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Biomedical subjects

C Fallai

Publications and source records attributed to C Fallai.

At least 19 recordsLinked to original sources
PubMed2000

FEC (5-fluorouracil, epidoxorubicin and cyclophosphamide) versus EM (epidoxorubicin and mitomycin-C) with or without lonidamine as first-line treatment for advanced breast cancer. A multicentric randomised study. Final results.

From May 1991 to December 1996, 326 patients with advanced metastatic breast cancer were enrolled in a multicentre, randomised, phase III clinical trial with four arms. Patients were randomised to receive chemotherapy according to the FEC regimen (5-fluorouracil (5-FU) 500 mg/m2, epidoxorubicin (EPI) 75 mg/m2 and cyclophosphamide (CFA) 500 mg/m2, intravenously (i.v.). every 3 weeks) or the EM regimen (EPI 75 mg/m2, i.v. every 3 weeks; mitomycin C (MMC) 10 mg/m2, i.v. every 6 weeks) or the same regimens with the addition of lonidamine (LND) until disease progression (orally, thrice daily, 150+150+300 mg); a maximum of eight chemotherapy cycles were planned. The aim of the trial was 2-fold: to compare the EM regimen with the commonly used FEC regimen and to evaluate the possible role of the addition of LND. Patients were eligible if they had histologically proven breast carcinoma, metastatic or locoregional relapse with measurable and/or evaluable disease and were aged between 18 and 70 years: 318 patients were considered eligible. Patients with previous anthracycline-based adjuvant chemotherapy or those who relapsed within 6 months after any adjuvant chemotherapy regimen were excluded. Chemotherapy-related toxicity of grade > or = 3 was manageable and there was no significant difference between the arms in terms of haematological side-effects. The impact on heart function was mild. No increased toxicity was observed in the LND arms (apart from myalgias in 27-30% of the cases). A significant increase in the complete response rate was observed for the FEC/EM + LND group (20.4%) versus the FEC/EM group (10.8%). The median survival time and the median time to progression for the overall series were 608 days and 273 days, respectively; EM+/-LND achieved significantly improved survival and time to progression versus FEC+/-LND (P=0.01). This result was confirmed also when the analysis was restricted to patients previously treated with adjuvant CMF schedules. On the basis of these results, we conclude that EM may represent a valuable alternative to FEC for patients requiring a first-line regimen for advanced/ metastatic breast carcinoma, especially in patients previously treated with CMF in an adjuvant setting. Furthermore, we conclude that, in spite of a better complete response rate in the LND arms, as there was no clear advantage in time to progression or survival resulting from the addition of LND to the FEC or EM regimens, the routine use of LND is not warranted outside a clinical trial.

Adult↗
PubMed1998

Vitamin D receptor gene polymorphism is associated with metastatic breast cancer.

The vitamin D receptor (VDR) has been detected in breast tumor cells. We tested the hypothesis that VDR gene polymorphism might influence the outcome of women affected by breast cancer. A total of 88 breast cancer patients were recruited: 50 women were affected by newly diagnosed breast cancer whereas 38 women suffered from relapsing disease. The individual genetic pattern for VDR was evaluated by DNA extraction followed by PCR amplification of the VDR gene, and digestion with the restriction enzyme BsmI. In 167 healthy women, participating in the osteoporosis prevention trial and being used as a control, we detected 121 Bb heterozygotes (72%), 26 homozygotes for the bb alleles (16%), and 20 homozygotes for the BB alleles (12%). In the newly diagnosed breast cancer group the occurrence of Bb patients was 58% (29/50); bb patients represented 22% (11/50), and BB cases were 20% (10/50). The VDR frequency distribution in the control and primary disease patient groups was not statistically different. In the metastatic cancer group, the prevalence of the bb genotype (14/38; 37%) was double the percentage of control subjects, whereas the percentage of BB women with metastases was half the control group (2/38; 5%). Women who were homozygous bb appeared to have almost a four times higher risk of developing metastases than BB women. Whatever the molecular mechanisms underlying the VDR effects in cancer cells, we believe that the VDR gene polymorphism may represent an important determinant in the evaluation of women affected by breast cancer and might help design targeted therapy.

Alleles↗
PubMed1997

Hyperfractionated and accelerated radiation therapy in central nervous system tumors (malignant gliomas, pediatric tumors, and brain metastases).

