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Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma.
Radiother Oncol 2007; 85(1):17-23RO

Abstract

BACKGROUND AND PURPOSE

Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial.

PATIENTS AND METHODS

From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria.

RESULTS

Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p=0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p=0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p=0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant.

COMMENTS

The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin fibrosis.

Authors+Show Affiliations

Department of Radiotherapy, Habib Bourguiba University Hospital, Sfax, Tunisia. jamel.daoud@rns.tnNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

17343938

Citation

Daoud, Jamel, et al. "Results of a Prospective Randomised Trial Comparing Conventional Radiotherapy to Split Course Bifractionated Radiation Therapy in Patients With Nasopharyngeal Carcinoma." Radiotherapy and Oncology : Journal of the European Society for Therapeutic Radiology and Oncology, vol. 85, no. 1, 2007, pp. 17-23.
Daoud J, Toumi N, Siala W, et al. Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma. Radiother Oncol. 2007;85(1):17-23.
Daoud, J., Toumi, N., Siala, W., Ghorbel, A., Drira, M. M., & Frikha, M. (2007). Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma. Radiotherapy and Oncology : Journal of the European Society for Therapeutic Radiology and Oncology, 85(1), pp. 17-23.
Daoud J, et al. Results of a Prospective Randomised Trial Comparing Conventional Radiotherapy to Split Course Bifractionated Radiation Therapy in Patients With Nasopharyngeal Carcinoma. Radiother Oncol. 2007;85(1):17-23. PubMed PMID: 17343938.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma. AU - Daoud,Jamel, AU - Toumi,Nabil, AU - Siala,Wissem, AU - Ghorbel,Abdelmonem, AU - Drira,Mohamed Mokthar, AU - Frikha,Mounir, Y1 - 2007/03/06/ PY - 2006/01/30/received PY - 2007/01/25/revised PY - 2007/01/30/accepted PY - 2007/3/9/pubmed PY - 2008/1/30/medline PY - 2007/3/9/entrez SP - 17 EP - 23 JF - Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology JO - Radiother Oncol VL - 85 IS - 1 N2 - BACKGROUND AND PURPOSE: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. PATIENTS AND METHODS: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. RESULTS: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p=0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p=0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p=0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. COMMENTS: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin fibrosis. SN - 0167-8140 UR - https://www.unboundmedicine.com/medline/citation/17343938/Results_of_a_prospective_randomised_trial_comparing_conventional_radiotherapy_to_split_course_bifractionated_radiation_therapy_in_patients_with_nasopharyngeal_carcinoma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0167-8140(07)00029-1 DB - PRIME DP - Unbound Medicine ER -