Translation and Pilot Validation of the EORTC QLQ-NHL-HG29 Module in Indian Languages (Hindi and Marathi) for Use in Indian Patients with Non-Hodgkin's Lymphoma.

Roshankumar PatilBackground Cancer and its related treatments have a huge impact on a patient's quality of life (QOL). To measure such QOL in cancer patients, the European Organization for Research and Treatment of Cancer (EORTC) has introduced various scales/questionnaires for various cancers. In the present study, we aimed to translate and validate high-grade Non-Hodgkin's lymphoma (NHL-HG) English questionnaire (EORTC QLQ-NHL-HG29) into Hindi and Marathi (two of the most popular Indian language) to make it available for patients and the scientific community. Materials and methods The EORTC QLQ-NHL-HG29 was translated into Hindi and Marathi languages as per EORTC guidelines. The translated questionnaire was pilot-tested in a sample of 20 patients (10 for each translation) with NHL-HG. Results After procuring required approvals from EORTC, the existing QLQ-NHL-HG29 English questionnaire was translated (forward and backward) into vernacular languages (Hindi and Marathi). Later, the translations were sent to EORTC for evaluation and all the queries raised by EORTC toward translations were discussed and included in the final questionnaires as per EORTC guidelines. On receiving approval from EORTC translation coordinator, pilot study was conducted in 20 patients. In the pilot study, 10 patients were given the Hindi questionnaire and other 10 patients were given the Marathi questionnaire. Based on the pilot testing interpretations or suggestions from the patients, all the necessary modifications were incorporated in the questionnaires and sent to EORTC for validation and approval. Conclusion Both the translations (Hindi and Marathi) submitted to the EORTC have now been approved (QLQ-NHL-HG29) by the EORTC-QOL unit and after procuring necessary permissions from the EORTC both of these translations can be used reliably in clinical practice and clinical trials to assess QOL in patients suffering from NHL-HG.

Depth of Invasion, Lymphovascular Invasion, and Perineural Invasion as Predictors of Neck Node Metastasis in Early Oral Cavity Cancers.

Aims: The present study examines the role of demographic and pathological features of primary tumours in predicting neck metastasis in early oral cavity cancers, which has been a matter of debate. Methods: A single-centre, retrospective, institution review was conducted of all the patients presented to our centre from January 2014 to December 2021. Patient characteristics were compared between the two lymph node groups (lymph node positive and lymph node negative) and significant prognostic factors were determined. Results: A total of 462 oral squamous cell carcinoma (OSCC) patients were included, 407 male and 55 female. Tobacco chewing (59.2%) was a major habit with buccal mucosa (49.5%) and tongue (44.8%) as primary sites. The majority of the patient's histology was of SCC (96.8%) with grade II (moderately differentiated, 74.5%). Univariate logistic regression analysis to predict lymph node metastasis showed pT size (< 0.001), LVI (< 0.001), and PNI (< 0.001) as significant tumor characteristics. On multivariate, pT size (OR-1.58, P - 0.0001) and LVI (OR-19.70, P - 0.0001) were reported to be statistically significant to predict lymph node metastasis. Conclusion: Reporting and studying the clinico-pathological features of primary tumors can give vital information in predicting the neck node metastasis in OSCC patients.

Long-term outcomes and prognostic factors in elderly patients with breast cancer: single-institutional experience.

