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DRUG:

megestrol

i
Other names: BDH 1298
Company:
Generic mfg.
Drug class:
Progesterone receptor agonist
8d
Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial. (PubMed, Gynecol Oncol)
These results support a potential role of the palbociclib-letrozole combination as treatment for hormone receptor-positive advanced/recurrent endometrial cancer. Based on these encouraging results, phase III evaluation of letrozole combined with a CDK4/6 inhibitor is planned.
P2 data • Journal • Metastases
|
ER (Estrogen receptor) • CCNA2 (Cyclin A2)
|
ER positive • HR positive
|
Ibrance (palbociclib) • letrozole • megestrol
14d
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy (clinicaltrials.gov)
P2, N=44, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025
Trial completion date • Trial primary completion date
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megestrol
16d
Megestrol acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and early-stage endometrial adenocarcinoma: a prospective study (PubMed, Nan Fang Yi Ke Da Xue Xue Bao)
Metformin combined with MA may provide an effective option for fertility-sparing treatment of AEH and grade 1 stage IA EAC, and the clinical benefits of metformin for controlling MA-induced weight gain and promoting endometrial expressions of IGFBP-rP1 and p-AMPK while inhibiting p-Akt expression warrants further study.
Journal
|
IGFBP7 (Insulin Like Growth Factor Binding Protein 7)
|
metformin • megestrol
1m
IKanEat: a Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children (clinicaltrials.gov)
P4, N=71, Active, not recruiting, University of Kansas Medical Center | Recruiting --> Active, not recruiting
Enrollment closed
|
megestrol
1m
New P3 trial
|
megestrol • Orgovyx (relugolix)
2ms
Leptin as a surrogate immune-metabolic marker to predict impact of anti-cachectic therapy: results of a prospective randomized trial in multiple solid tumors. (PubMed, ESMO Open)
Leptin is a reliable predictive marker for multitargeted anti-cachectic treatment outcomes. Thus, it can be an ideal candidate for monitoring and predicting the effects of anti-cachectic treatment and a surrogate marker of the immune-metabolic actions of the selected drugs.
Journal
|
LEP (Leptin)
|
megestrol • celecoxib oral
4ms
New trial • Mismatch repair
|
Keytruda (pembrolizumab) • Tyvyt (sintilimab) • megestrol
5ms
Consenso de expertos basado en la evidencia: perfilamiento y manejo del carcinoma epitelial de ovario de alto grado avanzado. (PubMed, Rev Colomb Obstet Ginecol)
Se sugiere utilizar bevacizumab u olaparib más bevacizumab en pacientes con CEO estadios III/IV BRCA1/2 negativo o desconocido (HRD positivo) que recibieron quimioterapia basada en platino más bevacizumab y obtuvieron RC/RP...Para pacientes con CEO de alto grado avanzado o metastásico en recaída platino-sensibles se sugiere: • Quimioterapia combinada basada en platino: carboplatino/doxorrubicina liposomal o carboplatino/paclitaxel o carboplatino/ nab-paclitaxel o carboplatino/docetaxel o carboplatino/gemcitabina, por seis ciclos. Si no se tolera la terapia combinada, dar carboplatino o cisplatino solo. • Quimioterapia combinada: carboplatino/gemcitabina o carboplatino/paclitaxel o carboplatino/doxorubicina liposomal, más bevacizumab, seguida de bevacizumab como mantenimiento (hasta progresión o toxicidad)...El paclitaxel semanal o la doxorrubicina liposomal pegilada o el topotecan pueden ser administrados con o sin bevacizumab. • Existen otros agentes que se consideran potencialmente act ivos (capecitabina, ciclofosfamida, ifosfamida, irinotecán, oxaliplatino, pemetrexed, vinorelbina, ciclofosfamida), que se podrían recomendar para líneas posteriores. • Las pacientes con receptores hormonales positivos que no toleran o no tienen respuesta a los regímenes citotóxicos pueden recibir terapia hormonal con tamoxifeno u otros agentes, incluidos los inhibidores de la aromatasa (anastrozol y letrozol) o acetato de leuprolide o acetato de megestrol...El niraparib podría ser útil en pacientes BRCA 1/2 +/-/desconocido, al igual que el rucaparib, sin embargo, este último no tiene aún aprobación del ente regulador en Colombia. Conclusiones: se espera que las recomendaciones emitidas en este consenso contribuyan a mejorar la atención clínica, el impacto oncológico y la calidad de vida de estas mujeres.
