Research Article

Experience Outside of Clinical Trial with Cyclin Inhibitors

Losada B*

Department of Medical Oncologist, Fuenlabrada University Hospital, Spain

Submission: September 05, 2018;Published: October 24, 2018

*Corresponding author: Losada B, Department of Medical Oncologist, Fuenlabrada university Hospital, Madrid, Spain

How to cite this article: Losada B. Experience Outside of Clinical Trial with Cyclin Inhibitors. Ann Rev Resear. 2018; 4(2): 555631. DOI: 10.19080/ARR.2018.04.555631

Keywords: Breast cancer; Cyclin inhibitor; Toxicity; Tolerance and Hepatic

Introduction

Luminal metastatic breast cancer has experienced a great advance thanks to the emergence of cyclin inhibitors, being a new line of treatment very well tolerated and that manages to prolong the overall survival in> 24 months based on the studies PALOMA-2, PALOMA-3 AND MONALEESA [1-3]. The aim of our study is to reflect the clinical characteristics of patients treated with cyclin inhibitor in the last months since its approval as well as the tolerance and toxicity profile.

Material and Methods

Retrospective study of 8 patients diagnosed in the University Hospital of Fuenlabrada in treatment with cyclin inhibitor in the last 4 months.

Results

50% of patients are <65 years old (3 premenopausal, on treatment with gnRH analog in 2/3 and 1/3 oophorectomy), with an ECOG 0-1 in 100%. 75% have expression of both estrogen and progesterone receptors, with 25% presenting only estrogen-positive receptors. 75% (6/8) was initially diagnosed as a locally advanced tumor and only 25% started as a metastatic disease. The disease-free interval was less than 2 years in 50% (4/8) of the patients. 25% present 3 or more metastatic locations, while the remaining 75% present between 1-2 locations. 25% have exclusive bone disease while 37.5% have visceral involvement. All patients except those with bone involvement have measurable disease. Regarding the treatments received, 25% had received fulvestrant and only one of them (12.5%) received chemotherapy for metastatic disease. 62.5% receive cyclins as the first line of metastatic disease while 25% receive it in the 5th line and the remaining 12.5% in the 3rd line. 50% receivec in combination with cyclins, while 37.5% combine it with letrozole, 12.5% with exemestane. 75% receive palbociclib while the other 25% ribociclib.

All patients currently continue to have cyclin inhibitors, except one (12.5%) that progresses to the pleural level at 3 months and is being treated with paclitaxel. The most frequently reported toxicity is in the form of neutropenia (grade 2 in 37.5%) that occurs in the first or second cycle and needs a delay of 1 week of treatment. Only in 1/8 (12.5%) dose adjustment to 100 mg daily of palbociclib is needed. No patient presented hepatic or cardiac toxicity

Conclusion

a) The treatment with cyclin inhibitors is safe and with a manageable profile of side effects.

b) The profile of patients being treated outside the clinical trial is both pre and postmenopausal (50%> 65 years, ECOG 0-1 and with several metastatic locations.

c) The most frequent toxicity is in the form of grade 2 neutropenia that after a dose delay of one week is recovered and usually does not need dose reduction [1-3].

References

1. Kaiser T, Köhler M, Wieseler B (2018) Reporting of HRQOL results from the PALOMA-2 trial: unfounded conclusions due to highly biased analyses. Ann Oncol 29(8): 1877.
2. Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, et al. (2016) Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 17(4): 425-439.
3. Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, et al. (2018) Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol 36(24): 2465-2472.