RESUMEN
Fifteen patients with inoperable non oat cell lung carcinoma, who had already been treated with telecobalt therapy in the mediastinum-hilar region, were treated with continuing therapy with misonidazole (MISO) and cyclophosphamide (Cy). MISO was administered in single doses of 1000 mg/m2 and 500 mg/m2, orally. Cy was administered in single doses of 500 mg/m2 and 250 mg/m2, i.v. This treatment was given every 4 weeks. All patients (15/15) suffered from hyporexia, nausea and vomiting within 48 hours from administration; furthermore, 2 patients had hemoragic cystitis, 2 had peripheral neurotoxicity, 3 had fever, and 2 had serious nervous depression. Leukopenia occurred in all patients immediately after drug administration, although it was not present in any patient by the time of the next administration. This clinical trial was concluded in December 1981. The follow-up at 18 months shows 7/15 cases of relapse (3 patients dead and 1 patient alive with recurrence, 2 patients dead and 1 patient alive with metastasis without recurrence). Eight of 15 patients are alive with progression of disease from 8 to 18 months.
Asunto(s)
Ciclofosfamida/uso terapéutico , Neoplasias Pulmonares/terapia , Misonidazol/uso terapéutico , Nitroimidazoles/uso terapéutico , Adulto , Anciano , Terapia Combinada , Ciclofosfamida/efectos adversos , Ciclofosfamida/sangre , Sinergismo Farmacológico , Quimioterapia Combinada , Femenino , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/radioterapia , Masculino , Persona de Mediana Edad , Misonidazol/efectos adversos , Misonidazol/sangre , Fármacos Sensibilizantes a Radiaciones/efectos adversos , Fármacos Sensibilizantes a Radiaciones/uso terapéuticoRESUMEN
Thirty-four patients affected by primary pulmonary carcinoma or in a state of recurrence after surgery were analyzed and 2g/m2 of etanidazole was administered intravenously. After 30 min (group A), 60 min (group B), and 120 min (group C), both the bronchus affected by the carcinoma and the contralateral bronchus were biopsied. Of the 34 patients, 24 had histologically proven carcinoma and were enrolled in the study. Etanidazole determination was carried out with a polarographic method both in plasma and tissue. The results obtained indicate that the most favorable concentration of etanidazole in the tissue is at 30 min after administration and at this point is most beneficial when associated with radiotherapy. The tumor/plasma ratio of etanidazole examined in three phases is relatively higher than that noted with HPLC; however, it is compatible with the methodology used and previous studies carried out on other tumors.
Asunto(s)
Carcinoma Broncogénico/radioterapia , Neoplasias Pulmonares/radioterapia , Nitroimidazoles/farmacocinética , Fármacos Sensibilizantes a Radiaciones/farmacocinética , Anciano , Carcinoma Broncogénico/tratamiento farmacológico , Carcinoma Broncogénico/metabolismo , Terapia Combinada , Etanidazol , Femenino , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/metabolismo , Masculino , Persona de Mediana Edad , Nitroimidazoles/sangre , Nitroimidazoles/uso terapéutico , Fármacos Sensibilizantes a Radiaciones/uso terapéutico , Valores de ReferenciaRESUMEN
PURPOSE: The aim of the study was to evaluate the efficacy and toxicity of Etanidazole, a hypoxic cell sensitizer, combined with radiotherapy in the treatment of head and neck squamous cell carcinoma. METHODS AND MATERIALS: A total of 374 patients from 27 European centers were included in this trial between 1987 and 1990. Treatment was either conventional radiotherapy alone (between 66 Gy in 33 fractions and 74 Gy in 37 fractions, 5 fractions per week), or the same radiotherapy dose plus Etanidazole 2 g/m2, three times weekly for 17 doses. A minimization procedure, balancing for center, site, and T stage (T1-T3 vs. T4) was used for randomization. RESULTS: Among the 187 patients in the Etanidazole group, 82% received at least 14 doses of the drug. Compliance to the radiotherapy protocol was 92% in the Etanidazole group and 88% in the control group; the main cause of deviation was acute toxicity, which was observed at an equal rate in the two treatment groups. Fifty-two cases of Grade 1 to 3 peripheral neuropathy were observed in the Etanidazole group vs. 5 cases, all of Grade 1, in the control group (p < 0.001). The 2-year actuarial loco-regional control rates were 53% in the Etanidazole group and 53% in the control group (p = 0.93), and the overall 2-year survival rates were 54% in each group (p = 0.99). CONCLUSION: Adding Etanidazole to conventional radiotherapy did not afford any benefit for patients with head and neck carcinoma. This study failed to confirm the hypothesis of a benefit for patients with N0-N1 disease, which had been suggested by the results of a previous study (10).
