A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
Background: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-posit...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-08-01
|
| Series: | Current Oncology |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1718-7729/30/8/535 |
| _version_ | 1797585067574296576 |
|---|---|
| author | Ricardo Fernandes Terry L. Ng Mashari Jemaan Alzahrani Jacques Raphael Phillip Blanchette Morgan Black Carol Stober Gregory R. Pond David Cella Lisa Vandermeer Mohammed Ibrahim Mark Clemons |
| author_facet | Ricardo Fernandes Terry L. Ng Mashari Jemaan Alzahrani Jacques Raphael Phillip Blanchette Morgan Black Carol Stober Gregory R. Pond David Cella Lisa Vandermeer Mohammed Ibrahim Mark Clemons |
| author_sort | Ricardo Fernandes |
| collection | DOAJ |
| description | Background: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-positive EBC patients were randomized to either P-H or TC-H treatment arms. The co-primary feasibility outcomes were: ≥75% patient acceptability rate, active trial participation of ≥50% of medical oncologists, ≥75% and ≥90% treatment completion, and receipt rate of planned cycles of chemotherapy, respectively. Secondary outcomes: Febrile neutropenia (FN) rate, treatment-related hospitalizations, health-related quality of life (HR-QoL) questionnaires. Analyses were performed by per protocol and intention-to-treat. Results: Between May 2019 and March 2021, 49 of 52 patients agreed to study participation (94% acceptability rate). Fifteen (65%) of 23 medical oncologists approached patients. Rates of FN were higher (8.3% vs. 0%) in the TC-H vs. P-H arm. Median (IQR) changes in scores from baseline in FACT-Taxane Trial Outcome Index at 24 weeks were −4 (−10, −1) vs. −6.5 (−15, −2) for TC-H and P-H arms, respectively. Conclusions: A randomized trial comparing P-H and TC-H was feasible. Expansion to a larger trial would be feasible to explore patient-reported outcomes of these adjuvant HER2 chemotherapy regimens. |
| first_indexed | 2024-03-11T00:01:37Z |
| format | Article |
| id | doaj.art-c4a34249d38c4c15b7d83418937e50a6 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-11T00:01:37Z |
| publishDate | 2023-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-c4a34249d38c4c15b7d83418937e50a62023-11-19T00:46:29ZengMDPI AGCurrent Oncology1198-00521718-77292023-08-013087384739710.3390/curroncol30080535A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast CancerRicardo Fernandes0Terry L. Ng1Mashari Jemaan Alzahrani2Jacques Raphael3Phillip Blanchette4Morgan Black5Carol Stober6Gregory R. Pond7David Cella8Lisa Vandermeer9Mohammed Ibrahim10Mark Clemons11Department of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, ON N6A 5W9, CanadaDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1H 8L6, CanadaDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1H 8L6, CanadaDepartment of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, ON N6A 5W9, CanadaDepartment of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, ON N6A 5W9, CanadaDepartment of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, ON N6A 5W9, CanadaCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, CanadaDepartment of Oncology, McMaster University, Hamilton, ON L8V 5C2, CanadaDepartment of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USACancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, CanadaDivision of Clinical Sciences, Northern Ontario School of Medicine, Thunder Bay, ON P7B 5E1, CanadaDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1H 8L6, CanadaBackground: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-positive EBC patients were randomized to either P-H or TC-H treatment arms. The co-primary feasibility outcomes were: ≥75% patient acceptability rate, active trial participation of ≥50% of medical oncologists, ≥75% and ≥90% treatment completion, and receipt rate of planned cycles of chemotherapy, respectively. Secondary outcomes: Febrile neutropenia (FN) rate, treatment-related hospitalizations, health-related quality of life (HR-QoL) questionnaires. Analyses were performed by per protocol and intention-to-treat. Results: Between May 2019 and March 2021, 49 of 52 patients agreed to study participation (94% acceptability rate). Fifteen (65%) of 23 medical oncologists approached patients. Rates of FN were higher (8.3% vs. 0%) in the TC-H vs. P-H arm. Median (IQR) changes in scores from baseline in FACT-Taxane Trial Outcome Index at 24 weeks were −4 (−10, −1) vs. −6.5 (−15, −2) for TC-H and P-H arms, respectively. Conclusions: A randomized trial comparing P-H and TC-H was feasible. Expansion to a larger trial would be feasible to explore patient-reported outcomes of these adjuvant HER2 chemotherapy regimens.https://www.mdpi.com/1718-7729/30/8/535early-stage breast cancerHER2-positivetrastuzumabchemotherapy |
| spellingShingle | Ricardo Fernandes Terry L. Ng Mashari Jemaan Alzahrani Jacques Raphael Phillip Blanchette Morgan Black Carol Stober Gregory R. Pond David Cella Lisa Vandermeer Mohammed Ibrahim Mark Clemons A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer Current Oncology early-stage breast cancer HER2-positive trastuzumab chemotherapy |
| title | A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer |
| title_full | A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer |
| title_fullStr | A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer |
| title_full_unstemmed | A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer |
| title_short | A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer |
| title_sort | multi centre randomized study comparing two standard of care chemotherapy regimens for lower risk her2 positive breast cancer |
| topic | early-stage breast cancer HER2-positive trastuzumab chemotherapy |
| url | https://www.mdpi.com/1718-7729/30/8/535 |
| work_keys_str_mv | AT ricardofernandes amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT terrylng amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT masharijemaanalzahrani amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT jacquesraphael amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT phillipblanchette amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT morganblack amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT carolstober amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT gregoryrpond amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT davidcella amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT lisavandermeer amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT mohammedibrahim amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT markclemons amulticentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT ricardofernandes multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT terrylng multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT masharijemaanalzahrani multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT jacquesraphael multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT phillipblanchette multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT morganblack multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT carolstober multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT gregoryrpond multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT davidcella multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT lisavandermeer multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT mohammedibrahim multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer AT markclemons multicentrerandomizedstudycomparingtwostandardofcarechemotherapyregimensforlowerriskher2positivebreastcancer |