Biomedical subjects

V Vitale

Publications and source records attributed to V Vitale.

At least 37 records · Page 2Linked to original sources

PubMed1997

Treatment with cisplatin and fluorouracil alternating with radiation favourably affects prognosis of inoperable squamous cell carcinoma of the head and neck: results of a multivariate analysis on 273 patients.

PURPOSE: The goal of the present analyses is to assess the association between different therapeutic approaches and both the probability of achieving a complete response and the risk of death in patients with stage III-IV, inoperable, squamous cell carcinoma of the head and neck (SCC-HN). PATIENTS AND METHODS: Between August 1983 and December 1990, 273 patients with stage III-IV, previously untreated, unresectable SCC of the oral cavity, pharynx and larynx, were included into two consecutive randomized multi-institutional trials (HN-7 and HN-8 protocols) coordinated by the National Institute for Cancer Research (NICR) of Genoa. The HN-7 protocol compared neo-adjuvant chemotherapy (four cycles of vinblastine, 6 mg/m2 i.v. followed by bleomycin, 30 IU i.m. six hours later, day 1; methotrexate, 200 mg i.v., day 2; leucovorin, 45 mg orally, day 3) (VBM) followed by standard radiotherapy (70-75 Gy in 7-8 weeks) (55 patients) to alternating chemoradiotherapy based on four cycles of the same chemotherapy alternated with three splits of radiation, 20 Gy each (61 patients). In the HN-8 protocol standard radiotherapy (77 patients) was compared to the same alternating program as the one used in the previous protocol but employing cisplatin, 20 mg/m2/day and fluorouracil, 200 mg/m2/day, bolus, both given for five consecutive days (CF) instead of VBM (80 patients). A single database was created with the patients on the two protocols. Age at diagnosis, gender, site of the primary tumor, size of the primary, nodal involvement, performance status and treatment approach were analyzed by the multiple logistic regression model and the Cox regression method. The analyses were repeated including the treating institutions as a covariate (coordinating center versus others). RESULTS: The multiple logistic regression analysis indicates that treatment (alternating more so than others, regardless of the chemotherapy regimen used) (P = 0.0001) is more likely to be associated with complete response. In addition, size of the primary tumor (P = 0.004), nodal involvement (P = 0.02) and performance status (P = 0.009) are prognostic variables affecting the probability of achieving a complete response. The Cox regression analysis indicates that treatment, performance status, size of the primary tumor, nodal involvement and, marginally, site of the primary tumor, are independent prognostic variables affecting the risk of death. When the radiation-alone therapy is adopted as the reference treatment, the relative risk of death is 0.58 (95% confidence interval (CI) 0.40-0.84) for alternating CF and radiation, 0.79 (95% CI 0.53-1.16) for alternating VBM and radiation and 1.30 (95% CI 0.89-1.92) for sequential VBM and radiation. When the treating institution is included in the model, a 34% increased risk of death (P = 0.04) is observed for patients treated outside the coordinating center. CONCLUSION: In our series of patients with advanced, unresectable SCC-HN, treatment with cisplatin and fluorouracil alternating with radiation was associated with a more favourable prognosis. The role of the treating institution in the modulation of the treatment outcomes was also relevant.

Adult↗

PubMed1997

Bone marrow transplantation for chronic myeloid leukemia (CML) from unrelated and sibling donors: single center experience.

