Translation and Pilot Validation of Hindi, Marathi, and Bangla Translation of Quality-of-Life EORTC Radiation Proctitis Module (PRT-20) for Routine Clinical Use.

Rahul Krishnatry The aim of this study was to translate and validate the European Organization for Research and Treatment for Cancer (EORTC) "Radiation Proctitis" (PRT-20) module in Hindi, Marathi, and Bangla languages. The EORTC PRT-20 was translated into Hindi, Marathi, and Bangla using EORTC guidelines. Two separate translators first translated the original questionnaire into the three regional languages, following which a reconciled forward translation was compiled. This reconciled version in each language was then back-translated into English by two other translators. This back-translated version was then compared with the original the EORTC questionnaire for correctness, and the preliminary questionnaires were formed in all three languages. The EORTC translation unit approved the questionnaires. The preliminary questionnaires were administered to 30 patients (10 for each language) diagnosed with rectal or anal canal cancer who had received pelvic radiotherapy and were at risk of developing PRT. None of the patients had seen the questionnaire before. After filling out the questionnaire, each patient was interviewed for difficulty in answering, confusion, understanding, or if any of the questions were upsetting and if patients would have asked the question differently. No changes were suggested for Marathi and Bangla translations. Two modifications were suggested in the Hindi translation, which was then retested in five patients and finalized. All the suggestions were incorporated into the preliminary questionnaires, which were sent back to the EORTC for final approval. After reviewing the entire report of pilot testing for the translated quality-of-life questionaire-PRT-20 in three languages, it was approved by the EORTC translation unit. The translated questionnaires were reliable, with Cronbach α values of 0.767, 0.799, and 0.898 for Hindi, Marathi, and Bangla, respectively. The Hindi, Marathi, and Bangla translations of PRT-20 have been approved by the EORTC and can be used in routine clinical practice.

Impact of immobilisation and image guidance protocol on planning target volume margins for supine craniospinal irradiation.

Background: The setup errors during supine-CSI (sCSI) using single or dual immobilisation (SM, DM) subsets from two institutions were reviewed to determine if DM consistently decreased the required planning target volumes (PTV) margins and to identify the optimal image guidance environments. Materials and methods: Ours and a sister institutional cohort, each with a subset of SM or DM sCSI and daily 3-dimensional online image verification sets, were reviewed for the cranial and spinal regions translational shifts. Using descriptive statistics, scatter plots and independent sample Mann-Whitney test we compared shifts in each direction for two subsets in each cohort deriving PTV margins (Van Herk: VH, Strooms: St recipes) for the cranial and spinal regions. Three image guidance (IG) protocols were simulated for two regions on the combined cohort with SM and DM subsets to identify the most optimal option with the smallest PTV margin. The IG protocols: 3F, 5F and 5FB where the systematic error correction was done using the average error from the first three, five and in the cranium alone (applied to both the cranium and spine, otherwise) for the first five set-ups, respectively. Results: 6968 image sets for 179 patients showed DM could consistently reduce the PTV margin (VH/St) for the cranium from 6/5 to 4/3.5 (31.8/30.8%) and 6/4 to 4/3.5 mm (30.5/16.8%) for primary and validation cohort, respectively. Similarly, for the spine it was 10/8.5 to 6/5.5 (38.6/38.4%) and 9/7.7 to 7/6 (21.6/21.4%), respectively. The "5F-IG" resulted in the smallest margins for both the cranial (3 mm) and spinal region (5 mm) for DM with estimated 95% CTV coverage probability. Conclusion: DM with 5F-IG would significantly reduce the required PTV margins for sCSI.

Dosimetric impact of target definition in brachytherapy for cervical cancer - Computed tomography and trans rectal ultrasound versus magnetic resonance imaging.

