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To reach a consensus on recommendations for the management of high-risk and post-operative non-metastatic prostate cancer by a group of Radiation Oncologists in Catalonia dedicated to prostate cancer.A modified Delphi approach was employed to reach consensus on controversial topics in Radiation Oncology on high-risk non-metastatic (eight questions) and post-operative (eight questions) prostate cancer. An agreement of at least 75% was considered as consensus. The survey was electronically sent 6 weeks before an expert meeting where topics were reviewed and discussed. A second-round survey for the controversial questions only was sent and answered by participants after the meeting.After the first round of the survey, 19 experienced Radiation Oncologists attended the meeting and 74% fulfilled the second-round online questionnaire. An agreement of 9 of the 16 questions was accounted for the first round. After the meeting, an additional agreement was reached in 3 questions leading to a final consensus on 12 of the 16 questions. There are still controversial topics like the use of PET for staging of high-risk and post-operative non-metastatic prostate cancer and the optimal dose to the prostate bed in the salvage setting.This consensus contributes to establish recommendations and a framework to help in prostate cancer radiation therapy and pharmacological management in daily clinical practice of high-risk and post-operative non-metastatic prostate cancer.

The optimal duration of androgen deprivation combined with high-dose radiotherapy in prostate cancer remains controversial. The DART 01/05 trial was designed to determine whether long-term androgen deprivation is superior to short-term androgen deprivation when combined with high-dose radiotherapy. The 5-year results showed that 2 years of adjuvant androgen deprivation combined with high-dose radiotherapy significantly improved biochemical control, metastasis, and overall survival, especially in patients with high-risk disease. In this report, we present the 10-year final results of the trial.This open-label, phase 3, randomised, controlled trial was done in ten hospitals in Spain. The eligibility criteria included patients aged 18 years or older with histologically confirmed T1c to T3, N0, and M0 adenocarcinoma of the prostate, according to the 2002 classification of the American Joint Committee on Cancer, with intermediate-risk and high-risk factors, prostate-specific antigen (PSA) less than 100 ng/mL, and a Karnofsky performance score of at least 70%. Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD), via a randomisation scheduled generated by Statistical Analysis Software programme (version 9.1) and an interactive web response system. Patients assigned to the STAD group received 4 months of neoadjuvant and concomitant androgen deprivation (oral flutamide 750 mg per day or oral bicalutamide 50 mg per day) with subcutaneous goserelin (2 months before and 2 months combined with high-dose radiotherapy). Anti-androgen therapy was added during the first 2 months of treatment. Patients assigned to LTAD continued with goserelin every 3 months for another 24 months. The primary endpoint was biochemical disease-free survival at 5 years. For this 10-year study we analysed overall survival, metastasis-free survival, biochemical disease-free survival, and cause-specific survival. Analysis was by intention to treat. This trial is closed and is registered at ClinicalTrials.gov (NCT02175212) and in the EU Clinical Trials Register (EudraCT 2005-000417-36).Between Nov 7, 2005, and Dec 20, 2010, 355 patients were enrolled. One patient in the STAD group withdrew from the trial, hence 354 participants were randomly assigned to STAD (n=177) or LTAD (n=177). The median follow-up was 119·4 months (IQR 100·6-124·3). The 10-year biochemical disease-free survival for LTAD was 70·2% (95% CI 63·1-77·3) and for STAD was 62·3% (54·9-69·7; hazard ratio [HR] 0·84; 95% CI 0·50-1·43; p=0·52). At 10 years, overall survival was 78·4% (72·1-84·8) for LTAD and 73·3% (66·6-80·0) for STAD (HR 0·84; 95% CI 0·55-1·27; p=0·40), and metastasis-free survival was 76·0% (69·4-82·7) for LTAD and 70·9% (64·0-77·8) for STAD (HR 0·90; 95% CI, 0·37-2·19; p=0·81). For the subgroup of high-risk patients, the 10-year biochemical disease-free survival was 67·2% (57·2-77·2) for LTAD and 53·7% (43·3-64·1) for STAD (HR 0·90; 95% CI 0·49-1·64; p=0·73), the 10-year overall survival was 78·5% (69·6-87·3) for LTAD and 67·0% (57·3-76·7) for STAD (HR 0·58; 95% CI 0·33-1·01; p=0·054), and the 10-year metastasis-free survival was 76·6% (95% CI 67·6-85·6) for LTAD and 65·0% (55·1-74·8) for STAD (HR 0·89; 95% CI 0·33-2·43; p=0·82). Only 11 (3%) of 354 patients died from prostate cancer, all of them in the high-risk subgroup (five in the LTAD group and six in the STAD group). 76 (21%) patients died from other causes (mainly second malignancies in 31 [9%] and cardiovascular disease in 21 [6%]). No treatment-related deaths were observed.After an extended 10-year follow-up, we were unable to support the significant benefit of LTAD reported at 5 years. However, the magnitude of the benefit was clinically relevant in high-risk patients. Intermediate-risk patients treated with high-dose radiotherapy do not benefit from LTAD. A biological characterisation with the inclusion of genomic testing is needed in the decision-making process.Grupo de Investigación en Oncología Radioterápica and Sociedad Española de Oncología Radioterápica, the National Health Investigation Fund, and AstraZeneca.