Asunto(s)
Carcinoma de Células Escamosas/radioterapia , Etanidazol/uso terapéutico , Neoplasias de Cabeza y Cuello/radioterapia , Fármacos Sensibilizantes a Radiaciones/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Supervivencia sin Enfermedad , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dosificación Radioterapéutica , Análisis de Regresión , Insuficiencia del TratamientoRESUMEN
UNLABELLED: The use of recombinant human thyroid-stimulating hormone (rhTSH) has recently become available as an alternative diagnostic tool to assess the persistence and recurrence of differentiated thyroid carcinoma (DTC) in patients on thyroid hormone-suppressive therapy (THST) after near-total or total thyroidectomy and ablative doses of (131)I. We report the results of rhTSH administration in patients who were monitored for DTC. METHODS: Thirty-three adult DTC patients (13 men, 20 women; mean age +/- SE, 45.6 +/- 2.31 y; age range, 21-65 y) underwent diagnostic follow-up after rhTSH administration at a dose of 0.9 mg once a day for 2 d. Whole-body scanning and serum thyroglobulin (Tg) measurement were performed after rhTSH administration. Patients were divided into 2 groups depending on serum Tg concentrations on THST: 29 patients had Tg concentrations of <2 ng/mL (group A) and 4 patients had Tg values of >2 ng/mL (group B). RESULTS: In group A, Tg values remained at <2 ng/mL in 25 patients and increased from 1.1 +/- 0.14 ng/mL to 22.0 +/- 5.75 ng/mL (mean +/- SE) in 4 patients after rhTSH administration. Whole-body scanning did not reveal any uptake of (131)I in the 25 patients without an increase in Tg, whereas (131)I uptake was evident in 2 of the 4 patients with a rise in Tg. In group B, Tg values increased in all 4 patients from 17.3 +/- 6.35 ng/mL to 55.3 +/- 12.75 ng/mL, and (131)I uptake was evident in 3 of the 4 patients. No major adverse effects were reported after rhTSH administration. CONCLUSION: Our results show that the measurement of serum Tg concentrations after rhTSH has a higher diagnostic value than whole-body scanning in detecting the persistence of thyroid tissue. Therefore, rhTSH should be administered in TSH-suppressed patients with basal serum Tg concentrations of <2 ng/mL because the increment in serum Tg concentrations may reveal the persistence of thyroid tissue in these patients.
Asunto(s)
Carcinoma/diagnóstico por imagen , Radioisótopos de Yodo , Proteínas Recombinantes , Tiroglobulina/sangre , Neoplasias de la Tiroides/diagnóstico por imagen , Tirotropina , Adulto , Anciano , Carcinoma/diagnóstico , Carcinoma/tratamiento farmacológico , Carcinoma/secundario , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasia Residual , Cintigrafía , Neoplasias de la Tiroides/sangre , Neoplasias de la Tiroides/diagnóstico , Neoplasias de la Tiroides/tratamiento farmacológicoRESUMEN
BACKGROUND: High dose Epirubicin (HD-EPI) (>90 mg/m2) and Vinorelbine (VNR) demonstrated antitumor activity as single agent (about 20%) in the treatment of advanced NSCLC. This trial compares these two agents combined with cisplatin (CP). PATIENTS AND METHODS: From August 1992 to February 1996, 228 patients with locally advanced or metastatic NSCLC were randomized to receive either EPI 120 mg/m2 as i.v. bolus plus Cisplatin (CP) 60 mg/m2 on day 1 (regimen A) or VNR 25 mg/m2 as i.v. bolus on day 1 and 8 plus CP 60 mg/m2 on day 1 (regimen B). Both treatments were recycled every 21 days up to a maximum cumulative dose of EPI of 840 mg/m2 or 12 cycles. Eligible patients were 212 and 198 patients were evaluable for objective response (95 in arm A and 103 in arm B). The main characteristics of eligible patients were: male/female 179/33; median age 61 (42-72); median Karnofsky PS 80 (70-100); stage IIIA 12%, stage IIIB 40%, stage IV 41%, recurrence 7%; histotype: epidermoid 48%, adenoca 36%, others 16%. RESULTS: The following response rates were observed in regimens A and B, respectively; CR, 1 and 2%, PR, 32 and 25% (P = 0.4567). Median CR + PR duration was 9 and 8 months, respectively. Median survival was 10.5 and 9.6 months, respectively. Grade III-IV leucopenia occurred in 38 and 21% in arm A and arm B, respectively(P = 0.01), thrombocytopenia in 6 and 0% (P = 0.02), anemia in 8 and 7% (n.s.). Non-hematological toxicity was moderate and the only difference between the treatments was alopecia (88 vs. 33% in arm A and B, respectively). Supraventricular arrhythmia occurred in three patients on regimen A; a >15% LVEF absolute decrease was observed in 9 (22.5%) and three (14%) patients on arm A and arm B, respectively (n.s.). No congestive heart failure was observed. CONCLUSION: HD-EPI+CP and VNR+CP are both active combinations in advanced NSCLC with a similar response rate, response duration and survival but regimen A was significantly more toxic (myelosuppression and alopecia).