Introduction: Despite advances in treatment, there is rising mortality in elderly patients with breast cancer. We aimed to conduct an audit of non-metastatic elderly breast cancer patients to understand the predictors of outcome. Methods: Data collection was done from electronic medical records. All time-to-event outcomes were analysed using Kaplan-Meier method and compared using log-rank test. Univariate and multi-variate analysis of known prognostic factors was also done. Any p-value ≤0.05 was considered statistically significant. Results: A total of 385 elderly (>70 years) breast cancer patients (range 70-95 years) were treated at our hospital from January 2013 to December 2016. The hormone receptor was positive in 284 (73.8%) patients; 69 (17.9%) patients had over-expression of HER2-neu, while 70 (18.2%) patients had triple-negative breast cancer. A large majority of women (N = 328, 85.9%) underwent mastectomy while only 54 (14.1%) had breast conservation surgery. Out of 134 patients who received chemotherapy, 111 patients received adjuvant, while the remaining 23 patients received neoadjuvant chemotherapy. Only 15 (21.7%) patients of the 69 HER2-neu receptor-positive patients received adjuvant trastuzumab. Adjuvant radiation was given to 194 (50.3%) women based on the type of surgery and disease stage. Adjuvant hormone therapy was planned using letrozole in 158 (55.6%) patients, while tamoxifen was prescribed in 126 (44.4%). At the median follow up of 71.7 months, the 5-year overall survival, relapse-free survival, locoregional relapse-free survival, distant disease-free survival, breast cancer-specific survival were 75.3%, 74.2%, 84.8%, 76.1% and 84.5%. Age, tumour size, presence of lymphovascular invasion (LVSI) and molecular subtype emerged as independent predictors of survival on multi-variate analysis. Conclusion: The audit highlights the underutilisation of breast-conserving therapy and systemic therapy in the elderly. Increasing age and tumour size, presence of LVSI and molecular subtype were found to be strong predictors of outcome. The findings from this study will help to improve the current gaps in the management of breast cancer among the elderly.

Psychological and Mental Health Burden on Health Care Providers in a Cancer Centre during COVID-19 Pandemic Outbreak in India.

BACKGROUND: The outbreak of novel coronavirus (COVID-19) is severely affecting the public health and posing a challenge to health care providers, especially working as front-line medical staff. This study was aimed to understand the psychological impact and mental burden of the present outbreak on Indian health care providers who are working at cancer care centre. SUBJECTS AND METHODS: A self-reporting online questionnaire was given to the multidisciplinary staff (n=344) and their mental health was assessed using various scales via GAD-7 scale for anxiety, PHQ-9 scale for depression, ISI for insomnia, K-10 for distress, and STAI for stress along with five self-made Pandemic specific questions. RESULTS: Response rate was 91% (n=344) among 190 (55%) were male and 154 (45%) were female. The frontline and second-line workers were 178 (52%) and 166 (48%), respectively. Symptoms of anxiety, depression, insomnia and distress was observed in 62 (18%), 75 (22%), 42 (12%), and 60 (17%) of the participants, respectively. They were predominantly influenced by variables such as gender (female), education (≥graduation), co-morbidities, and level of work (frontline). Followed by other less dominant variables such as contact with patients (frequent), and working in hospital (<3 years), respectively. CONCLUSION: A mild to moderate level of psychological burden was observed in the health care providers. Overall, there is a need to address the mental health issues by providing, timely training, counselling, rotation in shifts, lowering workload and inten¬sify the awareness programmes of the staff during this COVID-19 pandemic for better outcomes and promoting resilience in the staff.

The predictive role of neutrophil-to-lymphocyte ratio in the outcomes of patients with sarcomatoid carcinoma of oral cavity.

INTRODUCTION: The aim of the present study was to evaluate the prognostic value of the inflammatory response biomarkers and their impact on survival outcomes in the patients with sarcomatoid carcinoma (SC) of oral cavity, a rare variant of squamous cell carcinoma (SqC). MATERIALS AND METHODS: Seventeen patients diagnosed with SC of oral cavity without metastases treated between Jan 2017 to June 2020 were identified and included in the present study. Pre- and post-operative inflammatory biomarkers and other prognostic markers were evaluated and their impact on disease-free survival (DFS) and overall survival (OS) was studied. RESULTS: Seventeen patients (16 males and one female) were included in the present study with a median age of 42 years (IQR: 26-76 years). With the median follow-up of 15 months, nine of 17 patients had developed recurrence and were succumbed to either locoregional recurrence or distant progression. One-year Kaplan-Meier estimates of DFS and OS were 57% and 58.3% respectively. On univariate analysis, baseline NLR, PLR, and pathological bone/skin involvement were identified to be significant prognostic factors affecting the patient's DFS and OS. On multi-variate analysis, baseline NLR > 3 and pathological bone or skin involvement by tumour were emerged as some independent significant predictors. CONCLUSION: For the first time, the predictive role of inflammatory markers is studied and proven significant affecting patients' survival outcomes. Hence, these inflammatory biomarkers may be considered for routine clinical use as reliable and low-cost prognostic markers to tailor the management of SC of oral cavity.

