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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

660 - Can concomitant diseases predict the compliance with cisplatin plus RT in patients with LA SCCHN? An exploratory endpoint analysis of the COMPLY trial.


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Tumour Site

Head and Neck Cancers


Juergen Dunst


Annals of Oncology (2018) 29 (suppl_8): viii372-viii399. 10.1093/annonc/mdy287


J. Dunst1, G. Hildebrandt2, M. Becker-Schiebe3, T. Kuhnt4, F. Weykamp5, F. Martucci6, D. Vordermark7, M. Pless8, D. Hofmann9, V. Bühler10, S.I. Rothschild11

Author affiliations

  • 1 Klinik Für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, 24105 - Kiel/DE
  • 2 Radiooncology, Universitätsklinikum Rostock, Rostock/DE
  • 3 Radiooncology, Klinikum Braunschweig, Braunschweig/DE
  • 4 Radiooncology, Universitätsklinikum Leipzig, 04103 - Leipzig/DE
  • 5 Strahlentherapie, Universitätsklinikum Heidelberg, Heidelberg/DE
  • 6 Radiooncology, IOSI - Ospedale Regionale Bellinzona e Valli, Bellinzona/CH
  • 7 Radiooncology, Universitätsklinikum Halle/Saale, Halle/Saale/DE
  • 8 Radiooncology, Kantonsspital Winterthur, 8401 - Winterthur/CH
  • 9 Medical Affairs Oncology, Merck Serono GmbH, 64289 - Darmstadt/DE
  • 10 Medical Affairs Oncology, Merck (Schweiz) AG, Zug/CH
  • 11 Radiooncology, Universitätsspital Basel, 4031 - Basel/CH


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Abstract 660


International guidelines recommend the use of high-dose platinum chemoradiotherapy (CRT) (3 x 100 mg/m², q3w) for the treatment of LA SCCHN. The clinical benefit of CRT decreases with lower cumulative dosage. Dose reductions to ≤ 200 mg/m² lead to a significantly lowered OS. Predictive factors would help to select patients who are suitable for an optimal cumulative dose of cisplatin.


The COMPLY trial included patients with LA SCCHN from Germany and Switzerland. Eligible patients were treated in 2013/2014. The planned target dose of cisplatin had to be > 200 mg/m². Compliance was defined as an administration of > 200 mg/m² cisplatin. R/M SCCHN, nasopharyngeal carcinomas, adjuvant treatment or participation in other clinical trials were excluded. The exploratory objective was to identify a predictive score for therapy compliance with platinum-based CRT. A multiple logistic regression analysis was performed to identify independent explanatory variables associated with compliance with cisplatin. Only independent variables with a p-value <0.15 in the univariate analysis were considered for multiple logistic regression analysis.


184 patients in 9 sites were included. Median age was 61.0 years, 82.6% were male, 167 patients (90.8%) were ECOG 0-1. A significant difference in treatment compliance with cisplatin was shown for patients with concomitant musculoskeletal/connective tissue disorders (odds ratio for absence of disease vs. presence: 9.43; 95% CI: 1.20, 74.02; p = 0.03) and respiratory, thoracic and mediastinal disorders (odds ratio for absence of disease vs. presence: 6.59; 95% CI: 1.47, 29.48; p = 0.01) by system organ class. The probability of treatment compliance with cisplatin, being an estimate from a scoring system developed for the study, was 43.4% in subjects with absence of both disorders while the treatment compliance was 8.9% in subjects who presented with either one of the disorders and 1.2% in subjects with both disorders.


These exploratory results indicate that subjects without musculoskeletal/connective tissue and respiratory, thoracic and mediastinal disorders as concomitant diseases were more likely to have received cisplatin >200 mg/m².

Clinical trial identification

Legal entity responsible for the study

Merck Serono GmbH, Darmstadt, Germany.


Merck Serono GmbH, Darmstadt, Germany.

Editorial Acknowledgement

The Medical Affairs Oncology Department of Merck Serono GmbH, Darmstadt, Germany assisted in the writing of this abstract.


J. Dunst: Honoraria: Merck KGaA. D. Vordermark: Advisor: Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Merck KGaA; Honoraria as speaker: Roche, AstraZeneca, Merck KGaA, Lilly, Ferring. M. Pless: Advisory boards honoraria: Merck, D. Hofmann: Employee and stock ownership: Merck Serono GmbH. V. Bühler: Employee: Merck (Schweiz) AG. S.I. Rothschild: Advisory boards honoraria (to Institution): Merck; Research funding: Merck. All other authors have declared no conflicts of interest.

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