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09 Jun 2021

OUTBACK Trial presented at ASCO Plenary 2021

  • VCCC Alliance
  • Peter MacCallum Cancer Centre
  • NHMRC
OUTBACK trial among the most important clinical research advances for cervical cancer in the past year

Professor Linda Mileshkin, VCCC Research and Education Lead, Gynae-oncology, and Peter Mac Deputy Director of Medical Oncology presented at the 2021 ASCO Annual Meeting Plenary Session this week in a possible first for a clinical researcher working in Australia. Despite the inhospitable hour - well before dawn in Australia, the presentation was warmly received as one of the most important clinical research advances for cervical cancer in the past year.

Professor Mileshkin is the Principal Investigator of the OUTBACK trial - a phase III clinical trial that has clear impacts for more gentle and less toxic treatment for women affected by cervical cancer. 

The OUTBACK trial considered chemotherapy plus standard treatment for women with locally advanced cervical cancer. It 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).

It is a phase III randomised trial of adjuvant chemotherapy after chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone.

OUTBACK originated from observations that while standard chemoradiation for women with cervical cancer was working well to cure many, 1 in 3 women were dying due to later developing distant metastatic disease. The trial aimed to show whether the addition of adjuvant chemotherapy after chemoradiation could improve survival.

Adjuvant chemotherapy did not improve 5-year survival rates

The trial included 926 women recruited from seven countries. Professor 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.”

“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.”

"Great credit is due to Professor Mileshkin for her pivotal role..."

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  Professor Mileshkin for her pivotal role together with our collaborators in generating these important results.

View the full abstract online

 

Professor Mileshkin is the clinical lead in a further exciting study through her specialised CUP clinic at the Peter MacCallum Cancer Centre

SUPER-NEXT is a collaborative study co-led by research and clinical partners at the University of Melbourne and Peter MacCallum Cancer Centre. It is funded by the Medical Research Future Fund and is also supported by the University’s industry partner Illumina, a leading international genomics company. 

Read more in Pursuit, by Associate Professor Richard Tothill, University of Melbourne.

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