Clinical Audit of Survival Outcomes and Prognostic Factors in Adolescents and Adults with Medulloblastoma.

Purpose: Medulloblastomas, comprising 20%-25% of all primary brain tumors in children are much rarer in adulthood. Disease biology varies substantially across different age groups; however, owing to rarity, adults with medulloblastoma are traditionally treated using pediatric protocols. This is a retrospective audit of adolescent and adult medulloblastoma from a comprehensive cancer center. Methods: Data regarding demography, clinical presentation, imaging characteristics, histopathological features, molecular profiling, risk stratification, treatment details, and outcomes were retrieved from medical records. All time-to-event outcomes were analyzed using Kaplan-Meier method and compared with the log-rank test. Univariate and multivariate analysis of relevant prognostic factors was done with p value <0.05 being considered statistically significant. Results: A total of 162 patients ≥15 years of age with medulloblastoma were included. The median age was 25 years (range: 15-59 years) with leptomeningeal metastases seen in 31 (19%) patients at initial diagnosis. Following surgery, patients were treated with appropriate risk-stratified adjuvant therapy comprising of craniospinal irradiation plus boost with or without systemic chemotherapy. At a median follow-up of 50 months, 5-year Kaplan-Meier estimates of progression-free survival and overall survival were 53.5% and 59.5%, respectively. The addition of adjuvant systemic chemotherapy did not impact upon survival in standard-risk medulloblastoma. High-risk (HR) disease and anaplastic histology emerged as significant and independent predictors of poor survival on multivariate analysis. Conclusion: Medulloblastoma is a rare tumor in adolescents and adults with key differences in disease biology and resultant outcomes compared with the pediatric population. Contemporary management comprising maximal safe resection followed by appropriate risk-stratified adjuvant therapy provides acceptable survival outcomes.

Evaluation of Prognostic Factors that Affect Survival Outcomes of Breast Cancer Patients with Brain Metastases: A Single Institutional Experience.

OBJECTIVE: This study aimed to evaluate various prognostic factors that play a vital role in stratifying and guiding tailored treatment strategies and survival outcome in breast cancer patients with brain metastases (BM). MATERIALS AND METHODS: Data regarding demography, clinical presentation, molecular subtypes, risk-stratification, treatment details, and outcomes were retrieved from medical records. All time-to-event (survival) outcomes were analyzed by Kaplan-Meir method and compared using log-rank test. Univariate and multivariate analysis of relevant prognostic factors were performed and p-values ≤0.05 were considered statistically significant. RESULTS: A total of 88 patients (median age: 50 years) were included for this study. The median follow-up time of all surviving patients was ~20 months. During the follow-up, 82 (93.1%) patients died. The median survival of all patients was 12 months, with 1-year and 2-year overall survival (OS) rate of 51% and 22%, respectively. Based on univariate analysis, statistically significant prognostic factors for OS were molecular subtypes, number of BM, and Karnofsky Performance Status (KPS); however, number of BM and KPS emerged as independent predictors of survival based on multivariate analysis. CONCLUSION: We conclude that, there are other important prognostic factor, such as number of BM, which may affect the OS of these patients, in addition to variables included in the diagnosis-specific graded prognostic assessment score. Prospective studies evaluating these factors are necessary to further refine the stratification of patients, which will aid the initiation of appropriate treatment to improve the OS of patients.

