KEY TAKEAWAYS
- The NIFTY trial, a phase 2b multicenter, open-label, randomized study.
- No predictive or prognostic implication of serum vitamin D3 on overall survival (OS) was found in patients with advanced BTC treated with second-line chemotherapy.
- The study found no significant difference in the mean vitamin D3 concentration based on sex, BMI, previous surgery, ECOG performance status, and primary tumor site.
- After adjusting for key prognostic factors, including chemotherapy regimens, metastatic sites, or baseline CA 19-9 levels, no significant association was found between baseline serum vitamin D3 and OS.
- In the subgroup analysis, higher vitamin D3 levels were associated with poorer OS in female patients, but further larger studies are needed to confirm this finding.
No prospective cohort research on advanced biliary tract cancer (BTC) has been done, despite the expanding number of studies investigating the effect of vitamin D3 on various cancer types. Therefore, this study aimed to determine whether or not serum vitamin D3 levels were predictive or prognostic in patients with advanced BTC receiving second-line chemotherapy.
This study is a planned subgroup analysis of the NIFTY trial, a phase 2b randomized multicenter trial comparing second-line liposomal irinotecan plus 5-fluorouracil and leucovorin to second-line fluorouracil alone in patients with advanced breast or ovarian cancer. In the current analysis, 176 out of 178 pts in the ITT population had baseline (i.e., C1D1) serum vitamin D3 (25-hydroxyvitamin D [25(OH)D]) measurements taken. In addition, linear and non-linear correlations between osteoporosis and blood vitamin D3 were investigated.
Patients’ ages ranged from 37 to 84, with a median of 64. Among the 153 patients, 75 (42.6%) were female. Pts’ vitamin D3 levels at baseline varied from 1.39 ng/ml to 140.02 ng/ml. However, vitamin D3 levels did not differ significantly by gender (male vs. female, 24.1 vs. 26.7; p=0.43), BMI
(25 vs. 25-29.99 vs. 30, 24.0 vs. 30.0 vs. 15.9; p=0.18), history of surgery (no vs. yes, 24.1 vs. 27.4; p=0.40), ECOG performance status (0 vs. No significant correlation was seen between baseline blood vitamin D3 and OS (95% CI, 0.97-1.15; p=0.22) after adjusting for major prognostic variables such as chemotherapy regimens, metastatic locations, or baseline CA 19-9 levels.
Also, the vitamin D3-OS relationship was linear (p=0.52 for the linear model and p=0.62 for the model with restricted cubic splines) but not non-linear. In the subgroup analysis, there was a significant association between greater vitamin D3 levels and shorter OS in women
(HR=1.16 per 10 increase; 95% CI, 1.04-1.30; p=0.0072).Patients with advanced BTC treated with second-line chemotherapy showed no correlation between serum vitamin D3 levels and survival. Those who are female may fare worse if their vitamin D3 levels are high. There is a need for additional, larger-scale investigations.
Source:https://meetings.asco.org/abstracts-presentations/215589
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT03524508/
Lee, S.H., Cheon, J., Kim, I., Kim, K.-P., Ryoo, B.-Y., Jeong, J.H., Kang, M.J., Kang, B.W., Ryu, H., Lee, J.S. and Yoo, C. (2023). Serum vitamin D3 levels and overall survival (OS) in patients (pts) with advanced biliary tract cancer (BTC): Analysis of the NIFTY trial cohort.. Journal of Clinical Oncology, 41(4_suppl), pp.613–613. doi:https://doi.org/10.1200/jco.2023.41.4_suppl.613.
