Terence Tan1, Wan-Teck Lim2, Kam-Weng Fong3, Shie-Lee Cheah3, Yoke-Lim Soong3, Mei-Kim Ang2, Quan-Sing Ng2, Daniel Tan2, Whee-Sze Ong4, Sze-Huey Tan4, Connie Yip3, Daniel Quah3, Khee-Chee Soo5, Joseph Wee3. 1. Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. Electronic address: trdtwk@nccs.com.sg. 2. Division of Medical Oncology, National Cancer Centre Singapore, Singapore. 3. Division of Radiation Oncology, National Cancer Centre Singapore, Singapore. 4. Division of Clinical Trial and Epidemiological Sciences, National Cancer Centre Singapore, Singapore. 5. Division of Surgical Oncology, National Cancer Centre Singapore, Singapore.
Abstract
PURPOSE: To compare survival, tumor control, toxicities, and quality of life of patients with locally advanced nasopharyngeal carcinoma (NPC) treated withinduction chemotherapy and concurrent chemo-radiation (CCRT), against CCRT alone. PATIENTS AND METHODS: Patients were stratified by N stage and randomized to induction GCP (3 cycles of gemcitabine 1000 mg/m(2), carboplatin area under the concentration-time-curve 2.5, and paclitaxel 70 mg/m(2) given days 1 and 8 every 21 days) followed by CCRT (radiation therapy 69.96 Gy with weekly cisplatin 40 mg/m(2)), or CCRT alone. The accrual of 172 was planned to detect a 15% difference in 5-year overall survival (OS) with a 5% significance level and 80% power. RESULTS:Between September 2004 and August 2012, 180 patients were accrued, and 172 (GCP 86, control 86) were analyzed by intention to treat. There was no significant difference in OS (3-year OS 94.3% [GCP] vs 92.3% [control]; hazard ratio 1.05; 1-sided P=.494]), disease-free survival (hazard ratio 0.77, 95% confidence interval 0.44-1.35, P=.362), and distant metastases-free survival (hazard ratio 0.80, 95% confidence interval 0.38-1.67, P=.547) between the 2 arms. Treatment compliance in the induction phase was good, but the relative dose intensity for concurrent cisplatin was significantly lower in the GCP arm. Overall, the GCP arm had higher rates of grades 3 and 4 leukopenia (52% vs 37%) and neutropenia (24% vs 12%), but grade 3 and 4 acute radiation toxicities were not statistically different between the 2 arms. The global quality of life scores were comparable in both arms. CONCLUSION:Induction chemotherapy with GCP before concurrent chemo-irradiation did not improve survival in locally advanced NPC.
RCT Entities:
PURPOSE: To compare survival, tumor control, toxicities, and quality of life of patients with locally advanced nasopharyngeal carcinoma (NPC) treated with induction chemotherapy and concurrent chemo-radiation (CCRT), against CCRT alone. PATIENTS AND METHODS: Patients were stratified by N stage and randomized to induction GCP (3 cycles of gemcitabine 1000 mg/m(2), carboplatin area under the concentration-time-curve 2.5, and paclitaxel 70 mg/m(2) given days 1 and 8 every 21 days) followed by CCRT (radiation therapy 69.96 Gy with weekly cisplatin 40 mg/m(2)), or CCRT alone. The accrual of 172 was planned to detect a 15% difference in 5-year overall survival (OS) with a 5% significance level and 80% power. RESULTS: Between September 2004 and August 2012, 180 patients were accrued, and 172 (GCP 86, control 86) were analyzed by intention to treat. There was no significant difference in OS (3-year OS 94.3% [GCP] vs 92.3% [control]; hazard ratio 1.05; 1-sided P=.494]), disease-free survival (hazard ratio 0.77, 95% confidence interval 0.44-1.35, P=.362), and distant metastases-free survival (hazard ratio 0.80, 95% confidence interval 0.38-1.67, P=.547) between the 2 arms. Treatment compliance in the induction phase was good, but the relative dose intensity for concurrent cisplatin was significantly lower in the GCP arm. Overall, the GCP arm had higher rates of grades 3 and 4 leukopenia (52% vs 37%) and neutropenia (24% vs 12%), but grade 3 and 4 acute radiation toxicities were not statistically different between the 2 arms. The global quality of life scores were comparable in both arms. CONCLUSION: Induction chemotherapy with GCP before concurrent chemo-irradiation did not improve survival in locally advanced NPC.
Authors: Carlos Rodriguez-Galindo; Mark D Krailo; Matthew J Krasin; Li Huang; M Beth McCarville; John Hicks; Farzana Pashankar; Alberto S Pappo Journal: J Clin Oncol Date: 2019-09-25 Impact factor: 44.544
Authors: Laureen Ribassin-Majed; Sophie Marguet; Anne W M Lee; Wai Tong Ng; Jun Ma; Anthony T C Chan; Pei-Yu Huang; Guopei Zhu; Daniel T T Chua; Yong Chen; Hai-Qiang Mai; Dora L W Kwong; Shie-Lee Cheah; James Moon; Yuk Tung; Kwan-Hwa Chi; George Fountzilas; Jean Bourhis; Jean Pierre Pignon; Pierre Blanchard Journal: J Clin Oncol Date: 2016-12-05 Impact factor: 44.544
Authors: Kenneth C W Wong; Edwin P Hui; Kwok-Wai Lo; Wai Kei Jacky Lam; David Johnson; Lili Li; Qian Tao; Kwan Chee Allen Chan; Ka-Fai To; Ann D King; Brigette B Y Ma; Anthony T C Chan Journal: Nat Rev Clin Oncol Date: 2021-06-30 Impact factor: 66.675