1. Preoperative intensity-modulated chemoradiotherapy with simultaneous integrated boost in rectal cancer : five-year follow-up results of a phase II studyJasna But-Hadžić, Anja Meden Boltežar, Tina Škerl, Vesna Zadnik, Vaneja Velenik, 2021, original scientific article Abstract: We conducted a phase II study to investigate the feasibility and safety of preoperative radiochemo-therapy experimental fractionation, using intensity-modulated radiation therapy with simultaneous integrated boost (IMRT SIB) to shorten the overall treatment time without dose escalation in intermediate/locally advanced rectal cancer with the aim to improving treatment outcome.Patients and methods. A total of 51 patients with operable stage II–III rectal carcinoma were included between January 2014 and January 2015. Fifty patients completed preoperative IMRT treatment with an elective dose of 41.8 Gy and simultaneously delivered 46.2 Gy to T2/T3 and 48.4 Gy to T4 tumour in 22 fractions, with concomitant capecit-abine (825 mg/m2/12 h, including at weekends). Median follow-up was 70 months (range 11–80 m).Results. Forty-seven patients completed treatment per protocol. Acute toxicity occurred in 2 (4%) patients. R0 resec-tion was achieved in all but 1 and pathologic complete response (pCR) in 12 (25.5%) patients who had 5-year overall survival (OS), disease-free survival (DFS) and local control (LC) of 91.7%, 100% and 100%, respectively. The intention-to-treat analysis showed that the type of surgery significantly moderated OS and DFS, while total downstaging and pN were predictive for DFS only. For treatment per protocol 5-year OS, DFS and LC were 80.9% (95% confidence interval [CI] 69.7–92.1), 77.1% (95% CI 65.1–89.1) and 95.2% (95% CI 88.7–100), respectively. The proportion of patients with severe late (CTCAE G ≥ 3) gastrointestinal, urinary and sexual toxicity was 15%, 2% and 8% respectively, with one reported secondary carcinoma.
Keywords: rectal cancer, IMRT, simultaneous integrated boost, preoperative radiochemotherapy, acute toxicity
Published in DiRROS: 23.07.2024; Views: 567; Downloads: 184
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2. Influence of concurrent capecitabine based chemoradiotherapy with bevacizumab on the survival rate, late toxicity and health-related quality of life in locally advanced rectal cancer : a prospective phase II CRAB trialVaneja Velenik, Vesna Zadnik, Mirko Omejc, Jan Grosek, Mojca Tuta, 2020, original scientific article Abstract: Few studies reported early results on efficacy, toxicity of combined modality treatment for locally advanced rectal cancer (LARC) by adding bevacizumab to preoperative chemoradiotherapy, but long-term data on survival, and late complications are lacking. Further, none of the studies reported on the assessment of quality of life (QOL). Patients and methods. After more than 5 years of follow-up, we updated the results of our previous phase II trial in 61 patients with LARC treated with neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy. Secondary endpoints of updated analysis were local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL (before starting the treatment and one year after the treatment) with questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38. Results. Median follow-up was 67 months. During the follow-up period, 16 patients (26.7%) died. The 5-year OS, DFS and LC rate were 72.2%, 70% and 92.4%. Patients with pathological positive nodes or pathological T3%4 tumors had significantly worse survival than patients with pathological negative nodes or T0%2 tumors. Nine patients (14.8%) developed grade % 3 late complications of combined modality treatment, first event 12 months and last 87 months after operation (median time 48 months). Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased. Based on QLQ-CR38 scores body image scores significantly increase, problems with weight loss significantly decrease, but sexual dysfunction in men and chemotherapy side effects significantly increase. Conclusions. Patients with LARC and high risk factors, such as positive pathological lymph nodes and high pathological T stage, deserve more aggressive treatment in the light of improving long-term survival results. Patients after multimodality treatment should be given greater attention to the regulation of individual aspects of quality of life and the occurrence of late side effects.