Clinical guideline • Journal
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • PARP1 (Poly(ADP-Ribose) Polymerase 1)
|
Avastin (bevacizumab) • Lynparza (olaparib) • cisplatin • carboplatin • gemcitabine • tamoxifen • Zejula (niraparib) • Rubraca (rucaparib) • albumin-bound paclitaxel • pemetrexed • topotecan • megestrol • leuprolide acetate for depot suspension
5ms
Nutrition Impact on Immunotherapy of Cancer (clinicaltrials.gov)
P3, N=300, Recruiting, Qingdao Central Hospital
New P3 trial
|
megestrol • olanzapine
7ms
Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients (clinicaltrials.gov)
P3, N=360, Recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Apr 2024 --> May 2026
Trial completion date • Trial primary completion date
|
megestrol • olanzapine
7ms
Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women (clinicaltrials.gov)
P=N/A, N=75, Recruiting, Women's Hospital School Of Medicine Zhejiang University
New trial
|
TP53 wild-type
|
megestrol
7ms
iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children (clinicaltrials.gov)
P4, N=60, Recruiting, University of Kansas Medical Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
megestrol
8ms
Correlation between steroid receptor expression and response to progestational therapy in patients with atypical endometrial hyperplasia or cancer. (PubMed, Gynecol Oncol Rep)
Retrospective cohort study collected data for patients with AEH or EMCA who had an endometrial sample after receiving conservative therapy utilizing either Megestrol acetate or Levonorgestrel Intrauterine device (IUD). Immunohistochemistry (IHC) was performed on pre- and post- treatment biopsy samples to assess androgen receptor (AR), estrogen receptor (ER), and progesterone receptor (PR) expression...Patients who successfully responded to the treatment demonstrated a significantly greater decrease in IHC scores after the treatment compared to those who did not respond (p = 0.009). Steroid receptor expression could be used as a possible biomarker for response to progestin therapy in patients undergoing conservative management for AEH and EMCA.
Journal
|
ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
|
PGR expression
|
megestrol
8ms
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer (clinicaltrials.gov)
P2, N=104, Recruiting, Fudan University | Trial primary completion date: Mar 2024 --> Mar 2025
Trial primary completion date
|
letrozole • megestrol
10ms
Enrollment open • Metastases
|
AKT1S1 (AKT1 Substrate 1)
|
ipatasertib (RG7440) • megestrol
11ms
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine (clinicaltrials.gov)
P4, N=126, Completed, Children's Hospital of Fudan University | Recruiting --> Completed
Trial completion
|
megestrol • leuprolide acetate for depot suspension
11ms
Trial completion
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDH1 (Cadherin 1) • CDH2 (Cadherin 2)
|
ER positive • HER-2 negative • CDH1 expression
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letrozole • megestrol
11ms
Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma (clinicaltrials.gov)
P2, N=48, Recruiting, Fudan University | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
Trial completion date • Trial primary completion date
|
megestrol
11ms
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: May 2024 --> Nov 2024 | Trial primary completion date: May 2024 --> Nov 2024
Trial completion date • Trial primary completion date
|
megestrol
12ms
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy (clinicaltrials.gov)
P2, N=44, Active, not recruiting, City of Hope Medical Center | Trial primary completion date: Dec 2023 --> Nov 2024 | Trial completion date: Dec 2023 --> Nov 2024
Trial completion date • Trial primary completion date
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megestrol
1year
New P1 trial
|
megestrol
1year
Trial suspension • Metastases
|
AKT1S1 (AKT1 Substrate 1)
|
ipatasertib (RG7440) • megestrol
1year
Antiangiogenics in Malignant Granular Cell Tumors: Review of the Literature. (PubMed, Cancers (Basel))
Other reported targeted therapies for malignant GCTs included pazopanib in combination with crizotinib, which showed disease control for four months in one patient, and a PI3K inhibitor which achieved disease control for nine months in another patient. Dasatinib and megestrol were ineffective in two other different patients. Pazopanib has been demonstrated to be active in advanced GCTs and may be considered as a preferable treatment option.
