Body Protein and its Change in Patients During Anti-Tumor Treatment

The purpose of this study was to investigate how total body protein and its fraction of body weight (body protein fraction) change in cancer patients during different anti-tumor treatments, and to see if these changes have any clinical significance in the form of prognostic value or correlation with disease course and tumor response. In 84 patients, 28 with lung cancer, 24 with gastrointestinal tumors, 30 with breast cancer, 1 with non-Hodgkin lymphoma and 1 with kidney cancer, the total amount of body nitrogen was measured using an in vivo prompt gamma neutron activation technique. Using the relationship 1 g nitrogen to 6.25 g protein, the amount of total body protein was calculated. The measurements of body protein and body weight were made during the period of radiation, cytostatic or hormone treatment. Each patient was his or her own control. The precision of the method for measurement of body protein was ±5% (1 SD). In patients with lung cancer, we noted a significant correlation between changes in total body protein during radiotherapy and the recurrence-free interval and overall survival. Patients, in whom body protein decreased, had a significantly shorter time to tumor recurrence than those in whom body protein increased or remained constant. In patients with gastrointestinal tumors we noted a significant difference between the changes in body protein fraction in the patients with loco-regional disease and the patients with metastasized disease, in whom the changes were greatest. Finally, in patients with metastasized breast cancer there was no significant correlation between change in body protein fraction and tumor response. The conclusions are that the amount of body protein in cancer patients changes during the disease and anti-tumor treatment. The amount of body protein in patients with lung cancer has a prognostic value, as a decrease of body protein is an indicator of tumor invasion and early metastasis as well as a decreased overall survival. In patients with gastrointestinal tumors a correlation between change in body protein fraction and course of the disease was seen

Phase II studies on docetaxel alone every third week, or weekly in combination with gemcitabine in patients with primary locally advanced, metastatic, or recurrent esophageal cancer

Background The purpose of these studies was to compare efficacy and toxicity of docetaxel alone with the combination of gemcitabine and docetaxel for treatment of metastatic esophageal carcinoma. Patients and methods These studies enrolled patients with histopathologically verified squamous cell carcinoma or adenocarcinoma of the esophagus or cardia. Between March 1997 and June 1999, 52 patients were enrolled in the initial Phase II study (Study I). They were scheduled for treatment with docetaxel 100 mg/m(2) every third week as a 1-h infusion. The second Phase II study between September 2000 and March 2003 included 65 patients (Study II). They were given docetaxel 30 mg/m(2) administered as a 30-min i.v. infusion weekly for four times, followed by 2 weeks of rest, and gemcitabine starting with a dose of 750 mg/m(2) (if well-tolerated 1,000 mg/m 2) on days 1 and 15, followed by 3 weeks of rest. A new cycle began on day 36. Patients were premedicated with betamethasone 8 mg p.o. on the evening before, and 8 mg i.v. 30-60 min before the docetaxel infusion. Response was confirmed by computed tomography and assessed at 12 and 24 weeks. Toxicity was assessed according to WHO scales. Results In study I, 38 out of the 52 enrolled patients were valuable. Two patients experienced complete remission (CR) (5%), 10 patients partial remission (PR) (26%), nine patients stable disease (SD) (24%), and 17 patients showed progressive disease (PD) (45%). Toxicity mainly involved leukopenia, which in some cases required hospitalization and treatment with antibiotics. In Study II, 46 out of the 65 enrolled patients (70%) were assessable. Out of these, three patients (7%) had CR, eight patients (17%) had PR, 10 patients (22%) had SD, and 25 (54%) PD. Overall response was 24% while an additional 22% showed stable disease. Toxicity mainly consisted of leucopenia and pain. Conclusion Docetaxel as a single agent is active in esophageal cancer, both in treatment naive and in previously treated patients with recurrent disease. The overall response rate was 31%, with a good-safety profile. The addition of gemcitabine is well tolerated, but adds no efficacy. Weekly administration of docetaxel may be less effective. It demonstrates moderate efficacy and the doses used provide an acceptable safety profile

Randomized phase II study of sequential docetaxel and irinotecan with 5-fluorouracil/folinic acid (leucovorin) in patients with advanced gastric cancer: the GATAC trial

Background. The optimal chemotherapy in patients with advanced gastric carcinoma (GC) is yet to be determined. We compared sequential administration of docetaxel and irinotecan, both in combination with infused 5-fluorouracil/leucovorin (5-Fu/Lv), and randomly assigned patients to start with either of the two. Methods. Patients with previously untreated locally advanced or metastatic GC and with measurable lesions (response evaluation criteria in solid tumors; RECIST) were randomly assigned to start with docetaxel 45 m (arm T) or irinotecan 180 mg/m(2) (arm C) with bolus/44-h infusion of 5-Fu/Lv (day 1 every 2 weeks). After four courses, there was a pre-scheduled crossover to the alternative regimen for four additional courses. Results. Eighty-one patients were randomized and 78 started treatment. Complete and partial responses were seen in 31 (40%) patients after 8 weeks and in 32 (41%) after 16 weeks, with similar results in both study arms. The median overall survival (OS) was 11.5 and 10.6 months in arms T and C, respectively (P = 0.3). The two schedules were feasible and did not differ in the overall rate of severe adverse events (SAEs). Conclusion. This is the first randomized comparison of two of the newer cytostatic drugs in GC therapy. No differences favoring either arm T or arm C were found with respect to response rate, OS, or toxicity. The median OS of 11 months indicates that sequential administration of the two combinations is effective and is similar to triple combinations. Thus, comparable efficacy to platinum combinations appears to be obtained with newer, less toxic regimens when given sequentially