1923 - Disparities starting adjuvant chemotherapy for locally advanced cervix cancer in the international, academic, randomised, phase 3 OUTBACK trial (ANZGOG 0902, RTOG 1174, NRG 0274)

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