Meta AnalysisID 7158
来曲唑联合哌柏西利对比单用来曲唑一线治疗晚期HR+/HER2-乳腺癌：系统评价和Meta分析
CRD42023438659
is there a difference in efficacy and safety of letrozole with palbociclib versus letrozole as first-line treatment for advanced HR+/HER2- breast cancer in postmenopausal women?
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Record Fields
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- Meta Analysis Id
- 7158
- Evidence Id
- 15716
- Core Evidence Id
- 15716
- Source Meta Analysis Id
- 7141
- Herb2 Meta Analysis Id
- HBMA007141
- Crd Id
- CRD42023438659
- Title
- Letrozole with palbociclib versus letrozole alone as first-line treatment for advanced HR+/HER2- breast cancer: systematic review and meta-analysis.
- Review Question
- is there a difference in efficacy and safety of letrozole with palbociclib versus letrozole as first-line treatment for advanced HR+/HER2- breast cancer in postmenopausal women?
- Study Type Included
- - Phase 2 or 3 randomized clinical trials. - In case of studies with the same cohort of patients only the article with the longest duration of follow-up will be included. - Studies with follow-up in all settings, e.g., community, hospital or long-term care facilities, will be included.
- Condition Being Studied
- Breast cancer is the most common form of cancer detected in women worldwide, accounts for up to 35% of oncology patients and is the leading reason for female cancer-related mortality. About 70% are HR+ and HER2- and are risk factors for invasive breast cancer. Current first-line endocrine therapy alone may provide only modest benefit in patients with HR+, and some patients may not respond at all. Non-response is associated with acquired resistance to these drugs, as it has been shown to be linked to high mutation rates and high subclonal diversity. In that sense, combining two groups such as letrazole plus palbociclib showed very promising results. Based on these results, this combination has been approved in several countries for the management of recurrent or incurable breast cancer. Also, the guidelines have been expanded to include a CDK4/6 as first-line therapy. However, in other analyses of this same combination, no net overall survival benefit was evident. This suggests that the combined response may be prolonged in a particular subgroup. Therefore, it is important to continue to expand knowledge on the subject and to analyze the efficacy and safety of letrazole plus palbociclib by means of a meta-analysis.
- Participant
- - Studies with postmenopausal patients as defined by any of the following: a) Subjects at least 55 years of age; b) Subjects younger than 55 years and amenorrhea for at least 12 years or follicle stimulating hormone (FSH) values >= 40 IU/L and estradiol levels =< 40 pg/mL (140 pmol/L) or in postmenopausal ranges per local or institutional reference ranges. - Patients diagnosed with advanced breast cancer, comprising: a) locally advanced inoperable breast cancer (LABC) and b) metastatic breast cancer. - Hormone-sensitive cancer (estrogen receptor positive and/or progesterone receptor positive), but human epidermal growth factor receptor 2 (HER) negative.
- Animal
- Human Disease Modelled
- Intervention
- - Studies evaluating the safety and efficacy of letrozole plus pabociclib. Dose: letrozole 2.5 mg/day POV continuously plus palbociclib 125 mg/day POV, 3 weeks followed by 1 week off in a 4-week cycle.
- Comparator Control
- - Studies evaluating the safety and efficacy of letrazole plus placebo. Dosage: Letrozole 2.5 mg/day continuously plus placebo 125 mg orally once daily from day 1 to day 21 of each 28-day cycle, followed by 7 days without treatment.
- Main Outcome
- Studies that reported efficacy as investigator-assessed progression-free survival, defined as the period from randomization to the date of the first objective evidence of disease progression or death, whichever comes first. Measures of effect
- Outcome Measure
- Additional Outcome
- - Studies that reported efficacy as objective response rate, clinical benefit rate, and overall survival. Objective response rate was defined as a complete response or confirmed partial response. The clinical benefit rate was defined as a confirmed complete response, partial response or disease stability for at least 24 weeks. - Studies reporting safety in terms of adverse effects such as neutrophilia, leukopenia and anemia. - Studies reporting raw data or statistics related to the outcomes to be calculated.
- Study Method
- Intervention, Systematic review
- Keyword
- Breast Neoplasms; Female; Humans; Letrozole; Piperazines; Postmenopause; palbociclib
- Contact
- Shamir Barros-Sevillano [email protected]
- Organisational Affiliation
- .Universidad César Vallejo, Trujillo - Perú https://www.ucv.edu.pe/
- Funding Source
- Self-financed
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Peru
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-06-22
- Registration Date
- 2023-07-02
- Anticipated Start Date
- 2023-04-01
- Anticipated Completion Date
- 2023-09-20
- Title Cn
- 来曲唑联合哌柏西利对比单用来曲唑一线治疗晚期HR+/HER2-乳腺癌：系统评价和Meta分析
- Title En
- Letrozole with palbociclib versus letrozole alone as first-line treatment for advanced HR+/HER2- breast cancer: systematic review and meta-analysis.
- Bilingual Status
- complete