Our aim is to integrate translational research and, where applicable, functional imaging into all new studies as this may permit a fundamental advance in the understanding of a particular disease.
ROG Breast Working Party Trials and Activities 2016
Chair: Nicola Russell; co-chair/ YROG: Icro Meattini
Following a poll addressed to all ROG members in early 2016, the members listed below expressed interest in being actively or passively involved in the Breast working party.
Abdulla Al-Rashdan, Antonella Richetti, Cordula Petersen, David Pasquier, Eleonor Rivin, Erich Gerber, Giovanni Frezza, Helen Westenberg, Henk Struikmans, Icro Meattini, Igor Sirak, Isabelle barillot, Isabelle Kindts, Johannes Claßen, John Maduro, Mariacarla Valli, Mohamed Benchalal, Nicola Russell, Philip Poortmans, Philippe Couke, Rami Ben-Yosef, Reinhilde Weytjens, Samir Patel Stephan Roth, Vincent Gregoire, Vincent Remouchamps, Yazid Belkacemi, Zvi Bernstein.
One trial investigating neo-adjuvant timing of radiotherapy in high risk patients, and two trials investigating omitting radiotherapy altogether by low-risk patients (invasive or in-situ respectively)
Neo-APBI phase I-II study in high risk patients (Yazid Belkacemi)
This study investigates the feasibility of accelerated partial breast irradiation pre-operatively to the primary tumour in patients with high risk breast cancer undergoing neo-adjuvant chemotherapy and planned for breast conserving surgery. The phase I is a dose finding study with two dose levels, and the phase II will continue with the optimal dose from the phase I. Funding has been awarded in France for the trial, and it has started to accrue patients in the phase I. The trial has been discussed in the ROG and BCG and it has been decided to await the results of the phase I before developing the trial further in the EORTC.
Phase III exclusive APBI vs exclusive ET trial (Icro Meattini)
This ROG/YROG trial is in an advanced stage of protocol development. The trial will include patients over 70 years with low risk luminal A breast cancer after breast conserving surgery. The randomization is between only post-operative partial breast irradiation, or only endocrine therapy. A third arm of no further treatment was discussed but rejected by the ROG. There is a collaboration with the BCG group, QoL group and the Elderly Task Force. As we are not expecting an impact on survival from the adjuvant treatments in this age group, the primary end-point is Quality of Life. A grant for funding from the QoL group has been submitted. EORTC BCG fellow Kim Aalders will further develop the trial at the MCCR trial development workshop in Zeist, Netherlands. Currently feasibility is being established and the budget determined, funding is being sought from National Cancer charities.
Regional nodal irradiation after primary systemic therapy
This is a trial where patients will be randomized to RNI or not in case of ypN0 after PST. The trial will be an intergroup collaboration. PIs Meritxell, Arenas and Charlotte Coles. Study coordinators: Poortmans, Valentini and Aristei. The trial is in the early stages of development.
LORD trial EORTC 1401 (Nina Bijker)
This trial investigates whether screen detected grade I DCIS should be treated (standard treatment consisting of surgery and usually radiotherapy, sometimes endocrine therapy), or just kept under surveillance (yearly mammography). This trial is now in the process of being activated in the Netherlands. Other countries to follow (financing pending).
The final analysis of the IM-MS trial (EORTC 22922-10925) was published in NEJM in July 2015 by Poortmans et al. (www.nejm.org/doi/full/10.1056/NEJMoa1415369).
For IM-MS trial (EORTC 22922-10925), DCIS trial (EORTC 22085) and SUPREMO trial (EORTC 22051-10052), it remains important to continue to send the CRFs in a timely way as additionnal long term analyses are expected.
For SUPREMO (EORTC 22051-10052), an abstract on the pathology review was selected for the poster highlight session at the EBCC-9 in Amsterdam, March 2016, and a full manuscript has been submitted to Eur. J. cancer.
The 15-year follow-up results of AMAROS trial (EORTC 10853) was published by M. Donkerk et al. in JCO in November 2013 (http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2013.49.5077).
The 20-year follow-up results of the boost – no boost trial (EORTC 22881-10882) was published by H. Bartelink et al. in Lancet in December 2014 (http://dx.doi.org/10.1016/S1470-2045(14)71156-8).
An updated analysis of ipsilateral breast relapse based on pathology review published by van Werkhoven et al, Radiotherapy and Oncology 2011 was recently conducted by Conny Vrieling and should be published soon in JAMA Oncology, titled: The changing impact of prognostic factors on local control after long-term follow-up in the EORTC boost no-boost trial.
Survivorship project (Conny Vrieling and Lotte Moser)
This project explores the data from the long-term follow-up of several EORTC ROG breast cancer radiotherapy trials from the 1980’s onwards. At the ICTR-PHE 2016 conference in Geneva February 2016 a presentation was given about the project, titled: “Data from the EORTC Cancer Survivorship Task Force” and a poster was presented at EBCC in March 2016, titled: “EORTC breast cancer survivorship project: first analysis of 3 large early-breast cancer radiotherapy trials”.
Update of breast module QoL Group
The EORTC QoL questionnaire for breast cancer trials (BR23) is in the process of being updated. A young oncologist from Poland, Katarzyna Pogoda, will together with the BCG chair Fatima Cardoso liaise between the BCG and the QoL group on this item. The idea is to utilise the new BR23 in the APBI vs ET trial of Icro Meattini.