Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma.

Abstract

BACKGROUND:

Salvage treatment for locally recurrent nasopharyngeal carcinoma (NPC) is complicated and relatively limited. Radiotherapy, combined with effective concomitant chemotherapy, may improve clinical treatment outcomes. We conducted a phase II randomized controlled trial to evaluate the efficacy of intensity-modulated radiotherapy with concomitant weekly cisplatin on locally recurrent NPC.

METHODS:

Between April 2002 and January 2008, 69 patients diagnosed with non-metastatic locally recurrent NPC were randomly assigned to either concomitant chemoradiotherapy group (n = 34) or radiotherapy alone group (n = 35). All patients received intensity-modulated radiotherapy. The radiotherapy dose for both groups was 60 Gy in 27 fractions for 37 days (range 23-53 days). The concomitant chemotherapy schedule was cisplatin 30 mg/m(2) by intravenous infusion weekly during radiotherapy.

RESULTS:

The median follow-up period of all patients was 35 months (range 2-112 months). Between concomitant chemoradiotherapy and radiotherapy groups, there was only significant difference in the 3-year and 5-year overall survival (OS) rates (68.7% vs. 42.2%, P = 0.016 and 41.8% vs. 27.5%, P = 0.049, respectively). Subgroup analysis showed that concomitant chemoradiotherapy significantly improved the 5-year OS rate especially for patients in stage rT3-4 (33.0% vs. 13.2%, P = 0.009), stages III-IV (34.3% vs. 13.2%, P = 0.006), recurrence interval >30 months (49.0% vs. 20.6%, P = 0.017), and tumor volume >26 cm(3) (37.6% vs. 0%, P = 0.006).

CONCLUSION:

Compared with radiotherapy alone, concomitant chemoradiotherapy can improve OS of the patients with locally recurrent NPC, especially those with advanced T category (rT3-4) and stage (III-IV) diseases, recurrence intervals >30 months, and tumor volume >26 cm(3).

• Authors: Ying Guan, Shuai Liu, Han-Yu Wang, Ying Guo, Wei-Wei Xiao, Chun-Yan Chen, Chong Zhao, Tai-Xiang Lu, Fei Han
• Journal: Chinese journal of cancer (Chin J Cancer) Vol. 35 Pg. 20 (Feb 15 2016) ISSN: 1944-446X [Electronic] England
• PMID: 26879049 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Radiation-Sensitizing Agents
• Cisplatin

Topics

• Administration, Intravenous
• Adult
• Aged
• Carcinoma
• Cisplatin (administration & dosage, therapeutic use)
• Disease-Free Survival
• Dose-Response Relationship, Radiation
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms (drug therapy, pathology, radiotherapy)
• Radiation-Sensitizing Agents (administration & dosage, therapeutic use)
• Radiotherapy, Intensity-Modulated (methods)
• Salvage Therapy
• Survival Analysis
• Treatment Outcome