Psychometric analysis of Marathi version of an updated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N43).

BACKGROUND: The aim of this study was to perform a psychometric analysis of the Marathi version of an updated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N43) in patients of head and neck squamous cell carcinoma (HNSCC). MATERIAL AND METHODS: After an institutional ethics committee approval and linguistic validation, the Marathi version of EORTC QLQ-H&N43 was served to consecutive eligible, Marathi-speaking HNSCC patients of oral cavity, oropharynx, hypopharynx and larynx, registered from August 2019 to March 2021 and who consented to the study. Performance status scale was used for perceptive assessment of organ function. Psychometric analysis was performed using SYSTAT v. 12 (Cranes software, Bengaluru). RESULTS: A total of 129 patients participated in the study with a median age of 67 years and the man-to-woman ratio of 100:29. The commonest sub-site reported was the oral cavity (61.24%) and the majority were in stage IV disease (69.76%). Ninety patients completed the questionnaire before being started on active oncology treatment at our center. 39 patients completed the questionnaire at pre-treatment and first follow-up. The questionnaire was filled on their own (module) by 32.55% of patients while 67.44% of patients required some kind of assistance (schedule). Internal consistency was moderate to high. The criterion and construct validities were acceptable. The questionnaire was sensitive to change with stage and time. No significant difference was observed in module versus schedule subgroup except for 2 out of 19 item-scales. CONCLUSION: Marathi translation of EORTC QLQ-H&N43 is a sensitive, reliable and valid tool when applied to patients of HNSCC. It can be considered as a schedule.

Pretreatment hematological parameters as predictors of tumor granulocyte-colony-stimulating factor expression in patients of head-and-neck squamous cell carcinoma.

Background: Tumor secreting granulocyte-colony-stimulating factor (G-CSF) and/or G-CSF therapy has been documented as a poor prognostic factor. Tumor G-CSF study is a relatively costly and sparsely available investigation. Therefore, this study was undertaken to predict tumor G-CSF score from pretreatment hematological parameters (PTHP) in patients of head-and-neck squamous cell carcinoma (HNSCC). Materials and Methods: This pilot study was performed after institutional ethics committee approval. Consecutive nonmetastatic HNSCC patients of oral cavity, oropharynx, hypopharynx, and larynx registered from February to December 2019 were analyzed. Patients whose PTHP and formalin-fixed-paraffin-embedded tissue were available, were included. PTHP (absolute neutrophil count [ANC], absolute monocyte count [AMC], absolute lymphocyte count [ALC], neutrophil-to-lymphocyte ratio [NLR], and platelet-to-lymphocyte ratio [PLR]) done before any active oncology treatment, were noted. A semiquantitative tumor G-CSF score was calculated. Tumor G-CSF score and PTHP were correlated with clinicopathological factors. Statistical analysis was performed using SYSTAT version 12. Results: Data of 47 eligible patients were analyzed. The median age at presentation was 60 years. The male-to-female ratio was 43:4. The most common head-and-neck subsite was oropharynx (31.92%), and majority of patients presented with Stage IVA disease (51.1%). Higher tumor G-CSF score was significantly associated with a higher T-stage (P = 0.013). Tumor G-CSF score was directly proportional to ANC, AMC, and ALC while it was inversely proportional to NLR and PLR. Regression equations to predict the tumor G-CSF score when PTHP are known, were determined. Conclusions: PTHP can predict the tumor G-CSF score which may guide G-CSF-directed therapy. Future studies with large number of patients are needed to elucidate its clinical use.

Subjective and perceptive assessment of speech/voice and swallowing function before and after radiation therapy in patients of head-and-neck squamous cell cancer.

