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Charles L Loprinzi - One of the best experts on this subject based on the ideXlab platform.
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dronabinol versus Megestrol acetate versus combination therapy for cancer associated anorexia a north central cancer treatment group study
Journal of Clinical Oncology, 2002Co-Authors: Aminah Jatoi, Charles L Loprinzi, James A Mailliard, Jeff A Sloan, Harold E Windschitl, Shaker R Dakhil, Sarode Pundaleeka, Carl G Kardinal, Tom R Fitch, James E KrookAbstract:PURPOSE: To determine whether dronabinol administered alone or with Megestrol acetate was more, less, or equal in efficacy to single-agent Megestrol acetate for palliating cancer-associated anorexia. PATIENTS AND METHODS: Four hundred sixty-nine assessable advanced cancer patients were randomized to (1) oral Megestrol acetate 800 mg/d liquid suspension plus placebo, (2) oral dronabinol 2.5 mg twice a day plus placebo, or (3) both agents. Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight. RESULTS: Groups were comparable at baseline in age, sex, tumor type, weight loss, and performance status. A greater percentage of Megestrol acetate-treated patients reported appetite improvement and weight gain compared with dronabinol-treated patients: 75% versus 49% (P = .0001) for appetite and 11% versus 3% (P = .02) for ≥ 10% baseline weight gain. Combination treatment r...
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does Megestrol acetate down regulate interleukin 6 in patients with cancer associated anorexia and weight loss a north central cancer treatment group investigation
Supportive Care in Cancer, 2002Co-Authors: Aminah Jatoi, Jeff A Sloan, Harold E Windschitl, Jun Ichi Yamashita, Paul J Novotny, Charles L LoprinziAbstract:Megestrol acetate improves appetite and abrogates weight loss in some patients with advanced cancer. Moreover, preliminary studies suggest that progestational agents down-regulate interleukin-6 (IL-6), an inflammatory cytokine widely implicated in cancer-associated anorexia and weight loss. The present investigation examined the effects of Megestrol acetate on IL-6 in an attempt to confirm these earlier, preliminary studies. The translational component of a large multi-institutional trial, this investigation examined 85 patients with advanced cancer and weight loss. Patients had been randomly assigned to receive Megestrol acetate liquid suspension 800 mg/day + placebo tablets, or oral dronabinol tablets 2.5 mg b.i.d. + liquid placebo, or both agents. Other testing included serial physician-reported weight and patient-reported appetite and global quality of life. We found no significant differences in 1-month changes in serum IL-6 according to whether patients had been treated with Megestrol acetate, dronabinol, or the combination: the mean differences ± standard deviation were –1.52±4.7 pg/ml, –0.62±3.5 pg/ml, and –0.2±3.1 pg/ml, respectively (P=0.40, by one-way ANOVA). Among the patients who noted alterations in their appetite over 1 month, we observed no significant changes in IL-6. Finally, changes in serum IL-6 were not associated with shifts in weight or global quality of life. Our investigation provides no evidence that Megestrol acetate down-regulates IL-6 in patients with cancer-associated anorexia and weight loss.
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long term use of Megestrol acetate by cancer survivors for the treatment of hot flashes
Cancer, 1998Co-Authors: Susan K Quella, Charles L Loprinzi, Jeff A Sloan, Nancy L Vaught, W L Dekrey, Tammy Fischer, R Gwen N Finck, R Nancy N Pierson, Thomas M PisanskyAbstract:BACKGROUND Hot flashes are often a troublesome symptom in breast carcinoma survivors and men with prostate carcinoma who have undergone androgen deprivation therapy. A previous clinical study demonstrated that, on a short term basis, low dose Megestrol acetate markedly reduced hot flashes and was well tolerated. Little information has been available regarding the long term use of low dose Megestrol acetate for hot flashes. METHODS Patients previously enrolled on a randomized placebo-controlled trial that evaluated the short term use of Megestrol acetate for hot flashes were contacted and interviewed by telephone. RESULTS A total of 132 persons were contacted. Nine percent of the patients discontinued Megestrol acetate after resolution of their hot flashes. Forty-five percent of the patients contacted were continuing to utilize Megestrol acetate approximately 3 years beyond the conclusion of the 1992 study. Three-quarters of these patients were utilizing ≤20 mg of Megestrol acetate per day. Potential toxicities attributed to Megestrol acetate included episodes of chills, appetite stimulation/weight gain, vaginal bleeding, and carpal tunnel syndrome symptoms. CONCLUSIONS A substantial proportion of patients continue to use Megestrol acetate for periods of up to 3 years or longer with continued control of hot flashes. This treatment appears to be relatively well tolerated. Cancer 1998;82:1784-8. © 1998 American Cancer Society.
