Sex and gender differences in treatment intention, quality of life and performance status in the first 100 patients with periampullary cancer enrolled in the CHAMP study

Abstract

Background Periampullary cancer is a term for cancers arising in or in close proximity to the pancreas. Pancreatic cancer is the 3rd leading cause of cancer death for both sexes and while surgery is the only option for cure, chemotherapy is given in both the adjuvant and palliative settings. The aim of this study was to investigate any sex and gender differences in patients with pancreatic and other periampullary adenocarcinomas enrolled in a prospective, observational trial. Methods The study cohort consists of the first 100 patients, 49 women and 51 men, enrolled in the Chemotherapy, Host Response and Molecular dynamics in Periampullary cancer (CHAMP) study, an ongoing study of patients undergoing neoadjuvant, adjuvant or first-line palliative chemotherapy treatment. Twenty-five patients had surgery with curative intent and subsequent adjuvant treatment, and 75 patients were treated with palliative chemotherapy. Data regarding health-related quality of life (HRQoL, EORTC-QLQ-C30) at baseline, demographic and clinicopathological factors were examined and stratification by treatment intention according to sex. Overall survival (OS) was calculated through Kaplan–Meier analysis. Results There was a statistically significant difference between male and female patients treated with curative intent, with fewer women having undergone surgery (18 vs 7, p = 0.017), also after adjustment for age, tumor location and performance status. No statistical differences were found between the sexes regarding age, comorbidities, or clinicopathological factors. Before start of chemotherapy treatment, health-related quality of life (HRQoL) was lower in female than in male patients. However, HRQoL was not associated with performance status in female patients, whereas in male patients several HRQoL indicators were significantly positively associated with poorer performance status at baseline. Conclusions This study shows no clear differences between the sexes regarding biological factors concluding that gender bias might be responsible for the discrepancy between men and women being offered curative surgery. The observed difference between women and men regarding the association between HRQoL and performance status is unprecedented. Altogether these findings underline the importance of taking gender into consideration when assessing eligibility for curative surgery in order to improve biological outcome and decrease suffering in both sexes. Trial registration NCT03724994.

Trajectories of immune-related serum proteins and quality of life in patients with pancreatic and other periampullary cancer: the CHAMP study

“…This study includes 75 patients with completed EORCT-QLQ-30 questionnaires at baseline, as previously described [ 24 ]. Of these patients, 41 had completed questionnaires at three months and 23 at six months.…”

“…All patients treated with curative intent ( n = 18) had their tumours resected prior to receiving adjuvant chemotherapy. Patient and tumour characteristics have been detailed in a previous study [ 24 ]. Among adjuvant treated patients, 8(44%) received gemcitabine-capecitabine, 5(28%) received gemcitabine, 1(6%) received nab-paclitaxel, and 4(22%) received oxaliplatin.…”

“…The Chemotherapy, Host response And Molecular dynamics in Periampullary cancer (CHAMP) study is an ongoing prospective, single-arm observational study (Clinicaltrials.gov identifier NCT03724994) [ 23 , 24 ]. All patients with a diagnosis of pancreatic or other periampullary adenocarcinoma undergoing neoadjuvant, adjuvant or palliative first line chemotherapy treatment at the Department of Oncology, Skåne University Hospital, are invited to participate in the study.…”

“…Univariable and multivariable Cox regression was calculated using the function coxph from the R package survival and applied for analysis of OS in relation to the investigated parameters, using continuous scores for serum proteins and HRQoL scores and log 2 transformed values for routine parameters [ 37 ]. The multivariable analyses included adjustment for performance status and treatment intention, and sex was also included in the analyses related to HRQoL factors, given the previously shown differences between women and men [ 24 ]. The significance level was set to 0.1% for the Cox regression analysis.…”