Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221
BACKGROUND: Prior 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.
METHODS: We 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.
RESULTS: Of 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).
CONCLUSIONS: Pretreatment 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.
| Errataetall: | |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
|---|---|
| Enthalten in: |
Journal of the National Comprehensive Cancer Network : JNCCN - 21(2023), 11 vom: 11. Nov., Seite 1172-1180.e3 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Chen, Ciao-Sin [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 09.11.2023 Date Revised 10.04.2024 published: Print ClinicalTrials.gov: NCT00070564 UpdateOf: Res Sq. 2023 Sep 01;:. - PMID 37693586 Citation Status MEDLINE |
|---|
| doi: |
10.6004/jnccn.2023.7062 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM364268735 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM364268735 | ||
| 003 | DE-627 | ||
| 005 | 20240410232253.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.6004/jnccn.2023.7062 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1371.xml |
| 035 | |a (DE-627)NLM364268735 | ||
| 035 | |a (NLM)37935109 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Chen, Ciao-Sin |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221 |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 09.11.2023 | ||
| 500 | |a Date Revised 10.04.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT00070564 | ||
| 500 | |a UpdateOf: Res Sq. 2023 Sep 01;:. - PMID 37693586 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Prior 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 | ||
| 520 | |a METHODS: We 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 | ||
| 520 | |a RESULTS: Of 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) | ||
| 520 | |a CONCLUSIONS: Pretreatment 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a chemotherapy-induced peripheral neuropathy | |
| 650 | 4 | |a paclitaxel | |
| 650 | 4 | |a predictive biomarker | |
| 650 | 4 | |a racial disparity | |
| 650 | 4 | |a vitamin D | |
| 650 | 7 | |a Paclitaxel |2 NLM | |
| 650 | 7 | |a P88XT4IS4D |2 NLM | |
| 650 | 7 | |a Vitamin D |2 NLM | |
| 650 | 7 | |a 1406-16-2 |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 700 | 1 | |a Zirpoli, Gary |e verfasserin |4 aut | |
| 700 | 1 | |a Barlow, William E |e verfasserin |4 aut | |
| 700 | 1 | |a Budd, G Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a McKiver, Bryan |e verfasserin |4 aut | |
| 700 | 1 | |a Pusztai, Lajos |e verfasserin |4 aut | |
| 700 | 1 | |a Hortobagyi, Gabriel N |e verfasserin |4 aut | |
| 700 | 1 | |a Albain, Kathy S |e verfasserin |4 aut | |
| 700 | 1 | |a Damaj, M Imad |e verfasserin |4 aut | |
| 700 | 1 | |a Godwin, Andrew K |e verfasserin |4 aut | |
| 700 | 1 | |a Thompson, Alastair |e verfasserin |4 aut | |
| 700 | 1 | |a Henry, N Lynn |e verfasserin |4 aut | |
| 700 | 1 | |a Ambrosone, Christine B |e verfasserin |4 aut | |
| 700 | 1 | |a Stringer, Kathleen A |e verfasserin |4 aut | |
| 700 | 1 | |a Hertz, Daniel L |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of the National Comprehensive Cancer Network : JNCCN |d 2003 |g 21(2023), 11 vom: 11. Nov., Seite 1172-1180.e3 |w (DE-627)NLM156397676 |x 1540-1413 |7 nnns |
| 773 | 1 | 8 | |g volume:21 |g year:2023 |g number:11 |g day:11 |g month:11 |g pages:1172-1180.e3 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.6004/jnccn.2023.7062 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 21 |j 2023 |e 11 |b 11 |c 11 |h 1172-1180.e3 | ||