The HERA trial, which has been run by the Breast International Group (BIG) since 2001, is an international, multi-center, phase III randomized study involving 5102 women with early HER2-positive breast cancer. After finishing primary therapy with surgery, chemotherapy and radiotherapy as indicated, they were randomly assigned to trastuzumab therapy every 3 weeks for 1 year, 2 years or observation.
As of 12 April 2012, the unadjusted hazard ratio for a woman experiencing disease relapse in the 2-year treatment arm versus the 1-year arm was 0.99 (95% CI and P-value), Prof Richard Gelber of Harvard Medical School and Dana-Farber Cancer Institute, Boston, MA, USA, said. The overall survival rate in the two arms was comparable [HR=1.05 (95% CI 0.86-1.28; P=0.6333)].
"The key message for 2012 is that 1 year of treatment with trastuzumab remains the standard of care for HER2 positive early breast cancer patients," Prof Gelber said.
The researchers found that the durable benefit in disease-free survival and overall survival of 1-year trastuzumab compared to no trastuzumab that had been reported previously remained stable at 8 years of median follow-up.
"This prolonged benefit in disease-free survival and overall survival of 1-year trastuzumab over no trastuzumab is remarkably impressive and reassuring to patients," Prof Gelber said. "These results show that the benefit of adjuvant trastuzumab remains over time and it is not lost after some years. Patients can be reassured that 1 year trastuzumab is a very effective treatment, reducing the risk of disease recurrence and death by one-quarter compared to not using trastuzumab."
"While extending the duration of trastuzumab administration to 2 years did not significantly improve outcome compared with 1 year trastuzumab, ongoing trials are testing whether combining trastuzumab with other anti-HER2 agents (for example pertuzumab or lapatinib) might further benefit patients with HER2-positive early breast cancer," Prof Gelber noted.Commenting on the data, Prof Zielinski noted: "Progress in the treatment of patients with early breast cancer over-expressing HER2/neu was extremely impressive and particularly successful by the introduction of trastuzumab as adjuvant treatment. This was administered in the first trials for one year and resulted in a highly significant prolongation of progression-free and overall survival. However, the question lingered whether a prolongation of treatment to two years would result in even better data than the ones obtained before."
An academic randomized, non-inferiority trial instituted by the French National Cancer Institute (INCa) has compared a shorter trastuzumab exposure of 6 months versus the standard 12 months.
The Phare trial addressed the question of the trastuzumab duration in HER-positive early breast cancer adjuvant treatment. More than 150 cancer care centers all over France participated, recruiting more than 3380 patients representative of the French population. The trial's primary objective was to compare 6 months versus 12 months trastuzumab therapy in terms of disease free-survival according to a non-inferiority schema.
The trial results are inconclusive for this non-inferiority hypothesis," said Prof Xavier Pivot, of the Université de Franche Comté, France. "Nevertheless, there is a trend in favor of 12 months treatment for the overall population. Analysis of subgroups will be presented in December."
The median follow-up in the trial was 42.5 months and at the time of the analysis 395 disease-free survival events were reported. "According to the design of this trial, which allowed for a non-inferiority hazard ratio margin of 1.15, the 6-month trastuzumab arm (arm B) was not demonstrated to be significantly inferior to 12-month trastuzumab (arm A), since the confidence interval contains the 1.15 non inferiority margin (HR=1.28 (95%CI: 1.04 – 1.56, p=0.29). However despite the inconclusive result in terms of non-inferiority, the HR of 1.28 suggests a trend favoring 12 months," Prof Pivot said.
"Further exploration of the data, especially in selected subgroups is ongoing; further results will be presented in a couple of months. The results probably won't give a black and white answer, and the researchers will probably need to look at subsets of patients to see who benefits from six months of treatment and who should get a full year," Prof Pivot said.
ESMO PRESS OFFICE | EurekAlert!
New study: How does Europe become a leading player for software and IT services?
03.04.2017 | Fraunhofer-Institut für System- und Innovationsforschung (ISI)
Reusable carbon nanotubes could be the water filter of the future, says RIT study
30.03.2017 | Rochester Institute of Technology
More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.
Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...
Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.
"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...
The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.
Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...
The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...
Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.
Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...
20.04.2017 | Event News
18.04.2017 | Event News
03.04.2017 | Event News
27.04.2017 | Life Sciences
27.04.2017 | Physics and Astronomy
27.04.2017 | Earth Sciences