This is a report on 60 consecutive patients with chronic myeloid leukemia (CML) who received an allogeneic bone marrow transplant (BMT) in this Unit. Donors were HLA-identical siblings (SIB) (n = 36) or unrelated donors (MUD) (n = 24) matched by serology for HLA A and B and by molecular biology for HLA DR. All patients were prepared with cyclophosphamide 120 mg/kg and fractionated total body irradiation 10-12 Gy. GVHD prophylaxis consisted of cyclosporin A (CsA) starting on day -7 and short-course methotrexate. Bone marrow was unmanipulated in all cases. Cytomegalovirus prophylaxis consisted of acyclovir for SIBs and foscarnet for MUDs. When compared to SIB transplants, MUD patients were younger (29 vs 36 years; P = 0.002), had younger donors (31 vs 39; P = 0.001), had a longer interval between diagnosis and BMT (1459 vs 263 days; P < 0.001) and received a smaller number of nucleated cells at transplant (3.3 vs 4.4 x 10(8)/kg; P = 0.003). More MUDs had advanced disease (50 vs 17%, P = 0.005). The median day to 0.5 x 10(9)/l neutrophils was similar in both groups (18 days for SIBs vs 17 days for MUDs; P = 0.06); the median platelet count on days +30, +50, +100 was significantly (P < 0.01) higher in SIB than in MUD patients (122 vs 38, 113 vs 50 and 97 vs 45 x 10(9)/l, respectively). Acute GVHD was scored as absent-mild, moderate, or severe, in 36, 58 and 6% of SIBs vs 25, 42 and 33% in MUD patients (P = 0.01). Chronic GVHD was comparable (P = 0.1). The actuarial risk of CMV antigenemia at 1 year was 60% in both groups. There were six deaths in SIB patients (two leukemia, two infections, one GVHD, one pneumonitis) and four deaths in MUD patients (three acute GVHD and one infection). Fifty patients survive with a median follow-up of 656 days for SIBs and 485 for MUDs. The actuarial 3-year transplant-related mortality is 12% in SIBs and 17% in MUDs (P = 0.5); the actuarial relapse is 18% in SIBs vs 6% in MUDs (P = 0.4) and 3-year survival 78% in SIBs vs 82% in MUDs (P = 0.7). This study suggests that survival of CML patients after marrow transplantation from unrelated or sibling donors is currently similar, provided the former are well matched. The increased incidence of GVHD in MUD patients is possibly compensated by a lower risk of relapse.

Acyclovir↗

PubMed1997

[The application of the multileaf collimator in radiotherapy: the dosimetric problems and the technical implications for its clinical use].

INTRODUCTION: The multileaf collimator (MLC) now commercially available as an integral or optional retrofit component of linear accelerator heads, permitting to shield automatically irregular fields by computerized movements of multiple tungsten leaves. In the present paper we discuss the main characteristics of different MLC versions, MLC dosimetric drawbacks and the clinical fields where the MLC could he widely used. MATERIALS AND METHODS: Since February, 1995, we have studied the dosimetric characteristics and clinical implications of a multileaf collimator of a Clinac 2100 C/D linear accelerator used to replace conventional low melting alloy blocks. The scalloping effect of isodoses and the effective penumbra produced by the multileaf collimator in an irregular field were analyzed accurately. Secondly, radiation leakage through tungsten leaves was measured and compared with the values of low melting alloy blocks. Finally, the MLC was extensively used in clinical practice for the radiotherapy of different tumors. RESULTS: Different dosimetric steps were followed to obtain the monitor units/dose ratio. Our single MLC-shielded irregular fields measurements also showed several physical and dosimetric disadvantages related to wider effective penumbra than with conventional shielding when the angle between field margin and the normal to the direction of leaf travel is 45 degrees. In clinical practice, the MLC can be widely used for the conformal radiotherapy of pelvic and thoracic tumors. Conventional low melting alloy blocks should be replaced with MLC for radiotherapy of selected brain and head and neck cancers. DISCUSSION: The current use of a multileaf collimator improves both the accuracy and the effectiveness of radiation therapy and reduces the time for every treatment dose, which potentially increases the number of patients treated every day. The multileaf collimator is presently an important technical tool either to replace conventional shielding for static conformational radiotherapy or to administer 3D-planned dynamic radiotherapy.

Equipment Design↗

PubMed1997

Chemoradiotherapy as an alternative to radiotherapy alone in fast proliferating head and neck squamous cell carcinomas.

