Prophylactic rhG-CSF with platinum chemotherapy improves immune markers and response rates in advanced lung cancer patients.

This randomized controlled trial was conducted at The Third People's Hospital of Yuhang District involving 150 patients diagnosed with advanced lung cancer. The study population consisted of individuals treated with platinum-based doublet chemotherapy. Participants were randomized into two groups: an intervention group receiving prophylactic administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) within 24 to 72 hours after chemotherapy, and a comparator group managed with observation only, receiving no prophylactic rhG-CSF. The study design aimed to evaluate the impact of early rhG-CSF adoption on hematological recovery, immune function, and tumor response metrics.

The primary outcome of the study was not explicitly reported in the available data. However, the analysis focused on several key secondary outcomes including white blood cell (WBC) count, neutrophil (NEU) count, various immune function indicators, inflammatory factor levels, objective response rate (ORR), and disease control rate (DCR). Results indicated that the intervention group demonstrated significantly higher WBC counts compared to the background group, with a p-value less than 0.05. Similarly, neutrophil counts were higher in the rhG-CSF group, also reaching statistical significance (P < 0.05).

Regarding immune function indicators, the intervention group exhibited higher levels of CD4 T cells compared to the background group (P < 0.05). Conversely, CD8 T cells were lower in the intervention group relative to the background group (P < 0.05). Additionally, CD3PD-1 T cells were lower in the rhG-CSF group compared to the observation group (P < 0.05). These shifts suggest a modulation of specific T-cell subsets associated with the prophylactic use of rhG-CSF.

Inflammatory factor levels were also measured, showing distinct differences between groups. Interleukin-10 (IL-10) levels were lower in the intervention group than in the background group (P < 0.05). Interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) levels were similarly lower in the rhG-CSF group compared to the observation group, with both comparisons yielding p-values less than 0.05. These reductions indicate a potential anti-inflammatory effect or altered cytokine profile associated with the intervention.

Tumor response metrics revealed substantial differences between the two cohorts. The objective response rate (ORR) was 44.0% in the intervention group versus 26.7% in the background group (P < 0.05). The disease control rate (DCR) was 88.0% in the intervention group compared to 64.0% in the background group (P < 0.05). These data suggest that prophylactic rhG-CSF administration may enhance both tumor shrinkage and overall disease stabilization in patients with advanced lung cancer receiving platinum-based chemotherapy.

Safety and tolerability findings were not reported in the study data. There is no information provided regarding adverse events, serious adverse events, discontinuations, or general tolerability of the rhG-CSF regimen. Consequently, the risk-benefit profile cannot be fully assessed based on this evidence. The study limitations include the small sample size of 150 patients, the lack of reported primary outcome, and the absence of safety data. Furthermore, the study phase and publication type were not reported, which limits the ability to contextualize these results within the broader therapeutic landscape.

Clinical implications suggest that while prophylactic rhG-CSF appears to improve hematological recovery and immune markers, the absence of safety data prevents definitive recommendations for routine adoption. The observed increase in ORR and DCR is promising but must be weighed against the unknown safety profile. Questions remain unanswered regarding long-term toxicity, the optimal timing of administration beyond the 24-72 hour window, and the clinical significance of the specific shifts in T-cell subsets and inflammatory cytokines. Further research with larger cohorts and comprehensive safety monitoring is necessary before these findings can inform standard practice decisions.