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randomized double blind placebo controlled trial of cisplatin and etoposide plus Megestrol acetate placebo in extensive stage small cell lung cancer a north central cancer treatment group study
Journal of Clinical Oncology, 1996Co-Authors: Kendrith M Rowland, Charles L Loprinzi, Loren K Tschetter, Edward G Shaw, A W Maksymiuk, Steven A Kuross, Sinho Jung, John W Kugler, Chirantan Ghosh, Paul L SchaeferAbstract:PURPOSEMegestrol acetate has been reported to improve appetite and quality of life and to decrease nausea and vomiting in patients with cancer anorexia/cachexia. The present trial was formulated to evaluate the impact of Megestrol acetate on quality of life, toxicity, response, and survival in individuals with extensive-stage small-cell lung cancer who received concomitant chemotherapy.PATIENTS AND METHODSPatients were randomized to receive Megestrol acetate 800 mg/d orally or placebo. In addition, all patients were scheduled to receive a maximum of four cycles of cisplatin and etoposide chemotherapy. Quality of life was self-assessed at entry onto study, with every cycle of chemotherapy, and 4 months thereafter with a linear visual analog scale. Toxicity was evaluated by patient questionnaire and investigator reports.RESULTSA total of 243 eligible patients were randomized. Those who received Megestrol acetate had increased nonfluid weight gain (P = .004) and significantly less nausea (P = .0002) and vomi...
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phase iii evaluation of four doses of Megestrol acetate as therapy for patients with cancer anorexia and or cachexia
Journal of Clinical Oncology, 1993Co-Authors: Charles L Loprinzi, Daniel J Schaid, Laureen M Athmann, James A Mailliard, John C Michalak, Richard M Goldberg, Loren K Tschetter, Alan K Hatfield, Roscoe F MortonAbstract:PURPOSESeveral placebo-controlled randomized clinical trials have demonstrated that Megestrol acetate can result in appetite stimulation and nonfluid weight gain in patients with cancer anorexia/cachexia. The present trial was designed to compare Megestrol acetate doses ranging from 160 to 1,280 mg/d.METHODSThis trial randomized 342 assessable patients with cancer anorexia/cachexia to receive oral Megestrol acetate at doses of 160, 480, 800, or 1,280 mg/d. Patients were evaluated monthly by history, examination, patient-completed questionnaires, and serum albumin levels.RESULTSThe data demonstrate that there is a positive dose-response effect for Megestrol acetate on appetite stimulation (P < or = .02). In concert, there was a trend for more nonfluid weight gain with higher drug doses. Megestrol acetate was well tolerated in this group of patients with advanced malignant disease.CONCLUSIONThe positive dose-response effect that we observed for Megestrol acetate on appetite stimulation supports both our pre...
James E Krook - One of the best experts on this subject based on the ideXlab platform.
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dronabinol versus Megestrol acetate versus combination therapy for cancer associated anorexia a north central cancer treatment group study
Journal of Clinical Oncology, 2002Co-Authors: Aminah Jatoi, Charles L Loprinzi, James A Mailliard, Jeff A Sloan, Harold E Windschitl, Shaker R Dakhil, Sarode Pundaleeka, Carl G Kardinal, Tom R Fitch, James E KrookAbstract:PURPOSE: To determine whether dronabinol administered alone or with Megestrol acetate was more, less, or equal in efficacy to single-agent Megestrol acetate for palliating cancer-associated anorexia. PATIENTS AND METHODS: Four hundred sixty-nine assessable advanced cancer patients were randomized to (1) oral Megestrol acetate 800 mg/d liquid suspension plus placebo, (2) oral dronabinol 2.5 mg twice a day plus placebo, or (3) both agents. Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight. RESULTS: Groups were comparable at baseline in age, sex, tumor type, weight loss, and performance status. A greater percentage of Megestrol acetate-treated patients reported appetite improvement and weight gain compared with dronabinol-treated patients: 75% versus 49% (P = .0001) for appetite and 11% versus 3% (P = .02) for ≥ 10% baseline weight gain. Combination treatment r...
