Gastrointestinal Cancer

SS 07 - GI 1 - Gastric/GE Junction

54 - Final Results of A Phase 3 Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma

Monday, October 22
7:55 AM - 8:05 AM
Location: Room 214 A/B

Final Results of A Phase 3 Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma
Y. Chen1, J. Ye2, Z. Zhu1, W. Zhao1, L. Li1, M. Fan1, C. WU3, H. Tang3, G. Xu3, Q. Lin4, J. LI5, Y. Xia6, L. Yunhai6, J. Zhou7, and K. Zhao1; 1Fudan University Shanghai Cancer Center, Shanghai, China, 2JiangSu Cancer Hospital, Nanjing, China, 3Zhenjiang First People’s Hospital, Zhenjiang, China, 4The Fist Affiliated Hospital of Xiamen University, Xiamen, China, 5Fujian province cancer hospital, Fuzhou, China, 6Fudan University Shanghai Cancer Center Minhang Branch, Shanghai, China, 7Affiliated Hospital of Jiangnan University, Wuxi, China

Purpose/Objective(s): Concurrent chemoradiation (CCR) with cisplatin plus 5-Fu (PF) regimen is a standard modality for locally advanced esophageal squamous cell carcinoma (ESCC) patients. This trial aimed to assess the efficacy and safety of the paclitaxel plus 5-Fu (TF) regimen versus PF regimen in CCR for ESCC patients.

Materials/Methods: ESCC patients presenting with stage IIa to IVa were enrolled in a prospective multicenter randomized phase 3 study. Patients were randomized to either TF or PF group. Patients in TF group were treated with 5 cycles of weekly TF (5-Fu 300 mg/m2, civ 96h plus paclitaxel 50 mg/m2, d1) in CCR followed by 2 cycles of monthly TF (5-FU 1800 mg/m2, civ 72h, plus paclitaxel 175 mg/m2 d1) in consolidation chemotherapy. Patients in PF group were treated with 2 cycles of CCR followed by 2 cycles of consolidation chemotherapy with PF (cisplatin 25 mg/m2/d, d1-3, plus 5-Fu 1800 mg/m2, civ 72h, q28d). The radiation therapy dose was 61.2 Gy delivered in 34 fractions. The primary end-point was the 3-yr overall survival (OS). The secondary endpoints were disease progression-free survival (DPFS), local progression-free survival (LPFS), and number and grade of participants with adverse events. This trial was registered with ClinicalTrials.gov, number NCT01591135.

Results: 436 ESCC patients (217 assigned to TF group and 219 assigned to PF group) in 6 centers were recruited between April 2012 and July 2015. Median follow-up of patients who survived was 44.6 months [IQR 29.3–72.0]. The 3-yr OS was 57% in TF group and 51% in PF group (HR 0.91; 95% CI 0.69-1.18; P = 0.46). No significant differences were recorded in 3-yr DPFS or 3-yr LPFS between TF and PF groups (44.3% vs. 45.3% and 48.8% vs. 49.8%, respectively). TF group had a significant higher incidence of acute Grade 3/4 leukopenia (31.3% vs. 18.3%), dermatitis (5.1% vs. 1.4%), and pneumonitis (9.7% vs. 3.2%), and significant lower incidence of anemia (0.5% vs. 3.2%), thrombocytopenia (0.5% vs. 13.7%), fatigue (6.9% vs. 19.6%), anorexia (1.4% vs. 14.6%), nausea (1.4% vs. 14.2%), and vomiting (2.3% vs. 18.3%) than PF group (P < 0.05). There were 3 (1.4%) patients in TF group died of acute pneumonitis. For long-term adverse events, 1 (0.5%) patient in TF group and 2 (0.9%) patients in PF group died of delayed pneumonitis.

Conclusion: TF might be an option used in CCR in ESCC patients with a different type of side effects compared with PF, although it did not significantly prolong OS.

Author Disclosure: Y. Chen: None. J. Ye: None. Z. Zhu: None. L. Yunhai: None.

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