A randomized phase 2 trial of nintedanib and low-dose cytarabine in elderly patients with acute myeloid leukemia ineligible for intensive chemotherapy.

We investigated the safety and efficacy of nintedanib added to low-dose cytarabine (LDAC) in a phase 1/2 study in patients 60 years or older with newly diagnosed or relapsed/refractory (r/r) AML ineligible for intensive chemotherapy. The results of the dose-finding phase 1 part have been previously published. Patients were randomized 1:1 to LDAC plus nintedanib or LDAC plus placebo stratified by AML status (newly diagnosed vs r/r). LDAC was applied subcutaneously at 20 mg twice daily on days 1 to 10. Nintedanib/placebo was orally administered twice daily on days 1 to 28 in 28-day cycles. The primary endpoint was overall survival (OS). Between 05/2017 and 09/2019, 31 patients were randomized and 30 were treated, before the study was terminated prematurely due to slow recruitment. Median (range) age of patients was 76 (60-84) years. Twenty-two patients (73%) had r/r AML. Median OS in patients treated with LDAC and nintedanib was 3.4 months, compared with 3.6 months in those treated in the placebo arm, with a HR adjusted for AML status of 1.19 (corresponding confirmatory adjusted 95% CI, 0.55-2.56; univariate log-rank P = 0.96). In the 22 patients with r/r AML, median OS was 3.0 months in the nintedanib and 3.6 months in the placebo arm (P = 0.36). One patient in the nintedanib and two patients in the placebo arm achieved a CR and entered maintenance treatment. Nintedanib showed no superior therapeutic activity over placebo when added to LDAC in elderly AML patients considered unfit for intensive chemotherapy. The trial was registered at clinicaltrials.gov NCT01488344.

Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).

PURPOSE: To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer. METHODS: This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2­year overall survival (OS). Arm A was considered insufficiently active if 2­year OS was ≤40% (null hypothesis = H0), and promising if the lower limit of the 95% confidence interval was >45%. If that lower limit was >40%, H0 was rejected. Secondary objectives included progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity. The study was terminated early after 74 patients; 68 patients were evaluable. RESULTS: Two-year OS was 71% in arm A (95% CI: 55-87%) vs. 53% in arm B (95% CI: 36-71%); H0 was rejected. Median OS was 49.1 vs. 24.1 months (p = 0.147). Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21). At 2 years, PFS was 56% vs. 44%, LC 84% vs. 72%, and MFS 74% vs. 54%. HRs were 0.51 (0.25-1.04) for progression, 0.43 (0.13-1.40) for locoregional failure, and 0.43 (0.17-1.05) for distant metastasis. Overall response was 81% vs. 69% (p = 0.262). Twenty-six and 27 patients, respectively, experienced at least one toxicity grade ≥3 (p = 0.573). A significant difference was found for grade ≥3 allergic reactions (12.5% vs. 0%, p = 0.044). CONCLUSION: Given the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.

A predictive tool particularly designed for elderly myeloma patients presenting with spinal cord compression.

BACKGROUND: This study was performed to design a predictive tool that allows the estimation of overall survival (OS) of elderly myeloma patients (aged ≥ 65 years) presenting with myeloma-induced spinal cord compression (SCC). METHODS: One-hundred-and-sixteen patients irradiated for motor deficits of the legs due to myeloma-induced spinal cord compression were retrospectively evaluated. Ten characteristics were analyzed for OS including age, interval between myeloma diagnosis and radiotherapy, other osseous myeloma lesions, myeloma type, gender, time developing motor deficits, number of affected vertebrae, ECOG-PS, pre-radiotherapy ambulatory status, and fractionation regimen. Characteristics that achieved significance on multivariate analysis were included in the predictive tool. The score for each characteristic was obtained from the 1-year OS rate divided by 10. The sum of these scores represented the prognostic score for each patient. RESULTS: On multivariate analysis, myeloma type (hazard ratio 3.31; 95%-confidence interval 1.75-6.49; p < 0.001), ECOG-PS (HR 5.33; 95%-CI 2.67-11.11; p < 0.001), ambulatory status (HR 2.71; 95% CI 1.65-4.57; p < 0.001), and age (HR 1.95; 95% CI 1.03-3.78; p = 0.040) were significantly associated with survival. Sum scores ranged from 18 to 32 points. Based on the sum scores, three prognostic groups were designed: 18-19, 21-28 and 29-32 points. The corresponding 1-year survival rates were 0, 43 and 96%, respectively (p < 0.001). CONCLUSIONS: This new predictive tool has been specifically designed for elderly myeloma patients with SCC. It allows estimating the survival prognosis of this patient group and supports the treating physicians when looking for the optimal treatment approach for an individual patient.

