Adjuvant hypofractionated radiation therapy for breast cancer after conserving surgery.

AIMS: To evaluate the incidence of locoregional recurrence (LRR) and the cosmetic results in a group of patients with breast cancer treated with a hypofractionated schedule of adjuvant radiotherapy after conservative surgery. MATERIALS AND METHODS: In total, 539 patients with pTis-pT1-pT2 breast cancer underwent radiotherapy treatment after conservative surgery at the University of Florence and at the Pistoia Hospital. The dose delivered was 44 Gy (2.75 Gy daily fraction). The tumour bed boost (10 Gy) was given by electrons. RESULTS: At the time of the analysis, 1.8% of patients (10/539) had breast relapse. No patients developed nodal recurrence (supraclavicular, axillary and internal mammary nodes). The 3- and 5-year actuarial rates for LRR were 1.2% (+/- 0.5% standard error) and 2.1% (+/- 0.6% standard error), respectively. Considering the late toxicity, we found that 412 (76.4%) patients had grade 0 or grade 1 late toxicity, 113 patients (20.9%) had grade 2 late toxicity and 14 patients (2.5%) had grade 3 late toxicity. No patients developed grade 4 toxicity. CONCLUSION: This type of approach resulted in an effective treatment in terms of local control in patients with negative or one to three positive axillary nodes and negative surgical margins. Patients treated with a hypofractionated schedule showed very good cosmesis.

Nutrition intervention program of the Modification of Diet in Renal Disease Study: a self-management approach.

OBJECTIVE: To characterize the Modification of Diet in Renal Disease (MDRD) Study nutrition intervention program by determining the frequency of intervention strategies used by the dietitians and the usefulness of program components as rated by participants. DESIGN: Dietitians recorded which of 32 intervention strategies they used at each monthly visit. Participants rated the usefulness of 19 program components. SUBJECTS: 840 adults with renal insufficiency. INTERVENTION: Participants were assigned randomly to usual-, low-, or very-low-protein diet groups. Each eating pattern also specified a phosphorus intake goal. Each participant met monthly with a dietitian for an average of 26 months. STATISTICAL ANALYSES: Analyses of variance and chi 2 analyses. RESULTS: Dietitians used the following intervention strategies most often in all groups: providing feedback based on self-monitoring and/or food records, reviewing adherence or biochemistry data, providing low-protein foods, and reviewing graphs of adherence progress. In general, the dietitians used feedback, modeling, and support strategies more often, and knowledge and skills strategies less often, with participants who had to make the greatest reductions in protein intake and those with more advanced disease. In all groups, the dietitians' use of knowledge and skills, feedback, and modeling strategies decreased over time (P < .001), whereas use of support strategies was maintained. The type and frequency of intervention strategies used by dietitians and the usefulness ratings of participants did not vary by educational level of the participant. Both self-monitoring and dietitian support were rated as "very useful" by 88% of the participants. CONCLUSIONS: Three features were central to the MDRD Study nutrition intervention program: feedback, particularly from self-monitoring and from measures of adherence; modeling, particularly by providing low-protein food products; and dietitian support. We recommend the self-management approach.

Prognostic significance of tissue polypeptide antigen (TPA) in head and neck carcinomas.

The serum tissue polypeptide antigen (TPA) was determined before and at the end of radiotherapy in a group of patients with head and neck epidermoid carcinoma. The baseline values were significantly higher than those in healthy control subjects. They did not depend on the site of the neoplasia but increased with clinical stage. A cut-off value of 85 U/l discriminated two groups of patients according to survival: patients whose values were lower than the cut-off had a disease-free 6-year survival rate of 61%, compared to only 22% in patients with higher TPA levels. Until the second year of follow-up, patients with complete response had baseline values significantly lower than relapsed patients. However, at 5 years the pretreatment values were similar for patients being disease-free, patients with recurrence and patients deceased within the 2-5 year period.

[A new adjuvant therapy modality in the treatment of superficial bladder carcinoma. Study of feasibility of postoperative radiotherapy "flash"]. / Una nuova modalità di terapia adiuvante nel trattamento dei carcinomi vescicali superficiali. Studio di fattibilità del "flash" radioterapico postoperatorio.

