Table 3.

Adverse events attributed to cisplatin, gemcitabine, and/or bortezomib (any cycle)

SchemaTwice-weekly bortezomib 0.7 mg/m2 (n = 3)Twice-weekly bortezomib 1.0 mg/m2 (n = 12)Weekly bortezomib 1.0 mg/m2 (n = 12)Weekly bortezomib 1.3 mg/m2 (n = 7)
Toxicity grade1-2341-2341-2341-234
Constitutional
    Asthenia67%33%33%67%67%33%71%29%
    Flu-like syndrome67%50%50%29%
    Hot flush33%42%8%43%
Hematologic
    Anemia100%92%8%92%8%72%14%14%
    Neutropenia33%67%8%33%25%8%50%8%43%57%
    Trombocytopenia100%42%33%25%25%50%17%29%14%57%
Digestive
    Nausea100%92%8%75%100%
    Taste alteration100%83%83%71%
    Anorexia100%83%75%57%14%
    Vomiting100%42%33%50%8%86%
    Constipation67%92%83%57%
    Diarrhea33%67%42%57%14%
    Stomatitis33%25%25%14%
    Heart burn33%33%25%14%
    Dry mouth25%43%
Nervous system
    Sensory neuropathy67%75%50%57%
    Tinnitus67%67%67%86%
    Headache33%33%8%33%43%
    Orthostasis/dizziness33%50%17%29%
Skin and appendages
    Alopecia33%50%67%57%
    Rash33%50%58%29%
    Injection site reaction58%25%29%
    Dry skin33%25%8%14%
Respiratory system
    Cough33%33%67%43%
    Dyspnea33%17%33%25%
    Infection67%33%25%8%29%
    Epistaxis33%8%43%
    Hiccoughs8%25%14%
Ocular/visual
    Conjunctivitis67%42%17%14%
    Blurred vision33%42%8%14%
Fluid homeostasis
    Edema (except facial)67%42%67%57%
    Periorbital edema33%58%25%43%14%
Pain
    Pain abdomen33%33%33%29%
    Myalgia33%8%29%
    Skeletal pain25%29%
Nutritional/metabolic
    Weight loss67%58%67%57%
    Elevated ALT/AST67%58%42%29%14%
  • NOTE: Events reported by 15% or more of patients, considered possibly, probably, or certainly related to cisplatin, gemcitabine, and/or bortezomib by the treating physician and the investigator are presented. Several episodes in the same patient are counted as one adverse event and only the worst grade is mentioned.

    Abbreviations: ALT, alaninine aminotransferase; AST, aspartate aminotransferase.