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Proffered Paper - Supportive and palliative care

LBA87 - A pragmatic cluster-randomized trial of ambulatory toxicity management in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer (AToM)

Date

21 Sep 2020

Session

Proffered Paper - Supportive and palliative care

Presenters

Monika Krzyzanowska

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

M.K. Krzyzanowska1, J. Julian2, C. Gu2, M. Powis3, Q. Li4, K.A. Enright5, D. Howell6, C. Earle7, S. Gandhi8, S. Rask9, C. Brezden-Masley10, S.F. Dent11, L. Hajra12, O. Freedman13, S. Spadafora14, C. Hamm15, N. Califaretti16, M. Trudeau8, M. Levine2, E. Grunfeld17

Author affiliations

  • 1 Division Of Medical Oncology And Hematology, University Health Network - Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA
  • 2 Ontario Clinical Oncology Group, Hamilton Health Sciences Centre, Hamilton/CA
  • 3 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 4 Cancer Program, Institute for Clinical Evaluative Sciences, M4N 3M5 - Toronto/CA
  • 5 Division Of Medical Oncology, Trillium Health Partners, L5M 2N1 - Mississauga/CA
  • 6 Department Of Supportive Care, Princess Margaret Cancer Centre, M5G2M9 - Toronto/CA
  • 7 Medical Oncology, ICES Central, Toronto/CA
  • 8 Medical Oncology/ Hematology, Sunnybrook Health Sciences Centre, Toronto/CA
  • 9 Medical Oncology, Royal Victoria Hospital, Barrie/CA
  • 10 Medical Oncology, St. Michael's Hospital, Toronto/CA
  • 11 Medical Oncology, The Ottawa Hospital Regional Cancer Centre, K1H 8L6 - Ottawa/CA
  • 12 Medical Oncology, Markham Stouffville Hospital, Markham/CA
  • 13 Medical Oncology, Durham Regional Cancer Centre, Oshawa/CA
  • 14 Medical Oncology, Sault Area Hospital, Sault Ste Marie/CA
  • 15 Medical Oncology, Windsor Regional Hospital, Windsor/CA
  • 16 Medical Oncology, Grand River Regional Cancer Centre, N2J 4G8 - Waterloo/CA
  • 17 Department Of Family And Community Medicine, University of Toronto, Toronto/CA
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Resources

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Abstract LBA87

Background

Emergency department visits and hospitalizations (EDH) are common during chemotherapy (CH). EDH may be preventable with adequate support between CH visits but large-scale evaluations of virtual supportive care are limited.

Methods

We undertook a pragmatic, cluster-randomized trial to examine the effectiveness of pro-active telephone management of toxicities in early stage breast cancer (BC) patients receiving CH at 20 cancer centres in Ontario, Canada. Centres were allocated using a covariate-constrained approach to standardized, nurse-led calls to assess common toxicities at 2 time points following each cycle (intervention), or routine care (control). Participants were all patients with stage I-III BC commencing adjuvant or neo-adjuvant CH at participating centres during the centre recruitment period. A subset of 25 patients from each centre completed patient-reported outcome questionnaires. Cluster-level mean number of EDH visits/patient during the entire CH course, was evaluated using healthcare administrative data. Secondary outcomes included toxicity (NCI PRO CTCAE), self-efficacy (Stanford) and quality of life (QoL; FACTB). Penetration was the percentage of patients who received the intervention at the 10 intervention sites.

Results

Baseline characteristics of participants, enrolled from 02/16-11/17, were similar in the intervention (n=944) and control groups (n=1214); 22% were older than 65. Most common regimens were AC-paclitaxel (44%) and FEC-docetaxel (26%). Penetration ranged from 50-86%; 47% of patients had at least one EDH during CT. Mean number of ED+H visits/patient was 0.91 (SD=0.40) in the intervention arm and 0.94 (SD=0.28) in the control arm (p=0.94). There were fewer patients with any grade 3 toxicity in the intervention arm (48% vs 58%, p=0.028), especially fatigue and aching muscles and joints. There was no difference in self-efficacy but patients in the intervention arm had smaller decline in the FACT-TOI during treatment (p=0.004).

Conclusions

Virtual pro-active toxicity management during CH did not lead to fewer EDH but was associated with less grade 3 toxicities and a smaller decline in QoL.

Clinical trial identification

NCT02485678.

Editorial acknowledgement

Legal entity responsible for the study

Ontario Clinical Oncology Group.

Funding

Ontario Institute for Cancer Research.

Disclosure

M.K. Krzyzanowska: Advisory/ Consultancy, Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Exelixis; Advisory/Consultancy: Bayer. All other authors have declared no conflicts of interest.

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