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Biomedical subjects

E Bajetta

Publications and source records attributed to E Bajetta.

At least 109 records · Page 6Linked to original sources
PubMed1993

Effective salvage chemotherapy in relapsed or refractory non-Hodgkin's lymphoma.

BACKGROUND: Over the last few years, high-dose chemotherapy has been extensively investigated in relapsing/refractory non-Hodgkin's lymphoma (NHL). However, this approach is reserved to a limited subset of cases and new conventional-dose second-line chemotherapies need to be investigated. PATIENTS AND METHODS: Thirty consecutive out-patients with refractory or recurrent NHL were given polychemotherapy in a regimen consisting of ifosfamide, mitoxantrone and etoposide on day 1 and vindesine, cisplatinum and cytosine arabinoside on day 15: courses were repeated every 29 days. Five patients had refractory disease following first-line chemotherapy and 25 were relapsing. RESULTS: The median number of administered cycles was 4 (range 2-8). We observed 16 complete (53%; 95% confidence interval, 34%-72%) and 3 partial remissions, for an overall remission rate of 63% (95% confidence interval, 44%-80%). Responses were seen only among patients who achieved at least a partial response during first-line therapy. The median duration of complete remission was 15 months (range 5-47+), whereas median survival of the treated patients was 26 months (range 2-50+). Five patients were long-term responders after 34+, 35+, 46+, 46+ and 47+ months. No-life threatening toxicity was observed. The main side effects were myelosuppression, nausea/vomiting and alopecia. CONCLUSIONS: The proposed regimen is feasible and effective in terms of complete remission rate and disease-free survival, suggesting that this treatment may be potentially curative in a subgroup of relapsed patients with limited tumor burden and normal LDH values. A more aggressive approach is needed in refractory patients.

Adult↗
PubMed1993

Prognostic factors in patients affected by hepatocellular carcinoma treated with systemic chemotherapy: the experience of the National Cancer Institute of Milan.

BACKGROUND: Survival times and overall response rates are generally poor in patients with unresectable hepatocellular carcinoma submitted to systemic chemotherapy. Limited data are reported in the literature concerning the factors influencing survival among this subset of patients but the distribution of these variables may affect the results of clinical trials. PATIENTS AND METHODS: The data on 103 patients undergoing systemic chemotherapy at the Istituto Nazionale Tumori from January 1988 through July 1991 have been analyzed using univariate and Cox multivariate analysis. Forty-eight patients were treated with mitoxantrone alone, 40 with mitoxantrone plus beta-interferon, 11 with fluorouracil plus folinic acid and the remaining four with adriamycin. RESULTS: Median survival time, and 6-month and 12-month survival rates, were 7.1, 55% and 29%, respectively. Lactate dehydrogenase value (P = 0.0009), TNM stage (P = 0.001), vascular invasion (P = 0.001), bilirubin (P = 0.008), Child status (P = 0.01), aspartate amino-transferase (P = 0.02), extent of liver involvement (P = 0.02) and performance status (P = 0.03) were the most significant factors influencing survival in univariate analysis. In the multivariate analysis, aspartate amino-transferase (P = 0.02) and, particularly, TNM stage (p = 0.0009) were confirmed as independent variables correlating with survival. A prognostic index was calculated on the basis of these factors and high- and low-risk groups were identified. Median survival time and 12-month survival were 11.1 months and 43% for the low-risk group, and 4.0 months and 9% for the high-risk group (p = 0.0005). CONCLUSION: The results of this analysis may provide guidance for the design of future therapeutic trials in unresectable hepatocellular carcinoma. In particular, patient stratification should be considered for further clinical trials.

Aged↗
PubMed1993

Treatment of carcinoid syndrome with recombinant interferon alpha-2a.

