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  • 1
    ISSN: 1569-8041
    Keywords: clinical trials ; non-Hodgkin's lymphoma ; response criteria
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Oncologic literature cites many different definitionsof critical response measurements. Patients and methods:Response criteria (RC) for non-Hodgkin'slymphoma (NHL) were developed by lymphoma experts, endorsed by internationallymphoma clinicians, and applied to a 166-patient rituximab (Rituxan®,MabThera®) trial by a third-party, blinded panel of NHL experts (LEXCOR).Retrospectively, we analyzed this data using variations of the original RC andcomparing with recently published RC. Results:The definition of a ‘normal’ lymph node affected thecomplete response (CR) rate (≤1.0 × 1.0 cm, 6%; ≤1.5× 1.5 cm, 18%; ≤2.0 × 2.0 cm, 28%); overallresponse rate (ORR) was not affected. CR rates increased progressively without≥28 days response confirmation: 12% vs. 6% (≤1.0 ×1.0 cm), 26% vs. 18% (≤1.5 × 1.5 cm), and 36%vs. 28% (≤2.0 × 2.0 cm). CR rate and duration of response (DR)were unaffected when only the six largest, rather than all lesions, weremeasured. When the new RC were applied, CR rate (32%) was higher andDR (13.9 months) and time to progression (15.6 months) were shorter incomplete responders. Conclusions:Standard RC must be consistently and rigorouslyapplied for accurate comparisons between studies.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1569-8041
    Keywords: CHOPE ; infusional therapy ; non-Hodgkin's lymphoma ; refractory lymphoma ; relapsed lymphoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background:Patients with resistant diffuse aggressivenon-Hodgkin's lymphoma (DA-NHL) have a poor prognosis. Studies have suggestedinfusional therapy may be beneficial. Patients and methods:This trial used an infusional regimen calledI-CHOPE in resistant patients who had previously received only bolus CHOPE orCHOP regimen. Resistance was defined as: a) primary refractory disease, b)progression on therapy, c) partial response, d) complete remission lastingless than one year. Eligibility criteria included a diagnosis of DA-NHL (IWFE-H), no prior irradiation and adequate organ function. Results:Thirty-seven patients were entered and twenty-nine wereeligible. Reasons for ineligibility were incorrect histology (5) and other(3). The median age was 57 years (range 29–81) with 21 males. Theperformance status scores were: 0 (12 patients); 1 (9 patients); 2 (8patients). Prior therapy consisted of standard CHOP (26 patients), bolus CHOPE(2 patients), high dose CHOP (1 patient). Therapy consisted of a 120 hourcontinuous intravenous infusion of doxorubicin 10 mg/m2/day,vincristine 0.28 mg/m2/day (maximum 0.4 mg/day), and etoposide 48mg/m2/day. Cyclophosphamide 750 mg/m2 was given as aniv bolus day 6 and prednisone was given at 100 mg/day p.o. on days 1–5.G-CSF was allowed for myelosuppression. The overall response rate was48% (CR 17%; PR 31%). Freedom from progression was24% at six months and 8% at one year. Survival was 69%at six months and 40% at one year. In an exploratory analysis a priorCR or PR predicted response to I-CHOPE. Twelve of sixteen patients who had aCR/PR on previous therapy responded while two of thirteen who had no priorresponse, responded to I-CHOPE (P= 0.003). The toxicity wastolerable with grade 3–4 hematologic toxicity being leucopenia94% and thrombocytopenia 41%. The grade 3–4non-hematologic toxicities were infection in 28%, phlebitis in11%, and stomatitis in 15%. Conclusions:I-CHOPE can induce responses in this group ofpatients with a poor prognosis, but most were seen in those who had previouslyhad a response to bolus chemotherapy.
    Type of Medium: Electronic Resource
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