7/30/2023 0 Comments Gifox downloadEffective CD34+ cell mobilization was obtained in 4 out of 6 eligible patients and 2 already received ASCT. Among CRs no patient has relapsed at a median time of 5 months (range, 2+ − 10+). According to disease status, the ORR was 40% (1 CR, 1 PR) and 89% (6 CR, 2 PR) for primary refractory and relapsed patients, respectively. According to age, the ORR was 67% (4 CR, 2 PR) and 80% (3 CR, 1 PR) for patients aged ≤ 65 years and those older, respectively. The ORR assessed after three courses of R-GIFOX was 77%, with 7 complete responses (54% CR=5 CRu=2) and 3 partial CRu converted to CR at BM biopsy after 6 courses. CTCAE v3.0 G3/G4 thrombocytopenia was present in 26 % of courses, G3/G4 neutropenia in 22% febrile neutropenia and infections in 8% and 6% of cycles, respectively. Actual dose intensity of the first 3 courses was 81%, 83.5%, and 86.5% for G, Ifo and Ox, respectively. Forty-nine total courses were delivered (median 4, range 1–6) thirteen patients completed at least 3 courses of therapy and were evaluable for response. Results: Fourteen patients (median age 63 years, range 37–78 years) with relapsed (n = 9) or primary progressive (n = 5) aggressive, advanced (stage IV = 71%), poor risk (IPI 3–5 = 50% median number of previous therapy=2, r 1–4) NHL, were accrued. Responses were evaluated after three courses by the integrated FDG-PET/IWC criteria, and reassessed at the end of the entire program. Treatment was given every two weeks with G-CSF support (5 mcg/kg/day, dd 6–11 10 mcg/kg/day at the 3rd course for stem cells mobilization). R-GIFOX consisted of R (375 mg/m2, d 1), G (1000 mg/m2, d 2), Ox (130 mg/m2, d 3) and Ifo (5 g/m2, d 3), as a 24-hour single infusion in patients aged ≤ 65 years, or fractionated over 3 days (dd 3–5) in older patients. Therapy was delivered on a compassionate basis after written informed consent. Patients and methods: Patients were scheduled to receive three courses of therapy followed by mobilization and ASCT or three more courses if ineligible for ASCT. Based on the predicted clinical activity, tolerability and synergy among drugs, the R-GIFOX regimen may offer an effective and less toxic alternative to Cisplatin/ARA-C-based salvage regimens, also for patients aged or unfit for high-dose procedures. Objective: In this pilot study we evaluated the clinical activity, toxicity and mobilizing capacity of a new short-course (bi-weekly), dose intensive, cytoreductive/mobilizing salvage regimen (R-GIFOX) combining the cross-synergistic agents Gemcitabine (G), Ifosfamide (Ifo), Oxaliplatin (Ox) and Rituximab (R), in patients with relapsed and refractory CD20+ NHL.
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