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Megestrol and tamoxifen in patients with advanced endometrial cancer an eastern cooperative oncology group study e4882
American Journal of Clinical Oncology, 2001Co-Authors: Kishan J Pandya, Beow Y Yeap, Louis M Weiner, James E Krook, John K Erban, Roger A Schinella, Thomas E DavisAbstract:: To investigate the effect of adding tamoxifen to Megestrol in the hormonal therapy for advanced endometrial cancer, 66 patients were entered in this study. Initially, 41 patients were randomized to either the standard progestin therapy of Megestrol or to the combination of Megestrol and tamoxifen between October 1982 and October 1984. The Megestrol arm was terminated because of poor accrual and 25 patients were directly assigned to the combination arm. Among the 20 eligible cases on the Megestrol arm, the response rate of 20% consisted of I complete response and 3 partial responses. The response rate on the Megestrol plus tamoxifen arm was 19% with 1 (2%) complete response and 7 (17%) partial responses among 42 eligible cases. The median survival times were 12.0 months and 8.6 months, respectively. Only mild and moderate toxicities were observed on Megestrol compared with more toxic complications observed on the combination of Megestrol and tamoxifen, including a life-threatening case of pulmonary embolism. Although we could not carry out a comparative evaluation as intended, we conclude that the combination of Megestrol and tamoxifen offers no clinical advantage over Megestrol alone in the treatment of advanced endometrial carcinoma.
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controlled trial of Megestrol acetate for the treatment of cancer anorexia and cachexia
Journal of the National Cancer Institute, 1990Co-Authors: Charles L Loprinzi, James E Krook, Neil M Ellison, Daniel J Schaid, Laureen M Athmann, Ann Marie Dose, James A Mailliard, P S Johnson, Larry P Ebbert, L H GeeraertsAbstract:: Preliminary information has suggested that Megestrol acetate leads to appetite stimulation and nonfluid weight gain in patients with breast cancer, other cancers, and AIDS. Pursuant to this, we developed a randomized, double-blind, placebo-controlled trial of Megestrol acetate in patients with cancer-associated anorexia and cachexia. We randomly assigned 133 eligible patients to receive 800 mg of Megestrol acetate per day or a placebo. Patients assigned to Megestrol acetate more frequently reported improved appetite (P = .003) and food intake (P = .009) when compared with patients receiving the placebo. A weight gain of 15 lb or more over baseline was seen in 11 of 67 (16%) patients receiving Megestrol acetate compared with one of 66 (2%) given the placebo (P = .003). Patients receiving Megestrol acetate reported significantly less nausea (13% vs. 38%; P = .001) and emesis (8% vs. 25%, P = .009). No clinically or statistically significant toxic reactions were ascribed to Megestrol acetate, with the exception of mild edema. This study convincingly demonstrated that Megestrol acetate can stimulate appetite and food intake in patients with anorexia and cachexia associated with cancer, leading to significant weight gain in a proportion of such patients.
Cynthia H Miller - One of the best experts on this subject based on the ideXlab platform.
