Primary G-CSF prophylaxis in sacituzumab govitecan-treated mTNBC: real-world evidence from a multinational CEBCC-102 cohort.
Sacituzumab govitecan (SG) is a key treatment for metastatic triple-negative breast cancer (mTNBC). Neutropenia is a common toxicity, and the optimal use of G-CSF (primary prophylaxis versus reactive administration) remains uncertain. We evaluated the association of primary G-CSF prophylaxis with clinical outcomes and treatment-related toxicities.
We conducted a multinational retrospective real-world cohort study of 303 patients with mTNBC treated with SG in the second or a later line. Efficacy endpoints included progression-free survival (PFS) and overall survival (OS), analyzed using the Kaplan-Meier method. Adverse events were assessed according to CTCAE criteria.
Of 303 patients, 100 were included in the primary prophylaxis group and 203 in the no primary prophylaxis group. Median PFS was 4.2 months in the primary prophylaxis group versus 5.1 months in the no primary prophylaxis group (p = 0.66), with 6-month PFS rates of 38.5% vs. 42.1%, respectively. Median OS was 10.9 vs. 11.6 months (p = 0.95), with 12-month OS rates of 44.9% vs. 47.1%. The frequencies of the recorded individual AEs were similar between groups, apart from grade 3-4 neutropenia, which was less frequent in the primary prophylaxis group (33.0% vs. 50.7%, p = 0.005). Febrile neutropenia occurred in 4.0% vs. 4.4% of patients (p = 1.00). Other recorded AEs (anemia, diarrhea, nausea, vomiting, alopecia) were comparable. Dose reductions due to toxicity were similar (36.0% vs. 38.4%, p = 0.71). In the no primary prophylaxis group, 74.4% subsequently received secondary G-CSF.
In this retrospective real-world cohort, primary G-CSF prophylaxis was associated with a lower frequency of grade 3-4 neutropenia. No statistically significant differences in PFS, OS, or febrile neutropenia were observed between groups. These findings support a risk-adapted rather than universal approach to primary G-CSF prophylaxis.
We conducted a multinational retrospective real-world cohort study of 303 patients with mTNBC treated with SG in the second or a later line. Efficacy endpoints included progression-free survival (PFS) and overall survival (OS), analyzed using the Kaplan-Meier method. Adverse events were assessed according to CTCAE criteria.
Of 303 patients, 100 were included in the primary prophylaxis group and 203 in the no primary prophylaxis group. Median PFS was 4.2 months in the primary prophylaxis group versus 5.1 months in the no primary prophylaxis group (p = 0.66), with 6-month PFS rates of 38.5% vs. 42.1%, respectively. Median OS was 10.9 vs. 11.6 months (p = 0.95), with 12-month OS rates of 44.9% vs. 47.1%. The frequencies of the recorded individual AEs were similar between groups, apart from grade 3-4 neutropenia, which was less frequent in the primary prophylaxis group (33.0% vs. 50.7%, p = 0.005). Febrile neutropenia occurred in 4.0% vs. 4.4% of patients (p = 1.00). Other recorded AEs (anemia, diarrhea, nausea, vomiting, alopecia) were comparable. Dose reductions due to toxicity were similar (36.0% vs. 38.4%, p = 0.71). In the no primary prophylaxis group, 74.4% subsequently received secondary G-CSF.
In this retrospective real-world cohort, primary G-CSF prophylaxis was associated with a lower frequency of grade 3-4 neutropenia. No statistically significant differences in PFS, OS, or febrile neutropenia were observed between groups. These findings support a risk-adapted rather than universal approach to primary G-CSF prophylaxis.
Authors
Mirosława Mirosława, Anna Anna, Aleksandra Aleksandra, Małgorzata Małgorzata, Justyna Justyna, Miloš Miloš, Renata Renata, Hana Hana, Miroslava Miroslava, Agnieszka Agnieszka, Karolina Karolina, Maja Maja, Anika Anika, Daniel Daniel, Jan Jan, Iveta Iveta, Iwona Iwona, Magdalena Magdalena, Tomasz Tomasz, Lenka Lenka, Bogumiła Bogumiła, Aleksandra Aleksandra, Renata Renata, Michał Michał, Zuzana Zuzana, Marcin Marcin
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