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 26months versus not reached, P=0.021) and OS at 3years (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.