Tag: statistics

J Cancer Res Ther. 2021 Jan-Mar;17(1):204-210. doi: 10.4103/jcrt.JCRT_177_19.

ABSTRACT

OBJECTIVES: The primary objective of this study was to compare the treatment response of cervical carcinoma patients infected with human papillomavirus (HPV) 16 and HPV 18 who are treated with chemoradiation.

MATERIALS AND METHODS: Ninety-six biopsy-proven cervical cancer patients, suitable for curative treatment with definitive radio-chemotherapy with International Federation of Gynecology and Obstetrics Stage IB2-IIIB, were included in this prospective study. HPV testing was done using TRUPCR^® HPV 16 and 18 real-time polymerase chain reaction kit. All the patients received a dose of 83-90 Gy total equieffective dose to the high risk clinical target volume(HRCTV) using tele- and brachytherapy.

RESULTS: Of the 96 patients, 79 (82.3%) patients were positive for HPV DNA. Seventy-three patients showed HPV genotype 16 positivity and six patients were positive for genotype 18. The response was correlated with HPV genotype. There was a statistically significant increase in complete radiological response in HPV 16 compared to HPV 18 and negative groups at 3 months, 80.8%, 50%, and 52.9%, respectively (χ² = 36.5, P < 0.001). There was also a statistically significant increase in clinical response at 3 months in HPV 16 group compared to HPV 18 and negative groups, 87.5%, 50%, and 50%, respectively (χ² = 29.9, P < 0.001). The age, volume of the disease, overall treatment time, average hemoglobin level, and the number of blood transfusions did not have any correlation.

CONCLUSION: HPV genotype 16 positivity shows higher complete response in cervical carcinoma patients treated with definitive chemoradiation compared to HPV 18 genotype. Further HPV genotyping could potentially help stratify cervical cancer patients for more effective therapeutic regimens.

PMID:33723156 | DOI:10.4103/jcrt.JCRT_177_19

J Cancer Res Ther. 2021 Jan-Mar;17(1):218-224. doi: 10.4103/jcrt.JCRT_277_19.

ABSTRACT

OBJECTIVE: This cross-sectional, quantitative epidemiological study was aimed at finding the prevalence of depression in cancer patients and correlation of anxiety and depression with various factors such as age, sex, and type of malignancy while coming for treatment to the radiotherapy department of a tertiary cancer hospital, at the onset, midway, and at the end of radiotherapy treatment using the Hospital Anxiety and Depression Scale (HADS).

MATERIALS AND METHODS: A total of 100 consecutive cancer patients referred for definitive radiotherapy were included. All patients were administered the HADS. The percentage of respondents with anxiety increased significantly after initiating RT and maximum scores were recorded at the end of treatment. The association between anxiety scores and various factors such as age, site, and sex during various phases of RT was found using Chi-square test.

RESULTS: At the beginning of Radiotherapy (RT), 61% of our patients reported abnormal scores while this percentage increased to almost 89% at the end of treatment, the comparison between the scores at the beginning and at the end reach a statistical significance (P < 0.0005) while the comparison between the scores at the start and midway led to (P < 0.011). According to the subsite, maximum prevalence of anxiety and depression was seen in patients having head and neck malignancies while older age again was a significant factor leading to the symptoms of anxiety and depression.

CONCLUSION: The diagnosis of cancer carries with it a significant amount of psychological morbidity, both subjectively experienced and objectively observed. Cancer treatments such as chemotherapy and radiotherapy further aggravate anxiety by becoming additional stressors.

PMID:33723158 | DOI:10.4103/jcrt.JCRT_277_19

J Cancer Res Ther. 2021 Jan-Mar;17(1):114-121. doi: 10.4103/jcrt.JCRT_910_20.

ABSTRACT

BACKGROUND: This study is an overall clinical analysis of anti-programmed cell death 1 (PD1) antibodies used in a single institution, emphasizing the role of baseline peripheral blood markers as a prognostic or predictor biomarker of immunotherapy.

