Patient-reported function, health-related quality of life, and symptoms in APHINITY : pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer
BACKGROUND: We assessed health-related quality of life (symptoms of therapy/patient functioning/global health status), in APHINITY (pertuzumab/placebo, trastuzumab, and chemotherapy as adjuvant HER2-positive early breast cancer therapy).
METHODS: Patients received 1 year/18 cycles of pertuzumab/placebo with trastuzumab and chemotherapy and completed EORTC QLQ-C30 and BR23 questionnaires until 36 months post-randomisation/disease recurrence. Changes ≥10 points from baseline were considered clinically meaningful.
RESULTS: 87-97% of patients completed questionnaires. In the pertuzumab versus placebo arms, mean decrease in physical function scores (baseline → end of taxane) was -10.7 (95% CI -11.4, -10.0) versus -10.6 (-11.4, -9.9), mean decrease in global health status was -11.2 (-12.2, -10.2) versus -10.2 (-11.1, -9.2), and mean increase in diarrhoea scores (baseline → end of taxane) was +22.3 (21.0, 23.6) versus +9.2 (8.2, 10.2). Diarrhoea scores remained elevated versus baseline in the pertuzumab arm throughout HER2-targeted treatment (week 25: +13.2; end of treatment: +12.2). Role functioning was maintained in both arms.
CONCLUSIONS: Improved invasive disease-free survival achieved by adding pertuzumab to trastuzumab and chemotherapy did not adversely affect the ability to conduct activities of daily living versus trastuzumab and chemotherapy alone. Patient-reported diarrhoea worsened during taxane therapy in both arms, persisting during HER2-targeted treatment in the pertuzumab arm. CLINICALTRIALS.GOV: NCT01358877.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:125 |
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| Enthalten in: |
British journal of cancer - 125(2021), 1 vom: 07. Juli, Seite 38-47 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bines, José [VerfasserIn] |
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| Links: |
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| Themen: |
Antibodies, Monoclonal, Humanized |
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| Anmerkungen: |
Date Completed 09.12.2021 Date Revised 17.04.2022 published: Print-Electronic ClinicalTrials.gov: NCT01358877 Citation Status MEDLINE |
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| doi: |
10.1038/s41416-021-01323-y |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM323835325 |
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| 024 | 7 | |a 10.1038/s41416-021-01323-y |2 doi | |
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| 100 | 1 | |a Bines, José |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Patient-reported function, health-related quality of life, and symptoms in APHINITY |b pertuzumab plus trastuzumab and chemotherapy in HER2-positive early breast cancer |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 09.12.2021 | ||
| 500 | |a Date Revised 17.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01358877 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: We assessed health-related quality of life (symptoms of therapy/patient functioning/global health status), in APHINITY (pertuzumab/placebo, trastuzumab, and chemotherapy as adjuvant HER2-positive early breast cancer therapy) | ||
| 520 | |a METHODS: Patients received 1 year/18 cycles of pertuzumab/placebo with trastuzumab and chemotherapy and completed EORTC QLQ-C30 and BR23 questionnaires until 36 months post-randomisation/disease recurrence. Changes ≥10 points from baseline were considered clinically meaningful | ||
| 520 | |a RESULTS: 87-97% of patients completed questionnaires. In the pertuzumab versus placebo arms, mean decrease in physical function scores (baseline → end of taxane) was -10.7 (95% CI -11.4, -10.0) versus -10.6 (-11.4, -9.9), mean decrease in global health status was -11.2 (-12.2, -10.2) versus -10.2 (-11.1, -9.2), and mean increase in diarrhoea scores (baseline → end of taxane) was +22.3 (21.0, 23.6) versus +9.2 (8.2, 10.2). Diarrhoea scores remained elevated versus baseline in the pertuzumab arm throughout HER2-targeted treatment (week 25: +13.2; end of treatment: +12.2). Role functioning was maintained in both arms | ||
| 520 | |a CONCLUSIONS: Improved invasive disease-free survival achieved by adding pertuzumab to trastuzumab and chemotherapy did not adversely affect the ability to conduct activities of daily living versus trastuzumab and chemotherapy alone. Patient-reported diarrhoea worsened during taxane therapy in both arms, persisting during HER2-targeted treatment in the pertuzumab arm. CLINICALTRIALS.GOV: NCT01358877 | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Pragmatic Clinical Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a pertuzumab |2 NLM | |
| 650 | 7 | |a K16AIQ8CTM |2 NLM | |
| 650 | 7 | |a Trastuzumab |2 NLM | |
| 650 | 7 | |a P188ANX8CK |2 NLM | |
| 700 | 1 | |a Clark, Emma |e verfasserin |4 aut | |
| 700 | 1 | |a Barton, Claire |e verfasserin |4 aut | |
| 700 | 1 | |a Restuccia, Eleonora |e verfasserin |4 aut | |
| 700 | 1 | |a Procter, Marion |e verfasserin |4 aut | |
| 700 | 1 | |a Sonnenblick, Amir |e verfasserin |4 aut | |
| 700 | 1 | |a Fumagalli, Debora |e verfasserin |4 aut | |
| 700 | 1 | |a Parlier, Damien |e verfasserin |4 aut | |
| 700 | 1 | |a Arahmani, Amal |e verfasserin |4 aut | |
| 700 | 1 | |a Baselga, José |e verfasserin |4 aut | |
| 700 | 1 | |a Viale, Giuseppe |e verfasserin |4 aut | |
| 700 | 1 | |a Reaby, Linda L |e verfasserin |4 aut | |
| 700 | 1 | |a Frank, Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Gelber, Richard D |e verfasserin |4 aut | |
| 700 | 1 | |a Piccart, Martine |e verfasserin |4 aut | |
| 700 | 1 | |a Jackisch, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Petersen, Jennifer A |e verfasserin |4 aut | |
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