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Title: Concurrent Chemo-Radiation With or Without Induction Gemcitabine, Carboplatin, and Paclitaxel: A Randomized, Phase 2/3 Trial in Locally Advanced Nasopharyngeal Carcinoma

Abstract

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{sup 2}, carboplatin area under the concentration-time-curve 2.5, and paclitaxel 70 mg/m{sup 2} given days 1 and 8 every 21 days) followed by CCRT (radiation therapy 69.96 Gy with weekly cisplatin 40 mg/m{sup 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 armmore » 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.« less

Authors:
 [1];  [2]; ; ;  [1]; ; ;  [2]; ;  [3]; ;  [1];  [4];  [1]
  1. Division of Radiation Oncology, National Cancer Centre Singapore (Singapore)
  2. Division of Medical Oncology, National Cancer Centre Singapore (Singapore)
  3. Division of Clinical Trial and Epidemiological Sciences, National Cancer Centre Singapore (Singapore)
  4. Division of Surgical Oncology, National Cancer Centre Singapore (Singapore)
Publication Date:
OSTI Identifier:
22458668
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 91; Journal Issue: 5; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; CHEMOTHERAPY; COMPARATIVE EVALUATIONS; HAZARDS; IRRADIATION; LEUKOPENIA; METASTASES; PATIENTS; RADIATION DOSES; RADIOTHERAPY; STANDARD OF LIVING; TOXICITY

Citation Formats

Tan, Terence, E-mail: trdtwk@nccs.com.sg, Lim, Wan-Teck, Fong, Kam-Weng, Cheah, Shie-Lee, Soong, Yoke-Lim, Ang, Mei-Kim, Ng, Quan-Sing, Tan, Daniel, Ong, Whee-Sze, Tan, Sze-Huey, Yip, Connie, Quah, Daniel, Soo, Khee-Chee, and Wee, Joseph. Concurrent Chemo-Radiation With or Without Induction Gemcitabine, Carboplatin, and Paclitaxel: A Randomized, Phase 2/3 Trial in Locally Advanced Nasopharyngeal Carcinoma. United States: N. p., 2015. Web. doi:10.1016/J.IJROBP.2015.01.002.
Tan, Terence, E-mail: trdtwk@nccs.com.sg, Lim, Wan-Teck, Fong, Kam-Weng, Cheah, Shie-Lee, Soong, Yoke-Lim, Ang, Mei-Kim, Ng, Quan-Sing, Tan, Daniel, Ong, Whee-Sze, Tan, Sze-Huey, Yip, Connie, Quah, Daniel, Soo, Khee-Chee, & Wee, Joseph. Concurrent Chemo-Radiation With or Without Induction Gemcitabine, Carboplatin, and Paclitaxel: A Randomized, Phase 2/3 Trial in Locally Advanced Nasopharyngeal Carcinoma. United States. doi:10.1016/J.IJROBP.2015.01.002.
Tan, Terence, E-mail: trdtwk@nccs.com.sg, Lim, Wan-Teck, Fong, Kam-Weng, Cheah, Shie-Lee, Soong, Yoke-Lim, Ang, Mei-Kim, Ng, Quan-Sing, Tan, Daniel, Ong, Whee-Sze, Tan, Sze-Huey, Yip, Connie, Quah, Daniel, Soo, Khee-Chee, and Wee, Joseph. Wed . "Concurrent Chemo-Radiation With or Without Induction Gemcitabine, Carboplatin, and Paclitaxel: A Randomized, Phase 2/3 Trial in Locally Advanced Nasopharyngeal Carcinoma". United States. doi:10.1016/J.IJROBP.2015.01.002.
@article{osti_22458668,
title = {Concurrent Chemo-Radiation With or Without Induction Gemcitabine, Carboplatin, and Paclitaxel: A Randomized, Phase 2/3 Trial in Locally Advanced Nasopharyngeal Carcinoma},
author = {Tan, Terence, E-mail: trdtwk@nccs.com.sg and Lim, Wan-Teck and Fong, Kam-Weng and Cheah, Shie-Lee and Soong, Yoke-Lim and Ang, Mei-Kim and Ng, Quan-Sing and Tan, Daniel and Ong, Whee-Sze and Tan, Sze-Huey and Yip, Connie and Quah, Daniel and Soo, Khee-Chee and Wee, Joseph},
abstractNote = {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{sup 2}, carboplatin area under the concentration-time-curve 2.5, and paclitaxel 70 mg/m{sup 2} given days 1 and 8 every 21 days) followed by CCRT (radiation therapy 69.96 Gy with weekly cisplatin 40 mg/m{sup 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.},
doi = {10.1016/J.IJROBP.2015.01.002},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 91,
place = {United States},
year = {Wed Apr 01 00:00:00 EDT 2015},
month = {Wed Apr 01 00:00:00 EDT 2015}
}