Impact of weight loss on survival after chemoradiation for locally advanced head and neck Cancer: secondary results of a

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Impact of weight loss on survival after chemoradiation for locally advanced head and neck Cancer: secondary results of a randomized phase III trial (SAKK 10/94) Pirus Ghadjar1*, Stefanie Hayoz2, Frank Zimmermann3, Stephan Bodis4, David Kaul1, Harun Badakhshi1, Jacques Bernier5, Gabriela Studer6, Ludwig Plasswilm7, Volker Budach1, Daniel M Aebersold8 , For the Swiss Group for Clinical Cancer Research (SAKK)

Abstract Background: To analyze the impact of weight loss before and during chemoradiation on survival outcomes in patients with locally advanced head and neck cancer. Methods: From 07/1994-07/2000 a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to either hyperfractionated radiation therapy alone or the same radiation therapy combined with two cycles of concomitant cisplatin. The primary endpoint was time to any treatment failure (TTF); secondary endpoints were locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS) and overall survival (OS). Patient weight was measured 6 months before treatment, at treatment start and treatment end. Results: The proportion of patients with >5% weight loss was 32% before, and 51% during treatment, and the proportion of patients with >10% weight loss was 12% before, and 17% during treatment. After a median follow-up of 9.5 years (range, 0.1 – 15.4 years) weight loss before treatment was associated with decreased TTF, LRRFS, DMFS, cancer specific survival and OS in a multivariable analysis. However, weight loss during treatment was not associated with survival outcomes. Conclusions: Weight loss before and during chemoradiation was commonly observed. Weight loss before but not during treatment was associated with worse survival. Keywords: Weight loss, Chemotherapy, Cisplatin, Head and neck cancer, Hyperfractionated radiation therapy, Survival, Malnutrition

Background Weight loss is frequently observed in patients with head and neck squamous cell cancer (HNSCC). Weight loss before chemoradiation has been associated with decreased overall survival by us and others [1-3], however, weight loss during chemoradiation was also associated with poor cancer specific survival, overall survival and disease-free survival in HNSCC [3-5]. Here we report detailed weight loss data before and during chemoradiation and its * Correspondence: [email protected] 1 Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany Full list of author information is available at the end of the article

associations with survival outcomes using long-term follow-up data from our prospective trial testing concomitant cisplatin and hyperfractionated radiation therapy (RT) vs. hyperfractionated RT alone in advanced HNSCC.

Methods Patient selection and treatment

As previously described [1], all eligible patients had invasive HNSCC of the oral cavity, oro- or hypopharynx, or larynx. All patients gave informed consent and a total of 224 patients were randomized between July 1994 and July 200