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/m2 by intravenous infusion weekly during radiotherapy.ResultsThe 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 cm3 (37.6% vs. 0%, P = 0.006).ConclusionCompared 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 cm3.

Long‐term outcomes after reirradiation in nasopharyngeal carcinoma with intensity‐modulated radiotherapy: A meta‐analysis

“…Of the 55 studies for which full texts were reviewed, 43 were excluded as they were irrelevant or did not meet the inclusion criteria (see Figure ). We identified 12 studies, including 1768 patients (Table ) . Of the studies included, 11 were from China and 1 was from Spain.…”

Preserving the legacy of reirradiation: A narrative review of historical publications

“…Recent developments also include new isotopes for brachytherapy, updated recommendations for dose prescription, the introduction of proton and carbon ion beams, and integration of systemic agents and hyperthermia that modify the radiation response 43, 44, 45, 46, 47, 48, 49. In addition to retrospective analyses, many prospective studies have been performed since 1990,50, 51, 52, 53, 54, 55 including randomized phase 2 and 3 trials 56, 57, 58, 59, 60, 61. As a consequence, reirradiation has become part of clinical practice guidelines 62, 63.…”

Phase I/II trial evaluating concurrent carbon-ion radiotherapy plus chemotherapy for salvage treatment of locally recurrent nasopharyngeal carcinoma

“…Concurrent chemotherapy with definitive radiotherapy has been proven effective in the treatment of NPC [18]; however, its effectiveness in the management of locally recurrent NPC has not been confirmed. In addition, the use of concurrent chemotherapy plus high-LET irradiation, such as CIRT, for the purpose of radiosensitization has never been addressed.…”

“…Concurrent chemotherapy with IMXT is the current standard treatment for locally advanced NPC and has been studied against other chemotherapy scheduling [18, 19]. However, the addition of chemotherapy during IMXT for re-irradiation of locally recurrent NPC has never been studied in any prospective clinical trial.…”