METHODS: Sixty-one patients were retrospectively analyzed from hospital medical records. The endpoint of this study was death from any cause and the survival time was calculated from the date of start of immunotherapy to the date of death. Descriptive and survival statistics was performed using SPSS version 23. Cutoff values for baseline biomarkers (neutrophil-to-lymphocyte ratio [NLR], platelet-to-lymphocyte ratio [PLR], neutrophil-to-eosinophil ratio [NER], and lymphocyte-to-monocyte ratio [LMR]) were obtained using cutp function of Evaluate Cutpoints software (R survMisc package). Pearson and Pearman correlation coefficients were used to examine the relationship of peripheral blood biomarkers.

RESULTS: Nighty-eight percent of the study population had Stage IV disease and total median overall survival postanti-PD1 therapy was 10.7 months. Patients receiving more than 5 doses of anti-PD1 therapy (12.6 m vs. 4.4 m, P < 0.001) and used in front lines (18.9 m vs. 10.7 m vs. 10.1 m vs. 2.8 m in first line, second line, third line, and >3 lines, respectively, P = 0.049) were found to have an impact in overall survival. Pembrolizumab showed a better survival compared to nivolumab (17.4 m vs. 8.2 m, P = 0.049) in our study. Among baseline biomarkers assessed, NLR (cutoff – 2.81, P = 0.003) and LMR (cutoff – 5.76, P = 0.017) has shown a statistically significant relationship with immunotherapy response. NER (cutoff – 24.32, P = 0.051) and PLR (cutoff – 190.8, P = 0.072) were also found to exhibit a strong relationship with anti-PD1 therapy response. NLR exhibits a statistically significant positive correlation with PLR (r = 0.917 P < 0.001) and NER (r = 0.400 P = 0.014).

CONCLUSION: Real-life data analysis of anti-PD1 use for solid cancers highlights that baseline NLR, PLR, NER, and LMR have a significant role as immunotherapy biomarkers. However, larger studies are required to further prove the specificity and sensitivity.

PMID:33723141 | DOI:10.4103/jcrt.JCRT_910_20

J Cancer Res Ther. 2021 Jan-Mar;17(1):136-141. doi: 10.4103/jcrt.JCRT_612_18.

ABSTRACT

BACKGROUND: Herbal supplements (HS) are one of the most commonly used complementary and alternative medicines in cancer. Reduced therapeutic efficacy of prescription anticancer agents through unwarranted herb-drug interactions is a major efficacy/safety concern. In view of the rising cancer prevalence in India along with a high degree of reliance and cultural acceptability in favor of traditional medicine drugs, prevalence data exclusively of HS usage during cancer treatment are of considerable epidemiological significance.

METHODOLOGY: This questionnaire-based prospective observational study aimed at estimating the prevalence of HS among cancer patients during treatment at our tertiary care medical center. Taken on a population of 220 patients within a period of 9 months, data were generated by a customized validated questionnaire and the same processed by IBM SPSS Statistics for Windows, version XXIV, Armonk, NY: IBM Corp. Differences between HS use and nonuse with respect to demographic, disease, and treatment characteristics were assessed by Chi-square test. For examining the latter variables as possible predictors of HS usage, they were entered into bivariate logistic regression with odds ratio and confidence intervals calculated for each.

RESULTS: Out of 220 patients, 57 (26%) were HS users and 163 (74%) were nonusers. Majority of the users (42.1%) were on self-prepared folklore herbal medicine postdiagnosis of cancer (57.9%), the most common reason cited being symptom palliation (35.1%) on the advice of friends and family (64.9%). Fear of disapproval was the most common reason cited (68.4%) for not disclosing HS usage to the physician.

CONCLUSION: Chemotherapy and unemployment are predictors of HS usage, and there is a significant association between occupation status and HS usage. This first study on HS prevalence among South Indian population proposes the need for a more robust evidence base for understanding all aspects of HS use in cancer.

PMID:33723144 | DOI:10.4103/jcrt.JCRT_612_18

J Cancer Res Ther. 2021 Jan-Mar;17(1):174-179. doi: 10.4103/jcrt.JCRT_817_19.

