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• W2767111339 abstract "A randomised, controlled, phase 3 trial by Rolf Issels and colleagues 1 Issels RD Lindner LH Verweij J et al. European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group (EORTC-STBSG)European Society for Hyperthermic Oncology (ESHO)Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study. Lancet Oncol. 2010; 11: 561-570 Summary Full Text Full Text PDF PubMed Scopus (497) Google Scholar on neo-adjuvant chemotherapy alone or with regional hyperthermia for localised, high-risk, soft-tissue sarcoma published in 2010 in The Lancet Oncology is currently the only level 1 evidence in favour of regional hyperthermia for the treatment of soft-tissue sarcoma. 2 Lindner LH Issels RD Hyperthermia in soft tissue sarcoma. Curr Treat Options Oncol. 2011; 12: 12-20 Crossref PubMed Scopus (26) Google Scholar I believe a bias is present in this analysis because the combined treatment group received more chemotherapy than the chemotherapy alone group (median 8·0 cycles vs 5·0 cycles). Transformation of the medians into means by the Hozo algorithm 3 Hozo SP Djulbegovic B Hozo I Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005; 5: 13 Crossref PubMed Scopus (5414) Google Scholar returns the mean values of 6·0 (SD 2·6) for the combined treatment group versus 4·5 (2·3) for the chemotherapy alone group with a relative increase of 1·33 (95% CI 1·22–1·45; p<0·0001) in the combination treatment group, with a power of 98%. There was also a significant difference between the groups in post-induction treatment (53% for the combined treatment group vs 41% for the chemotherapy alone group who completed chemotherapy; p=0·027). Therefore, one cannot conclude that chemotherapy plus hyperthermia is superior to chemotherapy alone, because the difference in chemotherapy received outweighs the effect of the addition of hyperthermia. Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre studyTo our knowledge, this is the first randomised phase 3 trial to show that regional hyperthermia increases the benefit of chemotherapy. Adding regional hyperthermia to chemotherapy is a new effective treatment strategy for patients with high-risk STS, including STS with an abdominal or retroperitoneal location. Full-Text PDF Neo-adjuvant chemotherapy alone or with regional hyperthermia for soft-tissue sarcoma – Authors' replySergey Roussakow comments on four issues of our trial:1 bias caused by imbalanced post-induction chemotherapy application between study groups, subgroup-based analysis of the study endpoints, unreliable evaluation of tumour response, and an overall outcome worse than expected. Full-Text PDF" @default.
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• W2767111339 date "2017-11-01" @default.
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• W2767111339 title "Neo-adjuvant chemotherapy alone or with regional hyperthermia for soft-tissue sarcoma" @default.
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• W2767111339 doi "https://doi.org/10.1016/s1470-2045(17)30643-5" @default.
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