title: Concurrent paclitaxel/cisplatin chemoradiotherapy with or without consolidation chemotherapy in high-risk early-stage cervical cancer patients following radical hysterectomy: preliminary results of a phase III randomized study.
abstract: A phase III randomized study on the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin following radical hysterectomy and adjuvant chemoradiotherapy (CRT) in the treatment of high risk early-stage cervical cancer were reported. 146 eligible patients were randomized to arm A receiving concurrent CRT or arm B receiving CRT plus consolidation chemotherapy, respectively. An interim analysis showed a trend of improvement on disease-free survival (DFS) and overall survival (OS) in arm B with hazard ratios (HR) of 1.25 (95% CI = 0.60-2.60, p = 0.55) and 1.43 (95% CI = 0.64-3.20, p = 0.38) for DFS and OS, respectively. The 3-year DFS and OS were 82.0% vs.74.3%, and 86.6% vs. 78.3% for patients receiving CRT plus consolidation chemotherapy and CRT alone, respectively. There was significant difference between the two arms in distant alone recurrence (p = 0.048). Multivariate analysis indicated that pathologic type was a significant prognostic factor for OS (p = 0.045), positive pelvic nodes were significantly associated with both OS ( p=0.02) and DFS (P=0.03). Grade 2 to 4 gastrointestinal disorder (p = 0.95), radiation enteritis (P=0.48), radiation cystitis (p = 0.27) and radioepidermitis (p = 0.46) were similar in the two arms. Overall rates of grade 0-2/3-4 myelosuppression were 87.7%/12.3% for arm A and 74.6%/25.4% for arm B, respectively, but this difference was not statistically significant (p = 0.05). In conclusion, concurrent CRT plus consolidation chemotherapy may play a potential role in further improving survival outcomes for high-risk early stage cervical cancer patients compared CRT alone.
authors.affiliation: Departments of Gynecology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Hongqin
authors.initials: H
authors.lastname: Zhao
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Lili
authors.initials: L
authors.lastname: Li
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Huafang
authors.initials: H
authors.lastname: Su
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Baochai
authors.initials: B
authors.lastname: Lin
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Xuebang
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Shengliu
authors.initials: S
authors.lastname: Xue
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Zhenghua
authors.initials: Z
authors.lastname: Fei
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Lihao
authors.initials: L
authors.lastname: Zhao
authors.affiliation: Departments of Eye Fundus Surgery, Eye hospital of Wenzhou Medical University, Wenzhou, China, 325002.
authors.forename: Qintuo
authors.initials: Q
authors.lastname: Pan
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Xiance
authors.initials: X
authors.lastname: Jin
authors.affiliation: Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000.
authors.forename: Congying
authors.initials: C
authors.lastname: Xie
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001853:Bone Marrow / Q000528:radiation effects; D059186:Chemoradiotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000627:therapeutic use; D060830:Consolidation Chemotherapy / Q000379:methods; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000627:therapeutic use; D011379:Prognosis; D011832:Radiation Injuries / Q000453:epidemiology; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*
chemical_list: D017239:Paclitaxel; D002945:Cisplatin
keywords: cervical cancer; chemoradiotherapy; cisplatin; consolidation chemotherapy; paclitaxel