Dasatinib blocks transcriptional and promigratory responses to transforming growth factor-beta in pancreatic adenocarcinoma cells through inhibition of Smad signalling: implications for in vivo mode of action.

BACKGROUND: We have previously shown in pancreatic ductal adenocarcinoma (PDAC) cells that the SRC inhibitors PP2 and PP1 effectively inhibited TGF-ß1-mediated cellular responses by blocking the kinase function of the TGF-ß type I receptor ALK5 rather than SRC. Here, we investigated the ability of the clinically utilised SRC/ABL inhibitor dasatinib to mimic the PP2/PP1 effect. METHODS: The effect of dasatinib on TGF-ß1-dependent Smad2/3 phosphorylation, general transcriptional activity, gene expression, cell motility, and the generation of tumour stem cells was measured in Panc-1 and Colo-357 cells using immunoblotting, reporter gene assays, RT-PCR, impedance-based real-time measurement of cell migration, and colony formation assays, respectively. RESULTS: In both PDAC cell lines, dasatinib effectively blocked TGF-ß1-induced Smad phosphorylation, activity of 3TPlux and pCAGA(12)-luc reporter genes, cell migration, and expression of individual TGF-ß1 target genes associated with epithelial-mesenchymal transition and invasion. Moreover, dasatinib strongly interfered with the TGF-ß1-induced generation of tumour stem cells as demonstrated by gene expression analysis and single cell colony formation. Dasatinib also inhibited the high constitutive migratory activity conferred on Panc-1 cells by ectopic expression of kinase-active ALK5. CONCLUSIONS: Our data suggest that the clinical efficiency of dasatinib may in part be due to cross-inhibition of tumour-promoting TGF-ß signalling. Dasatinib may be useful as a dual TGF-ß/SRC inhibitor in experimental and clinical therapeutics to prevent metastatic spread in late-stage PDAC and other tumours.

Predicting the survival probability of gastric cancer patients developing metastatic epidural spinal cord compression (MESCC).

To create a tool for estimating the survival of gastric cancer patients developing MESCC, clinical factors were evaluated in 29 patients. Factors were age, gender, performance status, affected vertebrae, ambulatory status, further bone metastases, visceral metastases, time from gastric cancer diagnosis until MESCC and rapidity of developing weakness of legs. On multivariate analyses, visceral metastases (risk ratio: 6.80; p = 0.003) and rapidity of weakening of legs (risk ratio: 2.73; p = 0.023) had a significant effect on survival and were included in the tool. Scoring points for each of the two factors were either 0 or 1, depending on the 6-month survival rates. According to the sum of the points, three groups were built: 0 points (n = 12), 1 point (n = 10) and 2 points (n = 7). Six-month survival rates were 0, 20 and 100 % (p < 0.001). This tool for patients with MESCC from gastric cancer estimates survival probabilities, which is important for tailoring treatment to patients' needs.

A new instrument for estimating the survival of patients with metastatic epidural spinal cord compression from esophageal cancer.

BACKGROUND: This study was initiated to create a predictive instrument for estimating the survival of patients with metastatic epidural spinal cord compression (MESCC) from esophageal cancer. METHODS: In 27 patients irradiated for MESCC from esophageal cancer, the following nine characteristics were evaluated for potential impact on survival: age, gender, Eastern Cooperative Oncology Group (ECOG) performance score, histology, number of involved vertebrae, ambulatory status before irradiation, further bone metastases, visceral metastases, and dynamic of developing motor deficits before irradiation. In addition, the impact of the radiation regimen was investigated. According to Bonferroni correction, p-values of < 0.006 were significant representing an alpha level of < 0.05. RESULTS: ECOG performance score (p < 0.001), number of involved vertebrae (p = 0.005), and visceral metastases (p = 0.004) had a significant impact on survival and were included in the predictive instrument. Scoring points for each characteristic were calculated by dividing the 6-months survival rates (in %) by 10. The prognostic score for each patient was obtained by adding the scoring points of the three characteristics. The prognostic scores were 4, 9, 10, 14 or 20 points. Three prognostic groups were formed, 4 points (n = 11), 9-14 points (n = 12) and 20 points (n = 4). The corresponding 6-months survival rates were 0%, 33% and 100%, respectively (p < 0.001). Median survival times were 1 month, 5 months and 16.5 months, respectively. CONCLUSIONS: This new instrument allows the physician estimate the 6-months survival probability of an individual patient presenting with MESCC from esophageal cancer. This is important to know for optimally personalizing the treatment of these patients.