The authors review the main contributions of the international literature concerning the role of hyperfractionation (HF), accelerated fractionation (AF), and accelerated hyperfractionation (AHF) of the dose in radiation therapy (RT) of central nervous system tumors. Basic rationales, clinical results, acute/late toxicity, and current prospectives are summarized in three sections focusing on malignant gliomas, pediatric brainstem tumors, and brain metastases. In supratentorial malignant gliomas the superiority of AHF (0.89 Gy x 3 fractions/day; total dose 61.4 Gy) over conventional fractionation ((CF) total dose 58 Gy) was demonstrated by a randomized trial. However, the gain in median survival time was less than 6 months. No other randomized trials support the preferential choice of non-CF schedules outside clinical trials. Ongoing trials are exploring the role of AHF in combination with chemotherapy, hypoxic cell and radiosensitizing agents. As for pediatric brainstem tumors, there are no data to support the routine use of HF that should be preferably used in an investigative setting. As late sequelae have been reported in the few long-term survivors, patients should be carefully selected. Regarding brain metastases AF RT and AHF RT, with their faster treatment course, may represent a convenient alternative to CF RT for the palliation of brain metastases. In carefully selected patients with solitary brain metastases non-CF RT may be part of aggressive treatment approaches.

Brain Neoplasms↗
PubMed1995

Staging and follow-up of nasopharyngeal carcinoma: magnetic resonance imaging versus computerized tomography.

PURPOSE: To compare computerized tomography (CT) and magnetic resonance (MR) in relation to their accuracy in the staging of nasopharyngeal carcinoma (NPC); to compare CT and MR in postirradiation follow-up of NPC. METHODS AND MATERIALS: Staging: From 1985 to 1993, 53 patients affected with NPC were studied with MR and CT. All cases were biopsy-proved epithelial carcinoma. Plain and contrast-enhanced CT scans were performed with third-generation scanners. Magnetic resonance were obtained with 0.5 and 1.5 Tesla units in sagittal, axial, and coronal planes. Computerized tomography was chosen as reference method and findings obtained with MR were compared to those obtained with CT. FOLLOW-UP: From 1985 to 1993, 53 patients irradiated with radical intent were followed up with both CT and MR; 71 examinations were performed in all. The baseline follow-up scan was performed, in general, no sooner than 2 months after the end of radiotherapy. All patients were submitted to unlimited clinical follow-up. RESULTS: Staging: Magnetic resonance showed retropharyngeal adenopathies in 6 of 14 cases in which oropharyngeal involvement had been reported after CT; in 3 other patients, adenopathies were recognized on MR, while primary extent to parapharyngeal space had been diagnosed on CT initially. Infiltration of long muscles of the neck was revealed with MR in 14 cases. On the other hand, CT showed bone invasion in 12 patients vs. 8 on MR. Upstaging to T4 occurred in four cases on the basis of CT; no upstaging occurred after MR. FOLLOW-UP: Findings on CT were uncertain in 10 out of 53 patients, disease recurrence was excluded by MR in nine cases, whereas progressive disease was confirmed in one patient. CONCLUSION: Staging: Our series shows that either CT and MR can provide essential information in the staging of NPC. Magnetic resonance, however, seems to provide the most detailed imaging of soft tissue invasion outside the nasopharynx and of retropharyngeal node involvement. Nonetheless, its limitations in evaluating bone details suggest that CT should be always performed when the status of base of skull is uncertain on MR. General reasons and our data indicate that CT can still be considered a valuable tool in routine NPC staging. Follow up: Magnetic resonance may be the modality of choice because it seems to solve, more often than CT, the problems of differentiation between postradiation changes and recurring tumor, apart from those cases showing subtle bone erosions on initial CT scan.

Adolescent↗
PubMed1992

Altered fractionation schedules in radiotherapy of head and neck cancer. A review.

The authors review the main contributions of international literature to show the current status in clinical trials on unconventional fractionations of the dose in radiotherapy of head and neck cancers. Several clinical (but only a few randomized) trials have been conducted over the last 15 years using hyperfractionated (HF), accelerated (AF) or mixed (HF-AF) schedules. HF schedules have obtained promising results in terms of local control in comparison with conventional fractionation (CF) of the dose. Improvement in survival was also obtained by the random trials of Pinto and Sanchiz, whereas in EORTC trial no. 22791, the improvement in survival rate was only marginal. A significant increase in local control and, less frequently, in survival has been claimed in several studies using HF-AF. Such data still need to be confirmed by a random study, since EORTC trial 22811 showed superimposable results in comparison with CF. Selection of the most suitable cases for altered fractionation schemes is also being studied in ongoing trials of the EORTC (22851) and RTOG (90-03). As regards acute reactions during and after altered fractionation, they are more severe than after CF. Only pure HF with a dose intensity approximately comparable to CF seems to produce similar acute reactions. Several factors have been found to influence the severity of acute mucosal reactions: interfraction interval, overall treatment time, total dose, and field size. As regards late damage, genuine HF schemes seem to cause roughly equivalent late damage in comparison to CF, whereas high-dose intensity schedules have a higher rate of complications. Interfraction interval, overall treatment time, total dose, fraction size and field size can influence the risk of late sequelae. Before altered fractionations can be considered standard therapy, more data are needed, which should be provided by multicentric randomized trials, some of which are already in progress.