Pathological response to neoadjuvant therapy with chemotherapy vs chemoradiotherapy in stage III NSCLC. Contribution of IASLC recommendations

The optimal prognostic value of testosterone following androgen deprivation therapy (ADT) is controversial. We studied the effect of serum testosterone levels on clinical outcome in localized prostate cancer (PCa) treated with ADT and high-dose radiotherapy (HRT).The DART01/05 trial randomized 355 men with intermediate and high-risk PCa to 4 months of ADT plus HRT (STADT, N = 178) or the same treatment followed by 24 months of ADT (LTADT, N = 177). This study included patients treated with LTADT who had at least 3 determinations of testosterone during ADT (N = 154). Patients were stratified into 3 subgroups by testosterone level: minimum20 ng/dL; median 20-49 ng/dL; and maximum ≥50 ng/dL. Kaplan-Meyer and Cox regression analysis were used for overall survival (OS) and FineGray regression model for metastasis free survival (MFS), biochemical disease-free survival (bDFS) and time to TT recovery.There were no statistically significant differences in 10-year bDFS, MFS, or OS between the20 ng/mL and 20-49 ng/dL subgroups. Multivariate analysis showed that a median testosterone ≥50 ng/dL was significantly associated with a decrease in bDFS (HR: 6.58, 95%CI 1.28-33.76, p = 0.03). Time to testosterone recovery after ADT did not correlate with bDFS, MFS, or OS and was not significantly associated with any of the testosterone subgroups.Our results do not support the concept that additional serum testosterone suppression below 20 ng/dL is associated with better outcomes than 20-49 ng/dL. Time to testosterone recovery after ADT and HRT did not impact clinical failure.

BACKGROUND Neoadjuvant treatment (NT) with chemotherapy (Ch) is a standard option for resectable stage III (N2) NSCLC. Several studies have suggested benefits with the addition of radiotherapy (RT) to NT Ch. The International Association for the Study of Lung Cancer (IASLC) published recommendations for the pathological response (PHR) of NSCLC resection specimens after NT. AIM To contribute to the IASLC recommendations showing our results of PHR to NT Ch vs NT chemoradiotherapy (ChRT). METHODS We analyzed 67 consecutive patients with resectable stage III NSCLC with positive mediastinal nodes treated with surgery after NT Ch or NT ChRT between 2013 and 2020. After NT, all patients were evaluated for radiological response (RR) according to Response Evaluation Criteria in Solid Tumours criteria and evaluated for surgery by a specialized group of thoracic surgeons. All histological samples were examined by the same two pathologists. PHR was evaluated by the percentage of viable cells in the tumor and the resected lymph nodes. RESULTS Forty patients underwent NT ChRT and 27 NT Ch. Fifty-six (83.6%) patients underwent surgery (35 ChRT and 21 Ch). The median time from ChRT to surgery was 6 wk (3-19) and 8 wk (3-21) for Ch patients. We observed significant differences in RR, with disease progression in 2.5% and 14.8% of patients with ChRT and Ch, respectively, and partial response in 62.5% ChRT vs 29.6% Ch (P = 0.025). In PHR we observed ≤ 10% viable cells in the tumor in 19 (54.4%) and 2 cases (9.5%), and in the resected lymph nodes (RLN) 30 (85.7%) and 7 (33.3%) in ChRT and Ch, respectively (P = 0.001). Downstaging was greater in the ChRT compared to the Ch group (80% vs 33.3%; P = 0.002). In the univariate analysis, NT ChRT had a significant impact on partial RR [odds ratio (OR) 12.5; 95% confidence interval (CI): 1.21 - 128.61; P = 0.034], a decreased risk of persistence of cancer cells in the tumor and RLN and an 87.5% increased probability for achieving downstaging (OR 8; 95%CI: 2.34-27.32; P = 0.001). CONCLUSION We found significant benefits in RR and PHR by adding RT to Ch as NT. A longer follow-up is necessary to assess the impact on clinical outcomes.

Small cell lung cancer (SCLC) accounts for approximately 20% of all lung cancers. The main treatment is chemotherapy (Ch). However, the addition of radiotherapy significantly improves overall survival (OS) in patients with non-metastatic SCLC and in those with metastatic SCLC who respond to Ch. Prophylactic cranial irradiation reduces the risk of brain metastases and improves OS in both metastatic and non-metastatic patients. The 5-year OS rate in patients with limited-stage disease (non-metastatic) is slightly higher than 30%, but less than 5% in patients with extensive-stage disease (metastatic). The present clinical guidelines were developed by Spanish radiation oncologists on behalf of the Oncologic Group for the Study of Lung Cancer/Spanish Society of Radiation Oncology to provide a current review of the diagnosis, planning, and treatment of SCLC. These guidelines emphasise treatment fields, radiation techniques, fractionation, concomitant treatment, and the optimal timing of Ch and radiotherapy. Finally, we discuss the main indications for reirradiation in local recurrence. Sin financiación No data 2021 UEM