The aim of this pilot study was to explore the prognostic relevance of cell kinetics parameters on the local control of patients affected by head and neck squamous cell carcinoma (HN-SCC), randomly assigned to receive either alternating chemoradiotherapy or partly accelerated radiotherapy. Between 1992 and 1995, 40 patients with HN-SCC at stages III and IV entered the study. Multiple primary tumor biopsies were obtained 6 h after in vivo infusion of bromodeoxyuridine, an analogue of thymidine that is incorporated in DNA-synthesizing cells. In vivo S-phase fraction labeling index (LI), duration of S-phase (TS), and potential doubling time (Tpot) were obtained by analysis of the flow cytometric content of bromodeoxyuridine and DNA. Twenty patients were treated by alternating chemotherapy and conventional radiotherapy (arm A), whereas 20 other matching patients received partly accelerated radiotherapy alone (arm B). Univariate local control analysis showed that LI, TS, and Tpot were not prognostically significant in either arm. However, local control probability at 2 years for fast growing tumors, characterized by a LI of 9%, was higher for patients treated with alternating chemoradiotherapy than it was for those treated with partly accelerated radiotherapy alone (68 versus 39%). Conversely, local control probabilities for slow proliferating tumors (LI, <9%) treated in the two arms were similar. These results suggest a potential role for alternating chemotherapy and radiotherapy in HN-SCC patients with fast growing tumors.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1996

Postoperative radiotherapy for head and neck squamous cell carcinomas: feasibility of a biphasic accelerated treatment schedule.

PURPOSE: It has been suggested that postoperative tumor cell proliferation may influence the outcome of advanced head and neck squamous cell carcinomas treated by surgery and postoperative radiotherapy. This Phase I pilot study was undertaken to determine the feasibility of a biphasic accelerated radiotherapy regimen with early and late concomitant boost delivery for postoperative treatment of patients with advanced head and neck cancers. METHODS AND MATERIALS: From April 1993 to April 1994, 29 patients with advanced head and neck cancers were enrolled in this study after they underwent complete surgical resection. The basic radiation course delivered a median dose of 49 Gy in 25 fractions over 5 weeks at 1.8-2 Gy/fraction. The concomitant boost was delivered to the high-risk areas as a second daily fraction during the first (1.4 Gy/fraction) and fifth weeks (1.6 Gy/fraction). The total dose to the high-risk areas was 64 Gy in 35 fractions over 5 weeks. RESULTS: Twenty-seven patients (93%) completed the treatment without interruptions. Only two patients experienced severe acute toxicity requiring treatment breaks of 6 and 8 days, respectively. All patients developed confluent mucositis; in 69% of the cases it covered >50% of the treated surface. No patient developed Grade 5 (ulceration/bleeding) mucosal reaction. Mucositis required a median time of 7 weeks for complete healing (range 3-43). Two patients developed transient bone exposure. The median weight loss was 5.5% of pretreatment body weight (range 1.2-17.1%), and four patients required nutritional assistance with nasogastric feeding tube. CONCLUSION: The results of this study show that this biphasic acceleration regimen is feasible with acceptable acute toxicity.

Adult↗

PubMed1996

Cell kinetics and tumor regression during radiotherapy in head and neck squamous-cell carcinomas.

Head and neck squamous-cell carcinoma (HN-SCC) patient management is mainly based on TNM classification and needs be improved by considering other potentially useful prognostic factors. We examined the pre-radiotherapy tumor potential doubling time (Tpot) evaluated after in vivo infusion of bromodeoxyuridine and flow-cytometric analysis and the early clinical tumor regression after 40 Gy (40 Gy-TR). Tpot values and clinical 40 Gy-TR classes (minor and major) were available for 82 HN-SCC patients. Radiation therapy completion was done either with 1 dose per day (conventional regimen) or 2 doses per day (accelerated regimen). Local control was also available for follow-up times above 4 years. We found that major 40 Gy-TR was strongly correlated with fast tumor growth, characterized by Tpot values below 5 days, and that patients with major 40 Gy-TR showed better local control than those with minor 40 Gy-TR, independently from the radiotherapy regimen type. We also found that treatment completion with accelerated radiotherapy gave better local control for patients with major 40 Gy-TR and fast tumor growth than conventional radiotherapy. Multivariate analysis, performed on all patients, assigned an independent prognostic value to Tpot, tumor classification and 40 Gy-TR.

