Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor‐positive, advanced breast cancer: A real‐world experience

Pizzuti, Laura; Giordano, Antonio; Michelotti, Andrea; Mazzotta, Marco; Natoli, Clara; Gamucci, Teresa; Angelis, Claudia De; Landucci, Elisabetta; Diodati, Lucrezia; Iezzi, Laura; Mentuccia, Lucia; Fabbri, Agnese; Barba, Maddalena; Sanguineti, Giuseppe; Marchetti, Paolo; Tomao, Silverio; Mariani, Luciano; Paris, Ida; Lorusso, Vito; Vallarelli, Simona; Cassano, Alessandra; Aroldi, Francesca; Orlandi, Armando; Moscetti, Luca; Sergi, Domenico; Sarobba, Maria Giuseppina; Tonini, Giuseppe; Santini, Daniele; Sini, Valentina; Veltri, Enzo; Vaccaro, Angela; Ferrari, Laura; Tursi, Michele De; Tinari, Nicola; Grassadonia, Antonino; Greco, Filippo; Botticelli, Andrea; Verde, Nicla La; Zamagni, Claudio; Rubino, Daniela; Cortesi, Enrico; Magri, Valentina; Pomati, Giulia; Scagnoli, Simone; Capomolla, Elisabetta; Kayal, Ramy; Scinto, Angelo Fedele; Corsi, Domenico; Cazzaniga, Marina Elena; Laudadio, Lucio; Forciniti, Samantha; Mancini, Maria; Carbognin, Luisa; Seminara, Patrizia; Barni, Sandro; Samaritani, Riccardo; Roselli, Mario; Portarena, Ilaria; Russo, Antonio; Ficorella, Corrado; Cannita, Katia; Carpano, Silvia; Pistelli, Mirco; Berardi, Rossana; Maria, Ruggero De; Sperduti, Isabella; Ciliberto, Gennaro; Vici, Patrizia

doi:10.1002/jcp.27832

Cited by 22 publications

(29 citation statements)

References 43 publications

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“…With a longer follow-up, subsequent large US and international studies have shown similar PFS data and have suggested an OS benefit [13,14]. Other, more limited studies, were in line with those results [26][27][28][29][30][31][32][33].…”

Section: Discussionsupporting

confidence: 58%

Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer

et al. 2020

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Background Palbociclib is indicated for the treatment of hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC), in combination with endocrine therapy. Emerging real-life data suggest that the efficacy of a palbociclib-based therapy is highly conserved. We report the Institut Curie hospital experience. Patients and methods We retrospectively reviewed all patients with HR + HER2- ABC treated with a palbociclib-based therapy as first or second line for ABC, with an initial prescription from November 2016 to December 2018. Clinical, laboratory and imaging data were retrieved from electronic records. Data lock was December 31st, 2019. Descriptive analyses, univariate and multivariate Cox regression analyses were performed. Results We included 310 consecutive patients. Median age was 61.8 years old. Palbociclib was prescribed in first line in 225 patients (72.6%). Before palbociclib-based therapy initiation, 122 patients (39.3%) were endocrine naive, 96 (31.0%) endocrine sensitive and 92 (29.7%) endocrine resistant. Median follow-up was 20.7 months. Median progression free survival (PFS) was 23.4 months (95%CI: 21.6-NR) in endocrine naive patients, 22.7 months (95%CI: 14.7-NR) in endocrine sensitive, and 13.4 months (95%CI: 10.7–20.8) in endocrine resistant. At 12 months from the initiation of palbociclib, 94.5% of patients were alive. By multivariate analysis, poor prognosis factors for PFS were identified in the endocrine naive/sensitive population: initial ECOG status 2, previous endocrine therapy for ABC, 3 metastatic sites or more. Toxicity profile was similar to previously published data. Conclusion In a non-selected population of patients with HR + HER2- ABC, the efficacy and safety data are strikingly similar to those previously reported.

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Section: Discussionsupporting

confidence: 58%

Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer

et al. 2020

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“…Additional studies36,37 are summarized in Table 2 and are consistent with the data previously reported in activity and safety. Interestingly, Pizzuti and colleagues reported a reduced ORR in patients with prior exposure to everolimus/exemestane (16.7 versus 34.5%, respectively, p =0.002) and a higher ORR and CBR in patients without visceral metastasis ( p =0.0004 and 0.04, no data available).…”

Section: Real-life Studiessupporting

confidence: 83%

“…On the other hand, no statistically significant difference in ORR was observed according to previous fulvestrant exposure (31.7 versus 29.6%, p =0.72) and menopausal status. The study also supports the use of palbociclib in an elderly population (≥75 years) with no differences in the toxicity profile depending on treatment line and patients’ age 37…”

Section: Real-life Studiessupporting

confidence: 72%

Palbociclib in metastatic breast cancer: current evidence and real-life data

Serra

Lapidari

Quaquarini

et al. 2019

DIC

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The purpose of this review is to summarize the background and latest evidence for the use of palbociclib, an oral, first-in-class, highly selective cyclin-dependent kinase 4/6 inhibitor, in advanced breast cancer, with a focus on some of the unanswered questions about the performance of this agent in clinical practice. The available clinical data from both controlled clinical trials and real-life experiences concerning palbociclib-based combinations in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic disease, including patient-reported outcomes and subgroup analyses, have been reviewed and discussed. Palbociclib significantly improved progression-free survival and clinical benefit rates when added to letrozole in postmenopausal women as initial endocrine-based therapy, and it prolonged progression-free survival and overall survival when added to fulvestrant in women who progressed on previous endocrine therapy in randomized clinical trials. Tolerability profile was manageable, with neutropenia occurring most commonly, without detrimental impact on quality of life. Available data from real-life experiences confirm the good performance of palbociclib in unselected, heavily pretreated populations. Palbociclib in combination with endocrine therapy is a valuable emerging option for patients with HR+/HER2− advanced or metastatic breast cancer. Further investigation is needed to provide solutions for palbociclib resistance and to identify the best sequence to use for the best patient benefit with a minimal toxicity.

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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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Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor‐positive, advanced breast cancer: A real‐world experience

Cited by 22 publications

References 43 publications

Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer

Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer

Palbociclib in metastatic breast cancer: current evidence and real-life data

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

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