Background Tumor involvement of mediastinal lymph nodes is of high importance in non-small cell lung cancer (NSCLC). Invasive mediastinal staging is recommended in selected patients without evidence of mediastinal involvement on staging by imaging. In the present study we aimed to evaluate the effectiveness of invasive mediastinal staging in reducing pN2, its impact on survival and the risk factors for occult pN2. Methods Patients with NSCLC tumors larger than 3 cm, central tumors or cN1 cases treated in our institution between 2013 and 2018 were prospectively included in the study. Incidence of pN2 and overall survival was compared among invasively staged (IS) and non-invasively staged groups (NIS). Multivariate analysis was performed to identify risk factors of pN2. Results A total of 201 patients were included in the study, 79 (39.3%) of whom were not invasively staged (NIS group) and 122 (60.7%) were invasively staged (IS group). Incidence of cN1 and mean PET/CT uptake was different among both groups. Prevalence of pN2 was similar in both groups (7.6% in NIS vs. 12.6% in IS; P>0.05). Median survival in IS-pN2 patients was 11 months longer than in NIS-pN2 group (33.6 vs. 22.5 months; P=0.245). cN1 emerged as the only a risk factor for pN2. Conclusions Invasive staging does not reduce the incidence of pN2. However, this finding could be biased because in our series cN1 patients were more often staged and cN1 has been detected as a risk factor for pN2. In addition patient better selection after invasive staging might have an impact on overall survival. To conclude, invasive mediastinal staging in intermediate risk patients for positive mediastinal nodes is justified.

The coronavirus disease 2019 crisis has had a major and highly complex impact on the clinical practice of radiation oncology worldwide. Spain is one of the countries hardest hit by the virus, with devastating consequences. There is an urgent need to share experiences and offer guidance on decision-making with regard to the indications and standards for radiation therapy in the treatment of lung cancer. In the present article, the Oncological Group for the Study of Lung Cancer of the Spanish Society of Radiation Oncology reviews the literature and establishes a series of consensus-based recommendations for the treatment of patients with lung cancer in different clinical scenarios during the present pandemic. Sin financiación No data 2020 UEM

After publication of the PACIFIC trial results, immune checkpoint inhibitor-based immunotherapy was included in the treatment algorithm of locally advanced non-small cell lung cancer (NSCLC). The PACIFIC trial demonstrated that 12 mo of durvalumab consolidation therapy after radical-intent platinum doublet chemotherapy with concomitant radiotherapy improved both progression-free survival and overall survival in patients with unresectable stage III NSCLC. This is the first treatment in decades to successfully improve survival in this clinical setting, with manageable toxicity and without deterioration in quality of life. The integration of durvalumab in the management of locally advanced NSCLC accentuates the need for multidisciplinary, coordinated decision-making among lung cancer specialists, bringing new challenges and controversies as well as important changes in clinical work routines. The aim of the present article is to review-from a practical, multidisciplinary perspective-the findings and implications of the PACIFIC trial. We evaluate the immunobiological basis of durvalumab as well as practical aspects related to programmed cell death ligand 1 determination. In addition, we comprehensively assess the efficacy and toxicity data from the PACIFIC trial and discuss the controversies and practical aspects of incorporating durvalumab into routine clinical practice. Finally, we discuss unresolved questions and future challenges. In short, the present document aims to provide clinicians with a practical guide for the application of the PACIFIC regimen in routine clinical practice. Sin financiación No data 2020 UEM

Introduction: COVID-19 pandemic has drastically changed the management of patients with cancer The prioritization of the healthcare towards COVID-19 patients could interfere with the initial diagnosis, resulting in delayed treatment and worse outcome We aimed to study the incidence of lung cancer new diagnosis, severity and clinical outcomes during Covid-19-period (during-COVID) compared to the same period in 2019 (before-COVID) Methods: Bicenter retrospective cohort study of newly diagnosed non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) patients before (Jan-Jun/19) and during COVID-19 (Jan-Jun/20) in Spain Clinical data were collected We primarily assessed the difference on new lung cancer cases between both periods, and the disease severity considering: Performance status (PS), stage and any significant complication at diagnosis Secondarily, we assessed the 30 days-mortality rate, progression-free survival (PFS) and overall survival (OS) by period Results: 162 newly diagnosed lung cancer patients (68% NSCLC and 32% SCLC) were enrolled, with median age of 66 years, 70% were male, 33% smokers, 25% with PS ≥2 Advanced disease was diagnosed in 50% of NSCLC and 61% SCLC;13% of NSCLC harbored driver alterations During-COVID, the number of new cases diagnosed decreased by 38% (43 NSCLC;19 SCLC), compared to before-COVID period (67 NSCLC;33 SCLC) More symptomatic cases were new diagnosed during vs before-COVID The Table 1 summarized clinical data and complications of new lung cancer cases by period and histology In NSCLC population diagnosed during-COVID, we observed more respiratory symptoms at diagnosis (30% vs 23% before-COVID) with mainly locally-advanced/advanced disease (82% vs 76% before-COVID) Among the cases hospitalized, the mortality during-hospitalization was 44% (2/9) vs 17% before-COVID In SCLC population diagnosed during-COVID, respiratory symptoms were more common (32% vs 24% before-COVID), but no more aggressive disease observed in terms of stage, complications and hospitalizations Among the 4 cases hospitalized at diagnosis, none died during-hospitalization vs 18% before-COVID (2/11) Overall, during-Covid the mOS was 6 7 months [95% CI, 5 4-not reached] vs 7 9 months [95% CI, 4 7-12] before-COVID In NSCLC, the 30-days mortality was 49% vs 25% before-COVID;in SCLC, it was 32% vs 18% before-COVID Updated data and treatment outcomes will be presented in the meeting [Formula presented] Conclusion: Lung cancer diagnosis has been affected during the COVID-19 pandemic with fewer cases diagnosed and more symptomatic disease compared to 2019, which seems to be associated with worse outcomes This study is still ongoing Keywords: NSCLC, SCLC, COVID-19