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induction of adrenal suppression by Megestrol acetate in patients with aids
Annals of Internal Medicine, 1995Co-Authors: Matthew C Leinung, Ralph Liporace, Cynthia H MillerAbstract:Objective: To investigate the development of secondary adrenal suppression in a patient with the acquired immunodeficiency syndrome (AIDS) who was receiving Megestrol acetate. Design and Patients: Case report of one patient abruptly withdrawn from long-term therapy with Megestrol acetate; prospective study of four patients with AIDS who were starting therapy with Megestrol acetate for cachexia. Setting: Outpatient clinic of a university hospital. Interventions: Study patients received Megestrol acetate, 80 mg three times daily. Measurements: Study patients had cosyntropinstimulation testing and oral glucose tolerance testing before and after starting therapy with Megestrol acetate. Results: The patient described in the case report developed symptoms of adrenal insufficiency after withdrawal of Megestrol acetate after 4 years of treatment. His basal cortisol and adrenocorticotropic hormone (ACTH) levels were low. He showed an abnormally diminished response to a short cosyntropin-stimulation test but did respond to a 3-day cosyntropin-stimulation test. The morning cortisol levels of the study patients decreased significantly (from 11.0±1.8 μg/dL to 1.5±0.9 μg/dL; P<0.01), and the ACTH levels of these patients decreased to below normal (from 16.6±5.5 pg/mL to 6.3±3.3 pg/mL; P=0.02) during treatment with Megestrol acetate. Cortisol levels after administration of cosyntropin decreased significantly (from 27.3±3.3 pg/mL to 9.3±6.3 pg/mL; P= 0.01) during treatment with Megestrol acetate. The results of oral glucose tolerance testing in two patients were consistent with the development of insulin resistance, and daily insulin requirements increased 10-fold in a patient who had preexisting diabetes. Conclusions: Prolonged administration of Megestrol acetate can induce clinically significant secondary adrenal suppression, and abrupt withdrawal of Megestrol acetate after prolonged administration can cause adrenal insufficiency
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Induction of Adrenal Suppression by Megestrol Acetate in Patients with AIDS
Annals of Internal Medicine, 1995Co-Authors: Matthew C Leinung, Ralph Liporace, Cynthia H MillerAbstract:Objective: To investigate the development of secondary adrenal suppression in a patient with the acquired immunodeficiency syndrome (AIDS) who was receiving Megestrol acetate. Design and Patients: Case report of one patient abruptly withdrawn from long-term therapy with Megestrol acetate; prospective study of four patients with AIDS who were starting therapy with Megestrol acetate for cachexia. Setting: Outpatient clinic of a university hospital. Interventions: Study patients received Megestrol acetate, 80 mg three times daily. Measurements: Study patients had cosyntropinstimulation testing and oral glucose tolerance testing before and after starting therapy with Megestrol acetate. Results: The patient described in the case report developed symptoms of adrenal insufficiency after withdrawal of Megestrol acetate after 4 years of treatment. His basal cortisol and adrenocorticotropic hormone (ACTH) levels were low. He showed an abnormally diminished response to a short cosyntropin-stimulation test but did respond to a 3-day cosyntropin-stimulation test. The morning cortisol levels of the study patients decreased significantly (from 11.0±1.8 μg/dL to 1.5±0.9 μg/dL; P
Daniel J Schaid - One of the best experts on this subject based on the ideXlab platform.
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phase iii evaluation of four doses of Megestrol acetate as therapy for patients with cancer anorexia and or cachexia
Journal of Clinical Oncology, 1993Co-Authors: Charles L Loprinzi, Daniel J Schaid, Laureen M Athmann, James A Mailliard, John C Michalak, Richard M Goldberg, Loren K Tschetter, Alan K Hatfield, Roscoe F MortonAbstract:PURPOSESeveral placebo-controlled randomized clinical trials have demonstrated that Megestrol acetate can result in appetite stimulation and nonfluid weight gain in patients with cancer anorexia/cachexia. The present trial was designed to compare Megestrol acetate doses ranging from 160 to 1,280 mg/d.METHODSThis trial randomized 342 assessable patients with cancer anorexia/cachexia to receive oral Megestrol acetate at doses of 160, 480, 800, or 1,280 mg/d. Patients were evaluated monthly by history, examination, patient-completed questionnaires, and serum albumin levels.RESULTSThe data demonstrate that there is a positive dose-response effect for Megestrol acetate on appetite stimulation (P < or = .02). In concert, there was a trend for more nonfluid weight gain with higher drug doses. Megestrol acetate was well tolerated in this group of patients with advanced malignant disease.CONCLUSIONThe positive dose-response effect that we observed for Megestrol acetate on appetite stimulation supports both our pre...