Clinically Significant Dermatitis During Adjuvant Radiotherapy for Invasive Breast Cancer.

BACKGROUND/AIM: Patients with breast cancer receiving adjuvant radiotherapy may experience grade ≥2 dermatitis. In the Interreg-project HeAT, a mobile application (app) reminding patients to perform skin care will be prospectively tested with the goal of decreasing clinically significant radiation dermatitis. This study aimed to identify the prevalence of grade ≥2 dermatitis and risk factors, required for designing the prospective trial. PATIENTS AND METHODS: In a retrospective study of 327 patients with breast cancer irradiated during 2022-2023, the prevalence of grade ≥2 dermatitis and 23 potential risk factors were investigated. RESULTS: The prevalence of grade ≥2 dermatitis was 31.2%. On multivariate analysis, it was significantly associated with chronic inflammatory disease (p=0.001), significant cardiovascular disease (p<0.001), smoking history >10 pack years (p<0.001), advanced T-stage (p=0.017), normo-fractionation (p<0.001), and radiation boost (p<0.001). CONCLUSION: The prevalence of grade ≥2 dermatitis and independent risk factors during adjuvant radiotherapy for invasive breast cancer were identified that contribute to improved patient care and the design of a prospective trial.

Associations Between Mean Lung Dose and Prevalence of Radiation Pneumonitis in Elderly Lung Cancer Patients.

BACKGROUND/AIM: Pneumonitis is a serious radiotherapy complication. This study, which is a prerequisite for a prospective trial, aimed to identify the prevalence of pneumonitis and risk factors in elderly patients with lung cancer. PATIENTS AND METHODS: Ninety-eight lung cancer patients aged ≥65 years were included. Seventeen factors were investigated regarding grade ≥2 pneumonitis at 24 weeks following radiotherapy. RESULTS: The prevalence of grade ≥2 pneumonitis at 24 weeks was 27.3%. On univariate analysis, a significant association was observed for mean (ipsilateral) lung dose (MLD; ≤13.0 vs. 13.1-20.0 vs. >20.0 Gy; 0% vs. 24.9% vs. 48.7%). Results were significant also for ≤13.0 vs. >13.0 Gy (0% vs. 37.1%) or ≤20.0 vs. >20.0 Gy (13.4% vs. 48.7%). MLD achieved significance on multivariate analysis. CONCLUSION: Elderly patients receiving MLDs >13.0 Gy, particularly >20.0 Gy, have a high risk of grade ≥2 pneumonitis. These results are important for designing a prospective trial.

Seasonal Impact on Grade ≥2 Dermatitis in Patients With Breast Cancer Undergoing Radiotherapy: A Supplementary Analysis.

BACKGROUND/AIM: We investigated grade ≥2 dermatitis in patients irradiated for breast cancer. This study evaluated associations between dermatitis and the season during which radiotherapy took place. PATIENTS AND METHODS: Associations between the season and grade ≥2 dermatitis were retrospectively evaluated in 327 breast cancer patients. Seasons were March to May (spring), June to August (summer), September to November (autumn), and December to February (winter). Subgroup analyses were performed considering fractionation, radiation technique, treatment volume, radiation boost, and deep-inspiration breath-hold technique. Furthermore, warmer and cooler months were compared. RESULTS: The season had no significant impact on the rate of grade ≥2 dermatitis in the entire cohort (p=0.63) nor in the subgroup analyses (p-values between 0.17 and 0.82). No significant difference in rate was found between warm and cool months. CONCLUSION: Grade ≥2 dermatitis was not associated with the season during which radiotherapy was performed. This factor may not be important for stratification in prospective trials.

Emotional Distress Prior to Chemoradiation for Rectal or Anal Cancer.