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Cisplatino/administración & dosificación , Esquema de Medicación , Epirrubicina/administración & dosificación , Femenino , Humanos , Italia , Neoplasias Pulmonares/mortalidad , Masculino , Persona de Mediana Edad , Análisis de Supervivencia , Resultado del Tratamiento , Vinblastina/administración & dosificación , Vinblastina/análogos & derivados , VinorelbinaRESUMEN
Microcytoma (SCLC) is generally regarded as a disease requiring chemotherapy and is only treated with radiotherapy using combined protocols. A number of different approaches have been proposed, changing timing, dose and fractionation. A different role is played by irradiation of the brain in the treatment of metastases. The authors discuss the role of radiotherapy in the treatment of SCLC and in study protocols through an analysis of a personal series.
Asunto(s)
Carcinoma de Células Pequeñas/radioterapia , Neoplasias Pulmonares/radioterapia , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundario , Carcinoma de Células Pequeñas/tratamiento farmacológico , Carcinoma de Células Pequeñas/patología , Femenino , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Neoplasias Torácicas/radioterapia , Neoplasias Torácicas/secundarioRESUMEN
Forty-seven patients with advanced small-cell bronchogenic carcinoma (SCLC) were treated with a combination of epirubicin (4-EPIDX) (60 mg/m2 i.v.) and cisplatin (CDDP) (50 mg/m2 i.v.) on day 1, alternated with cyclophosphamide (CTX) (800 mg/m2 i.v.) day 1 and etoposide (VP16) (120 mg/m2 i.v.) on days 21-23. Four patients (9%) obtained a complete remission and 27 (57%) a partial remission with an overall remission rate of 66%. The median duration of response was 37 weeks (range 13-150) and the median duration of survival was 43 weeks (range 10-150). No severe bone marrow depression was noted. The other side-effects were of a mild grade.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Broncogénico/tratamiento farmacológico , Carcinoma de Células Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Epirrubicina/administración & dosificación , Epirrubicina/efectos adversos , Etopósido/administración & dosificación , Etopósido/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
An allogeneic irradiated RCC cell line, engineered to produce IL-2 (ACHN-IL-2), admixed with autologous metastatic formalin-treated tumour cells, was used to vaccinate ten MRCC patients in progression of disease in spite of IL-2 immunotherapy. The cells were administered subcutaneously and/or intra-tumourally. Sixty-four MRCC patients in progressive disease, not treated by vaccination but receiving similar IL-2 immunotherapy, were considered as the control group. Patients received 4-16 injections (mean 9 +/- 4), containing an average of 10.6 x 10(7) +/- 7.7 x 10(7) ACHN-IL-2-transfected cells (a minimum of 4 x 10(7), and a maximum of 31 x 10(7)). Four patients also received intra-tumour injections. Vaccination was administered during 30-418 days, and the follow-up continued for 649 +/- 353 days (190-1342). Throughout this period, the patients continued receiving the previously set immunotherapy treatment. No adverse side effects related to the treatment were observed. One complete and one partial tumour response were observed, as well as two stable and one no-relapse disease. All but one patient died. Responding patients resumed progression in 4-11 months and died 18 and 36 months after beginning the vaccine therapy. In spite of the small number of treated patients, Wilcoxon's test showed a significant (P < 0.05) improvement of the survival in the vaccinated group compared to that of the control. The described vaccination protocol seems safe, devoid of adverse side effects and promising. It warrants further investigation.
