Head and Neck Cancer
PV 02 - Poster Viewing Q&A - Session 2
MO_25_2887 - Low-Dose Fractionated Radiation with Induction Docetaxel and Cisplatin Chemotherapy followed by Concurrent Cisplatin and Radiation Therapy in Locally Advanced Nasopharyngeal Cancer, Randomized Phase II-III Trial.
Monday, September 16
10:45 AM - 12:00 PM
Location: ASTRO Innovation Hub
Low-Dose Fractionated Radiation with Induction Docetaxel and Cisplatin Chemotherapy followed by Concurrent Cisplatin and Radiation Therapy in Locally Advanced Nasopharyngeal Cancer, Randomized Phase II-III Trial.
N. M. Al-Rajhi1, E. M. Abdelrahman2, S. Ahmad3, H. Soudy4, M. AlGhazi1, M. O. Al Shabanah5, M. Memon6, and Y. M. Khafaga7; 1King Faisal Hospital & Research Centre, Riyadh, Saudi Arabia, 2National Cancer Institute., Cairo, Egypt, 3Leiscester University Hospital UK, Leisceste, United Kingdom, 4St. George/Sutherland cancer Center, Sydney, Australia, 5King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 6Geisinger Lewistown Hospital - Hematology and Oncology, High Land Park, PA, 7King Faisal Specialist Hospital, Riyadh, Saudi Arabia
Purpose/Objective(s): The primary endpoint was to assess the efficacy of LDFRT given in combination with induction chemotherapy (IC) Docetaxel and Cisplatin followed by radiation therapy with concurrent Cisplatin in patient with locally advanced nasopharyngeal carcinoma. The secondary endpoints were 3-years overall survival (OS), Loco-regional control (LRC) and metastases- free survival (MFS).
Materials/Methods: Single institute, phase II-III, prospectively controlled randomized trial Patients aged 18-70 years with WHO type II and III, stage III-IVB nasopharyngeal carcinoma, ECOG performance score of 0- 2, with adequate hematological, renal, and hepatic function were eligible All patients received 2 cycles of IC Docetaxel 75mg/m2 and Cisplatin 75mg/m2 on day 1 and 22 followed by definitive course of radiation therapy 70Gy in 33 fractions, using IGRT, with concurrent Cisplatin 25 mg/m2 for 4 days on day 43 and 64. Patient were randomly assigned to either receive IC only or IC with LDFRT 0.5 Gy twice daily 6 hours apart for 2 days. Sample size was estimated using Simon Optimal Two-Stage Designs for Phase II Clinical Trials. The Complete Response rate (CR) for the chemotherapy arm was 25%. A total of 108 sample size was calculated to detect a difference of 15% in CR rate in LDFRT treatment arm under a power of 80% and a confidence level of 90%. Simple randomization was utilized using random-numbers that generates random sequences in order to allow for unbiased treatment allocation among the study and the standard arms. Random numbers were generated using computer software program. Response to treatment in term of CR at the primary site, lymph node site and overall response among the two comparative arms were summarized using contingency tables and compared using Chi-squared test. Clinical response at the primary site and lymph nodes were assessed using RECIST criteria. Tolerance was scored using revised NCI (CTCAE) version 4.03. Analysis were done based on intention to treat. The probabilities of OS, LRC and DMFS were calculated using the Kaplan-Meier estimator with variance estimated using Greenwood’s formula. Survival curves were compared using log-rank test. P-value< 0.05 was considered significant
Results: Between March 31, 2013, and February 11, 2018, 108 patients were enrolled in this trial. They were randomly assigned to LDFRT in combination with IC (54 patients) and IC alone (54 patients). Data were available for all patients, with a median follow up of 37 months (3-72). All patients completed planned treatment except one patient who died after IC and was included in the analysis. Toxicity abd post IC phase treatment responses were not significantly different between the two treatment arms. 3-years OS (94 vs 93 p=0.8), LRC (84.1 vs 91.6 p=0.25), and DMFS (84.8 vs 87.5 p=0.58) for LDFRT with IC arm and IC only arm respectively.
Conclusion: No significant difference was observed between treatment arms indicating lack of benefit from adding LDFRT to IC in locally advanced Nasopharyngeal carcinoma.
Author Disclosure: N.M. Al-Rajhi: None. E.M. Abdelrahman: None. S. Ahmad: None. M. AlGhazi: None. Y.M. Khafaga: None.