Palbociclib‐letrozole as first‐line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study

Takahashi, Masato; Masuda, Norikazu; Nishimura, Reiki; Inoue, Kentaro; Ohno, Shinji; Iwata, Hiroji; Hashigaki, Satoshi; Muramatsu, Yasuaki; Umeyama, Yoshiko; Toi, Masakazu

doi:10.1002/cam4.3091

Cited by 13 publications

(17 citation statements)

References 21 publications

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“…The safety profile was analyzed for metastatic patients and for non-metastatic patients. Overall, 19 trials including 3378 patients were analyzed for the metastatic group, and 5 trials including 792 patients for the non-metastatic group [18,19,22,[26][27][28][29][30][31][32][33][34][35][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53]. Trials with abemaciclib were excluded from analysis, because no trials were available in a non-metastatic setting [54][55][56][57][58].…”

Section: Safety Results In Metastatic and In Non-metastatic Patientsmentioning

confidence: 99%

CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis

Onesti

Jerusalem

2020

Expert Review of Anticancer Therapy

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Introduction: CDK4/6 inhibitor approval for hormone-responsive breast tumors has significantly changed therapeutic algorithms, with three drugs currently approved. Areas covered: Here, we analyze the toxicity profiles of palbociclib, ribociclib, and abemaciclib through a systematic review and meta-analysis. Palbociclib and ribociclib showed high rates of hematological toxicity, primarily neutropenia, and were associated with a low rate of severe infections. Abemaciclib was associated with a high rate of gastrointestinal toxicities, primarily diarrhea, of grade 1-2 in most cases. Ribociclib was associated with a high rate of hepatic, and respiratory toxicity and with QTc prolongation. The toxicity rate of ribociclib was higher in metastatic patients than nonmetastatic patients, with approximately 33% more grade 3-4 toxicities and 21% more grade 3-4 neutropenic events. A 5% higher risk of diarrhea was observed in postmenopausal patients. Pretreated patients did not show a higher toxicity rate for palbociclib/ribociclib than previously untreated patients, while a 26% higher risk of any grade neutropenia and 6% higher risk of grade 3-4 diarrhea were observed with abemaciclib. Expert opinion: Considering the similar efficacies and indications of palbociclib, ribociclib, and abemaciclib, the evaluation of their toxicity profiles may facilitate treatment choice.

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Section: Safety Results In Metastatic and In Non-metastatic Patientsmentioning

confidence: 99%

CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis

Onesti

Jerusalem

2020

Expert Review of Anticancer Therapy

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“…An open-label, single-arm, Japanese phase 2 study also examined the efficacy of palbociclib plus letrozole among postmenopausal patients with ER+/HER2– ABC who had no prior systemic anticancer therapy for ABC [ 43 , 44 ]. A total of 42 patients received palbociclib plus letrozole and were included in efficacy analyses.…”

Section: Review Of Palbociclib Clinical Trial Datamentioning

confidence: 99%

“…A total of 42 patients received palbociclib plus letrozole and were included in efficacy analyses. In an updated analysis of the primary study [ 44 ], the 1-year PFS probability was 75.6%, and the median PFS was 35.7 months. All 42 Japanese patients experienced any-grade neutropenia.…”

Section: Review Of Palbociclib Clinical Trial Datamentioning

confidence: 99%

Palbociclib as an early-line treatment for Japanese patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer: a review of clinical trial and real-world data

et al. 2021

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Breast cancer is the most common type of cancer among women worldwide and in Japan. The majority of breast cancers are hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2‒), and endocrine therapy is an effective therapy for this type of breast cancer. However, recent substantial advances have been made in the management of HR+/HER2‒ advanced breast cancer (ABC) with the advent of targeted therapies, such as cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, resulting in significant improvements in survival outcomes versus endocrine therapy alone. To evaluate the optimal use of palbociclib, a CDK4/6 inhibitor, in HR+/HER2– ABC, this review summarizes clinical trial and real-world data for palbociclib. In addition, current biomarker studies in palbociclib clinical research are reviewed. In Japanese patients, palbociclib was shown to be effective with a manageable safety profile, although differences were observed in the frequency of adverse event and dosing parameters. Current evidence supporting palbociclib as a first-line treatment strategy for patients with HR+/HER2‒ ABC in Asia, and specifically japan, is also discussed.

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“…Letrozole is used in postmenopausal women after five years of treatment with TMX at a daily dose of 2.5 mg, orally. Very recently, a phase II study conducted in Japan in 42 postmenopausal patients investigated the efficacy and safety of the combination of palbociclib plus letrozole, concluding that this combination is effective in patients with ER + , EGFR − and advanced BC [ 337 ].…”

Section: Towards a H + -Related Concerted Utilimentioning

confidence: 99%

Towards an Integral Therapeutic Protocol for Breast Cancer Based upon the New H+-Centered Anticancer Paradigm of the Late Post-Warburg Era

Harguindey¹,

Alfarouk

Orozco³

et al. 2020

IJMS

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A brand new approach to the understanding of breast cancer (BC) is urgently needed. In this contribution, the etiology, pathogenesis, and treatment of this disease is approached from the new pH-centric anticancer paradigm. Only this unitarian perspective, based upon the hydrogen ion (H+) dynamics of cancer, allows for the understanding and integration of the many dualisms, confusions, and paradoxes of the disease. The new H+-related, wide-ranging model can embrace, from a unique perspective, the many aspects of the disease and, at the same time, therapeutically interfere with most, if not all, of the hallmarks of cancer known to date. The pH-related armamentarium available for the treatment of BC reviewed here may be beneficial for all types and stages of the disease. In this vein, we have attempted a megasynthesis of traditional and new knowledge in the different areas of breast cancer research and treatment based upon the wide-ranging approach afforded by the hydrogen ion dynamics of cancer. The concerted utilization of the pH-related drugs that are available nowadays for the treatment of breast cancer is advanced.

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Palbociclib‐letrozole as first‐line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study

Cited by 13 publications

References 21 publications

CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis

CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis

Palbociclib as an early-line treatment for Japanese patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer: a review of clinical trial and real-world data

Towards an Integral Therapeutic Protocol for Breast Cancer Based upon the New H+-Centered Anticancer Paradigm of the Late Post-Warburg Era

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