Safety and efficacy of scalp cooling system in preventing chemotherapy induced alopecia - A single center prospective study.

BACKGROUND: Alopecia is one of the most common and afflicting side effects associated with chemotherapy treatments. Scalp-cooling devices were introduced to reduce hair loss and improve the hair volume recovery in patients undergoing chemotherapy. METHODS: This is a single center, prospective observational study conducted from 01 February 2019 to 31 January 2020, in patients undergoing chemotherapy for various cancers. The extent of alopecia was assessed by two independent clinicians by reviewing the photographs taken at baseline, during each session, and 4 weeks from the last scalp cooling session. RESULTS: A total of 100 patients (female: 94 and male: 6) were enrolled in the study, with a mean age of 53.5 years. Of 100 patients, 40 received anthracycline based chemotherapy, 45 received taxane based chemotherapy, 9 received both, and 6 received other chemotherapeutic agents. By the end of the study, 31 patients experienced grade 0-1 alopecia and 69 patients had grade 2 alopecia. On multivariate analysis, chemotherapeutic agent was found to be an independent factor for delaying the onset of Grade 2 alopecia (anthracycline vs taxanes (OR: 0.71; 95% CI (0.51-0.92); P ≤ 0.04)The most common adverse events reported during the scalp cooling sessions were chills (7%), and chills with headaches (6%). Scalp metastasis and scalp cooling discontinuation rates were observed to be very rare. No serious adverse events related to device were observed. CONCLUSION: Scalp cooling was observed to be more effective in reducing chemotherapy-induced alopecia in patients treated with taxane-based chemotherapy over anthracyclines. Scalp cooling sessions were well tolerated. Scalp metastasis and scalp cooling discontinuation was observed to be very rare.

Patterns of blood pressure changes in patients with head and neck cancer receiving radiotherapy or chemo-radiotherapy at a tertiary cancer centre.

BACKGROUND: To evaluate patterns of blood pressure (BP) changes in patients with head and neck cancer (HNC) receiving radiation (RT)/chemo-radiation (CRT) METHODS: This study included data collection, compilation, and analysis of 451 consecutive HNC patients who underwent RT/CRT. RESULTS: Out of 451 patients, 376 (82%) were male and 75 (18%) were female with a median age of 52 years. Patients receiving 3DCRT experienced greater fall in BP, including for SBP and MAP, compared to those receiving IMRT-IGRT. Female patients experienced greater fall in diastolic BP as compared to male patients (p: 0.03). At the end of treatment, we observed a significant association between a fall in systolic BP (decrease by 10% of baseline) and weight loss of more than 10% of baseline weight (p: 0.03). CONCLUSION: Fall in BP during RT/CRT is significantly affected by treatment technique and sex and is strongly associated with significant weight loss.

Evaluation of outcomes in patients of cervical Cancer with lower one third vaginal involvement: A single institutional experience.

OBJECTIVE(S): The objective of this study was to evaluate the clinical outcomes and prognostic factors affecting survival of cervical cancer patients presenting with lower third vaginal involvement. MATERIALS/METHODS: The patients with histologically proven invasive cervical cancer with clinical FIGO-2009 stage IIIA and IIIB with lower one-third vaginal involvement, treated with radio (chemo) therapy between 2010 and 2016 at our institution were retrospectively analyzed. RESULTS: There were 118 cervical cancer patients with lower third vaginal involvement with median age of 56.5 years (Range: 33-77 years). Forty-five patients were of FIGO stage IIIA, 73 patients staged as stage IIIB at diagnosis with predominant squamous histology. At a median follow up of 30 months, 12 patients (10.1%) developed local vaginal recurrences and 4 patients (3.3%) had developed loco regional recurrences, 27 patients (23%) developed distant and 2 patients developed loco-regional and distant relapses. The 3- year DFS and OS rates were 61.5% and 69.8% respectively. The 3-year DFS and OS of patients with IIIA was significantly better than IIIB patients (71% vs 56%, p: 0.02 and 76% vs 66%, p: 0.01 respectively) on univariate analysis. Concurrent chemotherapy and absence of persistent disease emerged as independent predictors of survival on multi-variate analysis. CONCLUSION: The outcome of patients with FIGO IIIA is better than IIIB with lower vaginal involvement. Elderly patients, patients not receiving concomitant chemotherapy and presence of residual disease at BT are associated with poorer outcomes.

