Safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor during concurrent chemoradiotherapy for small-cell lung cancer: a retrospective, cohort-controlled trial

Abstract

Objective To investigate pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) safety and efficacy in preventing hematological toxicity during concurrent chemoradiotherapy (CCRT) for small-cell lung cancer (SCLC). Methods We retrospectively assessed 80 SCLC patients treated with CCRT from January 2013 to December 2018 who received PEG-rhG-CSF within 48 hours after the end of chemotherapy, defined as prophylactic use, as the experimental group. An additional 80 patients who were not treated with PEG-rhG-CSF were matched 1:1 by the propensity score matching method and served as the control group. The main observations were differences in hematological toxicity, neutrophil changes, febrile neutropenia (FN) incidence and adverse reactions. Progression-free survival (PFS) and overall survival (OS) were analyzed with regular assessment and follow-up. Results The leukocyte, neutrophil, erythrocyte, and platelet counts and hemoglobin level decreased after CCRT, but the experimental group had slightly higher leukocyte and neutrophil counts than the control group (P < 0.05). The incidences of grade III-IV leukopenia (18.75% vs. 61.25%) and neutropenia (23.75% vs. 67.5%) in the experimental group were significantly lower than those in the control group (P < 0.05). The absolute neutrophil count was 4.17 ± 0.79 (× 109/L) on day 1 and peaked 6.81 ± 2.37 (× 109/L) on day 10 in the experimental group; the value in the control group was 2.81 ± 0.86 (× 109/L) on day 1. It decreased significantly and reached the minimum 0.91 ± 0.53 (× 109/L) on day 10 (P < 0.05). The experimental group had a lower FN incidence than the control group (P < 0.05). There was also no significant acute esophagitis or pulmonary toxicity. The treatment had no significant effect on PFS (11.4 months vs. 8.7 months, P = 0.958) or OS (23.9 months vs. 17.3 months, P = 0.325) over an 18.6-month median follow-up time. Conclusion PEG-rhG-CSF has good efficacy and safety in preventing hematological toxicity in SCLC patients during CCRT and has no significant effects on PFS or OS.

Chinese expert consensus on the application of pegylated recombinant human granulocyte colony‐stimulating factor during concurrent chemoradiotherapy (2023 edition)

“…The results showed that the experimental group had a significantly lower incidence of grade 3/4 neutropenia (23.75% vs. 67.5%) and FN (2.5% vs. 16.25%) than the control group, without significant acute esophagitis or pulmonary toxicity 34 . However, the prophylactic administration of PEG‐rhG‐CSF did not confer a significant survival benefit to patients 34 . Apart from thoracic tumors, evidence supporting pelvic radiotherapy, such as CCRT for cervical cancer, is also gradually increasing.…”

“…18 Moreover, no significant differences were observed in radiation-related toxicity, treatment-related mortality rates, or sur- than the control group, without significant acute esophagitis or pulmonary toxicity. 34 However, the prophylactic administration of PEG-rhG-CSF did not confer a significant survival benefit to patients. 34 Apart from thoracic tumors, evidence supporting pelvic radiotherapy, such as CCRT for cervical cancer, is also gradually increasing.…”

“…34 However, the prophylactic administration of PEG-rhG-CSF did not confer a significant survival benefit to patients. 34 Apart from thoracic tumors, evidence supporting pelvic radiotherapy, such as CCRT for cervical cancer, is also gradually increasing. An RCT conducted by Li et al demonstrated that the prophylactic administration of PEG-rhG-CSF during CCRT for cervical cancer was effective in preventing neutropenia and related AEs with a favorable safety profile.…”

“…Meanwhile, 80 patients with similar characteristics who received only rhG‐CSF upon myelosuppression without PEG‐rhG‐CSF administration were selected through propensity score matching as the control group. The results showed that the experimental group had a significantly lower incidence of grade 3/4 neutropenia (23.75% vs. 67.5%) and FN (2.5% vs. 16.25%) than the control group, without significant acute esophagitis or pulmonary toxicity 34 . However, the prophylactic administration of PEG‐rhG‐CSF did not confer a significant survival benefit to patients 34 .…”

“…Simultaneously, evidence supporting the prophylactic administration of PEG‐rhG‐CSF during CCRT has increased. In a retrospective cohort study, 80 patients with SCLC who had received two cycles of etoposide‐cisplatin chemotherapy and experienced grade 3 or worse neutropenia received prophylactic PEG‐rhG‐CSF within 48 h of completing chemotherapy during CCRT 34 . Meanwhile, 80 patients with similar characteristics who received only rhG‐CSF upon myelosuppression without PEG‐rhG‐CSF administration were selected through propensity score matching as the control group.…”