The Authors present the preliminary results of a feasibility study on the use of adjuvant radiotherapy (6 Gy single fraction, postoperatively, "flash") as a new treatment modality for superficial bladder cancer (Ta-T1, N0, M0, previously relapsed or not, G I-III). The rationale for this study derives mainly from the favourable results obtained with external beam radiotherapy, when applied before interstitial radiotherapy as a method to avoid scar relapses. Data regarding 55 cases treated with the "flash" are compared retrospectively with those regarding more than 100 cases treated with different types of "conventional" adjuvant therapy at the INRCA Center of Urology, during the last 3-4 years. The Authors stress the need for a prospective, randomized study of selected cases, to clarify if an adjuvant therapeutic modality is superior to the others. The radiotherapeutic option ("flash"), however, clearly produces less iatrogenic damage than the others, and is simpler and cheaper.

[Comparison of the results of surgery and radiotherapy in 175 cases of T2 glottic carcinoma: 116 operated and 59 irradiated cases]. / Confronto fra i risultati della chirurgia e della radioterapia in 175 carcinomi T2 glottici: 116 casi operati e 59 irradiati.

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.

Causes of failure of curative radiation therapy in 205 early glottic cancers.

A retrospective analysis of the results obtained with curative radiation therapy in a series of 205 patients affected by early glottic cancer treated from 1970 to 1985 at the Florence University and Hospital Departments of Radiotherapy is presented. All patients were staged according to TNM System (UICC 1978) as T1-T2 NO. The overall 5-year local control rates were 88% for T1a, 75% for T1b, and 64 for T2. The main cause of failure was progression or recurrence in T (41/48); five failures were observed in T and N at the same time and two in N. Of these 48 patients, 21 (44%) were salvaged with surgery. After surgical salvage of radiation failures, the 5-year survival rates were 95%, 91%, and 73%, respectively, for T1a, T1b, and T2. The extent of T and the number of subsites involved significantly affected local control. Vocal cord mobility was less important. The incidence of failures and damages was analyzed according to the radiation beam, the size of the irradiated volume, fractionation, and total tumor dose.

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.

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.

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.

Serum tissue polypeptide antigen (TPA): a marker of acute injury of salivary glands during radiation therapy.

The modifications of serum concentrations of TPA were monitored in patients undergoing curative radiation therapy. Patients with tumors localized in the head and neck were treated with one of four different schedules based on conventional fractionation or multiple daily fractionation where the dose per fraction and total daily dose varied. Serum TPA increased immediately on the first day of irradiation: the higher the dose, the greater the increase. These increases disappeared rapidly after the first few days of treatment. A more limited rise was observed in some cases when treatment was renewed after the first week-end split or after more prolonged interruptions. Results demonstrated that TPA is a valid biochemical marker of acute radiation injury to the salivary tissue.

Effects of irradiation with conventional and multiple daily fractionation on serum amylase activity.

The behaviour of serum alpha-amylase activity was determined in patients with head and neck cancer treated by radiation therapy. The levels of serum alpha-amylase activity during conventional and multiple daily fractionation were compared. Starting from the second day of treatment an increase of serum alpha-amylase activity was observed. The increase and its duration depended on the total daily dose: after the first day of treatment a linear correlation between serum levels and total daily dose could be observed. The size of the amylase increase correlated to the proportion of salivary gland tissue included in the irradiated volume.

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.

Carcinoma of the nasopharynx: results of radiation therapy.

Of a series of 186 patients with nasopharyngeal neoplasm 138 cases were treated with curative irradiation between 1959 and 1978. All cases were reviewed and retrospectively classified according to the TNM system. The 5-year crude survival rate was 39.5 per cent. A better prognosis was found for women and for younger age groups. The degree of neck node involvement had more prognostic value than the extent of the primary tumor. The causes of failure were analyzed. In 35 cases distant metastases were observed.

Cervical lymph node metastases from an unknown primary tumour.

Forty-nine cases of cervical lymph node metastases from an unknown primary tumour have been reviewed. All the patients were treated by radiation therapy. In 7 cases the primary tumour was detected from 4 to 53 months after the end of treatment. The crude survival rates at 2 and 5 years were 39 and 32 per cent, respectively. The survival rate was correlated to sex, microscopic appearance, stage, and extent of the nodal involvement.