Prophylactic pyridoxine was not able to reduce the incidence of capecitabine-induced hand‑foot syndrome: A meta‑analysis

Zhou,Yun; Peng,Ling; Li,Yingjie; Chen,Lixun

doi:10.3892/br.2013.161

Prophylactic pyridoxine was not able to reduce the incidence of capecitabine-induced hand‑foot syndrome: A meta‑analysis

Authors:
- Yun Zhou
- Ling Peng
- Yingjie Li
- Lixun Chen
View Affiliations

Affiliations: Zhejiang Food and Drug Administration, Hangzhou, Zhejiang 310003, P.R. China, Department of Thoracic Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, P.R. China
Published online on: August 28, 2013 https://doi.org/10.3892/br.2013.161
Pages: 873-878

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

Hand‑foot syndrome (HFS) is a dose‑limiting adverse event of capecitabine, which commonly leads to early discontinuation of capecitabine‑based therapy in the palliative and adjuvant settings. Although pyridoxine has been used for the prevention of capecitabine‑associated HFS, its efficacy is controversial. The aim of this study was to evaluate whether prophylactic pyridoxine reduces the incidence of capecitabine‑associated HFS by performing a meta‑analysis of the literature involving available studies. Systematic searches for trials were undertaken through PubMed, Embase, Web of Science, the Cochrane Library, the American Society of Clinical Oncology (ASCO) and the ASCO Gastrointestinal Cancers Symposium, updated to March, 2013, to identify relevant studies. A meta‑analysis was conducted with eligible studies that evaluated the efficacy of the prophylactic use of pyridoxine against capecitabine‑induced HFS. We performed a meta‑analysis of five studies (n=793 patients) that evaluated the efficacy of the prophylactic use of pyridoxine in cancer patients treated with capecitabine. The odds ratio (OR) comparing prophylactic pyridoxine to placebo was 0.91 [95% confidence interval (CI): 0.67‑1.24] for HFS of all grades; OR=1.17 (95% CI: 0.82‑1.67) for HFS ≥ grade 2 and OR=1.05 (95% CI: 0.60‑1.85) for HFS ≥ grade 3. Based on our meta‑analysis, prophylactic pyridoxine did not appear to reduce the incidence of HFS in patients receiving capecitabine.

