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Goserelin
Dosing Options Included in the National Comprehensive
Cancer
Network® (NCCN)
Breast Cancer
Guidelines
2024-02-05
·
BioSpace
临床结果
上市批准
临床3期
放射疗法
DEERFIELD, Ill.--(BUSINESS WIRE)--
TerSera Therapeutics LLC
announced today that The National Comprehensive
Cancer
Network® (NCCN)
Breast Cancer
Panel included both
goserelin
3.6 mg every 4 weeks and
goserelin
10.8 mg every 12 weeks, as methods for ovarian function suppression in Version 1.2024 of the Breast Guidelines revised as of January 25, 2024.1 "In addition to the 3.6 mg monthly dose, I am pleased to see that NCCN recognizes the role of
goserelin
10.8 mg every 12 weeks as an option for premenopausal women with
hormone receptor positive (HR+) breast cancer
, ” said Virginia Kaklamani, MD, Professor of Medicine in the Division of Hematology and Medical Oncology at the
University of Texas Health Sciences Center San Antonio
and leader of the
breast cancer
program at the Mays Cancer Center, home to UT Health San Antonio MD Anderson. The inclusion of
goserelin
10.8 mg every 12 weeks in the
breast cancer
guidelines as a method for ovarian function suppression is a category 2A recommendation. Multiple international studies have evaluated the safety and efficacy of
goserelin
10.8 mg every 12 weeks for ovarian function suppression in premenopausal patients with
HR+
breast cancer.2-5 In the United States,
ZOLADEX
® (
goserelin implant
) 3.6 mg is the only dosage form approved for use in
breast cancer
.
ZOLADEX
10.8 mg is not approved by FDA for
breast cancer
. Please see the full Prescribing Information for
ZOLADEX
3.6 mg and
ZOLADEX
10.8 mg and additional Important Safety Information below. Worldwide,
ZOLADEX
3.6 mg is approved for use in
breast cancer
in 125 countries. Additionally,
ZOLADEX
10.8 mg is approved for use in
breast cancer
in over 60 countries, with multiple additional regulatory reviews underway. This is the third update to NCCN guidelines regarding
goserelin
over the past few months related to
head and neck cancers
(V1.2024),
ovarian cancer
(V1.2024), and
breast cancer
(V1.2024). About
ZOLADEX
® (
goserelin implant
)
ZOLADEX
is an injectable luteinizing hormone-releasing hormone agonist (LHRHa) used to treat
prostate cancer
,
breast cancer
, and certain
benign gynecological disorders
. First approved in the U.S. in 1989,
ZOLADEX
is available as a 3.6 mg implant dosed every 28 days or as a 10.8 mg implant dosed every 12 weeks.6,7 U.S. INDICATIONS
ZOLADEX
3.6 mg and
ZOLADEX
10.8 mg are indicated for: Management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate in combination with
flutamide
. Treatment with
ZOLADEX
and
flutamide
should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Palliative treatment of
advanced carcinoma of the prostate
.
ZOLADEX
3.6 mg is also indicated for: Management of
endometriosis
, including
pain
relief and reduction of
endometriotic lesions
for the duration of therapy. Experience with
ZOLADEX
for the management of
endometriosis
has been limited to women 18 years of age and older treated for 6 months. Use as an endometrial-thinning agent prior to endometrial ablation for
dysfunctional uterine bleeding
. Palliative treatment of
advanced breast cancer
in pre- and perimenopausal women. IMPORTANT SAFETY INFORMATION Anaphylactic reactions to
ZOLADEX
have been reported in the medical literature.
ZOLADEX
is contraindicated in patients with a known hypersensitivity to
GnRH
,
GnRH
agonist analogues, or any of the components in
ZOLADEX
.
ZOLADEX
is contraindicated during pregnancy unless used for palliative treatment of
advanced breast cancer
.
ZOLADEX
can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with
ZOLADEX
treatment.
ZOLADEX
should not be given to women with undiagnosed
abnormal vaginal bleeding
. Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking
ZOLADEX
. Effective nonhormonal contraception must be used by all premenopausal women during
ZOLADEX
therapy and for 12 weeks following discontinuation of therapy. Transient worsening of
tumor
symptoms, or the occurrence of additional signs and symptoms of
breast cancer
, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in
bone pain
. Monitor patients at risk for complications of
tumor
flare.
Hyperglycemia
and an increased risk of developing
diabetes
or worsening of glycemic control in patients with
diabetes
have been reported in men receiving
GnRH
agonists like
ZOLADEX
. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice. Increased risk of developing
myocardial infarction
,
sudden cardiac death
and
stroke
has been reported in association with use of
GnRH
agonists like
ZOLADEX
in men. Patients receiving a
GnRH
agonist should be monitored for symptoms and signs suggestive of development of
cardiovascular disease
and be managed according to current clinical practice.