Asunto(s)
Neoplasias Renales/genética , Neoplasias Renales/terapia , Anciano , Vacunas contra el Cáncer/inmunología , Femenino , Técnicas de Transferencia de Gen , Humanos , Inmunoterapia Adoptiva , Interleucina-2 , Neoplasias Renales/secundario , Masculino , Persona de Mediana Edad , Células Tumorales CultivadasRESUMEN
In a limited study, comprising only ten patients, we have previously reported that allogeneic irradiated RCC-cell-line cells, engineered to produce IL-2 (ACHN-IL-2), admixed with autologous metastatic formalin-treated tumour cells were used to vaccinate MRCC patients in progression of disease and also receiving IL-2 immunotherapy. The cells, admixed to autologous TC, were administered subcutaneously. We now report an extended study on thirty patients and one hundred thirty-one controls. Patients received 4-20 injections (mean 10 +/- 4), containing an average of 92 x 10(6) +/- 45 x 10(6) ACHN-IL-2 transfected cells (a minimum of 25 x 10(6), and a maximum of 200 x 10(6)). Autologous TC, admixed to allogeneic, were also administered by 4-16 s.c. injections (mean 7 +/- 3), i.e. a total of 12 x 10(6)-160 x 10(6) cells. Vaccination was administered during 73-1451 (307 +/- 316) days, and the follow-up continued for 1122 +/- 1240 days (106-5137). Throughout this period, the patients continued receiving the previously set immunotherapy treatment. No adverse side effects related to the treatment were noticed. One complete and four partial tumour responses were observed, as well as nine cases of stable disease. Thirteen patients died in the treated group (43%) and 63 (44%) in the control group. Responding patients resumed progression in 4-11 months and died 18 and 36 months after beginning the vaccine therapy. The Gehan Wilcoxon's test showed a significantly (P < 0.01) better survival in the vaccinated patients compared to that of the controls. Thus, we confirm, in an increased number of patients and an extensive follow-up, that our vaccination protocol is safe, devoid of adverse side effects, and promising.
Asunto(s)
Vacunas contra el Cáncer/uso terapéutico , Carcinoma de Células Renales/tratamiento farmacológico , Interleucina-2/genética , Neoplasias Renales/tratamiento farmacológico , Adulto , Anciano , Vacunas contra el Cáncer/efectos adversos , Vacunas contra el Cáncer/genética , Carcinoma de Células Renales/patología , Femenino , Humanos , Neoplasias Renales/patología , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Estadificación de Neoplasias , Resultado del Tratamiento , VacunaciónRESUMEN
PURPOSE: To compare the results, in terms of 10-year actuarial survival, between I-131-therapy and I-131-therapy + external beam radiotherapy (RT) in patients operated on for differentiated thyroid carcinoma. PATIENTS AND METHODS: Over a period of 13 years (1982-1995) 408 patients underwent thyroidectomy with or without linphoadenectomy for pT0/T4 Nx or pN0, pN1a, pN1b thyroid carcinoma. In all cases, thyroidectomy was radical. Patients were divided into two groups, which were comparable according to several prognostic factors: group A composed of 165 patients (surgery + I-131) and group B, 243 patients (surgery + I-131 + RT). RESULTS: The percentage of deaths related to relapsed or metastatic thyroid carcinoma was 6.25%. In the group treated with adjuvant radiotherapy, 14.8% of the patients experienced acute tracheal or esophageal side effects. Late toxicity (mouth dryness, skin and/or muscle fibrosis) was recorded only in a small percentage of the patients (2.4%). CONCLUSIONS: Adjuvant RT resulted in a statistically significant improvement (p < 0.01) in survival of patients with extracapsular diffusion of the cancer, especially those with pT4 N1b tumors or tumors involving the trachea.
