1029P - Real-world comparative effectiveness analysis of second-line (2L) nab-paclitaxel (nab-P) vs paclitaxel (Pac) in patients (Pts) with metastatic breast cancer (MBC)

Abstract

Backgroundnab-P monotherapy is approved for 2L treatment (Tx) of MBC. This real-world analysis evaluated comparative effectiveness of 2L nab-P vs Pac in pts with MBC.MethodsA retrospective cohort study was performed using fully de-identified data from a US electronic medical record platform of 1300 community (non-university based) oncologists. This analysis included pts with MBC who initiated 2L nab-P or Pac monotherapy from 12/1/10 to 4/6/15 (≥ 2 doses of nab-P or Pac required to be included in the analysis). The primary objectives were time to Tx discontinuation (TTD) and time to next Tx (TTNT). Adverse events (AEs) and supportive care were also examined. Subanalyses in pts with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2-) or triple-negative (TN) MBC were conducted.ResultsTabled 1nab-P n = 109Pac n = 302Unadjusted P-valueAdjusted P-valueOverall populationTx schedule, weekly, n (%)90 (83)286 (95)--TTD, median, mos4.52.8< 0.001< 0.001TTNT, median, mos5.94.20.0140.214Any grade AE in > 5% pts, %Overall45.058.30.0170.032Anemia26.636.80.0550.050Neutropenia15.610.60.1670.245Neuropathy4.613.60.0110.039Pain1.812.30.002-Thrombocytopenia7.33.00.087-Nausea + Vomiting9.23.00.008-Diarrhea2.87.00.109-Dehydration6.43.00.1450.467Infection0.96.30.0250.059Fatigue0.55.60.0010.023Hypersensitivity0.05.60.009-Supportive Care doses/pt/100 daysAntimetics5.918.49<0.001<0.001Tx for hydration3.764.73<0.0010.001Tx for bone loss1.960.96<0.001<0.001G-CSF1.220.66<0.001<0.001Tx for allergic reaction0.2710.57<0.001<0.001HR + /HER2-nMedian, mosnMedian, mosTTD724.51392.8<0.001<0.001TTNT396.1775.30.0590.107Triple NegativenMedian, mosnMedian, mosTTD184.1712.80.016-TTNT96.1179.60.100- Open table in a new tab ConclusionsIn this retrospective review, 2L nab-P was associated with significantly longer TTD vs Pac. Pts treated with nab-P had fewer AEs overall. A similar trend in favor of nab-P was shown in pts with HR + /HER2- or TN MBC.Legal entity responsible for the study: Monika ParisiFundingCelgene CorporationDisclosureC. Pelletier, M. Parisi, S. Glück, Q. Ni: Employee of Celgene Corporation. F. Braiteh: AbbVie, ActiveBiotech, Amgen, AstraZeneca, Bayer, BMS, BIND, BioMarin, BioTheranostics, BN Therapeutics, BI, Caris, Celgene, Daiichi, Dendreon, Genomic Health, Gilead, GSK, Halozyme, Heron, Eli Lilly, Incyte, Insys, Novartis, Pfizer. Backgroundnab-P monotherapy is approved for 2L treatment (Tx) of MBC. This real-world analysis evaluated comparative effectiveness of 2L nab-P vs Pac in pts with MBC. nab-P monotherapy is approved for 2L treatment (Tx) of MBC. This real-world analysis evaluated comparative effectiveness of 2L nab-P vs Pac in pts with MBC. MethodsA retrospective cohort study was performed using fully de-identified data from a US electronic medical record platform of 1300 community (non-university based) oncologists. This analysis included pts with MBC who initiated 2L nab-P or Pac monotherapy from 12/1/10 to 4/6/15 (≥ 2 doses of nab-P or Pac required to be included in the analysis). The primary objectives were time to Tx discontinuation (TTD) and time to next Tx (TTNT). Adverse events (AEs) and supportive care were also examined. Subanalyses in pts with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2-) or triple-negative (TN) MBC were conducted. A retrospective cohort study was performed using fully de-identified data from a US electronic medical record platform of 1300 community (non-university based) oncologists. This analysis included pts with MBC who initiated 2L nab-P or Pac monotherapy from 12/1/10 to 4/6/15 (≥ 2 doses of nab-P or Pac required to be included in the analysis). The primary objectives were time to Tx discontinuation (TTD) and time to next Tx (TTNT). Adverse events (AEs) and supportive care were also examined. Subanalyses in pts with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2-) or triple-negative (TN) MBC were conducted. ResultsTabled 1nab-P n = 109Pac n = 302Unadjusted P-valueAdjusted P-valueOverall populationTx schedule, weekly, n (%)90 (83)286 (95)--TTD, median, mos4.52.8< 0.001< 0.001TTNT, median, mos5.94.20.0140.214Any grade AE in > 5% pts, %Overall45.058.30.0170.032Anemia26.636.80.0550.050Neutropenia15.610.60.1670.245Neuropathy4.613.60.0110.039Pain1.812.30.002-Thrombocytopenia7.33.00.087-Nausea + Vomiting9.23.00.008-Diarrhea2.87.00.109-Dehydration6.43.00.1450.467Infection0.96.30.0250.059Fatigue0.55.60.0010.023Hypersensitivity0.05.60.009-Supportive Care doses/pt/100 daysAntimetics5.918.49<0.001<0.001Tx for hydration3.764.73<0.0010.001Tx for bone loss1.960.96<0.001<0.001G-CSF1.220.66<0.001<0.001Tx for allergic reaction0.2710.57<0.001<0.001HR + /HER2-nMedian, mosnMedian, mosTTD724.51392.8<0.001<0.001TTNT396.1775.30.0590.107Triple NegativenMedian, mosnMedian, mosTTD184.1712.80.016-TTNT96.1179.60.100- Open table in a new tab ConclusionsIn this retrospective review, 2L nab-P was associated with significantly longer TTD vs Pac. Pts treated with nab-P had fewer AEs overall. A similar trend in favor of nab-P was shown in pts with HR + /HER2- or TN MBC.Legal entity responsible for the study: Monika Parisi In this retrospective review, 2L nab-P was associated with significantly longer TTD vs Pac. Pts treated with nab-P had fewer AEs overall. A similar trend in favor of nab-P was shown in pts with HR + /HER2- or TN MBC.