Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia.
Delivering of > 80% planned relative dose intensity (RDI) of fludarabine-cyclophosphamide-rituximab (FCR) is key to benefit from longer progression free survival (PFS) and survivals in CLL. In this randomized trial, we sought to investigate whether a telephone intervention strategy (called AMA) delivered by an oncology nurse could reduce the risk of RDI < 80% by alleviating adverse events and supporting patients’ adherence. Sixty FCR patients were randomized 1:1 for AMA (stratified on Binet stage C). As per guidelines, patients received pegfilgrastim as primary prophylaxis of febrile neutropenia. At the end of therapy, RDI < 80% was reported in 31% of patients, shortening PFS (median 26 months versus not reached, P = 0.021) and OS at 3 years (100 vs 70%, P = 0.0089). Oncology nurse interventions tended to significantly reduce this event (RDI < 80%: 41.4% in non-AMA versus 20.7% in AMA patients (p = 0.09)). By adjusting our logistic regression model on published parameters exposing to RDI < 80%, we found that AMA protected significantly against the risk of reduced RDI (OR = 0.22, IC95% 0.05–0.84, p = 0.04), independently of grade 3/4 neutropenia (< 15% per cycle) and febrile neutropenia (< 5% per cycle) events. As a conclusion, we confirmed that > 20% reduction of FCR dose-intensity was detrimental for PFS/OS, but that oncology nurse interventions reduced the risk of dose concessions.
KeywordsRelative dose intensity CLL Immunochemotherapy Oncology nurse Survivorship
This work was funded by Amgen and the University Hospitals of Toulouse (sponsor of the study) provided the remaining funds allocated to the study. This work was also partly supported by the Agence Nationale de la Recherche through the project CAPTOR “Investissement d’avenir” (ANR-11-PHUC 001).
Compliance with ethical standards
Conflict of interest
LY has received research grants from Janssen and Roche, and speaker honoraria from Janssen, Roche, Gilead, Abbvie. All the other authors declare not to have received any financial support for this study.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual patients included in the study.
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