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

Ying Guan, Shuai Liu, Han-Yu Wang, Ying Guo, Wei-Wei Xiao, Chun-Yan Chen, Chong Zhao, Tai-Xiang Lu, Fei Han, Ying Guan, Shuai Liu, Han-Yu Wang, Ying Guo, Wei-Wei Xiao, Chun-Yan Chen, Chong Zhao, Tai-Xiang Lu, Fei Han

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).

Figures

Fig. 1
Fig. 1
Flowchart for trial participants of the study. NPC nasopharyngeal carcinoma, CCRT concomitant radiochemotherapy, RT radiotherapy alone, DDP cisplatin, No. number
Fig. 2
Fig. 2
Kaplan–Meier curves of overall survival in distinct subgroups of NPC patients treated with CCRT or RT. The results show that CCRT significantly improved the 5-year overall survival rate for patients with a rT3–4 category disease (33.0% vs. 13.2%, P = 0.009), b stages III–IV NPC (34.3% vs. 13.2%, P = 0.006), c recurrence interval >30 months (49.0% vs. 20.6%, P = 0.017), and d tumor volume >26 cm3 (37.6% vs. 0%, P = 0.006) as compared with RT

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Source: PubMed

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