Pegylated recombinant human granulocyte colony-stimulating factor for primary prophylaxis of neutropenia in patients with cervical cancer receiving concurrent chemoradiotherapy: a prospective study.

BACKGROUND: This study aimed to investigate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for primary prophylaxis of neutropenia in patients with cervical cancer receiving concurrent chemoradiotherapy. METHODS: In this prospective, single-center, single-arm study, we enrolled patients (18-70 years) with 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1r-IVA and IVB (distant metastasis only with inguinal lymph node metastasis) cervical cancer. Eligible patients should have normal function of the bone marrow (absolute neutrophil count (ANC) ≥ 2.0 × 109/L) and adequate hepatic and renal functions. Key exclusion criteria included: previous chemotherapy and/or radiotherapy; a history of bone marrow dysplasia or other hematopoietic abnormalities. All patients underwent radical radiotherapy (pelvic radiotherapy or extended-field irradiation) plus brachytherapy. The chemotherapy regimen included four cycles of 3-weekly paclitaxel and cisplatin. PEG-rhG-CSF was administered 48-72 h after each treatment cycle. Salvage granulocyte colony-stimulating factor (G-CSF) was only permitted in certain circumstances. The primary endpoint was the incidence of grade 3-4 neutropenia. The secondary endpoints included frequency of febrile neutropenia (FN), chemotherapy completion rate in cycles 2-4, time to complete radiotherapy, and safety. RESULTS: Overall, 52 patients were enrolled in this study from July 2019 to October 2020. The incidence of grade 3-4 neutropenia was 28.8%, with an average duration of grade 3-4 neutropenia persistence of 3.85 days (1-7 days). The incidence rate of FN was 3.8%. The chemotherapy completion rate was 94.2%, 82.7%, and 75.0% for cycles 2-4, respectively. The incidences of grade 3-4 neutropenia for cycles 1-4 were 9.6% (5/52), 8.2% (4/49), 14.0% (6/43), and 2.6% (1/39), respectively. All patients completed radiotherapy within 8 weeks (median, 48 days; range: 41-56 days), except one patient who withdrew consent and did not receive radiotherapy. Severe non-hematologic toxicity was not observed in any patient. CONCLUSION: PEG-rhG-CSF is an effective and safe prophylactic treatment for neutropenia in patients with cervical cancer undergoing concurrent chemoradiotherapy. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900024494. Date of Registration:13/July/2019.

Adjuvant chemotherapy after radiotherapy or concurrent chemoradiotherapy for pelvic lymph node-positive patients with locally advanced cervical cancer: a propensity score matching analysis.

OBJECTIVE: The benefit of adjuvant chemotherapy after definitive chemoradiotherapy in patients with pelvic lymph node-positive cervical cancer has been poorly studied. This study aimed to test the hypothesis that the addition of adjuvant chemotherapy to definitive radiotherapy or concurrent chemoradiotherapy improves survival in patients with pelvic lymph node-positive cervical squamous cell carcinoma. METHODS: This retrospective study enrolled patients with stage IB-IVA pelvic lymph node-positive cervical squamous cell carcinoma, without para-aortic lymph node metastases and initially treated with definitive radiotherapy or concurrent chemoradiotherapy between March 2007 and February 2018. Patients were classified into the adjuvant chemotherapy (5-fluorouracil or paclitaxel, plus cisplatin) and no-adjuvant chemotherapy groups. Treatment outcomes were compared between the two groups before and after 1:1 ratio propensity score matching. RESULTS: Medical records of 951 patients were reviewed and 792 patients were excluded. Finally, 159 patients were enrolled for analysis. Of these, 42 patients received a median of two cycles (range, 1-6) of adjuvant chemotherapy and 117 patients under observation after primary treatment. The median follow-up period was 33.8 months (range, 2.9-113.0). Before propensity score matching, no significant difference was observed in survivals between the two groups (P>0.05). After propensity score matching, 37 pairs of patients were selected. The 3-year rates of progression-free survival, overall survival, local control, and distant metastasis-free survival in the adjuvant chemotherapy and no-adjuvant chemotherapy groups were 80.2% and 60.4% (P=0.07), 83.0% and 63.7% (P=0.17), 94.0% and 81.9% (P=0.12), and 85.9% and 60.1% (P=0.04), respectively. The incidences of grade 3-4 acute and late toxicities were comparable between the two groups (P>0.05). DISCUSSION: Adjuvant chemotherapy significantly improved 3-year distant metastasis-free survival in patients with pelvic lymph node-positive cervical squamous cell carcinoma. Further prospective studies are needed to provide supportive evidence for the therapeutic efficacy of adjuvant chemotherapy.