Although a trimodality regimen for patients with stage IIIA/pN2 non-small-cell lung cancer (NSCLC) has been variably used owing to limited evidence for its benefits, it remains unknown whether any patient subgroup actually receives benefit from such an approach. To explore this question, the published data were reviewed from 1990 to 2015 to identify the possible predictors and prognosticators in this setting. Overall survival was the endpoint of our study. Of 27 identified studies, none had studied the predictors of improved outcomes with trimodality treatment. Of the potential patient- and tumor-related prognosticators, age, gender, and histologic type were the most frequently formally explored. However, none of the 3 was found to influence overall survival. The most prominent finding of the present review was the substantial lack of data supporting a trimodality treatment approach in any patient subgroup. As demonstrated in completed prospective randomized studies, the use of surgery for stage IIIA NSCLC should be limited to well-defined clinical trials.

Adjuvant radiotherapy (ART) for biochemical relapse (BR) after radical prostatectomy (RP) showed increased disease-free survival (DFS) in three previous randomized trials. Retrospective phase II trials evaluated if early salvage RT (ESRT) is equivalent to ART. Our study aims to compare ART and ESRT to salvage RT. We compared RP plus ART and ESRT versus SRT. Indication for RT was made by PSA determination after RP: ART when PSA ≤ 0.2 ng/ml, ESRT when PSA ≤ 0.3 after PSA rise from 0.0 to SRT PSA ≥ 0.3. The cause of death of each patients was analyzed, DFS, cause-specific survival (CSS) overall survival (OS) and metastasis-free survival (MFS) in relation to RT intention. Between 1993 and 2008, 204 patients with a median age of 65 years (44–75) were treated. The median follow-up was 160 months (28.1–273.3). At diagnosis, 89.7% had localized clinical stages and 90.2% had Gleason (G) ≤ 7. The median PSA was 10 (range 4–101). The postoperative G was ≥ 7 in 66.2%; 56.4% had ≥ 2 positive margins; 29.4% received ART, 20% ESRT and 59.3% SRT. The DFS for ART, ESRT and SRT was 74, 56 and 39% with significant differences between the three groups (p

Locally advanced non-small cell lung cancer (NSCLC) is a diversified illness in which postoperative radiation therapy (PORT) for complete resection with positive hiliar (pN1) and/or mediastinal (pN2) lymph nodes is controversial. Although several studies have shown that PORT has beneficial effects, randomized trials are needed to demonstrate its impact on overall survival. In this review, the Spanish Radiation Oncology Group for Lung Cancer describes the most relevant literature on PORT in NSCLC patients stage pN1-2. In addition, we have outlined the current recommendations of different national and international clinical guidelines and have also specified practical issues regarding treatment volume definition, doses and fractionation.

Recent years have witnessed a number of clinical trials in Stage IIIA non–small cell lung cancer (NSCLC) comparing (A) induction chemotherapy (CHT) with induction CHT and radiotherapy (RT), each followed by surgery; (B) either induction CHT or induction RT-CHT, each followed by surgery, with definitive RT-CHT (no surgery). Due to the heterogeneity of patient, tumor and treatment characteristics across these trials, various meta-analyses (MAs) have been performed to define the optimal treatment approach in this setting for this clinical presentation. Six such MAs exist. In spite of the differences between MAs, it appears that RT does not add extra benefit to induction CHT administered before surgery, and that a trimodality (i.e. including surgery) regimen is not superior to definitive concurrent RT-CHT. While one can consider both induction CHT followed by surgery and exclusive concurrent RT-CHT as feasible in this setting, lack of pre-treatment predictive factors identifying patients who might preferentially benefit from a surgical approach limits its use to well-planned clinical trials.

We compared biochemical control and quality of life with intermittent (6 months) versus continuous (36 months) androgen deprivation therapy (ADT) in a non-inferiority randomized phase 3 trial in patients with biochemical failure (BF) after external beam radical radiotherapy (EBRT). Patients were stratified according to the Gleason score (GS) and were classified as low risk with a GS < 6 and 7 (3 + 4) and high risk with a GS of 7 (4 + 3) and > 7. Patients were followed with PSA determinations and quality-of-life assessments (QLQ C-30 and QLQ PR-25) every 6 months for a period of 3 years. BF after radiation was defined as a PSA level of nadir +2 ng/ml. Disease progression (DP) after ADT was defined as PSA >4 ng/ml (BF) and/or metastases. Seventy-seven patients were included in this multicenter phase 3 trial from 2005 to 2009. Thirty-eight and 39 patients were included in the intermittent and continuous groups, respectively. The median follow-up for both groups was 48 months (40-68). DP after ADT in the intermittent group was seen in three patients (distant metastases in one patient) versus 0 in the continuous group. The QLQ-C30 and QLQ PR-25 scores did not show any statistically difference between the two ADT groups. No significant differences were seen in DP and QLQ between intermittent (6 months) and continuous (36 months) ADT in patients with BF after EBRT.

SUMMARY The evidence to date confirms that concurrent radiochemotherapy (RT–ChT) is the treatment of choice in small-cell lung cancer and locally advanced non-small-cell lung cancer. But these patients require a good performance status and an interdisciplinary group of clinicians, which is hard to find at some facilities around the world. Socioeconomic differences worldwide, inadequate tolerance to RT–ChT, tobacco comorbidities, the high percentage of elderly patients and their low level of recruitment in clinical trials could explain, in part, the reason why lung cancer still remains the leading cause of cancer-related death around the world. This review focuses on RT–ChT in a special population of eldery, comorbid patients and populations with limited resources from developing countries with locally advanced non-small-cell lung cancer and limited-disease small-cell lung cancer.

