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Randomized Controlled Trial
. 2022 May 13;22(1):542.
doi: 10.1186/s12885-022-09644-8.

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

Cunliang Wang #  1   2 , Shouhui Zhu #  2 , Chuanwang Miao  2 , Yu Wang  3 , Jiazhen Chen  1   2 , Shuanghu Yuan  1   2 , Xudong Hu  4   5
Affiliations
Randomized Controlled Trial

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

Cunliang Wang et al. BMC Cancer. .

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.

Keywords: Febrile neutropenia; Hematological toxicity; PEG-rhG-CSF; Radiotherapy; Survival time.

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Conflict of interest statement

All authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Blood count differences between the two groups. CCRT: concurrent chemoradiotherapy; WBC: white blood cell; ANC: absolute neutrophil count; RBC: red blood cell; PLT: platelet; HB: hemoglobin. * Factors with statistical significance: ns: no significance; *: p < 0.05; **: p < 0.01; ***: p < 0.001
Fig. 2
Fig. 2
ANC dynamics in the two groups
Fig. 3
Fig. 3
Differences in myelosuppression. * Factors with statistical significance: ns: no significance; *: p < 0.05; **: p < 0.01; ***: p < 0.001
Fig. 4
Fig. 4
Radiological reactions, incidence of FN and other adverse reactions. RP: Radiation pneumonia, RE: Radiation esophagitis, FN: Febrile neutropenia. * Factors with statistical significance: ns: no significance; *: p < 0.05; **: p < 0.01; ***: p < 0.001
Fig. 5
Fig. 5
Kaplan-Meier curves of PFS (A) and OS (B) of the two groups
See this image and copyright information in PMC

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