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

Towards an Egyptian guideline from screening to treatment of hepatocellular carcinoma [part I]

These recommendations provide a data-supported and based-evidenced approach to the screening, diagnosis, staging and treatment of Egyptian patients with hepatocellular carcinoma [HCC] in which we tried to construct an Egyptian algorithm for our Egyptian HCC patients in terms of type and timing of surveillance, readily available diagnostic tools that suit our means and the proper and efficient timely treatment that suits our resources. They are based on the experience of the authors in the specified topic and the AASLD Policy on the Development and Use of Practice Guidelines. These recommendations suggest preferred approaches to screening [for early detection of cases with hepatic nodule and/or elevated AFP], diagnosis [for accurate diagnosis of HCC cases], staging [for detection of specific category of treatment according the patient's general condition] and treatment [selection of the most suitable treatment option for the patient after his proper evaluation]. In an attempt to characterize the quality of evidence supported recommendations, the Egyptian Guidelines requires a category to be assigned and reported with each recommendation [Table I]

Towards an Egyptian guideline from screening to treatment of hepatocelhilar carcinoma [part II]

These recommendations provide a data-supported and evidence based approach to the screening, diagnosis, staging and treatment of Egyptian patients with hepatocellular carcinoma [HCC] in which we tried to construct an Egyptian algorithm for our Egyptian HCC patients in terms of type and timing of surveillance, readily available diagnostic tools that suits our means and the proper and efficient timely treatment that suits our resources. They are based on the experience of the authors in the specified topic and the AASLD Policy on the Development and Use of Practice Guidelines. These recommendations suggest preferred approaches to screening [for early detection of cases with hepatic nodule and/or elevated AFP], diagnosis [for accurate diagnosis of HCC cases], staging [for detection of specific category of treatment according the patient's general condition] and treatment [selection of the most suitable treatment option for the patient after his proper evaluation]. In an attempt to characterize the quality of evidence supported recommendations, the Egyptian Guidelines requires a category to be assigned and reported with each recommendation [Table 1]

Long term results of conservative management in T1 and T2 breast cancer among 170 cases

This retrospective study included 170 patients with histologically proven early breast carcinoma [T1 and T2 /<4 cm]. All patients underwent a conservative surgical resection of the primary tumor and axillary dissection. Postoperative radiation therapy was given as whole breast irradiation to a total dose of 50 Gy over 5 weeks in 25 fractions, followed by a boost 16 Gy over 1 and 1/2 weeks in 8 fractions to the tumor bed. Among the whole group, only 122 patients received adjuvant chemotherapy. At the end of the study with a median follow up period of 60 months, treatment failure was documented in 70 patients. Isolated local recurrence was detected in 26 patients and regional recurrence was reported in only 4 patients. Distant dissemination was recorded in 40 patients. Univariate analysis revealed that age group, menopausal status and adjuvant chemotherapy were significant factors influencing the relapse rate [0.006, 0.006 and 0.032, respectively]. The overall actuarial 5- and 10-year survival rates for the whole group were 80% and 60%, respectively. The overall actuarial 5 and 10-year survivals for patients developing local recurrence were significantly higher than the survival of patients who developed regional or distant relapse denoting a successful salvage treatment. While, the 5- and 10-year distant metastasis free survival rates of the whole group were 64.5% and 49.2%, respectively. Cox regression multivariate analysis showed that the relapse site, adjuvant chemotherapy, age group and number of involved axillary lymph nodes were independent prognostic factors that significantly influenced the over survival. On the other hand, the relapse site and age group were the significant factors that affected the distant metastasis free survival

DHAP: a regimen for treatment of relapsing and/or refractory Hodgkin's disease single institutional experience NEMROCK 1998-2002

This prospective non-randomized study included 52 patients with relapsed and/or refractory Hodgkin's disease. They are treated with combination chemotherapy DHAP [dexamethasone 40 mg i.v. D1-4 cytarabine 2 g/m2 i.v. 12q day 2, cisplatin 100 mg/m2 i.v. as 24-hr continuous infusion day 1]. Patients with complete and partial response after three cycles continued for three more cycles of the same regimen, while those with progressive disease were shifted to palliative treatment either third line chemotherapy or radiation therapy. From the results obtained, it was concluded that conventional chemotherapy regimen DHAP could be considered effective for patients with late relapses, especially those with good prognostic factors. However, more randomized trials are needed

Hypofractionated versus conventional radiotherapy for inoperable locally advanced bladder cancer

This randomized study included sixty patients with inoperable advanced transitional cell carcinoma [TCC] of the urinary bladder. At a follow up period of 18 months [range 2-22 months], the overall actuarial survival rate for the conventional group was 40% versus 27% for the hypofractionated group, while, the disease-free survival was 30% versus 21%, respectively, with no statistically significant difference. Acute complications induced by radiation therapy were observed more frequently among patients treated with conventional radiation, 40% versus 29%, in the hypofractionated group. However, the late morbidity was more common in patients treated with hypofractionation, 22% versus 11%, for those treated with conventional irradiation. It was concluded that for patients with low survival prospectives and poor prognostic factors where palliation is the aim, hypofractionation remains a valuable treatment option, however, for long survivors with good prognostic factors, hypofractionation deserves further investigation with special attention to long terms late side effects