A New Questionnaire (QRFPC25) Regarding the Religiosity and Spirituality in People with Life-Threatening Disease: Reliability and Validity in a Population of Cancer Patients Undergoing Radiotherapy.

The development of a questionnaire (QRFPC25) assessing the religiosity of cancer patients. The method used for the questionnaire comprises seven multi-item and three single-item scales formed from a 25-question module. The questionnaire was completed on-site and a week after antineoplastic therapy. The final sample included 156 patients. The main topics of the QRFPC25 are the following: worship, relationship with the divine, spiritual discussion, hope, participation in holly communion, faith, life after death, love, bioethics and global quality of life (QoL). The average time of both times taken to complete the questionnaire was approximately 10 min. All multi-item scales met the minimal standards of reliability (Cronbach's alpha coefficient ≥.70) before or after treatment. Test-retest reliability in terms of the intraclass correlation coefficient was also satisfactory (p < 0.01). Validity was assured by inter-item correlations and correlations with the European Organisation for Research and Treatment of Cancer's Core Quality of Life Questionnaire (QLQ-C30, version 3.0), along with factor analysis which showed eight factors incorporated in the model. The QRFPC25 is a reliable and valid gauge for the assessment of religiosity in cancer patients undergoing radiotherapy.

The first implementation of IMRT technique for head & neck and prostate cancer patients in public sector in Greece: feasibility, treatment planning and dose delivery verification using the delta(4PT) Pre-Treatment volumetric quality assurance system.

PURPOSE: Intensity Modulated Radiation Therapy (IMRT) is nowadays the treatment of choice, in terms of technique, for either head & neck or prostate cancer. With this paper, we are sharing our experience for the first inplementation of IMRT planning in the public sector in Greece, and especially in the Aretaieion University Hospital of Athens. METHODS: From May 2013 until January 2014 four prostate and four head & neck cancer patients were evaluated in the present study. We used the ONCENTRA IMRT treatment planning with a step and shoot technique in a SIEMENS ONCORE Linac. The dose verification method used was based on the delta4(PT) Pre-Treatment volumetric quality assurance system, by Scadidos. RESULTS: In all cases, the Relative Standard Deviation between the prescribed and the calculated average dose received by the target volume was less than 5%, while the γ-index was more than 90%. The acute toxicity was low and equivalent to published data with IMRT technique. CONCLUSION: In conclusion, the first implementation of IMRT technique in the Medical School of Athens was feasible and safe as well as in terms of dose verification. The IMRT technique is already in clinical use and further results with long term radiation induced toxicity will be reported.

Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: topical intrarectal versus subcutaneous application.

PURPOSE: To investigate the cytoprotective effect of subcutaneous vs. intrarectal administration of amifostine against acute radiation toxicity. METHODS AND MATERIALS: Patients were randomized to receive amifostine either intrarectally (Group A, n = 27) or a 500-mg flat dose subcutaneously (Group B, n = 26) before irradiation. Therapy was delivered using a four-field technique with three-dimensional conformal planning. In Group A, 1,500 mg of amifostine was administered intrarectally as an aqueous solution in 40 mL of enema. Two different toxicity scales were used: the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (RTOG) rectal and urologic toxicity criteria and the Subjective-RectoSigmoid scale based on the endoscopic terminology of the World Organization for Digestive Endoscopy. Objective measurements with rectosigmoidoscopy were performed at baseline and 1-2 days after radiotherapy completion. The area under the curve for the time course of mucositis (RTOG criteria) during irradiation represented the mucositis index. RESULTS: Intrarectal amifostine was feasible and well tolerated without any systemic or local side effects. According to the RTOG toxicity scale, Group A had superior results with a significantly lower incidence of Grades I-II rectal radiation morbidity (11% vs. 42%, p = 0.04) but inferior results concerning urinary toxicity (48% vs. 15%, p = 0.03). The mean rectal mucositis index and Subjective-RectoSigmoid score were significantly lower in Group A (0.44 vs. 2.45 [p = 0.015] and 3.9 vs. 6.0 [p = 0.01], respectively), and the mean urinary mucositis index was lower in Group B (2.39 vs. 0.34, p < 0.028). CONCLUSIONS: Intrarectal administration of amifostine (1,500 mg) seemed to have a cytoprotective efficacy in acute radiation rectal mucositis but was inferior to subcutaneous administration in terms of urinary toxicity. Additional randomized studies are needed for definitive decisions concerning the cytoprotection of pelvic irradiated areas.