Background and Purpose: Magnetic Resonance Imaging (MRI) based target definition in cervix brachytherapy is limited by its availability, logistics and financial implications, therefore, use of computed tomography (CT) and Trans Rectal UltraSonography (TRUS) has been explored. The current study evaluated the dosimetric impact of CT + TRUS based target volumes as compared to gold standard MRI. Methods and Materials: Images of patients (n = 21) who underwent TRUS followed by MRI and CT, were delineated with High-Risk Clinical Target Volume in CT (CTVHR-CT) and in MRI (CTVHR-MR). CTVHR-CT was drawn on CT images with TRUS assistance. For each patient, two treatment plans were made, on MRI and CT, followed by fusion and transfer of CTVHR-MR to the CT images, referred as CTVHR-MRonCT. The agreement between CTVHR-MRonCT and CTVHR-CT was evaluated for dosimetric parameters (D90, D98 and D50; Dose received by 90%, 98% and 50% of the volumes) using Bland-Altman plots, linear regression, and Pearson correlation. Results: No statistically significant systematic difference was found between MRI and CT. Mean difference (±1.96 SD) of D90, D98 and D50 between CTVHR-MRonCT and CTVHR-CT was 2.0, 1.2 and 5.6 Gy respectively. The number of patients who have met the dose constraints of D90 > 85 Gy were 90% and 80% in MR and in CT respectively, others were in the borderline, with a minimum dose of 80 Gy. The mean ± SD dose-difference between MR and CT plans for bladder was significant (5 ± 13 Gy; p = 0.12) for D0.1cm3, while others were statistically insignificant. Conclusion: CT + TRUS based delineation of CTVHR appear promising, provide useful information to optimally utilize for brachytherapy planning, however, MRI remains the gold standard.

Outcome and treatment toxicity in east-indian versus white-canadian patients with oral cavity cancer following postoperative (chemo-)radiotherapy delivered under similar multidisciplinary care: A propensity-matched cohort study.

PURPOSE: We compare clinical behaviour of East-Indians and White-Canadians with oral cavity squamous cell carcinoma (OSCC) treated at a Western institution within a uniform health care system. MATERIALS/METHODS: Newly diagnosed OSCC patients who underwent postoperative (chemo-)radiotherapy (PORT/POCRT) between 2005 and 2017 were included. Data on ethnicity and other variables were extracted from patient-questionnaires, a prospective database and supplemented by chart review. Baseline characteristics were compared between East-Indian versus White-Canadian groups. A propensity-matched (1:1 ratio) of East-Indian versus White-Canadian cohorts was generated to compare locoregional control (LRC), distant control (DC), overall survival (OS), and acute and late toxicities. RESULTS: A total of 53 East-Indian and 467 White-Canadian OSCC patients were identified. Compared to White-Canadians, East-Indian patients were younger, had less exposure to smoking and alcohol (p < 0.001), but more chewed betel (areca) nut /tobacco (43% vs 0.2%, p < 0.001). Buccal/retromolar-trigone/lower gingiva primaries were more common in East-Indians (49% vs 25%, p < 0.001). Median follow-up was 5.0 years. Propensity-score paired analysis revealed inferior 3-year LRC (68% vs 81%, p = 0.030), non-significantly lower OS (61% vs 75%, p = 0.257), but similar DC (81% vs 87%, p = 0.428) in East-Indian versus White-Canadian patients. Actuarial rate of toxicities was higher in East-Indians vs White-Canadians: acute toxicity at 6 weeks: 47% vs 30%, p = 0.012; chronic trismus at 5-years: 16% vs 2%, p = 0.013. CONCLUSION: East-Indian OSCC patients have a greater betel nut/ chewable tobacco exposure compared to White-Canadians and a different distribution of OSCC sites. Propensity-matched cohort analysis showed lower LRC and higher toxicities in East-Indian OSCC patients, suggesting a complicated interaction between genetic/biological and life-style factors.

Statistical fundamentals on cancer research for clinicians: Working with your statisticians.

