Biomedical subjects

Razvan Galalae

Publications and source records attributed to Razvan Galalae.

8 recordsLinked to original sources

PubMed2006

Validation of the German prostate-specific module.

Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.

Adaptation, Psychological↗

PubMed2005

Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime.

PURPOSE: High-dose radiotherapy, delivered in an accelerated hypofractionated course, was utilized to treat prostate cancer. Therapy consisted of external beam radiotherapy (EBRT) and transrectal ultrasound (TRUS)-guided conformally modulated high-dose rate (HDR) brachytherapy. The purpose of this report is (1) to assess long-term comparative outcomes from three trials using similar accelerated hypofractionated regimes; and (2) to examine the long-term survival impact of a short course of < or =6 months adjuvant/concurrent androgen deprivation when a very high radiation dose was delivered. METHODS AND MATERIALS: Between 1986 and 2000, 1,260 patients were treated at three institutions with pelvic EBRT (36-50 Gy) integrated with HDR prostate brachytherapy. The total dose including brachytherapy was given over 5 weeks. The biologic equivalent EBRT dose ranged between 90 and 123 Gy (median, 102 Gy) using an alpha /beta of 1.2. Patient eligibility criteria included a pretreatment prostate-specific antigen > or =10, Gleason score > or =7, or clinical stage > or =T2b. A total of 1,260 patients were treated, and 934 meet the criteria. Kiel University Hospital treated 198 patients; William Beaumont Hospital, 315; and California Endocurietherapy Cancer Center, 459 patients. Brachytherapy dose regimes were somewhat different between centers and the dose was escalated from 5.5 x 3 to 15 Gy x 2 Gy. Patients were divided for analysis between the 406 who received up to 6 months of androgen deprivation therapy and the 528 patients who did not. All patients had a minimum follow-up of 18 months (3 times the exposure to androgen deprivation therapy). The American Society for Therapeutic Radiology and Oncology biochemical failure definition was used. RESULTS: Mean age was 69 years. Median follow-up time was 4.4 years (range, 1.5-14.5); 4 years for androgen deprivation therapy patients and 4.9 for radiation alone. There was no difference at 5 and 8 years in overall survival, cause-specific survival, or biochemical control among the three institutions. The corresponding 8-year rates with and without androgen deprivation therapy were biochemical control 85% and 81%; overall survival 83% and 78%; cause-specific survival 89% and 94%; and metastatic rates of 16.6% and 7.3%. A multivariate analysis revealed androgen deprivation therapy did not predict for biochemical failure for either the entire group or the subset of 177 patients harboring all three poor prognostic factors. Moreover, adding androgen deprivation therapy strongly correlated with higher rates of both metastasis (p = 0.09; hazard ratio, 2.08) and cancer-related deaths (p = 0.02, hazard ratio 3.25). These negative results for the most unfavorable group led us to question if androgen deprivation therapy might have a deleterious impact through delay in delivery of the potentially curative radiation or whether there may be a biologic basis by fixing the cycling cells in G0. CONCLUSIONS: Accelerated hypofractionated pelvic EBRT integrated with TRUS-guided conformally modulated HDR administered to 1,260 patients in three institutions was an excellent method of delivering very high radiation dose to the prostate in 5 weeks. Similar high overall, cause-specific, and biochemical no evidence of disease survival rates achieved show that prostate HDR can be successfully delivered in academic and community settings. At 8 years, the addition of a course of < or =6 months of neoadjuvant/concurrent androgen deprivation therapy to a very high radiation dose did not confer a therapeutic advantage but added side effects and cost. Furthermore, for the most unfavorable group, there was a higher rate of distant metastasis and more prostate cancer-related deaths. We question the value of a short course of androgen deprivation therapy when used with high-dose radiation.

Aged↗

PubMed2005

Feasibility and preliminary outcome of salvage combined HDR brachytherapy and external beam radiotherapy (EBRT) for local recurrences after radical prostatectomy.

PURPOSE: Feasibility of combined fractionated intensity modulated brachytherapy (IMBT) and external beam radiotherapy (EBRT) as well as the effect of local dose escalation was investigated in a non-randomized retrospective observation trial for histologically-proven macroscopic local recurrences of prostate cancer after radical prostatectomy. METHODS AND MATERIALS: Thirty-five patients with transrectal ultrasound (TRUS) detectable tumors were treated. Applied dose per IMBT fraction was 15 Gy, prescribed on the target (TRUS visible tumor) surface. For the first 21 patients, two fractions of IMBT were delivered in 2 weeks interval, complementary to 30 Gy EBRT to the small pelvis. Further, as second step of dose escalation, 14 patients were treated with 2 x 15 Gy IMBT combined with 40 Gy EBRT. The total treatment time was 4 and 5 weeks, respectively. RESULTS: PSA was decreased in 34 out of 35 patients post-therapeutically. After a mean follow-up of 27 months, 32 out of 35 patients are alive. However, in 67% of the patients, we observed postimplant PSA elevation with or without detectable local and/or systemic progress. The mean duration of biochemical non-evidence of disease (bNED) after radiation was 12 months for all patients (31% in the 30 Gy group and 42% in the 40 Gy group). No RTOG/EORTC grade III or IV side effects were registered during/after radiotherapy. CONCLUSION: Combined EBRT and IMBT-boost of TRUS detectable recurrences of prostate cancer after radical prostatectomy seems to be a feasible method of salvage treatment. These early results need to be confirmed by further prospective randomized trials and by longer follow-up in all dose groups.

