Stereotactic body radiotherapy for early-stage non-small cell lung cancer: a multicentre study by the Oncologic Group for the Study of Lung Cancer (Spanish Radiation Oncology Society)

Purpose/objective(s)Stereotactic body radiotherapy (SBRT) has become the standard of care for patients with medically inoperable early-stage non-small cell lung cancer (NSCLC) and for patients who refuse surgery. The aim of this study was to evaluate the effectiveness and safety of primary SBRT in patients with early-stage NSCLC.Materials/methodsRetrospective multicenter study of 397 patients (416 primary lung tumours) treated with SBRT at 18 centres in Spain. 83.2% were men. The median age was 74.4 years. In 94.4% of cases, the tumour was inoperable. The pathological report was available in 54.6% of cases. SPSS vs 22.0. was used to perform all statistical analyses.ResultsComplete response was obtained in 53.6% of cases. Significant prognostic factors were standard CT planning (p = 0.014) and 4D cone beam CT (p = 0.000). Acute and chronic toxicity ≥ grade 3 was observed in 1.2% of cases. At a median follow-up of 30 months, local relapse was 9.6%, lymph node relapse 12.8%, distant metastasis 16.6%, and another lung tumour 11.5%. Complete response was the only significant prognostic factor for local relapse (p = 0.012) and distant metastasis (p = 0.001). The local relapse-free survival was 88.7%. The overall survival was 75.7%. The cancer-specific survival was 92.7%. The disease-free survival was 78.7%.ConclusionSBRT is an effective and well-tolerated treatment option for patients with early-stage lung cancer who are not suitable for surgery. The most important prognostic factor for local and distant recurrence was complete response, which in our sample depended on the type of CT planning and the IGRT technique.

Consensus statement from the Spanish Brachytherapy Group (GEB) on accelerated partial breast irradiation using multicatheter interstitial brachytherapy.

AIM: To establish consensus guidelines for a safe clinical practice of accelerated partial breast irradiation (APBI) interstitial multicatheter brachytherapy (BT). BACKGROUND: APBI with interstitial multicatheter BT has proved to be effective in the treatment of early stage breast cancer. This paradigm shift in the approach to early breast cancer conservative treatment, along with the existing controversies on the clinical practice of APBI, prompted the Spanish Brachytherapy Group (GEB) of the Spanish Societies of Radiation Oncology (SEOR) and Medical Physics (SEFM) to address BT APBI in a consensus meeting. MATERIALS AND METHODS: Prior to the meeting, a survey with 27 questions on indication, inclusion criteria, BT modality, implant technique, image guidance and simulation, CTV and OAR definition, dose prescription and fractionation, dose calculation, implant quality metrics and OAR dose constrains was distributed. Items not reaching a level of agreement of 70% were discussed and voted during the meeting. RESULTS: 26 Institutions completed the survey, 60% of them perform APBI procedures. The analysis of the survey showed consensus reached on approximately half the questions. An expert panel discussed the remaining items; thereafter, a voting established the definite consensus. CONCLUSIONS: This document summarizes the consensus guidelines agreed during the meeting of the Spanish Brachytherapy Group SEOR-SEFM. Institutions with BT facilities available should offer interstitial BT APBI as a treatment option to patients fulfilling the inclusion criteria. Institutions willing to implement interstitial BT APBI are encouraged to follow the consensus guidelines established herein.

SIMBOSPROST: Prevalence of metabolic syndrome and osteoporosis in prostate cancer patients treated with radiotherapy and androgen deprivation therapy: A multicentre, cross-sectional study.

AIM: To assess the prevalence of metabolic syndrome (MetS) and osteoporosis in patients with prostate cancer (PCa) treated with radical radiotherapy (RT) with or without androgen deprivation therapy (ADT). BACKGROUND: Worldwide, the prevalence of MetS is estimated to range from 20% to 25% of the adult population. However, prevalence rates are much higher in PCa patients (pts) who undergo ADT. MATERIALS AND METHODS: Multicentre cross-sectional study of 270 pts in Spain with PCa. Patients were divided into 3 groups based on the duration of ADT (6, 12-18, ≥24 months) and compared to a control group without ADT. MetS was defined according to NCEP ATP III criteria. Osteoporosis was assessed by DEXA. RESULTS: A total of 270 pts, treated from November 2011 to October 2012, were included. Of these, 122 pts (47%) fulfilled the criteria for MetS. The median age of this group was significantly higher (71.3 vs. 69.38 years, p = 0.028). MetS prevalence was 50% in the control group. In pts who received ADT, prevalence was 44.8% after 6 months of ADT, 45.3% after 12-18 months, and 50% after ≥24 months (pns). Most pts (168/270; 62%) underwent DEXA. Of those tested, 78 (46.4%) had osteopenia and only 11 (6.5%) had osteoporosis. CONCLUSIONS: The prevalence of MetS in pts with PCa treated with radical RT was higher (47%) than in the general population. However, there were no significant differences in the duration of ADT administration. The prevalence of osteoporosis was low. These findings suggest that the prevalence of MetS in PCa patients may be higher than previously reported.