Keywords: rectal cancer, bevacizumab, preoperative chemoradiotherapy
Published in DiRROS: 15.07.2024; Views: 591; Downloads: 193
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3. Definitive radiochemotherapy in esophageal cancer : a single institution experienceFranc Anderluh, Miha Toplak, Vaneja Velenik, Irena Oblak, Ajra Šečerov Ermenc, Ana Jeromen, Jasna But-Hadžić, Marija Skoblar Vidmar, 2019, original scientific article Keywords: radiochemotherapy, definitive radiochemotherapy, esophageal cancer
Published in DiRROS: 05.07.2024; Views: 612; Downloads: 151
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4. Total neoadjuvant treatment of locally advanced rectal cancer with high risk factors in SloveniaMojca Tuta, Nina Boc, Erik Brecelj, Mirko Omejc, Franc Anderluh, Ajra Šečerov Ermenc, Ana Jeromen, Irena Oblak, Bojan Krebs, Vaneja Velenik, 2019, original scientific article Keywords: total neoadjuvant treatment, radiochemotherapy, rectal cancer
Published in DiRROS: 05.07.2024; Views: 592; Downloads: 179
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6. Induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer : long-term results of phase II OIGIT-01 TrialDanijela Golo, Jasna But-Hadžić, Franc Anderluh, Erik Brecelj, Ibrahim Edhemović, Ana Jeromen, Mirko Omejc, Irena Oblak, Ajra Šečerov Ermenc, Vaneja Velenik, 2018, original scientific article Abstract: The purpose of the study was to improve treatment efficacy for locally advanced rectal cancer (LARC) by shifting half of adjuvant chemotherapy preoperatively to one induction and two consolidation cycles. Patients and methods Between October 2011 and April 2013, 66 patients with LARC were treated with one induction chemotherapy cycle followed by chemoradiotherapy (CRT), two consolidation cycles, surgery and three adjuvant capecitabine cycles. Radiation doses were 50.4 Gy for T2-3 and 54 Gy for T4 tumours in 1.8 Gy daily fraction. The doses of concomitant and neo/adjuvant capecitabine were 825 mg/m2/12h and 1250mg/m2/12h, respectively. The primary endpoint was pathologic complete response (pCR). Results Forty-three (65.1%) patients were treated according to protocol. The compliance rates for induction, consolidation, and adjuvant chemotherapy were 98.5%, 93.8% and 87.3%, respectively. CRT was completed by 65/66 patients, with G % 3 non-hematologic toxicity at 13.6%. The rate of pCR (17.5%) was not increased, but N and the total-down staging rates were 77.7% and 79.3%, respectively. In a median follow-up of 55 months, we recorded one local relapse (LR) (1.6%). The 5-year disease-free survival (DFS) and overall survival (OS) rates were 64.0% (95% CI 63.89%64.11) and 69.5% (95% CI 69.39%69.61), respectively. Conclusions In LARC preoperative treatment intensification with capecitabine before and after radiotherapy is well tolerated, with a high compliance rate and acceptable toxicity. Though it does not improve the local effect, it achieves a high LR rate, DFS, and OS.
