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Efficacy and safety of PEG-rhG-CSF combined with sintilimab and chemotherapy in the treatment of advanced non-squamous non-small cell lung cancer
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Abstract:
[Abstract] Objective: To evaluate the efficacy and safety of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF) combined with sintilimab and platinum-based chemotherapy in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC). Methods: A prospective, randomized controlled study was conducted on 187 patients with stage Ⅳ nonsquamous NSCLC admitted to the Department of Oncology at Jinan Eighth People's Hospital from January 2020 to December 2021. The patients were randomly divided into an experimental group (PEG-rhG-CSF + sintilimab + pemetrexed + platinum; n = 94) or a control group (sintilimab + pemetrexed + platinum, n = 93) using a random number table method. All patients were followed for two years. Short-term clinical efficacy, progression-free survival (PFS), overall survival (OS), and treatment-related adverse reactions were compared between the two groups. Results: The objective response rate (ORR) in the experimental group was higher than that in the control group (61.63% [53/86] vs 45.35% [39/86], χ2 = 4.554, P = 0.032 8). The disease control rate (DCR) did not differ significantly between the two groups (87.21% [75/86] vs 81.40% [70/86], χ2 = 1.092, P = 0.079 1). The median progression-free survival (PFS) in the experimental group was significantly longer than that in the control group [10.6 months vs 9.1 months; HR = 0.72; χ2 = 3.899 8, P = 0.048 3]. The median overall survival (OS) in the experimental group was also significantly longer than that in the control group [not reached vs 22.6 months; HR = 0.63; χ2 = 4.7716, P = 0.028 9]. Consistent OS benefits (all HR < 1) were observed in the predefined subgroup analyses, including age < 65 years (yes or no), gender, smoking history (yes or no), PD-L1 TPS ≥ 1% (yes or no), platinumbased drugs (cisplatin or carboplatin), and ECOG PS score (0 or 1). The incidence of neutropenia was significantly lower in the experimental group than that in the control group (P < 0.000 1), while the incidence of fever was significantly higher (P = 0.045 1). No significant differences were observed between the two groups in nausea, anemia, fatigue, constipation, diarrhea, decreased appetite, vomiting, cough, dyspnea, peripheral edema, muscle pain, rash, thrombocytopenia, hypothyroidism, immune pneumonitis, or immunerelated colitis (all P > 0.05). Conclusion： The combination of PEG-rhG-CSF with sintilimab, pemetrexed, and platinum-based chemotherapy in advanced non-squamous NSCLC patients may improve short-term clinical efficacy and long-term survival, reduce the incidence of neutropenia, and maintain controllable safety.
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