Clinical Trials as Topic↗
PubMed1991

[Impact of diagnostic imaging on: staging, results and follow-up of rhinopharyngeal carcinoma].

Ninety-seven patients affected with nasopharyngeal carcinoma (NPC) were examined with both conventional and Computed Tomography (CT) to evaluate the involved sites with both methods. CT staging was more accurate, showing involvement in more locations than conventional tomography, so that staging was modified in 23 of 97 patients. Two hundred and seventeen patients treated from 1970 to 1985 were subdivided into group A (111 patients who underwent conventional tomography only) and group B (106 patients examined with CT, from 1978 on). A trend toward more advanced stages at presentation was observed in group B; nevertheless, local control at 5 years was higher in group B (59%) than in group A (42%). The role of Magnetic Resonance (MR) imaging in NPC staging was also evaluated in 30 patients: there was disagreement in 2 cases. Involvement of different structures was shown in 10 of 28 cases with the same CT and MR staging. MR imaging proved a valuable tool in the follow-up as well: in fact, it clarified 12 questionable opacities on CT in a group of 35 followed patients as inflammatory lesions in 10 patients and tumors in 2.

Female↗
PubMed1991

[Comparison of the results of surgery and radiotherapy in 175 cases of T2 glottic carcinoma: 116 operated and 59 irradiated cases].

The results were analyzed of 175 patients with glottic squamous cell carcinomas who were treated with curative purposes (1970-1986). One hundred and sixteen of them underwent surgery at the Otolaryngology Department of the University of Florence, and 59 were treated by radiation therapy at the Florence University and Hospital Departments of Radiotherapy. In the surgical series 78 cases were treated with radical surgery and 38 with conservative surgery. All patients were staged according to TNM system (UICC 1978) as T2. Overall 10-year local control rates were 74% for the surgical series and 69% for the cases treated by radiation therapy. After salvage therapy 10-year survival rates were 83% and 76%, respectively. The analysis of the results showed no statistically significant difference. In the group treated by radical surgery 80% local control was observed, versus 66% in the cases treated with conservative surgery. 10-year survival rate was higher in the latter group (89% versus 81%) because of better results of salvage therapy: 7 of 10 recurrences were salvaged with the second treatment. Several prognostic factors were evaluated, i.e., T extent, anterior commissure involvement, subglottic invasion, vocal cord mobility impairment, and ventricular involvement. Anterior commissure involvement was the main factor affecting outcome in the surgical series: in the presence of this factor, 64% 10-year local control was observed versus 85% in the patients without commissure involvement. This factor proved more important in the patients treated with conservative surgery (10-year control: 42% versus 88%) than in those undergoing radical surgery (78% versus 85%). Anterior commissure involvement and the number of involved subsites were found to worsen prognosis in the series treated by radiation therapy: cases with anterior commissure involvement had 59% 10-year local control versus 83%. The cases with a deeper spread had 60% local control versus 75%. Vocal cord mobility impairment was a less important prognostic factor in both series. Our results suggest radiation therapy as a valuable method in the treatment of the small T2 laryngeal cancers which are not suitable for conservative surgery.

Carcinoma, Squamous Cell↗
PubMed1991

[Follow-up of breast carcinoma].

The rationalization of the follow-up schedule for patients treated for breast cancer appears essential due to the high incidence of this disease. The authors retrospectively analyze their series (3,596 patients, from 1971 to 1990) to assess the patterns of both early loco-regional recurrences and distant metastases. Patterns and outcome of local and regional recurrences are reported according to site. The international literature on the subject is reviewed, and the schedule currently employed in the follow-up of breast cancer patients at the Radiotherapy Unit of Florence is reported. Due to the patterns of relapse a more intensive clinical follow-up schedule is suggested during the first 5 years. Less intensive follow-up continues over the whole patients' life span, since failures can occur even after 5 years. Mammography should be repeated every year in the same period to detect eventual homolateral and/or contralateral relapses. Other diagnostic tools should be employed only when symptoms set in. On the ground of the current literature on the subject, no negative impact on survival should be expected from this follow-up schedule.