Aged↗

PubMed2004

CT-guided lymphoscintigraphy in patients with squamous cell carcinoma of the head and neck: a feasibility study.

Accurate knowledge of lymphatic drainage facilitates planning of surgery for patients with squamous cell carcinoma of the head and neck. The aim of this study was to evaluate the feasibility of a new injection technique for lymph node detection in patients with squamous cell carcinoma of the hypopharynx and larynx, in whom simple peritumoural injection is hampered by the tumour localisation. Computed tomography (CT)-guided lymphoscintigraphy was performed in a total of 13 patients with squamous cell carcinoma of the hypopharynx and larynx who could not be injected by simple visual inspection. In a first step, contrast medium-enhanced axial 5-mm-thick CT slices of the neck were obtained. After tumour localisation on these CT images, 1-2 ml contrast medium and, in the event of appropriate distribution, subsequently 50 MBq technetium-99m colloid were injected at one to three peritumoural sites under CT guidance. Peritumoural tracer distribution was controlled by thin-slice CT. Subsequently, planar scintigrams from anterior, right and left lateral views were obtained. In all patients, peritumoural colloid application was feasible, as shown on control CT scans. Post injection, neither severe nor minor complications were noted. The patients complained of only low pain sensations with an average score of 1.8 on a pain scale from 0 to 10. Lymphatic drainage was identified in nine of the 13 patients, with a total of 14 detected lymph nodes. In six patients, ipsilateral sentinel lymph nodes were visualised; bilateral sentinel lymph nodes were identified in one patient and contralateral lymphatic drainage was observed in two patients. CT-guided lymphoscintigraphy is a feasible and minimally invasive diagnostic tool for sentinel lymph node detection in patients with squamous cell carcinoma of the hypopharynx and the larynx. In contrast to endoscopic colloid injection under general anaesthesia, this technique seems to be a well-tolerated method for lymphatic mapping prior to surgical procedures.

Adult↗

PubMed2004

[Results of radiation therapy in periarthritis humeroscapularis].

BACKGROUND: Radiation therapy is applied in painful degenerative shoulder diseases. Aim of this work was to evaluate the contribution of radiation therapy to symptomatic improvement in periarthritis humeroscapularis. METHODS: Ninety-four patients with periarthritis humeroscapularis were treated in two institutions. Mean age was 68 years, sex distribution were 32 men and 62 women. In 58 cases the right side was affected, left in 36 cases. At single doses of 0.75 Gy once a week a total dose of 6 Gy was applied (Fig. 1). The treatment effect was evaluated by the standardized von Pannewitz-score at the end of the treatment up to 6 months thereafter. RESULTS: The treatment results of all the 94 patients were documentated at the end of therapy. Seventy-one patients were followed at least for further 4 months. Radiogenic side-effects were not noticed. The symptoms of 54 patients (57.4%) were improved or vanished, in 40 cases the symptoms were not significantly affected (42.6%) (Table 1). Four months after therapy 42 of 71 patients were improved (59.2%), 29 unchanged (40.8%) (Table 2). The treatment effect occured typically up to 2 months after therapy, there were no age-related differences. Also in recurrent radiation therapies the symptoms improved, in 80 percent after one preceding therapy (Table 3), however only in 31.2 percent after multiple prior radiotherapies (Table 4). CONCLUSION: Radiation therapy is effective in the symptomatic treatment of periarthritis humeroscapularis. Treatment should be performed early after initial conservative treatment prior to any invasive therapy.

Age Factors↗

PubMed2003

Fractionated perineal high-dose-rate temporary brachytherapy combined with external beam radiation in the treatment of localized prostate cancer: is lymph node sampling necessary?