BACKGROUND/AIM: Anticipation of chemoradiation has been reported to cause psychosocial distress in patients with rectal cancer. This study provides additional data regarding prevalence and risk factors of emotional distress in patients who received chemoradiation for rectal or anal cancer. PATIENTS AND METHODS: Sixty-four patients were analyzed for emotional distress utilizing 12 factors. When applying the Bonferroni correction, p-values <0.0042 were considered significant. RESULTS: Worry, fears, sadness, depression, nervousness, and loss of interest in usual activities were reported by 31%, 47%, 33%, 11%, 47%, and 19% of patients, respectively. More physical problems were associated with fears (p=0.0030) and loss of interest (p=0.0021). Strong trends were observed for associations between female sex and sadness (p=0.0098) and between lower performance score and worry (p=0.0068) or fears (p=0.0064). CONCLUSION: A considerable proportion of patients reported emotional distress prior to chemoradiation for rectal or anal cancer. High-risk patients may benefit from early psycho-oncological support.

Risk Factors for Sleep Problems Prior to Radiochemotherapy for Malignant Gliomas.

BACKGROUND/AIM: Many patients with malignant gliomas are scheduled for radiochemotherapy, which may cause emotional distress associated with sleep problems. This study aimed to determine the prevalence of such sleep problems in these patients and identify risk factors. PATIENTS AND METHODS: Fifty-seven patients scheduled for radiochemotherapy for grade II-IV gliomas were retrospectively investigated for pre-treatment sleep problems. Fifteen characteristics were evaluated including temporal relation to COVID-19 pandemic, age, gender, performance status, comorbidity, (family) history of malignancies, distress score, emotional problems, physical problems, practical problems, involved sites, glioma grade, upfront surgery, and corticosteroids. RESULTS: Nineteen patients stated pre-treatment sleep problems (prevalence=66.7%). Significant associations with sleep problems were found for female gender (p=0.023), presence of emotional problems (p=0.006), and ≥4 physical problems (p<0.001). A trend was found for distress scores ≥5 (p=0.077). CONCLUSION: The prevalence of sleep problems was high. Risk factors were determined that can be used to identify patients who likely benefit from psychological support.

Evaluation of Sleep Disturbances in Patients With Bladder Cancer Scheduled for Local or Loco-regional Radiochemotherapy.

BACKGROUND/AIM: Organ-sparing treatment is increasingly used for bladder cancer, particularly for patients with significant comorbidities or advanced age. The upcoming treatment can cause distress and sleep disturbances. This study investigated pre-radiotherapy sleep disturbances in these patients. PATIENTS AND METHODS: Twenty-two patients with bladder cancer scheduled for local or loco-regional radiotherapy were retrospectively evaluated. Sixteen characteristics were analyzed for sleep disturbances including age, sex, performance score, comorbidities, previous malignancy, distress score, emotional problems, physical problems, treatment situation, treatment intent, current primary tumor and nodal stage, distant metastasis, treatment volume, concurrent chemotherapy, and Coronavirus Disease 2019 pandemic. RESULTS: Eleven patients (50.0%) reported sleep disturbances that were significantly associated with distress scores ≥5 (p=0.035). Trends were found for age ≤75 years (p=0.183), ≥2 emotional problems (p=0.183), ≥5 physical problems (p=0.064), and distant metastasis (p=0.090). CONCLUSION: Half of the patients reported pre-radiotherapy sleep disturbances. Risk factors facilitate identification of patients requiring psychological support.

Sleep Problems Prior to Radio-chemotherapy in Patients With Locally Advanced Cancer of the Esophagus or the Esophagogastric Junction.

BACKGROUND/AIM: Many patients with locally advanced cancer of the esophagus or esophagogastric junction receive definitive or neoadjuvant radiochemotherapy. Patient anticipation of this treatment can cause or aggravate distress and sleep disorders. This study aimed to identify the prevalence of sleep disorders and risk factors. PATIENTS AND METHODS: Thirty-eight patients assigned to radio-chemotherapy were retrospectively evaluated for pre-treatment sleep disorders. Investigated characteristics included age; sex; performance score; comorbidity index; previous malignancies; family history; distress score; emotional, physical or practical problems; tumor site; histology and grading; tumor stage; planned treatment; and relation to 2019 Coronavirus pandemic. RESULTS: Sleep problems were reported by 15 patients (39.5%). Significant associations were found for higher distress scores (p=0.016) and greater numbers of emotional problems (p<0.0001). A trend was observed for greater numbers of physical problems (p=0.176). CONCLUSION: The prevalence of sleep problems was high. Risk factors were found that can help identify patients requiring psychological support already prior to radio-chemotherapy.

Sleep Disturbances in Lung Cancer Patients Assigned to Definitive or Adjuvant Irradiation.

