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.
Highlights
Cervical cancer is one of the most common gynecologic cancers worldwide
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 and 1.43 for DFS and OS, respectively
Since 1999, randomized trials have reported that patients with cervical cancer treated by concurrent CRT had a significant survival advantage compared with those treated by radiotherapy alone [15]
Summary
Cervical cancer is one of the most common gynecologic cancers worldwide. Approximately 83% of the cases happened in the developing countries [1]. Stage cervical cancer can be effectively treated with radiotherapy or radical hysterectomy plus pelvic lymph node dissection. Several pathological risk factors, such as lymph node metastasis, positive vaginal resection margin and parametrial invasion have been identified as high risk factors that will compromise patients’ prognosis [2, 3]. According to the National Comprehensive Cancer Network (NCCN) guidelines, concurrent radiotherapy with cisplatin-based chemotherapy has become the www.impactjournals.com/oncotarget standard treatment for early stage cervical cancer patients with positive pelvic nodes and/ or positive surgical margin and/ or positive parametrium [7, 8]. Patients with early cervical cancer achieved relatively high survival rates, many patients with pathological risk factors treated with CRT still suffered from local or distant relapse. How to improve the treatment outcome of these patients is a major concern and requires further clinical investigation
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