Disparities starting adjuvant chemotherapy for locally advanced cervix cancer in the international, academic, randomised, phase 3 OUTBACK trial (AN...

Date 29 September 2019
Event ESMO 2019 Congress
Session Poster Display session 2
Topics Cervical Cancer
Presenter Linda Mileshkin
Citation Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250
Authors L.R. Mileshkin1, E. Barnes2, K.N. Moore3, V. Gebski2, M. King4, K. Narayan5, I.K. Kolodziej2, K. Sjoquist2, A. Fyles6, W. Small7, D. Gaffney8, M. Quinn9, J. Andrews10, S. Thompson3, W. Huh11, M. Carlson12, P.A. Disilvestro13, D. Rischin1, M.R. Stockler14, B.J. Monk15
  • 1Department Of Medical Oncology, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 2Nhmrc Clinical Trials Centre, University of Sydney, Sydney/AU
  • 3Stephenson Cancer Centre, University of Oaklahoma Health Sciences Center, Oaklahoma/US
  • 4Faculty Of Science, School Of Psychology, Quality Of Life Office, University of Sydney, Sydney/AU
  • 5Department Of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 6Department Of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto/CA
  • 7Department Of Radiation Oncology, Stritch School of Medicine, Loyala University Chicago Director, Cardinal Bernardin Cancer Center, Chicago/US
  • 8Department Of Radiation Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City/US
  • 9Department Of Surgery, Peter MacCallum Cancer Centre, Melbourne/AU
  • 10Clinical Trials, Australia New Zealand Gynaecological Oncology Group, Sydney/AU
  • 11Department Of Obstetrics And Gynecology, University Of Alabama at Birmingham, Birmingham/US
  • 12Department Of Obstetrics And Gynecology, University of Texas Southwestern Medical Center, Dallas/US
  • 13Department Of Obstetrics And Gynecology, Women and Infants Rhode Island, Providence/US
  • 14Nhmrc Clinical Trials Centre, University of Sydney, 2050 - Sydney/AU
  • 15Division Of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospitla, Phoenix/US

Abstract

Background

OUTBACK is testing the addition of 4 cycles of adjuvant carboplatin/paclitaxel chemotherapy (chemo) after definitive chemoradiation in locally advanced cervix cancer. We aimed to determine characteristics associated with not starting randomly assigned adjuvant chemo.

Methods

We assessed associations between not starting assigned adjuvant chemo and baseline characteristics of: age; race; country; smoking status; ECOG; BMI; FIGO stage; node involvement; and participants’ self-rated physical, role, emotional, cognitive, social functional status, and financial difficulties (by EORTC QLQ-C30). We also assessed for associations with completion of chemoradiation and grade 3-4 toxicities during chemoradiation. Odds ratios (OR), 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 non-Caucasian women, and those aged >/= 60, even after accounting for other factors.

Conclusions

Adjuvant chemo was less likely to be started in non-Caucasian women, those aged >/= 60, and those with poor self-rated physical function. Further research is required to understand the causes, implications, and methods for mitigating these disparities.

Clinical trial identification

ACTRN12610000732088.

Editorial acknowledgement

Legal entity responsible for the study

University of Sydney.

Funding

National Health and Medical Research Council. In addition, Hospira provided paclitaxel treatment for Australian and New Zealand patients in the study.

Disclosure

L. Mileshkin: Research grant / Funding (self), Provided supply of Paclitaxel for trial patients in Australia and New Zealand: Hospira; Travel / Accommodation / Expenses: Beigene; Travel / Accommodation / Expenses: Roche. K.N. Moore: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Clovis; Advisory / Consultancy, Research grant / Funding (institution): Immunogen; Advisory / Consultancy, Research grant / Funding (institution): Tesaro; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Research grant / Funding (self): Merck; Advisory / Consultancy: Aravive; Advisory / Consultancy, Research grant / Funding (institution): OncoMed; Advisory / Consultancy: Samumed; Advisory / Consultancy: Eisai; Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy: Janssen; Advisory / Consultancy: Cue; Research grant / Funding (self): Lilly; Research grant / Funding (self): PTC Therapeutics; Research grant / Funding (institution): Regeneron; Research grant / Funding (institution): Agenus. K. Sjoquist: Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Servier; Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Ipsen; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Astellas; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Bionomics; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Tilray. W. Small: Honoraria (self), Travel / Accommodation / Expenses: Zeiss; Advisory / Consultancy: Merck. S. Thompson: Honoraria (self): Mevion Medical Systems. W. Huh: Honoraria (self): Antiva; Advisory / Consultancy: Inovio. P.A. Disilvestro: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Tesaro; Research grant / Funding (institution): Immunogen; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Syros; Research grant / Funding (institution): Janssen. D. Rischin: Advisory / Consultancy, Research grant / Funding (institution), Uncompensated: MSD; Advisory / Consultancy, Research grant / Funding (institution), Uncompensated: Regeneron; Advisory / Consultancy, Research grant / Funding (institution), Uncompensated: GSK; Advisory / Consultancy, Research grant / Funding (institution), Uncompensated: BMS; Research grant / Funding (institution): Roche. M.R. Stockler: Research grant / Funding (institution): Astellas; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Bionomics; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Tilray. B.J. Monk: Advisory / Consultancy: AbbVie; Advisory / Consultancy: Advaxis; Advisory / Consultancy: Agenus; Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: ChemoCare; Advisory / Consultancy: ChemoID; Honoraria (self), Advisory / Consultancy: Clovis; Advisory / Consultancy: Conjupro; Advisory / Consultancy: Esaias; Advisory / Consultancy: Geistlich; Advisory / Consultancy: Genmab; Advisory / Consultancy: Immunogen; Advisory / Consultancy: Immunomedics; Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy: Janssen/Johnson & Johnson; Advisory / Consultancy: Merck; Advisory / Consultancy: Myriad; Honoraria (self), Advisory / Consultancy: Roche/Genentech; Honoraria (self), Advisory / Consultancy: Tesaro. All other authors have declared no conflicts of interest.Table: 1052P

CharacteristicValueAdjuvant chemo not started/ assigned: N (%)Univariable OR (95% CI)Univariable p-valueMultivariable OR (95% CI)Multivariable p-value
Age>/= 60 < 6024/70 (34%) 81 / 393 (21%)2.01 (1.2-3.5)0.012.30 (1.10-4.81)0.026
RaceOther White/Caucasian43/127 (34%) 62/336 (18%)2.26 (1.4–3.6)0.00052.11 (1.13-3.96)0.019
Nodes involvedYes No/unknown42/225 (19%) 63/238 (26%)0.64 (0.4–0.99)0.0460.75 (0.42-1.35)0.34
QLQ-C30 Physical FunctionWorst 33.37% Best 66.67%5/11 (45%) 59/310 (19%)3.55 (1.05–12.0)0.043.66 (1.03-13)0.045
ChemoradiationNot completed Completed46/114 (40%) 59/349 (17%)3.33 (2.01–5.3)<0.00013.21 (1.75-5.88)0.0002