The therapeutic efficacy of the combination of cyclophosphamide + epirubicin + cisplatin was evaluated in 107 previously treated or untreated patients with advanced ovarian cancer. The overall response rate was 58.8%, complete remission 36.4% (mean duration 7.62 months) and partial remission 22.4% (mean duration – 6.74 months). The response was rated in function of age, menopausal status, performance status and previous therapy. Toxicity (in case of 109 patients) was evaluated according to the WHO recommendation. The similar therapeutic effectiveness and less toxicity of the above drug combination compared to CAP regimen is demonstrated.
The prospective controlled Phase III clinical trial tested the therapeutic value of the cis-platinum-adriamycin-cyclophosphamide combination (CAP), compared with the combination including cyclophosphamide, methotrexate, 5-fluorouracil, vincristine and prednisolone (CMFVP), in untreated metastatic breast cancer. One hundred and twenty-three patients (greater than 2 cycles) were evaluated: 61 on the CAP, and 62 on the CMFVP schedule. An objective response (CR + PR) to CAP combination chemotherapy was achieved in 72% of patients (43/61), with a high rate (36%) of complete remissions. In terms of metastatic site, the response rate appeared to be particularly high in soft tissue and visceral organ (lung, liver) metastases. In the CMFVP group, an objective response was noted in 26 of 62 patients (42%), with 16% complete remissions. The difference in overall therapeutic response - and in the complete remission rate as well - was statistically significant to the advantage of the CAP regimen (P less than 0.01). The duration of remissions was 6-28 + months (means = 14) for the CAP, and 4-15 + months (mean = 9) for the CMFVP schedule. Toxic side effects were more pronounced in the CAP group, particularly myelosuppression, with anemia prevailing. Side effects of CMFVP treatment were moderate. In 39 CMFVP previously treated cases, CAP was administered as second-line treatment, and an objective response was observed in 51% of cases (20/39). Results of this controlled trial showed the advantage of the CAP combination chemotherapy in the treatment of metastatic breast cancer.
Adding anthracyclin to conventional platinum-based chemotherapy of ovarian cancer has been found to improve survival. The aim of this study was to evaluate the effect on survival on adding epirubicin to the standard treatment with carboplatin and paclitaxel. Between March 1999 and August 2001, 887 patients with epithelial ovarian, tubal, or peritoneal cancer FIGO stage IIB-IV were enrolled. They were randomized to receive six to nine cycles of paclitaxel (175 mg/m 2 , 3 h iv) followed by carboplatin (AUC 5, Calvert formula) with or without epirubicin (75 mg/m 2 iv prior to paclitaxel) on a 3-weekly schedule. The primary end point was progression-free survival, and 542 progression events were required to detect a hazard ratio of 0.786 or less. Patient characteristics were similar across the treatment arms. Residual disease less than 1 cm at surgery with no measurable disease before chemotherapy was reported in 328 patients (37%), with 159 in the TEC arm and 169 in the TC arm. A total of 63 patients had to be withdrawn from the study: 20 due to ineligibility, 32 due to hypersensitivity reaction to paclitaxel during the first or second course, and 11 due to withdrawal of informed consent, leaving 824 patients for the survival analysis. The median follow-up is 30 months for patients still alive. Progressive disease has been reported for 573 patients, and 326 have died. In the total group of patients, the median time to progression was 17.2 months in the TEC arm and 16.3 in the TC arm (P ¼ 0.99). In the group with residual tumor of 1 cm or less, the median time to progression was 24.7 months in the TEC arm and 24.4 months in the TC arm (P ¼ 0.94). In patients with more than 1 cm of residual tumor, the median time to progression in the TEC arm was 14.6 months and 13.8 months in the TC arm (P ¼ 0.75). The median overall survival has not yet been reached. The addition of epirubicin to the standard carboplatin and paclitaxel treatment did not improve progression-free survival. The evaluation of effect on long-term survival awaits further follow-up.
The results of treatment with 5-fluorouracil, imidazole carboxamide, BCNU and prednisolone (FIB-P) salvage chemotherapy in 60 patients with heavily pretreated advanced breast cancer are presented. For most of the patients (82%) this was the third line of chemotherapy. Performance status (ECOG) was 1, 2 and 3 in respectively 13, 27, and 20 patients. Predominant metastatic sites were: soft tissue (3/60, 5%), bone (22/60, 37%), and viscera (35/60, 58%). Tumor burden (number of affected organic systems) was 1, 2 and 3 or more in respectively 18, 24 and 16 patients. Average dose intensity received was 0.74 (range, 0.47-0.98); the average number of cycles was 3.8 (range, 2-8). Objective response (CR + PR) was observed in 22 patients (1 CR, 21 PR), with a response rate of 37% (22/60). Median duration of remission was 7 months (range, 3-15). Tumor burden was the only pretreatment patient characteristic that significantly influenced the remission rate (p less than 0.10). Dose intensity significantly affected tumor response (p less than 0.05). Toxic side effects (gastrointestinal disorders, alopecia and myelotoxicity) were generally moderate and tolerable. No treatment-related death occurred. FIB-P proved to be an active salvage chemotherapy in heavily pretreated patients with advanced breast cancer.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.