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Disparities starting adjuvant chemotherapy for locally advanced cervical cancer in the international, academic, randomised, phase 3 OUTBACK trial (ANZGOG 0902, RTOG 1174, NRG 0274) (#335)

Linda Mileshkin ¹ , Elizabeth Barnes ² , Kathleen Moore ³ , Val Gebski ² , Madeleine King ⁴ , Kailash Narayan ⁵ , Ilka Kolodziej ² , Katrin Sjoquist ² , Anthony Fyles ⁶ , William Small ⁷ , David Gaffney ⁸ , Michael Quinn ¹ , John Andrews ⁹ , Spencer Thompson ³ , Warner Huh ¹⁰ , David Miller ¹¹ , Paul Silvestro ¹² , Danny Rischin ¹ , Martin Stockler ² , Bradley Monk ¹³

Department of Medical Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia
NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
Faculty of Science, School of Psychology, Quality of Life Office, University of Sydney, Sydney, NSW, Australia
Department of Radiation Oncology , Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada
Department of Radiation Oncology, Stritch School of Medicine, Loyola University, Chicago, IL, USA
Department of Radiation Oncology , Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA
Australian New Zealand Gynaecological Oncology Group, Sydney, NSW, Australia
University of Alabama, Tuscaloosa, AL, USA
South Western Medical Centre of Texas, Dallas, TX, USA
Women and Infants Rhode Island, Providence, RI, USA
Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospital, Phoenix, AZ, USA

Background OUTBACK is testing the addition of 4 cycles of adjuvant chemotherapy(chemo) with carboplatin and paclitaxel after definitive chemoradiation in locally advanced cervix cancer. The aim of this analysis was to determine characteristics associated with not starting randomly assigned adjuvant chemo.

Methods We assessed associations between not starting randomly assigned adjuvant chemo and the baseline characteristics of: age; race; smoking status; ECOG; BMI; FIGO stage; nodal involvement; and participants’ self-ratings of physical, role, emotional, cognitive, social functional domains, and financial difficulties (by the EORTC QLQ-C30). We also assessed for associations with completion of chemoradiation and reporting of grade 3-4 toxicities during chemoradiation. Odds ratios, p-values, and 95% confidence intervals (CI) were calculated with univariable and multivariable logistic regression analyses.

Results Adjuvant chemo was not started in 105 of 463(23%) women randomly assigned to receive it. Predictors of not starting adjuvant chemo with a p-value of < 0.05 in univariable analyses, and their effects in multivariable analysis are shown in the table. The odds of not starting chemo were approximately doubled in people of colour, and those aged ≥ 60, even after accounting for other associated factors.

Conclusions Adjuvant chemo was less likely to be started in people of colour, those aged ³ 60, and those with poor self-rated physical function. Further research is required to understand the causes, implications, and methods for mitigating these disparities.

Characteristic	Value	Adjuvant chemo not started/assigned: N(%)	Univariable odds-ratio(95%CI)	Univariable p-value	Multivariable odds-ratio(95%CI)	Multivariable p-value
Age(years)	≥60 ≤60	24/70(34%) 81/393(21%)	2.01(1.16-3.49)	0.01	2.30 (1.10-4.81)	0.02
Race	People of colour Whites	43/127(34%) 62/336(18%)	2.27(1.43–3.58)	0.005	2.11 (1.13-3.96)	0.02
Lymph nodes involved	Yes No/unknown	42/225(19%) 63/238(26%)	0.64(0.41–0.99)	0.05	0.75 (0.42-1.35)	0.3
QLQ-C30 Physical Function	Worst 33.37% Best 66.67%	5/11(45%) 59/310(19%)	3.54(1.05–12.0)	0.04	3.66 (1.03-13)	0.05
Chemoradiation	Notcompleted Completed	46/114(40%) 59/349(17%)	3.32(2.08–5.31)	<0.0001	3.21 (1.75-5.88)	.0002

Best of Best Poster Oral Clinical Oncology Society of Australia Annual Scientific Meeting 2019

Disparities starting adjuvant chemotherapy for locally advanced cervical cancer in the international, academic, randomised, phase 3 OUTBACK trial (ANZGOG 0902, RTOG 1174, NRG 0274) (#335)