A phase 2 study of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines with/without taxanes.

BACKGROUND AND OBJECTIVES: Many patients with relapsed metastatic breast cancer are pre-treated with taxanes and anthracyclines, which are usually given in the neoadjuvant/adjuvant setting or as first-line treatment for metastatic disease. The primary objective of this study was to determine the overall response rate for combination treatment with gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who had relapsed after receiving one adjuvant/neoadjuvant or first-line metastatic chemotherapy regimen containing an anthracycline with/without a taxane. Secondary endpoints included duration of response, time to progression, one-year survival probability, and toxicity. DESIGN AND SETTING: A single-arm, open-label, phase 2 study conducted at 17 investigative sites in Egypt. PATIENTS AND METHODS: treatment consisted of gemcitabine (1250 mg/m2) on Days 1 and 8 and cisplatin (70 mg/m2) on Day 1 of each 21-day cycle. Treatment continued until disease progression or a maximum of 6 cycles. RESULTS: Of 144 patients all were evaluable for safety and 132 patients were evaluable for efficacy. The overall response rate was 33.3% and 45.5% of the patients with stable disease as their best response. The median time-to-progression was 5.1 months and the one-year survival probability was 73%. The most common grade 3/4 adverse events were nausea/vomiting (20.1%), neutropenia (19.4%), anemia (13.9%), asthenia (11.1%), diarrhea (9.7%), stomatitis (7.6%), leucopenia (7.6%), and thrombocytopenia (6.2%). twelve (8.3%) patients had serious adverse events. CONCLUSIONS: The results of this study indicate that gemcitabine and cisplatin were active and generally well tolerated in pretreated patients with locally advanced or metastatic breast cancer.

[A case of pulmonary plasma cell granuloma with a cavity].

Plasma cell granuloma of the lung is an uncommon and non-malignant neoplasm that may present difficulties in both diagnosis and management. We report a 52-year-old male who was admitted to our hospital due to fever and an abnormal shadow on chest roentgenography. Chest computed tomography revealed a tumor shadow with a cavity in the left upper lobe. However, neither bronchofiberscopy nor serum examinations suggested a diagnosis. Video-assisted thoracoscopic surgery (VATS) was performed and postoperative pathological examination of the resected specimen showed plasma cell granuloma. The postoperative course was uneventful. No recurrence was observed 10 months after the operation. As plasma cell granuloma of the lung is histologically benign, surgery should be performed to preserve the maximal residual lung with no lesion. VATS is the method of choice for treatment of pulmonary plasma cell granuloma.

Semiquantitative evaluation for diagnosis of Helicobacter pylori infection in relation to histological changes.

OBJECTIVES: Several methods are used to detect Helicobacter pylori (HP) infection. However, few reports have evaluated the accuracy of each method and compared the grade of HP infection with the severity of histological changes. HP infection was evaluated semiquantitatively in relation to the severity of gastritis, and the sensitivity, specificity, and accuracy of several methods to detect HP infection were compared. METHODS: Biopsy specimens, obtained from a total of 64 patients who underwent endoscopy for evaluation of gastroduodenal diseases, were studied using a rapid urease test, culture, and histological assessment. An immunohistochemical method was used as the gold standard and graded according to the number of individual bacteria seen, as follows: 0 = 0; 1+ = <10; 2+ = 10-29; 3+ = 30-99; 4+ = >100. The severity of gastritis was evaluated histologically in each specimen and compared with the grade of HP infection. RESULTS: The rapid urease test had a sensitivity of 53%, specificity of 100%, and accuracy of 73%. The culture method had a sensitivity of 75%, specificity of 100%, and accuracy of 86%. Sensitivities of the rapid urease test and the culture method decreased in a positive correlation with the decrease in total number of HP bacteria counted. Using the rapid urease test, sensitivity was <30% when the grade of HP infection was < or =2+, whereas 100% sensitivity was obtained when the grade of HP infection was 4+. On the other hand, sensitivity of the culture method remained between 80% and 90% when HP infection was > or =2+. The severity of gastritis determined with Rauws scores increased in a positive correlation with the grade of HP infection as evaluated by immunohistochemical stain. CONCLUSIONS: The rapid urease test and culture of HP may result in false-negative tests for a mild infection, although they had high sensitivity and specificity for moderate to severe infection. Immunohistochemical stain provides a reliable semiquantitative diagnosis of HP infection and a positive correlation with histological changes. Clinicians should be aware of the characteristics of each method to detect HP infection and select the appropriate one(s) for their purposes.

[Semi-quantitative detection of Helicobacter pylori using immunohistochemical staining].

Several methods have been used for the detection of Helicobacter pylori (HP) infection. However, few reports have evaluated the accuracy of each method and compared the level of HP infection. HP infection was evaluated semi-quantitatively using immunohistochemical staining and accuracy of several methods to detect HP infection were compared. Biopsy specimens, obtained from a total 64 patients who underwent endoscopy for evaluation of gastroduodenal diseases, were studied using a rapid urease test, culture method, and immunohistochemical method. The infection was graded according to the number of the individual bacteria seen in a highly magnified visual field, and defined as follows: (0) = 0; (1+) < 10; (2+) = 10-29; (3+) = 30-99, (4+) > 100. The rapid urease test had a sensitivity of 53%, specificity of 100%, and accuracy of 73%. The culture method had a sensitivity of 75%, specificity of 100%, and accuracy of 86%. Sensitivity of rapid urease test and the culture method decreased in a positive correlation to the decrease in total number of HP bacteria counted. Using the rapid urease test, sensitivity was < 30% when the grade of HP infection was (2+) or less, while 100% sensitivity was obtained only when the grade of HP infection was (4+). On the other hand, sensitivity of culture method, remained between 80 and 90% when HP infection was (2+) or more. The rapid urease test and culture of HP may result in false negative tests for mild infection although those have high sensitivity and specificity for moderate to severe infection. Immunohistochemical stain provides a reliable semi-quantitative diagnosis of HP infection. Clinicians should be aware of the characteristics of each method to detect HP infection, and select the appropriate ones for their purpose.