Volume 18, Issue 10, Pages (October 2017)

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Volume 18, Issue 10, Pages 1397-1410 (October 2017) Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial  Dr Beatrice Seddon, PhD, Sandra J Strauss, FRCP, Prof Jeremy Whelan, MD, Michael Leahy, MBBS, Prof Penella J Woll, FRCP, Fiona Cowie, MD, Christian Rothermundt, MD, Zoe Wood, MSc, Charlotte Benson, MBChB, Nasim Ali, MD, Maria Marples, FRCP, Gareth J Veal, PhD, David Jamieson, PhD, Katja Küver, BSc, Roberto Tirabosco, MD, Sharon Forsyth, BSc, Stephen Nash, MSc, Hakim-Moulay Dehbi, PhD, Sandy Beare, PhD  The Lancet Oncology  Volume 18, Issue 10, Pages 1397-1410 (October 2017) DOI: 10.1016/S1470-2045(17)30622-8 Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Terms and Conditions

Figure 1 Trial profile *Other reasons were: 43 multidisciplinary team decision not to approach patient, five deaths, three referred to or treated at other hospital, one patient did not fully understand trial, one trial closed before patient finished radiotherapy. †Clinical decision made not to treat (doxorubicin group), withdrawn consent (gemcitabine and docetaxel group), disease progression (gemcitabine and docetaxel group). ‡Histology review reclassified as ineligible histological subtypes (one gastrointestinal tumour in the doxorubicin group and one extra-skeletal myxoid chondrosarcoma in the gemcitabine and docetaxel group). §Two moved away, one being treated locally. ¶One moved away. ||See appendix p 6 for a breakdown of reasons for treatment discontinuation. The Lancet Oncology 2017 18, 1397-1410DOI: (10.1016/S1470-2045(17)30622-8) Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Terms and Conditions

Figure 2 Progression-free survival HR=hazard ratio. The Lancet Oncology 2017 18, 1397-1410DOI: (10.1016/S1470-2045(17)30622-8) Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Terms and Conditions

Figure 3 Overall survival HR=hazard ratio. The Lancet Oncology 2017 18, 1397-1410DOI: (10.1016/S1470-2045(17)30622-8) Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Terms and Conditions

Figure 4 Quality-of-life outcomes at 12 weeks post-randomisation The plotted points represent the mean treatment effect between the groups (a positive number for the treatment effect indicates a better quality of life on gemcitabine and docetaxel than doxorubicin). For symptom scales and FA13 scores, lower scores are associated with better quality of life. Consequently, values are the opposite between table 4 and figure 4); horizontal lines are 99% CIs. FA13=fatigue questionnaire. The Lancet Oncology 2017 18, 1397-1410DOI: (10.1016/S1470-2045(17)30622-8) Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Terms and Conditions