Endometrial carcinoma is predominantly a disease of postmenopausal women, so we don't have to consider fertility. But in case of young women who want to preserve their fertility, it is very difficult to approach. We experienced one case of treatment using high-dose Megestrol Acetate (Megace(R)) combined with PDT (Photodynamic Therapy) on early stage of endometrial carcinoma, in young aged woman who wanted to preserve her fertility. And, we described briefly clinicopathologic findings, reviews of literatures and possibility of combined therapy with Megestrol and PDT.
Endometrial Neoplasms* ; Female ; Fertility ; Humans ; Megestrol Acetate* ; Megestrol*

The effectiveness of progestogens in advanced and recurrent endometrial carcinoma has been widely accepted. But the use of progestogens in young women with early stage of endometrial carcinoma (Stage Ia) is controversial. Some authors reported that progestogens alone therapy improved or cured the endometrial pathology in young patients with early stage of endometrial carcinoma. The response to the progestogens has known to be better in cases of early stage, well-differentiated histologic type and narrow depth of invasion. We used the high-dose megestrol acetate (Megace(R)) as the primary treatment in four young women with early stage of endometrial carcinoma (Stage Ia) for the purpose of saving the fertility. We made the patients to have 320~400 mg of Megace(R) per day for 3 months, and then repeated the endometrial curettage for the purpose of finding changes of endometrial pathology. Three cases revealed no response to the Megace(R), so they were operated later. One case showed the resolution of endometrial pathology and delivered a baby following therapy. There have been no evidences of clinical recurrence in all cases. Even though the therapeutic efficacy is limited, high-dose therapy with megestrol acetate can be used as primary therapy in young women with early stage of endometrial carcinoma.
Curettage ; Endometrial Neoplasms* ; Female ; Fertility ; Humans ; Megestrol Acetate* ; Megestrol* ; Pathology ; Progestins ; Recurrence ; Treatment Outcome*

Loss of appetite is an important factor in the quality of life for advanced cancer patients. Megestrol acetate is used to stimulate appetite, but it can cause suppression of the pituitary adrenal axis due to the affinity of the glucocorticoid receptor. Adrenal insufficiency is a life threatening disorder if left, untreated, but the initial clinical symptoms of the patients are vague. Awareness of the glucocorticoid-like activity of megestrol acetate and its side effects are important for the diagnosis of adrenal insufficiency. We present a case of secondary adrenal insufficiency associated with megestrol acetate in a patient with lung cancer.
Adrenal Insufficiency ; Appetite ; Axis, Cervical Vertebra ; Humans ; Lung ; Lung Neoplasms ; Megestrol ; Megestrol Acetate ; Quality of Life ; Receptors, Glucocorticoid

PURPOSE: Maintenance hemodialysis (HD) patients have a high prevalence of malnutrition and inflammation. Megestrol acetate (MA) has been shown to increase appetite in cancer patients but the usual dose of MA (400-800 mg/day) was associated with serious side effects in HD patients. We evaluated the changes in nutritional and inflammatory parameters after low dose of MA treatment in malnourished HD patients METHODS: Inclusion criteria were maintenance HD patients who showed serum albumin <3.5 g/dL or <4.0 g/dL with anorexia. Serum chemical parameters, cytokines, Subjective Global Assessment, dry weight, Kt/V, nPCR, SF36 quality of life, fat free mass (FFM), and body fat mass (BFM) were measured. Patients were instructed to take 5 mL (200 mg) of MA solution once a day. RESULTS: Fourteen patients (seven male, age 52+/-10 years, mean HD duration 48+/-59 months) were included. One patient died of pneumonia. Seven patients dropped out because they refused to take the drug after one to three months of treatment; two of them complained of thirst, three of them ate too much, and two had both. Six patients (four male and two female) have completed six months of study. Serum albumin (3.1+/-0.5 to 3.6+/-0.4 g/dL), TIBC (184.2+/-27.9 to 205.0+/-25.8 microgram/ dL), BFM (11.9+/-5.7 to 16.6+/-7.4 kg), protein intake (57.0+/-32.5 to 68.7+/-39.2 g/day), and energy intake (1,521+/-690 to 1,724+/-879) were increased. Serum CRP and IL-6 decreased without statistical significance. No significant adverse effects were observed in all patients who had completed study. CONCLUSION: Low dose MA can improve the nutritional status, inflammation, and anorexia in maintenance HD patients.
Adipose Tissue ; Anorexia ; Appetite ; Cytokines ; Energy Intake ; Humans ; Inflammation ; Interleukin-6 ; Male ; Malnutrition ; Megestrol ; Megestrol Acetate ; Nutritional Status ; Pneumonia ; Prevalence ; Quality of Life ; Renal Dialysis ; Serum Albumin ; Thirst

PURPOSE: The study was aimed to review and understand the meaning of cancer cachexia. METHODS: Using the keywords "cachexia" and "cancer cachexia" 30 oncology research published from 1974 to 2009 were selected for the review. RESULTS: The mechanism of cancer cachexia has not been fully understood, but various pathogenesis appears to be involved in the development cachexia including altered metabolism of carbohydrate, lipid, and protein associated with cytokines and hormone. As a result, muscle strength, food intake and resting energy expenditure (REE) are reduced. Most medications for the treatment of cachexia show debating results except some drugs such as megace. Supportive care including nutritional education, nursing care, and social support are found another effective treatment options. CONCLUSION: The results of this study would help oncology nurses to understand the mechanism of cancer cachexia and its management.
Cachexia ; Cytokines ; Eating ; Education, Nursing ; Energy Metabolism ; Megestrol Acetate ; Muscle Strength