BACKGROUND/AIM: A considerable number of patients with lung cancer are scheduled for definitive or adjuvant radiotherapy. Prevalence and potential risk factors of pre-radiotherapy sleep disturbances were evaluated. PATIENTS AND METHODS: Nineteen factors were retrospectively investigated for associations with pre-radiotherapy sleep disturbances in 77 lung cancer patients. Factors included COVID-19 pandemic; age; gender; performance score; comorbidity index; history of another malignancy; distress score; number of emotional, physical or practical problems; patient's request for psychological support; histology; tumor stage; upfront surgery; chemotherapy; and type of radiotherapy. RESULTS: Thirty-one patients (40.3%) reported sleep disturbances that were significantly associated with distress score 6-10 (p=0.019), ≥2 emotional problems (p=0.001), ≥5 physical problems (p<0.001), and request for psychological support (p=0.006). Trends were found for female gender (p=0.064) and stereotactic body radiation therapy (p=0.057). CONCLUSION: Many lung cancer patients assigned to radiotherapy reported sleep disturbances. Risk factors can be used to identify patients in need of psychological support already before treatment.

Frequency and Risk Factors of Sleep Disturbances in Patients With Prostate Cancer Assigned to Local or Loco-regional Radiotherapy.

BACKGROUND/AIM: Many patients with prostate cancer receive definitive or adjuvant radiotherapy. This study aimed to identify the frequency of sleep disturbances and corresponding risk factors prior to radiation treatment. PATIENTS AND METHODS: Data of 48 patients assigned to local or loco-regional irradiation for prostate cancer were retrospectively analyzed for pre-radiotherapy sleep disturbances. Fifteen characteristics were analyzed including age, performance status, comorbidity, history of previous malignancy, distress score, (emotional, physical or practical) problems, prostate-specific antigen, primary tumor stage, Gleason-score, upfront androgen deprivation therapy (ADT), treatment volume, brachytherapy, and COVID-19 pandemic. RESULTS: Pre-radiotherapy sleep disturbances were reported by 20.8% of patients and significantly associated with distress scores ≥4 (p<0.0001) and ≥3 physical problems (p=0.0001). Trends were found for Karnofsky performance score ≤80 (p=0.095), Gleason score 7b-9 (p=0.079), and ADT (p=0.067). CONCLUSION: Pre-radiotherapy sleep disturbances were less common in prostate cancer patients than in other cancer patients. Risk factors were identified that can help identify patients requiring psychological support prior to radiotherapy.

Evaluation of Pre-radiotherapy Sleep Disorders in Patients With Rectal or Anal Cancer.

BACKGROUND/AIM: Radiotherapy and radiochemotherapy are common treatments for rectal and anal cancer. Anticipation of treatment may cause distress and sleep disorders. This study aimed to identify risk factors for sleep disorders. PATIENTS AND METHODS: In 42 patients with rectal or anal cancer scheduled for radiotherapy, 16 characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, gender, performance score, comorbidity, patient's or family history of additional cancer/melanoma, distress score, emotional/physical/practical problems, tumor site and stage, surgery and relation to COVID-19 pandemic. RESULTS: Overall prevalence of pre-radiotherapy sleep disorders was 42.9%. Sleep disorders were significantly associated with Karnofsky performance score 60-80 (p=0.044), Charlson comorbidity index ≥3 (p=0.0012), distress score 6-10 (p=0.00012), and more emotional (p=0.0012), physical (p=0.0004) or practical (p=0.033) problems. A trend was found for female gender (p=0.061). CONCLUSION: Sleep disorders were common in patients with rectal or anal cancer scheduled for radiotherapy. Risk factors can help identify patients requiring psychooncological support already prior to the start of radiotherapy.

Risk Factors for Sleep Disturbances in Patients Scheduled for Radiotherapy of Head-and-Neck Cancer.

BACKGROUND/AIM: Many patients with head-and-neck cancer are scheduled for irradiation. This study was performed to determine the frequency of and risk factors for pre-radiotherapy sleep disturbances in these patients. PATIENTS AND METHODS: A total of 103 patients with head-and-neck cancer scheduled for radiotherapy were included in this retrospective study. Eighteen characteristics were evaluated including timing of start of radiotherapy relative to COVID-19 pandemic; age; gender; Karnofsky performance score; Charlson comorbidity index; history of another malignancy; family history of malignancy; distress score; number of emotional, physical or practical problems; request for psychological support; tumor site and stage; upfront surgery; planned chemotherapy; and brachytherapy boost. RESULTS: The frequency of pre-radiotherapy sleep disturbances was 42.7%. This was significantly associated with age ≤63 years (p=0.049), Karnofsky performance score ≤80 (p=0.002), Charlson comorbidity index ≥3 (p=0.005), history of another malignancy (p=0.012), emotional (p=0.001) or physical (p<0.001) problems, and request for psychological support (p=0.002). CONCLUSION: Sleep disturbances were frequent in patients assigned to radiotherapy of head-and-neck cancer. Recognizing risk factors for sleep disturbance helps identify patients requiring psychological support.

