scholarly journals Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study

2018 ◽  
Vol 29 (9) ◽  
pp. 1972-1979 ◽  
Author(s):  
R.L. Hong ◽  
C.F. Hsiao ◽  
L.L. Ting ◽  
J.Y. Ko ◽  
C.W. Wang ◽  
...  
2019 ◽  
Vol 37 (35) ◽  
pp. 3369-3376 ◽  
Author(s):  
Carlos Rodriguez-Galindo ◽  
Mark D. Krailo ◽  
Matthew J. Krasin ◽  
Li Huang ◽  
M. Beth McCarville ◽  
...  

PURPOSE The treatment of childhood nasopharyngeal carcinoma has been adapted from adult regimens; pediatric-specific studies are limited. The ARAR0331 study sought to evaluate the impact of induction chemotherapy (IC) and concurrent chemoradiotherapy (CCR). PATIENTS AND METHODS Patients with American Joint Committee on Cancer stages IIb to IV were scheduled to receive three cycles of IC with cisplatin and fluorouracil, followed by CCR with three cycles of cisplatin. Patients with complete or partial response to IC received 61.2 Gy to the nasopharynx and neck, and patients with stable disease received 71.2 Gy. RESULTS Between February 2006 and January 2012, 111 patients (75 male) were enrolled. Median age was 15 years, and 46.8% of the patients were African American. After a feasibility analysis, the study was amended to reduce cisplatin to two cycles during CCR. The 5-year event-free survival (EFS) and overall survival estimates were 84.3% and 89.2%, respectively. The 5-year EFS for stages IIb, III, and IV were 100%, 82.8%, and 82.7%, respectively. The 5-year cumulative incidence estimates of local, distant, and combined relapse were 3.7%, 8.7%, and 1.8%, respectively. Patients treated with three versus two CCR cycles of cisplatin had improved 5-year postinduction EFS (90.7% v 81.2%, P = .14). CONCLUSION Patients in ARAR0331 were characterized by advanced disease and by a high proportion of black children and adolescents. Treatment with IC and CRT resulted in excellent outcomes. A radiation dose reduction is possible for patients responding to IC. Although the outcomes are comparable, we observed a trend toward decreased EFS for patients assigned to receive fewer doses of cisplatin during CCR.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7528-7528 ◽  
Author(s):  
S. Kim ◽  
M. Kim ◽  
E. Choi ◽  
H. Sohn ◽  
D. Lee ◽  
...  

7528 Background: We conducted a prospective randomized phase III trial comparing induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) versus immediate CCRT to evaluate whether the addition of induction chemotherapy would result in improved survival. Methods: Patients with unresectable stage III NSCLC, ECOG PS 0–1, and weight loss up to 10% were eligible. They were randomized to receive either induction chemotherapy followed by CCRT (arm A) or immediate CCRT (arm B) after stratification for stage (T4N0–2, T1–3N3, T4N3, and stage IIIA), histology (squamous vs non-squamous), and SCLN positivity. Induction chemotherapy consisted of two cycles of gemcitabine (1,000 mg/m2 D1, D8) and cisplatin (70 mg/m2 D1) q 21days. Chemotherapy during CCRT consisted of 6 cycles of weekly paclitaxel (50 mg/m2) and cisplatin (20 mg/m2). Radiation therapy performed with hypofractionated scheme (2.2 Gy/fraction, once a day) and total dose was 66 Gy. Irradiated volume encompassed gross tumor plus 1.0 cm margin. Results: Between March 2003 and June 2006, 134 patients were enrolled. 92% of patients were male and 60% were age 60 or older. Objective tumor response was obtained in 38% after induction chemotherapy. Response rates after completion of CCRT were 72% (95% CI, 61%–83%) on arm A and 79% (95% CI, 69%–89%) on arm B. Grade 3/4 toxicities during induction chemotherapy consisted mainly of neutropenia (11%/3%). During CCRT, grade 3/4 neutropenia was noted in 8%/5% (arm A) versus in 8%/0% (arm B), grade 3 anemia was 8% vs 0%, grade 3 thrombocytopenia 5% vs 0%, and grade 3 esophagitis 16% vs 16%. At median follow-up of 28 months, median survival was 12.6 months (95% CI, 8.6–16.7 months) on arm A versus 18.2 months (95% CI, 11.7–24.8 months) on arm B (P=0.18). Two year survival estimates was 25% (15%–35%) and 43% (31%–55%), respectively. Median progression free survival was 7.5 months (95% CI, 5.6–9.4 months) on arm A and 11.6 months (95% CI, 9.6–13.6 months) on arm B (P=0.04). Conclusions: The addition of induction chemotherapy to CCRT failed to increase the survival of unresectable stage III NSCLC over immediate CCRT. Moreover, the progression free survival was inferior to immediate CCRT. No significant financial relationships to disclose.


2020 ◽  
pp. 1-8
Author(s):  
Sarah W.M. Lee ◽  
Sarah W.M. Lee ◽  
Philip Y. Wu ◽  
Tommy C.Y. So ◽  
K. C. Lee ◽  
...  

Objectives: Two phase III studies using docetaxel, cisplatin and 5-fluorouracil (TPF) followed by concurrent chemoradiotherapy (CCRT) have reported survival benefit compared to CCRT. However, TPF was used at 80% of the conventional dose in the Chinese study due to the concern of tolerability. We aim to explore the tolerability of TPF using standard dose in Chinese patients with stage IVA (AJCC 8th edition) nasopharyngeal carcinoma and report on its preliminary efficacy. Methods: Consecutive patients treated with induction chemotherapy (IC) TPF followed by CCRT between 2017 and 2020 were reviewed. TPF regimen consisted of three cycles of Docetaxel 75 mg/m2 D1; Cisplatin 75 mg/m2 D1; 5-fluorouracil 750 mg/m2 D1-5 every 3 weeks; with G-CSF D7-11. Radiotherapy consisted of 70 Gy in 35 fractions with concomitant cisplatin 100 mg/m2 every 3 weeks. Results: 28 patients were identified. 92.8% patients completed three cycles of IC. 79% patients received concomitant cisplatin of ≥ 200 mg/m2 . The most common grade 3 or 4 acute toxicity was diarrhea (25%). Grade 3 or 4 neutropenia occurred in 10.7% of patients, of which only 3.6% resulted in febrile neutropenia. Median follow-up was 2 years. The 2-year overall survival, locoregional failure-free survival and distant failure-free survival were 100%, 96.4% and 91.3% respectively. Conclusion: IC using standard dose TPF was well tolerated in Chinese patients with manageable toxicities and allowed adequate delivery of subsequent concurrent cisplatin. Survival outcomes were encouraging and unnecessary dose reduction of TPF should be avoided.


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