Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North central cancer treatment group study N05C5

Journal of Clinical Oncology

Volumn 28, Issue 35, 2010, Pages 5182-5187

  Wolf, Sherry L ^a   Qin, Rui ^a   Menon, Smitha P ^a   Rowland Jr , Kendrith M ^a   Thomas, Sachdev ^a   Delaune, Robert ^a   Christian, Diana ^a   Pajon Jr , Eduardo R ^a   Satele, Daniel V ^a   Berenberg, Jeffrey L ^a   Loprinzi, Charles L ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; HYPSO; KERATOLYTIC AGENT; LACTIC ACID; PLACEBO; UNCLASSIFIED DRUG; UREA;

ADULT; AGED; ARTICLE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; HAND FOOT SYNDROME; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; UNITED STATES;

ADMINISTRATION, TOPICAL; ANTIMETABOLITES, ANTINEOPLASTIC; DEOXYCYTIDINE; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; FLUOROURACIL; FOOT DERMATOSES; HAND DERMATOSES; HUMANS; KERATOLYTIC AGENTS; LACTIC ACID; MALE; MIDDLE AGED; NEOPLASMS; SYNDROME; UREA;

EID: 79951912347     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.31.1431     Document Type: Article

References (29)

1. Clark AS, Vahdat LT: Chemotherapy-induced palmar-plantar erythrodysesthesia syndrome: Etiology and emerging therapies. Support Cancer Ther 1:213-218, 2004
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 (Pubitemid 32952493)
3. Fumoleau P, Largillier R, Clippe C, et al: Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer 40:536-542, 2004 (Pubitemid 38220770)
4. Oshaughnessy JA, Blum J, Moiseyenko V, et al: Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 12:1247-1254, 2001 (Pubitemid 32994752)
5. Reichardt P, Von Minckwitz G, Thuss-Patience PC, et al: Multicenter phase II study of oral capecitabine (Xeloda('')) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 14:1227-1233, 2003 (Pubitemid 37039048)
6. Miller KD, Chap LI, Holmes FA, et al: Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 23:792-799, 2005 (Pubitemid 46224178)
7. Schmoll HJ, Cartwright T, Tabernero J, et al: Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: A planned safety analysis in 1,864 patients. J Clin Oncol 25:102-109, 2007 (Pubitemid 350003057)
8. Chin SF, Tchen N, Oza AM, et al: Use of "Bag Balm" as topical treatment of palmer-plantar erythrodysesthsia syndrome (PPES) in patients receiving selected chemotherapeutic agents. Proc Am Soc Clin Oncol 20:409a, 2001 (suppl; abstr 1632)
9. Lopez AM, Wallace L, Dorr RT, et al: Topical DMSO treatment for pegylated liposomal doxorubicin-induced palmar-plantar erythrodysesthesia. Cancer Chemother Pharmacol 44:303-306, 1999 (Pubitemid 29402199)
10. Nagore E, Insa A, Sanmartín O: Antineoplastic therapy-induced palmar plantar erythrodysesthesia ('hand-foot') syndrome: Incidence, recognition and management. Am J Clin Dermatol 1:225-234, 2000
11. Blum J, Jones S, Buzdar A, et al: Capecitabine (Xeloda) in 162 patients with paclitaxel-pretreated MBC: Updated results and analysis of dose modifications. Eur J Cancer 37, 2001 (abstr 693)
12. Cassidy J, Twelves C, Van Cutsem E, et al: First-line oral capecitabine therapy in metastatic colorectal cancer: A favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 13:566-575, 2002 (Pubitemid 34461140)
13. Pendharkar D, Goyal H, Batra Cancer Center: Novel and effective management of capecitabine induced hand foot syndrome. J Clin Oncol 22:751, 2004 (suppl; abstr 8105)
14. Ademola J, Frazier C, Kim SJ, et al: Clinical evaluation of 40% urea and 12% ammonium lactate in the treatment of xerosis. Am J Clin Dermatol 3:217-222, 2002 (Pubitemid 34533780)
15. Kneedler JA, Sky SS, Sexton LR: Understanding alpha-hydroxy acids. Dermatol Nurs 10:247-254, 1998
16. Van Scott EJ, Yu RJ: Control of keratinization with alpha-hydroxy acids and related compounds: I. Topical treatment of ichthyotic disorders. Arch Dermatol 110:586-590, 1974
17. Van Scott EJ, Yu RJ: Alpha hydroxy acids: Procedures for use in clinical practice. Cutis 43:222-228, 1989 (Pubitemid 19088743)
18. Milano G, Etienne-Grimaldi MC, Mari M, et al: Candidate mechanisms for capecitabine-related hand-foot syndrome. Br J Clin Pharmacol 66:88-95, 2008 (Pubitemid 351822156)
19. Tsuruta D, Mochida K, Hamada T, et al: Chemotherapy-induced acral erythema: Report of a case and immunohistochemical findings. Clin Exp Dermatol 25:386-388, 2000
20. Pocock SJ, Simon R: Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31:103-115, 1975
21. Lee S, Lee S, Chun Y, et al: Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study. J Clin Oncol 25:494s, 2007 (suppl; abstr 9007)
22. Sloan JA, Loprinzi CL, Novotny PJ, et al: Methodologic lessons learned from hot flash studies. J Clin Oncol 19:4280-4290, 2001 (Pubitemid 33096775)
23. Abushullaih S, Saad ED, Munsell M, et al: Incidence and severity of hand-foot syndrome in colorectal cancer patients treated with capecitabine: A single-institution experience. Cancer Invest 20:3-10, 2002 (Pubitemid 34151055)
24. Scheithauer W, Blum J: Coming to grips with hand-foot syndrome: Insights from clinical trials evaluating capecitabine. Oncology (Williston Park) 18:1161-1168, 2004; discussion 1173-1176, 1181-1184
25. Wood L, Lemont H, Jatoi A, et al: Practical considerations in the management of hand-foot skin reaction caused by multikinase inhibitors. Community Oncol 7:23-29, 2010
26. Tate L, Laferriere N, Lentini G, et al: 12414, A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation. Bayer HealthCare, AG, D-51368, Leverkusen, Germany, 2008
27. E2805, Phase III Randomized Study of Adjuvant Sunitinib Malate Versus Sorafenib in Patients With Resected Renal Cell Carcinoma. National Cancer Institute, 2006
28. Perez E: N063D/BIG 2-06, ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study - A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. GlaxoSmithKline, North Central Cancer Treatment Group (NCCTG), Breast International Group (BIG), 2008
29. 14387: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy. Bayer HealthCare AG, D-51368 Leverkusen, Germany, 2010