Safety in the use of granulocyte-colony stimulating factor during concurrent chemotherapy and thoracic radiotherapy in patients with small-cell lung cancer: A meta-analysis.

person Fabíola Furtuoso Zarpelão UNICAMP - State University of Campinas, Campinas, Brazil info_outline Fabíola Furtuoso Zarpelão, Larissa Irigoyen Teixeira Barbosa, Jhefferson da Silva Sousa, Luísa Napoleão, Abner Lucas De Souza, Maysa Vilbert

Authors person Fabíola Furtuoso Zarpelão UNICAMP - State University of Campinas, Campinas, Brazil info_outline Fabíola Furtuoso Zarpelão, Larissa Irigoyen Teixeira Barbosa, Jhefferson da Silva Sousa, Luísa Napoleão, Abner Lucas De Souza, Maysa Vilbert Organizations UNICAMP - State University of Campinas, Campinas, Brazil, Santa Marcelina College, São Paulo, Brazil, Afya, Palmas, Brazil, Unipam, Patos De Minas, Brazil, Evangélica University of Goiás, Anápolis, Brazil, Massachusetts General Hospital Cancer Center, Boston, MA Abstract Disclosures Research Funding No funding sources reported Background: There is an ongoing debate about whether patients with small cell lung cancer (SCLC) undergoing concurrent chemoradiotherapy should receive granulocyte-colony stimulating factor (G-CSF). The main concern relies on safety issues. Therefore, we performed a systematic review and meta-analysis to assess the safety and efficacy of prophylactic G-CSF use in patients with SCLC receiving concurrent chemoradiotherapy. Methods: We systematically searched the MEDLINE, Cochrane, and EMBASE databases up to December 2023 for studies assessing prophylactic use of G-CSFs versus non-prophylactic use in SCLC undergoing concurrent chemoradiotherapy. We included randomized and non-randomized clinical trials. The main safety outcomes were thrombocytopenia, febrile neutropenia, anemia, and radiotherapy toxicity. We performed statistical analysis using RevMan 5.4.1 and pooled odds ratio (OR) and 95% confidence interval (95%CI) of binary outcomes. We defined a significant threshold as p-value < 0.05. We used I² statistics for heterogeneity, with I²> 25% being defined as high heterogeneity. Results: We included five studies with a total of 774 patients, of whom 322 (42%) received G-CSF prophylactically, and 452 (58%) were in the control group. The majority of patients (97.5%) presented with Limited Stage disease. The minimum follow-up period had a median duration of 16.9 months, while the maximum follow-up extended to a median of 45 months (Table). Patients in the prophylactic group had a significantly lower incidence of neutropenia (OR: 0.34; 95% CI: 0.14-0.85; p = 0.02) than those who did not use G-CSF prophylactically. Radiotherapy toxicity (OR: 0.98; 95% CI: 0.63-1.53; p = 0.93) and severe hematological toxicity (grade III-IV) were similar in both groups. Hematological toxicity included thrombocytopenia (OR: 1.21; 95% CI: 0.32-4.58; p = 0.78), febrile neutropenia (OR: 1.11; 95% CI: 0.29-4.28; p = 0.88), and anemia (OR: 0.51; 95% CI: 0.13-1.97; p = 0.33). Conclusions: Our systematic review and meta-analysis supports the prophylactic use of G-CSF during concurrent chemoradiotherapy for patients with SCLC. Prophylactic G-CSF promoted a significant reduction in the incidence of neutropenia without any hematologic or radiotherapy-related toxicity increase. Incorporating G-CSF prophylaxis into SCLC chemoradiotherapy regimens can be a beneficial strategy for minimizing neutropenic complications without compromising overall treatment safety. Study Design Number of Patients Intervention (Type of G-CSF) Follow-up (Months) Woll 1995 RCT 65 Lenograstim 24 Glisson 1998 Non-RCT 24 Filgrastim 43 Sheik 2011 RCT 38 Filgrastim, Lenograstim, Pegfilgrastim 16,9 Gomes 2021 RCT 487 Investigator choice 45 Wang 2022 Non- RCT 160 PEG-rhG-CSF 18,6 RCT: Randomized Clinical Trial; Non-RCT: Non-Randomized Clinical Trial.