Asunto(s)
Carcinoma/cirugía , Neoplasias de la Tiroides/cirugía , Carcinoma/patología , Carcinoma/radioterapia , Diferenciación Celular , Humanos , Metástasis de la Neoplasia , Cuidados Posoperatorios , Neoplasias de la Tiroides/patología , Neoplasias de la Tiroides/radioterapia , Tiroidectomía , Resultado del TratamientoRESUMEN
BACKGROUND: Radiotherapy is an established treatment modality for prostate cancer; however, up to a third of patients develops a radiation-induced proctopathy. AIM: To assess the effect of topical beclomethasone dipropionate (BDP) in the prevention of radiation-induced proctopathy in patients undergoing radiotherapy for prostate cancer through a double-blind, placebo-controlled, randomised trial. METHODS: Patients were randomised either to BDP or to placebo (PL). Patients received daily a 3mg BDP enema or identical-looking PL during radiotherapy and, subsequently, two 3mg BDP suppositories or PL for 4 more weeks. Clinical and endoscopic evaluations before, 3 and 12months after the end of radiotherapy were assessed with the RTOG/EORTC toxicity scales, the modified Simple Clinical Colitis Activity Index (SCCAI), the modified Inflammatory Bowel disease Quality of Life Index (IBDQ) and the Vienna Rectoscopy Score (VRS). RESULTS: From June 2007 to October 2008, 120 patients were randomised to the BDP (n=60) and PL (n=60) arms and were followed up for 12months. The overall assessment of rectal side effects did not show significant differences between the two groups of treatment. However, when only rectal bleeding was considered, a significantly reduced risk was observed in patients on BDP (OR 0.38; 95% CI 0.17-0.86; P=0.02; NNT=5). Patients on BDP had also significantly lower VRS scores (P=0.028) and significantly higher IBDQ scores (P=0.034). CONCLUSIONS: Preventive treatment with topical rectal BDP during radiotherapy for prostate cancer significantly reduces the risk of rectal bleeding and radiation-induced mucosal changes and improves patient's quality of life, but does not influence other radiation-induced symptoms.
Asunto(s)
Antiinflamatorios/administración & dosificación , Beclometasona/administración & dosificación , Hemorragia Gastrointestinal/prevención & control , Neoplasias de la Próstata/radioterapia , Traumatismos por Radiación/prevención & control , Enfermedades del Recto/prevención & control , Administración Tópica , Método Doble Ciego , Estudios de Seguimiento , Humanos , Italia , Masculino , Oportunidad Relativa , Recto/efectos de la radiación , Supositorios , Resultado del Tratamiento , Población BlancaRESUMEN
Thirty-seven patients with unresectable NSCLC received epirubicin (EPI) as i.v. bolus at the dose of 120 mg/sm+cisplatinum (CP) at the dose of 60 mg/sm every 28 days up to the maximum cumulative dose of 840 mg/sm of EPI. Of 35 evaluable patients, 19 (54%) (95% confidence limits: 37%-71%) achieved PR for a median duration of 10 months (range: 2-21). The majority of responsive patients experienced improvement in performance status, related-disease symptoms and body weight. Grades 3-4 leukopenia occurred in 42% of the patients. In five patients there was a > 10% reduction in the left ventricular ejection fraction as calculated by radionuclide angiocardiography. None of these patients suffered from cardiac symptoms. The median survival was 9 months (range 2-26). This study shows that inclusion of HD-EPI in a combination regimen contributes to obtaining a high remission rate in advanced NSCLC.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Cisplatino/administración & dosificación , Epirrubicina/administración & dosificación , Neoplasias Pulmonares/tratamiento farmacológico , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
Seven patients suffering from advanced metastatic tumours, unresponsive to standard therapies, were treated with 3 to 5 intra-lymphatic injections of interleukin-2 (IL-2) and IL-2-activated-peripheral blood lymphocytes (PBL). A partial (50-70%) regression was obtained in three of the patients, and complete regression in the other four. It thus seems that intra-lymphatic injections of IL-2 and PBL can be used for the treatment of certain solid tumours (e.g., hypernephroma, adenocarcinoma, seminoma, epidermoid carcinoma) without noticeable side effects. This method could advantageously replace intravenous IL-2 administration and warrants further investigation.
