Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients

Masuda, Norikazu; Inoue, Kentaro; Nakamura, Rikiya; Rai, Yoshiaki; Mukai, Hirofumi; Ohno, Shinji; Hara, Fumikata; Mori, Yuko; Hashigaki, Satoshi; Muramatsu, Yasuaki; Nagasawa, Takashi; Umeyama, Yoshiko; Huang, Xin; Iwata, Hiroji

doi:10.1007/s10147-018-1359-3

Cited by 46 publications

(53 citation statements)

References 16 publications

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“…The palbociclib-fulvestrant group had significantly better ORR and CBR compared to the fulvestrant group. In the palbociclib-fulvestrant group of the PALOMA-3 trial, the ORRs were 21% in the overall population and 18.5% in the Japanese subgroup, and the CBRs were 66.3% in the overall population and 74.1% in the Japanese subgroup (18). The CBR in this study was like the trial, but the current study had a better ORR.…”

Section: Discussionsupporting

confidence: 40%

“…However, there were fewer patients with visceral metastasis than in the PALOMA-3 trial (48% and 63%, respectively). Our result indicated better clinical response with palbociclib-fulvestrant than fulvestrant for Japanese patients with ER+HER2-MBC (18). We observed higher CBRs: i) in patients aged <70 years, ii) with BMI ≥25, iii) PgR positivity, iv) stage I-III at initial diagnosis, v) DFI 24 months or longer, vi) ≤1 previous line of endocrine therapy, vii) ≤1 previous line of chemotherapy, viii) no sensitivity to prior endocrine therapy, ix) two or more metastatic sites, and x) visceral metastasis in the palbociclib-fulvestrant group.…”

Section: Discussionmentioning

confidence: 54%

“…In a phase 3 trial, palbociclib-fulvestrant did not improve PFS in Japanese patients with ER+/HER2-MBC. The frequency of grade 3/4 neutropenia was higher in Japanese patients than the overall population (18). Therefore, it was necessary to verify the efficacy and safety of palbociclibfulvestrant for Japanese patients with ER+/HER2-MBC.…”

Section: Discussionmentioning

confidence: 99%

“…A subgroup analysis of Japanese patients in the PALOMA-3 study (18) reported that palbociclib-fulvestrant had no significant effect on PFS compared to placebofulvestrant. In addition, the study showed that there was no significant difference in adverse events between the overall population and Japanese patients, except for a higher rate of neutropenia in Japanese patients receiving palbociclib.…”

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confidence: 99%

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Efficacy and Safety of Palbociclib and Fulvestrant in Japanese Patients With ER+/HER2− Advanced/Metastatic Breast Cancer

Seki

Sakurai

Maeda

et al. 2019

In Vivo

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Background/Aim: Published data have shown that palbociclib-fulvestrant can significantly improve the progressionfree survival (PFS) of estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer patients, but not of Japanese patients. We conducted this retrospective study to verify the efficacy and safety of palbociclib-fulvestrant in Japanese patients. Patients and Methods: ER+/HER2-metastatic breast cancer patients treated with fulvestrant (n=39) or palbociclib-fulvestrant (n=31) at the Saitama Medical Center from July 2012 to November 2018 were evaluated. Results: Overall response rates (ORRs) were 2.6% (fulvestrant) and 41.9% (palbociclib-fulvestrant) (p<0.001), and clinical benefit rates (CBRs) were 23.1% and 61.3% (p=0.002), respectively. The palbociclib-fulvestrant group had significantly higher CBR and PFS (hazard ratio(HR):0.272, 95% confidence interval(95CI):0.128-0.574 for PFS). Grade 3/4 neutropenia occurred in 80.6% of the palbociclib-fulvestrant group, while febrile neutropenia was not detected. Conclusion: Japanese ER+/HER2-metastatic breast cancer patients tolerated palbociclib-fulvestrant, with significantly improved clinical outcomes.

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Section: Discussionsupporting

confidence: 40%

Section: Discussionmentioning

confidence: 54%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Efficacy and Safety of Palbociclib and Fulvestrant in Japanese Patients With ER+/HER2− Advanced/Metastatic Breast Cancer

Seki

Sakurai

Maeda

et al. 2019

In Vivo

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“…Palbociclib (125 mg, 28-day cycle with aromatase inhibitor) is used as the targeted therapy against ER + /HER2 − advanced and metastatic breast cancer in conjunction with hormone therapy. The open label PALOMA (Palbociclib: Ongoing Trials in the Management of Breast Cancer) clinical trials were designed recently with either aromatase inhibitor (letrozole) (PALOMA-1 or PALOMA-2 Trials) [111,112] or Fulvestrant hormone therapies (PALOMA-3 trails) [113]. An improvement in the overall survival of metastatic breast cancer patients was reported in PALOMA-3 phase III clinical trials.…”

