Concomitant Cisplatin and Hyperfractionated Radiotherapy in Locally Advanced Head and Neck Cancer: 10-Year Follow-Up of a Randomized Phase III Trial (SAKK 10/94)

Ghadjar, Pirus; Simcock, Mathew; Studer, Gabriela; Allal, Abdelkarim S.; Ozsahin, Mahmut; Bernier, Jacques; Töpfer, Michael; Zimmermann, Frank; Betz, Michael; Glanzmann, Christoph; Aebersold, Daniel M.; Swiss Group for Clinical Cancer Research (SAKK),

doi:10.1016/j.ijrobp.2010.11.067

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Volume 82, Issue 2 , Pages 524-531, 1 February 2012

Concomitant Cisplatin and Hyperfractionated Radiotherapy in Locally Advanced Head and Neck Cancer: 10-Year Follow-Up of a Randomized Phase III Trial (SAKK 10/94)

Presented in part at the 52th Annual meeting of the American Society for Radiation Oncology, San Diego, California, October 31th - November 4th, 2010.

Pirus Ghadjar, M.D.
- Department of Radiation Oncology, Inselspital, Bern University Hospital, and University of Bern, Switzerland, 3010 Bern, Switzerland
- Reprint requests to: Pirus Ghadjar, M.D., Department of Radiation Oncology, Inselspital, Bern University Hospital, Freiburgstrasse, 3010 Bern, Switzerland. Tel: (+41) 31 632 2431; Fax: (+41) 31 382 2342
Mathew Simcock, M.Sc.
- Swiss Group for Clinical Cancer Research Coordinating Center (SAKK CC), 3008 Bern, Switzerland
Gabriela Studer, M.D.
- Department of Radiation Oncology, University Hospital Zürich, Zürich, Switzerland
Abdelkarim S. Allal, M.D.
- Department of Radiation Oncology, Kantonsspital Fribourg, Fribourg, Switzerland
Mahmut Ozsahin, M.D., Ph.D.
- Department of Radiation Oncology, University Hospital Lausanne, Lausanne, Switzerland
Jacques Bernier, M.D.
- Department of Radiation Oncology, Clinique de Genolier, Genolier, Switzerland
Michael Töpfer, M.D.
- Department of Radiation Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland
Frank Zimmermann, M.D.
- Department of Radiation Oncology, University Hospital Basel, Basel, Switzerland
Michael Betz, M.D.
- Department of Radiation Oncology, Geneva University Hospital, Geneva, Switzerland
Christoph Glanzmann, M.D.
- Department of Radiation Oncology, University Hospital Zürich, Zürich, Switzerland
Daniel M. Aebersold, M.D.
- Department of Radiation Oncology, Inselspital, Bern University Hospital, and University of Bern, Switzerland, 3010 Bern, Switzerland
Swiss Group for Clinical Cancer Research (SAKK)

Received 24 June 2010; received in revised form 5 November 2010; accepted 12 November 2010. published online 07 February 2011.

Purpose

To compare the long-term outcome of treatment with concomitant cisplatin and hyperfractionated radiotherapy versus treatment with hyperfractionated radiotherapy alone in patients with locally advanced head and neck cancer.

Methods and Materials

From July 1994 to July 2000, a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to receive either hyperfractionated radiotherapy alone (median total dose, 74.4 Gy; 1.2 Gy twice daily; 5 days per week) or the same radiotherapy combined with two cycles of cisplatin (20 mg/m² for 5 consecutive days during weeks 1 and 5). The primary endpoint was the time to any treatment failure; secondary endpoints were locoregional failure, metastatic failure, overall survival, and late toxicity assessed according to Radiation Therapy Oncology Group criteria.

Results

Median follow-up was 9.5 years (range, 0.1–15.4 years). Median time to any treatment failure was not significantly different between treatment arms (hazard ratio [HR], 1.2 [95% confidence interval {CI}, 0.9–1.7; p = 0.17]). Rates of locoregional failure-free survival (HR, 1.5 [95% CI, 1.1–2.1; p = 0.02]), distant metastasis-free survival (HR, 1.6 [95% CI, 1.1–2.5; p = 0.02]), and cancer-specific survival (HR, 1.6 [95% CI, 1.0–2.5; p = 0.03]) were significantly improved in the combined-treatment arm, with no difference in major late toxicity between treatment arms. However, overall survival was not significantly different (HR, 1.3 [95% CI, 0.9–1.8; p = 0.11]).

Conclusions

After long-term follow-up, combined-treatment with cisplatin and hyperfractionated radiotherapy maintained improved rates of locoregional control, distant metastasis-free survival, and cancer-specific survival compared to that of hyperfractionated radiotherapy alone, with no difference in major late toxicity.

Chemotherapy, Cisplatin, Head and neck cancer, Hyperfractionated radiotherapy, Toxicity