Aim: To prospectively assess subjective and perceptive speech/voice and swallowing function before and after radiation therapy (RT) in patients of head-and-neck squamous cell cancer (HNSCC). Materials and Methods: The study cohort comprised eligible consecutive HNSCC patients planned for curative RT from April 2018 to July 2018 who consented for the study. Prospective evaluation of speech/voice and swallowing function was done before and after RT. For subjective and perceptive evaluation of speech/voice, speech handicap index (SHI) and Grade, Roughness, Asthenia, Breathiness, and Strain (GRABS) Scale was used, respectively. For subjective and perceptive evaluation of swallowing, M D Anderson Dysphagia Inventory (MDADI) and Performance Status Scale for head and neck (PSSHN) were used, respectively. All patients were taught speech/voice and swallowing exercises before RT. Statistical analysis was performed using SYSTAT version-12 (Cranes software, Bengaluru). Results: The study cohort comprised 30 patients of HNSCC with a median age of 57 years and male-to-female ratio of 4:1. The most common subsite was the oral cavity (43.33%) and a majority (76.66%) presented in the locally advanced stage. Post-RT there was significant improvement in speech/voice function (SHI P = 0.0006, GRABS score P = 0.003). Perceptive assessment of swallowing function by PSSHN showed significant improvement (P = 0.0032), but subjective assessment by MDADI showed no significant (P = 0.394) improvement until the first follow-up. Conclusion: Speech/voice function improved significantly after radiotherapy when combined with rehabilitation exercises. Swallowing function did not improve till the first follow-up. Future studies with the large number of patients and long-term follow-up are needed to document the changes in organ function.

Serum 25-hydroxy vitamin-D levels in head and neck cancer chemoradiation therapy: Potential in cancer therapeutics.

Background: To evaluate the relation between serum-25-hydroxy Vitamin-D levels (S25OHVDL) and concurrent chemoradiation therapy (CTRT) toxicities in patients of head and neck squamous cell cancer (HNSCC). Methods: After an institutional ethics committee approval, consecutive HNSCC patients who received radical/adjuvant CTRT were prospectively evaluated. Patients were assessed for CTRT toxicities using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE-v5.0) and the response was evaluated according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST-1.1). S25OHVDL was assessed at the time of the first follow-up. Patients were divided into group A (Optimal) and group B (suboptimal) according to S25OHVDL. The treatment toxicities were correlated with S25OHVDL. Results: Twenty-eight patients were evaluated for the study. S25OHVDL was optimal in eight (28.57%) and suboptimal in 20 patients (71.42%). Mucositis and radiation dermatitis were significantly more in subgroup B (P-value 0.0011 and 0.0505, respectively). Relatively lower but nonsignificant hemoglobin and peripheral white blood cell counts were observed in subgroup B. Conclusion: Suboptimal S25OHVDL was associated with significantly more skin and mucosal toxicities in HNSCC patients treated with CTRT.

Association between depressive symptoms and socioeconomic status in head and neck cancer patients attending rural tertiary health care center.

AIM: To study the association between depressive symptoms and socio-economic status (SES) in patients with head and neck cancer (HNC). MATERIALS AND METHODS: Histopathology-proven non-metastatic and non-recurrent HNC patients attending radiation oncology services in February and June 2021 who consented to the study were evaluated with an interview. Hamilton Depression Rating Scale (HDRS) and modified BG Prasad classification were used to assess depressive symptoms and SES, respectively. Statistical analysis was done using SYSTAT version 12 (by Crane's software, Bangalore). RESULTS: The study cohort comprised 100 patients. The median age was 55 years (minimum: 28, maximum: 86) with a male-to-female ratio of 2.57:1. The majority of patients were educated beyond middle-school level (44%), of middle SES (47%), oral cavity subsite (68%), stage IVA (36%) disease, and were on treatment (79%). HDRS scores showed absent, moderate, and severe depressive symptoms in 21, 63, and 16 patients, respectively, that is, the prevalence of depressive symptoms was 79%. Lower socioeconomic strata showed a significantly higher prevalence of severe depressive symptoms (P-value = 0.01). HDRS score was significantly higher in females (P-value = 0.024) and in patients who were illiterate or were educated less than middle-school level (P-value = 0.010). No statistically significant difference was found between HDRS score and age of patient, stage and site of disease, and on treatment or follow-up status. CONCLUSION: Depressive symptoms are common in patients with head and neck cancer. Low socioeconomic status (SES), female gender, and education less than middle school are associated with severe depressive symptoms. Psycho-oncological and psychotherapeutic interventions are the need of the hour.

