Corazzelli Gaetano, Capobianco Gaetana, Arcamone Manuela, Ballerini Pier Ferruccio, Iannitto Emilio, Russo Filippo, Frigeri Ferdinando, Becchimanzi Cristina, Marcacci Gianpaolo, De Chiara Annarosaria, Pinto Antonio
Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione G Pascale, IRCCS, Naples, Italy.
Cancer Chemother Pharmacol. 2009 Oct;64(5):907-16. doi: 10.1007/s00280-009-0941-9. Epub 2009 Feb 15.
To determine the efficacy and safety of the combination of gemcitabine plus oxaliplatin, with and without rituximab, in patients with relapsed/refractory B-cell lymphoma unsuitable for high dose therapy.
Patients were prospectively enrolled in two subsequent trials, GEMOX [gemcitabine (1200 mg/m(2), days 1 and 8) and oxaliplatin (120 mg/m(2), day 2), three-weekly] and R-GEMOX [rituximab (375 mg/m(2), day 1), gemcitabine (1200 mg/m(2), day 1) and oxaliplatin (120 mg/m(2), day 2), bi-weekly], up to six courses.
Sixty-two patients were enrolled: GEMOX [n = 30; median age, 66 years (range, 46-85); previous chemotherapy > or =2, 70%; PS ECOG > or = 2, 57%]; R-GEMOX [n = 32; median age, 65 years (range 32-79); previous chemotherapy > or =2, 75%; PS ECOG > or = 2, 47%]. Overall and complete response rates were 57 and 30% (95% CI, 15-49) for GEMOX and 78 and 50% (95% CI, 32-68) in R-GEMOX, respectively. Grade 3/4 neutropenia occurred in 57 and 47% of cycles and grade 3/4 thrombocytopenia in 26 and 17% of courses for GEMOX and R-GEMOX, respectively. At 42 months, the failure-free survival (FFS) was 7% (95% CI, 0-16) for GEMOX and 28% (95% CI, 9-47) for R-GEMOX (P = 0.014), with overall survivals of 7 (95% CI, 0-16) and 37% (95% CI, 20-55), respectively (P = 0.016).
Both regimes showed good tolerability and appealing response rates. FFS was more prolonged in R-GEMOX, but patients continuously relapsed without a clear plateau on survival curves.
确定吉西他滨联合奥沙利铂（联合或不联合利妥昔单抗）用于不适于高剂量治疗的复发/难治性B细胞淋巴瘤患者的疗效和安全性。
患者前瞻性纳入两项后续试验，即GEMOX方案[吉西他滨（1200mg/m²，第1天和第8天）和奥沙利铂（120mg/m²，第2天），每三周一次]和R - GEMOX方案[利妥昔单抗（375mg/m²，第1天）、吉西他滨（1200mg/m²，第1天）和奥沙利铂（120mg/m²，第2天），每两周一次]，最多六个疗程。
共纳入62例患者：GEMOX组[n = 30；中位年龄66岁（范围46 - 85岁）；既往化疗≥2次，70%；东部肿瘤协作组（ECOG）体能状态评分≥2分，57%]；R - GEMOX组[n = 32；中位年龄65岁（范围32 - 79岁）；既往化疗≥2次，75%；ECOG体能状态评分≥2分，47%]。GEMOX组的总缓解率和完全缓解率分别为57%和30%（95%可信区间，15 - 49），R - GEMOX组分别为78%和50%（95%可信区间，32 - 68）。GEMOX组和R - GEMOX组3/4级中性粒细胞减少分别发生在57%和47%的周期中，3/4级血小板减少分别发生在26%和17%的疗程中。在42个月时，GEMOX组的无进展生存期（FFS）为7%（95%可信区间，0 - 16），R - GEMOX组为28%（95%可信区间，9 - 47）（P = 0.014），总生存率分别为7%（95%可信区间，0 - 16）和37%（95%可信区间，20 - 55）（P = 0.016）。
两种方案均显示出良好的耐受性和可观的缓解率。R - GEMOX组的FFS延长，但患者持续复发，生存曲线无明显平台期。
