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.

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.

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.

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.

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.

Encyclopedic tumor analysis for guiding treatment of advanced, broadly refractory cancers: results from the RESILIENT trial.

RESILIENT (CTRI/2018/02/011808) was a single arm, open label, phase II/III study to test if label agnostic therapy regimens guided by Encyclopedic Tumor Analysis (ETA) can offer meaningful clinical benefit for patients with relapsed refractory metastatic (r/r-m) malignancies. Patients with advanced refractory solid organ malignancies where disease had progressed following ≥2 lines of systemic treatments were enrolled in the trial. Patients received personalized treatment recommendations based on integrational comprehensive analysis of freshly biopsied tumor tissue and blood. The primary end points were Objective Response Rate (ORR), Progression Free Survival (PFS) and Quality of Life (QoL). Objective Response (Complete Response + Partial Response) was observed in 54 of 126 patients evaluable per protocol (ORR = 42.9%; 95% CI: 34.3%-51.4%, p < 0.0001). At study completion, Disease Control (Complete Response + Partial Response + Stable Disease) was observed in 114 out of 126 patients evaluable per protocol (CBR = 90.5%; 95% CI: 83.9% - 95.0%, p < 0.00001) and Disease Progression in 12 patients. Median duration of follow-up was 138 days (range 31 to 379). Median PFS at study termination was 134 days (range 31 to 379). PFS rate at 90 days and 180 days were 93.9% and 82.5% respectively. The study demonstrated that tumors have latent vulnerabilities that can be identified via integrational multi-analyte investigations such as ETA. This approach identified viable treatment options that could yield meaningful clinical benefit in this cohort of patients with advanced refractory cancers.

Objective assessment of swallowing function after definitive concurrent (chemo)radiotherapy in patients with head and neck cancer.

The aim of this study was to objectively assess swallowing function and factors impacting it after curative intent definitive (chemo)radiotherapy (CRT) for head and neck squamous cell carcinoma (HNSCC). Swallowing function was studied in a cohort of 47 patients with locoregionally advanced (T1-4, N0-3) HNSCC treated with definitive CRT. Objective assessment of swallowing function was done using modified barium swallow (MBS) at baseline (pre-CRT) and subsequent follow-ups. Scoring of MBS was done using penetration-aspiration scale (PAS). Abnormal swallowing was defined in terms of incidence and severity of penetration-aspiration, pharyngeal residue, postural change, and regurgitation. Aspiration, residual, postural change, and regurgitation were present on baseline pre-CRT assessment in 9 (19%), 11 (23%), 10 (21%), and 5 (10%) patients that increased to 11 (29%), 11 (29%), 12 (32%), and 10 (26%) patients, respectively, at 6-month post-CRT evaluation. The proportion of patients with high PAS scores (3-7) increased from 27% at baseline to 37% at 6-month post-CRT evaluation. Among patients (n = 34) with low PAS scores (≤2) at baseline, additional impairment of swallowing function was seen in 53 and 46% at 2- and 6-month assessment, respectively. Residue (44%) and aspiration (18%) domains were impaired in a higher proportion of patients after CRT. Thin and thick barium had higher aspiration and residue function impairment, respectively. Patients with pre-CRT poor subjective swallowing function (P = 0.004), hypopharyngeal primary (P = 0.05), and large tumor volume (P = 0.05) had significantly worse objective swallowing function at baseline as demonstrated by pretreatment PAS scores. This study provides useful information regarding patterns of objective swallowing dysfunction in patients treated with definitive (chemo)radiotherapy. There is significant impairment of objective swallowing function in all domains following CRT, with residue and aspiration domains being affected most significantly.

Prospective subjective evaluation of swallowing function and dietary pattern in head and neck cancers treated with concomitant chemo-radiation.

AIM: Prospective subjective evaluation of swallowing function and dietary pattern in locally advanced head and neck cancer patients treated with concomitant chemo-radiotherapy (CRT). MATERIALS AND METHODS: Prospective evaluation of swallowing function with performance status scale for head and neck cancer patients (PSSHN) at pre-CRT, CRT completion and at subsequent follow-ups in adult with loco-regionally advanced head and neck squamous cell carcinoma (HNSCC) patients. RESULTS: In 47 patients (40 male, seven females; mean age 53; 72% smoker 53%, oropharyngeal cancer), the mean total PSSHN score at pre-CRT was 258.5 and decreased to 225.2 and 219.2 at two and six months respectively. Understandability of speech, normalcy in diet and eating in public at pre-CRT and six months were 91.5 and 84.4; 80.4 and 63.1; 87.3 and 76.6 respectively. In univariate analysis, pre-CRT PSSHN scores were significantly lesser in patients with severe pre-CRT dysphagia (P = 0.001), hypopharyngeal cancer (P = 0.244) and advanced T-stage (T3/4) disease (P = 0.144). At CRT completion, there was significant reduction of PSSHN scores in patients with severe pre-CRT dysphagia (P = 0.008), post-CRT weight loss (>10%) and disease progression (P = 0.039). At two months and six months, 17 (57%) and 11 (73.5%) patients respectively showed change in dietary habit. Mean increase in meal time was 13% and 21% at two and six-month follow-up. CONCLUSIONS: HNSCC patients show deterioration in swallowing function after CRT with normalcy of diet in maximum and eating in public least affected. Pre-CRT severity of dysphagia, weight loss> 10% and disease progression have significant correlation with higher swallowing function deterioration after CRT.