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

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.