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

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Bioethics, Legal, and Economic Issues
Presenter Corey Pelletier
Citation Annals of Oncology (2016) 27 (6): 351-358. 10.1093/annonc/mdw377
Authors C. Pelletier1, M. Parisi1, S. Glück2, Q. Ni1, F. Braiteh3
  • 1U.s. Health Economics And Outcomes Research, Celgene Corporation, 07901 - Summit/US
  • 2Pancreatic Cancer And Immuno-oncology, Celgene Corporation, 07901 - Summit/US
  • 3Clinical Associate Professor Of Medicine, Comprehensive Cancer Centers of Nevada, 89169 - Las Vegas/US

Abstract

Background

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.

Methods

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.

Results

This analysis included 411 pts (109 treated with nab-P Tx and 302 with Pac Tx). Pts treated with nab-P were older (mean 61 vs 57 y) and more frequently had HR+ (78% vs 65%) or HER2− (83% vs 70%) disease. Most pts received weekly Tx (Table). Prior use of a taxane or concurrent use of a targeted agent was similar between groups. nab-P was associated with significantly longer TTD vs Pac. TTNT was similar between groups. Pts treated with nab-P had less fatigue, pain, and neuropathy but more nausea and vomiting vs Pac. Antiemetics (IV) and Tx for hydration and allergic reaction were used less with nab-P, and Tx for bone loss and granulocyte colony-stimulating factor (G-CSF) were used less with Pac. In subgroup analyses, TTD was significantly longer with nab-P vs Pac in pts with HR + /HER2− or TN MBC, and TTNT was numerically longer with nab-P vs Pac in pts with HR + /HER2− MBC.

nab-P n = 109 Pac n = 302 Unadjusted P-value Adjusted P-value
Overall population
Tx schedule, weekly, n (%) 90 (83) 286 (95) - -
TTD, median, mos 4.5 2.8 < 0.001 < 0.001
TTNT, median, mos 5.9 4.2 0.014 0.214
Any grade AE in > 5% pts, %
Overall 45.0 58.3 0.017 0.032
Anemia 26.6 36.8 0.055 0.050
Neutropenia 15.6 10.6 0.167 0.245
Neuropathy 4.6 13.6 0.011 0.039
Pain 1.8 12.3 0.002 -
Thrombocytopenia 7.3 3.0 0.087 -
Nausea + Vomiting 9.2 3.0 0.008 -
Diarrhea 2.8 7.0 0.109 -
Dehydration 6.4 3.0 0.145 0.467
Infection 0.9 6.3 0.025 0.059
Fatigue 0.5 5.6 0.001 0.023
Hypersensitivity 0.0 5.6 0.009 -
Supportive Care doses/pt/100 days
Antimetics 5.91 8.49

Conclusions

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.

Clinical trial identification

This study is a retrospective analysis, therefore the protocol number and release data is not applicable.

Legal entity responsible for the study

Monika Parisi

Funding

Celgene Corporation

Disclosure

C. 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.