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Peer-reviewedCC BYThe oncologist

Real-world patient-reported outcome comparing antibody-drug conjugates and conventional chemotherapy in metastatic breast cancer.

  • Manuela Milani1
  • Francesco Riccetelli1
  • Carla Strina1
  • Marzia Alberio1
  • Valeria Cervoni1
  • Nicoletta Ziglioli1
  • Donatella Caffi1
  • Francesca Ferrè2
  • Massimo Di Maio3
  • Gabriella Pravettoni4
  • Daniele Generali1
4 affiliations
  1. 1SC Oncologia 2 Multidisciplinare-Azienda Socio-Sanitaria di Cremona, Cremona, 26100, Italy.
  2. 2Dipartimento di Scienze Biomediche per la Salute, University of Milan, Milan, 20122, Italy.
  3. 3Department of Oncology, University of Turin, at A.O. Ordine Mauriziano Hospital, Turin, 10124, Italy.
  4. 4Department of Oncology and Hemato-Oncology, University of Milan, Milan, 20122, Italy.
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Abstract

Background

Antibody-drug conjugates (ADCs) have transformed second-line metastatic breast cancer (MBC) therapy, yet their multidimensional quality-of-life impact vs conventional intravenous chemotherapy in real-world practice, particularly on lifestyle and caregiver burden, remains poorly characterized.Materials and methods

This prospective cohort enrolled 122 consecutive patients with MBC starting second-line therapy: 51 received ADCs and 71 conventional intravenous chemotherapy, allocated by tumor biology and clinical factors. The DAMA (Digital Antibody drug conjugate Modulator in breAst cancer) framework collected electronic patient-reported outcome measures (ePROMs) on anthropometric, lifestyle, symptom, psychosocial, and caregiver-burden domains at baseline, 3 and 6 months, analyzed with linear mixed-effects models.Results

At baseline, measured lifestyle, symptom, psychosocial, and caregiver variables were broadly similar between cohorts, although treatment-related characteristics differed. At 3 months, ADC patients had greater mean weight loss (-3.1 vs -1.2 kg), a larger decline in weekly physical activity (-41 vs -22 min/wk), higher stress and caregiver burden, but lower pain scores (3.7 vs 5.3). By 6 months, several differences attenuated. In pooled descriptive analyses, weekly physical activity showed little association with pain (r = 0.03, P = .56), stress (r = -0.12, P = .03), anxiety (r = -0.02, P = .73), caregiver emotional wellbeing (r = 0.00, P = .97), or sleep duration (r = 0.04, P = .47).Conclusion

In this prospective real-world cohort, ADC and conventional chemotherapy cohorts showed different longitudinal patterns of patient- and caregiver-reported burden. Because treatment allocation was biology- and clinically driven, these findings are exploratory and should not be interpreted as causal treatment effects. Systematic ePROM collection within the DAMA framework was feasible and may support identification of supportive-care needs.

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Cite

BibTeXRIS
BibTeX
@article{milani2026realworld,
  title = {{Real-world patient-reported outcome comparing antibody-drug conjugates and conventional chemotherapy in metastatic breast cancer.}},
  author = {Manuela Milani and Francesco Riccetelli and Carla Strina and Marzia Alberio and Valeria Cervoni and Nicoletta Ziglioli and Donatella Caffi and Francesca Ferrè and Massimo Di Maio and Gabriella Pravettoni and Daniele Generali},
  journal = {The oncologist},
  year = {2026},
  month = oct,
  doi = {10.1093/oncolo/oyag394},
  url = {https://europepmc.org/article/MED/42834440},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Real-world patient-reported outcome comparing antibody-drug conjugates and conventional chemotherapy in metastatic breast cancer.
AU  - Manuela Milani
AU  - Francesco Riccetelli
AU  - Carla Strina
AU  - Marzia Alberio
AU  - Valeria Cervoni
AU  - Nicoletta Ziglioli
AU  - Donatella Caffi
AU  - Francesca Ferrè
AU  - Massimo Di Maio
AU  - Gabriella Pravettoni
AU  - Daniele Generali
PY  - 2026
DA  - 2026/10/01
JO  - The oncologist
DO  - 10.1093/oncolo/oyag394
UR  - https://europepmc.org/article/MED/42834440
AB  - Background  Antibody-drug conjugates (ADCs) have transformed second-line metastatic breast cancer (MBC) therapy, yet their multidimensional quality-of-life impact vs conventional intravenous chemotherapy in real-world practice, particularly on lifestyle and caregiver burden, remains poorly characterized.Materials and methods  This prospective cohort enrolled 122 consecutive patients with MBC starting second-line therapy: 51 received ADCs and 71 conventional intravenous chemotherapy, allocated by tumor biology and clinical factors. The DAMA (Digital Antibody drug conjugate Modulator in breAst cancer) framework collected electronic patient-reported outcome measures (ePROMs) on anthropometric, lifestyle, symptom, psychosocial, and caregiver-burden domains at baseline, 3 and 6 months, analyzed with linear mixed-effects models.Results  At baseline, measured lifestyle, symptom, psychosocial, and caregiver variables were broadly similar between cohorts, although treatment-related characteristics differed. At 3 months, ADC patients had greater mean weight loss (-3.1 vs -1.2 kg), a larger decline in weekly physical activity (-41 vs -22 min/wk), higher stress and caregiver burden, but lower pain scores (3.7 vs 5.3). By 6 months, several differences attenuated. In pooled descriptive analyses, weekly physical activity showed little association with pain (r = 0.03, P = .56), stress (r = -0.12, P = .03), anxiety (r = -0.02, P = .73), caregiver emotional wellbeing (r = 0.00, P = .97), or sleep duration (r = 0.04, P = .47).Conclusion  In this prospective real-world cohort, ADC and conventional chemotherapy cohorts showed different longitudinal patterns of patient- and caregiver-reported burden. Because treatment allocation was biology- and clinically driven, these findings are exploratory and should not be interpreted as causal treatment effects. Systematic ePROM collection within the DAMA framework was feasible and may support identification of supportive-care needs.
SN  - 1083-7159
SN  - 1549-490X
ER  -