Conservative surgery, external radiotherapy, and HDR brachytherapy in a single fraction of 7 Gy in early breast cancer: long-term toxicity and esthetic assessment.

INTRODUCTION: The essential issue in conservative treatment is the quality in breast preservation. When risk factors for local relapse exist, a tumour bed boost is required, but the boost choice remains controversial. Prospectively, we studied long-term toxicity, cosmetic outcome and prognostic factors. MATERIALS AND METHODS: After conservative treatment, 115 patients received a single dose of 7 Gy HDR-brachytherapy (HDR-BT) boost between June 1996 and December 2005. Late toxicity was assessed using the LENT-SOMA scale. For esthetic assessment, a subjective scale was used for patients and a modified Fehlauer scale for physicians. Mean age was 56.6 years. Invasive ductal carcinoma (78 %) and lumpectomy (60 %) were predominantly reported. 48 % received chemotherapy (CT). RESULTS: Regarding toxicity, 39 % of patients reported breast pain, 75 % fibrosis, 56 % telangiectasias, 19 % lymphoedema, and 51 % retraction/atrophy. Concerning management, 22 % of patients with pain and 45 % with lymphoedema were treated. The esthetic result was found satisfactory by 96 % of the patients and 85 % of the physicians. Fibrosis was influenced by CT and a larger irradiated volume and telangiectasias by a greater implant volume. CONCLUSIONS: HDR-BT boost shows good cosmetic effects with acceptable toxicity. Patients overestimate the esthetic outcome. LENT/SOMA is useful to assess chronic toxicity.

Early-stage breast cancer conservative treatment: high-dose-rate brachytherapy boost in a single fraction of 700 cGy to the tumour bed.

BACKGROUND AND PURPOSE: Conservative treatment represents the current therapy for early-stage breast cancer. When risk factors for local relapse exist, a tumour bed boost is required. Retrospectively, we evaluated the prognostic factors influencing local recurrence (LR), overall survival (OS) and disease-free survival (DFS). MATERIAL AND METHODS: After conservative treatment, 210 patients received a single-dose HDR brachytherapy (HDRBT) boost between June 1996 and December 2005. Mean age was 57 years; 75% had invasive ductal carcinoma. The most frequent surgery was lumpectomy (55.7%); 39.4% were G3, 18.6% intraductal component >25% and only 22% had negative margins. RESULTS: With a mean follow-up of 85 months, at 5 and 10 years the OS was 93% and 88%, DFS 92% and 89%, and LR 3.6% and 5.3%, respectively. For LR, the risk factors were carcinoma in situ, N+ and involved margins, whereas for metastasis, the risk factors were T2 tumours, stage III, N+ and the presence of local recurrence. CONCLUSIONS: HDR-BT boost in one fraction is an effective, simple and safe method for reducing LR. The outpatient setting and shorter treatment duration represent undeniable advantages.

Consensus of the Spanish Society of Radiation Oncology (SEOR) Brachytherapy Group on Brachytherapy in breast cancer.

Breast cancer is the most frequent neoplasia in women. Randomized studies which compare mastectomy with conservative treatment show no differences in global survival. In cases in which conservative surgery is performed, breast radiation therapy and boost reduces the rate of local recurrence. On March 2010, the 8th Consensus Meeting of the Spanish Society for Radiation Oncology (SEOR) Brachytherapy Group was held in Madrid about «Treatment of Breast Cancer with Brachytherapy¼. In this article we presented the conclusions about brachytherapy boost, Partial breast irradiation and clinical dosimetry.

PITASOR epidemiological study: prevalence, incidence and treatment of anaemia in radiation therapy oncology departments in Spain.

