Prolonged infusion of low-dose gemcitabine and cisplatin (GC) proved to be an effective treatment for patients with advanced bladder cancer. One hundred and twenty untreated patients with stage III/IV bladder cancer were randomized to receive either gemcitabine (250 mg/m(2)) 6-h infusion on days 1 and 8, and cisplatin (70 mg/m(2)) on day 2 every 21-day cycle (arm 1) or gemcitabine (1,250 mg/m(2)) 30-min infusion on days 1 and 8, with the same dose of cisplatin (arm 2). The 92 males and 28 females included in the study had a median age of 62 years (range 40-85 years). Among the 120 patient, complete response was achieved in 11.7 % (7/60 patients of arm 1) and 5 % (3/60 patients of arm 2). Eighteen patients in arm 1 (30 %) and 17 patients (28.3 %) in arm 2 had partial response on therapy. Thus, the overall response rate of patients in arm 1 and arm 2 was 41.7 % (25/60 patients) and 33.3 % (20/60 patients), respectively (p = 0.37). No significant difference in median time to disease progression (26 vs. 24 months, p = 0.4), median survival (12 vs. 16 months, p = 0.8), and 1-year survival (49.9 vs. 54.7 %, p = 0.8) was detected between arms 1 and 2, respectively. Main toxicities were similar in both arms with no statistically significant differences. Low-dose, prolonged infusion gemcitabine in combination with cisplatin is not inferior to the standard GC regimen with favorable toxicity profile and less financial costs.
Background and aim Axillary lymph node metastasis is the most important prognostic factors in breast carcinoma. The metastatic burden can be determined either by the number of lymph nodes with metastases (pN) or by the metastatic ratio (LNR), which is the ratio of positive nodes to the total nodes removed. The aim of the present investigation was to quantify the anatomic distribution of axillary lymph nodes by levels as well as to compare the metastatic burden of breast cancer at different nodal levels. A hypothetical model of incomplete lymphadenectomy was tested to determine the risk of such operations if performed in Egyptian patients.
Patients and methods This study included 110 patients.In all operations, axillary dissection was complete including the three levels of nodes. The total series (110 patients) was used to study the anatomic distribution of axillary nodes at different levels as well as to study the rate of metastases at different levels. However, cases with positive nodes (56 patients) were used to determine the metastatic burden.
ResultsThe total number of lymph nodes removed in the 110 cases was 2463 nodes. There were 1196 (48.6%) nodes at level I, 919 (37.3%) at level II, and 348 (14.1%) at level III (P < 0.001). The rate of lymph node metastases was 50.9%. The rates of node metastases at axillary levels I, II, and III were 50.9, 34.5, and 20%, respectively. The median number of metastatic lymph nodes in node-positive cases was 4, whereas the median numbers per level were 3, 4, and 3, respectively. The median lymph node ratio (LNR) for positive patients was 0.18, whereas the median LNRs per level were 0.3, 0.5, and 1, respectively (P < 0.001). Most of the node-positive patients (55.4%), according to LNR, were considered to be at low risk (r 0.2), whereas 28.6% were at an intermediate risk (0.2-0.65) and 16% were at a high risk (> 0.65%).Conclusion It can be concluded from this study that Egyptian patients with operable breast cancer present at a late stage (63.6% of tumors are >T1 and 50.9% have positive nodes). Anatomically, axillary nodes are commonly located (85.9%) at levels I and II and most metastases (86.8%) affect these two levels. However, level III is also involved in metastases in 20% of patients, hence the importance of a complete axillary lymphadenectomy in Egyptian patients.
4537 Background: Bladder carcinoma is still one of the foremost oncologic problems in Egypt. In previous single-arm and double-arm phase II studies, prolonged infusion of low dose gemcitabine and cisplatin proved to be an effective treatment for such patients with advanced disease. Methods: To compare efficacy and safety of both prolonged infusion and standard gemcitabine-cisplatin combination, we updated the data and duplicated the number of patients of our previously published phase II randomized study to 120 untreated patients with stage III/IV bladder cancer. Patients were randomized to receive either gemcitabine (250 mg/m2) 6-hour infusion on days 1 and 8, and cisplatin (70 mg/ m2) on day 2 every 21-day cycle (Arm1) or gemcitabine (1,250 mg/ m2) 30-min infusion on days 1 and 8, and cisplatin (70 mg/ m2) on day 2 every 21-day cycle (Arm 2). Results: The 92 males and 28 females had a median age of 62 years (range 40-85 years). A total of 87 patients had transitional cell, 28 had squamous cell, and 5 had undifferentiated cell carcinoma. Among the 105 evaluable patients (52patients in arm1 and 53patients in arm 2), complete response rate was achieved in 13.5% (7/52 patients of arm 1) and 5.7% (3/53 patients of arm 2). Eighteen patients in arm 1 (34.6%) and 17 patients (32.1%) in arm 2 had partial response on therapy. Thus the overall response rate of patients in arm1 and arm 2 was 48% (25/52 patients) and 37.7% (20/53patients), respectively (p = 0.26). No significant difference in median time to disease progression (26 months versus 24 months, p =0.4), median survival (12 months versus 16 months, p =0.8), and 1-year survival (49.9 % versus 54.7%, p = 0.8) was detected between arms 1 and 2, respectively. No treatment- related deaths occurred. Main hematologic and nonhematologic toxicities were similar in both arms with no statistically significant differences. Conclusions: In the treatment of advanced bladder cancer, gemcitabine in low dose and prolonged infusion in combination with cisplatin is not inferior to high-dose short infusion gemcitabine and cisplatin in terms of overall survival, time to disease progression, and response rates with favorable toxicity profile and less financial costs.
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