Assessment of combination treatment with gemcitabine, cisplatin, and methylprednisolone (Gem-P) in the management of non-Hodgkin T-cell lymphoma.

Abstract

8052 Background: T-cell lymphoma is rare and generally confers a poorer prognosis compared to B-cell lymphoma but traditionally receive CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone). We investigated the feasibility of a gemcitabine-based regimen. Methods: Between 2000 to 2009, 29 consecutive patients who received Gem-P were identified through our clinical database. Treatment regimen: gemcitabine 1,000 mg/m2 D1, 8, 15 with cisplatin 100 mg/m2 D15 and methylprednisolone 1,000 mg D1-5 of each 28-day cycle. Cisplatin was substituted with oxaliplatin in patients with tinnitus or carboplatin where there was impaired renal function. Two patients also received combination rituximab. Assessment endpoint was response rate. Results: Median age at presentation was 53 years (range 17–72). M:F = 17:12. Stage I 5/29 (17%), stage II 2/29 (7%), stage III 10/29 (35%), stage IV 12/29 (41%). Subtypes included angioimmunoblastic (10), anaplastic large cell (6) [ALK-1 -ve (5), ALK-1 +ve (1)], peripheral T-cell not otherwise specified (6), NK/T-cell (3), adult T-cell leukemia/ lymphoma (2), mycosis fungoides (1), and enteropathy type (1). Patients received between one to six cycles of treatment. Average number of cycles received was 2.2. Overall radiological responses (complete response [CR] and partial response [PR]) were found in 21/29 patients (73%; 95% CI: 53-87%). Objective response rate in first line therapy was 80%. 10/11 of the patients who attained CR had stage III or IV disease. In addition, three patients achieved repeat objective response (1CR, 2PR) when rechallenged at relapse after 6 months or more. Overall grade 3/4 neutropenia and thrombocytopenia rates were 41.4% and 55.2% respectively. Conclusions: Gem-P achieved response both as initial treatment or salvage therapy after multiple line relapse. Prospective randomized trials will be needed to confirm its benefit in this distinct subgroup. Response n= 29 Overall (%) First line Second line Third line Fifth-sixth line CR 11/29 (38) 4/10 (40) 4/9 (45) 2/8 (24) 1/2 (50) PR 10/29 (35) 4/10 (40) 2/9 (22) 3/8 (38) 1/2 (50) Stable 1/29 (3) — 1/9 (11) — — Progressive 7/29 (24) 2/10 (20) 2/9 (22) 3/8 (38) — Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche