Low-dose chemotherapy with methotrexate and vinblastine for patients with advanced aggressive fibromatosis.

BACKGROUND: This Phase II study was undertaken to assess the activity of methotrexate plus vinblastine in the treatment of patients with inoperable aggressive fibromatosis (AF) and to observe the evolution of the disease after such low-dose chemotherapy. METHODS: Thirty patients with a median age of 27 years who were affected by primary (20%) or recurrent (80%), advanced, inoperable AF were treated with weekly methotrexate at a dose of 30 mg/m(2) plus vinblastine at a dose of 6 mg/m(2) for a median interval of 1 year. Patients with recurrent disease had received surgery, radiotherapy, tamoxifen, and antracycline-based chemotherapy. Tumor response was assessed in all patients as well as time to disease progression. RESULTS: Eighteen patients (60%) showed stable disease or minor tumor shrinkage along with symptom relief. A partial response was detected in 12 patients (40%). No complete responses were observed, and no patients had tumor progression during treatment. Four patients received fewer than 15 cycles of chemotherapy, mainly because of severe myelotoxicity. One of these patients died of local disease progression 33 months later, and the other three patients were stable. After a median follow-up of 75 months, the 10-year actuarial progression free interval is 67%. CONCLUSIONS: Methotrexate plus vinblastine given every 7-10 days for several months is associated with prolonged stable disease in a substantial subset of patients with advanced (inoperable) aggressive fibromatosis.

Tumor size and prognosis of breast cancer with negative axillary nodes.

A report on 1877 consecutive node negative (N-) breast cancer cases is presented in which the prognostic value of the main clinico-pathologic features is evaluated. Tumor size (and UICC-TNM T category) and lobular infiltrating histologic type were significantly associated with a more favorable prognosis whereas no association was found for patient age, tumor site and number of examined axillary nodes. However tumor size (and T category) is not a very accurate prognostic predictor (71% of all recurrences observed occurred in cases with tumor diameter of more than 20 mm, which represented 58% of the total series), although its efficiency seems almost as good as that of other more recent prognostic predictors such as estrogen receptor content or labeling index. None of the prognostic predictors currently available, including tumor size, seems sufficiently specific and they do not allow for a reliable selection of high risk N-patients for adjuvant treatment.

Quadrantectomy versus lumpectomy for small size breast cancer.

Between 1985 and 1987 quadrantectomy plus external radiotherapy and lumpectomy plus external and interstitial radiotherapy were compared in a randomized trial of patients with small carcinomas of the breast. Quadrantectomy involves excision of 2-3 cm of normal tissue around the tumour plus the removal of a sufficiently large portion of overlying skin and underlying fascia whilst lumpectomy removes only the tumour mass with a narrow margin of normal tissue. Patients in both groups also received total axillary dissection. 705 cases were evaluable, 360 quadrantectomies and 345 lumpectomies. No differences in distant metastases and survival were observed in the two groups. However, lumpectomy patients had a much higher frequency of local recurrences (7.0 vs. 2.2%). Since a local recurrence needs a second operation and creates severe psychological distress to the patient, conservative surgical procedures should include generous excision of normal tissue around the primary carcinoma plus intensive postoperative radiotherapy.

Lack of efficacy of xeroradiography to preoperatively detect axillary lymph node metastases in breast cancer.

Xeroradiography of the axilla was performed in 132 patients with operable breast cancer to investigate the status of the axillary lymph nodes. Pathologic findings were correlated with the results of clinical examination and xeroradiographic findings. Xeroradiography does not appear to have improved our ability to identify axillary lymph node metastases in patients with breast cancer.

Lymphnodal metastases from unknown primary tumors.

