Rachel Wuerstlein1,2, Nadia Harbeck1,2, Eva-Maria Grischke3, Dirk Forstmeyer4, Raquel von Schumann5, Petra Krabisch6, Kerstin Lüdtke-Heckenkamp7, Andrea Stefek8, Oliver Stoetzer9, Andrea Grafe10, Gabriele Kaltenecker11, Helmut Forstbauer12, Doris Augustin13, Iris Schrader14, Joke Tio15, Ulrike Nitz2,5, Oleg Gluz2,5,16, Ronald E Kates2, Monika Karla Graeser2,5. 1. Breast Center and CCC Munich, Department of Obstetrics and Gynecology, University of Munich (LMU), Munich, Germany. 2. West German Study Group, Mönchengladbach, Germany. 3. University Clinic Tübingen, Women's Clinic, Tübingen, Germany. 4. University Clinic Leipzig, University Cancer Center Leipzig (UCCL), Leipzig, Germany. 5. Evangelical Hospital Bethesda, Breast Center Niederrhein, Mönchengladbach, Germany. 6. Clinic Chemnitz, Breast Center, Chemnitz, Germany. 7. Niels Stensen Clinics, Franziskus Hospital Harderberg, Georgsmarienhütte, Germany. 8. Johanniter Clinics Stendal, Breast Center Altmark, Stendal, Germany. 9. Medical Center for Hematology and Oncology Munich, Munich, Germany. 10. MVZ Nordhausen, Nordhausen, Germany. 11. Municipal Clinic Karlsruhe, Breast Center, Karlsruhe, Germany. 12. Practice Network Troisdorf, Troisdorf, Germany. 13. Donau-Isar Clinic Deggendorf, Breast Center, Deggendorf, Germany. 14. Gynecological Oncological Practice Hanover, Hanover, Germany. 15. University Clinic Münster, Breast Center, Münster, Germany. 16. University Hospital Cologne, Cologne, Germany.
Abstract
BACKGROUND: Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT). PATIENTS AND METHODS: Of the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed. RESULTS: Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis (n = 222) had febrile neutropenia of grade 3-4 (5 patients) or infection of grade 3-4 (4 patients); 1/26 of those receiving secondary prophylaxis had an event. Dose reductions were performed in 9.5% of the patients. Postponement of cancer CT cycles for >3 days occurred in <15% of patients; 10.8% (92/851 AEs) and 8% (2/25 SAEs) of documented adverse events and serious adverse events, respectively, were related to lipegfilgrastim. CONCLUSIONS: Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.
BACKGROUND: Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT). PATIENTS AND METHODS: Of the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed. RESULTS: Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis (n = 222) had febrile neutropenia of grade 3-4 (5 patients) or infection of grade 3-4 (4 patients); 1/26 of those receiving secondary prophylaxis had an event. Dose reductions were performed in 9.5% of the patients. Postponement of cancer CT cycles for >3 days occurred in <15% of patients; 10.8% (92/851 AEs) and 8% (2/25 SAEs) of documented adverse events and serious adverse events, respectively, were related to lipegfilgrastim. CONCLUSIONS: Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.
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