Feasibility, tolerability, and efficacy of the concurrent addition of erlotinib to thoracic radiotherapy in locally advanced unresectable non-small-cell lung cancer: a Phase II trial.

PURPOSE: Although many studies have confirmed the synergic effects of combining chemotherapy (CT) and radiotherapy (RT), clinical data evaluating safety and efficacy of erlotinib in combination with RT in locally advanced non-small-cell lung cancer (NSCLC) are limited. The aim of this study was to determine the feasibility, tolerability, and efficacy of the concurrent addition of erlotinib to the standard three-dimensional conformal thoracic RT in patients with unresectable or locally advanced NSCLC who are not candidates for receiving standard CT. PATIENTS AND METHODS: Feasibility and tolerability, assessed by evaluating adverse events (AEs), and effectiveness, by calculating progression-free survival (PFS), overall survival (OS), cancer-specific survival (CSS), and objective response rate (ORR), were analyzed in 30 patients receiving RT alone and 60 receiving RT and erlotinib. RESULTS: Erlotinib with RT showed an extended CSS and a higher rate of complete responses compared with RT alone. No differences between groups were found regarding OS, PFS, and ORR. AEs were significantly higher in the combined treatment, which mainly included cutaneous toxicity, dyspnea, fatigue, hyporexia, diarrhea, and infection. Erlotinib did not increase the toxicity produced by RT. CONCLUSION: The combination of erlotinib with RT produced, in our study, a scarce clinical benefit in the treatment of unresectable or locally advanced NSCLC, limited to complete responses and longer CSS rate compared with RT alone. Increased toxicity events were associated with combined therapy, which mainly included cutaneous toxicity. In our opinion, further studies in molecularly unselected lung cancer patients treated with EGFR TKIs and RT are not indicated. The use of biomarkers for the identification of patients that are most likely to benefit from this treatment is an essential next step in the research of this condition.

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.

Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study.

The optimal schedule and regimen of chemotherapy (CT) in association with chemoradiation has not been established in stage III non-small-cell lung cancer (NSCLC). We have compared three schedules of non-platinum-based CT plus either radiotherapy or chemoradiation. From May 2001 to June 2006, 158 patients with unresectable stage III NSCLC were enrolled in a randomized phase II trial with overall response rate (ORR) as the primary endpoint. The initial design included three arms: sequential CT followed by thoracic radiation (TRT); concurrent CT/TRT followed by consolidation CT; and induction CT followed by concurrent CT/TRT. However, based on the preliminary results of the RTOG 9410 trial, the sequential arm was closed when 19 patients had been enrolled. All patients received two cycles of docetaxel 40 mg/m(2) days 1 and 8 plus gemcitabine 1200 mg/m(2) days 1 and 8, as either induction or consolidation therapy. Concurrent CT/TRT consisted of docetaxel 20 mg/m(2) and carboplatin AUC 2 weekly plus 60 Gy TRT. No differences were found in ORR between the two arms (56% and 57%). Hematological toxicity was mild but significantly superior with consolidation CT; the esophagitis rate was similar in both arms (16% and 15%). With a median follow-up of 57 months, no differences were found in median survival (13.07 and 13.8 months) or 5-year survival (16.4% and 22%). This regimen cannot be recommended as an alternative to platinum-based CT/TRT although it has an acceptable toxicity profile and encouraging long-term survival data (ClinicalTrials.gov NCT01652820).

Merkel cell carcinoma from 2008 to 2012: reaching a new level of understanding.

Merkel cell carcinoma (MCC) is a rare primary cutaneous carcinoma of the skin who has high aggressiveness, high risk of locoregional and distant spread, a mortality rate considerably higher than that of cutaneous melanoma and a poor survival. Its incidence has increased during the past twenty years. The studies published from 2008 to early 2012 have introduced interesting changes in the understanding of its epidemiology, pathogenesis and consequently in the diagnostic codes and the therapeutic approach. Early and detailed nodal diagnosis with posterior multidisciplinary decision is mandatory. Surgery and Radiotherapy play a fundamental role in the management of this tumor. Both are associated with improved locoregional control and disease free survival; but patients continue to have distant failure because, currently, there is no effective systemic treatment available. Consequently, there remain controversies about its appropriate management, and this review is an attempt to contribute to their clarification.

Merkel cell carcinoma: what do we know about it and what should we do?

Merkel cell carcinoma (MCC) is a rare primary cutaneous carcinoma of the skin that is highly aggressive, and has a high risk of locoregional and distant spread, a mortality rate considerably higher than that of cutaneous melanoma and poor survival. Its incidence has increased during the past twenty years. The studies published since 2008 have introduced changes in the understanding of its epidemiology and pathogenesis, and consequently the therapeutic approach. Despite this, there is still controversy surrounding its optimal management, which requires clarification. This is the purpose of this review.

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.

Impact of neoadjuvant hormonal therapy on dose-volume histograms in patients with localized prostate cancer under radical radiation therapy.

