Concurrent chemoradiotherapy with paclitaxel and cisplatin for patients of locally advanced cervical squamous cell carcinoma: A single-arm phase II clinical study

Objectives: A phase II study was conducted to investigate the safety and efficacy of a regimen of cisplatin (DDP) plus paclitaxel (PTX) concurrent with radiotherapy (RT) in patients with locally advanced cervical squamous cell carcinoma (LACSC). Patients and Methods: 34 patients with newly diagnosed LACSC confirmed by histopathology, with a Karnofsky performance status ≥ 60, no prior cervical cancer treatment, and no chemotherapy contraindications were enrolled. Concurrent chemoradiotherapy (CCRT) was delivered to all cases. The chemotherapy consisted of two 3-week cycles of DDP (30 mg/m2/d) for 3 d plus PTX (135 mg/m2) for 1 d. Concurrent radiation (pelvic irradiation of 45 Gy/25 Fx (PTV); lesion boost of 5-10 Gy (GTV); total dose 70-80 Gy) was administered by 3-dimensional conformal radiotherapy (3DCRT; N=14) or intensitymodulated radiation therapy (IMRT; N=20). Short-term efficacy and 1, 2 and 3 y, overall survival (OS) rates, and adverse reactions were analyzed. Results: The cohort of 34 patients (median age, 60 y; range, 35-74) included 4 stage Ib2 cases, 16 stage II cases, 10 stage III cases, and 4 stage IV cases. With a median follow-up period of 38 months, the overall response rate (ORR) was 28/34 (82.4%), including a 12 (35.3%) with a complete response (CR) rate and 16 (47.1%) with a partial response (PR). The 1, 2 and 3 y OS rates were 100%, 94.1%, and 88.2%, respectively. Grade III occurred in 12 patients (35.3%), but no patients suffered from grade IV myelosuppression. Gastrointestinal tract reactions, vaginitis, proctitis, and cystitis were common by mild in all cases. Conclusion: CCRT with DDP plus PTX produced an encouraging and OS rates and ORR with relatively tolerable hematological toxicity.