Breast Cancer: Targets and Therapy (Oct 2022)
Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial
Abstract
Roberta Caputo,1 Alessandra Fabi,2,3 Emanuela Romagnoli,4 Editta Baldini,5 Donatella Grasso,6 Nicola Fenderico,6 Andrea Michelotti7 1Dipartimento di Senologia, Istituto Nazionale Tumori Fondazione Pascale, IRCCS, Naples, Italy; 2Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena - Istituti Fisioterapici Ospitalieri, Rome, Italy; 3Precision Medicine in Breast Cancer, Department of Woman and Child Health and Public Health, Scientific Directorate, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Roma, Italy; 4U.O.C. Oncologia, Presidio Ospedaliero di Macerata, Macerata, Italy; 5Director of the U.O.C. Medical Oncology, San Luca Hospital via Guglielmo Lippi Francesconi, Lucca, Italy; 6Oncology, Novartis Farma SpA, Origgio, Italy; 7UO Oncologia Medica 1, Azienda Ospedaliero Universitaria Pisana, Ospedale S. Chiara, Pisa, ItalyCorrespondence: Roberta Caputo, Dipartimento di Senologia, Istituto Nazionale Tumori Fondazione Pascale, IRCCS, Via Mariano Semmola, 53, Napoli, 80131, Italy, Tel +39 3339714308, Fax +39 0815903726, Email [email protected]: Male breast cancer (BC) is rare, globally constituting only 0.5– 1% of all patients with BC. In Italy, more than 2000 new male BC cases were registered between 2000 and 2014. The survival rate was lower in males than in females. Delayed diagnosis may be the reason for poorer outcome observed in male BC patients compared with female patients. Due to lack of substantial evidence and low availability of published data on male BC, the current treatment recommendations are based on evidence derived from trials on female patients. In Italy, most of the male BC patients are estrogen and progesterone receptor–positive. Targeted therapy in combination with endocrine therapy provides a clinically meaningful outcome in patients with hormone receptor–positive (HR-positive), human epidermal growth factor receptor 2–negative (HER2-negative) advanced BC. CompLEEment-1 is a single-arm, open-label, multicenter, phase 3b trial investigating the safety and efficacy of a CDK4/6 inhibitor, ribociclib, in combination with letrozole in men and women. Herein, we report the results from a retrospective analysis of five Italian male patients who completed the core phase. In this case series, the combination of ribociclib and letrozole was well tolerated and appeared to be effective in the male cohort with HR-positive, HER2-negative advanced BC in Italy. CompLEEment-1 trial representative of a real-world setting would add value by supporting the existing efficacy and safety profile of ribociclib in combination with letrozole in male patients with HR-positive, HER2-negative advanced BC.ClinicalTrials.gov Registration Number: NCT02941926.Keywords: CDK4/6 inhibitor, targeted therapy, male breast cancer, progression-free survival, case report