Introduction: Long-term results of a phase II study on the use of induction chemotherapy (CHT) using paclitaxel (P)-carboplatin (C) followed by a concurrent radiation therapy (RT) and weekly P and consolidation PC were reviewed. Patients and Methods: Thirty-two patients with stage III non-small cell lung cancer started treatment with induction CHT (two cycles of P 175 mg/m2, day 1 and C, area under the curve 6, day 1, given at 3-week interval), after which accelerated RT with a concomitant boost ("field-in-a-field") (1.8 Gy large fields and the boost dose 0.88 Gy) was administered in 23 fractions with 61.64 Gy and concurrent weekly P (45 mg/m2). Consolidation with two cycles of PC was administered. Results: The median follow-up for all 32 patients was 17.2 months (range, 3.8-107 months). The median survival time was 16.9 months, and the 5-year survival and 10-year survival were 25% and 17.5%, respectively. The median time for disease progression was 9.5 months, and disease-free survival was 21% at 5 and 10 years. The median time to local progression was 14.6 months, and the 5- to 10-year local progression-free survival was 35.7%. The median time to distant metastasis was 17.5 months. Toxicity was acceptable, with only one (3.1%) patient experiencing grade 5 (lung) toxicity and another patient presenting grade 4 toxicity (leucopenia). Conclusions: The results of this single-institutional phase II study of induction CHT followed by concurrent RT-CHT and consolidation CHT in very unfavorable patient population showed acceptable results with acceptable toxicity.

Prostate cancer (PC) is one of the tumours with the highest incidence in recent years. PC therapies have several adverse effects. A panel consensus recommendation has been made to prevent or ameliorate complications in PC treatment to improve quality of life.Fifteen specialists have met to analyse the different toxicities associated with PC treatment. Each medical specialist performed a National Library of Medicine PubMed search citations searching about these secondary effects and his specialty from 1999 to 2009 to propose measures for their prevention/amelioration.Surgery is associated with incontinence and impotence. Radiotherapy can produce acute, late urological and gastrointestinal toxicity. Brachytherapy can produce acute urinary retention. Chemotherapy is associated with haematotoxicity, peripheral neuropathy and diarrhoea, and hormone therapy can produce osteoporosis, metabolic syndrome, cognitive and muscular alterations, cardiotoxicity, etc.Improvement in surgical techniques and technology (IMRT/IGRT) can prevent surgical and radiotherapeutic toxicity, respectively. Brachytherapy toxicity can be prevented with precise techniques to preserve the urethra. Chemotherapy toxicity can be prevented with personalized schedules of treatment and close follow-up of iatrogenia and hormone therapy toxicity can be prevented with close follow-up of possible secondary effects.

Objectives The aim of the study was to evaluate the clinical outcome and toxicity after adjuvant whole abdominal radiotherapy (WART) in patients with ovarian cancer. Material and methods Ten patients with optimal cytoreduced ovarian cancer, with a mean age of 58 years (40–70) and stage Ic: 4, stage II: 2, stage III: 4, were treated with WART and adjuvant chemotherapy (9/10). The total radiation dose was 22.5 Gy in the whole abdomen and 42–45 Gy in the pelvis. Results The mean follow-up was 8 years. The 5-year actuarial disease-free survival (DFS) was 60%, and the overall survival (OS) was 70%. Four patients had disease recurrence. The sites of recurrence were the abdomen in 2 patients and distant metastases in the other 2 patients (liver and brain metastasis). Gastrointestinal toxicity was as follows: acute 3/10 grades I and II, and late toxicity: 2/10 grades I and II, and only 1 patient developed small bowel obstruction (SBO) that required surgery. Conclusions Whole abdominal radiotherapy after surgery and platinum-based chemotherapy achieves high locoregional disease control with an acceptable risk of acute toxicity.

Thoracic radiotherapy and prophylactic cranial irradiation (PCI) in combination with chemotherapy is an established standard of treatment of limited-disease (LD) small-cell lung cancer (SCLC). Both types of radiotherapy increase 3-year survival by approximately 5%, as shown in the meta-analyses. There is some evidence that earlier commencement of thoracic radiotherapy for good performance status LD-SCLC patients results in better outcome. Total dose, fractionation type and irradiation volume are still matter of debate. The ongoing Phase III randomized trials aim to answer the question of total dose in LD-SCLC. For PCI, in LD-SCLC a standard dose of 25 Gy in ten fractions should remain a standard, as has recently been demonstrated. The PCI in extensive-disease SCLC improves survival at the expense of worsening of short-term health-related quality of life. There is evidence that consolidation thoracic radiotherapy may be of value in extensive-disease SCLC. The recently initiated prospective trials may answer this question.

