Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma

👉J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma.

👉Calais G1, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Bertrand P. Abstract

👉BACKGROUND

• The Calais et al group designed a randomized clinical trial to test whether the addition of three cycles of chemotherapy during standard radiation therapy would improve disease-free survival in patients with stages III and IV (i.e., advanced oropharynx carcinoma).

👉METHODS

• A total of 226 patients have been entered in a phase III multicenter, randomized trial comparing radiotherapy alone (arm A) with radiotherapy with concomitant chemotherapy (arm B).
• Radiotherapy was identical in the two arms, delivering, with conventional fractionation, 70 Gy in 35 fractions.
• In arm B, patients received during the period of radiotherapy three cycles of a 4-day regimen containing carboplatin (70 mg/m(2) per day) and 5-fluorouracil (600 mg/m(2) per day) by continuous infusion.
• The two arms were equally balanced with regard to age, gender, stage, performance status, histology, and primary tumor site.

👉RESULTS

• Radiotherapy compliance was similar in the two arms with respect to total dose, treatment duration, and treatment interruption.
• The rate of grades 3 and 4 mucositis was statistically significantly higher in arm B (71%; 95% confidence interval [CI] = 54%-85%) than in arm A (39%; 95% CI = 29%-56%).
• Skin toxicity was not different between the two arms.
• Hematologic toxicity was higher in arm B as measured by neutrophil count and hemoglobin level.
• Three-year overall actuarial survival and disease-free survival rates were, respectively,:
  • 51% (95% CI = 39%-68%) versus 31% (95% CI = 18%-49%) and 42% (95% CI = 30%-57%) versus 20% (95% CI = 10%-33%):
    • For patients treated with combined modality versus radiation therapy alone (P =.02 and.04, respectively).
• The locoregional control rate:
  • Was improved in arm B (66%; 95% CI = 51%-78%) versus arm A (42%; 95% CI = 31%-56%).

👉CONCLUSION

• The statistically significant improvement in overall survival that was obtained supports the use of concomitant chemotherapy as an adjunct to radiotherapy in the management of carcinoma of the oropharynx.

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