The prognosis and the quality of life of patients with carcinoid tumors is related either to symptoms from the substances secreted or to progressive tumor growth. Medical treatment with cytotoxic agents is of marginal value for increasing life expectancy and reducing clinical symptoms. Recent studies with interferon have shown interesting results. In the present investigation, 22 patients with carcinoid tumors and syndrome were treated with recombinant interferon alpha-2a (r-IFN alpha-2a) at the dose of 6 x 10(6) IU intramuscularly daily for 8 weeks and three times weekly thereafter. The primary tumor was localized in the foregut (n = 11), midgut (n = 7), hindgut (n = 1), and unknown site (n = 3). Most cases had liver metastasis. Seventeen patients had elevated 5-hydroxyindoloacetic acid (5-HIAA) excretion and 5 had flushing and/or diarrhea as the only clinical manifestation. Six cases presented a complete syndrome (flushing, diarrhea and 5-HIAA excretion). Control of symptoms was obtained in 80% and a 5-HIAA level reduction in 58% of the patients. The interferon treatment was more effective for control of the carcinoid syndrome than for control of tumor growth. The treatment was well tolerated and fever, myalgia, anorexia and fatigue were the most frequent side-effects.

Adult↗
PubMed1993

Salvage treatment after r-interferon alpha-2a in advanced neuroendocrine tumors.

The use of inteferon (IFN) in neuroendocrine advanced tumors has achieved control of hormonal symptoms but low objective tumor response rate. In patients resistant to, or failing on, IFN a second line treatment may be required. Seventeen patients having received recombinant IFN alpha-2a as last treatment entered the study. There were 12 carcinoids, 3 medullary thyroid carcinomas, one Merkel cell carcinoma, and one neuroendocrine pancreatic tumor. Two different treatments were used: one radiometabolic therapy with metaiodobenzylguanidine (MIBG) in 3 patients with high MIGB uptake and one polychemotherapy regimen, including streptozotocin 500 mg/m2 intravenously days 1, 2, 3 and epirubicin 75 mg/m2 intravenously day 1, in the remaining 14 patients. Stable disease with relief of symptoms and tumor marker reduction was obtained in two patients receiving MIGB therapy, whereas the third patient had progressive disease. In the chemotherapy group only one partial response was obtained and neither tumor marker reduction nor subjective improvement were seen. Our second-line treatment was not especially effective but may be considered for rapidly progressive and/or symptomatic disease. The radiometabolic therapy appears promising in symptomatic patients with small tumor burden whereas our chemotherapy regimen appears ineffective.

3-Iodobenzylguanidine↗
PubMed1992

Adjuvant chemotherapy for cancer of gastrointestinal tract: a critical review.

Surgery is the only curative therapeutic approach for gastrointestinal tumors. If the tumor is deeply infiltrating through serosa or invading regional lymph nodes, the 5-year patient's survival is about 60% and < 40%, respectively. The natural history and prognosis of neoplasms from colon, rectum and stomach are different. Despite the unsatisfactory results obtained with radical treatment of advanced disease, there are positive studies on adjuvant treatment of colon and rectal cancer, whereas the role of such an approach is still controversial for gastric cancer. The combination of fluorouracil containing chemotherapy with radiotherapy was suggested as the most effective adjuvant treatment for patients with Dukes' B and C rectal cancer. However, the choice of chemotherapeutic regimen is still debated. A recent report, from the North Central Cancer Tumor Group, stated survival and disease-free survival advantages for patients with Dukes' C colon cancer treated with FU + levamisole for 1 year after radical surgery. Since this regimen was not proven effective in advanced disease, ongoing adjuvant trials are comparing it with the combination of FU + biochemical modulator. The role of adjuvant therapy for gastric cancer is debated. The recent development of regimens active on advanced disease result in more promising future adjuvant trials.

Chemotherapy, Adjuvant↗
PubMed1992

Reversal of resistance to doxifluridine and fluorouracil in metastatic colorectal cancer: the role of high-dose folinic acid.

