ABSTRACT
High dose therapy [HDT] with autologous stem-cell transplantation is the treatment of choice for patients with relapsed lymphoma, but is not appropriate for all patients. Effective and less toxic alternatives to conventional salvage regimens are needed. To determine efficacy and safety of gemcitabine, cisplatin and dexamethasone in patients with relapsed or refractory B-cell lymphoma who are not candidates for high dose therapy. Thirty patients with relapsed or refractory B-cell lymphoma were treated with gemcitabine 1000mg/m[2] intravenously [iv] on days 1 and 8, cisplatin 75mg/m[2] iv on day 1, and dexamethasone 40mg/m[2] orally on days 1-4, every 21 days on an outpatient, for a maximum of 6 cycles. The majority [66.7%] had diffuse large B-cell lymphoma. All 30 patients were evaluable for response and toxicity, Five patients [16.7%] achieved complete remission and 12 patients [40%] had partial remission of their disease with an overall response rate of 56.7%. The 2-year progression-free and overall survival rates were 20% and 33.3% respectively. Myelosuppression was the main toxicity. Grade 3 and 4 neutropenia occurred in 40% and 26.7% respectively. Grade 3 and 4 thrombocytopenia occurred in 30% and 23.3% respectively. Only one patient had neutropenic sepsis. Grade 3 non hematological toxicity was minimal with no patients suffered from grade 4 toxicity. Gemcitabine in combination with cisplatin and dexamethasone is an effective and well tolerated salvage regimen in patients with relapsed or refractory B-cell lymphoma who are not eligible for HDT
Subject(s)
Humans , Male , Female , Recurrence , Cisplatin/toxicity , Dexamethasone , Treatment Outcome , Follow-Up Studies , Survival Rate , Deoxycytidine/analogs & derivativesABSTRACT
To compare the efficacy and safety of paclitaxel plus carboplatin versus carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma. Forty patients with platinum-sensitive ovarian carcinoma relapsing after 6 months of being treatment-free and with no more than two previous chemo-therapy lines were enrolled in this trial. Twenty one patients were randomized to receive carboplatin [300 mg/m[2] and 19 to receive the same dose of carboplatin plus paclitaxel [175mg/m[2] The primary outcome measure was objective response. Secondary outcomes were progression-free survival [PFS], overall survival [OS] and toxicity. The response rate in the combination arm was 79% [26% complete response [CR] and 53% partial response [PR]] compared with 48% in the carboplatin arm [19% CR and 29 PRI [p=0.041]. Median PFS was higher in paclitaxel carboplatin arm [12 versus 8 months]. Median OS was also better in the combination arm [24 versus 18 months]. However, these differences were not statistically significant [p=0.23 and 0.35 respectively]. No significant differences were observed in grade 3-4 hematological toxicity. Conversely, alopecia, mucositis, myalgia/arthralgia and sensory neuropathy were more frequent in the combination arm and the differences were statistically significant [p=0.0009, 0.027, 0.001, and 0.027 respectively]. Paclitaxel plus carboplatin is a tolerable regimen. It seems to be more effective among patients with platinum-sensitive recurrent ovarian carcinoma compared with single-agent carboplatin