Review • Journal
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PDGFRB (Platelet Derived Growth Factor Receptor Beta) • ATP6AP1 (ATPase H+ Transporting Accessory Protein 1)
|
Xalkori (crizotinib) • dasatinib • pazopanib • megestrol
1year
Phase classification • Metastases
|
AKT1S1 (AKT1 Substrate 1)
|
ipatasertib (RG7440) • megestrol
1year
Clinical relevance of circulating ESR1 mutations during endocrine therapy for advanced hormone-dependent endometrial carcinoma. (PubMed, BMC Cancer)
ESR1 mutations do not seem to be involved in the mechanisms of resistance to AI or M in HR+ endometrial cancer. The clinical relevance of their detection is not demonstrated.
Retrospective data • Journal • Metastases
|
ER (Estrogen receptor)
|
ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER Y537C
|
megestrol
1year
MA-EEC: Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer (clinicaltrials.gov)
P1, N=5, Terminated, Sunnybrook Health Sciences Centre | N=73 --> 5 | Trial completion date: Sep 2024 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Oct 2023; Slow enrollment
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Surgery
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TP53 wild-type
|
megestrol
1year
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2023 --> May 2024 | Trial primary completion date: Oct 2023 --> May 2024
Trial completion date • Trial primary completion date
|
ER (Estrogen receptor) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog) • CASP3 (Caspase 3) • PAX2 (Paired Box 2)
|
megestrol
1year
Feasibility and Activity of Megestrol Acetate in Addition to Etoposide, Doxorubicin, Cisplatin, and Mitotane as First-Line Therapy in Patients with Metastatic/Unresectable Adrenocortical Carcinoma with Low Performance Status. (PubMed, Cancers (Basel))
No differences in PFS and OS curves were observed; the CBR was 75.0% and 60.4%, respectively. (4) The association of EDP-M + megestrol acetate in ACC pts with a low PS is feasible and well tolerated; its efficacy appeared to be non-inferior to EDP-M administered to pts with a good PS.
Journal • Metastases
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cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane) • megestrol
over1year
Should we abandon hormonal therapy in endometrial cancer? Outcomes of recurrent and metastatic endometrial cancer treated with systemic progestins. (PubMed, Cancer Med)
This real-world data on RMEC suggests there is a role for progestins in select subgroups of women. The PFS for chemotherapy-naïve patients was 17.9 months (14.3, 27.0), versus 6.2 months (3.9, 14.8) following ≥1 line of treatment. The OS was 29.1 months (17.9, 61.1) for chemotherapy-OS was 29.1 months (17.9, 61.1) for chemotherapy-naïve patients versus 23.0 months (10.5, 37.6) for patients previously exposed.
Retrospective data • Journal • Metastases
|
megestrol
over1year
Fertility -Preserving Approach In P53 Mutant Grade 2 Endometrioid Endometrial Canser- Cases Presentation (ESGO 2023)
The patient used Megestrol acetate 160 mg for 3 months...Following the procedure, the pathology report showed low-grade endometrial endometrioid carcinoma (FIGO grade 2).Conclusion Fertility-preserving approaches can be considered as a rare option for P53 Mutant Grade2 endometrioid endometrial cancer patients. However, as seen in our case, despite close monitoring, disease progression has been observed.