Oncology treatment outcome in human immunodeficiency virus-positive cancer cervix patients: Where we are and what we achieved?

Objective: To find out the epidemiological factors and oncology treatment outcome in human immunodeficiency virus-positive cancer cervix patients (HPCCP). Materials and Methods: After institutional ethics committee approval, hospital case records of HPCCP registered at the radiation oncology department from January 2011 to December 2018 were retrospectively studied. Results: The case records of 22 eligible HPCCP were studied. Median age at presentation was 42.5 years. 90.90% of the patients were below 55 years of age. The duration of symptom was <3 months in 63.64% of patients. 68.18% of the patients were FIGO Stage III. Only 11 patients completed the planned treatment. Total target equivalent dose of 2 Gy per fraction delivered was 66 Gy. Seven patients had complete response. Four patients had local recurrence. Median disease-free and overall survival was 27 (14-38) and 18 months (2-48), respectively. Conclusion: HPCCP present at relatively early age and advanced stage despite short symptom duration. Poor patient compliance and treatment alteration have led to suboptimal outcome.

Marathi Translation and Linguistic Validation of an Updated European Organization for Research and Treatment of Cancer Quality of Life Module for Head and Neck.

Aim This study was aimed to translate an updated European Organization for Research and Treatment of Cancer (EORTC) quality of life module for head and neck (EORTC QLQ-H&N43) in grammatically and conceptually acceptable Marathi language and its linguistic validation. Materials and Methods Approval was obtained from the Institutional Ethics Committee. The permission for translation was obtained from the EORTC translation unit (TU). The EORTC guidelines for the translation were followed to form a translation for pilot testing which was administered to 10 Marathi speaking head and neck squamous cell cancer (HNSCC) patients who gave informed written consent for the participation in the study. Patients were interviewed personally. The final Marathi translation was prepared and sent to EORTC TU for approval. Statistical analysis was performed using SYSTAT version 12 by Cranes software, Bengaluru, Karnataka, India. Results After getting permission, the translation files were received from EORTC TU, including Marathi EORTC QLQ-H&N35 for reference. Two forward translations, reconciled translation, back translations, first interim translation, translation for proof editing, and second interim translation (SIT) were prepared. This SIT was pilot tested in 10 Marathi-speaking HNSCC patients. Each patient was interviewed regarding difficulty in answering, confusing or offensive word, and reframing sentence. The questionnaire was well understood by patients reflecting its linguistic validity. After incorporating the changes as per the patient's interview, updated translation was prepared and sent to EORTC TU which was accepted and approved by EORTC. The psychometric analysis of pilot testing showed that the questionnaire is acceptable. Conclusion Marathi translation of EORTC QLQ-H&N43 is well accepted and understandable. It can be used for future studies.

A prospective cross-sectional study of fetal middle cerebral artery peak systolic velocity in a normal obstetric population attending an Indian Medical College.

PURPOSE: Fetal middle cerebral artery peak systolic velocity (MCA-PSV) is now an established method of noninvasive diagnosis of moderate to severe fetal anemia of different origins. This being a population-based parameter, it may have different values in individuals from different locations. A standard local reference range of normal individuals specific to each geographic locality is therefore needed. MATERIALS AND METHODS: Fetal MCA-PSV was measured in 1,015 healthy pregnant women attending the antenatal ultrasound clinic at least once between 12 and 40 weeks of gestation (35 patients per week of gestation). Statistical analysis was done using the SPSS 12 software. RESULTS: A positive correlation between MCA-PSV and gestational age was found. MCA-PSV was seen to increase with advancing gestational age. The Tukey-Kramer multiple comparisons test showed a normal distribution that was highly significant (p < 0.01). The multiples of median values of fetal MCA-PSV to label a fetus as severely anemic were consistently and significantly lower than internationally accepted values. CONCLUSIONS: A normal reference range of fetal MCA-PSV for local use was thus scientifically and successfully constructed. Significant differences between local values and internationally accepted value were found.