Randomized study of concurrent carboplatin, paclitaxel, and radiotherapy with or without prior induction chemotherapy in patients with locally advanced non-small cell lung cancer

Multiple concepts of combined modality therapy for locally advanced inoperable non-small cell lung cancer have been investigated. These include induction chemotherapy, concomitant chemo-radiotherapy, and radiation only. To date, combined modality therapy specially the use of concomitant chemo-radiotherapy has led to promising results and was shown to be superior to radiotherapy alone in phase II studies. However the optimum chemo-therapeutic regimen to be used as well as the benefit of induction chemotherapy before concomitant chemo-radiotherapy are yet to be determined. Based on these observations, we investigated the use of paclitaxel and carboplatin concomitantly with radiotherapy and the benefit of prior two cycles induction chemotherapy. In this trial 60 patients with locally advanced inoperable non small cell lung cancer, good performance status and minimal weight loss have been randomized into 3 groups each of 20 patients. Group A received induction 2 cycles paclitaxel [175 mg/m2] and carboplatin [AUC 6] on day 1 and 28th followed by concomitant paclitaxel [45 mg/m2] and carboplatin [AUC 2] weekly with radiotherapy. Group B received concomitant carboplatin, paclitaxel [same doses as in group A] and radiotherapy with no prior induction chemotherapy. Group C received only radiotherapy to a total dose of 60 Gy in conventional fractionation. A total of 60 patients were enrolled in this study between 1998 and 2000. Pretreatment characteristics, including age, gender, performance status, histological features and stage were comparable in each group. The incidence of oesophagitis was significantly higher in group A and B than in group C [p>0.023]. Hematological toxicities was also significantly higher in group A and B than in group C [p=0.003]. The response rate was significantly higher in group A and B than in group C [75%, 79%, and 40% respectively] [p=0.02]. The time to in-field progression was significantly higher in group B as compared to group A [48% vs. 32% failure in 2 years respectively] [p>0.001]. The median 2 year survival was significantly higher in group A and B than in group C [p=0.039] but no statistical difference was seen between group A and B. Combined chemo-radiotherapy resulted in better response and survival as compared to conventional radiotherapy in the treatment of locally advanced non-small cell lung cancer Early initiation of radiation with concomitant chemotherapy resulted in prolonged time to infield progression. On the other hand, two cycles of induction chemotherapy did not show any significant difference regarding the response or survival. Weekly paclitaxel and carboplatin plus radiotherapy is a well tolerated regimen for outpatients with encouraging results

role of gemcitabine and cisplatin as first line therapy in patients with advanced ovarian carcinoma

This study included 40 patients with histopathologically proved advanced stages III and IV ovarian carcinoma according to 1998 criteria of International Federation of Gynecology and Obstetrics [FIGO] staging system. Patients were divided into two groups: Group I: a prospectively studied group of 20 previously untreated patients, seen during the period from December 1999 to December 2000, who received cisplatin [100mg/m[2]] day I and gemcitabine [1250mg/m[2]] day and day 8 and the cycle was repeated every 21 days. Group II: a retrospectively 20 patients, fulfilling the same eligibility criteria, who received cisplatin [100mg/m[2]] and cyclophosphamide [750mg/m[2]], both in day I and the cycle was repeated every 21 days. All patients in both groups received a total of six courses of treatment and the response was determined by clinical examination as well as pelvi-abdominal ultrasound, and pelvi-abdominal computed tomography. Complete response was achieved in 35% of cases in group I vs 15% in group II, while partial response was obtained in 35% in both groups. There were no statistical significant difference between overall response rate [O.R.R] in both groups [X2 = 3.86, P 0.277]. Patients who received gemcitabine/ cisplatin combination chemotherapy showed less anemia and less renal toxicity with better tolerance than the cyclophosphamide / cisplatin arm. There were no statistical significant difference between overall survival [O.S] in both arms, however the progression free survival [P.F.S] was better in group I and reached the level of significance compared to group II [P=0.03]

Adjuvant chemotherapy in surgicallyresect able locally advanced colorectal carcinoma: fluoro-uracilbiomodulationby folinicacid versus interferon

Surgical curative resection of locally advanced colorectal cancer [stage B2 and C] is unfortunately followed by high risk of recurrent malignancies. Ultimate control requires effective adjuvant therapy. The aim of this study was to evaluate efficiency of two regimens of modulation of adjuvant 5 fluorouracil [5 FU] by folinic acid versus interferon after surgical resection of locally advanced colorectal carcinoma. 105 patients with histologically proven colorectal carcinoma [stage B2 and C only] were included in this study. Patients were subjected to surgical treatment with operative resection followed by randomization into 3 groups, each of 35 patients. Group A received 5 FU alone, group B received in addition calcium leucovarin [L V], while group C received interferon in addition to 5 FU. Patients were followed up for a median of three years. All groups were comparable as regard age, sex, histological type, stage and clinical presentation. Three years overall and disease- free survival were relatively higher in patients of group B and C, that received 5 FU modulators. Also recurrence rate was less in group B and C than in group A, but not reaching a significant level. The clinical stage of the disease was the most important prognostic factor followed by the histopathological differentiation of the tumour. Most of patients tolerated chemotherapy with transient mild to moderate degree toxicities. Hematological and gastro intestinal toxicities were comparable in the 3 groups in group C there was mild toxicities related to interferon

Adjuvant systemic treatment after resection of colorectal carcinoma utilizing 5-fluorouracil versus 5-fluorouracil plus levamisole

The study included 90 patients with resected stages B2-C colorectal carcinoma. All patients received localized postoperative radiotherapy to a dose of 5000-5500 cGy. Patients were divided into three treatment groups. Group A: receiving no adjuvant systemic treatment [Controls], group B: receiving 5-fluorouracil [5FU] alone [450 mg/m[2] IV bolus for 5 consecutive days] repeated every 28 days; and group C: receiving 5FU as in group B/ and levamizole [Lev] [50 mg, 3 times daily for 3 days and repeated every 2 weeks]. Adjuvant treatment in groups B and C was given for one year. The follow up ranged between 25-62 months [median 3.5 years]. Patients of 5FU/Lev group showed significantly lower recurrence rates than controls [P<0.025], but no difference in rate of recurrence between 5FU group and controls. The advantage of 5FU /Lev group over controls in reduction of recurrences was significant only in patients with stage C disease [P<0.01]. Also patients treated by 5FU/Lev combination showed significantly better overall survival compared to controls [P<0.05]. Toxicity of 5FU/Lev combination was mild and consistent with what might be expected with 5FU alone. 5FU /Lev is tolerable adjuvant therapy to patients with colorectal carcinoma with significant reduction of recurrence rate and significant improvement of overall survival

Effect of the anti-oestrogen tamoxifen on some bile constituents in the dog

The effect of oral administration of tamoxifen in a dose of 0.3 mg/kg daily for 3 months was investigated on some constituents of hepatic bile, gallbladder bile and serum of mongrel dogs. Tamoxifen caused significant increase in the level of total cholesterol, triglycerides, alkaline phosphatase and bilirubin in bile and serum. Total protein concentration did not change significantly in both bile and serum. Also, serum albumin did not alter, while albumin/globulin ratio significantly decreased. Osmolality and sodium increased in bile while potassium level decreased. No changes were observed in serum osmolality, sodium or potassium levels. These results support the concept that tamoxifen has some estrogen-like effects