Clinical Evaluation of Low-Molecular-Weight Hyaluronic Acid-Based Treatment on Onset of Acute Side Effects in Women Receiving Adjuvant Radiotherapy after Cervical Surgery: A Randomized Clinical Trial.

BACKGROUND: Radiotherapy treatment for cervical cancer (CC) often induces side effects, including inflammation, dryness, dyspareunia. Considering its key role in the healing process, hyaluronic acid (HA) could be useful for the completion of radiotherapy. OBJECTIVES: The aim of this work was to evaluate the ability of HA to reduce the onset of side effects due to radiotherapy. MATERIALS AND METHODS: In total, 180 women undergoing radiotherapy were randomized into two arms: controls and those treated with vaginal suppositories containing low-molecular-weight HA from day 1 of radiotherapy. The study lasted 5 weeks and was characterized by three visits: at baseline (T0), 15 days later (T1), and at the end of the radiotherapy cycle (T2). The onset of side effects, pain, safety, efficacy, acceptability of treatment, and compliance to the therapy were evaluated. RESULTS: Patients in the control arm reported the onset and worsening of all symptoms with a moderate or severe grade at T2, whereas in the treatment arm almost 90% of patients reported the absence of symptoms or a mild grade. All patients in the treatment arm referred a lower intensity of pain on a visual analog scale compared with the control arm at T2 (6.85 ± 0.94 vs. 1.88 ± 1.02). CONCLUSIONS: HA was able to help vaginal mucosa healing during radiotherapy in patients with CC.

Nodal Ratio as a Prognostic Factor in Patients with Four or More Positive Axillary Nodes Treated with Breast-conserving Therapy and Regional Nodal Irradiation.

AIM: This study aimed to investigate the prognostic value of the axillary lymph node ratio (i.e. positive axillary nodes to nodes removed) in patients with breast cancer treated with conservative surgery and regional radiotherapy. PATIENTS AND METHODS: We retrieved the records of 195 patients with breast cancer with pathological stage pT1-2 pN2-3, treated from January 2005 to December 2013 at our Radiation Oncology Centers; their clinical data were retrospectively evaluated. All patients underwent lumpectomy or quadrantectomy with axillary lymph node dissection, adjuvant chemo-with/without hormonal therapy and irradiation to the whole breast and ipsilateral axillary apex, infraclavicular and supraclvicular nodes, excluding internal mammary nodes. The primary end-point was to evaluate the nodal ratio as a prognostic factor; moreover, the following prognostic factors were evaluated: age, biological status and molecular profile. RESULTS: The median follow-up was 58 months (range=32-117.6 months). Two- and 5-year overall and recurrence-free survival rates were 96% and 88%, and 92% and 85%, respectively. On univariate analysis, factors influencing overall survival were nodal ratio >0.65 (p=0.033) and age (p=0.023); time to recurrence was detrimentally impacted only by Ki67 positivity ≥50% (p=0.049). At multivariate analysis, no significant associations were found. CONCLUSION: Adding irradiation to regional nodes after conservative surgery in patients with breast cancer with more than three positive axillary nodes does not alter the prognostic value of the nodal ratio, and we confirm this to be an important factor for predicting overall survival.

Breast cancer bone metastases: an epidemiologic study in selected radiation departments.

AIMS: To quantify radiation treatments for bone metastases from breast cancer in three Sicilian provinces (Messina, Catania, Ragusa) with respect to the general population and the incidence and prevalence of breast cancer in this macro-area in a 8-year period. METHODS: All bone metastasis patients treated using radiotherapy in 8 radiation departments operating in the provinces of Messina, Catania and Ragusa were collected. Among these, metastases from breast carcinoma were analyzed according to year of irradiation. An analysis of breast cancer incidence and prevalence with respect to inhabitants in this macro-area was conducted using literature and census data. RESULTS: From January 2004 to December 2011, irradiation was delivered in 4419 bone metastasis patients. Among these, 1617 had a primary breast cancer with a median treatment per year of 206.5 (range, 164-251); 211 patients were treated in 2004 and 206 in 2011. In 2004, there were 1,048,957 female residents in the three provinces and 1,065,422 in 2011. The reported breast cancer incidence and prevalence in Sicily was respectively 100.79/100,000 and 908.54/100,000 in 2004 and 108.41/100,000 and 1091.29/100,000 in 2010. CONCLUSIONS: There has been an increase in both incidence and prevalence of breast cancer in Sicily. Nevertheless, it seems that there was no increment in skeletal-related events requiring irradiation in such patients in eastern Sicily radiation departments.

Diarrhoea in irradiated patients: a prospective multicentre observational study.

AIMS: To determine the incidence of cancer treatment-induced diarrhoea in patients submitted to irradiation. METHODS: Forty-five Italian radiation oncology departments took part in this prospective observational study and a total of 1020 patients were enrolled. The accrual lasted three consecutive weeks; evaluation was based on diary cards filled in daily by patients during radiotherapy and one week after cessation. Diary cards recorded both the onset and intensity of diarrhoea. RESULTS: A total of 1004 patients were eligible for this analysis. 147/1004 (14.6%) patients had diarrhoea. The median minimum number of daily events was 1 (range 1-7) with a median maximum events of 3 (range 1-23). 82/147 patients (56.2%) had a drug prescription for diarrhoea. In the evaluation of the onset of diarrhoea, in multivariate analysis, we found the following factors to be statistically significant predictors of an increased likelihood of diarrhoea: primitive tumour site, therapeutic purpose and field size. CONCLUSIONS: Patients with abdominal-pelvic cancer, treated with curative purpose and using large field sizes are at high risk of cancer treatment-induced diarrhoea. Diarrhoea was also observed in patients treated at other sites. In this population group there is the need for more stringent monitoring during the delivery of radiation therapy.

Muscle-invasive bladder cancer in elderly-unfit patients with concomitant illness: can a curative radiation therapy be delivered?

AIMS AND BACKGROUND: There is no standard treatment for elderly-unfit patients with muscle-invasive bladder cancer. Pelvic irradiation alone is an usual approach in this instance, and some reports have demonstrated that curative radiotherapy is feasible in elderly patients. To our knowledge, no data exist about the feasibility of a curative treatment in elderly patients with concomitant illness and a Charlson Comorbidity Index (an index of comorbidity that includes age) greater than 2. The main purpose of the present study was to establish the feasibility of irradiation in a cohort of elderly patients in poor general condition. METHODS: The records of 45 elderly-unfit patients (median age, 75 years; range, 70-85), with a comorbid Charlson score >2, treated with curative dose, planned continuous-course, external beam radiotherapy for muscle-invasive bladder cancer were reviewed. The patients were treated to a median total dose of 60 Gy (range, 56-64), with an average fractional dose of 190 +/- 10 cGy using megavoltage (6-15 MV). All patients were treated with radiation fields encompassing the bladder and grossly involved lymph nodes with a radiographic margin of at least 1.5 cm. RESULTS: No treatment-related mortality and clinically insignificant acute morbidity was recorded. No patient was hospitalized during or after the irradiation because of gastrointestinal or urogenital side effects. In one patient a week rest from therapy was necessary due a febrile status. Median survival was 21.5 months; overall 3- and 5-year survival was 36% and 19.5%, respectively. CONCLUSIONS: Elderly-unfit patients with comorbidities and >70 years of age can be submitted to radical pelvic irradiation. The results observed in this retrospective analysis have encouraged us to use non-palliative radiotherapy doses in these patients with muscle-invasive bladder cancer.