ABSTRACT

CONTEXT: Sigmoid colon, due to its close proximity to central tandem in intracavitary brachytherapy (BT), is at risk of receiving high dose, the clinical significance of which is not documented.

AIM: This study was designed to assess the dose received by sigmoid colon following radical treatment and to correlate clinically with the sigmoid mucosal changes seen on sigmoidoscopy.

SETTINGS AND DESIGN: This is a prospective study.

SUBJECTS AND METHODS: Thirty histologically proven carcinoma cervix patients treated with radical radiotherapy were accrued. A baseline sigmoidoscopy was done and repeated at 6 months following completion of BT. The dose-volume parameters (DVP) were used to calculate the dose received by the sigmoid colon and correlate with symptoms along with the sigmoid mucosal changes.

STATISTICS: The following were the statistical methods used: frequency; percentages; and descriptive statistics such as mean ± standard deviation, Chi-square test, Kolmogorov-Smirnov test, and independent sample t-test. P < 0.05 was considered statistically significant.

RESULTS: The dose of the sigmoid colon in patients with a sigmoidoscopy score of ≥2 was significantly high compared to that of patients with a score of <2 for DVP such as D0.1cc, D1cc, D2cc, D5cc, and mean dose, whereas max dose was not significantly high.

CONCLUSIONS: The dose received by the sigmoid colon is directly proportional to the mucosal changes and hence possibly a higher morbidity. Tighter dose-volume constraints, better optimization techniques, and close follow-up sigmoidoscopy will help in the prevention and early treatment of long-term morbidity.

PMID:33723151 | DOI:10.4103/jcrt.JCRT_817_19

J Cancer Res Ther. 2021 Jan-Mar;17(1):186-190. doi: 10.4103/jcrt.JCRT_9_19.

ABSTRACT

CONTEXT: Vulvar carcinoma accounts for 3%-5% of gynecologic malignancies. The past three decades has observed changes in the trends of clinical characteristics and treatment modalities used in managing this disease.

AIMS: The aim of the present study is to analyze the clinic-pathological characteristics and survival of women with squamous cell carcinoma vulva who underwent primary surgical management.

SETTINGS AND DESIGN: This was a retrospective observational study.

SUBJECTS AND METHODS: Case records of 30 consecutive patients with squamous cell carcinoma of vulva during the period of 2010-2016 were retrospectively reviewed and their clinical profile, treatment details, complications, and survival were analyzed.

STATISTICAL ANALYSIS USED: Kaplan-Meier survival analysis, followed by logrank test, was used for survival outcome, and Cox proportional hazard model was used to assess significant risk factors.

RESULTS: The mean age of patients was 58 ± 12.9 years. The most common symptom was growth over vulva (73.3%), itching (63.3%), and nonhealing vulval ulcer (26.6%). The most common site for disease was labia majora. The surgical treatments ranged from wide local excision to radical vulvectomy. Postoperative adjuvant therapy was required for 16 patients. The median (95% confidence interval [CI]) overall survival was 27 (21.7-32.2) months. Five-year survival probability for early-stage disease (I + II) was 49% (95% CI: 12.9, 78.4) and for advanced disease (III + IV) was 24.8% (95% CI: 4.8, 42.6). Lymph node-positive status was found to have a significant impact on survival (hazard ratio of 4.9 [95% CI: 1.15-21.02, P = 0.02]).

CONCLUSIONS: Despite advances in detection and management modalities, the survival for vulval malignancies has not improved.

PMID:33723153 | DOI:10.4103/jcrt.JCRT_9_19

J Cancer Res Ther. 2021 Jan-Mar;17(1):69-74. doi: 10.4103/jcrt.JCRT_217_19.

ABSTRACT

BACKGROUND: Malignant pleural mesothelioma (MPM) is a pleural tumor with high mortality rate and short-term survival expectancy after diagnosis. Assessment of the response to chemotherapy, which is the first choice in treatment of MPM, is important for the transition to alternative chemotherapy protocols and immunotherapy. There is no clarity in the response to chemotherapy treatment.