The benefits from medical treatment in colorectal cancer are limited. Fluorouracil remains the only recognized drug, and how to treat unresponsive patients is still debated. To evaluate the role of folinic acid (FA) in circumvence resistance in colorectal cancer, 28 patients pretreated with fluoropyrimidine were candidated to receive one of the following schedules: fluorouracil (600 mg/m2) associated with FA (500 mg/m2) weekly for 6 weeks (Regimen A: 21 cases), or fluorouracil (370 mg/m2) plus FA (200 mg/m2) daily for 5 days every 4 weeks (Regimen B: 7 cases). Fourteen patients were pretreated with doxifluridine, a new fluoropyrimidine derivative with a peculiar mechanism of action, and the remaining 14 patients with fluorouracil. All but 2 patients were unresponsive to first-line treatments. When the treatment began, the median age of the patients was 60 years (range, 30-68). The performance status (ECOG) was 0/1 in 25 of them, and the primary tumor was in the colon and rectum in 19 and 9 patients, respectively. Sites of disease were liver (64%), lung (35%), local recurrence (10%) and peritoneum (10%). A median of 3 cycles (range, 1-7) was delivered, and no objective response was observed in the group of patients pretreated with doxifluridine or in the group pretreated with fluorouracil. In 5 cases a significant decrease in baseline CEA values was observed. Therapy was well tolerated, and no grade 4 toxicity was encountered. Severe toxicity was limited and included diarrhea (7 patients), stomatitis (1 patient) and nausea/vomiting (1 patient). High-dose FA has no role in reversing resistance to fluoropyrimidine, and other mechanisms of refractoriness are surely involved. FA should be associated with fluoropyrimidine as first-line therapy together with other biochemical modulators. Further rescue therapies need to be developed.

Adult↗
PubMed1992

Classic Kaposi's sarcoma: a review of 90 cases.

A series of 90 cases of classic Kaposi's sarcoma observed and treated over the last 25 years was examined retrospectively. Fifty-one were the localized and 39 the disseminated form. Outpatient surgery for the localized and vinblastine chemotherapy for the disseminated form are probably the best treatments. Radiotherapy may be a valid alternative.

Adolescent↗
PubMed1992

Mitoxantrone in patients affected by hepatocellular carcinoma with unfavorable prognostic factors.

Patients affected by hepatocellular carcinoma (HCC) with unfavorable prognostic factors have limited therapeutic options due to moderate responsiveness to chemotherapeutic agents and lack of compliance with such treatments. In this study the feasibility and efficacy were evaluated of a treatment with mitoxantrone(dihydroxyanthracenedione, DHAD), 12 mg/m2 i.v. on day 1 every 3 weeks. We included 18 patients with poor-risk HCC ineligible for our other trials in relation to their performance status [8], pretreatments [6], age over 70 years [5], severe concomitant illness [6], and altered blood count [platelets less than 100,000/mm3) [8]. Of 17 evaluable cases, there were 4 partial remissions (23%) (95% confidence interval, 10-47%), 6 no changes, and 7 progressions. There were no drug-related deaths, and side effects were moderate and documented only in a few cases. Median survival of evaluable patients was 5 months (range, 1-15). The results were comparable with those obtained with adriamycin but without important toxicity. We conclude that DHAD seems to be safe and moderately active in poor-risk HCC.

Aged↗
PubMed1991

Well-differentiated neuroendocrine carcinoma of the lung: a case report.

Well-differentiated neuroendocrine carcinoma (WDNC) of the lower respiratory tract displays clinical and radiologic features intermediate between carcinoids and small cell carcinoma and shares some biologic characteristics with both. We describe a case of WDNC resistant to three different treatments. The patient, a 42-year-old woman, received 2 cycles of chemotherapy before coming to our observation, including cyclophosphamide, adriamycin and vincristine, with progression of disease. We administered r-alpha-2a interferon for 2 months, but the patient showed clinical progression. Therefore, streptozotocin associated with epirubicin was utilized, but the patient died of disease progression after 4 cycles and 10 months from the first treatment. The case of WDNC described in this report showed an unusual aggressive clinical course and was refractory to conventional and unconventional treatments. The proper management for WDNC is still unknown. However, according to literature data, the chemotherapeutic schemes employed for small cell lung cancer represent the first treatment choice for WDNC. Further studies are needed to help define treatment strategies according to the biology of the tumor.

Adult↗
PubMed1991

New developments in breast cancer research.

The last few years have shown an extraordinary development of laboratory and clinical research in breast cancer. The areas which appear particularly important for possible clinical application are many and diversified. In this review we will update the present knowledge regarding four major issues: 1) biologic and molecular tests of prognostic significance in operable breast cancer patients; 2) detection of breast cancer cells in the bone marrow; 3) the endocrine aspects of breast cancer treatment; and 4) the indication of conservative treatments.