A phase II randomized study of topical intrarectal administration of amifostine for the prevention of acute radiation-induced rectal toxicity.

PURPOSE: To investigate the cytoprotective effect of intrarectal amifostine administration on acute radiation-induced rectal toxicity. PATIENTS AND METHODS: 67 patients with T1b-2 N0 M0 prostate cancer were randomized to receive amifostine intrarectally (group A, n = 33) or not (group B, n = 34) before irradiation. Therapy was delivered using a four-field technique with three-dimensional conformal planning. In group A, 1,500 mg amifostine was administered intrarectally as an aqueous solution in a 40-ml enema. Two different toxicity scales were used: EORTC/RTOG rectal and urologic toxicity criteria along with a Subjective-RectoSigmoid (S-RS) scale based on the endoscopic terminology of the World Organization for Digestive Endoscopy. Objective measurements with rectosigmoidoscopy were performed at baseline and 1-2 days after the completion of radiotherapy. The area under curve for the time course of mucositis (RTOG criteria) during irradiation represented the mucositis index (MI). RESULTS: Intrarectal amifostine was feasible and well tolerated without any systemic or local side effects. According to the RTOG toxicity scale, five out of 33 patients showed grade 1 mucositis in group A versus 15 out of 34 patients with grade 1/2 in group B (p = 0.026). Mean rectal MI was 0.3 +/- 0.1 in group A versus 2.2 +/- 0.4 in group B (p < 0.001), while S-RS score was 3.9 +/- 0.5 in group A versus 6.3 +/- 0.7 in group B (p < 0.001). The incidence of urinary toxicity was the same in both groups. CONCLUSION: Intrarectal administration of amifostine seems to have a cytoprotective efficacy in acute radiation-induced rectal mucositis. Further randomized studies are needed for definitive therapeutic decisions.

Impact on cytoprotective efficacy of intermediate interval between amifostine administration and radiotherapy: a retrospective analysis.

PURPOSE: To evaluate the cytoprotective impact of the interval between amifostine administration and radiotherapy (RT). METHODS AND MATERIALS: In a nonrandomized study, we reviewed the records of 177 patients with tumors localized in the pelvis (prostate, bladder, or gynecologic cancer), upper abdomen (pancreas, stomach, kidney), thorax (lung and breast cancer), head and neck (nasopharynx), soft tissue (sarcomas), and central nervous system. The patient records were stratified according to whether the patients had undergone RT either 25-40 min (Group 1, 96 subjects) or 10-15 min (Group 2, 81 subjects) after i.v. amifostine administration. The mean toxicity score was the mean value of recorded acute radiation toxicity. The mean interruption time was the mean value of the recorded interruption time due to radiation toxicity. RESULTS: A significantly reduced severity of symptoms related to oral (p = 0.023), esophageal (p = 0.05) and rectal (p = 0.015) mucosa was noted in Group 2. A statistically significant reduction in the mean toxicity score (p <0.001) and mean interruption time (p = 0.001) was observed in Group 2 vs. Group 1. In terms of the incidence of radiation-induced dermatitis and alopecia, multivariate logistic analysis revealed only the total dose (p = 0.018) and the amifostine-RT interval (p = 0.002) as independent factors. CONCLUSION: A significantly better cytoprotective effect of amifostine against radiation-induced mucositis, dermatitis, and alopecia was noted if RT was administered no later than 15 min after i.v. amifostine infusion. The results presented here need additional investigation with randomized prospective trials.

Duration of bisphosphonate treatment: results of a non-randomised study in patients previously treated with local irradiation for bone metastases from breast cancer.

