Meeting
2020 ASCO Virtual Scientific Program
GAIN-2: Neo-/adjuvant phase III trial to compare intense dose-dense chemotherapy (CT) to tailored dose-dense CT in patients (pts) with high risk early breast cancer (EBC): Results on safety and interim invasive disease-free survival (iDFS).
Authors
Volker Moebus
Internal Medicine II, Dept. of Hematology & Oncology University of Frankfurt, Frankfurt, Germany
Volker Moebus , Hans-Joachim Lueck , Ekkehart Ladda , Peter Klare , Marcus Schmidt , Andreas Schneeweiss , Michael Untch , Frederik Marmé , Jens Bodo Huober , Elmar Stickeler , Mattea Reinisch , Theresa Link , Bruno Valentin Sinn , Jenny Furlanetto , Christine Solbach , Sabine Schmatloch , Julia Rey , Nicole Burchardi , Sibylle Loibl , Toralf Reimer
Organizations
Internal Medicine II, Dept. of Hematology & Oncology University of Frankfurt, Frankfurt, Germany, Gynaekologisch-Onkologische Praxis am Pelikanplatz, Hannover, Germany, Onkologische Praxis Neumarkt, Neumarkt, Germany, Praxisklinik Krebsheilkunde, Berlin, Germany, Department of Obstetrics and Gynecology University Hospital Mainz, Mainz, Germany, University Hospital Heidelberg, Heidelberg, Germany, Helios Klinikum Berlin-Buch, Berlin, Germany, Leitung Sektion Translationale Gynäkologische Onkologie Nationales Centrum für Tumorerkrankungen und Universitätsfrauenklinik Heidelberg, Heidelberg, Germany, Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Ulm, Ulm, Germany, Universitätsklinik RWTH Aachen, Aachen, Germany, Breast Unit, Kliniken Essen Mitte, Essen, Germany, TU Dresden, Dresden, Germany, Institut für Pathologie, Charité-Universitätsmedizin, Berlin, Germany, German Breast Group (GBG), Neu-Isenburg, Germany, University Hospital Frankfurt, Frankfurt Am Main, Germany, Brustzentrum, St. Elisabeth Krankenhaus, Kassel, Kassel, Germany, Universitätsfrauenklinik und Poliklinik am Klinikum Südstadt Rostock, Rostock, Germany
Research Funding
No funding received
None
Background: GAIN-2 (NCT01690702) compared efficacy and safety of intense, dose-dense epirubicin, nab-paclitaxel, and cyclophosphamide (iddEnPC) vs dose-dense, dose-tailored epirubicin/ cyclophosphamide followed by dose-dense, dose-tailored docetaxel (dtEC-dtD) as adjuvant or neoadjuvant CT for node-positive or high risk node-negative EBC. Here, we report safety results and interim analysis (IA) of the primary endpoint iDFS. Methods: Pts (luminal A ≥N2; luminal B N+; HER2+ and TNBC) were randomized between iddEnPC (E 150 mg/m2, nP 330 mg/m2, C 2000 mg/m2, all q2w x 3) or dtEC-dtD (dtEC q2w x 4 followed after 1 week rest by dtD q2w x 4). Primary objective was to compare iDFS. 797 events are needed to detect a hazard ratio of 0.819 with a 2-sided log-rank-test with 80% power and α=0.05. The IA of iDFS was planned after 50% of the events have occurred. Safety and compliance were secondary objectives. Results: Between 10/2012 and 09/2018, 2887 pts were randomized and 2857 started treatment (iddEnPC 1429; dtEC-dtD 1428). Median age was 51 (range 18-75) years. Overall, 18.1% were luminal A, 31.5% luminal B/HER2-, 18.8% hormone-receptor (HR)+/HER2+, 8.5% HR-/HER2+ and 23.2% TNBC. Overall, 88.1% of pts completed all treatment in both arms. 66.8% with iddEnPC vs 58.8% with dtEC-dtD delayed CT dose (p<0.001). Grade 3-4 non-hematological adverse events (AEs) were more frequent with iddEnPC (iddEnPC 50.8% vs dtEC-dtD 45.1%, p=0.002). Grade 3-4 leukopenia, neutropenia, febrile neutropenia, arthralgia, and peripheral sensory neuropathy were significantly higher with iddEnPC. There were 1464 serious AEs (iddEnPC 870 vs dtEC-dtD 594) and 26 (9 vs 17) predefined AEs of special interest (anaphylaxis, any AE affecting cranial nerves, macula edema). Two deaths occurred during dtEC-dtD. After a median follow-up of 45.8 months, there was no difference in iDFS between arms (log-rank p=0.9102, hazard ratio iddEnPC vs dtEC-dtD 1.01, 95% CI 0.83-1.23). Conclusions: No new safety concerns were observed. Use of both iddEnPC and dtEC-dtD appears feasible in the (neo)adjuvant treatment of high risk EBC. Clinical trial information: NCT01690702.
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Breast Cancer—Local/Regional/Adjuvant
Track
Breast Cancer
Sub Track
Adjuvant Therapy
Clinical Trial Registration Number
NCT01690702
Citation
J Clin Oncol 38: 2020 (suppl; abstr 516)
DOI
10.1200/JCO.2020.38.15_suppl.516
Abstract #
516
Poster Bd #
8
Abstract Disclosures
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