Bone Neoplasms↗
PubMed1990

Accelerated fractionation in advanced head and neck cancer: results and analysis of late sequelae.

From 1975 to 1985, 161 patients affected by head and neck cancer (58 oropharynx, 67 oral cavity, 36 paranasal sinuses) were treated with radiotherapy using an accelerated fractionation (AF) schedule at the University and Hospital Radiotherapy Departments of Florence. Most cases, classified with U.I.C.C. and A.J.C. TNM (1978) were advanced (137/161 = 85%). Five-year actuarial local control and survival was 38% for the oropharynx, 18% and 20% for the oral cavity, and 38% and 31% for the paranasal sinuses. Results were analysed according to T and N stage as well. Severe late sequelae were evaluated in 53 patients without local disease and with a minimum follow-up of one year: 8 patients developed osteonecrosis; there were 3 cases of trismus, 2 cases of laryngeal oedema, one case of blindness and one case of ophthalmitis.

Adenocarcinoma↗
PubMed1990

Computed tomography in nasopharyngeal carcinoma: Part I: T-stage conversion with CT-staging.

Two hundred seventeen consecutive patients were treated with radiotherapy alone, with curative intent, from 1970 to 1985 at the Radiotherapy Unit of the University and Hospital of Florence. The distribution according to T and N staging with polytomography was compared to patients (106 out of 217) who had CT scans done at presentation. T1 cases were less frequent (6.6% vs 27%) in the CT-staged series, whereas T3 showed a higher incidence (30.2% vs 12.6%). The advantages of CT over conventional tomography were quantitated in a subset of 97 patients who underwent both staging procedures. Site-by-site, CT displayed a higher percentage of involvement than polytomography: parapharyngeal spread 18% vs 2%, oropharynx 16% vs 8%, choanae and nasal cavities 28% vs 13%, ethmoid and maxillary sinus 29% vs 13%. Information provided by CT caused a T-stage conversion in 23 out of 97 cases (23%): 4 out of 11 T1, 16 out of 44 T2, 3 out of 16 T3.

Humans↗
PubMed1990

Computed tomography in nasopharyngeal carcinoma: Part II: Impact on survival.

Two hundred and seventeen consecutive patients affected by nasopharyngeal carcinoma (NPC) were treated with radiotherapy alone, with curative intent, from 1970 to 1985 at the Radiotherapy Unit of the University and Hospital of Florence. A group (A) of 111 patients staged with conventional clinical and radiological method was compared to a second group (B) of 106 patients who underwent CT staging before treatment. Group B showed better 5-year NED survival and local control; only the differences in local control were significant (p less than 0.01). As to primary control statistically significant differences were observed in T2 and T4 cases. We feel that CT could have contributed to the improvement, probably through a more reliable display of the primary extent and a more adequately planned radiotherapeutic treatment. With CT staging we could not increase our skills in prognostically separating stages according to UICC criteria (1978); in Group B only T2 patients presented significant differences in primary control when compared to T3 and T4 patients. However, a multivariate analysis of prognostic factors showed that nodal involvement, primarily, and histology, secondarily, were the most important factors; T stage showed a minor influence on prognosis.

Humans↗
PubMed1986

Paranasal sinuses and nasal cavity cancer: different radiotherapeutic options, results and late damages.

From 1970 to 1983, 69 patients, affected by malignant epithelial tumors of paranasal cavities and nasal fossae, were treated with radiotherapy at the Radiology Institute of the University and Radiotherapy Hospital Department of Florence. Primary carcinoma of the maxillary sinus occurred in 44 patients, of the nasal cavity in 20, and of the other sinuses in 5. Most of the patients had locally advanced lesions (63 T3-4: 91.5%) according to the adopted TNM system (Lederman-Gadeberg, Sisson-Jesse). Crude survival data showed 35% and 13% of NED patients at 2 and 5 years, respectively. Local progression was the most important cause of death; patients relapsed within 2 years. The actuarial 5-year survival, corrected for causes of death other than disease, was 32% for the overall series, 32% for maxillary sinus, and 41% for the nasal cavity. There was no difference in survival in patients treated with conventional fractionation (CF) vs. multiple daily fractionation (MDF) -30% vs. 33% at 5 years. The late damages of the radiation therapy in 22 patients without local disease, with a minimum follow-up of 2 years, is also analyzed.