PURPOSE: To assess whether disodium pamidronate (DP) once started should be given life-long in women with lytic bone metastases. PATIENTS AND METHODS: One hundred and three women with breast cancer who had at least one osteolytic lesion received 180 mg of DP as a 2-h intravenous infusion given every 4 weeks for a life-time, following local radiotherapy. After six cycles, 26 out of 103 patients (25%) refused to continue their bisphosphonate-treatment. Thus two groups were constituted: non-stop (group A) and premature discontinued (group B). The new skeletal complication free survival (NSCFS) was the primary endpoint verified during extramural review. Performance status, pain-score and biochemical markers were secondary endpoints. RESULTS: Generally DP was well tolerated. At 36 months, the proportion of patients having had any skeletal complication was 54.5 and 84.6% in group A and B, respectively. The median time of NSCFS was apparently longer for group A. In group A, the pain score and the ECOG status were significantly lower, while the overall survival appeared to be longer. Multivariate analysis revealed age, nodal status and interruption of treatment as prognostic factors to NSCFS, with relative risk 1.05, 2.3 and 1.5 respectively. CONCLUSION: Data concerning the suspension of new skeletal complications, as well as the apparent improvement of overall survival, pain score and ECOG status, suggest that the pamidronate-treatment should not be stopped once started. These results should be confirmed in a randomised trial.

Amifostine as radioprotective agent for the rectal mucosa during irradiation of pelvic tumors. A phase II randomized study using various toxicity scales and rectosigmoidoscopy.

AIM: To evaluate the cytoprotective effect of amifostine against radiation-induced acute toxicity to the rectal mucosa. PATIENTS AND METHODS: 36 patients irradiated for prostate or gynecologic cancer were randomized to receive amifostine (n = 18, group A) or not (n = 18, group B). The radiation-induced acute rectal toxicity was evaluated by using three different toxicity scales: WHO scale, EORTC/RTOG toxicity criteria, and a modified toxicity scale based on the LENT-SOMA grading scale and the endoscopic terminology of the World Organization for Digestive Endoscopy. The objective measurements were coming from flexible rectosigmoidoscopy performed at baseline and 1-2 days after completion of the radiotherapy schedule. Anterior-posterior fields were used in the gynecologic patients while 3-D conformal 4-field technique was applied in the prostate cancer patients. The area under the curve (AUC) for dose-volume histograms (DVHs) of the rectum was also assessed during a 3-D treatment planning schedule, and no significant differences were assessed between the two groups, indicating a homogeneous dose-volume effect. RESULTS: Amifostine was well tolerated. No grade 2 or higher WHO and EORTC/RTOG acute toxicity was noted in group A, while acute rectal toxicity (> or = grade 1) was observed in 16/18 patients of group B versus 2/18 of group A (p < 0.001). The onset as well as the duration of acute rectal toxicity were significantly improved in group A (p = 0.002). Rectosigmoidoscopy revealed more severe rectal mucositis in noncytoprotected patients (group B), and modified LENT-SOMA overall mucositis grading score was significantly lower in group A (p = 0.003). CONCLUSION: Amifostine seems to have a significant cytoprotective efficacy in acute radiation-induced rectal mucositis in terms of symptomatic and objective endpoints.

The cytoprotective effect of amifostine in acute radiation dermatitis: a retrospective analysis.

To study the impact of amifostine as a cytoprotective agent against acute radiation dermatitis, we reviewed 220 patient records. One hundred cancer patients, with tumors localised in the pelvis (bladder, rectum, prostatic carcinomas, or gynecological cancer), who received radiotherapy and cytoprotective treatment with intravenous infusion of amifostine (group A) were included in this study. Retrospectively, we randomly selected from a database in our hospital 120 historical controls, who received only radiotherapy without cytoprotection (group B). Mean gross dermatitis score (MGDS) was the mean value of recorded acute radiation dermatitis according to common toxicity criteria. In group A versus B patients, a significantly reduced severity of dermatitis (P < 0.001, Fisher's exact test) and significant reduction of MGDS as well as mean interruption treatment time (P < 0.001, Mann-Whitney U test) was observed. The relative risk of the outcome of the two study groups was 0.23 (95% CI: 0.15 to 0.34). The significant dermato-cytoprotective effect of amifostine noticed in our retrospective analysis warrants further investigation with randomised trials.