Trial reportJournal of the National Comprehensive Cancer Network : JNCCN2023
Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221.
Trial report in Journal of the National Comprehensive Cancer Network : JNCCN, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00070564 (Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Pooled it
- Relationship between BMI and chemotherapy-induced peripheral neuropathy in cancer patients: a dose-response meta-analysis.World journal of surgical oncology · 2025Pooled it
- Limb Compression Therapy and Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Cancers: A Prospective Self-Controlled Study(NEURO-GLOVE Trial).International journal of cancer · 2026Trial
- Impact of vitamin D3 supplementation on motor functionality and the immune response in Parkinson's disease patients with vitamin D deficiency.Scientific reports · 2025Trial
- Pre-treatment amino acids and risk of paclitaxel-induced peripheral neuropathy in SWOG S0221.Cancer chemotherapy and pharmacology · 2024Trial
- Correlation of vitamin D and diabetic peripheral neuropathic pain: A cross-sectional study.The Journal of international medical research · 2026Article
- Article
- Risk Prediction Model for Taxane-Induced Peripheral Neuropathy in Early-Stage Cancer.JAMA network open · 2026Observational
- Chemotherapy-induced peripheral neuropathy in breast cancer: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026Review
- Chemotherapy-induced peripheral neuropathy in patients with breast cancer treated with taxanes (Review).Oncology letters · 2025Review
- Prehabilitation Prior to Chemotherapy in Humans: A Review of Current Evidence and Future Directions.Cancers · 2025Review
- Review of the contribution of clinical and genetic factors to the racial disparity in taxane-induced peripheral neuropathy.Critical reviews in oncology/hematology · 2025Review
- Tolerance for chemotherapy-induced peripheral neuropathy among women with metastatic breast cancer: a discrete-choice experiment.Breast cancer research and treatment · 2025Article
- Quantitation of Plasma Proteins to Predict Taxane-Induced Peripheral Neuropathy.JCO precision oncology · 2025Article
- Review
- The therapeutic potential of 1, 25-dihydroxy vitamin D3 on cisplatin-affected neurological functions is associated with the regulation of oxidative stress and inflammatory markers as well as levels of MMP2/9.Metabolic brain disease · 2024Article
- Integrative Approaches for Cancer Pain Management.Current oncology reports · 2024Review
- The correlation between vitamin D and the occurrence of peripheral neuropathy induced by paclitaxel chemotherapy.Frontiers in medicine · 2024Article
Corrections and comments
- Update of
Authors and funding
15 authors at 11 institutions in 1 country.
Funding
Abstract
backgroundPrior work suggests that patients with vitamin D insufficiency may have a higher risk of chemotherapy-induced peripheral neuropathy (CIPN) from paclitaxel. The objective of this study was to validate vitamin D insufficiency as a CIPN risk factor.
methodsWe used data and samples from the prospective phase III SWOG S0221 (ClinicalTrials.gov identifier: NCT00070564) trial that compared paclitaxel-containing chemotherapy regimens for early-stage breast cancer. We quantified pretreatment 25-hydroxy-vitamin D in banked serum samples using a liquid chromatography-tandem mass spectrometry targeted assay. We tested the association between vitamin D insufficiency (≤20 ng/mL) and grade ≥3 sensory CIPN via multiple logistic regression and then adjusted for self-reported race, age, body mass index, and paclitaxel schedule (randomization to weekly or every-2-week dosing). We also tested the direct effect of vitamin D deficiency on mechanical hypersensitivity in mice randomized to a regular or vitamin D-deficient diet.
resultsOf the 1,191 female patients in the analysis, 397 (33.3%) had pretreatment vitamin D insufficiency, and 195 (16.4%) developed grade ≥3 CIPN. Patients with vitamin D insufficiency had a higher incidence of grade ≥3 CIPN than those who had sufficient vitamin D (20.7% vs 14.2%; odds ratio [OR], 1.57; 95% CI, 1.14-2.15; P=.005). The association retained significance after adjusting for age and paclitaxel schedule (adjusted OR, 1.65; 95% CI, 1.18-2.30; P=.003) but not race (adjusted OR, 1.39; 95% CI, 0.98-1.97; P=.066). In the mouse experiments, the vitamin D-deficient diet caused mechanical hypersensitivity and sensitized mice to paclitaxel (both P<.05).
conclusionsPretreatment vitamin D insufficiency is the first validated potentially modifiable predictive biomarker of CIPN from paclitaxel. Prospective trials are needed to determine whether vitamin D supplementation prevents CIPN and improves treatment outcomes in patients with breast and other cancer types.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.