Prognosis and adequate therapy of lymphnodal metastases from unknown tumors are still uncertain. At the Milan Cancer Institute 71 patients with neoplastic adenopathies of unknown origin were hospitalized between 1965 and 1979. Men were 45 and women 26 with a M/F ratio of 1.7: 1. Most of patients were aged 51-70 years. Laterocervical adenopathies were the more frequent, followed by supraclavicular, axillary, inguinal, submandibular and retroperitoneal ones. In 11 cases the primary tumor was subsequently found (3 cases in tongue, 3 in rhinopharynx. 2 in lung. 2 in breast and 1 in thyroid). Of the remaining 60 cases, only histologic diagnosis of the metastasis was available and the primary tumor has never been found. Squamous cell carcinoma was the most frequent histologic type, followed by adenocarcinoma, undifferentiated carcinoma and malignant melanoma. No significant relationship between histologic types and lymphnodal sites could be demonstrated. In different cases treated with all possible combined therapies (surgery, chemotherapy and radiotherapy), no correlation between survival and therapy was possible. 35 patients (58.3%) were dead 18 months after diagnosis. No significant correlation between survival and histology was either shown. The natural history of these tumors remains unclear and any specific therapy cannot be proposed to be scheduled in such cases.

Conservative treatment for breast cancer of limited extent. Results of a randomized trial.

From 1973 to 1980, a controlled clinical trial was carried out at the National Cancer Institute of Milan to compare the Halsted mastectomy with breast quadrantectomy and axillary dissection followed by radiotherapy in patients with breast cancer of less than 2 cm in size. Cases of breast cancer classified as T1N0 were randomized into the two treatment procedures: 349 cases were treated with the Halsted mastectomy and 352 with the quadrantectomy technique. The two series were comparable with regard to age distribution, size, site of primary tumor, menopausal status and frequency of axillary metastases. Three local recurrences occurred in the Halsted group and one in the quadrantectomy group. Actuarial curves showed no difference in the two series with regard to disease-free and overall survival. In view of these results, mastectomy appears to be an unnecessary mutilation for patients with breast carcinomas less than 2 cm in size and no palpable axillary nodes.

Breast cancer: primary tumor characteristics related to lymph node involvement.

From November 1st 1977 to August 31st 1978, 842 consecutive patients with operable breast cancer were observed at the National Cancer Institute of Milan. Characteristics of the primary tumor and the status of regional lymph nodes were evaluated at clinical and postsurgical examination: it was found that qualitative characteristics of the primary were properly defined by clinicians, who usually overestimated maximum diameter of the primary. The status of regional lymph nodes is not reliable at clinical examination: 34.5% of clinically uninvolved nodes were found to contain metastatic growth at histologic examination. Age of patients, maximum diameter of the primary, histologic type and quadrant of origin of the primary tumor were significantly related to the frequency of regional node metastases. Multifactorial analysis showed that the last three factors were independent variables, while age, which is significant by itself, loses importance when adjusted by at least one of the other three factors. Frequently of extension of node metastases beyond the lymph node capsule was found to be related to the number of involved nodes: maximum diameter, histologic type and site of origin are significantly related to the frequency of extracapsular invasion. This study confirms that the evaluation of the status of regional lymph nodes is not reliable at clinical examination and indicates that characteristics of the primary may be useful in predicting regional lymph node involvement. The direct correlation between the number of involved nodes and the frequency of infiltration beyond the capsule suggests that prognosis of patients with positive nodes depends more on this factor than on the number of involved nodes.

[Topical ampicilin and local infectious complications in oncological surgery]. / Ampicillina topica e complicanze infettive locali in chirurgia oncologica

420 consecutive patients having clean surgical operations were studied: 210 of them, selected at random, received 0.5-1 g of ampicillin into the wound before closure, the remainder being controls. Patients were examined for wound infection during the first postoperative week, in line with the opinion that topical antibiotic treatment can afford significant protection against wound infection caused by peroperative contamination. Wound infection has been defined as a local inflammation (redness and hyperthermia), usually with fever and/or discharge of pus. In some doubtful cases, a longer observation period was necessary to obtain a correct interpretation. Four out of 210 clean wounds (1.9%) became infected in the patients receiving ampicillin compared with 12 out of 210 (5.7%) in the control group. The difference could have arisen by chance less that one in a hundred times (p less than 0.01). It is our opinion therefore that after clean operations, the higher the risk of local infection, the more effective the topical use of antibiotics.