title: Higher rate of skin rash in a phase II trial with weekly nanoparticle albumin-bound paclitaxel and cisplatin combination in Chinese breast cancer patients.
abstract: BACKGROUND
  The aim of this sub-study is to explore the incidence of skin rash among advanced breast cancer(ABC) patients in a phase II trial treated with weekly nab-paclitaxel and cisplatin combination.
  
  
  METHODS
  Nab-paclitaxel(125 mg/m2) was administered on days 1, 8, 15, followed by cisplatin(75 mg/m2) on day 1 every 28 day cycle until disease progression, intolerable toxicities or the maximum of 6 cycles. Patients who received at least one injection of the study drug were included in this analysis of the incidence of skin rash among Chinese patients. Toxicity was graded using the CTCAE4.0 criteria. Statistical analysis was carried out by using SPSS 16.0 (SPSS Inc, Chicago, IL).
  
  
  RESULTS
  Seventy three patients were enrolled and eligible for analysis. A total of 384 cycles were administered at the time of this analysis. Rash was presented in 27 patients (37.0%). The most common sites involved were face (14/27), neck (14/27), limbs (18/27) and frictional parts of the trunk (10/27). Macular and papular rash with pruritus commonly occurred 2 (95% CI: 1-7) days after the first day of chemotherapy. Only one patient developed Grade 3 skin toxicity with generalized erythroderma and disfigurement of the face requiring dose reduction. The rash gradually regressed 2 (95% CI: 1-10) days after antihistamines used, but pigmentation remained in 13/27 cases. The incidence rate of skin rash was significantly higher than what has been described for western patients (approximate 4%, P < 0.0001).
  
  
  CONCLUSIONS
  A higher rate of maculo-papular rash occurred in Chinese breast cancer patients treated with weekly nab-paclitaxel compared to western patients. The albumin component of nab-paclitaxel might be the cause of the skin disorder.
  
  
  BACKGROUND
  NCT01149798.
authors: Li Chen
authors: LC
authors: Tang
authors: Bi Yun
authors: BY
authors: Wang
authors: Si
authors: S
authors: Sun
authors: Jian
authors: J
authors: Zhang
authors: Zhen
authors: Z
authors: Jia
authors: Yun Hua
authors: YH
authors: Lu
authors: Geng Hong
authors: GH
authors: Di
authors: Zhi Ming
authors: ZM
authors: Shao
authors: Xi Chun
authors: XC
authors: Hu
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D005076:Exanthema / Q000139:chemically induced* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D017239:Paclitaxel; D002945:Cisplatin
references: Eur J Cancer. 2009 Jan;45(2):228-47
references: 19097774
references: J Clin Oncol. 1995 Oct;13(10):2575-81
references: 7595709
references: J Thorac Oncol. 2008 May;3(5):521-6
references: 18449006
references: Crit Rev Ther Drug Carrier Syst. 1993;10(4):307-77
references: 8124728
references: Womens Health (Lond). 2010 Jul;6(4):495-506
references: 20597612
references: J Clin Oncol. 2005 Nov 1;23(31):7794-803
references: 16172456
references: J Interferon Cytokine Res. 1997 Jul;17 Suppl 1:S29-33
references: 9241613
references: J Clin Oncol. 2005 Sep 1;23(25):6019-26
references: 16135470
references: J Interferon Cytokine Res. 1997 Jul;17 Suppl 1:S15-21
references: 9241611
references: Clin Breast Cancer. 2001 Oct;2(3):190-208; discussion 209
references: 11899413
references: Oncologist. 2005;10 Suppl 3:20-9
references: 16368868
references: CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300
references: 20610543
references: J Clin Oncol. 2009 Aug 1;27(22):3611-9
references: 19470941
references: J Clin Oncol. 2008 Apr 1;26(10):1642-9
references: 18375893
references: Clin Ther. 2009 Aug;31(8):1619-40
references: 19808124
references: Onco Targets Ther. 2011;4:123-36
references: 21792318
references: Nephrol Dial Transplant. 2005 Jun;20 Suppl 6:vi3-9
references: 15958824
references: Breast Cancer Res Treat. 2006 Nov;100(2):229-35
references: 16932852
references: Cancer Res. 1999 Apr 1;59(7):1454-7
references: 10197613
references: Hematol Oncol Clin North Am. 2007 Apr;21(2):257-72
references: 17512448
references: Cancer Treat Rev. 2004 Feb;30(1):53-81
references: 14766126