A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer

Lu, Yen‐Shen; Lee, Keun Seok; Chao, Tsu Yi; Tseng, Ling Ming; Chitapanarux, Imjai; Chen, Shin Cheh; Liu, Chien Ting; Sohn, Joohyuk; Kim, Jee Hyun; Chang, Yuan; Yang, Youngsen; Shotelersuk, Kanjana; Jung, Kyung Hae; Valenti, Roberta; Slader, Cassandra; Gao, Melissa; Park, Yeon Hee

doi:10.1158/1078-0432.ccr-20-1008

Cited by 25 publications

(16 citation statements)

References 32 publications

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“…Equal benefit from an when HER2 ve 108,109 More HER2 muta s (targetable with novel HER2 inhibitors and HER2-targeted ADCs) 31,60 More PIK3CA muta with alpelisib) 33,174 Novel HER2-and HER3-targeted drugs and ADCs…”

Section: Benefit Of Cdk4/6 Inhibitors In Adjuvant Sementioning

confidence: 99%

Current and future diagnostic and treatment strategies for patients with invasive lobular breast cancer

et al. 2022

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Section: Benefit Of Cdk4/6 Inhibitors In Adjuvant Sementioning

confidence: 99%

Current and future diagnostic and treatment strategies for patients with invasive lobular breast cancer

et al. 2022

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“…The 141 included papers consisted of 82 (58%) quantitative studies [ 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , <...…”

Section: Resultsunclassified

Psychosocial Aspects of Living Long Term with Advanced Cancer and Ongoing Systemic Treatment: A Scoping Review

Kolsteren¹,

Deuning-Smit²,

Chu

et al. 2022

Cancers

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(1) Background: Studies examining the psychosocial impact of living long term on systemic treatment in advanced cancer patients are scarce. This scoping review aimed to answer the research question “What has been reported about psychosocial factors among patients living with advanced cancer receiving life-long systemic treatment?”, by synthesizing psychosocial data, and evaluating the terminology used to address these patients; (2) Methods: This scoping review was conducted following the five stages of the framework of Arksey and O’Malley (2005); (3) Results: 141 articles published between 2000 and 2021 (69% after 2015) were included. A large variety of terms referring to the patient group was observed. Synthesizing qualitative studies identified ongoing uncertainty, anxiety and fear of disease progression or death, hope in treatment results and new treatment options, loss in several aspects of life, and worries about the impact of disease on loved ones and changes in social life to be prominent psychosocial themes. Of 82 quantitative studies included in the review, 76% examined quality of life, 46% fear of disease progression or death, 26% distress or depression, and 4% hope, while few studies reported on adaptation or cognitive aspects. No quantitative studies focused on uncertainty, loss, or social impact; (4) Conclusion and clinical implications: Prominent psychosocial themes reported in qualitative studies were not included in quantitative research using specific validated questionnaires. More robust studies using quantitative research designs should be conducted to further understand these psychological constructs. Furthermore, the diversity of terminology found in the literature calls for a uniform definition to better address this specific patient group in research and in practice.

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“…73 A small pilot phase Ib study (B-YOND) tested alpelisib or buparlisib combined with tamoxifen plus goserelin as first-line endocrine therapy in Asian premenopausal patients with HR+/HER2-advanced breast cancer. 74 The recommended phase 2 doses of alpelisib and buparlisib in combination with tamoxifen and goserelin were 350 mg and 100 mg, respectively. No unexpected safety findings were reported.…”

mentioning

confidence: 99%

Role of Alpelisib in the Treatment of PIK3CA-Mutated Breast Cancer: Patient Selection and Clinical Perspectives

Chang

2021

TCRM

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The PI3K/AKT/mTOR pathway has long been known to play a major role in the growth and survival of cancer cells. Breast tumors often harbor PIK3CA gene alterations, which therefore constitute a rational drug target. However, it has taken many years to demonstrate clinically-relevant efficacy of PI3K inhibition and eventually attain regulatory approvals. As data on PI3K inhibitors continue to mature, this review updates and summarizes the current state of the science, including the prognostic role of PIK3CA alterations in breast cancer; the evolution of PI3K inhibitors; the clinical utility of the first-in-class oral selective PI3Kα inhibitor, alpelisib; PIK3CA mutation detection techniques; and adverse effect management. PIK3CA -mutated breast carcinomas predict survival benefit from PI3K inhibitor therapy. The pan-PI3K inhibitor, buparlisib and the beta-isoform-sparing PI3K inhibitor, taselisib, met efficacy endpoints in clinical trials, but pictilisib did not; moreover, poor tolerability of these three drugs abrogated further clinical trials. Alpelisib is better tolerated, with a more manageable toxicity profile; the principal adverse events, hyperglycemia, rash and diarrhea, can be mitigated by intensive monitoring and timely intervention, thereby enabling patients to remain adherent to clinically beneficial treatment. Alpelisib plus endocrine therapy shows promising efficacy for treating postmenopausal women with HR+/HER2– advanced breast cancer. Available evidence supporting using alpelisib after disease progression on first-line endocrine therapy with or without CDK4/6 inhibitors justifies PIK3CA mutation testing upon diagnosing HR+/HER2– advanced breast cancer, which can be done using either tumor tissue or circulating tumor DNA. With appropriate toxicity management and patient selection using validated testing methods, all eligible patients can potentially benefit from this new treatment. Further clinical trials to assess combinations of hormone therapy with PI3K, AKT, mTOR, or CDK 4/6 inhibitors, or studies in men and women with other breast subtypes are ongoing.

show abstract

A Phase Ib Study of Alpelisib or Buparlisib Combined with Tamoxifen Plus Goserelin in Premenopausal Women with HR-Positive HER2-Negative Advanced Breast Cancer

Cited by 25 publications

References 32 publications

Current and future diagnostic and treatment strategies for patients with invasive lobular breast cancer

Current and future diagnostic and treatment strategies for patients with invasive lobular breast cancer

Psychosocial Aspects of Living Long Term with Advanced Cancer and Ongoing Systemic Treatment: A Scoping Review

Role of Alpelisib in the Treatment of PIK3CA-Mutated Breast Cancer: Patient Selection and Clinical Perspectives

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