Randomized Phase III Study Comparing Neoadjuvant Chemotherapy Followed by Surgery Versus Chemoradiation in Stage...

Area of Science:

• Gynecologic Oncology
• Radiation Oncology
• Medical Oncology

Background:

• Conflicting evidence exists regarding the optimal treatment for stage IB2-IIB cervical carcinoma.
• Neoadjuvant chemotherapy followed by surgery (NACT-S) and concomitant chemoradiotherapy (CCRT) are both standard treatment options.

Purpose of the Study:

• To compare the efficacy and safety of NACT-S versus standard CCRT in patients with stage IB2-IIB cervical cancer.
• To evaluate 5-year overall survival (OS) as the primary endpoint.

Main Methods:

• A multicenter randomized trial involving 626 patients with stage IB2-IIB cervical cancer.
• Patients were assigned to either NACT-S (n=314) or CCRT (n=312).
• Primary endpoint: 5-year OS rate. Secondary endpoints: progression-free survival, OS, toxicity, and health-related quality of life (HRQOL).

Main Results:

• Median follow-up was 8.7 years; 198 deaths (31.6%) occurred.
• Five-year OS rates were similar: 72% (NACT-S) versus 76% (CCRT).
• Short-term adverse events (≥grade 3) were more frequent with NACT-S (41% vs 23%), while long-term events were more frequent with CCRT (21% vs 15%).

Conclusions:

• NACT-S did not demonstrate superiority over CCRT in terms of 5-year OS for stage IB2-IIB cervical cancer.
• Both treatment strategies resulted in acceptable morbidity and health-related quality of life.
• Further research may explore optimizing treatment sequencing or patient selection.