Section: Cdk4/6 Inhibitormentioning

confidence: 99%

Drug repurposing for breast cancer therapy: Old weapon for new battle

Aggarwal

Verma

Aggarwal

et al. 2021

Seminars in Cancer Biology

111

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Despite tremendous resources being invested in prevention and treatment, breast cancer remains a leading cause of cancer deaths in women globally. The available treatment modalities are very costly and produces severe side effects. Drug repurposing that relate to new uses for old drugs has emerged as a novel approach for drug development. Repositioning of old, clinically approved, off patent non-cancer drugs with known targets, into newer indication is like using old weapons for new battle. The advances in genomics, proteomics and information computational biology has facilitated the process of drug repurposing. Repositioning approach not only fastens the process of drug development but also offers more effective, cheaper, safer drugs with lesser/known side effects. During the last decade, drugs such as alkylating agents, anthracyclins, antimetabolite, CDK4/6 inhibitor, aromatase inhibitor, mTOR inhibitor and mitotic inhibitors has been repositioned for breast cancer treatment. The repositioned drugs have been successfully used for the treatment of most aggressive triple negative breast cancer. The literature review suggest that serendipity plays a major role in the drug development. This article describes the comprehensive overview of the current scenario of drug repurposing for the breast cancer treatment. The strategies as well as several examples of repurposed drugs are provided. The challenges associated with drug repurposing are discussed. Current breast cancer therapyUnlike a decade ago, clinicians today have multiple choices for breast cancer treatment depending on the size, stage, grade, metastatic behavior, aggressiveness and intrinsic molecular subtyping of tumor, age, menopausal status, overall health, comorbidities, and preferences of the patient [9-13]. Chemotherapy, hormone therapy, immunotherapy, radiotherapy, and surgery are the common modalities for breast cancer [10,14]. Primary choice of treatment usually includes surgery with the aim of complete resection of the major tumor mass on the first hand. Breast conserving (lumpectomy) and breast reconstruction surgeries, mastectomy or lymph node dissections are performed initially in the breast cancer patients [15]. Surgery may be preceded with the systemic neoadjuvant therapies in order to shrink the tumor for effective surgery and to maximize breast conservation. For example, in HER2+ cases, Trastuzumab (Herceptin) and Pertuzumab (Perjeta)

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

Takahashi

Masuda

Nishimura³

et al. 2020

Cancer Medicine

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Palbociclib is a highly selective, reversible, oral inhibitor of cyclin‐dependent kinases 4 and 6 that is approved to treat hormone receptor‐positive/human epidermal growth factor receptor 2‐negative advanced breast cancer. An open‐label, single‐arm, Japanese phase 2 study was conducted to investigate the efficacy and safety of palbociclib plus letrozole as first‐line treatment in 42 postmenopausal patients with estrogen receptor‐positive/human epidermal growth factor receptor 2‐negative advanced breast cancer. The probability of progression‐free survival originally reported at 1 year was 75.0% (90% confidence interval, 61.3‐84.4), but median progression‐free survival was not attained at the primary analysis. In this report, updated efficacy and safety results with a longer follow‐up period are presented. The median duration of treatment in the updated analysis was 33.0 months (range, 1.8‐49.2). The probability of progression‐free survival at 1 year was 75.6% (90% confidence interval, 62.4‐84.7). Median progression‐free survival was 35.7 months (95% confidence interval, 21.7‐46.7). Objective response rate and disease control rate were 47.6% (95% confidence interval, 32.0‐63.6) and 85.7% (95% confidence interval, 71.5‐94.6), respectively. Common treatment‐related adverse events (all grades; grade 3/4) were neutropenia (100%; 93%), leukopenia (83%; 60%), and stomatitis (76%; 0%). Treatment‐related febrile neutropenia was reported in one patient. In general, no clinically meaningful deterioration in health‐related quality of life was observed. Palbociclib plus letrozole remained effective and tolerable in Japanese postmenopausal patients with estrogen receptor‐positive, human epidermal growth factor receptor 2‐negative advanced breast cancer in this updated analysis.

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Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients

Cited by 46 publications

References 16 publications

Efficacy and Safety of Palbociclib and Fulvestrant in Japanese Patients With ER+/HER2− Advanced/Metastatic Breast Cancer

Efficacy and Safety of Palbociclib and Fulvestrant in Japanese Patients With ER+/HER2− Advanced/Metastatic Breast Cancer

Drug repurposing for breast cancer therapy: Old weapon for new battle

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

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