PURPOSE: To study the influence of imaging based nodal staging and local dose escalation by a high-dose-rate brachytherapy (HDR-BT) boost in the treatment of locally confined prostate cancer in terms of prostate specific antigen (PSA) recurrence-free survival (biochemical non-evidence of disease (bNED)), treatment toxicity and prognostic variables. PATIENTS AND METHODS: The prospectively recorded files of 144 men aged in a median of 68 years with a mean follow-up of 8 years (60-171 months) receiving curatively intended, transrectal ultrasound guided high-dose-rate 192-iridium-brachytherapy (HDR-BT) combined with external beam radiation therapy (EBRT) for locally confined prostate cancer were analyzed. T-stages were defined by digital rectal investigation and transrectal sonography (TRUS), nodal staging was performed with computed tomography(CT)/magnetic resonance imaging (MRI) (UICC/AJCR 1992). Twenty-nine patients (20.1%) had T1b-T2a tumors, and 115 patients had T2b-T3 tumors. Median initial PSA (iPSA) was 12.15 ng x mL(-1) (mean 25.61 ng x mL(-1)). The total planned dose applied by external beam radiation was 50 Gy in the pelvis, and 40 Gy in the prostate by in-field-dose modification by individual compensators. The perineal, TRUS guided HDR-BT was delivered in two fractions of 15 Gy each. The target of BT boost was the peripheral zone of the prostate. RESULTS: The overall survival was 71.5% and that of the disease free survival 82.6%. Freedom from distant metastases in T3 stage was 91.3%, whereas for G3 lesions, it was 88.23%. The bNED rate was 72.9%. Regarding treatment related late toxicity according to the EORTC/RTOG score, we observed grade 1, 2, 3 proctitis in 9.72%, 6.94%, 4.10% as well as grade 1, 2, 3 cystitis in 12.5%, 4.16%, 2.08%, respectively. Grade 4 and 5 proctitis or cystitis were not registered. CONCLUSION: The minimum 5-year and mean 8-year results confirm that local dose escalation by TRUS guided perineal HDR-BT and complementary external beam radiation of the pelvic lymphatics has curative potential in men with locally confined high-risk prostate cancer, although surgical staging results in the literature suggest a high probabilityof microscopic nodal involvements at the level of 25.61 ng x mL(-1) mean PSA. The influence of additional short-term (< 6 months) hormonal ablation on the treatment results could not be stated.

Aged↗

PubMed2003

[A fast procedure of patient set-up verification in pelvic radiotherapy].

Accuracy of patient positioning is an important aspect in radiation therapy. The present paper presents a new procedure for the determination of set-up errors in radiotherapy, which is based on a special form of the Fast Fourier Transform (FFT), i.e., the Fast Hartley Transform (FHT). The use of this method allows to compare in short time verification and simulator films, and to calculate the translation vector or the in-plane rotation of the patient. Standard deviations < 1 mm for shifting measurements and < 1 degree for measurements of the rotation were detected, provided that the positioning remained within the common clinical range. The present results were in good agreement with data obtained using a landmark-based method.

Computer Simulation↗

PubMed2003

No apparent benefit at 5 years from a course of neoadjuvant/concurrent androgen deprivation for patients with prostate cancer treated with a high total radiation dose.

PURPOSE: We examined the survival impact of a course of 6 months or less of adjuvant/concurrent androgen deprivation in patients with unfavorable prostate cancer treated to high radiation doses with external beam (EBRT) and a high dose rate (HDR) brachytherapy boost. MATERIALS AND METHODS: Between 1986 and 2000, 507 patients were treated with pelvic EBRT (46 Gy) with HDR prostate brachytherapy as a boost. The biological equivalent EBRT dose was between 90 and 130 Gy. At Kiel University and at William Beaumont Hospital 198 and 309 patients were treated. Patient eligibility was pretreatment prostate specific antigen 10 ng/ml or greater, Gleason score 7 or greater, or clinical stage T2b or greater. The brachytherapy dose was escalated from 5.5 x 3 to 15 x 2 Gy. Patients were divided between 177 receiving and 330 not receiving androgen suppression therapy (AST). AST was given for a mean of 6 months. The American Society for Therapeutic Radiology and Oncology biochemical failure definition was used. RESULTS: Mean patient age was 68 years. Mean followup was 4.8 years (range 0.7 to 15.3), that is 4.5 years for AST and 4.9 for radiation alone. Five-year actuarial rates for biochemical control were 74% and 76%, for overall survival they were 81% and 87%, and for disease-free survival they were 67% and 66%, while cause specific survival with and without AST was 90% and 98%, and the 5-year metastatic rates were 10.7% and 6.9%, respectively. On multivariate analysis AST did not improve biochemical control. CONCLUSIONS: Pelvic EBRT interdigitated with a transrectal ultrasound guided HDR boost is an excellent method of delivering a high radiation dose to the prostate without rendering the patient radioactive. This trial showed high overall, cause specific and no biochemical evidence of disease survival. For this unfavorable group of patients the addition of a course of 6 months or less of neoadjuvant/concurrent AST to a high radiation dose did not appear to confer a 5-year therapeutic advantage. However, it added side effects and the significant cost of hormones.

Actuarial Analysis↗