OBJECTIVE: Our study aims to compare the assessment of chemotherapy response using the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria and volumetric measurements and to correlate with median survival.

MATERIALS AND METHODS: Thirty-two patients (16 females and 16 males) were included in the study, and their ages ranged from 28 to 78 years. Chemotherapy response was determined by both mRECIST and volumetric approach. Tumor volume was measured by linear interpolation and semi-automatic segmentation. Log-rank multiple cutoff analysis was used to determine appropriate cutoff values of volumetric response criteria.

RESULTS: According to both mRECIST and volumetric approach, median survival times in partial response, stable disease, and progressive disease groups were 24, 15, and 9 months, respectively. The survival times of the three groups were different (logrank: 17.76; P < 0.001) by mRECIST. The survival of the progressive disease group was shorter than that of the other groups (logrank: 18.91; P < 0.001) by volumetric approach.

CONCLUSIONS: In the assessment of chemotherapy response, even though classifications obtained according to the mRECIST criteria and volumetric measurements are statistically compatible, we think that the measurement of the volumetric values will increase the standardization. In our study, threshold values for volumetric measurements were determined; however, these values should be supported by large-scale multicenter studies.

PMID:33723135 | DOI:10.4103/jcrt.JCRT_217_19

J Cancer Res Ther. 2021 Jan-Mar;17(1):99-105. doi: 10.4103/jcrt.JCRT_32_19.

ABSTRACT

CONTEXT: Radiotherapy may have side effects on the brain, such as radiation necrosis, cognitive impairment, and a high chance of tumor recurrence, which has been considered the most common cause of treatment failure.

AIMS: Using intensity-modulated radiotherapy (IMRT) and volumetric-modulated arc therapy (VMAT) techniques, we aimed to test the potential outcome of sparing the contralateral hippocampus (CLH) in radiotherapy for brain tumors by comparing dosimetric parameters.

SETTINGS AND DESIGN: A prospective clinical comparative study.

SUBJECTS AND METHODS: Using IMRT and VMAT, sparing CLH in radiotherapy of brain tumors was tested in ten patients, and various dosimetric parameters were compared. The treatment plans were accepted only if they met the set of planning objectives defined in the protocol.

RESULTS: The dose delivered to 95% of the CLH volume (CLH D95), and the mean (CLH Dmean) and max (CLH Dmax) doses were found to be significantly highest in the standard IMRT (P = 0.002, <0.001, and < 0.001, respectively). The lowest CLH D95, CLH Dmean and CLH Dmax for the hippocampus were detected in sparing VMAT planning than in the other plans (P < 0.05). None of the post hoc comparisons for CLH D95 was different among any of the plans, whereas the mean dose to CLH was statistically different among all paired comparisons (P < 0.008). The maximum dose to CLH was also statistically different among all paired plans (P < 0.008), except the dose difference between standard VMAT and IMRT plans.

CONCLUSIONS: Although VMAT planning is troublesome and time-consuming, the advantage of sparing the hippocampus is beneficial, preserving the hippocampus and cognitive functions during radiotherapy.

PMID:33723139 | DOI:10.4103/jcrt.JCRT_32_19

J Cancer Res Ther. 2021 Jan-Mar;17(1):106-113. doi: 10.4103/jcrt.JCRT_854_19.

ABSTRACT

CONTEXT: Malignant peripheral nerve sheath tumor (MPNST) is a rare and aggressive soft-tissue sarcoma.

AIMS: The aim of this study was to analyze various prognostic factors and treatment outcome of patients with MPNST.

SETTINGS AND DESIGN: This was a retrospective study.

SUBJECTS AND METHODS: Ninety-two patients, who presented with MPNST at a tertiary care cancer center from 2011 to 2018, were included in this study. The median follow-up of all living patients was 33 months. Neurofibromatosis 1 (NF1) was seen in 12 (13%) patients. Sixty (65.2%) patients received curative-intent treatment.

STATISTICAL ANALYSIS USED: Kaplan-Meier method was used for survival analysis. