OUTBACK is an academic collaboration of the Australia New Zealand Gynaecological Oncology Group (ANZGOG), NHMRC Clinical Trials Centre at the University of Sydney, and NRG Oncology under the auspices of the international Gynecologic Cancer Intergroup (GCIG).
OUTBACK is a phase 3, randomised trial of adjuvant chemotherapy after chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone. OUTBACK included 926 women recruited from seven countries. The trial was sponsored by the University of Sydney and is registered on the Australian & New Zealand Clinical Trial Registry (ACTRN12610000732088).
Principal Investigator of the trial, Professor Linda Mileshkin, said,
“The OUTBACK results confirm that chemoradiation alone is currently our best standard treatment for women with locally advanced cervical cancer. The addition of adjuvant chemotherapy did not improve 5-year survival rates, but it did add significant side effects. Although some oncologists have been giving adjuvant chemotherapy outside of trials while awaiting the results of OUTBACK, this practice should now stop.”
Professor Mileshkin is Deputy Director of Medical Oncology at Peter MacCallum Cancer Centre.
“We need to find ways to improve the tolerability and completion of standard chemoradiation, as well as investigate other ways to improve survival rates for this group of women.”
Associate Professor Philip Beale, Chair of ANZGOG, said,
“OUTBACK has been a fantastic effort from investigators and trial units around the world. This global effort has culminated in a high-quality, rigorously conducted clinical trial, producing robust results that answer an important question for women with cervical cancer. Great credit is due to Principal Investigator Professor Linda Mileshkin for her pivotal role together with ANZGOG and our collaborators in generating these important results. Our heartfelt thanks go to the women, and their families, who participated in this trial, enabling us to move forward and test new ideas to improve the outcomes of women affected by cervical cancer”.
The trial results have been described as ‘immediately practice-changing’ by ASCO President Lori J. Pierce, MD, FASTRO, FASCO:
“This trial provides clear evidence that the addition of chemotherapy after chemoradiation does not extend survival. The results are immediately practice-changing, showing that this approach should not be used to treat locally advanced cervical cancer. We can now spare our patients the side effects and toxicity that comes with additional chemotherapy.”