaken the therapy achieved positive results and had responded in a positive way, however the rest 19%of the patients did not respond well to the induction therapy. The possible reasons for such outcomes were early relapse, residual toxicity and bone marrow transplantation.

Patients:
The total sum of the enrolled patients was 2078, out of which 6 patients did not meet the requirements because of improper consents, however two patients were already undertaking sessions of chemo therapy. During the induction therapy twenty-eight patients were found dead, out of which only three patients died during the first week of therapy. Patients did undertake two courses of intensification therapy. Patients had to be eligible and fall in the criteria to undertake the therapy, which included the age of the patient which was supposed to be between 15 years to 60 years. The patients were not supposed to have any major lung, liver or heart disease. Patients who received chemo therapy before or had any sort of pre-existing cardiac failure were ineligible for the therapy .72% of the patients were male, and the rest 28% were females. Patients were excluded because of significant hepatic, cardiac or pulmonary disfunction, and the patients diagnosed with leukemia were not eligible to undertake the therapy. Diagnosis were made according to the French American standards and to be more confirm the results used to be re-examined by the central review committee. Insulin usage was decreased by the patients after undertaking the therapy, moreover a few patients were recommended to undertake a more aggressive intensification therapy in order to achieve better results. Later studies revealed that the patients who were below the age of 60 years and were cured had survived for four years disease free.

Cost:
There are many possible factors which may contribute towards the total cost of the therapy, such as emergency department visits, inpatient visits and outpatient visits. However, other costs such as medication, transportation and accommodation do not play a major role towards the cost. To be exact the medical cost for the first year was $8591, similarly the patients with diabetes had to pay $1333 more over the total cost. Thus, these costs varied regarding the different groups (cohort). Moreover, pharmacy related costs cannot be overseen as it plays a major role in the total costs. Diabetic patients will also incur more pharmacy costs as they will have to take more drugs than the non-diabetic ones. Other sources also elucidate data on the topic of costs incurred to undertake intensification therapy, the sources from which the data had been derived is verifiable, such as the Danish hospital patient registry. It states that the major areas of therapy which contribute largely towards the total cost are diagnosis costs and the cost incurred during the treatment procedure, these costs were calculated in total, however the cost for drugs were calculated individually for every patient according to the intensity of their therapy, their age, and other medical conditions because the usage of drugs vary from patient to patient. Cost was accumulated from many different factors, in which day care treatment had a share of 15%, the cost varied from patients to patients if they had certain allergies. Other expenses also took made a bigger share in the total costs. A study was carried out to distinguish the factors affecting the total costs of the patients with allergies. In the following study it was shown that if a first line drug was used in the treatment of the allergic patients so that will increase the costs and would increase the burden on the patient and his family. Therefore, doctors and other specialists came up with another plan to tackle this situation. Doctors planned to tackle the allergies at first in each of the patient and try to cure them. If the patient gets rid of the allergies so apparently, they would not be needing that line a drug anymore. According to this plan the cost would decreased at least by 25-30% for the allergic patients.

Treatment plan:
Therapy consisted of drugs such as cytarabine 200 mg on daily basis for seven continuous days, and daunorubicin 45mg on daily basis for three consecutive days. If results were not satisfactory a second course of therapy was given to the patients with the same drugs but for lesser days. Therapy includes fractioned radiation therapy given parallel with chemotherapy. The techniques used to deliver radiation therapy is called ‘three dimensional’ techniques, in which two plans were made for the patients, however this plan was securely stored centrally at the Image-Guided Therapy Centre (ITC). Another important aspect of the treatment plan is the statistical analysis, because the future treatment depends on the results of the statistical analysis. Patients who survive the first twelve months of the treatment will have to undertake survival tests and if the result is greater than 0.7113 this means that the patient’s body is responding positively to the therapy. Frequency tables were used to examine toxicities for each arm and to describe their characteristics, the reports were made according to the common toxicity criteria. Quality control of the treatment plan is another important factor as it directly effects the treatment plan. Doctors intended to give chemotherapy with the shortest intervals in between, however at first patients used to get their blood counts checked thrice in a week on the following days Monday, Wednesday and Friday. After 14 days if their blood count gets normal according to the doctors only then patients proceed to the chemo therapy.