INTRODUCTION: Prostate volume involves a defined toxicity predictor in the radiation therapy of localized prostate cancer. Neoadjuvant hormone therapy (nHT) can reduce prostate volume and, therefore, the planned volume. The objective of this study was to establish if the value of nHT reduces the planned volume and if this reduction correlates with a reduction of the dose received in the target organs. MATERIAL AND METHODS: 28 patients diagnosed of localized prostate cancer and referred to our departments for radiation therapy with radical intention, in the period ranging between April 2002 and October 2003, were included prospectively. The patients received nHT (triptorelin + flutamide) for 2 months and adjuvant HT until completing 2 years in the high-risk cases. A transrectal ultrasound study was performed in all patients, simulation CT and planning before the start of HT and after 2 months of treatment. The radiation therapy was carried out with 6 or 18 MV LINAC photons, with a dose fractioning scheme of 5 x 180-200 cGy, a total dosage of 66-72 Gy to prostate, 56 Gy to seminal vesicles and, in the high-risk cases, 46 Gy to pelvic lymph nodes. RESULTS: The distribution according to risk group was: low risk 3.6%, intermediate risk 28.6% and high risk 67.9%. By transrectal ultrasound, prostate volume on diagnosis was 50.65 cc pre HT and 38.97 cc post HT (p < 0.001), which means a volume reduction of 24%. The comparative analysis of the dose-volume histograms of the first versus the second CT shows a reduction in the planned volume GTV1 (prostate) (81.33 cc vs 63.96 cc, p < 0.05), PTV1 (prostate and margin) (197.51 cc vs 168.38 cc, p < 0.001) and PTV2 (prostate, vesicles and margin) (340.5 cc vs 307.26 cc, p < 0.05), a reduction of the maximum dose in the seminal vesicles (70.2 versus 68.75 Gy, p < 0.05), a reduction of the mean dose in the seminal vesicles (65.07 Gy versus 63.07 Gy, p < 0.05), PTV2 (67.72 Gy versus 66.9 Gy, p < 0.01) and PTV3 (prostate, vesicles, pelvic lymph nodes and margin) (58.86 Gy versus 57.21 Gy, p < 0.01), a reduction of the D90 in the seminal vesicles (61.83 Gy versus 60.06 Gy, p < 0.05) and PTV2 (61.04 Gy versus 59.45 Gy, p < 0.05) and a reduction of V60 of the rectum (32.45% versus 28.22%, p < 0.05) and V60 of the bladder (41.78% versus 31.67%, p < 0.005). CONCLUSIONS: Neoadjuvant hormone therapy reduces significantly prostate volume and as a result the planned volume and consequently the rectal and bladder V60 can be significantly reduced.

Impact of neoadjuvant hormonal therapy on dose-volume histograms in patients with localized prostate cancer under radical radiation therapy

No disponible

Introduction. Prostate volume involves a definedtoxicity predictor in the radiation therapy of localizedprostate cancer. Neoadjuvant hormone therapy(nHT) can reduce prostate volume and, therefore,the planned volume. The objective of thisstudy was to establish if the value of nHT reducesthe planned volume and if this reduction correlateswith a reduction of the dose received in thetarget organs.Material and methods. 28 patients diagnosed of localizedprostate cancer and referred to our departmentsfor radiation therapy with radical intention,in the period ranging between April 2002 andOctober 2003, were included prospectively. The patientsreceived nHT (triptorelin + flutamide) for 2months and adjuvant HT until completing 2 yearsin the high-risk cases. A transrectal ultrasoundstudy was performed in all patients, simulation CTand planning before the start of HT and after 2months of treatment. The radiation therapy wascarried out with 6 or 18 MV LINAC photons, with adose fractioning scheme of 5 x 180-200 cGy, a totaldosage of 66-72 Gy to prostate, 56 Gy to seminalvesicles and, in the high-risk cases, 46 Gy to pelviclymph nodes.Results. The distribution according to risk groupwas: low risk 3.6%, intermediate risk 28.6% and highrisk 67.9%. By transrectal ultrasound, prostate volumeon diagnosis was 50.65 cc pre HT and 38.97 ccpost HT (p < 0.001), which means a volume reductionof 24%. The comparative analysis of the dosevolumehistograms of the first versus the second CTshows a reduction in the planned volume GTV1(prostate) (81.33 cc vs 63.96 cc, p < 0.05), PTV1(prostate and margin) (197.51 cc vs 168.38 cc, p <0.001) and PTV2 (prostate, vesicles and margin)(340.5 cc vs 307.26 cc, p < 0.05), a reduction of themaximum dose in the seminal vesicles (70.2 versus68.75 Gy, p < 0.05), a reduction of the mean dose inthe seminal vesicles (65.07 Gy versus 63.07 Gy, p <0.05), PTV2 (67.72 Gy versus 66.9 Gy, p < 0.01) andPTV3 (prostate, vesicles, pelvic lymph nodes andmargin) (58.86 Gy versus 57.21 Gy, p < 0.01), a reductionof the D90 in the seminal vesicles (61.83 Gyversus 60.06 Gy, p < 0.05) and PTV2 (61.04 Gy versus59.45 Gy, p < 0.05) and a reduction of V60 of the rectum(32.45% versus 28.22%, p < 0.05) and V60 of thebladder (41.78% versus 31.67%, p < 0.005).Conclusions. Neoadjuvant hormone therapy reducessignificantly prostate volume and as a resultthe planned volume and consequently the rectaland bladder V60 can be significantly reduced