To assess the effectiveness of a single dose of radio therapy (8 Gy vs. 6 Gy) plus zoledronic acid in cancer patients with bone metastases in treating pain; quality of life, time to onset of skeletal events and functional status.A total of 139 patients from 22 Spanish hospitals were randomly assigned to: Group A, administered a single dose of 8 Gy+zoledronic acid (4 mg iv, in 15-min infusions), and Group B, administered a single dose of 6 Gy+zoledronic acid (4 mg iv, in 15-min infusions). The main variable was pain, which was assessed with the Visual Analogue Pain Scale (VAS) in supine, seated and standing positions.There was a total of 118 patients for intention to treat (n=67 in Group A and n=51 in Group B). The most frequent primary neoplasms were the lung (29.66%), prostate (22.03%) and breast (21.19%). Sixty patients were analysed per protocol, n=34 in group A and n=26 in group B. Improvements were observed in the VAS scores for pain in all three positions. The mean time to onset of the event was greater (p=0.0211) in Group A than in Group B (122 vs. 81.62 days). Functional status improved in Group A, and quality of life improved in both groups.The two groups achieved similar levels of pain control in supine, seated and standing positions. Quality of life also improved in both groups. However, the higher dose (8 Gy dose) in combination with zoledronic acid is associated with a longer period without skeletal events.

[This corrects the article DOI: 10.1016/j.rpor.2015.04.003.].

Intramedullary spinal cord metastases (ISCM) are uncommon and present with rapidly progressing neurological deficits. The objective of this study was to determine the rate, duration of neurological response and survival after radiation therapy. We have retrospectively reviewed the clinical outcome of six cases with a diagnosis of ISCM from primary lung cancer, non-small cell (NSCLC) (n=3) and small cell (SCLC) (n=3). Total radiation dose ranged from 27 Gy/5 fr to 40 Gy/20 fr. Ambulation was preserved in 3 patients and partially recovered in one. Five out of the six patients (83%) showed improvement in neurological signs/symptoms with a mean duration of 17.2 days (max: 40 days; min: 6 days). Median survival time was 5 months (confidence interval (CI) 95%: 0-12) for NSCLC and 5 months (CI 95%: 4-6) for SCLC. Although radiation response rate is high, the interval free of neurological progression is very short. A therapeutic approach should be considered for each individual.

Fundamento y objetivo: Determinar la influencia de la edad en el momento del diagnostico en la evolucion clinica de los pacientes tratados con radioterapia en 2 dimensiones en el Hospital Clinic de Barcelona por un cancer de prostata. Pacientes y metodo: Se incluyo a 183 pacientes tratados desde noviembre de 1993 hasta abril de 1999. La mediana de seguimiento fue de 41,8 meses y la mediana de la edad se situo en los 70 anos. La dosis mediana administrada a la prostata fue de 70 Gy. Se realizaron analisis univariado (Kaplan-Meier, comparacion mediante rangos logaritmicos) y multivariado (modelos de regresion de Cox) para valorar la influencia de la edad en la toxicidad y el estudio de factores pronostico para el control de la enfermedad, supervivencia y toxicidad. Resultados: La supervivencia libre de enfermedad alcanzo un 61,94% a los 5 anos, con una supervivencia global del 82,83%. La comorbilidad, que se incremento significativamente con la edad, redujo la supervivencia global en un factor de 0,4, de modo que paso del 94,85 al 78,55% a los 5 anos. La probabilidad de estar libre de toxicidad a los 5 anos fue del 66,46%, sin observar diferencias significativas en funcion de la edad. Conclusiones: La comorbilidad reduce la esperanza de vida de los pacientes tratados con radioterapia por un cancer de prostata. La edad no incrementa necesariamente la toxicidad.

Despite a high initial response to treatment, only a small percentage of all small cell lung cancer patients survive for more than 3 years. This low survival rate justifies intensive treatment from the beginning, which is not without toxicity, mainly located in the bone marrow, esophagus, and normal lung tissue. The acute manifestations of treatment-derived toxicity in these critical organs may compromise not only the administration of adequate or more effective treatment but also the life of the patient. The acute effects of treatment may be modified or prevented during the administration of treatment. Thus, the concept of preventive or support treatment for toxicity has emerged, with the aim of increasing tolerance, quality of life of the patients during concomitant therapy, treatment compliance, and survival.

A prospective Phase II trial was carried out to evaluate the effectiveness of erythropoietin in improving or maintaining performance status as determined by the Karnofsky performance status (KPS) score and hemoglobin (Hb) levels in lung cancer patients treated with concurrent chemoradiation (CH-RT).A total of 51 patients with lung cancer (11 with small-cell, limited stage and 40 with non-small-cell disease, 17 with Stage IIIA and 23 with Stage IIIB), who underwent three different concurrent CH-RT protocols were enrolled. Baseline Hb and KPS values were recorded, as were the nadir Hb and KPS values before concurrent CH-RT. The final Hb and KPS values were recorded the last week of concurrent CH-RT. An Hb level ofor=11 g/dL before concurrent CH-RT was required before receiving erythropoietin. Prognostic factors for KPS improvement and survival were assessed by univariate and multivariate studies.Of the 51 patients, 47 (92.3%) were men (mean age 63.6 years, range 40-75). The median baseline KPS score was 80, and the mean baseline Hb was 12.2 +/- 1.76 g/dL (range 9-16.9). The mean nadir and final Hb value was 9.98 +/- 0.67 g/dL (range 8.6-11) and 11.33 +/- 1.59 g/dL (range 6.9-14.4), respectively. A significant increase was seen in the Hb and KPS score (p0.05) in the final measurements. Differences were found between the final and nadir Hb in the predictive value for differences in performance status (p = 0.001). On univariate study, pathologic findings (p = 0.0234), weight loss (p = 0.0049), baseline Hb (p = 0.0057), and final Hb improvement (p = 0.0237) were prognostic factors for survival. Nadir Hb (p = 0.027), final Hb improvement (p = 0.0069), pathologic findings (p = 0.0006), and weight loss (p = 0.0001) had significant prognostic value for survival in multivariate analysis.In this study, erythropoietin appears to have a significant, beneficial impact on the KPS and Hb of patients undergoing concurrent CH-RT.

