Biomedical subjects
G Papa
Publications and source records attributed to G Papa.
Multiple skin tumors in long-term treatment with hydroxyurea.
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Extended-field radiotherapy is superior to MOPP chemotherapy for the treatment of pathologic stage I-IIA Hodgkin's disease: eight-year update of an Italian prospective randomized study.
PURPOSE: To compare the effectiveness of chemotherapy (CHT) with extended-field radiotherapy (RT) in the treatment of early-stage Hodgkin's disease (ESHD), we report an 8-year updated analysis of a study in which treatment with six cycles of mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) CHT was randomly compared with extended-field RT. PATIENTS AND METHODS: From August 1979 to December 1982, 89 adult patients with pathologic stage I-IIA Hodgkin's disease (HD) were randomly allocated to receive either RT with mantle field followed by periaortic irradiation (n = 45) or six monthly courses of MOPP CHT (n = 44). RESULTS: All patients in the RT arm and 40 of 44 in the CHT arm achieved complete remission. Twelve relapses occurred in each group. Eight patients treated with MOPP and two of the RT arm died of HD. Three other patients of the CHT group died because of a second cancer. With a median follow-up greater than 8 years, the overall survival rate is significantly higher in the RT than in the CHT group (93% v 56%; P less than .001), whereas the rates of freedom from progression and relapse-free survival (RFS) were similar in the two groups (76% v 64% and 70% v 71%, respectively). Of the 12 patients relapsing after RT, 11 (92%) achieved a second CR, compared with only six of the 12 (50%) in the MOPP group. Analysis of the response rate to salvage treatments showed that the type of relapse in the MOPP group was a prognostic indicator for the achievement of a second CR, whereas in the RT group, a second CR was obtained regardless of the characteristics of the relapses. At 80 months, the probability of survival of relapsing patients calculated from time of relapse was 85% and 15% in the RT and CHT groups, respectively (P = .02). CONCLUSION: We conclude that RT alone is the treatment of choice for adult patients with ESHD with favorable prognostic factors.
[Recent biological and therapeutic advances in multiple myeloma].
Multiple myeloma still remains a fatal disease. However, in the last months new biological and clinical informations have been provided about this disease. In particular, the immunophenotype of myeloma cells seems indicate, in some patients, a clonal involvement of a stem cell in the pathogenesis of mieloma. Moreover, new biological insights concerning the cytokine network, have revealed a probable effect of some cytokines, such as IL6, IL3, IL4. Finally, new insights in the biology of multiple myeloma have been provided by studies of molecular biology and flow cytometry. As for therapy, the best conventional induction treatment still remains to be defined. In the last years, the increased use of alpha Interferon and new therapeutic modalities, such as transplantation procedures in multiple myeloma, open new hopes toward a cure of this disease. Therefore, in the future a better knowledge of the multiple myeloma biology, associated with a wider use of new effective therapeutic approaches will certainly improve the natural course of this disease.
F-MACHOP in advanced aggressive lymphoma.
The results of our ten years experience indicate that F-MACHOP, conceptually designed to exploit cell kinetic and synergistic principles, is an effective regimen with acceptable toxicity in a large proportion of adults with advanced stages of diffuse large cell or small non-cleaved cell lymphoma. More than 60% of all treated patients all expected to achieve long-term EFS. Patients achieving CR within 3 courses have a very high chance of being cured of their disease and do not require, in our opinion, intensification with other regimens. On the other hand the identification of a group of patients with poorer outcome (i.e. those failing to achieve an early CR) enabled testing of the potential efficacy of superintensive salvage regimens. Together with other 6 Italian hematologic institutions, we have recently participated in a prospective comparative randomized trial in which F-MACHOP was compared to MACOP-B in adults with advanced stages of diffuse large cell or small non-cleaved cell lymphoma. The preliminary results of this trial appear to confirm that F-MACHOP is an effective and tolerable regimen in such patients and there is a suggestion that its efficacy is superior to that of MACOP-B. This trial was closed to accrual in September 1991 and we look forward to the first complete analysis in March 1992.
[Efficacy and safety of amrinone in the treatment of heart insufficiency in intensive care].