Breast Neoplasms↗
PubMed1990

Phase II study of interferon alpha-2a and dacarbazine in advanced melanoma.

Based on the report of some activity of combination therapy with dacarbazine (DTIC) and interferon alpha-2a (rIFN alpha-2a) in disseminated melanoma, we conducted a phase II study to determine the feasibility and efficacy in a large series of patients. DTIC was administered in 79 patients at the dose of 800 mg/m2 every 3 weeks and rIFN alpha-2a was given daily at the dose of 9 X 10(6) IU for the first 10 weeks and three times a week thereafter. Among the 75 evaluable patients, 25% achieved an objective response, with 8% complete and 17% partial remissions. The regression occurred within a mean time of 1.9 +/- 1.03 months from starting therapy and the mean duration of response was 8.2 +/- 4.2 months. The major side effects were vomiting, anorexia, fever, fatigue, and myalgia. There was one death related to sepsis after myelosuppression. In the other patients bone marrow and liver toxicities were not remarkable. Our data reveal that a combination regimen of rIFN alpha-2a with a cytotoxic agent has some therapeutic activity in the management of advanced malignant melanoma.

Adolescent↗
PubMed1988

Phase II study with ifosfamide in advanced malignant melanoma.

Ifosfamide was tested in a phase II study in 12 evaluable patients with advanced malignant melanoma. The drug was administered at the dose of 3 g/m2 on days one and two every 3-weeks. Seven patients were not previously treated and 5 received only minimal prior chemotherapy. Visceral involvement was present in 9 patients, and the remaining 3 had only soft tissue lesions. No patient showed objective tumor response. Mild vomiting was observed in 75% of patients; alopecia occurred in all of them. No other major side effects were observed, in particular, myelotoxicity and urotoxicity. Lack of response advised us to discontinue patient accrual. Our data do not support a therapeutic role of ifosfamide at the given dose schedule in the treatment of metastatic malignant melanoma.

Adult↗
PubMed1988

Combined modality treatment for stage I-II non-Hodgkin's lymphomas: CVP versus BACOP chemotherapy.

This paper reports the 5-year results of a prospective randomized study beginning in 1976 on 177 evaluable patients with pathologic Stage I-IE and II-IIE non-Hodgkin's lymphomas with diffuse histology according to the Rappaport classification. Treatment consisted of either CVP or BACOP chemotherapy (3 cycles) followed by regional radiotherapy (40 to 50 Gy) and further cycles of either combination. In both arms, complete remission at the end of combined treatment was high (CVP 93%, BACOP 98%) regardless of age, stage or bulky disease. At 5 years, the comparative freedom from first progression was 62% for CVP vs 78% for BACOP (p = 0.02), respectively. Clinically relevant differences favoring BACOP chemotherapy were essentially documented in patients with large cell lymphomas (International Working Formulation), those with Stage II having more than three involved anatomical sites, bulky disease and age over 60 years. Recurrence within radiation fields was documented in only 5% of complete responders. Combined treatment was, in general, well tolerated particularly when BACOP was used. In only 2 patients given CVP post radiation cutaneous fibrosis was documented. Second solid tumors were detected in 4 patients. One patient started on CVP died because of brain stem necrosis after 45 Gy. We conclude that in Stage I-II patients with nodal and extranodal diffuse non-Hodgkin's lymphomas, particularly large cell lymphomas, combined modality approach with primary Adriamycin and bleomycin containing regimen, such as BACOP, followed by adjuvant radiotherapy offers high chances of cure with minimal toxicity.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

Cyclophosphamide, adriamycin, and cis-platinum (CAP) in metastatic and locally advanced breast cancer.

