Oral capecitabine in combination with gemcitabine in management of advanced pancreatic carcinoma

Preclinical studies indicate positive biochemical and synergistic effects between capecitabine, an oral fluorouracil, and gemcitabine, the standard treatment for advanced pancreatic cancer [APC]. The goals of this study were to investigate the efficacy and safety of such combination for patients with APC. Twenty-two eligible patients with APC were treated with oral capecitabine and gemcitabine [CapGem regimen]. Capecitabine was given in a dose of 750 mg/m2 BID daily from day 1 to day 14 followed by one-week rest. Gemcitabine was given on day 1 and day 8 in a dose of 1000 mg/m2/dose given as i.v. infusion in 250 ml normal saline for 30 minutes of each 3-week cycle. Tumor lesions were assessed for objective response by physical examination and abdominal CT every two cycles of chemotherapy. Adverse events were monitored continuously during treatment and for one month after the last dose of the study. Estimation of survival was done every two months alter completion of chemotherapy cycles. The results revealed that among the 22 studied patients, two patients achieved complete clinical response [9.1%] and five patients [22.7%] achieved partial response with overall objective response rate 31.8% [95% CI, 0.21 to 0.39]. The median response duration of all responders was 31 weeks [95% CI, 18 to 39 weeks]. CA-19-9 was dropped >50% in eight patients and dropped >90% in five patients. The median time to disease progression in all 22 patients was 32 weeks [95% CI, 21 to 40 weeks]. The median survival for the whole studied group was 36 weeks [95% CI, 27 to 48 weeks]. Treatment was generally well tolerated in the outpatient settings. In conclusion, capecitabine in combination with gemcitabine was well tolerated regimen with apparent efficacy in patients with APC. Therefore, the supra-additive antitumor effect of such combination regimen of CapGem plus the advantage of oral administration of capecitabine merits this protocol promising

therapeutic outcome of multimodality approach in management of locally advanced, stage III and IVa invasive thymoma

Background: surgery is the treatment of choice for malignant thymoma whenever a complete resection can be accomplished. For locally advanced [LA] and unresectable stage III and IVa thymoma, the therapeutic outcome has been poor

Purpose: to assess tumor response, respectability, event-free survival and, overall survival of multimodality approach in therapy of LA stage III and IVa malignant invasive thymoma

Patients and Methods: fourteen patients [7 males and 7 females] with histologically confirmed invasive thymoma were treated. The median age was 48 years [range: 24-64 years]. Six patients [42.9%] were in clinical stage III disease and, 8 patients [57.1%] had stage IVa disease. The most common histological type was lymphoepithelial [57.1%]. The treatment protocol consisted of 3 courses of induction cisplatin-based chemotherapy [PAC with corticostreoids: cisplatin: 50 mg/m[2] IV DI, doxorubicin: 50 mg/m[2] IV DI, cyclophosphamide: 50 mg/m2 IV DI and, prednisolone: 60 mg/m[2] PO D1-5], then surgery followed by postoperative radiotherapy and completion consolidation chemotherapy; another 3 courses of PAC plus corticosteroids

Results: fourteen patients were enrolled and assessed for response. After induction chemotherapy, complete response encountered in four patients [28.6%], partial response in 7 patients [50%], stable disease in 1 patient [7.1%] and progressive disease in 2 patients [14.3%]. Ten patients [71.4%] performed surgical resection: total resection in 8 patients [57.1%] and, subtotal in 2 patients [14.3%]. 1 refused surgery, 1 patient died with stable disease [7.1%], and 2 patients [lied with progressive disease [14.3%]. At the end of the study and after a median follow-up of 18 months. 11 patients were alive [78.6 %] and 9 patients are event-free [64.3%]. The 3-year calculated actuarial overall and event-free survival of studied patients was 71.3% and 57.1% respectively

Conclusion: Combined treatment approach in management of LA and unresectable invasive thymema is encouraging and demonstrated high objective overall response rates with increased respectability rate and, improvement of overall survival. Preoperative induction chemotherapy followed by surgical resection, postoperative radiotherapy and consolidation chemotherapy may become the standard treatment of LA and unresectable invasive thymoma

Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin and cisplatin in locally advanced or metastatic bladder cancer

This trial was undertaken to compare gemcitabine plus cisplatin [GC] versus methotrexate, vinblastine, doxoruhicin and cisplatin [MVAC] in patients with locally advanced or metastatic transitional cell carcinoma [TCC] of the bladder. A total of 46 patients with locally advanced [n=21] or metastatic [n=25] TCC of the bladder and with no prior systemic chemotherapy were included in this study. They were randomized to GC [gemcitabine 1000 mg/m2 days 1, 8 and 15, cisplatin 70 mg/m2 day 2] or standard MVAC [methotrexate 30 mg/m2 on days 2, 15, 22, doxorubicin 30 mg/m2 on day 2 and cisplatin 70 mg/m2 on day 2]. The cycles were repeated every 28 days for a maximum of six cycles. It was found that gemcitabine/cisplatin combination is an active and safe treatment option in advanced and metastatic bladder cancer. It is a real alternative to MVAC with the same clinical benefits and significantly improving safety and tolerability

Activity and safety of navelbine and fractionated dose doxorubicin as first line therapy for advanced breast cancer

Very promising results have been obtained by vinorelbine-doxorubicin combination in the treatment of advanced breast cancer. However previous experience with schedules in which the doxorubicin dose was administered on day 1 alone were associated with a high level of cardiac toxicity. There is evidence that fractionating the dose of doxorubicin and administering it at weekly intervals may reduce the cardiac toxicity without substantially impairing the efficacy. To asses the efficacy and tolerability of vinorelbine and fractionated dose doxorubicin [the total dose was divided into two administrations on days 1 and 8] in patients with advanced breast cancer. Fifty-two patients with locally advanced or metastatic breast cancer who had received no prior chemotherapy except in an adjuvant setting were entered into the study. They were treated vinorelbine 25 mg/m[2] plus doxorubicin 25 mg/m[2] both administered in day 1 and 8 every three weeks. Objective responses were observed in 30 patients [71, 4%]. There were 7 [16.6%] complete responses [CR] and 23 [54.8%] partial responses [PR]. In addition 10 patients [23.8%] had stable disease [SD] and 2 [4.8%] progressed while on treatment. Twenty of 28 patients with visceral disease responded to treatment [71.4%]. The median duration of response was 11.5 months [range, 2 to > 24+] and the median overall survival was 21.5 months [range 2 to > 36+]. Hematological toxicity was predominantly related to neutropenia with Grade 3-4 reported in 18.1% of the cycles. Alopecia was reported in 66.7% of the patients. Grade 3 nausea/vomiting in 3.6% of the cycles. No clinically significant cases of cardiac dysfunction were seen. The fractionated schedule of vinorelbine and doxorubicin is associated with excellent tolerability [especially cardiac], coupled with high levels of activity comparable to those observed using the un-fractionated regimen