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.

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.

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.

A Retrospective Analysis of Invasive Fungal Diseases (IFD) of the Central Nervous System in Children With Lymphoid Malignancies.

BACKGROUND: Outcomes of childhood hematolymphoid malignancies have improved several fold because of immunosuppressive chemotherapy and broad-spectrum antibiotics for managing febrile neutropenia. An apparent trade-off has been an increase in invasive fungal disease (IFD), affecting multiple organs. We report the diagnostic and therapeutic challenges in 8 children with lymphoid cancers who developed intracranial (IC) fungal abscesses between 2010 and 2017. METHODS: Children below 15 years of age undergoing treatment for leukemia/lymphoma with clinicoradiologic and microbiologic evidence of IC fungal abscess were included. Demographic details, clinical profile, and management were retrospectively audited. Treatment was guided by European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions for IFD with therapeutic drug monitoring (TDM)-directed azole dosing, and surgical intervention. RESULTS: Eight patients (4 B-cell acute lymphoblastic leukemia, 2 relapsed B-cell acute lymphoblastic leukemia, and 2 non-Hodgkin lymphoma) were eligible for analysis. Proven, probable, and possible IFDs were seen in 2 (25%), 4 (50%), and 2 (25%) patients, respectively. Proven IFDs were invasive mucormycosis with remaining having mold infections. Cerebrospinal fluid galactomannan was positive in all 4 patients in whom it was tested. TDM was possible in 5/8 (63%) patients. Antifungal therapy was given for a median period of 4.2 months with 5 (63%) patients having complete resolution. Three (37%) patients expired, of which 2 were attributable to IFDs. CONCLUSIONS: IC fungal abscesses in children can cause significant morbidity and mortality in children with hematolymphoid cancers. Evaluation of cerebrospinal fluid galactomannan may help in early diagnosis and therapy. Prolonged antifungal therapy steered by TDM can help achieve resolution in some cases.

Outcome of uncommon EGFR mutation positive newly diagnosed advanced non-small cell lung cancer patients: a single center retrospective analysis.

BACKGROUND: The significance of uncommon EGFR mutations in newly diagnosed advanced non-small-cell lung cancer (NSCLC) patients is incompletely known. We aimed to analyze the demographic profile, outcome, and treatment attributes of these patients. PATIENTS AND METHODS: We retrospectively surveyed 5,738 advanced NSCLC patients who underwent EGFR testing in our center from 2013 to 2017 by in-house primer probes on real time PCR platform. Descriptive data were accumulated from electronic medical records. Survival plot was calculated using Kaplan-Meier method and compared between groups using log-rank test. RESULTS: Out of 1,260 EGFR mutation-positive patients, 83 (6.58%) had uncommon mutations in isolation or in various combinations. Uncommon mutations were more frequent in men, never-smokers, and adenocarcinomas. Overall, exon 18 G719X, exon 20 insertion, exon 20 T790M, exon 20 S768I, and exon 21 (L858R/L861Q) were present in 9.6%, 19.3%, 12%, 3.6%, and 3.6% patients, respectively. Dual mutation positivity was found in 50.6% patients. On classifying patients as per tyrosine kinase inhibitor (TKI) sensitivity, it was found that majority of the patients had a combination TKI sensitive and insensitive mutations. The median duration of follow-up was 13 months. Five patients were lost to follow-up. Median progression-free survival on first line therapy was 6.7 months (95% CI: 4.8-8.5). Median overall survival (OS) of patients who received TKI during the course of their disease was 20.2 months (95% CI: 11.4-28.9). Median overall survival (mOS) of the entire cohort was 15.8 months (95% CI: 10.1-21.5). Among all uncommon mutations, patients with dual mutations did better, with an mOS time of 22.6 months (95% CI: 8.2-37.0, P=0.005). It was observed that TKI sensitive/TKI insensitive dual mutations had a superior OS of 28.2 months (95% CI: 15.2-41.2, P=0.039) as compared to TKI sensitive and TKI insensitive EGFR mutations. CONCLUSION: Uncommon EGFR mutations constitute a heterogeneous group, hence, it is imperative to understand each subgroup more to define optimal treatment.

Thromboembolic events in patients with advanced stage non-small cell lung cancer treated with platinum-based chemotherapy: a prospective observational study.

OBJECTIVES: Cancer is frequently complicated by thromboembolic events (TEs). We aimed to determine the incidence of TEs in lung cancer patients treated with platinum-based chemotherapy and study patients' baseline and treatment attributes correlating with its onset. MATERIALS AND METHODS: Advanced lung cancer patients started on platinum-based chemotherapy were evaluated at baseline and during routine visits for the development of TEs. The duration of follow-up was 4 weeks from the last chemotherapy. A TE occurring between the first dose of chemotherapy and 4 weeks after the last dose was considered to be chemotherapy associated. RESULTS: Of the 165 patients on platinum chemotherapy who completed follow-up, TEs occurred in 4.8% (8 out of 165) patients. Among these, three patients had developed venous pulmonary thromboembolism and five patients had developed cerebral infarction, out of which four had arterial cerebral infarction and one patient had a superior sagittal sinus thrombosis. The majority of events (7 out of 8) occurred within 100 days of starting platinum chemotherapy. Overall, the median time until occurrence of TE was 48 days (range, 10-130 days). None of the presumed risk factors were found be associated with the occurrence of TEs on univariate analysis. CONCLUSIONS: Advanced lung cancer patients on platinum chemotherapy are predisposed to thromboembolism due to many factors. Despite its lower incidence in our study, exclusion of patients with prior thrombosis suggests the incidence of de novo thrombosis, and hence raises a valid question of the need of thromboprophylaxis in a selected group of patients.

Acute psychosis as a presentation of hypopituitarism.

Acute onset neuropsychiatric manifestations in hypopituitarism are uncommon. We report a case of a 60-year-old man who was a follow-up case of macroprolactinoma with hypopituitarism for the last 9 years. He was on medical treatment with cabergoline, thyroxine and depot testosterone. During the last 2 years he was non-adherent to medications especially cabergoline. He was hospitalised for 2 days through emergency services following acute onset psychosis. His pituitary hormone profile was suggestive of adrenal insufficiency, secondary hypothyroidism and hypogonadism. MRI of the hypothalamic pituitary region revealed a pituitary macroadenoma which was larger in size compared to the previous scan. Further, this lesion was compressing on the adjoining structures including optic chiasma. The patient was treated with intravenous fluids, hydrocortisone and thyroxine replacement therapy. With this treatment he completely recovered from psychosis within 48 h.