PMID- 22585689
OWN - NLM
STAT- MEDLINE
DCOM- 20120816
LR  - 20171116
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 30
IP  - 18
DP  - 2012 Jun 20
TI  - Intracutaneous and intravesical immunotherapy with keyhole limpet hemocyanin 
      compared with intravesical mitomycin in patients with non-muscle-invasive bladder 
      cancer: results from a prospective randomized phase III trial.
PG  - 2273-9
LID - 10.1200/JCO.2011.39.2936 [doi]
AB  - PURPOSE: Despite current treatment after transurethral resection of a bladder 
      tumor, recurrences and progression remain a problem. Keyhole limpet hemocyanin 
      (KLH) was beneficial in earlier studies. In this study, safety and efficacy of 
      KLH were compared with that of mitomycin (MM). PATIENTS AND METHODS: Patients 
      with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) 
      without carcinoma in situ were enrolled in a randomized phase III trial. In all, 
      283 patients were randomly assigned for 16 adjuvant intravesical instillations 
      with KLH after preimmunization, and 270 patients were randomly assigned for 11 
      adjuvant intravesical instillations with MM. Primary outcome measurement was 
      recurrence-free survival (RFS). Secondary outcome measurements were 
      progression-free survival, adverse events (AEs), and the effect of delayed-type 
      hypersensitivity (DTH) response on clinical outcome. RESULTS: There were 
      significantly more pT1 tumors in the MM group (P = .01). In a log-rank test, 
      univariate and multivariate Cox regression analysis, KLH was less effective than 
      MM regarding RFS (all P < .001). Progression was uncommon (n = 20). In univariate 
      Cox regression analyses, KLH tended to prevent progression more effectively than 
      MM, but in multivariate Cox regression analyses, this could not be shown. AEs 
      were common but mild. Fever, flu-like symptoms, and fatigue occurred 
      significantly more after KLH treatment. Allergic reactions and other skin 
      disorders occurred significantly more after MM treatment. Significantly more 
      DTH-positive patients developed a recurrence than DTH-negative patients. 
      CONCLUSION: KLH had a different safety profile and was inferior to MM in 
      preventing NMIBC recurrences. KLH tended to be more effective than MM in 
      preventing progression. More research is needed to clarify the immunologic 
      effects of KLH and the effects of KLH on progression.
FAU - Lammers, Rianne J M
AU  - Lammers RJ
AD  - CuraTrial Site Management Organisation & Research, Arnhem, The Netherlands.
FAU - Witjes, Wim P J
AU  - Witjes WP
FAU - Janzing-Pastors, Maria H D
AU  - Janzing-Pastors MH
FAU - Caris, Christien T M
AU  - Caris CT
FAU - Witjes, J Alfred
AU  - Witjes JA
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120514
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 50SG953SK6 (Mitomycin)
RN  - 9013-72-3 (Hemocyanins)
RN  - FV4Y0JO2CX (keyhole-limpet hemocyanin)
SB  - IM
CIN - J Urol. 2013 Feb;189(2):483-4. PMID: 23312153
MH  - Administration, Cutaneous
MH  - Administration, Intravesical
MH  - Aged
MH  - Disease-Free Survival
MH  - Female
MH  - Hemocyanins/*administration & dosage
MH  - Humans
MH  - Hypersensitivity, Delayed
MH  - Male
MH  - Mitomycin/*administration & dosage
MH  - Muscles/pathology
MH  - Recurrence
MH  - Urinary Bladder Neoplasms/*drug therapy
EDAT- 2012/05/16 06:00
MHDA- 2012/08/17 06:00
CRDT- 2012/05/16 06:00
PHST- 2012/05/16 06:00 [entrez]
PHST- 2012/05/16 06:00 [pubmed]
PHST- 2012/08/17 06:00 [medline]
AID - JCO.2011.39.2936 [pii]
AID - 10.1200/JCO.2011.39.2936 [doi]
PST - ppublish
SO  - J Clin Oncol. 2012 Jun 20;30(18):2273-9. doi: 10.1200/JCO.2011.39.2936. Epub 2012 
      May 14.