Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: Radiation therapy oncology group phase II trial 0225 Journal Article
| Authors: | Lee, N.; Harris, J.; Garden, A. S.; Straube, W.; Glisson, B.; Xia, P.; Bosch, W.; Morrison, W. H.; Quivey, J.; Thorstad, W.; Jones, C.; Ang, K. K. |
| Article Title: | Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: Radiation therapy oncology group phase II trial 0225 |
| Abstract: | Purpose: To investigate the feasibility of intensity-modulated radiation therapy (IMRT) with or without chemotherapy, and to assess toxicities, failure patterns, and survivals in patients with nasopharyngeal carcinoma (NPC). Patients and Methods: Radiation consisted of 70 Gy given to the planning target volumes of primary tumor plus any N+ disease and 59.4 Gy given to subclinical disease, delivered over 33 treatment days. Patients with stage T2b or greater or with N+ disease also received concurrent cisplatin (100 mg/m<sup>2</sup>) on days 1, 22, and 43 followed by adjuvant cisplatin (80 mg/m<sup>2</sup>) on day 1; fluorouracil (1,000 mg/m<sup>2</sup>/d) on days 1 through 4 administered every 4 weeks for three cycles. Tumor, clinical status, and acute/late toxicities were assessed. The primary objective was to test the transportability of IMRT to a multi-institutional setting. Results: Between February 2003 and November 2005, 68 patients with stages I through IVB NPC (of which 93.8% were WHO types 2 and 3) were enrolled. Prescribed IMRT (target delineation) was given to 83.8%, whereas 64.9% received chemotherapy per protocol. The estimated 2-year local progression-free (PF), regional PF, locoregional PF, and distant metastasis-free rates were 92.6%, 90.8%, 89.3%, and 84.7%, respectively. The estimated 2-year PF and overall survivals were 72.7% and 80.2%, respectively. Acute grade 4 mucositis occurred in 4.4%, and the worst late grade 3 toxicities were as follows: esophagus, 4.7%; mucous membranes, 3.1%; and xerostomia, 3.1%. The rate of grade 2 xerostomia at 1 year from start of IMRT was 13.5%. Only two patients complained of grade 3 xerostomia, and none had grade 4 xerostomia. Conclusion: It was feasible to transport IMRT with or without chemotherapy in the treatment of NPC to a multi-institutional setting with 90% LRPF rate reproducing excellent reports from single institutions. Minimal grade 3 and lack of grade 4 xerostomia were encouraging. © 2009 by American Society of Clinical Oncology. |
| Keywords: | survival; cancer chemotherapy; cancer survival; controlled study; treatment outcome; survival analysis; treatment failure; major clinical study; overall survival; clinical trial; mortality; neutropenia; intensity modulated radiation therapy; cisplatin; fluorouracil; dose response; multimodality cancer therapy; skin toxicity; treatment duration; treatment planning; cancer adjuvant therapy; cancer patient; comparative study; disease free survival; radiation dose; combined modality therapy; cancer staging; neurotoxicity; follow up; methodology; follow-up studies; antineoplastic agent; neoplasm staging; anorexia; progression free survival; controlled clinical trial; infection; liver toxicity; lung toxicity; multiple cycle treatment; nephrotoxicity; phase 2 clinical trial; bleeding; blood toxicity; esophagitis; leukopenia; mucosa inflammation; stomatitis; antineoplastic combined chemotherapy protocols; drug administration schedule; cancer pain; clinical protocol; pathology; dose-response relationship, drug; radiation injury; distant metastasis; radiation response; time; time factors; risk assessment; dose-response relationship, radiation; drug hypersensitivity; febrile neutropenia; pneumonia; kaplan-meiers estimate; confidence interval; confidence intervals; dysphagia; gastrointestinal toxicity; hyponatremia; feasibility study; sexual dysfunction; radiotherapy, intensity-modulated; probability; multicenter study; brain disease; radiation injuries; xerostomia; nasopharynx carcinoma; salivary gland disease; maximum tolerated dose; kaplan meier method; heart arrhythmia; drug administration; urogenital tract disease; nasopharynx tumor; nasopharyngeal neoplasms; esophagus disease; hearing disorder; bone necrosis; hearing impairment; musculoskeletal disease; eye toxicity; radiation pneumonia; arthropathy; bone disease; bone marrow disease; larynx disorder; mucosal disease; reproductive toxicity; soft tissue disease; spinal cord disease; disease-free survival |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 27 |
| Issue: | 22 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2009-08-01 |
| Start Page: | 3684 |
| End Page: | 3690 |
| Language: | English |
| DOI: | 10.1200/jco.2008.19.9109 |
| PUBMED: | 19564532 |
| PROVIDER: | scopus |
| PMCID: | PMC2720082 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 11" - "Export Date: 30 November 2010" - "CODEN: JCOND" - "Source: Scopus" |
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