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effect of Megestrol acetate on the human pituitary adrenal axis
Mayo Clinic Proceedings, 1992Co-Authors: Charles L Loprinzi, Michael D Jensen, N S Jiang, Daniel J SchaidAbstract:A few previous reports have suggested that Megestrol acetate, a synthetic progestational agent frequently used as an antineoplastic drug, suppresses serum cortisol concentrations in humans. To explore this concept further, we prospectively performed several measurements of the pituitary-adrenal axis in patients receiving Megestrol acetate (160 or 800 mg/day). The data from these evaluations demonstrate that Megestrol acetate reversibly decreases serum cortisol concentrations in humans and that this effect seems to originate from a suppression of the pituitary-adrenal axis. Additional studies should be conducted to determine the implications of the low levels of serum cortisol.
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controlled trial of Megestrol acetate for the treatment of cancer anorexia and cachexia
Journal of the National Cancer Institute, 1990Co-Authors: Charles L Loprinzi, James E Krook, Neil M Ellison, Daniel J Schaid, Laureen M Athmann, Ann Marie Dose, James A Mailliard, P S Johnson, Larry P Ebbert, L H GeeraertsAbstract:: Preliminary information has suggested that Megestrol acetate leads to appetite stimulation and nonfluid weight gain in patients with breast cancer, other cancers, and AIDS. Pursuant to this, we developed a randomized, double-blind, placebo-controlled trial of Megestrol acetate in patients with cancer-associated anorexia and cachexia. We randomly assigned 133 eligible patients to receive 800 mg of Megestrol acetate per day or a placebo. Patients assigned to Megestrol acetate more frequently reported improved appetite (P = .003) and food intake (P = .009) when compared with patients receiving the placebo. A weight gain of 15 lb or more over baseline was seen in 11 of 67 (16%) patients receiving Megestrol acetate compared with one of 66 (2%) given the placebo (P = .003). Patients receiving Megestrol acetate reported significantly less nausea (13% vs. 38%; P = .001) and emesis (8% vs. 25%, P = .009). No clinically or statistically significant toxic reactions were ascribed to Megestrol acetate, with the exception of mild edema. This study convincingly demonstrated that Megestrol acetate can stimulate appetite and food intake in patients with anorexia and cachexia associated with cancer, leading to significant weight gain in a proportion of such patients.
Alan Webster - One of the best experts on this subject based on the ideXlab platform.
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anastrozole versus Megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma results of a survival update based on a combined analysis of data from two mature phase iii trials
Cancer, 1998Co-Authors: U Aman M D Buzdar, M Walter D Jonat, M Anthony D Howell, E Stephen M D Jones, P Carl M D Blomqvist, L Charles M D Vogel, M Wolfgang D Eiermann, M Janet M D Wolter, M Steinberg, Alan WebsterAbstract:BACKGROUND. This report presents the results of a survival update based on the combined data from two studies that compared the efficacy and tolerability of anastrozole (1 or 10 mg once daily), a selective, nonsteroidal aromatase inhibitor administered orally, and Megestrol acetate (40 mg 4 times daily) in the treatment of postmenopausal women with advanced breast carcinoma whose disease had progressed after treatment with tamoxifen. METHODS. Two randomized, parallel-group, multicenter trials were conducted, involving a total of 764 patients. The two trials were identical in design; both were double blind for anastrozole and open label for Megestrol acetate. Overview analyses were conducted with the intent of strengthening the interpretation of results from each trial. The median follow-up duration for this survival update was 31 months. RESULTS. At the clinical dose of 1 mg daily, anastrozole demonstrated a statistically significant survival advantage over Megestrol acetate, with a hazard ratio of 0.78 (P , 0.025)(0.60 , 97.5% confidence interval [CI] ,1.0). The 1 mg anastrozole group also had a longer median time to death (26.7 months) compared with 22.5 months for the Megestrol acetate group. The 10 mg anastrozole group also had a survival benefit over the Megestrol acetate group, with a hazard ratio of 0.83 (P 5 0.09, not significant)(0.64 , 97.5% CI , 1.1). Higher 2-year survival rates were observed for both anastrozole treatment groups than for the Megestrol acetate group (56.1%, 54.6%, and 46.3% for the groups given 1 mg anastrozole, 10 mg anastrozole, and Megestrol acetate, respectively).