Adult↗

PubMed1996

Five-year update of a randomized trial of alternating radiotherapy and chemotherapy compared with radiotherapy alone in treatment of unresectable squamous cell carcinoma of the head and neck.

BACKGROUND: In 1992, we reported the first analysis of a randomized trial comparing alternating radiotherapy and chemotherapy with radiotherapy alone in the treatment of squamous cell carcinoma of the head and neck. The results of that 3-year analysis indicated that the combined treatment had superior efficacy. PURPOSE: After an additional 2 years of follow-up, we again compared the efficacy of the two treatment regimens, with attention paid to differences in overall survival, progression-free survival, and locoregional relapse-free survival. METHODS: One hundred fifty-seven patients with untreated, unresectable squamous cell carcinoma of the head and neck were randomly assigned to receive either chemotherapy (four courses of cisplatin [20 mg/m2] and fluorouracil [200 mg/m2], given daily for 5 consecutive days during weeks 1, 4, 7, and 10) plus radiotherapy (three courses of 20 Gy each, given in fractions of 2 Gy per day during weeks 2-3, 5-6, and 8-9) or radiotherapy alone (70 Gy total dose, given in fractions of 2 Gy per day, 5 days per week). Eighty patients received the combined therapy, and 77 were treated with radiotherapy alone. Responses, failures, and toxic effects associated with the two treatment regimens were compared. Overall survival, progression-free survival, and locoregional relapse-free survival were calculated according to the Kaplan-Meier method; the logrank test was used to compare survival parameters between the two patient groups. Reported P values are two-sided. RESULTS: As reported previously, toxic effects associated with the combined therapy included both chemotherapy- and radiotherapy-related effects; however, the incidence and severity of mucositis were nearly identical among patients in the two treatment arms. The combined treatment was associated with a statistically significant increase in the frequency of complete response (i.e., the disappearance of clinically detectable disease for at least 4 weeks) (43% for the combined-treatment group compared with 22% for the radiotherapy-only group; P = .037, chi-squared test). Five-year estimates of overall survival in the combined-treatment group compared with the radiotherapy-only group were 24% (95% confidence interval [CI] = 14%-40%) and 10% (95% CI = 4%-24%), respectively (P = .01, logrank test). The estimates of progression-free survival at 5 years in the combined-treatment group compared with the radiotherapy-only group were 21% (95% CI = 11%-37%) and 9% (95% CI = 3%-22%), respectively (P = .008, logrank test). Finally, the 5-year estimates of locoregional relapse-free survival were 64% (95% CI = 36%-84%) in the combined-treatment group and 32% (95% CI = 10%-65%) in the radiotherapy-only group (P = .038, logrank test). CONCLUSIONS AND IMPLICATIONS: The superiority of alternating chemotherapy and radiotherapy over radiotherapy alone in treating unresectable squamous cell carcinoma of the head and neck seen at 3 years was confirmed at 5 years. However, additional trials must be conducted before considering the combined approach as standard therapy.

Antimetabolites, Antineoplastic↗

PubMed1996

[Hodgkin's lymphoma: problems in the treatment of the early stages].

The prognosis for Hodgkin's disease patients has improved markedly in the past 3 decades, thanks to improved staging techniques and therapeutic advances in both radiation and chemotherapy. Yet, individual treatment schedules continue to evolve: in particular, the extent of irradiation fields, the allocation of Hodgkin's patients to prognostic groups using information from clinical staging techniques and the choice of radiotherapy alone versus combined modalities are still controversial in the early stages of this disease. To try to eliminate the need for staging laparotomy, the EORTC investigated the role of clinical staging in different studies and found that favorable clinical stage I/II patients do not need laparotomy and that irradiation alone yields satisfactory results. Current treatment goals include maximizing the cure rate while minimizing toxicity, late side-effects in particular. An approach is to reduce irradiation fields and combine irradiation with chemotherapy. There is no doubt that various organ sites can be cumulatively damaged by this combined approach, but new protocols seem to yield better results. Several literature findings are reviewed in this paper. The allocation of stage IA and IIA Hodgkin's disease patients to prognostic groups using information from clinical staging procedures appears to be a very important step. The combined approach seems to be useful in patients at intermediate risk of relapse. We conclude that excellent results and very little toxicity and morbidity can be achieved through respect and collaboration between the chemotherapist and the radiotherapist.

