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Proffered Paper session: Supportive and palliative care

1553O - Health-related quality of life (HRQoL) in the phase III TROPiCS-02 trial of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (MBC)

Date

11 Sep 2022

Session

Proffered Paper session: Supportive and palliative care

Topics

Supportive Care and Symptom Management

Tumour Site

Breast Cancer

Presenters

Aditya Bardia

Citation

Annals of Oncology (2022) 33 (suppl_7): S713-S742. 10.1016/annonc/annonc1075

Authors

H.S. Rugo1, P. Schmid2, S.M. Tolaney3, F. Dalenc4, F. Marmé5, L. Shi6, W. Verret7, M. Gharaibeh8, A. Bardia9, J. Cortés10

Author affiliations

  • 1 Department Of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 94158-1710 - San Francisco/US
  • 2 Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ - London/GB
  • 3 Department Of Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 4 Iuct-oncopole, Institut Claudius Regaud, 31052 - Toulouse/FR
  • 5 Medical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, 68167 - Mannheim/DE
  • 6 Evidence Synthesis, Modeling & Communication, Evidera PPD, 02451 - Waltham/US
  • 7 Department Of Clinical Development, Gilead Sciences, Inc., 33126 - Foster City/US
  • 8 Department Of Health Economics And Outcomes Research, Gilead Sciences, Inc., 94404 - Foster City/US
  • 9 Medical Oncology, Massachusetts General Hospital Cancer Center, 02114 - Boston/US
  • 10 Medical Oncology Department, International Breast Cancer Center (ibcc), International Breast Cancer Center, Quironsalud Group, Madrid & Barcelona, Spain Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain, Barcelona/ES
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Resources

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Abstract 1553O

Background

The antibody-drug conjugate SG comprises an anti-Trop-2 antibody coupled to SN-38 via a hydrolyzable linker. In the ongoing randomized TROPiCS-02 trial, SG is being evaluated vs single-agent chemotherapy treatment of physician’s choice (TPC) after CDK 4/6 inhibitor, endocrine therapy, and at least 2 chemotherapies in HR+/HER2- MBC setting. Here we assess the impact of SG on HRQoL in TROPiCS-02.

Methods

Patients (pts) with locally determined HR+/HER2- MBC following (2-4 prior chemotherapies) for metastatic disease, were randomized to receive SG (10 mg/kg IV on days 1 and 8 of a 21-day treatment [Tx] cycle) or TPC (capecitabine, eribulin, gemcitabine, or vinorelbine). HRQoL was assessed at baseline (BL), day 1 of each Tx cycle (CxDx) and at end of treatment visit using the EORTC QLQ-C30. The analysis included all pts with valid HRQoL assessments at BL and ≥1 post-BL visit. Linear mixed-effect models for repeated measures were used to estimate differences in overall least-square mean changes from BL between Tx arms, using on-Tx data up to C11D1 (n ≥25 in both arms).

Results

The analysis included 446 pts (236 SG, 210 TPC; median age 56 y). The EORTC QLQ-C30 completion rate was ≥85% up to C13D1 in both Tx arms. Mean HRQoL scores at BL were generally similar for SG and TPC. The SG arm showed a trend of improvement in most HRQoL domains. A significantly greater improvement in physical functioning and dyspnea was observed for SG vs TPC and greater worsening in diarrhea (table). Table: 1553O

EORTC QLQ-C30 least-square mean change from baseline

SG vs TPC (95% CI)
Global health status/QoL 2.4 (-0.7, 5.5)
Functioning
Physical 3.9 (0.9, 6.9)
Role 3.1 (-1.2, 7.4)
Emotional 0.9 (-2.4, 4.3)
Cognitive -0.2 (-3.3, 2.9)
Social 0.8 (-3.2, 4.7)
Summary Score 0.6 (-1.8, 3.1)
Symptoms
Fatigue -3.3 (-7.1, 0.5)
Pain -1.6 (-5.5, 2.3)
Nausea/Vomiting 1.4 (-0.9, 3.8)
Dyspnea -4.3 (-8.5, -0.1)
Insomnia -3.7 (-8.1, 0.8)
Appetite Loss -3.3 (-7.3, 0.8)
Constipation -1.0 (-5.5, 3.4)
Diarrhea 10.4 (6.3, 14.5)
Financial Difficulties 0.9 (-2.5, 4.2)
Positive value represents improvement for functioning and worsening for symptoms.

SG, sacituzumab govitecan; TPC, treatment of physician’s choice.

Conclusions

Despite the association with worsening diarrhea, SG demonstrated an overall HRQoL benefit in heavily-pretreated patients with HR+/HER2- MBC.

Clinical trial identification

NCT03901339.