Clinical
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TP53 (Tumor protein P53) • POLE (DNA Polymerase Epsilon)
|
TP53 mutation • POLE mutation
|
megestrol
over1year
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer (clinicaltrials.gov)
P=N/A, N=57, Recruiting, Peking University People's Hospital
New trial
|
TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
TP53 expression
|
triptorelin • goserelin acetate • megestrol
over1year
Fertility-sparing hormonal treatment in patients with stage I endometrial cancer of grade 2 without myometrial invasion and grade 1-2 with superficial myometrial invasion: Gynecologic Oncology Research Investigators coLLaborAtion study (GORILLA-2001). (PubMed, Gynecol Oncol)
The overall response rate to FST was promising, however, the PD rate was significant during the first 12 months of FST. Therefore, performing thorough endometrial biopsy and imaging studies is essential to strictly evaluate the extent of the disease every 3 months from FST initiation.
Journal
|
megestrol
over1year
New P2 trial • Metastases
|
cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane) • megestrol
over1year
A Curious Case of Psychosis (ENDO 2023)
Two of her medications, gabapentin and mirtazapine were thought to be the contributors and were stopped upon admission, however with little improvement...She was ultimately started on hydrocortisone replacement therapy, with subsequent improvement and stabilization of her mental status, mood, and behavior; and was discharged with outpatient Endocrinology follow-up.This case highlights the importance of the broad differentials to consider for mental and behavioral changes...Megestrol is an established cause of secondary adrenal insufficiency, and monitoring is essential with long-term use.*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*
Clinical
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megestrol
over1year
CLINICAL IMPLICATION OF MEGESTROL ACETATE IN ADVANCED CANCER: A BIG DATA ANALYSIS FROM HEALTH INSURANCE REVIEW AND ASSESSMENT (HIRA) DATABASE (MASCC-JASCC-ISOO 2023)
Conclusions This study demonstrated that most patients with advanced gastrointestinal and pancreatobiliary cancer required MA prescription. The difference in the incidence of VTE was modest between the MA and non-MA prescription groups (not at the level of statistical significance on multivariate analyses).
Clinical • Reimbursement • Review • US reimbursement • Metastases
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megestrol
over1year
Preclinical Evidence of Progesterone as a New Pharmacological Strategy in Human Adrenocortical Carcinoma Cell Lines. (PubMed, Int J Mol Sci)
Our results give support to the role of progesterone in ACC. The involvement of its analog (megestrol acetate) in reducing ACC progression in ACC patients undergoing EDP-M therapy is now under investigation in the PESETA phase II clinical study.
Preclinical • Journal
|
MUC1 (Mucin 1) • MMP2 (Matrix metallopeptidase 2)
|
cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane) • megestrol
over1year
Megestrol Acetate resistance in Estrogen Receptor Positive Advanced Breast Cancer in the MEGA trial (ESMO-BC 2023)
Methods Eligible patients (pts) had metastatic ER+ HER2- BC, and were randomized to receive MA or another HT agent (AHT), Tamoxifen or Exemestane, with 10 pts planned for each arm. Conclusions Translational analysis find evidence of increased transcriptional activity at ER regulated genes in most resistant samples. This could indicate that MA resistant tumours will retain sensitivity to further HT, requiring future research to proof this hypothesis.
Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative
|
tamoxifen • exemestane • megestrol
almost2years
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy (clinicaltrials.gov)
P2, N=44, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=28 --> 44
Enrollment closed • Enrollment change • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2) • CASP3 (Caspase 3)
|
BCL2 expression
|
megestrol
almost2years
Enrollment open • Metastases
|
ER (Estrogen receptor) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
|
ipatasertib (RG7440) • megestrol
2years
The effect of progestin therapy in advanced and recurrent endometrial cancer: a systematic review and meta-analysis. (PubMed, BJOG)
Progestin therapy is a viable treatment option in patients with advanced stage and recurrent EC with low toxicity and high ORR in PR positive disease. The role of PR expression in relation to progression free survival and overall survival is unclear.
Retrospective data • Review • Journal
|
PGR (Progesterone receptor)
|
PGR positive • PGR expression • PGR negative
|
megestrol