View Figures

View References

1	Van Cutsem E, Twelves C, Cassidy J, et al: Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol. 19:4097–4106. 2001.
2	Blum JL, Dieras V, Lo Russo PM, et al: Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 92:1759–1768. 2001. View Article : Google Scholar : PubMed/NCBI
3	Twelves C, Wong A, Nowacki MP, et al: Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 352:2696–2704. 2005. View Article : Google Scholar : PubMed/NCBI
4	Bang YJ: Capecitabine in gastric cancer. Expert Rev Anticancer Ther. 11:1791–1806. 2011. View Article : Google Scholar : PubMed/NCBI
5	Scheithauer W and Blum J: Coming to grips with hand-foot syndrome. Insights from clinical trials evaluating capecitabine. Oncology (Williston Park). 18:1161–1168; discussion 1173–1176. 1181–1184. 2004.PubMed/NCBI
6	Nagore E, Insa A and Sanmartin O: Antineoplastic therapy-induced palmar plantar erythrodysesthesia (‘hand-foot’) syndrome. Incidence, recognition and management. Am J Clin Dermatol. 1:225–234. 2000.
7	Gressett SM, Stanford BL and Hardwicke F: Management of hand-foot syndrome induced by capecitabine. J Oncol Pharm Pract. 12:131–141. 2006. View Article : Google Scholar : PubMed/NCBI
8	Chiara S, Nobile MT, Barzacchi C, et al: Hand-foot syndrome induced by high-dose, short-term, continuous 5-fluorouracil infusion. Eur J Cancer. 33:967–969. 1997. View Article : Google Scholar : PubMed/NCBI
9	Vukelja SJ, Lombardo FA, James WD and Weiss RB: Pyridoxine for the palmar-plantar erythrodysesthesia syndrome. Ann Intern Med. 111:688–689. 1989. View Article : Google Scholar : PubMed/NCBI
10	Fabian CJ, Molina R, Slavik M, Dahlberg S, Giri S and Stephens R: Pyridoxine therapy for palmar-plantar erythrodysesthesia associated with continuous 5-fluorouracil infusion. Invest New Drugs. 8:57–63. 1990. View Article : Google Scholar : PubMed/NCBI
11	DerSimonian R and Laird N: Meta-analysis in clinical trials. Control Clin Trials. 7:177–188. 1986. View Article : Google Scholar : PubMed/NCBI
12	Yusuf S, Peto R, Lewis J, Collins R and Sleight P: Beta blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis. 27:335–371. 1985. View Article : Google Scholar : PubMed/NCBI
13	Egger M, Davey Smith G, Schneider M and Minder C: Bias in meta-analysis detected by a simple, graphical test. BMJ. 315:629–634. 1997. View Article : Google Scholar : PubMed/NCBI
14	Macaskill P, Walter SD and Irwig L: A comparison of methods to detect publication bias in meta-analysis. Stat Med. 20:641–654. 2001. View Article : Google Scholar : PubMed/NCBI
15	Mortimer JE, Lauman MK, Tan B, Dempsey CL, Shillington AC and Hutchins KS: Pyridoxine treatment and prevention of hand-and-foot syndrome in patients receiving capecitabine. J Oncol Pharm Pract. 9:161–166. 2003. View Article : Google Scholar
16	Corrie PG, Bulusu R, Wilson CB, et al: A randomised study evaluating the use of pyridoxine to avoid capecitabine dose modifications. Br J Cancer. 107:585–587. 2012. View Article : Google Scholar : PubMed/NCBI
17	Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 92:205–216. 2000. View Article : Google Scholar
18	Lokich JJ and Moore C: Chemotherapy-associated palmar-plantar erythrodysesthesia syndrome. Ann Intern Med. 101:798–799. 1984. View Article : Google Scholar : PubMed/NCBI
19	Banfield GK, Crate ID and Griffiths CL: Long-term sequelae of palmar-plantar erythrodysaesthesia syndrome secondary to 5-fluorouracil therapy. J R Soc Med. 88:356P–357P. 1995.PubMed/NCBI
20	Zimmerman GC, Keeling JH, Burris HA, et al: Acute cutaneous reactions to docetaxel, a new chemotherapeutic agent. Arch Dermatol. 131:202–206. 1995. View Article : Google Scholar : PubMed/NCBI
21	Gordon KB, Tajuddin A, Guitart J, Kuzel TM, Eramo LR and VonRoenn J: Hand-foot syndrome associated with liposome-encapsulated doxorubicin therapy. Cancer. 75:2169–2173. 1995. View Article : Google Scholar : PubMed/NCBI
22	Abushullaih S, Saad ED, Munsell M and Hoff PM: Incidence and severity of hand-foot syndrome in colorectal cancer patients treated with capecitabine: a single-institution experience. Cancer Invest. 20:3–10. 2002. View Article : Google Scholar : PubMed/NCBI
23	Lin E, Morris JS and Ayers GD: Effect of celecoxib on capecitabine-induced hand-foot syndrome and antitumor activity. Oncology (Williston Park). 16:31–37. 2002.PubMed/NCBI
24	Lopez AM, Wallace L, Dorr RT, Koff M, Hersh EM and Alberts DS: Topical DMSO treatment for pegylated liposomal doxorubicin-induced palmar-plantar erythrodysesthesia. Cancer Chemother Pharmacol. 44:303–306. 1999. View Article : Google Scholar : PubMed/NCBI
25	Andres R, Mayordomo JI, Lara R, et al: Gemcitabine/capecitabine in patients with metastatic breast cancer pretreated with anthracyclines and taxanes. Clin Breast Cancer. 6:158–162. 2005. View Article : Google Scholar : PubMed/NCBI
26	Chalermchai T, Tantiphlachiva K, Suwanrusme H, Voravud N and Sriuranpong V: Randomized trial of two different doses of pyridoxine in the prevention of capecitabine-associated palmar-plantar erythrodysesthesia. Asia Pac J Clin Oncol. 6:155–160. 2010. View Article : Google Scholar : PubMed/NCBI
27	Rossi D and Catalano G: Pyridoxine as prophylactic therapy for palmar-plantar erythrodysesthesia associated with administration of pegylated liposomal doxorubicin (caelyx): a single-center experience. Oncology. 73:277–278. 2007. View Article : Google Scholar
28	Stewart LA and Parmar MK: Meta-analysis of the literature or of individual patient data: is there a difference? Lancet. 341:418–422. 1993. View Article : Google Scholar : PubMed/NCBI
29	Begg CB and Mazumdar M: Operating characteristics of a rank correlation test for publication bias. Biometrics. 50:1088–1101. 1994. View Article : Google Scholar : PubMed/NCBI
30	Yoshimoto N, Yamashita T, Fujita T, et al: Impact of prophylactic pyridoxine on occurrence of hand-foot syndrome in patients receiving capecitabine for advanced or metastatic breast cancer. Breast Cancer. 17:298–302. 2010. View Article : Google Scholar : PubMed/NCBI
31	Kang YK, Lee SS, Yoon DH, et al: Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: results of a randomized, double-blind, placebo-controlled study. J Clin Oncol. 28:3824–3829. 2010. View Article : Google Scholar : PubMed/NCBI
32	Braik T, Yim B, Evans AT, et al: A randomized trial to determine if vitamin B6 can prevent hand and foot syndrome in cancer patients treated with capecitabine chemotherapy. J Clin Oncol. 30(Suppl): abstr 9085. 2012.