Editorial acknowledgement

Legal entity responsible for the study

Gilead Sciences, Inc.

Funding

Gilead Sciences, Inc.

Disclosure

H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma Biotechnology, Mylan, Samsung Bioepis; Financial Interests, Institutional, Funding: Macrogenics, OBI Pharma, Pfizer, Novartis, Lilly, Genetech, Merck, Odonate Therapeutics, Daiichi Sankyo, Seattle Genetics, Sermonix Pharmaceuticals, Astra Zeneca, Gilead Sciences, Ayala Pharmaceuticals. P. Schmid: Financial Interests, Institutional, Research Grant, Grant/Funding to Institution: Astellas, AstraZeneca, Genentech, Novartis, Oncogenex, Roche, Medivation; Financial Interests, Personal, Advisory Role, Consulting fees: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai, Celgene; Financial Interests, Personal, Writing Engagements, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Eisai, Celgene; Financial Interests, Personal, Full or part-time Employment, Employee – Roche (spouse): Roche (spouse). S.M. Tolaney: Financial Interests, Institutional, Funding, Funding to institute for duration of study: Gilead; Financial Interests, Institutional, Funding, All funding to institute: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead, Exelixis, BMS, Eisai, Nanostring, Cyclacel, Sanofi, Odonate, SeaGen; Financial Interests, Personal, Invited Speaker, Honorarium payments to self for participation in advisory boards/consulting from all companies listed: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech/Roche, Gilead, BMS, Eisai, Nanostring, Sanofi, Odonate, SeaGen, Daiichi-Sankyo, Athenex, CytomX, Blueprint Medicines, Zentalis, Zymeworks, Ellipses Pharma, 4D Pharma, OncoSec, Infinity Therapeutics, BeyondSpring Pharma, OncXerna, Reveal Genomics, ARC Therapeutics; Financial Interests, Personal, Invited Speaker, Honorarium payments to self for participation in advisory boards/consulting from all companies listed – 1 time event: Kyowa Kirin Pharma, G1 Therapeutics, Silverback Therapeutics, Certara, Mersana Therapeutics, OncoPep; Financial Interests, Personal, Invited Speaker, To self – lecture/educational series: Chugai, Genentech/Roche, Eisai, Gilead, AstraZeneca, BMS. F. Marmé: Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Personal and Institutional, Research Grant: Roche, Novartis, Astra Zeneca, GSK/Tesaro, MED, Clovis, Vaccibody, Gilead Sciences, Eisai; Financial Interests, Personal, Advisory Role, Consulting Fees: Astra Zeneca, Tesaro/GSK, Pfizer, EISAI, Gilead, Genomic Health; Financial Interests, Institutional, Advisory Role, Consulting Fees: VACIIBODY; Financial Interests, Personal, Invited Speaker, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Astra Zeneca, Clovis, GSK/Tesaro, Eli Lilly, Novartis, Pfizer, Roche, Myriad Genetics, PharmaMar, Eisai, MSD, Immunomedis/Gilead, Pierre-Fabre, Agendia, Genomic Health, Seattle Genetics; Financial Interests, Personal and Institutional, Sponsor/Funding, Support for attending meetings and/or travel: Pfizer, Roche, Astra Zeneca ; Financial Interests, Personal and Institutional, Advisory Role, Participation on a Data Safety Monitoring Board or Advisory Board: Palleos, Amgen. L. Shi: Financial Interests, Personal and Institutional, Funding, Evidera received payment for statistical analysis for this project: Gilead. W. Verret: Financial Interests, Personal, Full or part-time Employment: Genentech, Gilead; Financial Interests, Personal, Stocks/Shares: Genentech. M. Gharaibeh: Financial Interests, Personal, Full or part-time Employment, Gilead employee – therefore, granted with Gilead stocks and stocks options: Gilead. A. Bardia: Financial Interests, Personal and Institutional, Research Grant, Grants or contracts from any entity: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health/Menarini, Immunomedics/Gilead, Daiichi Pharma/Astra Zeneca, Eli Lilly; Financial Interests, Personal, Advisory Role, Consulting fees: Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead, Sanofi, Daiichi Pharma/Astra Zeneca, Phillips, Eli Lilly, Foundation Medicine. J. Cortés: Financial Interests, Personal, Advisory Role: Roche +, Celgene -, Celestial, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp&Dohme +, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin; Financial Interests, Personal, Invited Speaker: Roche +, Novartis +, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo; Financial Interests, Institutional, Funding: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London; Financial Interests, Personal, Stocks/Shares, Stock, patents and intellectual property: MedSIR; Financial Interests, Personal, Travel, accommodation, expenses: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo. All other authors have declared no conflicts of interest.

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