Marc Thill1, Pauline Wimberger2,3,4,5, Andrea Grafe6, Peter Klare7, Kerstin Luedtke-Heckenkamp8, Dietmar Reichert9, Matthias Zaiss10, Katja Ziegler-Löhr11, Tanja Eckl12, Andreas Schneeweiss13. 1. Department of Gynecology and Gynecological Oncology, Agaplesion Markus Hospital, Frankfurt A. M, Germany. marc.thill@agaplesion.de. 2. Department of Gynecology and Obstetrics, TU Dresden and National Center for Tumor Diseases (NCT/UCC), Dresden, Germany. 3. German Cancer Research Center (DKFZ), Heidelberg, Germany. 4. Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. 5. Helmholtz-Zentrum Dresden - Rossendorf (HZDR), Dresden, Germany. 6. Medical Center Nordhausen gGmbH, Nordhausen, Germany. 7. Gynecological Out-Patient Clinic, Berlin, Germany. 8. Center for Oncology and Hematology, Niels-Stensen-Clinics, Franziskus-Hospital Harderberg, Georgsmarienhütte, Germany. 9. Center for Oncology, Westerstede, Germany. 10. Practice for Interdisciplinary Oncology & Hematology, Freiburg, Germany. 11. Practice for Gynecological Oncology, Cologne, Germany. 12. Roche Pharma AG, Grenzach-Wyhlen, Germany. 13. National Center for Tumor Diseases (NCT), Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.
Abstract
PURPOSE: NIS HELENA documented outcomes in clinical routine practice of first-line therapy with P plus T and docetaxel (D) of patients with advanced HER2-positive BC and prior (neo)adjuvant T. METHODS: Between 06/2013 through 07/2016, 126 patients (in-label use of P at study start = full analysis set, FAS) in 81 German study sites were included. Intense documentation period was limited to 28 treatment cycles. Maximum follow-up (FU) was 24 months (mos). Safety was assessed in the safety set (SAF = eligible patients with at least one dose of P, n = 132). Median progression-free survival (PFS) was the main parameter of interest. RESULTS: Mean age of FAS patients was 55.1 [30.7-80.2] years, 81.7% (95.2%) were < 65 (75) years of age. 51.6% of the FAS patients were hormone receptor-positive (HR+), 91.3% had distant, 73.0% visceral, and 18.3% non-visceral metastases. Median disease-free interval was 40.2 [6.6-95.9] mos. Effectiveness (FAS): Median PFS was 18.8 [15.1; 24.2] mos. Overall response rate was 64.3% (55.6; 72.1). Median overall survival was 55.9 mos [41.2, not reached]. Safety (SAF): 93.9% of patients had an adverse event (AE), 32.6% a serious AE (SAE). AEs related to P occurred in 53.8% of SAF, SAEs related to P in 13.6%. Diarrhea was the most frequently reported related (S)AE. There were 8 (6.1%) patients with a fatal AE. CONCLUSION: Based on the outcomes from NIS HELENA, results of dual blockade with P+T in patients relapsing after (neo)adjuvant T as reported from the CLEOPATRA study (NCT01777958) can be transferred to routine clinical practice. No new safety signals were detected.
PURPOSE: NIS HELENA documented outcomes in clinical routine practice of first-line therapy with P plus T and docetaxel (D) of patients with advanced HER2-positive BC and prior (neo)adjuvant T. METHODS: Between 06/2013 through 07/2016, 126 patients (in-label use of P at study start = full analysis set, FAS) in 81 German study sites were included. Intense documentation period was limited to 28 treatment cycles. Maximum follow-up (FU) was 24 months (mos). Safety was assessed in the safety set (SAF = eligible patients with at least one dose of P, n = 132). Median progression-free survival (PFS) was the main parameter of interest. RESULTS: Mean age of FAS patients was 55.1 [30.7-80.2] years, 81.7% (95.2%) were < 65 (75) years of age. 51.6% of the FAS patients were hormone receptor-positive (HR+), 91.3% had distant, 73.0% visceral, and 18.3% non-visceral metastases. Median disease-free interval was 40.2 [6.6-95.9] mos. Effectiveness (FAS): Median PFS was 18.8 [15.1; 24.2] mos. Overall response rate was 64.3% (55.6; 72.1). Median overall survival was 55.9 mos [41.2, not reached]. Safety (SAF): 93.9% of patients had an adverse event (AE), 32.6% a serious AE (SAE). AEs related to P occurred in 53.8% of SAF, SAEs related to P in 13.6%. Diarrhea was the most frequently reported related (S)AE. There were 8 (6.1%) patients with a fatal AE. CONCLUSION: Based on the outcomes from NIS HELENA, results of dual blockade with P+T in patients relapsing after (neo)adjuvant T as reported from the CLEOPATRA study (NCT01777958) can be transferred to routine clinical practice. No new safety signals were detected.
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