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Advanced Colorectal Cancer survival is increased somewhat with 4,000 IU of vitamin D – RCT April 2019

Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival
Among Patients With Advanced or Metastatic Colorectal Cancer -The SUNSHINE Randomized Clinical Trial

JAMA. 2019;321(14):1370-1379. doi:10.1001/jama.2019.2402


Would have had far more benefit if they had done one or more of the following

  1. Started with a Vitamin D loading dose (e.g. 400,000 IU over a week)
  2. Had used a dose size of at least 4,000 IU of vitamin D
  3. Had used less frequent than daily dosing
  4. Had supplemented to increase the activation of the vitamin D Receptor - such as Resveratrol

Note: Even better if had high vitamin D years before, as Vitamin D PREVENTS colon cancer

Colon Cancer

see wikipage http://www.vitamindwiki.com/tiki-index.php?page_id=64
Overview of ColonCancer and vitamin D
derived from Grassroots 2013

Vitamin D Receptor and Cancers

Items in both categories Vitamin D Receptor and Cancer - Colon:

Items in both categories Vitamin D Receptor and  Cancer

 Download the PDF from VitaminDWiki

Fewer adverse effects if get Vitamin D

Key Points

  • Question Does high-dose vitamin D3 supplementation prolong progression-free survival when added to standard chemotherapy in patients with advanced or metastatic colorectal cancer?
  • Findings In this phase 2 randomized clinical trial that included 139 patients with advanced or metastatic colorectal cancer, treatment with chemotherapy plus high-dose vitamin D3 supplementation vs chemotherapy plus standard-dose vitamin D3 resulted in a median progression-free survival of 13 months vs 11 months, respectively, that was not statistically significant, but a multivariable hazard ratio of 0.64 for progression-free survival or death that was statistically significant.
  • Meaning These findings regarding a potential role for high-dose vitamin D3 supplementation in the treatment of patients with advanced or metastatic colorectal cancer warrant further evaluation in a larger multicenter randomized clinical trial.

Importance In observational studies, higher plasma 25-hydroxyvitamin D (25OHD) levels have been associated with improved survival in metastatic colorectal cancer (CRC).

Objective To determine if high-dose vitamin D3 added to standard chemotherapy improves outcomes in patients with metastatic CRC.

Design, Setting, and Participants Double-blind phase 2 randomized clinical trial of 139 patients with advanced or metastatic CRC conducted at 11 US academic and community cancer centers from March 2012 through November 2016 (database lock: September 2018).

Interventions mFOLFOX6 plus bevacizumab chemotherapy every 2 weeks and either high-dose vitamin D3 (n = 69) or standard-dose vitamin D3 (n = 70) daily until disease progression, intolerable toxicity, or withdrawal of consent.

Main Outcomes and Measures The primary end point was progression-free survival (PFS) assessed by the log-rank test and a supportive Cox proportional hazards model. Testing was 1-sided. Secondary end points included tumor objective response rate (ORR), overall survival (OS), and change in plasma 25(OH)D level.

Results Among 139 patients (mean age, 56 years; 60 [43%] women) who completed or discontinued chemotherapy and vitamin D3 (median follow-up, 22.9 months), the median PFS for high-dose vitamin D3 was 13.0 months (95% CI, 10.1 to 14.7; 49 PFS events) vs 11.0 months (95% CI, 9.5 to 14.0; 62 PFS events) for standard-dose vitamin D3 (log-rank P = .07); multivariable hazard ratio for PFS or death was 0.64 (1-sided 95% CI, 0 to 0.90; P = .02). There were no significant differences between high-dose and standard-dose vitamin D3 for tumor ORR (58% vs 63%, respectively; difference, −5% [95% CI, −20% to 100%], P = .27) or OS (median, 24.3 months vs 24.3 months; log-rank P = .43). The median 25(OH)D level at baseline for high-dose vitamin D3 was 16.1 ng/mL vs 18.7 ng/mL for standard-dose vitamin D3 (difference, −2.6 ng/mL [95% CI, −6.6 to 1.4], P = .30); at first restaging, 32.0 ng/mL vs 18.7 ng/mL (difference, 12.8 ng/mL [95% CI, 9.0 to 16.6], P < .001); at second restaging, 35.2 ng/mL vs 18.5 ng/mL (difference, 16.7 ng/mL [95% CI, 10.9 to 22.5], P < .001); and at treatment discontinuation, 34.8 ng/mL vs 18.7 ng/mL (difference, 16.2 ng/mL [95% CI, 9.9 to 22.4], P < .001). The most common grade 3 and higher adverse events for chemotherapy plus high-dose vs standard-dose vitamin D3 were neutropenia (n = 24 [35%] vs n = 21 31%, respectively) and hypertension (n = 9 [13%] vs n = 11 [16%]).

Conclusions and Relevance Among patients with metastatic CRC, addition of high-dose vitamin D3, vs standard-dose vitamin D3, to standard chemotherapy resulted in a difference in median PFS that was not statistically significant, but with a significantly improved supportive hazard ratio. These findings warrant further evaluation in a larger multicenter randomized clinical trial.

Created by admin. Last Modification: Wednesday April 10, 2019 10:15:40 GMT-0000 by admin. (Version 3)

Attached files

ID Name Comment Uploaded Size Downloads
11737 Adverse events.jpg admin 10 Apr, 2019 66.26 Kb 623
11736 Cancer 4,000 IU.jpg admin 10 Apr, 2019 26.46 Kb 537
11735 Advanced or Metastatic Colorectal Cancer.pdf admin 10 Apr, 2019 188.98 Kb 787