INTRODUCTION: Anemia is the most common haematological complication in cancer patients. OBJECTIVE: Analysis of the incidence, prevalence and treatment of anemia in oncologic patients treated in Radiation Oncology Departments in Spain (ROD) and monitoring of the existing recommendations for the treatment of anemia. MATERIAL AND METHODS: Observational, prospective, multicenter study which involved 19 Spanish ROD. The study was approved by the CEIC Central Defense Hospital. 477 patients with solid tumors, subsidiary of RT with radical intent referred to such centers within a period of one month (5/5/09 to 5/6/09) and gave their consent to participate in the study. We gathered the main characteristics of patients and their oncologic disease. All patients underwent a determination of Hb levels before RT, upon reaching 25-35 Gy and at the end treatment. In patients with anemia we assessed the existence of related symptoms and its treatment. RESULTS: Basal situation: The prevalence of anemia was 34.8% (166 patients). Mean Hb in patients with anemia was 11.17 ± 1.07 g/dl. Anemia-related symptoms were present in 34% of the patients. Anemia predisposing factors were: stage of the disease, previously received chemotherapy, and hormonal therapy. 39% (66 patients) received anemia treatment, with a mean Hb of 10.43 ± 1.04 g/dl. During RT: The prevalence of anemia was 38.9% (182 patients) with a mean Hb of 11.24 ± 1.21 g/dl. Predisposing factors for anemia during RT treatment were: age, male sex, chemotherapy prior to RT, basal anemia and chemotherapy during RT. 36.3% (66 patients) had anemia-related symptoms. 34.6% (63 patients) with a mean Hb of 10.5 ± 1.37 g/dl received treatment for anemia. The prevalence of anemia at the end of the RT was 38.1% (177 patients) with a mean Hb of 11.19 ± 1.18 g/dl. The predisposing factors for the appearance of anemia at the end of RT were: male sex, anemia at basal situation and during treatment and chemotherapy during RT. 34% (61 patients) had anemia-related symptoms and 73 patients (41.2%) with a mean Hb of 10.5 ± 1.22 g/dl received treatment for anemia. The presence of anemia-related symptoms was significantly correlated with the beginning of treatment for anemia. The incidence of anemia (new cases) during radiotherapy was 17.5%. CONCLUSION: The prevalence of anemia in basal situation, during RT and at the end of RT is 34.8%, 38.9% and 38.1%. During RT the incidence of anemia is 17.5%. 39.8%-41.2% of patients with anemia and 64.2%-68% of patients with anemia-related symptoms received treatment. Treatment of anemia starts with Hb<11 g/dl and the goal is to achieve Hb 12 g/dl. In our Radiotherapy Oncology Departments, the treatment of anemia complies with the current recommendations and guidelines in use.

Serum C-telopeptide levels predict the incidence of skeletal-related events in cancer patients with secondary bone metastases.

INTRODUCTION: We evaluated serum C-telopeptides (CTX) to see whether they may be useful as predictive markers for disease progression in cancer patients with bone metastases who are being treated with zoledronic acid (ZA). PATIENTS AND METHODS: This was a prospective, nonrandomised study in which 26 patients with solid tumours and confirmed bone metastases were treated with ZA (4 mg every 3-4 weeks) for 24 months or until a skeletal-related event (SRE) was observed. Serum CTX levels were determined at baseline and 6, 12, 18 and 24 months after study initiation. SRE were evaluated using bone scintigraphy. RESULTS: Study participants had prostate (50%), breast (31%), lung (11%) or bladder (8%) tumours. Mean age was 69 (range 52-84) years, and 65% men. At baseline, overall mean CTX levels were 562.47 ± 305.17 pg/dl. Patients who showed disease progression during the study period showed significantly higher CTX levels at baseline and after 18 months of ZA treatment than patients who did not progress (p = 0.040 and p = 0.006, respectively). Patients with ≥ 5 bone metastases at diagnosis had significantly higher CTX levels after 18 months of ZA treatment than patients with < 5 bone metastasis (p = 0.001). Similarly, at 12 and 18 months, patients without SRE had significantly lower CTX levels than patients in whom a SRE was observed (p = 0.005 and p = 0.001, respectively). CONCLUSIONS: Changes in serum CTX levels seem to predict the potential for tumour control and the likelihood of developing an SRE in a sample of patients with solid tumours and bone metastases treated with ZA.

Extrapulmonary small cell carcinoma in breast and prostate.