Asunto(s)
Interleucina-2/administración & dosificación , Neoplasias/terapia , Adulto , Anciano , Ensayos Clínicos como Asunto , Femenino , Humanos , Inmunoterapia , Inyecciones Intralinfáticas , Interleucina-2/uso terapéutico , Activación de Linfocitos , Transfusión de Linfocitos , Linfocitos/inmunología , Masculino , Persona de Mediana Edad , Trasplante AutólogoRESUMEN
The rationale for using transfer factor (TF) in lung cancer patients is that the possibility of improving their cell-mediated immunity to tumour associated antigens (TAA) may improve their survival. From Jan 1984 to Jan 1995, 99 non-small cell lung cancer (NSCLC) resected patients were monthly treated with TF, extracted from the lymphocytes of blood bank donors. In the same period, 257 NSCLC resected patients were considered as non-treated controls. The survival rates of the TF treated group appear significantly improved both for patients in stages 3a and 3b, and patients with histological subtype "large cell carcinoma" (P < 0.02). Survival of TF treated patients is also significantly higher (P < 0.02) for patients with lymph node involvement (N2 disease). The results of this study suggest that the administration of TF to NSCLC resected patients may improve survival.
Asunto(s)
Adyuvantes Inmunológicos/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/terapia , Neoplasias Pulmonares/terapia , Factor de Transferencia/uso terapéutico , Adyuvantes Inmunológicos/efectos adversos , Anciano , Anciano de 80 o más Años , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Terapia Combinada , Femenino , Humanos , Inmunoterapia , Estudios Longitudinales , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/cirugía , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Factor de Transferencia/efectos adversosRESUMEN
It is well known that thymic hormones can counteract immunodepression due to radiation therapy, preventing and reducing the severity and the number of myelotoxic and hematologic reactions. We tried to confirm these findings in a controlled multicenter clinical study involving 1,060 patients undergoing radiation therapy (580 treated with thymopentin 50 mg s.c. every other day, after irradiation and for at least 6 cycles of 4 weeks each, and 480 control patients). Highly statistically significant results (to the ANOVA test) were obtained in the protection against radiation-induced leukopenia in the treated group; furthermore, the treated patients had a marked reduction (p = 0.003 chi 2 test) in the early delayed reactions to irradiation, namely in the upper aero-digestive tract. In general, we observed a better, but not statistically significant recovery of the blood parameters, lymphocyte subsets and skin tests in the treated group versus the control group. Both of the treated groups showed the same trend for Karnofsky performance status and body weight. The local and general protection provided by thymopentin against the reactions to irradiation could be advantageously used for the administration of higher doses of radiation therapy.
Asunto(s)
Leucopenia/prevención & control , Neoplasias/radioterapia , Traumatismos por Radiación/prevención & control , Timopentina/uso terapéutico , Adulto , Femenino , Humanos , Estado de Ejecución de Karnofsky , MasculinoRESUMEN
From April 1986 to September 2000, 122 MRCC patients were treated by monthly intralymphatic injections (containing a mean of 573 IL-2 U and 26 x 10(6) LAK cells) and i.m. administration of IFN and TF; 71 patients also received a 3-day cycle of monthly IL-2 inhalations with a mean of 998 daily U. MRCC cases not treated by immunotherapy (n = 89) represent our historical controls. Adverse clinical side effects related to treatment were negligible. CR (n = 11) and PR (n = 13) were noticed in 24/122 patients. Of 24 responding patients, 17 resumed progression, whereas 7 remain in remission 11-69 months later. The overall median survival of treated patients (28 months) was 3.5-fold higher than the median survival of historical controls (7.5 months), and a Kaplan-Meier curve showed 25% survival 11 years after the beginning of immunotherapy. Apparently, the addition of IL-2 by inhalation improved survival. The present immunotherapy protocol appears to be efficacious, safe, devoid of adverse side effects, far less costly than others and able to offer a good quality of life to MRCC patients; if confirmed in a multicenter trial, it could set the basis for developing low-dose immunomodulatory treatments.