Endometrial cancer is increasing in South Korea. In young women, endometrial cancer can be treated by progestins for preserving fertility. We experienced a successful case of twin pregnancy after conservative therapy of endometrial cancer with Megestrol acetate. Ovulation induction and intrauterine insemination was done. A brief review of related literature was done.
Endometrial Neoplasms* ; Female ; Fertility ; Humans ; Insemination ; Korea ; Megestrol Acetate ; Ovulation Induction ; Pregnancy ; Pregnancy, Twin* ; Progestins ; Twins*

OBJECTIVE: The aim of this study is to investigate the effectiveness of high dose progestins in young patients with early stage of endometrial cancer. METHODS: Between April 1998 and December 2005, 10 women with early stage of endometrial carcinoma were treated with high dose progestins as primary therapy for the purpose of saving fertility. RESULTS: They took 80~160 mg of megestrol acetate or 500~1,000 mg of medroxyprogesterone acetate per day, and then followed up with the endometrial curettages. Seven patients (70.0%) responded to the treatment. Three patients didn't respond and so underwent hysterectomy as definite treatment. Four patients were able to become pregnant after completing treatment. No patients died of their disease. CONCLUSION: The majority of patients with well-differentiated endometrial adenocarcinoma who underwent conservative treatment with a progestational agent responded to the treatment. High-dose progestin therapy can be used as primary therapy in selected young women with early stage of endometrial carcinoma.
Adenocarcinoma ; Curettage ; Endometrial Neoplasms* ; Female ; Fertility ; Humans ; Hysterectomy ; Medroxyprogesterone Acetate ; Megestrol Acetate ; Progestins ; Treatment Outcome*

In generic drug development, comparative pharmacokinetic (PK) studies are conducted to assess equivalence in pharmacokinetics and safety profiles between test and reference formulations. However, there is no established quantitative approach available for safety assessment. This study aimed to propose a method for drug safety evaluation in generic drug development, as assessed by drug influence on blood pressure and heart rate change. Data were taken from a randomized, open label, 2-way cross-over comparative PK study for megestrol conducted in 39 healthy male volunteers. Vital signs of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at 0 (pre-dose), 4, 8, 12, 24, 48, 72, 96 and 120 hours after the dose. Safety parameters used in the analysis were area under vital sign change versus time curve to the last measured time (AUVlast) and maximum vital sign change (Vmax). Considering highly variable nature of vital signs, the scaled bioequivalence approach developed by US FDA was adopted as a decision rule for safety evaluation between formulations. With the FDA scaled approach, 90% confidence intervals of geometric mean ratio for DBP, 0.7969~1.0377 for Vmax and 0.7304~1.0660 for AUVlast, were both included in the equivalence ranges of 0.7694~1.2997 and 0.6815~1.4674, respectively, and similarly, those for HR were included in their respective scaled equivalence limits, while SBP satisfied the conventional equivalence criterion of 0.8-1.25. These results illustrate the feasibility of applying the suggested approach in cardiovascular safety evaluation in a generic drug.
Blood Pressure ; Heart Rate ; Humans ; Male ; Megestrol ; Pharmacokinetics ; Therapeutic Equivalency ; Vital Signs ; Volunteers

A rapid and highly selective liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for the determination of megestrol in human plasma was described using medrysone as internal standard (IS). Blood samples were collected from 20 healthy volunteers after oral administration of 160 mg megestrol acetate dispersible tablets. The analytes were extracted by liquid-liquid extraction procedure and separated on a hanbon lichrospher column with the mobile phase of methanol and water containing 0.1% formic acid and 20 mmol/L ammonium acetate (5:1, v/v). Positive ion electrospray ionization with multiple reaction-monitoring mode (MRM) was employed by monitoring the transitions m/z 385.5-325.4 and m/z 387.5-327.4 for megestrol and medrysone, respectively. Under the isocratic separation conditions, the chromatographic run time was approximately 2.54 min for megestrol and 2.59 min for medrysone. The calibration curve range was from 0.5 to 200.0 ng/mL. The inter-batch and intra-batch precision and accuracy were less than 5.2% relative standard deviation (RSD) and 6.4% relative error (RE). The proposed method was successfully applied in the bioequivalence study of megestrol acetate dispersible tablets.
Calibration ; Gas Chromatography-Mass Spectrometry ; methods ; standards ; Humans ; Megestrol ; blood ; chemistry ; pharmacokinetics ; Therapeutic Equivalency

AIMTo study the impurity in the drug megestrol acetate.

METHODSChromatography methods were used to separate the chemical constituents. Their structures were determined by NMR and MS spectral analysis.

RESULTSTwo new epimers were isolated from the mother liquid of the drug megestrol acetate.

CONCLUSIONThese new epimers were identified as 17alpha-acetoxy-2beta,6alpha-dimethylprega-4-ene-3,20-dione (1) and 17alpha-acetoxy-2alpha,6alpha-dimethylprega-4-ene-3,20-dione (2).

Drug Contamination ; Megestrol Acetate ; chemical synthesis ; chemistry ; Molecular Conformation ; Molecular Structure ; Pregnanediones ; chemistry ; isolation & purification ; Stereoisomerism