Hodgkin Disease↗

PubMed1995

Growth in patients after allogeneic bone marrow transplant for hematological diseases in childhood.

The growth of 66 long-term survivors, transplanted in two centres (Genoa S. Martino and Monza) is reported. Patients were all under age 15 at the time of bone marrow transplantation (mean 9.8 +/- 3.4 years; range 1.07-15 years) with a minimum follow-up of at least 12 months. They were divided into four groups. Group 1: eight patients with severe aplastic anemia (SAA): conditioning included cyclophosphamide (CY) 200 mg/kg only. Group 2: 32 patients with acute lymphoblastic leukemia (ALL), and acute myeloid leukemia (AML): conditioning included CY 120 mg/kg and 10-12 Gy fractionated total body irradiation (fTBI). Group 3: 20 patients with ALL, who had previously received cranial irradiation; conditioning included CY 120 mg/kg and fTBI with an additional testicular irradiation (4 Gy). Group 4: six patients with chronic myeloid leukemia (CML) and AML; conditioning included CY 200 mg/kg and busulfan (BU) 16 mg/kg. Group was impaired in all four groups, including the unirradiated groups (-0.2 +/- 0.7 and -0.5 +/- 0.6 delta-SDS in groups I and 4, respectively). Growth impairment-SDS was statistically significant in the two irradiated groups (-0.7 +/- 1.0 and -0.9 +/- 1.0 delta-SDS in groups 2 and 3, respectively), more marked in patients who had had previous cranial irradiation. Chronic graft-versus-host disease and its treatment were not found to have a major effect on growth.

Acute Disease↗

PubMed1995

[Single-dose palliative radiotherapy in inoperable non-small-cell lung carcinoma].

The treatment of choice for advanced inoperable non-small cell lung cancer (NSCLC) is radiation therapy. Palliative radiotherapy schedules vary considerably in different centers, but a 30-Gy dose given in ten fractions over two weeks is a typical standard schedule. Our study was aimed at investigating whether a shorter course of only one 10-Gy fraction allows good palliation in the treatment of inoperable NSCLC patients whose main symptoms are related to an intrathoracic lesion. Patients of both sexes and any age, untreated with radiotherapy, with inoperable and histologically or cytologically proved NSCLC were examined. Seventeen patients, too advanced for radical "curative" radiotherapy and whose main symptoms were related to primary intrathoracic lesions, entered the study even though they had metastases. On admission, 76% (13/17) of patients had cough 76% (13/17) dyspnea, 70.7% (12/17) chest pain and 23.6% (4/17) hemoptysis. They received a single dose of 10 Gy, delivered with an 18-Mv linear accelerator via anteroposteriorly opposing portals without spinal cord shielding. Treatment volume usually included the macroscopically detected lesion identified with a CT simulator. Palliation of symptoms was achieved in high rates of patients: 46% for cough, 69% for dyspnea, 83% for pain and 75% for hemoptysis. These results were obtained within one month of treatment. Unfortunately, palliation of symptoms did not last long, decreasing to 42% within two months of the end of treatment and to 32% at three months. Four patients were retreated, one patient three months and three patients two months after the end of radiotherapy. Ten Gy to the target volume were administered as retreatment with spinal cord shielding. Side-effects were mild: nausea in 3 patients (17%), vomiting in one patient (5%) and grade-II dysphagia in two patients were observed and classified according to WHO criteria. Pain increased 24 hours after radiotherapy in five patients. We can conclude that single dose radiotherapy yields good, but short, palliation of symptoms with acceptable side-effects.

Adult↗

PubMed1994

Primary site as predictive factor of local control in advanced head and neck tumors treated by concomitant boost accelerated radiotherapy.