Hypercalcemia
has been reported in some
breast cancer
patients with
bone metastases
after starting treatment with
ZOLADEX
. If
hypercalcemia
does occur, appropriate treatment measures should be initiated. Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with
GnRH
agonist analogues.
ZOLADEX
may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation.
GnRH
agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with
congenital long QT syndrome
,
congestive heart failure
, frequent
electrolyte abnormalities
, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Injection site injury
and
vascular injury
including
pain
,
hematoma
,
hemorrhage
and
hemorrhagic shock
, requiring blood transfusions and surgical intervention, have been reported with
ZOLADEX
. Extra care should be taken when administering
ZOLADEX
to patients with low BMI and/or to patients receiving full dose anticoagulation.
Depression
may occur or worsen in women receiving
GnRH
agonists. Treatment with
ZOLADEX
may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients. In women, the most frequently reported adverse reactions were related to
hypoestrogenism
. The adverse reaction pro similar for women treated for
breast cancer
,
dysfunctional uterine bleeding
, and
endometriosis
. The most commonly reported adverse reactions with
ZOLADEX
in clinical trials for
endometriosis
were:
hot flashes
(96%),
vaginitis
(75%),
headache
(75%),
decreased libido
(61%),
emotional lability
(60%),
depression
(54%), sweating (45%),
acne
(42%),
breast atrophy
(33%),
seborrhea
(26%), and
peripheral edema
(21%). The most commonly reported adverse reactions with
ZOLADEX
in clinical trials for endometrial thinning were: vasodilation/
hot flashes
(57%),
headache
(32%), sweating (16%), and
abdominal pain
(11%). The most commonly reported adverse reactions with
ZOLADEX
in
breast cancer
clinical trials were
hot flashes
(70%), decreased libido (47.7%),
tumor
flare (23%),
nausea
(11%),
edema
(5%), and malaise/
fatigue
/
lethargy
(5%). Injection site reactions were reported in less than 1% of patients. For
ZOLADEX
3.6 mg:
Hot flashes
(62%),
sexual dysfunction
(21%),
decreased erections
(18%),
lower urinary tract symptoms
(13%),
lethargy
(8%),
pain
(worsened in the first 30 days) (8%),
edema
(7%),
upper respiratory infection
(7%),
rash
(6%), and sweating (6%). For
ZOLADEX
10.8 mg:
Hot flashes
(64%),
pain
(general) (14%),
gynecomastia
(8%),
pelvic pain
(6%), and
bone pain
(6%). In the
locally advanced carcinoma of the prostate
clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were
hot flashes
(46%),
diarrhea
(40%),
nausea
(9%), and
skin rash
(8%). Treatment with
ZOLADEX
and
flutamide
did not add substantially to the toxicity of radiation treatment alone. Please see Full Prescribing Information for
ZOLADEX
3.6 mg and
ZOLADEX
10.8 mg. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088. You can also contact
TerSera Therapeutics
at 1-844-334-4035 or medicalInformation@tersera.com. About
TerSera Therapeutics
TerSera Therapeutics
is a biopharmaceutical company with a focus in
oncology
, acute care, and non-opioid
pain
management. Founded in 2016,
TerSera
is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. For more information about
TerSera Therapeutics
, please visit tersera.com. References NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for
Breast Cancer
Version 1.2024. © National Comprehensive
Cancer
Network, Inc 2024. All rights reserved. [Accessed January 29, 2024]. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE
CANCER
NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive
Cancer
Network, Inc. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly
goserelin
in pre-menopausal women with
estrogen receptor-positive advanced breast cancer
estrogen receptor
-positive advanced breast cancer.
Breast Cancer
. 2016; 23:771-779. Masuda N, Iwata H. Rai Y, et al. Monthly versus 3-monthly
goserelin acetate
treatment in pre-menopausal patients with
estrogen receptor-positive early breast cancer
estrogen receptor
-positive early breast cancer.
Breast Cancer
Res Treat. 2011; 126:443-451. El Zawawy SF, Khedr G. 209P Efficacy and feasibility of long acting every three months
goserelin
for
premenopausal breast cancer
patients during
COVID pandemic
. Annals of Oncology. 2022;33: S631. Wu H, Bian L, Xie J, et al. 111P
Goserelin
3 monthly depot is noninferior to
goserelin
monthly depot in the treatment of
breast cancer
: A real-world evidence study. ESMO Open. 2023;8(1):101335. ZOLADEX (goserelin implant) 3.6 mg prescribing information. TerSera Therapeutics LLC. ZOLADEX (goserelin implant) 10.8 mg prescribing information. TerSera Therapeutics LLC.
ZOLADEX
® is a registered trademark of AstraZeneca or its affiliates and is used herein under license. ©2024 TerSera Therapeutics LLC. All rights reserved.
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机构
TerSera Therapeutics LLC
University of Texas Health Science Center At San Antonio
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