Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Chemotherapy with Weekly Paclitaxel and Carboplatin Followed by Radical Chemoradiation in Locally Advanced Cervical Cancer in Egyptian Population
Since 1999, platinum based chemoradiation (CRT) is the standard treatment for locally advanced cervical cancer patients, but the estimated increase in overall survival (OS) over a 5-year period was only 6% in patients treated with CRT versus radiotherapy alone.There have been no additional developments in the treatment of locally advanced cervical cancer(LACC) patients since CRT introduction and approximately 30-40% of those patients failed to achieve complete response to CRT. Therefore, alternative approaches are needed to improve the outcome for such patients. NACT with Weekly paclitaxel and carboplatin for 4 - 6 weeks as dose-dense chemotherapy prior to CRT could be one such potential approach. A phase II, prospective , non randomized study was conducted at the Clinical Oncology Department of Ain Shams University hospital. 42 patients diagnosed with locally advanced cervical cancer patients (FIGO 2018 stage IIB to IVA ) and were treated by NACT carboplatin (AUC2) and paclitaxel (80 mg/m 2) for 4 - 6 week, then they proceeded to definitive CCRT (with a dose of 45-50.4 Gy) with weekly cisplatin followed by brachytherapy. Response rate and toxicity were the primary endpoints and Survival were the secondary endpoints. Median age at diagnosis - 48 years ; 90% (38/42 ) of cases diagnosed with squamous cell carcinoma and 9% (4/42) diagnosed with other histologies; 38% (16/42) had FIGO stage IIB , 40% (17/42) with stage IIIC, 7% (3/42) stage IIIB, 7% (3/42) with stage IVA, 5% (2 /42) with stage 2A and only 1 case diagnosed with stage 3A. 42 patients were evaluated.The overall response rate post-NACT was 71% and 61% developed complete response rate (CR) at end of all treatment course. Grade 3and 4 adverse events during NACT were most common, with hematological toxicity occurring in 21% of patients. There were no treatment- related deaths. The 9-month and 12-month overall survival rates were 94% and 84% , respectively. NACT with dose dense protocol, followed by CCRT, is a treatment option for locally advanced cervical cancer with controllable adverse events and agood response rate.