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

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. A single-arm, open-label, phase 2 study conducted at 1 7 investigative sites in Egypt. Treatment consisted of gemcitabine [1250 mg/m[2]] on Days 1 and 8 and cisplatin [70 mg/m[2]] on Day 1 of each 21-day cycle. Treatment continued until disease progression or a maximum of 6 cycles. 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. 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

Diagnosis of pneumocystis jiroveci [carinii] pneumonia- PCP- in children with haematological malignancies

Giemsa stain and PCR [single and nested PCR; which amplified a portion of the mitochondrial large-subunit rRNA gene of Pneumocystis jiroveci] were compared to a direct immunofluorescence assay [IFA] for the detection of Pneumocystis jiroveci in immuno-compromised patients with haematological malignancies, suspected of having P. jiroveci pneumonia. A total of 50 specimens [3 bronchoalveolar lavages [BAL], 16 sputum samples and 31 nasopharyngeal aspirate samples] were obtained from patients treated in the Paediatric Oncology Unit of Kasr El-Aini Oncology Centre, Faculty of Medicine, and Cairo University from hematological malignancies and refractory neutropenic fever with persistent fever on 2 consecutive antibio-therapy. Direct immunofluorescence [the gold standard] could detect 4 positive cases. Giemsa stain could only detect one positive case, being 25% sensitive and 100% specific. Single PCR could detect 3 positive cases, being 75% sensitive and 100% specific. Nested PCR could detect 36 positive cases, being 100% sensitive and 19.2% specific. We conclude that whenever possible, BAL samples should be obtained, for the diagnosis of P. jiroveci pneumonia [PJP]. Diagnosis of PJP should best be performed by IF or single PCR, especially if non-invasive samples are used. Nested PCR is recommended for detection of P. jiroveci in all immunosuppressed asymptomatic patients to identify a group of patients at high risk of developing PJP in the future, for whom proper chemoprophylaxis against P. jiroveci may he beneficial

Metronomic oral etoposide in metastatic pediatric solid tumors

Etoposide has shown activity against most pediatric solid tumors and has been an integral part in many of the pediatric oncology protocols. The administration of a low dose metronomic etoposide has an anti-angiogenic effect as well as mild toxicity. The aim of this study is to asses the activity and toxicity of oral etoposide as a palliative chemotherapy after failure of all active lines of treatment in pediatric solid tumors Eighteen children suffering from various metastatic pediatric solid tumors and relapsing after two or three lines of chemotherapy were include and evaluated in the study. Females were 10, males were 8. Avarage age was 9 years [range 4-15 years]. Six patients were suffering from Ewing sarcoma, 5 from Neuroblastoma, 4 from Rhabdomyosarcoma and 3 from retinoblastoma Oral etoposide was given at dose of 50 mg/m2 for 14 consecutive days followed by one week rest. The cycles were repeated at day 21 and continued till progression or unacceptable toxicity. No complete response was seen with the protocol, partial response was seen in 3 patients [17%]. Stable disease was seen in 6 patients [33%]. Disease progression was seen in 9 patients [50%]. Mean time to disease progression was 4.5 months [SD +/- 2]. One year survival was 17%. Longest time to disease progression was 12 months and was achieved in a patient with Rhabdomyosarcoma. Observed toxicity with the protocol was mild, Grade III - IV neutropenia was 4%, neutropenic fever was 1% and thrombocytopenia was 3%. Five patients needed platelet transfusion and 8 needed packed RBCs transfusion. Metronomic oral etoposide provides a good option for palliation of pediatric solid tumors after failure of active chemotherapy lines. It is an outpatient protocol which provides good disease control with moderate toxicity levels

Comparison of different methods to diagnose pneumocystis jiroveci pneumonia in children with haematological malignancies

Giemsa stain and PCR [single and nested PCR] were compared to a direct immunofluorescence assay [IFA] for the detection of Pneumocystis jiroveci in immuno-compromised patients with haematological malignancies, suspected of having P. jiroveci pneumonia. A total of 50 specimens [3 bronchoalveolar lavages [BAL], 16 sputum samples and 31 nasopharyngeal aspirate samples] were obtained from the Paediatric Oncology Unit of Kasr El-Aini Oncology Centre, Faculty of Medicine, Cairo University. Direct immunofluorescence [the gold standard] could detect 4 positive cases. Giemsa stain could only detect one positive case, being 25% sensitive and 100% specific. Single PCR could detect 3 positive cases, being 75% sensitive and 100% specific. Nested PCR could detect 36 positive cases, being 100% sensitive and 19.2% specific. We conclude that whenever possible, BAL samples should be obtained, for the diagnosis of P. jiroveci pneumonia [PJP]. Diagnosis of PJP should best be performed by IF or single PCR, especially if non-invasive samples are used. Nested PCR is recommended for detection of P. jiroveci in all immunosuppressed asymptomatic patients to identify a group of patients at high risk of developing PJP in the future, for whom proper chemoprophylaxis against P. jiroveci may be beneficial