Dataset Information

Palbociclib combined with endocrine therapy in heavily pretreated HR⁺/HER2^- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

ABSTRACT:

Background

This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavily-pretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR⁺/HER2^-) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017.

Patients and methods

Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HR⁺/HER2^- mBC who had progressed on ≥4 treatments for advanced disease were eligible.

Results

A total of 219 patients received palbociclib in combination with aromatase inhibitors (110; 50.2%), fulvestrant (87; 39.7%), tamoxifen (8; 3.6%) or as single agent (10; 4.6%). Mean age of the patients was 58 years; 31 patients (16.1%) were premenopausal and 162 (83.9%) were postmenopausal at the beginning of treatment with palbociclib. Patients had received a median of 3 previous lines of endocrine therapy (ET) for advanced disease. Real-world tumor response (rwTR) and clinical benefit rate were 5.9% (n = 13) and 46.2% (n = 101), respectively. The median real world progression-free survival (rwPFS) was 6.0 months (95% CI 5.7-7.0) and the median overall survival was 19.0 months (95% CI 16.4-21.7). Subgroup analysis revealed a significant difference in median rwPFS in patients treated with palbociclib plus fulvestrant depending on the duration of prior treatment with fulvestrant monotherapy (>6 versus ≤6 months; HR 1.93, 95% CI 1.37-2.73, p < 0.001). The most frequently reported toxicities were neutropenia, asthenia, thrombopenia and anemia.

Conclusions

Palbociclib can be an effective and safe treatment option in patients with heavily pretreated endocrine-sensitive mBC, especially in those with longer PFS to previous ET.

SUBMITTER: Manso L

PROVIDER: S-EPMC7695980 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Palbociclib combined with endocrine therapy in heavily pretreated HR<sup>+</sup>/HER2<sup>-</sup> advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

Manso Luis L Hernando Cristina C Galán María M Oliveira Mafalda M Cabrera Miguel A MA Bratos Raquel R Rodríguez César A CA Ruiz-Borrego Manuel M Blanch Salvador S Llombart-Cussac Antonio A Delgado-Mingorance Juan I JI Álvarez-Busto Iñaki I Gallegos Isabel I González-Cortijo Lucía L Morales Serafín S Aguirre Elena E Hernando Blanca A BA Ballesteros Ana A Alés-Martínez José E JE Reboredo Cristina C Oltra Amparo A González-Cao María M Santisteban Marta M Malón Diego D Echeverría Isabel I García-Garre Elisa E Vega Estela E Servitja Sònia S Andrés Raquel R Robles Carlos E CE López Rafael R Galve Elena E Echarri María J MJ Legeren Marta M Moreno Fernando F

Breast (Edinburgh, Scotland) 20201113

<h4>Background</h4>This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavily-pretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR<sup>+</sup>/HER2<sup>-</sup>) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017.<h4>Patients and methods</h4>Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HR<sup>+</sup>/HER2<sup>-</sup> ...[more]

PMID: 33242755

Similar Datasets

Project description:BackgroundPalbociclib is the first cyclin dependent kinase 4/6 (CDK4/6) inhibitor approved in China to be combined with endocrine therapy (ET) for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. However, palbociclib has only been used in China for a short amount of time, and there is limited data on its real-world applications. This study observed the efficacy and safety of palbociclib plus ET in a real-world setting in southwest China and we hope to provide some references for the treatment of patients with breast cancer in China.MethodsThis was an observational study of patients with HR+/HER2- advanced breast cancer (ABC) who received palbociclib plus ET. The primary endpoint of the study was progression-free survival (PFS) and the 6- and 12-month progression-free rates. The secondary endpoint included the objective response rate (ORR) and the clinical benefit rate (CBR).ResultsA total of 64 patients were enrolled in this study, and 54.7% of them received palbociclib plus ET as the first-line treatment for ABC. The median PFS was 21.6 months (95% CI: 11.2-32.0 months) after a median follow-up period of 13.8 months (95% CI: 11.9-15.7 months). The 6-month progression-free rate was 75.4%, and 48.9% of patients remained progression-free at 12 months. Overall, the ORR was 21.6% and the CBR was 76.5%. Patients with the molecular typing of Luminal A (P=0.035), a lower Ki67 level (P<0.001), sensitivity or acquired resistance to ET (P=0.003), less than 3 visceral metastases lesions (P=0.001), and those who received palbociclib plus ET as first-line or second-line of treatment for ABC (P=0.001) showed longer PFS. A total of 53.1% of patients had grade 3-4 adverse events (AEs), but only 4.7% of patients experienced permanent discontinuation of treatment due to intolerable AEs.ConclusionsThe efficacy of palbociclib plus ET is worthy of recognition and the toxicity was acceptable in this study, which is similar to previously reported data from randomized clinical trials and other real-world evidence. Treatment for ABC using palbociclib plus ET should be recommended more widely in China due to the efficacy and safety.

Project description:PurposeThe aim of this study was to evaluate the cost-effectiveness of ribociclib compared to palbociclib, both in combination with letrozole, in the first-line treatment of postmenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (ABC) from the perspective of the Spanish National Health System (NHS).Patients and methodsDisease progression was simulated with a partitioned survival model developed from the parameterization and extrapolation of survival curves of postmenopausal women with HR+/HER2- ABC from clinical trials with ribociclib or palbociclib, both in combination with letrozole. The model was structured on the basis of three health states (progression-free, progressed disease, and death), with a 1-month cycle length and inclusion of subsequent treatments administered for disease progression, over a time horizon of 15 years. Clinical, economic, and quality of life parameters were drawn from clinical trials and the literature. The use of resources and clinical practice in the Spanish setting was validated by a panel of experts. The Spanish NHS perspective was adopted, taking into account exclusively direct health costs from 2017 expressed in Euros. Drug prices used were the reported ex-factory prices. Uncertainty of the parameters and robustness of the results were evaluated using deterministic and probabilistic sensitivity analyses (2,000 iterations).ResultsThis cost-effectiveness analysis showed a greater benefit (0.437 and 0.285 life-years gained [LYGs] and quality-adjusted life years [QALYs] gained, respectively) and a slightly higher cost (€439.86) for ribociclib+letrozole compared to palbociclib+letrozole. The resulting incremental cost-effectiveness and cost-utility ratios were €1,007.69 per LYG and €1,543.62 per QALY gained, respectively. The results of the multiple sensitivity analyses showed limited dispersion of the outcomes, thus corroborating their robustness.ConclusionFrom the NHS perspective, considering the most commonly established willingness-to-pay thresholds in the Spanish setting, ribociclib+letrozole would represent a cost-effective therapeutic option compared to palbociclib+letrozole in the first-line treatment of HR+/HER2- ABC in postmenopausal women.

Dataset Information

Palbociclib combined with endocrine therapy in heavily pretreated HR⁺/HER2^- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

Background

Patients and methods

Results

Conclusions

Publications

Palbociclib combined with endocrine therapy in heavily pretreated HR<sup>+</sup>/HER2<sup>-</sup> advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

Background

Patients and methods

Results

Conclusions

Publications

Palbociclib combined with endocrine therapy in heavily pretreated HR<sup>+</sup>/HER2<sup>-</sup> advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Palbociclib combined with endocrine therapy in heavily pretreated HR⁺/HER2^- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).