AIMS AND BACKGROUND: The purpose of this phase II study was to assess the efficacy and toxicity of an accelerated radiotherapy schedule with the concomitant boost technique in the management of patients with advanced head and neck squamous cell carcinomas (HN-SCC) of various primary sites. METHODS: From May 1989 to December 1992 45 patients were scheduled to receive a total dose of 75 Gy in 40 fractions over 40 days. The boost encompassing the macroscopic disease was given as a second daily dose during the last 2 weeks of the basic treatment. RESULTS: Severe mucositis was recorded in 27 (60%) patients. Late side effect occurred in 2. As regards local control the primary tumor site was the most significant prognostic factor: at a median follow-up of 24 months (range 12-52 months) the actuarial local control rate was 79%, 48% and 15% for oronasopharyngeal, laryngohypopharyngeal and oral cavity primary sites, respectively (p = 0.004). CONCLUSIONS: This high dose concomitant boost regimen appears feasible in advanced HN-SCC. However, our results indicate the primary tumor site as a major prognostic factor even with an accelerated treatment schedule.

Adult↗

PubMed1994

Randomized study comparing chemotherapy plus radiotherapy versus radiotherapy alone in FIGO stage IIB-III cervical carcinoma. GONO (North-West Oncologic Cooperative Group).

Between January 1989 and December 1991, 64 patients with advanced cervical carcinoma FIGO stage IIb-III were randomized to receive radiotherapy (RT) alone or the sequential combination of chemotherapy (CT) and RT. RT consisted of external RT (40 Gy fractionated over 4 weeks)+brachy-therapy (40 Gy to point A)+an additional boost to the parameters (15-20 Gy) in arm RT; CT consisted of cisplatin 60 mg/m2 i.v. day 1 q 15 days administered for 2 cycles before the start of RT and for 4 cycles after the end of radiation treatment in CT+RT arm. Among the 58 evaluable patients objective response rate was as follows: in RT arm, CR in 40.7% of patients, PR in 40.7%, and SD in 18.6%; in CT+RT arm, CR in 42% of patients, PR in 35.5%, and SD in 22.5%. The median duration of response was 12 months (range: 3-38 + months). At a median follow-up of 36 months survival (S) and progression-free survival (PFS) were 83% and 72.4% in RT arm, 72% and 59.3% in CT+RT arm, respectively. No significant difference was observed between the 2 treatment arms, neither in terms of objective response nor in terms of S and PFS. Both treatments were generally well tolerated. In our experience the addition of chemotherapy to standard radiotherapy does not enhance morbidity and does not interfere with the correct delivery of the planned treatment. However, results of this combined modality regimen remain unsatisfactory, since no improvement in pelvic control and survival of patients with advanced cervical carcinoma was observed.

Adult↗

PubMed1994

[Accelerated radiotherapy with the concomitant-boost technic in patients with squamous cell carcinoma of the head and neck].

The purpose of this phase I-II study was to assess the efficacy and toxicity of an accelerated radiation therapy schedule in patients affected with head and neck squamous cell carcinomas of various primary sites. We adopted the concomitant boost technique which allows 1-2 weeks' shorter treatment time by delivering the boost treatment phase as second daily dose during the last part of the basic field irradiation. May 1989 to December 1992, fifty-one patients were scheduled to receive a total dose of 71-75 Gy in 40 fractions over 6 weeks. The boost encompassing the macroscopic disease was given as second daily dose during the last two weeks of the basic treatment. Severe mucositis was observed in 62% of the patients. Late side-effects occurred in 4 patients. At a median follow-up of two years (range: 12-56 months), actuarial locoregional control rate is 44% and overall survival is 54%. At univariate analysis, primary site is the only predictive factor of locoregional control (p = 0.009): neoplasms arising from the oral cavity did worse than those from larynx/hypopharynx and oro/nasopharynx. We conclude that this regimen is feasible in head and neck squamous cell carcinoma of various primary sites. However, since primary site seems to exhibit a predictive value, data from controlled studies are needed to assess its role in primary sites other than oropharynx and nasopharynx.

