Sequential administration of 5-fluorouracil (5FU)/leucovorin (LV) followed by irinotecan (CPT-11) at relapse versus CPT-11 followed by 5-FU/LV in advanced colorectal carcinoma. A phase III randomized study.

PURPOSE: The purpose of the present study was to evaluate the differences in the sequence of administration of 5-fluorouracil (5-FU)/leucovorin (LV) followed by irinotecan (CPT-11), or CPT-11 followed by 5-FU/LV in advanced colorectal cancer (ACC). PATIENTS AND METHODS: Chemotherapy-naïve patients with ACC were allocated to the following treatment groups: group A, a bolus of 20 mg/m(2) LV and 425 mg/m(2) 5-FU for 5 days until progression/relapse, and upon progression treatment with weekly CPT-11 (100 mg/m(2)), and group B, CPT-11 followed at progression/relapse by 5-FU/LV at the same doses and schedules as in group A. RESULTS: 120 patients were randomized to receive one of the two treatment sequences and their pretreatment characteristics were equally balanced between treatment arms. No statistically significant difference was found in the objective response rate to CPT-11 (p = 0.45); partial response (PR) was 23.3% for group A patients and 33.3% for group B. Following documented progression and second line treatment there was a significant difference between the response rate in group A (23.3%) and group B where no patients were found to respond to second-line treatment with 5-FU/LV (p = 0.024). The median overall survival was 42.0 weeks (range, 36.6-47.4 weeks) for group A and 32.0 weeks (range, 28.2-35.8 weeks) for group B. The median time to progression for patients in group A following first-line 5-FU/LV was 18 weeks (range, 10-36 weeks) and 12 weeks (range, 10-16 weeks) for group B following first-line CPT-11 (p = 0.0005). Toxicity, according to WHO, was similar between groups. CONCLUSIONS: Treating patients with CPT-11 upon progression to 5-FU/LV treatment seems to be superior to the opposite sequence. We used these treatments as sequential monotherapies (at progression/relapse), and the best results are gained when 5-FU/LV is followed by CPT-11 at disease progression or relapse.

Hand-assisted laparoscopic surgery with a Pfannenstiel incision in beta-thalassemia patients: initial experience.

INTRODUCTION: beta-Thalassemia patients have splenomegaly significant enough to require splenectomy; furthermore, these patients also often require concurrent procedures. METHODS: Between January and October 2005, seven patients with beta-thalassemia underwent hand-assisted laparoscopic splenectomy with cholecystectomy, appendectomy, and liver biopsy with the hand-port device introduced through a Pfannenstiel incision. RESULTS: The median age of the patients was 28 years, and the median spleen length was 23 cm. The median operating time was 210 minutes; there were no conversions to an open procedure; and the median spleen weight was 1072 g. One major postoperative complication occurred. The median hospital stay was 6 days. CONCLUSIONS: The proposed hand-assisted laparoscopic approach is safe and feasible. It provides a minimally invasive alternative that may become the treatment of choice in beta-thalassemia patients who require concurrent operations.