A combination of cyclophosphamide, adriamycin, and cis-platinum (CAP) was tested in 20 previously untreated patients with locally advanced or metastatic breast cancer with the aim of assessing the ability of this platinum-containing regimen to induce a high complete remission rate. The drug regimen was given on a 3/week schedule at the following doses: cyclophosphamide 200 mg/m2 i.v. on days 1, 2, 3; adriamycin 40 mg/m2 i.v. or day 1 and cis-platinum 20 mg/m2 i.v. plus hydration on days 1, 2, 3. In the absence of progression, six cycles of CAP were planned and response was evaluated at that time. Thirteen of 20 patients achieved partial remission (65%) but only one obtained complete remission (5%). Overall median duration of response was 9 months (range 4-20 + months). Tumor response was mainly documented in soft tissues (primary tumor: 14 of 16; other sites: 19 of 20). Grade II leukopenia was documented in 60% of patients. All patients experienced moderate to severe gastrointestinal toxicity and alopecia was universal. No renal toxicity was observed. Although CAP regimen at the given dose schedule induced a high overall response rate (70%), the complete remission rate in this limited number of patients was lower than expected. These results do not appear superior to those achieved with conventional drug regimens.

Adult↗
PubMed1988

Mitoxantrone: an active agent in refractory non-Hodgkin's lymphomas.

A phase II oriented study with mitoxantrone was undertaken in 31 patients with refractory non-Hodgkin's lymphomas (NHL); 30 patients had evaluable disease. The drug was administered through a 30-min intravenous infusion at the dose of 14 mg/m2 every 3 weeks. A minimum of two cycles were required to define treatment response. Twenty patients were previously treated with Adriamycin whose total dose was not exceeding 300 mg/m2. Complete response (CR) was documented in 9 patients, and partial response (PR), in 5 for a total response rate of 47% (14 of 30). Of 20 patients previously treated with Adriamycin, CR occurred in five and PR in two. The median time to progression was 3 months. Mitoxantrone was well tolerated, and no patient refused treatment. Mild leukopenia was evident in 10 patients and thrombocytopenia in 5 patients. In all cases, electrocardiograms (EKGs) was obtained before each treatment cycle. Systolic time intervals and left ventricular ejection fraction were repeated after 3 cycles and at the end of therapy. Laboratory tests failed to document any major cardiac abnormality. Mitoxantrone is an effective agent in refractory NHL and should be taken into consideration in the design of salvage regimens.

Adult↗
PubMed1987

Four-drug sequential regimen in advanced breast cancer.

The results of two empirically designed and potentially non-cross-resistant combinations administered sequentially in advanced breast cancer with the intent of achieving a high rate of durable complete remissions were analyzed. The two drug combinations consisted of cyclophosphamide plus Adriamycin and high-dose methotrexate plus cisplatin given for a total of three cycles; twenty evaluable patients, not previously treated with chemotherapy, were entered into the study. Ten patients were allocated to receive cyclophosphamide and Adriamycin first followed by high-dose methotrexate and cisplatin, while the remaining patients received the opposite sequence. The overall response rate for the entire group was 85% (17 of 20). However, only three of 20 (15%) patients achieved complete remission. One additional complete response was observed when treatment was prolonged for an additional complete cycle. The overall median duration of response was 13 months (range, 5-20+ months). Responses were similarly distributed among different sites of lesions. Myelosuppression and gastrointestinal toxicity were mild and transient. Reversible acute renal failure was observed after methotrexate administration in three cases. Present results indicate that overall this sequential treatment appears effective in patients with advanced breast cancer. However, the lack of an increased complete remission rate over conventional regimens coupled with a potential risk of renal toxicity prevents further studies with this multiple drug combination.

Adult↗
PubMed1987

The clinical significance of melatonin serum determination in oncological patients and its correlations with GH and PRL blood levels.

In order to investigate the pineal function and its relation with the hypophysis in human neoplasms, melatonin and GH serum levels were determined in 63 patients, 42 affected by solid tumours and 21 by lymphoma or leukaemia. In women with breast cancer PRL was also measured. Melatonin, GH and PRL were evaluated in 52 healthy subjects acting as controls. The oncological patients showed significantly higher mean melatonin serum levels than the control subjects. Mean melatonin values were lower in patients with solid tumours who had metastases, than in cases without metastases. Chemotherapy caused an evident decrease in melatonin levels. Surgery was followed by a fall in melatonin in patients without metastases. Mean GH serum levels observed in oncological patients were similar to those in control subjects and were not influenced by therapy. PRL levels were within the normal range in women suffering from breast cancer.

Adolescent↗