Emotional Problems Prior to Adjuvant Radiation Therapy for Breast Cancer.

BACKGROUND/AIM: Being scheduled for radiotherapy can cause emotional distress. This study aimed to identify risk factors in 338 patients assigned to radiotherapy for breast cancer. PATIENTS AND METHODS: Nineteen potential risk factors including the COVID-19 pandemic were investigated for associations with the six emotional problems included in the National Comprehensive Cancer Network Distress Thermometer. RESULTS: Worry and fears were significantly associated with age ≤60 years; sadness with age and Karnofsky performance score (KPS) <90; depression with KPS and Charlson Comorbidity Index ≥3; loss of interest with KPS. Trends were found for associations between sadness and additional breast cancer/DCIS, Charlson Index and chemotherapy; between depression and additional breast cancer/DCIS, treatment volume and nodal stage N1-3; between nervousness and additional breast cancer/DCIS, mastectomy and triple-negativity; between loss of interest and Charlson Index, family history of breast cancer/DCIS, invasive cancer, chemotherapy, and treatment volume. The COVID-19 pandemic did not increase emotional problems. CONCLUSION: Several risk factors for emotional problems were identified. Patients with such factors should receive psychological support well before radiotherapy.

Sleep Disorders Prior to Adjuvant Radiation Therapy for Gynecological Malignancies.

BACKGROUND/AIM: Many patients with gynecological malignancies receive postoperative radiotherapy, which can lead to fear and sleep disorders. We aimed to identify the prevalence of and risk factors for sleep disorders. PATIENTS AND METHODS: Sixty-two patients assigned to radiotherapy for gynecological malignancies were retrospectively evaluated. Seventeen characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, Karnofsky performance score, Charlson comorbidity index, history of additional malignancy, family history of gynecological cancer, distress score, emotional, physical or practical problems, tumor site/stage; chemotherapy, treatment volume, brachytherapy, and the COVID-19 pandemic. RESULTS: The prevalence of pre-radiotherapy sleep disorders was 46.8%. Sleep disorders were significantly associated with Charlson comorbidity index ≥3 (p=0.012), greater number of physical problems (p<0.0001), and advanced primary tumor stage (p=0.005). A trend was found for greater number of emotional problems (p=0.075). CONCLUSION: Pre-radiotherapy sleep disorders are common in patients with gynecological malignancies, particularly in those with specific risk factors. Patients should be offered early psychological support.

Accelerated Fractionation Plus Chemotherapy Versus Conventionally Fractionated Radiochemotherapy for Unresectable Head-and-Neck Cancer.

BACKGROUND/AIM: Prognosis of patients with unresectable squamous cell carcinomas of the head and neck requires improvement. This retrospective study compared accelerated radiotherapy plus chemotherapy to conventional radiochemotherapy. PATIENTS AND METHODS: Patients received definitive treatment with accelerated radiotherapy plus chemotherapy (group A, n=10) or conventional cisplatin-based radiochemotherapy (group B, n=85). Groups were matched for several patient and tumor characteristics and compared for locoregional control (LRC), overall survival (OS) and toxicities. Additionally, accelerated radiotherapy plus chemotherapy and chemotherapy regimens in group B were compared for LRC and OS. RESULTS: Treatment type had no significant impact on LRC (p=0.98) and OS (p=0.57). In group A, toxicities occurred more often, including grade ≥3 mucositis (p=0.041), grade ≥2 lymphedema (p=0.007) and grade ≥3 leucopenia (p=0.007). Best 2-year LRC (p=0.39) and OS (p=0.015) was achieved with 20 mg/m2 cisplatin days 1-5 every 4 weeks; accelerated radiochemotherapy resulted in second-worst outcomes. CONCLUSION: Given the limitations of this study, accelerated radiotherapy plus chemotherapy provided no significant benefit but increased toxicity compared to conventional radiochemotherapy.