Biomedical subjects
Publications and source records attributed to E Bajetta.
Non-Hodgkin's lymphomas are among the most challenging diseases to treat and their course ranges from very aggressive and rapidly fatal tumors to some of the most indolent, well-tolerated malignancies in man.
To test the feasibility of fine needle (22 gauge) percutaneous intratumoral chemotherapy (PIC) under ultrasound guidance, a trial was conducted on 12 selected neoplastic patients with tumors not responsive to conventional treatments (5 adenocarcinomas of the pancreas, 1 hepatocellular carcinoma, 1 squamous cell carcinoma of the lung, 1 leiomyosarcoma of the hepatic hilum, 1 malignant fibrous histiocytoma of the ischiatic region, 2 liver and 1 peritoneal metastases). The drugs used were 5-fluorouracil, methotrexate and cyclophosphamide, according to the histotype. The doses given never exceeded the routine intravenous doses; 119 sessions of PIC were administered. There have been no significant local complications due to needle injury and drug toxicity or biochemical changes attributable to general toxicity. Partial or total pain control and stable disease or response to 60% was observed. This research has not been described previously to our knowledge.
It has been known for many years that the pineal gland is involved in regulating tumor growth. In order to evaluate the functional activity of the pineal gland in neoplastic diseases, melatonin serum levels and its light/dark rhythm have been determined with the RIA method in patients affected by various forms of tumor. Irrespectively of the type of the tumor and of its localization, existence of two subpopulations has been observed within the oncologic patients, the former with normal levels of melatonin, and the latter with high ones. The light/dark rhythm of melatonin was anomalous in some cases. An evident decrease of serum melatonin values was seen after chemotherapy. It might be interesting to establish whether melatonin levels may conditionate the prognosis of patients with cancer.
Twenty-seven consecutive patients with advanced malignant melanoma were treated with cytarabine (Ara-C) and cisplatin. Of 25 evaluable patients, four achieved partial response, for a median duration of 3 months. Three of four responders belonged to the group of seven patients given Ara-C at a dose of 3 g/m2. The predominant toxic effect was hematologic and related to the dose of Ara-C. The cost-benefit ratio of this combination is inferior to that of dacarbazine or carmustine alone.
A prospective randomized study was conducted to compare the antiemetic efficacy of metoclopramide (MCP) versus its recent derivative alizapride (ALZ) in patients undergoing cancer chemotherapy. Both drugs were given at a dose of 2 mg/kg i.v. push for 5 doses. A positive response was defined as absence of nausea or emesis, or moderate nausea with one or two emeses per day. Eighty-two patients were evaluable. Forty-two received MCP and 40 received ALZ. A positive response was observed in 54% MCP-treated and 41% ALZ-treated patients. Neurologic toxicity, mainly extrapyramidal disturbances, was the most remarkable adverse side effect; it occurred more frequently in the MCP-treated group (31%) than in the ALZ-treated group (17%). Both drugs were found to be more effective in previously untreated patients and when employed together with steroids. MCP was more effective (52% positive response) than ALZ (41% positive response) in cisplatin-treated patients. To better control drug-induced vomiting, we believe that future trials should evaluate slow i.v. infusion of antiemetic agents and their combination with dexamethasone.
Thirty-seven consecutive patients with disseminated malignant melanoma and previously untreated with chemotherapy were randomly allocated to receive vindesine, cis-platinum, and etoposide (Regimen A) or vindesine, cis-platinum, and lomustine (Regimen B). In 31 evaluable patients, Regimen A induced an overall response rate of 31% and a complete response rate of 6%; with Regimen B the corresponding findings were 20% and 20%, respectively. The median duration of complete response was 12 months with both regimens and the comparative median total survivals were 8 and 6 months, respectively. In no case was toxicity so severe to require treatment discontinuation, and the major dose-limiting side effect was myelosuppression, especially in the patients treated with Regimen B. Present results confirm once more the limited activity of drugs and regimens presently utilized in the treatment of advanced malignant melanoma.
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A total of 70 patients with malignant lymphomas refractory to one or more chemotherapeutic regimens were treated with iv amsacrines (m-AMSA and m-AMSA lactate). Of 58 evaluable patients, 12 had Hodgkin's disease and 46 had non-Hodgkin's lymphoma. Twenty-nine of the evaluable patients received m-AMSA and 29 received m-AMSA lactate. The amsacrines were recycled every 3 weeks. The doses of m-AMSA were 90-120, 70, and 25-30 mg/m2/day for 3 days, respectively. All patients treated with m-AMSA lactate received a single dose of 225 mg/m2. In Hodgkin's disease, the response rate was 58.3% (one complete response among 12 patients), and in non-Hodgkin's lymphoma, the response rate was 30.4% (six complete responses among 46 patients). The median duration of response was 3 and 5 months, respectively. The response rate was unfavorably affected by the presence of extra-nodal disease and a Karnofsky performance status less than 80. There was no important difference in the incidence and duration of response between m-AMSA and m-AMSA lactate. After vomiting, myelosuppression was the most frequent observed toxic effect. One patient showed an unexpected fatal bone marrow aplasia following the first course of 90 mg/m2. This study indicates that m-AMSA and m-AMSA lactate are active and moderately toxic in previously treated malignant lymphomas. Thus, amsacrines could be effectively incorporated into salvage polydrug regimens.
