Concomitant chemoradiation versus radical radiotherapy in advanced squamous cell carcinoma of oropharynx and nasopharynx using weekly cisplatin: a phase II randomized trial

Ann Oncol. 2010 Nov;21(11):2272-2277. doi: 10.1093/annonc/mdq219. Epub 2010 Apr 28.

Abstract

Background: To know the effectiveness and tolerance of weekly cisplatin added to radiotherapy (RT) in advanced carcinoma of oropharynx and nasopharynx.

Patients and methods: Stage II-IV cancer patients were randomly assigned to either radical RT, 70 Gy/35 fractions over 7 weeks (RT arm), or chemoradiotherapy (CRT), cisplatin 40 mg/m² weekly for seven doses plus RT. Primary end points were (i) the responses, (ii) toxicity profile, and (iii) overall survival (OS) in two groups. Study period was from June 2003 to July 2005.

Results: One hundred and fifty-three patients were randomly allocated to the study, 76 in RT arm and 77 in CRT arm. Seventy-one in each arm completed the planned treatment; complete response (CR): 67.1% versus 80.5% in RT and CRT arms (P = 0.04). Grade III and IV toxicity were 16% and 40% in RT and CRT arms, respectively (P = 0.01). There were frequent treatment interruptions (9.3% versus 28.9%; P = 0.003) and hospitalization (20% versus 40.8%) in the CRT group. OS was superior in the CRT arm (P = 0.02): 27 months [95% confidence interval (CI) 15.2-36.8] for RT versus not reached for CRT. Three-year OS was 42% for RT and 62% for CRT group. CRT and CR were independent prognostic factors.

Conclusion: This trial on Indian head and neck squamous cell carcinoma patients confirms that the use of weekly cisplatin is safe and CRT is superior to RT alone resulting in higher OS.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / therapy*
  • Cisplatin / therapeutic use*
  • Combined Modality Therapy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nasopharyngeal Neoplasms / pathology
  • Nasopharyngeal Neoplasms / therapy*
  • Neoplasm Staging
  • Oropharyngeal Neoplasms / pathology
  • Oropharyngeal Neoplasms / therapy*
  • Prospective Studies
  • Radiotherapy Dosage
  • Survival Rate
  • Treatment Outcome
  • Young Adult

Substances

  • Antineoplastic Agents
  • Cisplatin