The authors describe the results obtained treating with amrinone for 48 hours 11 patients with acute heart failure. The patients (4 males and 7 females), age range between 50 and 82 years) received an initial bolus of 0.75 mg/kg followed by and infusion which on average was of 5.82 +/- 1.06 (SD) micrograms/kg/min. Besides a subjective and objective clinical improvement they could observe a quick and remarkable improvement of the main hemodynamic parameters (cardiac index, cardiac output, pulmonary capillary wedge pressure, mean pulmonary pressure). The tolerability of the drug was good, except for a decrease in platelet, already described in literature. In conclusion, the Authors consider amrinone a very interesting drug for its positive inotropic and vasodilating activity and because it does not cause an increase of the myocardial oxygen consumption.
[Role of oxygen venous saturation monitoring and CAVH in the multiple organ failure syndrome. Description of a clinical case].
A 42 year old man was admitted to the intensive Care Unit with signs and symptoms of septic shock, associated with adult respiratory distress syndrome (ARDS), jaundice and acute renal failure. In order to support different organs failures mechanical ventilation (IPPV, PSV, CPAP), continuous arteriovenous hemofiltration were affected, and continuous intravenous infusion of dopamine and dobutamine was started. After and during application of these therapeutic measures, continuous monitoring of mixed venous blood oxygen saturation (SvO2) was applied by Swan-Ganz fiber optic catheter in the pulmonary artery. Monitoring of SvO2 represented a useful means to guide inotropic therapy and to assess the hemodynamic effects of CAVH and mechanical ventilation. The case reported emphasized the role of continuous venous oximetry in multiple organ failure syndrome.
A metastatic breast carcinoma presenting as autoimmune hemolytic anemia.
The authors describe the case of a 75-year-old female who was hospitalized for anemia of unknown origin. Physical examination revealed a swelling in the right mammary region, where a mastectomy scar was present from surgery for a breast carcinoma. On admission, laboratory tests disclosed anemia (Hb, 8.5 g/dl), with a reticulocyte count of 65,000/mm3 and slightly increased bilirubin. Immunohematologic study revealed the presence of a red cell autoantibody with anti-D specificity in the serum and in the eluate from the patient's erythrocytes. A biopsy of the swelling was performed and histologic examination showed the presence of metastatic cells of breast carcinoma. The patient was given chemotherapy and radiotherapy. At this writing the anemia was absent, the immunohematologic study was negative, the swelling was greatly reduced, and no other metastatic lesions of breast carcinoma were present.
Prevention of relapse in nasal polyposis.
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Non-Hodgkin lymphomas of the central nervous system.
Non-Hodgkin lymphomas (NHL) of the Central Nervous System (CNS) are rare but they nonetheless constitute a clinical, biological and therapeutic problem of great interest. Primary lymphomas of the CNS account for 2% of all malignant lymphomas and for 0.3-1.5% of all intracranial tumors. Surgery and radiotherapy afford only poor control of the disease. The most satisfactory results have been achieved with combination therapy, surgery + radiotherapy + chemotherapy, but the optimal combination has still to be devised. Secondary neuromeningeal involvement affects a fair number of patients with systemic NHL. The symptoms are broadly the same as in CNS NHL and the treatment as problematic. There have recently been suggestions that the onset of CNS NHL may be exacerbated by immunodeficiency states such as occur in patients who have undergone organ transplantation, in autoimmune disease and, still more recently, in the acquired immunodeficiency syndrome (AIDS). The frequency of these tumors is anyway on the increase and a better insight into the disease in essential.
In vitro radiation survival parameters of human colon tumor cells.
As part of an ongoing research program in the biology of human colon cancer cells, a database is being generated on the radiation responses of established lines in vitro. In this report, data are summarized on the graded single dose clonogenic survival responses to graded single doses of 250 kVp X rays of 16 exponentially growing lines. These data were analyzed using the linear quadratic (LQ) formalism for X ray inactivation; the 95% confidence limits on the colony forming efficiencies (CFEs), the alpha and beta parameters from the LQ equation, the surviving percentage at 2 Gy, and the mean inactivation dose (D, Gy) are listed herein. The average D from these 16 colon tumor lines was 2.35 Gy (95% confidence limits 2.10-2.60 Gy), which indicates that these tumor cells are of equal radioresistance to melanoma or head and neck cells, with only glioblastoma cells being of greater radioresistance.
Is interferon alpha in cutaneous T-cell lymphoma a treatment of choice?