We report a Burkitt's type lymphoblastic lymphoma (B-LL) case characterized by an abnormal IgMk immunoglobulin secretion and referred to us on February 12, 1982. The diagnosis has been histologically documented and the pathological stage of the disease (IV B) was determined according to the diagnostic criteria usually employed for the non-Hodgkin's lymphoma (NHL). Serum proteins were determined by electrophoresis and immunodiffusion. The review of the literature has allowed us to ascertain that the presence of a monoclonal IgM peak can be associated with NHL, particularly with those of B cell type and in adult subjects. Up to now, only six IgM B-LL secreting cases have been described. The biological and prognostic significance of this elevated Ig secretion is uncertain; therefore it may be important for the future to evaluate, in B-LL this immunological parameter.
One-hundred and ninety-four adult patients with histologically proven stage III and IV non-Hodgkin's lymphomas, treated with CVP (cyclophosphamide, vincristine and prednisone) alternated with ABP (adriamycin, bleomycin and prednisone), were analyzed to test the validity of the clinicoprognostic correlation offered by the working formulation in comparison with the Rappaport and Kiel classifications. Actuarial overall survival at 5 yr showed a significant difference among the three prognostic subgroups of the working formulation (low grade, 53.3%; intermediate grade, 47.5%; high grade, 27.7%). Overall survival of favorable subgroups of the Rappaport and Kiel classifications was superior to that of unfavorable prognostic groups. The percentage of systemic symptoms and bulky disease increased in patients with low-grade compared to those with intermediate-grade and intermediate-to-high-grade malignancy. The achievement of complete remission was not related to any of the prognostic groups of the Working Formulation, and no difference could be detected within the various prognostic groups of the Rappaport and Kiel classifications. Within the diffuse histiocytic lymphomas of the Rappaport classification, two groups with a different prognostic outcome were evidenced by the working formulation (G, with an overall survival of 50%, and H, with an overall survival of 26.7% at 5 yr) and by the Kiel classification. The possibility of reporting results in the three different groups of the working formulation instead of two can be considered a step forward. Within the diffuse histiocytic histology, the working formulation allows separation, as does the Kiel classification, into two main different prognostic subgroups.
From 1970 to 1980, 171 consecutive cases with non-Hodgkin's lymphomas (NHL) of Waldeyer's ring were admitted to this Institute. The cases were reviewed to evaluate whether involvement of Waldeyer's ring might represent a distinct clinicopathologic entity. Adequate pathologic staging was performed in 86% of cases. All slides were reviewed, and the histologic diagnosis given according to the Rappaport classification, the Kiel classification, and the recent Working Formulation of NHL for Clinical Usage. Waldeyer's ring alone was involved in 12.3% of the cases at presentation; regional nodes were positive in one-third (35.7%), and distant involvement was detected in half of the patients (52%). The tonsils represented the most frequent site of involvement by NHL within Waldeyer's ring. Treatments employed were heterogeneous, but most of the patients with stage I-II received radiotherapy alone. The present series shows that the association of involvement of Waldeyer's ring and the stomach by NHL occurs in less than 10% of the cases. Treatment results and patterns of recurrence fail to differentiate NHL involving Waldeyer's ring from those of other sites. Prognosis remains related to the classical variables and is independent of the site of onset.
In a randomized trial of adjuvant chemotherapy, immunotherapy, or immunochemotherapy, 761 evaluable patients with pathological Stage II cutaneous melanoma anywhere on the body or with pathological Stage I melanoma of the trunk (Clark's level 3 to 5) were studied by the World Health Organization International Melanoma Group. Wide local excision and excisional regional lymphadenectomy alone were performed in 185 patients and the results were compared with those of surgery plus chemotherapy with dacarbazine (in 192 patients), surgery plus immunotherapy with bacille Calmette-Guérin vaccine (in 203), and surgery plus chemotherapy combined with immunotherapy (in 181). The rates of disease-free survival and overall survival at 36 months were 30.4 +/- 8.3 per cent (mean +/- S.E.) and 41.6 +/- 10.0 per cent, respectively, after surgical treatment alone; 37.2 +/- 7.9 per cent and 46.5 +/- 8.3 per cent after surgery plus chemotherapy; 34.8 +/- 7.9 per cent and 48.7 +/- 8.7 per cent after surgery plus immunotherapy; and 33.6 +/- 7.9 per cent and 50.0 +/- 8.8 per cent after surgery plus a combination of chemotherapy and immunotherapy. None of the differences between groups was significant, and thus no effect of adjuvant therapy could be demonstrated in this study.
