See the published version of this preprint at BMC Cancer.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Research article
Katsuhiko Nakatsukasa
Kyoto Prefectural University of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1411-1436
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE.
Methods: Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months.
Results: There were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI < 25 mg/m2 and non-visceral metastasis were associated with longer PFS (P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS (P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial.
Conclusions: POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI < 25 mg/m2, and who did not receive BMA while receiving EVE and EXE may have better prognoses.
Trial registration: The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov (NCT02376985).
Keywords
breast cancer, everolimus, progression-free survival, oral care, Oral Care-BC
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Cancer.
Version 3
Posted 09 Jan, 2021
No community comments so far
Submission checks complete
On 27 Dec, 2020
Editorial decision: Accept
On 15 Dec, 2020
No comments provided
Editorial decision: Major revision
On 22 Nov, 2020
Review #3 received
Received 16 Nov, 2020
Reviewer #3 agreed
On 09 Nov, 2020
Review #1 received
Received 21 Jul, 2020
Reviewer #2 agreed
On 17 Jul, 2020
Review #2 received
Received 17 Jul, 2020
Submission checks complete
On 16 Jul, 2020
Editor invited
On 16 Jul, 2020
Editor assigned
On 16 Jul, 2020
Reviewers invited
Invitations sent on 16 Jul, 2020
Reviewer #1 agreed
On 16 Jul, 2020
No comments provided
Editorial decision: Major revision
On 30 Jun, 2020
Review #3 received
Received 25 Jun, 2020
Reviewer #3 agreed
On 09 Jun, 2020
Review #2 received
Received 23 Feb, 2020
Review #1 received
Received 23 Feb, 2020
Reviewers invited
Invitations sent on 05 Feb, 2020
Reviewer #1 agreed
On 05 Feb, 2020
Reviewer #2 agreed
On 05 Feb, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 29 Dec, 2019
Editor invited
On 29 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at BMC Cancer.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Katsuhiko Nakatsukasa
Kyoto Prefectural University of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1411-1436
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Cancer.
Version 3
Posted 09 Jan, 2021
No community comments so far
Submission checks complete
On 27 Dec, 2020
Editorial decision: Accept
On 15 Dec, 2020
No comments provided
Editorial decision: Major revision
On 22 Nov, 2020
Review #3 received
Received 16 Nov, 2020
Reviewer #3 agreed
On 09 Nov, 2020
Review #1 received
Received 21 Jul, 2020
Reviewer #2 agreed
On 17 Jul, 2020
Review #2 received
Received 17 Jul, 2020
Submission checks complete
On 16 Jul, 2020
Editor invited
On 16 Jul, 2020
Editor assigned
On 16 Jul, 2020
Reviewers invited
Invitations sent on 16 Jul, 2020
Reviewer #1 agreed
On 16 Jul, 2020
No comments provided
Editorial decision: Major revision
On 30 Jun, 2020
Review #3 received
Received 25 Jun, 2020
Reviewer #3 agreed
On 09 Jun, 2020
Review #2 received
Received 23 Feb, 2020
Review #1 received
Received 23 Feb, 2020
Reviewers invited
Invitations sent on 05 Feb, 2020
Reviewer #1 agreed
On 05 Feb, 2020
Reviewer #2 agreed
On 05 Feb, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 29 Dec, 2019
Editor invited
On 29 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Cancer.
Background: The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE.
Methods: Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months.
Results: There were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI < 25 mg/m2 and non-visceral metastasis were associated with longer PFS (P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS (P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial.
Conclusions: POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI < 25 mg/m2, and who did not receive BMA while receiving EVE and EXE may have better prognoses.
Trial registration: The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov (NCT02376985).
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
Loading...