Adult↗
PubMed1984

Plasma amylase activity as a biochemical indicator of radiation injury to salivary glands.

Irradiation of the salivary glands produces a rapid increase of salivary amylase in serum, released by the highly radiation sensitive serous cells of the glands. Serial assays of salivary amylase in serum were performed in patients treated by radiation to the upper neck region. The changes observed were compared with the amount of salivary gland mass irradiated and with the dose fractionation modality used. The irradiated volume included either the entire salivary gland mass or less than 50 per cent of the gland. Two fractionation modalities were used: a conventional fractionation of 2 Gy per day, 5 times a week, or a multiple daily fractionation of 2 Gy, 3 times a day in two series of 4 days with a 4-day interval. Both parameters (salivary gland mass irradiated and fractionation modality used) significantly influenced the shape of the amylase curve in the serum. Serum amylase may therefore be considered a reliable biologic indicator of early injury to the salivary glands.

Adolescent↗
PubMedDate not supplied

Advanced carcinomas of the oropharynx treated with radiotherapy--a comparison of three different fractionation schemes.

INTRODUCTION: This report reflects a retrospective comparison among historical series of patients with similar site and stage of disease treated by three fractionation schemes. MATERIALS AND METHODS: A hyperfractionation (HF) scheme delivered 1 Gy three times a day, 5 days a week, to a total dose of 60 to 63 Gy over 26 to 29 days. A group of 48 patients received HF. Accelerated fractionation (AF) consists of 2 Gy three times a day, 5 days a week, to a total of 48 to 52 Gy delivered over 11 to 12 days. A group of 46 patients underwent this therapy. A third group of 48 patients were treated with conventional fractionation (CF). These patients received 2 Gy each day, 5 days a week, to a total dose of 60 to 66 Gy. RESULTS: Ned survival at 5 years was 23.8%, 32.8%, and 29.3% for CF, AF, and HF, respectively. The most important cause of failure was inability to control disease at the primary site; however, isolated distant metastasis were observed in 15.4% of all failures. Treatment delays were more common in the HF and CF groups. The highest incidence of late complications occurred in the AF group. CONCLUSIONS: Advanced lesions of the oropharynx have an ominous prognosis. New fractionation regiments represent a warranted approach as an alternative to or an integration into combined chemotherapy and radiotherapy.

Adult↗
PubMedDate not supplied

Nonstandard fractionation schedules in radiation therapy of head and neck cancer: a review.

The authors present an updated review of the clinical trials on hyperfractionated and accelerated fractionation schedules in radiotherapy of head and neck cancer. The available results in terms of survival and local control, and acute and late toxicity data are summarized in order to show the current status of this research field. The new breed of fractionation schedules that are on study, designed on the ground of new rationales, are presented as well. Finally, an introductory overview of combination therapy including non standard fractionation radiotherapy associated with chemotherapy is reported.

Chemotherapy, Adjuvant↗
PubMedDate not supplied

Randomized trials on altered fractionation in head and neck cancer radiotherapy with conventional fractionation as control arm: another lap to go.

The Authors present a review of randomized trials on non conventional fractionation in head and neck cancer radiotherapy with conventional fractionation as control arm. Hyperfractionation was studied in 5 trials, accelerated hyperfractionation in 4 trials and accelerated fractionation in 3 trials. Furthermore, the reviews of eminent Authors dealing with the above mentioned trials are summarized. In spite of improved local control rate reported with hyperfractionation, non conventional radiotherapy schedules are not yet recommended as routine clinical practice, but all the radiation oncologists are Invited to join trials on this subject.

Dose Fractionation, Radiation↗
PubMedDate not supplied

[Supportive therapy in oncology].

The current trend towards a more intensive cancer treatment is possible thanks to the availability of a really important and effective supportive care. It is our opinion that it would be essential for the junior staff in oncology, for the practitioners, but also for the knowledge of anyone contributing in different ways to give the cancer treatment, to have reference points to give also the best supportive care. With this aim we thought to start a study, in Italy, to investigate, first, which is the supportive care used in the most common acute toxicities during or immediately after cancer therapy. We decided to begin with a survey addressed to hematologists, medical oncologists, radiotherapists; 105 centers were contacted. In order to have a high number of people able to answer to different clinical questions we decided to use Internet to communicate with participating centers without moving people. The final goal of the project is to formulate guidelines in supportive care, but also to promote the use of Internet as much as possible in the medical world with the aim to make easier every kind of communication and exchange of information.

Computer Communication Networks↗