Protroca: a non-interventional study on prophylaxis of chemotherapy induced neutropenia using Lipegfilgrastim in non-selected breast cancer patients

Background:

WSG (West German Study Group)-Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer (BC) patients receiving neo-adjuvant or adjuvant treatment in routine praxis.

Methods:

Eligibility: histologically confirmed BC patients, age ≥18 years, prior or concurrent neo-adjuvant or adjuvant treatment with dose-dense chemotherapy, or moderate risk chemotherapy with risk factors (age > 65 years, severe co-morbidities). Primary endpoint: occurrence rate of febrile neutropenia (FN) and/or severe infection (SI) (grade 3 – 4). Secondary endpoints: i.a., adverse events (AEs) and serious adverse events (SAEs) related to Lonquex®.

Results:

Of the 255 enrolled patients (2015 – 2017), 248 patients were evaluable for the intent to treat (ITT) set (222 and 26 patients with primary and secondary prophylaxis, respectively). 5 patients of the ITT set receiving Lonquex® as primary prophylaxis had FN grade 3 – 4 (2.3%). Regarding SI, 5 patients of the ITT population (2.0%) had an infection of grade 3 – 4; 4 patients got primary prophylaxis (1.8%) and one received secondary prophylaxis (3.9%). 67.6% (84.6%) and 6.3% (11.5%) of ITT patients with primary (secondary) prophylaxis exhibited AEs and SAEs, respectively. 10.8% (92/851 AEs) and 8% (2/25 SAEs of 851 AEs) of documented AEs and SAEs, respectively, were related to Lonquex®.

Conclusions:

The application of Lonquex® was effective as primary and secondary prophylaxis in the prevention of chemotherapy-induced neutropenia. Adverse drug reactions and AEs were in line with the Lonquex® summary of product characteristics and chemotherapy, respectively; no new toxicities were identified.