[Problems concerning the optimal use of celluloses as adjuvants in tabletting. 2. Insertion characteristics of certain adjuvants with the use of regression models].
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A randomized study assessing the efficacy of three treatment of ftorafur (FT), ftorafur plus Tamoxifen (TAM), and Tamoxifen in patients diagnosed as having stage II (N1b) or stage III breast cancer was carried out at 90 institutions in the Chubu district of Japan. After 10 mg of MMC administration on the day of surgery and the next day, patients were allocated to one of three treatments: FT 600 mg/day for 2 years, FT 600 mg/day plus TAM 20 mg/day for 2 years, or TAM 20 mg/day for 2 years. A total of 647 cases were analyzed. No significant differences were observed in the 5-year disease-free survival rates or in the 5-year survival rates. In the stratified analysis, however, a beneficial effect of adding FT to TAM was observed in the patients with ER-positive tumors in the 5-year survival rate, and FT plus TAM treatment was favorable compared with the other two treatments for postmenopausal patients with ER-positive tumors.
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A multi-center collaborative study was conducted in curatively resected gastric cancer patients at Stages II and III to compare oral 5-FU (Group A), oral Tegafur (Group B) and i.v. MMC + oral 5-FU (Group C). From May 1982 to April 1985, 1,012 cases were enrolled at 55 institutions. Some 138 (13.8%) were excluded, and 874 were analyzable. In the analysis of background factors, Group B had more cases with tumor of large diameter and advanced Stage. Adverse effects were relatively mild in all groups, and there was no problem in drug tolerance. Five-year survival rate was 67.6%, 62.4% and 68.6% in Groups A, B and C, respectively, reflecting no significant difference among them. It was 85.0%, 83.0% and 81.1% in Stage II and 52.5%, 51.0% and 59.0% in Stage III of Groups A, B and C, respectively. No significant difference was found, but Stage III of Group C showed a slightly higher survival rate. Supportive clinical study will be required to assess the usefulness of MMC as an introduction therapy. We found no difference in efficacy between 5-FU and Tegafur as maintenance therapy. The life-prolongation effect of fluoropyrimidines in comparison with surgery alone should be studied separately.
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PURPOSE: To determine prognostic factors in patients with cervical cancer treated with surgery followed by radiotherapy. PATIENTS AND METHODS: In a retrospective analysis, patients treated at the Department of Radiotherapy, University of Halle-Wittenberg, Germany, from 1980 through 1993 were evaluated for local control, survival and treatment sequelae with special emphasis on prognostic factors. 298 patients (age 23-81 years, median 46 years) with cervical cancers were treated with surgery followed by radiotherapy to a minimum of 50 Gy. 250 patients received radiotherapy after radical hysterectomy with pelvic lymphadenectomy and 48 patients after hysterectomy. Most of the cancers were squamous cell carcinomas (81%) with few adenocarcinomas (12.4%). Grading was G1/G2 in 28.9% of the patients and G3/G4 in 39.6%. RESULTS: The 5-year overall survival was 68.8% for the whole group, 70.5% for squamous cell carcinomas (n = 241), 64.4% for adenocarcinomas (n = 37; not significant), 80% for G1/G2 tumors (n = 86), and 69% for G3/G4 carcinomas (n = 118; p = 0.074). Survival dependent on tumor size and positive nodes was 76.2% (n = 94) for pT1N0, 65.8% for pT1N+ (n = 31), 68.2% for pT2N0 (n = 62), and 41.4% for pT2N+ (n = 35). An impact of grading on 5-year survival was only found in patients with positive nodes: G1/G2N0 84% (n = 62) versus G1/G2N+ 64.8% (n = 23); G3/G4N0 79.6% (n = 71) versus G3/G4N+ 39.9% (n = 31). The number of positive nodes was the strongest prognostic factor. Multivariate analysis (Cox regression) established a risk factor of 3.06 (p < 0.01) for positive nodes, of 1.7 for grading G1/G2 versus G3/G4 (p = 0.087), and of 1.3 for tumor size (pT1 vs. pT2; p = 0.079). There were no differences in the clinical outcome between patients in stage pT1 with or without lymphadenectomy (75% [n = 130] vs. 79% [n = 39]). CONCLUSION: In patients with cervical cancers treated with surgery and radiotherapy, positive nodes were an independent prognostic factor for local control and survival and should be an indication for additional chemotherapy. A value of lymphadenectomy for survival in this group of irradiated patients could not be established.
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