CDK4/6 inhibitors combined with endocrine therapy have revolutionized the management of luminal advanced breast cancer (ABC). In case of visceral crisis (VC), chemotherapy is still recommended because of its supposed quicker efficacy. The ABC 5 ESO-ESMO international consensus guidelines clarified the definition of VC, using specific situations. However, many clinical scenarios remain unclear. To aid the practitioner in treating these patients with a poor prognosis, we aim to establish a standardized and reproductible definition of VC in ABC.
A three-step modified Delphi method was used to establish consensus. 52 experts from the French Breast Cancer Intergroup Unicancer (UCBG) were invited to participate as the expert panel. In both rounds, they had to score items on a six-option scale. In round 2, the questionnaire was modified according to the answers in round 1. A specific scoring method was used to define the consensual items. Round 3 will consist of a face-to-face expert meeting to discuss nonconsensual criteria.
Items considered as defining VC after two rounds were: symptomatic lung lesions, symptomatic peritoneal carcinosis resistant to medical treatment, grade 3 cytolysis, symptomatic cytopenia regardless of grade, grade 4 cytopenia independently of symptoms, and massive liver tumor burden, with a cutoff value to be determined. Panelists excluded from VC definition: the presence of asymptomatic lung, brain, liver or bone lesions, increase in LDH level, any kind of pain, grade 1 cytopenia, hypercalcemia resolved by medical treatment, reversible hyperbilirubinemia after drainage and peritoneal or pleural effusions before drainage. Some items remain nonconsensual after two rounds, such as symptomatic pleural or peritoneal effusions despite drainage, symptomatic brain lesions, or the cutoff value of hyperbilirubinemia.
To our knowledge, this is the first study aiming to define VC using specific clinical situations. The acquired definition could help the clinician in his daily practice, and become a base for the inclusion and exclusion criteria of clinical trials. The findings reported are preliminary, as the final expert meeting will be held in spring 2023.
The authors.
Has not received any funding.
M.J. Rodrigues: Financial Interests, Personal, Advisory Board: AZ, GSK, Immunocore; Financial Interests, Personal and Institutional, Research Grant: MSD, BMS, Daiichi. P.H. Cottu: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer, lilly; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Institutional, Invited Speaker: daichi, lilly, gilead; Financial Interests, Institutional, Funding: Novartis. J. Pierga: Financial Interests, Personal, Other: Roche, Novartis, Pfizer, Lilly, AstraZeneca, Daiichi; Financial Interests, Personal, Advisory Board: Roche/Genentech, Novartis, Lilly, Pfizer, AstraZeneca, AbbVie, MSD, Daiichi, Seattle Genetics, Gilead, Eisai, Pierre Fabre oncologie; Financial Interests, Personal, Speaker’s Bureau: Roche, Novartis, Pfizer, Lilly, AstraZeneca, Daiichi, Gilead. T. Bachelot: Financial Interests, Personal, Advisory Board: Roche, Novartis, AstraZeneca, Pfizer, Seagen, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Novartis, Roche, AstraZeneca, Seagen, Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: AstraZeneca. N. Penel: Financial Interests, Institutional, Research Grant, Research grant for clinical trials in sarcoma filed: Bayer HealthCare. A. Moreira: Financial Interests, Personal, Advisory Board: Daiichi, AstraZeneca, Gilead. All other authors have declared no conflicts of interest.