PURPOSE: To facilitate understanding statistical principles and methods for clinicians involved in cancer research. METHODS: An overview of study design is provided on cancer research for both observational and clinical trials addressing study objectives and endpoints, superiority tests, non-inferiority and equivalence design, and sample size calculation. The principles of statistical models and tests including contemporary standard methods of analysis and evaluation are discussed. Finally, some statistical pitfalls frequently evident in clinical and translational studies in cancer are discussed. RESULTS: We emphasize the practical aspects of study design (superiority vs non-inferiority vs equivalence study) and assumptions underpinning power calculations and sample size estimation. The differences between relative risk, odds ratio, and hazard ratio, understanding outcome endpoints, purposes of interim analysis, and statistical modeling to minimize confounding effects and bias are also discussed. CONCLUSION: Proper design and correctly constructed statistical models are critical for the success of cancer research studies. Most statistical inaccuracies can be minimized by following essential statistical principles and guidelines to improve quality in research studies.

Indian Brachytherapy Society Guidelines for radiotherapeutic management of cervical cancer with special emphasis on high-dose-rate brachytherapy.

Brachytherapy (BT) for locally advanced cervical cancer is vital for optimal outcomes. There is heterogeneity in brachytherapy treatment practice for cervical cancer across India. In an attempt to standardize various processes involved in cervical cancer brachytherapy, the expert members of the Indian Brachytherapy Society (IBS) developed a document related to radiation therapy treatment of cervical cancer with special emphasis on brachytherapy. The guidelines are based on high quality clinical evidence, expert opinion and consensus wherever evidence was lacking. The document provides a guide for external beam radiation and details of all the processes involved in high-dose-rate (HDR) brachytherapy including patient selection, preparation, principles and technique of BT applications, target and normal tissue definition, dose prescriptions, BT planning, reporting parameters, common complications of BT and their management, scope for research, etc. In summary, we present here practical tips and tricks, recording and reporting of cervical cancer brachytherapy, which can be implemented in various clinical environments and forms the basis of this report.

A Prospective Comparison of Computed Tomography with Transrectal Ultrasonography Assistance and Magnetic Resonance Imaging-Based Target-Volume Definition During Image Guided Adaptive Brachytherapy for Cervical Cancers.

PURPOSE: Although magnetic resonance imaging (MRI) represents the gold standard for image guided adaptive brachytherapy (IGABT) for cervical cancer, the majority of brachytherapy (BT) continues to be guided by computed tomography (CT). However, CT seems to overestimate the target-volume definition, and the potential of transrectal ultrasonography (TRUS) needs further evaluation. This prospective, comparative study aimed to evaluate CT-based target contouring with the incorporation of TRUS during BT. METHODS AND MATERIALS: Patients with locally advanced cervical cancer undergoing magnetic resonance IGABT between January 2013 and March 2014 were included. During the BT procedure, TRUS imaging with central tandem in situ was acquired at 3 representative levels. Reference points/dimensions (D1-D4) of the hypoechoic region on TRUS images with respect to the central tandem were recorded. CT and magnetic resonance BT planning imaging was performed after BT application. The high-risk clinical target volume (HR-CTV) was contoured on CT scans with incorporation of clinical and TRUS imaging findings and was compared with the gold standard MRI-based target approach. RESULTS: The image sets of 25 patients (International Federation of Gynecology and Obstetrics clinical stage IIB [11; 44%] and IIIB [14; 56%]) were evaluable. The mean (±standard deviation) volumes of HR-CTV on CT and MRI imaging were 39.1 (±20) cm³ and 39 (±19) cm³, respectively (r = 0.92; P < .001). A significant correlation was found between the HR-CTV dimensions (width and thickness) of CT and MRI scans at various levels (r = 0.70-0.80; P < .001). In addition, the absolute differences in target dimensions between CT and MRI were <0.5 cm. A strong correlation was seen between CT and MRI for patients with medial and lateral parametrial invasion (P < .05) compared with no parametrial disease at BT. Furthermore, the mean differences in HR-CTV width between CT and MRI contours at various levels, irrespective of parametrial involvement, was only 0.1 to 0.4 cm. CONCLUSIONS: This study suggests that a CT-based target and organ-at-risk delineation using MRI at diagnosis and real-time TRUS information during BT seems comparable with the gold standard MRI-based approach in IGABT for cervical cancer.