This study was designed to evaluate the therapeutic efficacy and toxicity of recombinant interferon alpha-2a (rIFN alfa-2a) given as initial systemic therapy in untreated mycosis fungoides and/or Sezary's syndrome patients, at a slowly escalating schedule up to the maximal tolerated dose. At the same time this schedule was administered in patients who had relapsed or were refractory to previous treatment; 28 newly diagnosed and 15 previously treated patients entered the study. IFN was given daily with dose escalation from 3 to 18 MU. The last follow-up in June 1990 indicates that 90% of previously untreated patients who obtained a complete remission remain in continuous complete remission after 18 to 40 months and that 75% of previously untreated patients who obtained partial remission remain in partial remission after 20-44 months. The event-free survival projected, calculated using the Kaplan and Meier product limit technique, was 21% of all patients at 54.7 months (40% in the previously untreated groups and 14% in the previously treated group: P = 0.12). In conclusion, interferon is very effective as a single agent in cutaneous T-cell lymphomas.
Second primary cancer following Hodgkin's disease: updated results of an Italian multicentric study.
The risk of second primary cancer (SPC) was evaluated in 947 patients treated for Hodgkin's disease (HD) during the period January 1969 to December 1979. The median follow-up of this series was 10.5 years (range, 9 to 19). Treatment categories included radiotherapy (RT) alone (115 patients, 12%), chemotherapy (CHT) alone (161 patients, 17%), combined RT plus CHT (381 patients, 40%), and salvage treatment for resistant or relapsing HD (290 patients, 30.6%). Fifty-six SPCs were observed, occurring between 1 and 17 years from initial treatment. Among these, secondary acute nonlymphoid leukemia (s-ANLL) was the most frequent SPC (23 cases). Secondary non-Hodgkin's lymphoma (s-NHL) occurred in 5 patients, whereas a secondary solid tumor (s-ST) was observed in 28 patients. The calculated actuarial risk (+/- SE) of developing SPC was 5.0% (+/- 0.9%) and 23.1% (+/- 5.8%) at 10 and 19 years, respectively. Concerning treatment modalities and s-ANLL risk, no cases were observed in the radiotherapy group, whereas CHT plus RT and salvage groups showed the highest actuarial risk. This was, in fact, at 10 and 19 years, 3.1% (+/- 0.9%) and 8.1% (+/- 4.0%) in the former group, and 1.8% (+/- 1.0%) and 16% (+/- 9.0%) in the latter. A statistically significant difference was observed when the CHT plus RT group was compared with CHT and RT groups (P = .04). Concerning the relationships with chemotherapeutic regimens, 12 s-ANLL cases occurred in the mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) plus RT group, and only one case in the group receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus RT. A statistically significant difference of s-ANLL actuarial risk was found comparing patients receiving MOPP plus RT to all other treatment groups (P = .04). With respect to s-ST, the actuarial risk at 10 and 19 years was 2.0% (+/- 0.6%) and 13.0% (+/- 3.8%), respectively. No significant differences were found among groups treated with different modalities. These data were confirmed by a multivariate analysis, which indicated treatment modality and age as independent variables for s-ANLL and s-ST development, respectively. Based on the prolonged follow-up analysis, the actuarial SPC risk at 10 years hereby reported should reflect the real SPC incidence in our series.
MACOP-B vs F-MACHOP in the treatment of high-grade non-Hodgkin's lymphomas.
From September 1988 two hundred-sixty-seven (267) untreated patients (pts) with stage II to IV high grade non Hodgkin's lymphoma (NHL) have been enrolled in a multicenter, randomized, still ongoing study, comparing two third-generation combination chemotherapy regimens, MACOP-B versus F-MACHOP. At the present time, 177 pts have completed the treatment program and are evaluable, with a median follow-up of 13 months. Clinical, histologic and laboratory characteristics are equally distributed in both groups. Among the 92 pts treated with MACOP-B, 58 (63%) achieved a complete remission (CR), 17 complete responders have relapsed (29%), and 21 have died (23%), including 3 treatment-related deaths. Among the 85 pts who received F-MACHOP, 65 (76%) achieved a CR, 9 complete responders have relapsed (14%), and 11 pts have died (13%), including 3 treatment related deaths. 30 months-projected survival is 64% for MACOP-B treated pts compared to 84% for F-MACHOP treated pts; 30 months-projected relapse- free survival is 80% and 84%, respectively. F-MACHOP seems to be superior in immunoblastic lymphoma (overall survival, OS, 82% vs. 54%) and in Burkitt-type lymphoblastic lymphoma (OS 100% vs, 42%). The degree of hematological and non-hematological toxicity was similar in both regimens. More reliable conclusions will be drawn after a longer follow-up.
Intranasal treatment with lysine acetylsalicylate in patients with nasal polyposis.
Forty-three patients suffering from nasal polyposis underwent intranasal treatment with increasing doses of lysine acetylsalicylate (LAS) corresponding to 20, 200, and 2000 micrograms of aspirin (ASA), until a maximal dose of 2000 micrograms weekly was reached. The patients were divided in two groups: a group of 28 patients with ASA intolerance, including 20 with ASA triad, and a group of 15 patients without ASA intolerance. The local treatment was usually started 1 month after polypectomy and was well tolerated without side effects. A control group included 191 subjects with nasal polyposis, 130 of whom had ASA intolerance. After polypectomy the controls received no further medical treatment. Patients were examined every 3 months and radiographs of the paranasal sinuses were obtained every 6 months. After 24 months 34 of 43 patients (79.1%) treated with topical LAS had suffered no relapse of polyposis. Only 45 of 191 control patients (23.6%) failed to relapse after 24 months (P less than .0001). Nine of 28 (32.1%) ASA-intolerant patients treated with LAS and 105 of the 130 (80.77%) control subjects relapsed (P less than .0001). None of the 15 ASA-tolerant patients treated with LAS relapsed, but 41 of the 61 (67.21%) nontreated control subjects relapsed (P less than .00001). These data indicate topical LAS is effective in preventing recurrence of nasal polyps after polypectomy.
The F-MACHOP regimen in advanced diffuse aggressive lymphomas: summary of ten years' experience at a single institution.
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Alpha-2b recombinant interferon (Intron) in Hodgkin's lymphoma: therapeutic perspective.
In an ongoing phase II study we are evaluating the role of alpha-2b recombinant interferon in Hodgkin's disease; the study design includes patients with high-risk parameters who are treated by combination chemotherapy MOPP, ABVD, MOPP + ABVD or equivalent combinations. At the end of the therapeutic program which could include also radiotherapy, patients will be randomly assigned to receive alpha-2b interferon at 3 MU/day over 3 months and then 3 MU/three times/week over 9 months or no further treatment. Up to September 1989, 107 patients were randomized; evaluable patients with a minimum follow-up of 3 months are 95, 56 in the arm of interferon and 39 in the arm of no further treatment. The results are preliminary and differences could not be disclosed between the two arms concerning either the relapse rate or the incidence of infections. Tolerance and toxicity due to alpha-2b interferon in patients with Hodgkin's disease could be defined as acceptably good considering that mild and reversible hematological toxicity was experienced in 12 (21%) patients; objective clinical toxicity was recorded in 4 (7%) patients although 7 (12%) patients refused to continue the treatment. Definite conclusions will be drawn when 100 patients per arm become evaluable.
Interferon alpha-2a in cutaneous T-cell lymphoma.
23 newly diagnosed patients affected by cutaneous T-cell lymphoma were treated with sub-cutaneous interferon alpha-2a to evaluate the therapeutic efficacy and the toxicity of this agent. IFN was administered daily with dose escalation from 3 to 18 million units for 12 weeks; thereafter, patients induced into complete (CR) or partial (PR) remission were given IFN at maximal tolerated dose 3 times weekly for 6 or 9 months. The objective tumor response was observed in 17 patients (74%): 8 (35%) were CR and 9 (39%) were PR. A 74-yr-old patient died because of neutropenia and sepsis at the end of induction phase, while receiving IFN at dose of 18 million units. Disease stage is the initial feature predictive of response to IFN therapy. The dose schedule of this study was well tolerated: only 3 patients developed liver toxicity, while leukopenia was evident in 6 patients. Only 2 CR patients have relapsed, 18 and 24 months from response; the remaining 6 CR patients are in continuous complete remission with a median follow-up of 41.8 months. 6 PR patients have progressed from 8 to 17 months after response, and in the 3 PR patients not yet progressed the response duration ranges from 20 to 24 months. In conclusion, interferon alpha-2a is a very effective agent in therapy of untreated cutaneous T-cell lymphoma with an overall response rate of 74%.