Clinical Research Papers:
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
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Hongqin Zhao1,*, Lili Li2,* Huafang Su2, Baochai Lin2, Xuebang Zhang2, Shengliu Xue2, Zhenghua Fei2, Lihao Zhao2, Qintuo Pan3, Xiance Jin2, Congying Xie2
1Departments of Gynecology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000
2Departments of Radiation Oncology and Chemotherapy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, 325000
3Departments of Eye Fundus Surgery, Eye Hospital of Wenzhou Medical University, Wenzhou, China, 325002
*These authors contributed equally to this work
Xiance Jin, email: firstname.lastname@example.org
Congying Xie, email: email@example.com
Keywords: cervical cancer, chemoradiotherapy, consolidation chemotherapy, cisplatin, paclitaxel
Received: March 23, 2016 Accepted: June 30, 2016 Published: July 06, 2016
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.
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