Extrapulmonary small cell carcinoma in breast and prostate are uncommon neoplasms. In the literature most of the data come from case reports and these show that these tumours are highly aggressive. Histologically, they bear striking similarities to small cell carcinomas of the lung and usually show evidence of additional histologies. Treatment, which may include surgery, radiotherapy and chemotherapy, is based on the clinical stage. We present the evolution of two cases.

Vesical instillations of hyaluronic acid to reduce the acute vesical toxicity caused by high-dose brachytherapy do not affect the survival: a five-year follow-up study.

OBJECTIVE: To determine whether the intravesical use of hyaluronic acid (HA) reduces acute and late vesical toxicity induced by radiotherapy. METHODS: Single-centre retrospective study of patients diagnosed with cervical and endometrial cancer treated with brachytherapy (BT) with or without intravesical instillation of HA. Patients were assigned consecutively to the two treatment groups. Forty milligrams of HA was instilled intravesically for approximately 30 min prior to each BT session. Rates of acute and late vesical toxicity were recorded using the RTOG criteria. RESULTS: Ninety-five clinical histories were reviewed (48 with HA instillation and 47 without). Surgery had been performed in 85.3% of cases, external radiotherapy in 76.8% and chemotherapy in 25.3%. There were no significant differences between groups with regard to the total number of BT sessions, dose per session, total dose or biological equivalent dose. In all the sessions the percentage of patients presenting acute vesical toxicity was lower in the HA group, the differences being statistically significant (p<0.05) after the 2nd (20.8% vs. 40.4%) and 4th sessions (10.9% vs. 31.9%). No patients in the HA group presented vesical toxicity after six months of follow-up. Over the whole study period, the percentage of patients presenting vesical toxicity of degree 2 or more was significantly lower in the HA group (2.08% vs. 12.8%; p<0.05). CONCLUSION: Vesical instillations of HA decrease the incidence and the degree of acute vesical toxicity induced by high-dose BT, and reduce the percentage of patients that develop toxicity of degree 2 or more.

Granulocytic sarcoma of the right humerus in a non-leukaemia patient.

Granulocytic sarcoma (GS), an uncommon solid extramedullary tumour, should be considered even in the absence of leukaemia, as delay in diagnosis and treatment worsens the prognosis. We present a GS (single humeral bone lesion) in a non-leukaemia patient, treated with intensive AML (Acute Myeloid Leukaemia) chemotherapy and sequential radiotherapy, in complete response 26 months after diagnosis, confirmed by histopathology and without leukaemia progression.

Superoxidase dismutase (SOD) topical use in oncologic patients: treatment of acute cutaneous toxicity secondary to radiotherapy.

OBJECTIVE: The objective of this study is to evaluate the efficiency of SOD applied topically in oncologic patients affected by acute radiodermatitis. MATERIALS AND METHOD: This study includes 57 patients who showed a dermatitis grade 2 or superior; they were administered SOD ointment b.i.d. (40 mg, weekly) and follow-up continued for 12 weeks. RESULTS: At the end of radiotherapy, 77.1% of the patients ameliorated completely or partially, and at the end of the 12-week period 100% of patients were free of toxicity. No acute toxicity relapses were reported. Response time reduced during radiotherapy, as well as the treatment time at the end of it. CONCLUSIONS: The employment of SOD topically is efficient in the treatment of radiodermatitis, which is an acute side effect of radiotherapy.

Once-weekly dose of epoetinum alfa in cancer patients with anemia receiving radiotherapy

