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Quality of life (QOL) evaluation of patients in a phase 3 study comparing NEPA with an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV)

Date

09 Sep 2017

Session

Supportive and palliative care

Presenters

Li Zhang

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

L. Zhang1, S. Lu2, J. Feng3, A. Dechaphunkul4, S. Chessari5, C. Lanzarotti6, K. Jordan7, M.S. Aapro8

Author affiliations

  • 1 State Key Laboratory Of Oncology In South China, Collaborative Innovation Center For Cancer Medicine, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2 Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai/CN
  • 3 Jiangsu Cancer Hospital, Medical Oncology, Nanjing/CN
  • 4 Internal Medicine, Division Of Medical Oncology, Prince of Songkla University, Songkhla/TH
  • 5 Corporate Clinical Development, Helsinn Healthcare, Lugano/CH
  • 6 Statistics & Data Management, Helsinn Healthcare, Lugano/CH
  • 7 Department Of Medicine V, University of Heidelberg, Heidelberg/DE
  • 8 Breast Center, Cancer Center, Clinque de Genolier, Genolier/CH
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Resources

Background

Suboptimal CINV prevention can negatively impact patients’ (pts) QOL by interfering with daily functioning. Antiemetic guidelines recommend co-administration of a NK1 receptor antagonist (RA)/5-HT3RA/corticosteroid to optimize CINV control in pts at high risk for CINV. NEPA, a fixed combination of the NK1RA netupitant and 5-HT3RA palonosetron (PALO) has shown superior CINV prevention and improvement in QOL over PALO. A single dose of NEPA recently showed non-inferiority to a 3-day aprepitant/granisetron (APR/GRAN) regimen in preventing CINV in the first head-to-head comparison of NK1RA-containing regimens. The impact of CINV on pts’ QOL in this study was explored.

Methods

This randomized, double-blind, Phase 3 study in chemotherapy-naïve pts receiving cisplatin-based chemotherapy (CT) assessed the non-inferiority of NEPA versus APR/GRAN for complete response (CR: no emesis/no rescue medication [RM]) rates during the overall (0-120 h) phase post-CT. All pts received dexamethasone on days 1-4. Secondary endpoints included proportion of pts with no emesis, no significant nausea (NSN:

Results

Treatment groups were similar for the 828 pts analyzed: male (71%); mean age 55 years; lung cancer (58%). NIDL rates were higher for NEPA, particularly during the delayed phase; similar results were seen for no emesis, NSN, and no RM.rnTable:

1548PD

rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn
% PatientsNEPA (N = 412)APR/GRAN (N = 416)Risk Difference (95% CI)
NIDL (overall domain) Acute (0-24h) Delayed (25-120 h)86.2% 76.0%83.2% 70.7%3.3 (-1.6%, 8.1%) 5.8% (-0.1%, 11.8%)
NIDL (nausea domain) Acute Delayed81.8% 71.1%80.0% 65.1%2.0% (-3.3%, 7.3%) 6.5% (0.2%, 12.8%)*
NIDL (vomiting domain) Acute Delayed87.9% 81.3%86.8% 77.4%1.4% (-3.1%, 5.9%) 4.5% (-1.0%, 9.9%)
No Emesis Acute Delayed85.2% 79.4%87.5% 76.2%−2.2% (-6.9%, 2.4%) 3.3% (-2.4%, 8.9%)
NSN Acute Delayed89.8% 78.2%87.3% 72.8%2.6% (-1.7%, 6.9%) 5.4% (-0.4%, 11.2%)
No RM Acute Delayed98.8% 97.6%98.3% 94.7%0.5% (-1.2%, 2.1%) 2.9% (0.2%, 5.5%)*
rn*

statistically significant difference NEPA: fixed combination netupitant/palonosetron, APR: aprepitant, GRAN: granisetron, NIDL: no impact on daily life, NSN: no significant nausea, RM: rescue medication

rn

Conclusions

In this first study comparing NK1RA regimens, NEPA administered only on day 1 was numerically similar to a 3-day oral APR/GRAN regimen in maintaining functional status in patients receiving highly emetogenic CT.

Clinical trial identification

Legal entity responsible for the study

Helsinn Healthcare, SA

Funding

Helsinn Healthcare

Disclosure

L. Zhang: Consultant for MSD; research funding from MSD and Lilly. S. Lu: Consultant Boehinger and Roche; speaker\'s bureau Lilly; travel expenses from Hutchison and Medipharm Limited. S. Chessari, C. Lanzarotti: Employee: Helsinn Healthcare. K. Jordan: Honorarium/consultant for Helsinn, Tesaro, MDS, and Merck. Travel accommodations from MSD. M. Aapro: Honorarium from Amgen. Consultant for Helsinn, Teva, Hospira, Merck KGaA, Merck, Sandoz, Pierre Fabre, Vifor Pharma, Tesaro. Research funding from Helsinn, Sandoz, Hopsira, Novartis, Pierre Fabre. Expert Testimony for Amgen. All other authors have declared no conflicts of interest.

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