Predictors of Weight Loss in Patients With Head and Neck Cancer Receiving Radiation or Concurrent Chemoradiation Treated at a Tertiary Cancer Center.

BACKGROUND: Radiation therapy (RT) has remained the mainstay treatment approach for head and neck cancers. Weight loss due to tumor or tumor-related factors remains a major health issue among head and neck cancer patients. METHODS: A total of 357 patients were identified for the study. Possible weight-loss predictors were determined in the patients undergoing RT based on the patient demographics, tumor site, and treatment characteristics. RESULTS: The mean age of patients was 52 years, whereas the median age was 51 years (range, 18-87). Two hundred and thirteen (66%) patients had oral cavity cancers, 43 (14%) had oropharyngeal cancer, 26 (8%) had hypopharyngeal cancer, 13 (6%) had larynx cancer, and 19 (6%) had other site involvement. A total of 192 patients received 3-dimensional conformal radiation therapy (3DCRT), whereas 127 patients received intensity modulated radiation therapy-image guided radiation therapy (IMRT-IGRT), 212 (66%) received concurrent chemotherapy, and 107 (34%) patients did not receive concurrent chemotherapy. A total of 127 (40%) of the patients gained weight during the first week of RT; on the other hand, maximum weight loss among patients was occurred during the third and fourth weeks of RT. CONCLUSION: Analysis by logistic regression determined there is significant weight loss (>10%) in patients receiving radical RT as compared with adjuvant RT. Better outcomes were observed in patients receiving RT by IMRT-IGRT technique as compared with 3DCRT technique.

Prevalence of Molecular Subtypes of Breast Cancer: A Single Institutional Experience of 2062 Patients.

OBJECTIVE: The aim of the study was to analyze the prevalence of molecular subtypes of all breast cancer patients treated at tertiary cancer centre in West India in 12 years. MATERIALS AND METHODS: A retrospective observational study carried out in Tertiary Cancer Care Centre in Western India. Electronic medical records of all breast cancer patients were retrieved from the hospital database between March 2007 to March 2019. Patient's characteristic, histological features and molecular subtypes were collected and analyzed. RESULTS: A total of 2062 women fulfilled the criteria for this study and were analyzed. The median age of study population was 51 years (range 22-100 years). Among these, 1357 (65.8%) were of ≤55 years and 705 (34.2%) were over 55 years. The overall incidence of Hormonal Receptor-positive patients (either estrogen-receptor (ER) or progesterone-receptor (PR) or both) was 1162 (56.4%). The Mean tumor size was 3.8cm (range 0-18cm). The most common histology was IDC (96%). Axillary nodes were positive in 62.5%. Luminal type A was positive in 762 (37%) patients while Luminal type B was present in 157 (7.6%) patients. Basal-like subtype was observed in 537 (26%) patients while HER2 rich subtype was seen in 229 (11.1%). The incidence of Luminal A subtype increased with age. The highest observed among patients (72%) aged 70 years or more. Incidence of Basal like subtype was highest in patients less than 30 years (52%). CONCLUSION: Luminal-like disease is the most common molecular subtype in India. Identification of Basal like breast cancer, a highly aggressive, biologically and clinically distinct subtype different than its non-basal variant, is important for treatment planning and target therapy.