Carcinoma, Squamous Cell↗

PubMed1994

Allogeneic bone marrow transplantation for acute myeloid leukemia in first complete remission: the effect of FAB classification and GVHD prophylaxis.

Ninety-one patients with de novo acute myeloid leukemia (AML) in first complete remission (CR) undergoing an HLA-identical sibling BMT and with a minimum follow-up of 12 months were analyzed for disease-related and transplant-related variables predicting survival and relapse. The overall actuarial 5 year survival is 53% and the relapse rate 29%, with a medium follow-up for surviving patients of 1552 days (range 365-4094 days). In univariate analysis the following variables were found to be associated with an increased risk of failure: high-dose cyclosporin (CsA), M4-M6 FAB subtype and a long interval (> or = 180 days) between diagnosis and BMT. Other disease-related variables at presentation were not significant, including WBC count > 50 x 10(9)/l, marrow blasts < 70%, time to enter remission > 40 days and > 2 courses to enter remission. Survival was 58% vs 43% for M1-M3 vs M4-M6 FAB subtypes (p = 0.03) and 71% vs 42% for low-dose vs high-dose CsA (p = 0.01). A multivariate analysis was then run separately on survival, relapse and transplant related mortality (TRM). Survival was negatively influenced by M4-M6 FAB subtypes (p = 0.009), high-dose CsA (p = 0.03) and a long interval between diagnosis and BMT (p = 0.04). Leukemia relapse was higher in patients receiving high-dose CsA (p = 0.003) and in females (p = 0.04). Transplant-related mortality was higher in FAB M4-M6 patients (p = 0.01) and patients grafted late after diagnosis (p = 0.03).(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗

PubMed1994

Treatment of FIGO stage Ib cervical carcinoma with nodal involvement.

One hundred and eighty one patients with stage Ib cervical cancer underwent hysterectomy with pelvic lymphadenectomy. The overall incidence of lymph node metastases was 20%. Twenty seven (71%) patients with nodal involvement were treated by external radiotherapy (TCT) and 11 (29%) by both chemotherapy and radiotherapy (Lin. Acc.). The overall survival at 5 years was 80%; it was 43% for patients with positive nodes and 89% for patients without metastatic nodal disease. The 3 year survival of patients with positive nodes who underwent radiation therapy by TCT was 58%, while it was 72% for those treated by chemotherapy plus radiotherapy. We observed a recurrence in 23% of the cases, 52% in patients with positive nodes and 15% in those with negative nodes. The association chemo-radiotherapy in patients with metastatic lymph nodes seems to improve the survival and reduce the recurrence rate.

Adenocarcinoma↗

PubMed1993

Radio-hyperthermia in post-surgical recurrence of melanoma.

AIMS AND BACKGROUND: Malignant melanoma is one of the most radioresistant tumors. It can be treated with combinated hyperthermia and radiation therapy. METHODS: From January 1991 through June 1992, 7 patients, 1 male and 6 female, aged 40-88 years (mean 75), with skin and nodal post-surgical recurrences of melanoma, were treated with a combination of radiation therapy and hyperthermia. Two patients presented systemic disease when they reached our observation, but all of them were without symptoms. None of them underwent surgical excision of the recurrence before or during thermoradiotherapy. None received chemotherapy for these recurrences or had received radiotherapy in the past. They were irradiated with electron beams, with electron energies selected according to the depth of the lesions. The total dose was 40 Gy in 10 fractions in 5 weeks. Hyperthermia was administered for 10 minutes to 1 hour after irradiation. An inductive method of radiofrequency heating at 434 of 915 MHz was used depending on the depth of the lesions. In all of these treatments a ionized water bolus was used. The prescribed hyperthermic dose was 42 degrees C for half a hour. The treatments were carried out twice a week for 5 weeks. A fiberoptic multichannel thermometer was used for thermometry. RESULTS: Four patients (57%) achieved a complete response, 2 patients (29%) a partial response, and 1 patient (14%) stabilization. We found no correlation between tumor volume and response rate. Site effects and complications of the treatment were minimal (moderate erythema). CONCLUSIONS: Our results are in the wide range of values reported in the literature.