Summary Background The optimum duration of androgen deprivation combined with high-dose radiotherapy in prostate cancer remains undefined. We aimed to determine whether long-term androgen deprivation was superior to short-term androgen deprivation when combined with high-dose radiotherapy. Methods In this open-label, multicentre, phase 3 randomised controlled trial, patients were recruited from ten university hospitals throughout Spain. Eligible patients had clinical stage T1c–T3b N0M0 prostate adenocarcinoma with intermediate-risk and high-risk factors according to 2005 National Comprehensive Cancer Network criteria. Patients were randomly assigned (1:1) using a computer-generated randomisation schedule to receive either 4 months of androgen deprivation combined with three-dimensional conformal radiotherapy at a minimum dose of 76 Gy (range 76–82 Gy; short-term androgen deprivation group) or the same treatment followed by 24 months of adjuvant androgen deprivation (long-term androgen deprivation group), stratified by prostate cancer risk group (intermediate risk vs high risk) and participating centre. Patients assigned to the short-term androgen deprivation group received 4 months of neoadjuvant and concomitant androgen deprivation with subcutaneous goserelin (2 months before and 2 months combined with high-dose radiotherapy). Anti-androgen therapy (flutamide 750 mg per day or bicalutamide 50 mg per day) was added during the first 2 months of treatment. Patients assigned to long-term suppression continued with the same luteinising hormone-releasing hormone analogue every 3 months for another 24 months. The primary endpoint was biochemical disease-free survival. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02175212. Findings Between Nov 7, 2005, and Dec 20, 2010, 178 patients were randomly assigned to receive short-term androgen deprivation and 177 to receive long-term androgen deprivation. After a median follow-up of 63 months (IQR 50–82), 5-year biochemical disease-free survival was significantly better among patients receiving long-term androgen deprivation than among those receiving short-term treatment (90% [95% CI 87–92] vs 81% [78–85]; hazard ratio [HR] 1·88 [95% CI 1·12–3·15]; p=0·01). 5-year overall survival (95% [95% CI 93–97] vs 86% [83–89]; HR 2·48 [95% CI 1·31–4·68]; p=0·009) and 5-year metastasis-free survival (94% [95% CI 92–96] vs 83% [80–86]; HR 2·31 [95% CI 1·23–3·85]; p=0·01) were also significantly better in the long-term androgen deprivation group than in the short-term androgen deprivation group. The effect of long-term androgen deprivation on biochemical disease-free survival, metastasis-free survival, and overall survival was more evident in patients with high-risk disease than in those with low-risk disease. Grade 3 late rectal toxicity was noted in three (2%) of 177 patients in the long-term androgen deprivation group and two (1%) of 178 in the short-term androgen deprivation group; grade 3–4 late urinary toxicity was noted in five (3%) patients in each group. No deaths related to treatment were reported. Interpretation Compared with short-term androgen deprivation, 2 years of adjuvant androgen deprivation combined with high-dose radiotherapy improved biochemical control and overall survival in patients with prostate cancer, particularly those with high-risk disease, with no increase in late radiation toxicity. Longer follow-up is needed to determine whether men with intermediate-risk disease benefit from more than 4 months of androgen deprivation. Funding Spanish National Health Investigation Fund, AstraZeneca.

Background To determine the optimal single-dose radiotherapy schedule for pain from bone metastases in a multi-centre, international, randomised trial. Patients and methods 651 patients were randomised to either 8Gy ( n =325) or 4Gy ( n =326) radiotherapy. Pain at 4, 8, 12, 24 and 52weeks was assessed using a Categorical Scale (CS) and a Visual Analogue Scale (VAS). The primary endpoint was response at 4weeks. Results There was no significant difference in patient demographics and other co-variates. The complete response (CR) rate and ORR (complete or partial response) for all follow-up times were higher after 8Gy ( p =0.02). The Kaplan–Meier actuarial rate (categorical scale) at 4weeks for ORR was 80% after 8Gy compared to 68% after 4Gy ( p =0.0015). 117 re-treatments were given of which 72 were in the 4Gy group and 45 in 8Gy arm ( p =0.01). Conclusions There was a marked consistent difference in pain relief at all time points in favour of 8Gy. These data reinforce the case for single dose 8Gy radiotherapy to be recommended for metastatic bone pain in all healthcare settings.

