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CA 15.3 is an antigen expressed by human breast carcinoma cells, and defined by two monoclonal antibodies, 115D8 and DF3. We used IRMA to determine the circulating serum levels of CA 15.3 in 1178 subjects with breast cancer, non-breast malignancies, benign diseases and controls. A threshold level of 40 U/ml was established with 140 healthy controls and 650 patients with benign diseases (respectively 0% subjects and 1.5% patients had abnormal antigen levels). Elevated CA 15.3 was found in 12 of 184 patients with malignancies different from breast cancer (6.5%), either epithelial carcinomas with distant metastases, mainly in the liver, or primary liver tumors. Breast cancer patients (n = 204) were analysed by prior therapy, UICC stage and WHO response to therapy. Eight of 134 (5.9%) patients with stage II or III breast cancer at presentation and no evidence of disease (NED) had elevated CA 15.3. All of 22 patients with stage IV breast cancer not responding to therapy (SD and PD) had antigen levels greater than 40 U/ml, as did 10 of 34 (29.4%) stage IV patients in objective response (CR + PR). Three of 14 pretreatment patients had abnormal marker levels, and they later proved to have distant metastases. Serum CA 15.3 values were statistically different (p less than 0.01) in NED (20.6 +/- 11.2 U/ml), CR + PR (33.5 +/- 24.0 U/ml), stable disease (98.8 +/- 50.4 U/ml) and progressive disease (greater than 200 U/ml) breast cancer patients. Our results suggest that circulating CA 15.3 antigen levels agree with the stage of breast cancer and with the response to therapy.

A case of palmar-plantar erythrodysesthesia syndrome (PPES) observed during a 120-h infusion of 5-fluorouracil (5-FU) is presented. This syndrome has been described in the literature after protracted infusion chemotherapy of over 30 days. The agent most frequently associated with this syndrome was 5-FU. A 53-year-old man was admitted to the hospital with a well-differentiated squamous cell carcinoma of the retromolar trigone. The patient received 100 mg/m2 of cisplatin on day 1 and 120-h continuous infusion of 1000 mg/m2 of 5-FU every 3 weeks. After the second course, the patient developed clinical features consistent with PPES. This side effect has not been previously reported with short-term (5-day or 120-h) continuous infusion of 5-FU. Less frequently, the syndrome has also been described with 10-day continuous infusion. The etiopathogenesis of PPES is unclear, but it seems to be dose-dependent and probably related to cutaneous drug accumulation.

Background. Tegafur is an antimetabolite slowly metabolized to 5‐fluorouracil in vivo. Protracted administration of oral tegafur is active in metastatic breast cancer, with reported response rates ranging from 29 to 44%. The addition of folinic acid could improve the efficacy of tegafur by means of biochemical modulation. Methods. A prospective Phase II trial in patients with pretreated metastatic breast cancer was performed. The regimen consisted of oral tegafur (750 mg/m2/day) and oral folinic acid (45 mg/day) for 21 days, recycling at day 28. Results. Twenty‐five patients were included. Eight partial responses were observed for an objective response rate of 32% (95% confidence intervals for response, 23‐41%). The median duration of response was 7 months. According to WHO criteria, 24% of patients experienced grade 3 mucositis and 12% grade 3 diarrhea, but no other significant toxicities were observed. Twenty‐eight percent of patients required dose reductions for toxicity. Conclusions. A significant response rate with oral tegafur and folinic acid in patients with heavily pretreated breast cancer was found. This all‐oral regimen, which could be safely administered on an outpatient basis, deserves further evaluation to define the role of folinic acid on the activity of tegafur in metastatic breast cancer. Cancer 1995; 75:831‐5.

Carboplatin, methotrexate, and vinblastine (M-CAVI) is an active and well-tolerated regimen for bladder cancer patients ineligible for cisplatin-based regimens. We treated 47 T2-4 N0 M0 bladder cancer patients with M-CAVI in a neoadjuvant phase II trial. These 47 patients are evaluable for clinical response and toxicity. Clinical overall response rate was 34%, for a 95% confidence interval (CI95%) of 21-49%. Pathological response was seen in 40% of the patients (CI95%, 26-56%) with a 26.5% rate of pathological complete response (CI95%, 15-42%). Factors associated with the achievement of a response to therapy were the initial TNM stage (pT3a or lower, greater than pT3a, p = 0.001) and a Karnofsky score greater or equal than 90%, which was marginally significant (p = 0.08). With a median follow-up of 14 months, the disease-specific actuarial survival at 2 years is 42%. No patient has relapsed beyond 21 months of follow-up in a disease-free status. Toxic effects have been moderate. In conclusion, M-CAVI is an active and well-tolerated regimen that should be compared in terms of response rate and survival with a cisplatin-based regimen for invasive bladder cancer.

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