Funding for this research was provided by:
Received: 16 November 2018
Accepted: 29 July 2019
First Online: 13 August 2019
Ethics approval and consent to participate
: PALETTE (EORTC 62072; NCT00753688) was a randomized, double-blind, placebo-controlled, phase 3 trial, conducted by the Soft Tissue and Bone Sarcoma Group of the European Organization for Research and Treatment of Cancer between October 2008 and November 2010. An additional file provides an overview of all study sites and details on affiliated ethics committees (see Additional file InternalRef removed). As part of the original PALETTE study, all patients provided written informed consent and the trial was approved by the institutional review board of each participating institution. Because the subgroup analyses used existing data from the primary study, additional consent was not required. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.
: Not applicable.
: ALC received honoraria from Pfizer, Lilly, Amgen, Novartis, PharmaMar, and Bayer.SB received grants/research support from Novartis, Incyte, and Blueprint Medicine; received honoraria or consultation fees from Novartis, Lilly, Pfizer, PharmaMar, Deciphera, Bayer, and Nanobiotix.GDD received consulting fees from Novartis, Pfizer, EMD-Serono, Sanofi Oncology, Janssen Oncology, Ignyta, Loxo Oncology, Mirati Therapeutics, Epizyme, PharmaMar, Daiichi-Sankyo, WIRB Copernicus Group, Ziopharm, and Polaris Pharmaceuticals; received research support to Dana-Farber from Bayer, Novartis, Pfizer, Janssen Oncology, Ignyta, Loxo Oncology, AbbVie, Epizyme, and Adaptimmune; patent licensed to Novartis from Dana-Farber with royalty paid to Dana-Farber; member, Board of Directors, Blueprint Medicines and Merrimack Pharmaceuticals; member, Scientific Advisory Board with consulting fees and equity, Blueprint Medicines and Merrimack Pharmaceuticals; consultant, Scientific Advisory Board with consulting fees and equity, G1 Therapeutics, Caris Life Sciences, and Champions Oncology; consultant with equity, Bessor Pharmaceuticals.GH, LD, and QA are employees of Novartis Pharmaceuticals Corporation.J-YB received research support and honoraria from Novartis and GSK.IJ received honoraria from GSK for giving lectures at industry sponsored symposia.PH received grants from Novartis; honoraria and consultation fees from GSK, Lilly, Pfizer, AROG, and PharmaMar.PS received institutional support from providing consulting or an advisory role for 6th Element Capital, Adaptimmune, Amcure, Blueprint Medicines, BMS, Deciphera, Eisai, Eli Lilly, Ellipses Pharma, Epizyme, Genzyme, Ipsen, Loxo Oncology, Medpace, Merck, Nektar, Piqur Therapeutics, and Plexxikon; received institutional support for speaker’s bureau from Eisai, PharmaMar, and Eli Lilly; received institutional support (research funding) from Blueprint Medicines, Boehringer Ingelheim, Cobiores nv, Eisai, Eli Lilly, Exelixis, G1Therapeutics, Novartis, PharmaMar, and Plexxikon; received institutional support for travel, accommodation, and expenses from 6th Element Capital, Adaptimmune, Amcure, AstraZeneca, Bayer, Blueprint Medicines, BMS, Boehringer Ingelheim, Daiichi Sankyo, Eisai, Eli Lilly, Epizyme, Genzyme, GSK, Ipsen, Loxo Oncology, Medpace, Nektar, Novartis, PharmaMar, Philogen, Piqur Therapeutics, and Plexxikon.MA and HG declare that they have no competing interests.