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

Abstract

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\xa0 /= 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. 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 . Characteristic Value Adjuvant chemo not started/ assigned: N (%) Univariable OR (95% CI) Univariable p-value Multivariable OR (95% CI) Multivariable p-value Age >/= 60 24/70 (34%) 81 / 393 (21%) 2.01 (1.2-3.5) 0.01 2.30 (1.10-4.81) 0.026 Race Other White/Caucasian 43/127 (34%) 62/336 (18%) 2.26 (1.4–3.6) 0.0005 2.11 (1.13-3.96) 0.019 Nodes involved Yes No/unknown 42/225 (19%) 63/238 (26%) 0.64 (0.4–0.99) 0.046 0.75 (0.42-1.35) 0.34 QLQ-C30 Physical Function Worst 33.37% Best 66.67% 5/11 (45%) 59/310 (19%) 3.55 (1.05–12.0) 0.04 3.66 (1.03-13) 0.045 Chemoradiation Not completed Completed 46/114 (40%) 59/349 (17%) 3.33 (2.01–5.3) 3.21 (1.75-5.88) 0.0002