Keywords: rectal cancer, neoadjuvant chemotherapy, preoperative chemoradiotherapy
Published in DiRROS: 11.06.2024; Views: 618; Downloads: 297
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8. The influence of the distal resection margin length on local recurrence and long- term survival in patients with rectal cancer after chemoradiotherapy and sphincter- preserving rectal resectionJan Grosek, Vaneja Velenik, Ibrahim Edhemović, Mirko Omejc, 2017, original scientific article Keywords: rectal cancer, distal resection margin, chemoradiotherapy, local recurrence, survival
Published in DiRROS: 31.05.2024; Views: 877; Downloads: 382
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9. Health-related quality of life assessed by the EORTC QLQ-C30 questionnaire in the general Slovenian populationVaneja Velenik, Ajra Šečerov Ermenc, Jasna But-Hadžić, Vesna Zadnik, 2017, original scientific article Abstract: The aim of our study was to obtain reference data of the EORTC QLQ-C30 quality of life dimensions for the general Slovenian population. We intend to provide the researchers and clinicians in our country with the expected mean health-related quality of life (HRQL) scores for distinctive socio-demographic population groups. Methods. The EORTC QLQ-C30 questionnaire supplemented by a socio-demographic inquiry was mailed or distributed to 1,685 randomly selected individuals in the Slovenian population aged 18 % 90. Answers from 1,231 subjects representing socio-demographic diversity of the Slovenian population were collected and transformed into EORTC dimensions and symptoms. The impact of socio-demographic features on HRQL scores was assessed by multiple linear regression models. Results. Gender, age and self-rated social class are the important confounders in the quality of life scores in our population. Men reported better quality of life on the majority of the specific scales and, at the same time, reported fewer symptoms. There was no gender-specific difference in cognitive functioning. The mean scores were consistently lower with age in both sexes. Conclusions. This is the first study to report the normative EORTC QLQ-C30 scores for one of the south-eastern European populations. The reported expected mean scores allow Slovenian oncologists to estimate what the quality of life in cancer patients would be, had they not been ill. As they are derived by common methodology, our results can easily be included in any further international comparisons or in the calculation of European summarized HRQL scores.
Published in DiRROS: 24.05.2024; Views: 634; Downloads: 255
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10. The impact of anaemia on treatment outcome in patients with squamous cell carcinoma of anal canal and anal marginIrena Oblak, Monika Češnjevar, Mitja Anžič, Jasna But-Hadžić, Ajra Šečerov Ermenc, Franc Anderluh, Vaneja Velenik, Ana Jeromen, Peter Korošec, 2016, original scientific article Abstract: Radiochemotherapy is the main treatment for patients with squamous cell carcinoma of the anal canal. Anaemia is reported to have adverse effect on survival in cancer patients. The aim of the study was to evaluate the influence of anaemia on radiochemotherapy treatment outcome in patients with squamous cell carcinoma of the anal canal. Patients and methods. One hundred consecutive patients with histologically confirmed squamous cell carcinoma of the anal canal were treated radically with 3-dimensional conformal or intensity-modulated radiation therapy followed by brachytherapy or external beam radiotherapy boost and with concurrent mitomycin C and 5-fluorouracil. The influence on survival of pre-treatment, mean on-treatment and end-of-treatment haemoglobin (Hb) concentrations was studied. Results. The 5-year locoregional control, disease free survival, disease specific survival and overall survival rates for all patients were 72%, 71%, 77% and 62%, respectively. In univariate analysis, patients with pre-treatment and end-oftreatment Hb > 120 g/L survived statistically significantly better compared to patients with Hb % 120 g/L. Patients with mean on-treatment Hb > 120 g/L only had statistically significant better locoregional control and overall survival than patients with Hb % 120 g/L. In multivariate analysis, independent prognostic factors were pre-treatment Hb (> 120 g/L vs. % 120 g/L) for overall survival (hazard ratio [HR] = 0.419, 95% confidence interval [CI] = 0.190%0.927, p = 0.032) and stage (I & II vs. III) for disease specific (HR = 3.523, 95% CI = 1.375%9.026, p = 0.009) and overall survival (HR = 2.230, 95% CI = 1.167%4.264, p = 0.015). Conclusions. The pre-treatment, mean on-treatment and end-of-treatment Hb concentration > 120 g/L carried better prognosis for patients for with squamous cell carcinoma of the anal canal treated with radiochemotherapy. The pre-treatment Hb > 120 g/L was an independent prognostic factor for overall survival of patients with anal canal cancer.
Keywords: anaemia, anal canal squamous cell carcinoma, radiochemotherapy
Published in DiRROS: 30.04.2024; Views: 727; Downloads: 407
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