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a phase iii trial comparing anastrozole 1 and 10 milligrams a potent and selective aromatase inhibitor with Megestrol acetate in postmenopausal women with advanced breast carcinoma
Cancer, 1997Co-Authors: Aman U Buzdar, Janet Wolter, Stephen E Jones, Charles L Vogel, Paul V Plourde, Alan WebsterAbstract:BACKGROUND Anastrozole is a new oral aromatase inhibitor with highly potent and selective activity for the aromatase enzyme. In a Phase III trial, the efficacy and tolerability of anastrozole, given in doses of 1 and 10 mg orally once daily, and Megestrol acetate, given in doses of 40 mg orally 4 times daily, were compared in 386 postmenopausal women with advanced breast carcinoma who progressed after tamoxifen therapy. METHODS The trial was randomized, double blind for anastrozole, open label for Megestrol acetate, parallel group, and multicenter. Patients were randomly assigned to receive anastrozole, 1 mg (n = 128); anastrozole, 10 mg (n = 130); or Megestrol acetate (n = 128). The primary efficacy measures were time to progression and tumor response; secondary measures were time to treatment failure, duration of response, quality of life, and time to death. RESULTS With a median duration of follow-up of 6 months, there was no statistical evidence of a difference between either 1 or 10 mg doses of anastrozole and Megestrol acetate for any efficacy endpoint. According to rigid response criteria, 10%, 6%, and 6% of patients in the anastrozole 1 mg, anastrozole 10 mg, and Megestrol acetate groups, respectively, had an objective response (complete response or partial response) and 27%, 24%, and 30% of patients in the respective groups had stable disease for a duration of 24 weeks or longer. Quality-of-life assessments revealed that anastrozole in a 1-mg dose was associated with better physical scores and anastrozole in a 10-mg dose with better psychologic scores than Megestrol acetate. Both anastrozole and Megestrol acetate were generally well tolerated. Among anticipated adverse events, gastrointestinal disturbance was more common among patients in the anastrozole groups, whereas weight gain occurred more frequently among patients in the Megestrol acetate groups. Weight increases of 5% or more and 10% or more were more common among Megestrol acetate-treated patients; moreover, patients in this group continued to gain weight over time. CONCLUSIONS Anastrozole, given in doses of 1 and 10 mg once daily, represents a well tolerated and effective therapeutic option for the treatment of postmenopausal women with advanced breast carcinoma who progress after tamoxifen treatment. Cancer 1997; 79:730-9. © 1997 American Cancer Society.
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anastrozole a potent and selective aromatase inhibitor versus Megestrol acetate in postmenopausal women with advanced breast cancer results of overview analysis of two phase iii trials arimidex study group
Journal of Clinical Oncology, 1996Co-Authors: Aman U Buzdar, Charles L Vogel, Walter Jonat, Anthony Howell, S Jones, Carl Blomqvist, Wolfgang Eiermann, Janet M Wolter, Mohammed Azab, Alan WebsterAbstract:PURPOSETo compare the efficacy and tolerability of anastrozole (1 and 10 mg once daily), a selective, oral, nonsteroidal aromatase inhibitor, and Megestrol acetate (40 mg four times daily), in postmenopausal women who progressed following tamoxifen treatment.PATIENTS AND METHODSTwo randomized, double-blind for anastrozole, open-label for Megestrol acetate, parallel-group, multicenter trials were conducted in 764 patients. Because both trials were identical in design, an analysis of the combined results was performed to strengthen interpretation of results from each trial.RESULTSThe median follow-up duration was approximately 6 months. The estimated progression hazards ratios were 0.97 (97.5% confidence interval [CI], 0.75 to 1.24) for anastrozole 1 mg versus Megestrol acetate and 0.92 (97.5% CI, 0.71 to 1.19) for anastrozole 10 mg versus Megestrol acetate. The overall median time to progression was approximately 21 weeks. Approximately one third of patients in each group benefited from treatment. Twenty-s...