Purpose: The study of acoustic voice parameters (fundamental frequency, jitter, shimmer, and harmonics-to-noise ratio) in extended vowel production, oral reading of a standard paragraph, spontaneous speech and a song in irradiated patients for Tis-T1 vocal cord carcinoma. Methods and Materials: Eighteen male patients irradiated for Tis-T1 vocal cord carcinoma and a control group of 31 nonirradiated subjects of the same age were included in a study of acoustic voice analysis. The control group had been rigorously selected for voice quality and the irradiated group had previous history of smoking in two-thirds of the cases and a vocal cord biopsy. Radiotherapy patients were treated with a 6MV Linac receiving a total dose of 66 Gy, 2 Gy/day, with median treatment areas of 28 cm 2 . Acoustic voice analysis was performed 1 year after radiotherapy, the voice of patients in extended vowel production, oral reading of a standard paragraph, spontaneous speech, and in a song was tape registered and analyzed by a Kay Elemetric's Computerized Speech Lab (model CSL# 4300). Fundamental frequency, jitter, shimmer, and harmonics-to-noise ratio were obtained in each case. Mann Whitney analysis was used for statistical tests. Results: The irradiated group presented higher values of fundamental frequency, jitter, shimmer, and harmonics-to-noise ratio. Mann-Whitney analysis showed significant differences for fundamental frequency and jitter in vowel production, oral reading, spontaneous speech, and song. Shimmer only showed differences in vowel production and harmonics-to-noise ratio in oral reading and song. Conclusions: In our study only fundamental frequency and jitter showed significant increased values to the control group in all the acoustic situations. Sustained vowel production showed the worst values of the acoustic parameters in comparison with the other acoustic situations. This study seems to suggest that more work should be done in this field.

Few studies of patients with esophageal small cell carcinoma (SCC) have been conducted. Choice of treatment remains controversial.The authors analyzed data on 199 evaluable esophageal SCC patients, selected from among 230 patients found in the literature, and a data extraction form that recorded 11 features was completed. To allow for the evaluation of prognostic factors that influenced survival, the patients were grouped according to limited stage (LS), which was defined as disease confined to the esophagus, or extensive stage (ES), which was defined as disease that had spread beyond locoregional boundaries. Univariate and multivariate analyses were performed. Treatment was categorized as either local or local with systemic; for the ES cases, the categories were defined as treatment versus no treatment.The tumor site was described in 178 cases (89%). Mean tumor size was 6.1. Pure SCC was found in 137 cases (68.8%), whereas 62 cases (31.2%) showed mixed SCC; 93 (46.7%) were LS, whereas 95 (47.7%) were ES. In 11 cases (5.5%), the stage was not determined. There was a significant difference in survival between patients with LS and those with ES (P0.0001). The median survival was 8 months for patients with LS and 3 months for those with ES. Univariate analysis of LS showed 3 significant prognostic factors: age (for patients ageor =60 years, the median survival was 11 months, whereas for those age60 years, the median survival was 6 months), tumor size (for those with tumorsor =5 cm, the median survival was 12 months, whereas for those with tumors5 cm, the median survival was 4 months), and type of treatment (with local plus systemic treatment, the median survival was 20 months, whereas with local it was 5 months). In multivariate analysis, tumor size (P = 0.007) and type of treatment (P0.001) were shown to be independent predictive variables.Esophageal SCC is an aggressive type of tumor. This study shows that there are significant differences between LS and ES and that in LS, both tumor size and type of treatment are possible prognostic factors.

The aim of this study was to assess the impact of adapted ice cream as a dietary supplement on the quality of life (QLQ) of malnourished patients with cancer.We present an exploratory prospective observational study comparing two patterns of nutrition in cancer patients admitted during the study period who presented malnutrition disorders: adapted ice cream (Group I: 39 patients) and nutritional supplements (Group II: 31 patients). Patients were selected from two different hospitals from the same Oncologic Institute. QLQ was evaluated with the Hospital Anxiety and Depression Scale (HADS) and QLQ of the European Organization for Research and Treatment of Cancer (EORTC QLQ C30). Nutrition was determined by the PG-SGA test.HADS showed significant differences in anxiety (p = 0.023) and depression (p = 0.011) at the end of the study only in Group I. QLQ-C30 revealed statistically significant differences in baseline measures of global dimension between the two groups (Group I: 40.64-56.36 CI; Group II: 25.70-43.11 CI; p = 0.017). Differences were also present in the social dimension (Group I: 77.42-93.51 CI; Group II: 55.85-82.85 CI; p = 0.039). Statistically significant differences were observed between the two groups at the end of the study in the global scale: Group I had 49.36-63.88 CI and Group II had 33.05-51.88 CI (p = 0.016), and in the fatigue scale: Group I had 36.19-53.83 CI and Group II had mean = 65.87, 52.50-79.23 CI (p = 0.007).The administration of ice cream could cover, in part, the social aspect of food and improve QLQ in malnourished cancer patients. These results are encouraging and deserve further confirmation.

The toxicity of tumor cells after chemo and radiotherapy, administered either alone or in combination is dose-dependent. Aggression to the bone marrow, which is expressed by a reduction in circulating blood cells, is often the main dose-limiting toxicity because of the risks of anemia, bleeding, and infection. Prophylactic treatment with granulocyte-colony stimulating factors (G-CSFs) is available to reduce the risk of chemotherapy-induced neutropenia. In 2005, a European Guidelines Working Party was set up by the European Organization for Research and Treatment of Cancer (EORTC) to systematically review the data published on the appropriate use of G-CSF in adult patients receiving chemotherapy. An update of this review was published in 2010. The ASCO has made evidence level II recommendations concerning the treatment of anemia with r-Hu-EPO. For patients with chemotherapy-associated anemia the Committee continues to recommend the implementation of an erythropoiesis-stimulating agent (ESA) when hemoglobin (Hb) values approach or fall below 10 g/dL, to increase Hb values and decrease transfusions. An individual patient data-analysis has shown that ESA increase the mortality in all patients with cancer, and a similar increase might exist in patients on chemotherapy. Finally, only a few trials have examined indications for ESA similar to the indications approved by the Food and Drug Administration.