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A Phase 2 Trial of Chemoradiation Therapy Using Weekly Docetaxel for High-Risk Postoperative Oral Squamous Cell Carcinoma Patients.
- Source :
-
International Journal of Radiation Oncology, Biology, Physics . Jul2020, Vol. 107 Issue 3, p462-468. 7p. - Publication Year :
- 2020
-
Abstract
- <bold>Purpose: </bold>To evaluate the efficacy and safety of postoperative concurrent chemoradiation therapy using weekly docetaxel in patients with high-risk oral squamous cell carcinoma (OSCC).<bold>Methods and Materials: </bold>This is a prospective single-arm study from a single institute in Shanghai Ninth People's Hospital, Shanghai, China. Patients with locally stage III to IV OSCC who underwent radical surgery with at least 1 high-risk feature were enrolled for the study. High-risk features evaluated included (1) pathologically confirmed positive or close margins in the primary site or extracapsular nodal extension; (2) histologic involvement of ≥2 regional lymph nodes; and (3) locoregional recurrent OSCC (after initial surgery alone) treated with salvage surgery with curative intent. Docetaxel was administered at a dose of 20 mg/m2 concurrently with postoperative radiation therapy (total dose 60-66 Gy). The primary outcome was 2-year disease-free survival (DFS). Secondary endpoints included 2-year locoregional progress-free survival, 2-year overall survival (OS), and toxicities.<bold>Results: </bold>From March 2016 to February 2018, 91 patients (59 males, 32 females) were recruited. Median age was 59 years (range, 26-70). All patients were included in final analysis. Fifty-eight patients (63.7%) completed the 6 planned cycles of docetaxel, and all patients completed postoperative radiation therapy. With a median follow-up of 24 months, the 2-year DFS and OS were 75.3% (95% confidence interval, 65.7%-84.2%) and 82.4% (95% confidence interval, 73.0%-89.6%), respectively. Patterns of failure were 13 local recurrences, 2 regional lymph nodes recurrences, and 8 distant failures. Seven patients (7.7%) were recorded as having grade 3 oral cavity mucositis. Two patients had grade 3 hypersensitivity reaction. No other grade 3 or higher adverse events, including hematologic toxicities, were observed.<bold>Conclusions: </bold>The addition of low-dose weekly docetaxel with concurrent radiation therapy is a tolerable regimen with favorable DFS and OS in patients with high-risk, resected OSCC. [ABSTRACT FROM AUTHOR]
- Subjects :
- *SQUAMOUS cell carcinoma
*DOCETAXEL
*MOUTH
*CHEMORADIOTHERAPY
*PROGRESSION-free survival
*LIMB salvage
*SAFETY
*RELATIVE medical risk
*RESEARCH
*MOUTH tumors
*CLINICAL trials
*RESEARCH methodology
*EVALUATION research
*MEDICAL cooperation
*TREATMENT effectiveness
*COMPARATIVE studies
*POSTOPERATIVE period
Subjects
Details
- Language :
- English
- ISSN :
- 03603016
- Volume :
- 107
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- International Journal of Radiation Oncology, Biology, Physics
- Publication Type :
- Academic Journal
- Accession number :
- 143681201
- Full Text :
- https://doi.org/10.1016/j.ijrobp.2020.02.464