Thirty-two consecutive patients with metastatic malignant melanoma were treated with vinblastine, bleomycin, and cisplatin (VBD) chemotherapy. There were 29 evaluable patients; complete remission was observed in three and partial remission in five. No patient with visceral metastasis showed objective response. The 10-month survival rate of responders was significantly higher than that of nonresponders (57.1% vs 18.2%, P = 0.01); however, present results do not confirm that VBD is superior to other drug combinations for malignant melanoma.
The medical records of women taking part in the first 2 prospective adjuvant CMF (cyclophosphamide, methotrexate, fluorouracil) programs were reviewed to evaluate the incidence of liver damage which could be attributable to prolonged methotrexate administration. In 802 evaluable patients abnormal liver studies occurred in 7 of 170 controls (4.1%) and 20 of 632 CMF-treated patients (3.2%). In 22 of 27 patients they were reversible, while the persistence of enzyme abnormalities in 2 patients treated with 12 CMF cycles was followed by the occurrence of viral hepatitis and osseous metastases, respectively. Adjuvant CMF was never discontinued in the presence of liver function abnormalities. In 22 women liver biopsies through laparoscopy were performed for various diagnostic purposes. They yielded an incidence of aspecific histologic changes (fatty metamorphosis, subcapsular fibrosis) which was similar between controls and CMF-treated patients. Present analysis failed to demonstrate a higher incidence of acute and/or chronic liver changes in patients treated with cyclical CMF compared to controls treated with surgery alone.
The pertinent radiographs of 151 patients treated with radical mastectomy who showed relapse in the chest and/or in the skeleton as first site were reevaluated. Diagnostic accuracy was calculated by comparing the first examination considered as positive with the previous ones reported as negative. For chest lesions the accuracy was 80% (70% for parenchymal nodular densities), with no difference between symptomatic and asymptomatic patients. For bone metastases retrospective evaluation confirmed the radiological report (i.e., the time of relapse), in 73.8%, with a value of 89.7% in symptomatic and 53.4% in asymptomatic patients. The site of involvement and morphological characteristics of the lesions did not influence the diagnostic accuracy. Therefore chest examination and, for symptomatic patients, radiographic bone survey still represent a useful modality to assess the diffusion of breast cancer. For asymptomatic patients other modalities, such as bone scan and biochemical tests, should be utilized.
Adjuvant trials ongoing at the Istituto Nazionale Tumori of Milan for operable breast cancer with nodal involvement are reviewed in this paper. In the first trial (cyclophosphamide, methotrexate, 5-fluorouracil [CMF] versus control), the early 5-year results confirm the usefulness of combination chemotherapy in significantly affecting the relapse-free survival (RFS) and total survival rates. The degree of axillary node involvement remains the most important prognostic indicator also in patients receiving adjuvant chemotherapy. The contention concerning the therapeutic effect of CMF in pre- versus postmenopausal women is overcome by the observation that about 80% of patients receiving greater than 85% of the planned dose are surviving relapse free at 5 years regardless of their menopausal status. The 3-year results of the second CMF trial indicate that both RFS and total survival are comparable between the groups receiving 12 or 6 cycles of adjuvant CMF. The results were not affected by drug-induced amenorrhea nor by estrogen receptor status. Provided the percent of dose administered is high, there is probably no real advantage in prolonging CMF chemotherapy beyond the sixth month. However, the results are still preliminary.
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Sixty-one consecutive patients with chronic lymphocytic leukemia (CLL) treated at the Istituto Nazionale Tumori of Milan from September 1962 to August 1976 were classified according to the staging system of Rai et al. (16). Analysis of this series showed the following median survival (in months) from diagnosis: stage 0-I, 73; stage II, 44; stage III-IV, 32. In 11 patients without peripheral palpable adenopathies, the lymphangiogram showed abnormal retroperitoneal lymph nodes. Therefore, the initial stage was changed from 0 to I in 5 cases. The median survival for the entire series was 50 months. Patients with "indolent" disease had a median survival of 52 months, while in patients with "active" CLL, the median survival was 32 months. Both sex and age were shown to be poor predictors of survival. Increased duration of survival was observed in patients with less compared to those with more than 30,000 lymphocytes/mm3 (66 versus 41 months). The method of staging proposed by Rai et al. and utilized to classify this series at the time of diagnosis was confirmed to be a reliable predictor for survival.