Income generated by women treated with magnetic resonance imaging-based brachytherapy: A simulation study evaluating the macroeconomic benefits of implementing a high-end technology in a public sector healthcare setting.

PURPOSE: To estimate the difference in income generated if all women presenting in our institute over a 5-year period were treated with MRI-based image-guided brachytherapy (MR-IGBT) instead of conventional radiograph-based brachytherapy (CR-BT). METHODS AND MATERIALS: Outcome data from 463 patients (94 treated with MR-IGBT) treated in our institute was used to simulate cumulative women-days of work and cumulative income over 5 years for 5526 patients expected to be treated in this period. The average daily income for a woman was derived from the National Sample Survey Organization (NSSO) survey data. Outcomes from both unmatched and propensity score-matched data sets were simulated. RESULTS: The cumulative income in 5 years ranged between Rs 101-168 million if all patients presenting at our institute underwent MR-IGBT. The simulated excess income ranged from Rs 4-45 million after 5 years, which represented 6-66% of the expenditure incurred for acquiring the required equipment and manpower for practicing exclusive MR-IGBT. CONCLUSIONS: Using outcome data from a prospective cohort of patients treated with MR-IGBT in our institute, we demonstrated that significant economic gains may be realized if MR-IGBT was used instead of CR-BT.

Radiation Oncology in India: Challenges and Opportunities.

Rising cancer incidence and mortality in India emphasize the need to address the increasing burden of this disease and the stark inequities in access to radiotherapy and other essential medical treatments. State-of-the-art technology is available within the private sector and a few hospitals in the public sector, but 75% of patients in the public sector in India do not have access to timely radiotherapy. This inequity in access to radiotherapy in the public sector is amplified in rural areas, where most of India׳s population lives. A long-term government commitment to machine purchase and human resource development in the public sector is needed to improve access. A number of innovative initiatives to improve cancer treatment and access have emerged that could support such an investment. These include local production of equipment, twinning programs between institutions in high- and low-income countries to exchange knowledge and expertise, and nongovernmental and state-sponsored schemes to sponsor and support patients in their cancer journey. Strengthening of cancer registries and regulatory bodies with authority to enforce minimum standards is also required to improve care. The more uniform and frequent availability of high-quality radiotherapy can improve cancer outcomes and may be regarded as a marker of a comprehensive and equitable system of health care delivery.

Interobserver Variability in the Delineation of Gross Tumour Volume and Specified Organs-at-risk During IMRT for Head and Neck Cancers and the Impact of FDG-PET/CT on Such Variability at the Primary Site.

PURPOSE: To assess interobserver variability (IOV) in the delineation of structures during intensity-modulated radiation therapy for head and neck squamous cell carcinoma and the impact of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) on such variability at the primary site. METHODS: Three experienced head-neck radiation oncologists, blinded to each other, delineated the primary site gross tumour volume (GTV) and specified organs-at-risk (OARs) viz parotid gland, spinal cord, and cochlea in 10 patients with pharyngolaryngeal cancers suited for definitive intensity-modulated radiation therapy. IOV was assessed by concordance index (CI), Dice similarity coefficient (DSC), and Fleiss' kappa. Subsequently, the observers refined their corresponding GTVs incorporating information from FDG-PET/CT. The impact of FDG-PET/CT on variability of GTV was assessed by comparing the overlap indices with and without FDG-PET/CT using paired 't' test. RESULTS: There was moderate IOV in the delineation of GTV as evidenced by mean CI, DSC, and Fleiss' kappa of 0.41, 0.57, and 0.56, respectively. The use of FDG-PET/CT improved consistency of target volume delineation with resultant improvement in the overlap indices (mean CI, DSC, and Fleiss' kappa of 0.54, 0.69, and 0.69, respectively) that was statistically significant (P < .001). There was good agreement between the three observers for delineation of spinal cord and parotid glands. Concordance was worst for the cochlea. CONCLUSION: This study demonstrates the presence of moderate IOV between three experienced head and neck radiation oncologists in an academic institutional setting for the delineation of GTV. The use of FDG-PET/CT for target volume delineation results in significant reduction of such variability.