Introduction. Anaemia is present in 30%-90% of all patients with cancer, and its origin is multifactorial. Human recombinant erythropoietin has been shown to be useful in treating anemia in patients with cancer. The aim of this study was to evaluate the effectiveness of treatment of anaemia with epoetin alfa (EPO) given as a single weekly dose, and its repercussions on quality of life (QoL). Materials and methods. From January to October 2002, a total of 139 patients referred to our service for radiotherapy (RT) had anemia and received treatment with EPO as a single weekly dose of 40,000 IU subcutaneously, with oral iron supplement. If haemoglobin (Hb) values after 1 month of treatment did not increase by >=1 g/dl, the dose was increased to 60,000 IU/week. Treatment with EPO ended when Hb values reached >=14 g/dl or one month after the end of RT regardless of Hb values. QoL was evaluated with the Functional Assessment of Cancer Therapy-Anaemia subscale (FACT-An) and the Cancer Linear Analogue Scale (CLAS). Results. Mean Hb at the start of treatment with EPO was 11.49 ± 1.08 g/dl, and the mean value at the end of treatment was 14.52 ± 1.41 g/dl (p < 0.001). The mean increase in Hb was 2.97 ± 1.65 g/dl. Mean duration of treatment was 7.13 ± 2.91 weeks. In 11 patients (7.9%) the dose was increased after 4 weeks. In 84 patients (60.4%) EPO treatment was implemented before the commencing of RT. Mean Hb values in this group was 11.34 ± 1.11 g/dl at the start of EPO treatment, 12.69 ± 1.56 g/dl at the start of RT, 13.96 ± 1.54 g/dl at the end of RT and 14.68 ± 1.3 g/dl at the end of EPO treatment (p < 0.001). In 55 patients (39.6%) anaemia developed during RT and, therefore, EPO treatment was implemented after commencing of RT. In this group the mean Hb values were 12.29 ± 1.6 g/dl at the start of RT, 11.72 ± 1.01 g/dl at the start of EPO treatment, 13.97 ± 1.53 g/dl at the end of RT and 14.28 ± 1.54 g/dl at the end of EPO treatment (p < 0.001). Hemoglobin levels at the start of EPO were lower in patients who commenced EPO before RT (p < 0.05). In 60 patients who received combined RT and chemotherapy, mean Hb values were 11.42 ± 1.16 g/dl at the start of EPO and 13.98 ± 1.55 g/dl at the end of EPO (p < 0.005). In 75 patients who had received RT alone, the mean Hb values was 11.53 ± 1.05 g/dl at the start of EPO and 14.98 ± 1.17 g/dl at the end of treatment (p < 0.001). Patients treated with RT alone had higher Hb levels at the end of RT and at the end of EPO treatment than did patients who had received combined treatment (p < 0.005). The duration of EPO treatment was shorter in the group treated with RT alone than in the combined treatment group (6.41 ± 2.99 weeks versus 7.96 ± 2.67 weeks; p < 0.005). No significant differences were observed in FACT-An and CLAS scores at the beginning and the end of the study. Conclusions. Treatment with epoetin alfa as a single weekly dose significantly increased Hb levels in patients with cancer who were undergoing radiotherapy. The response was greater in patients treated with radiotherapy alone than in those receiving combined therapy. The duration of EPO treatment was shorter in the group treated with radiotherapy alone than in the combined treatment group

Early stage breast cancer conserving treatment: high dose rate brachytherapy boost to the tumour bed.

INTRODUCTION: The dose administered to the tumour bed is a risk-factor for local recurrence in localised breast cancer following breast-conserving surgery. MATERIALS AND METHODS: All patients (n=94) received 50 Gy external beam radiotherapy and one application of 700 cGy at 85% isodose with high dose rate brachytherapy. RESULTS: Of the cases, 84% were infiltrating ductal carcinoma; 31.2% were G3; 28% were intraductal component > 25%; 54% had margin < 1 cm or unknown. With a mean follow-up of 65 months (range: 36-107 months), the overall actuarial survival at 5 and 8 years was 93.2% and 84.2%, respectively; disease-free survival was 88.3% and 84.6%, respectively; local control was 92.2% and 88.75%, respectively. Local recurrence rate was 5.3%, and distant dissemination rate was 8.5%. Among the risk-factors analysed, only the presence of 4 or more lymph node involvement implied a higher risk for local recurrence (p =0.0001). For distant dissemination, the risk-factors were: 4 or more lymph nodes involved (p = 0.0001),G3 (p =0.029), tumour >3 cm (p = 0.001), irradiation volume with external beam radiotherapy (p =0.0001), and presence of local recurrence (p = 0.001). CONCLUSION: High dose rate brachytherapy is an effective method for reducing local recurrence, and increasing local control.

Early stage breast cancer conserving treatment: high dose rate brachytherapy boost to the tumour bed

Introduction. The dose administered to the tumour bed is a risk-factor for local recurrence in localised breast cancer following breast-conserving surgery. Materials and Methods. All patients (n=94) received 50 Gy external beam radiotherapy and one application of 700 cGy at 85% isodose with high dose rate brachytherapy. Results. Of the cases, 84% were infiltrating ductal carcinoma; 31.2% were G3; 28% were intraductal component > 25%; 54% had margin 3 cm (p = 0.001), irradiation volume with external beam radiotherapy (p = 0.0001), and presence of local recurrence (p = 0.001). Conclusion. High dose rate brachytherapy is an effective method for reducing local recurrence, and increasing local control

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