Adult↗

PubMed1993

Potential doubling time in head and neck tumors treated by primary radiotherapy: preliminary evidence for a prognostic significance in local control.

PURPOSE: The aim of the study was to determine preliminarily whether cell kinetic parameters evaluated using in vivo infusion of bromodeoxyuridine (BrdUrd) and flow cytometry, play a role as prognostic factors of loco-regional control in squamous cell head and neck carcinoma treated with radiotherapy. METHODS AND MATERIALS: Between April 1989 and December 1991, 42 patients with unresectable Stage II-IV squamous cell carcinoma of the oral cavity, pharynx or larynx were given an infusion of BrdUrd solution prior to primary tumor biopsy sampling at 4-6 hr later. The simultaneous labeling S-phase fraction (LI) and duration (Ts) as well as the estimated potential doubling time (Tpot) were measured using flow cytometric analysis of BrdUrd and DNA content. Twenty-six patients received standard radiotherapy (70 Gy/35 fractions/7 weeks) whereas 15 patients were treated with the concomitant boost technique (75 Gy/40 fractions/6 weeks). RESULTS: A complete set of flow cytometric data was available for 31 patients. The median value of LI, Ts, and Tpot were 9%, 9 hr and 5 days, respectively. Univariate analysis among the patients treated homogeneously by standard radiotherapy, indicated that local control was affected by Tpot value (p = 0.02). When the same analysis was performed for the patients treated with either standard radiotherapy or concomitant boost regimen, we found a p = 0.04. Thus, patients with a tumor Tpot value < or = 5 days had a significantly lower three-year local control than patients with Tpot > 5 days. Log-rank test univariate analysis showed, in addition, that nodal status was the strongest prognostic factor of local control (p = 0.005). Age, tumor stage, tumor site, performance status, grading, radiotherapy regimen, DNA ploidy and LI value were, instead, not significantly related to loco-regional control. Finally, when comparing the type of radiotherapy for tumors with Tpot < or = 5 days, we found a trend toward a better local control after concomitant boost regimen, with respect to standard regimen (p = 0.06). CONCLUSION: The present preliminary results suggest that Tpot could play a role as additional prognostic factor influencing the disease outcome in head and neck carcinoma treated by radiotherapy.

Actuarial Analysis↗

PubMed1993

Successful bone marrow transplantation in children with severe aplastic anemia using HLA-partially matched family donors.

Bone marrow transplantation (BMT) using HLA-partially matched family donors has produced disappointing results (25-30% of long-term survivors) in patients with severe aplastic anemia. We describe two children affected by severe aplastic anemia, not responsive to immunosuppressive therapy, who underwent allogeneic bone marrow transplantation using a HLA-partially matched family donor. Both cases presented 2 first class HLA-antigens (A and B) disparity between donor and recipient. The pretransplant conditioning regimen consisted of cyclophosphamide, thoracoabdominal irradiation, cytosine-arabinoside, and antilymphocyte globulin. As graft versus host disease (GVHD) prophylaxis, Cyclosporine-A was administered at usual dosages for 6 months. A full marrow engraftment was observed in both cases. Only grade I acute GVHD, promptly responsive to corticosteroid therapy, developed with no chronic GVHD. Five months after transplant, both children progressively developed hypertension, renal function impairment, thrombocytopenia, and severe normochromic anemia, with erythropoietin serum levels lower than expected for the haematocrit. After antihypertension treatment and supportive therapy, the clinical picture progressively improved, while treatment with recombinant human erythropoietin completely corrected the long-lasting anemia. The two children are alive and well 28 months after the transplant, with a Karnofsky score of 100% and a normal peripheral blood count. The authors suggest that, once immunosuppressive therapy has failed, BMT from donors other than HLA-identical sibling is a feasible approach in children affected by severe aplastic anemia, not having an HLA-identical donor.

Anemia, Aplastic↗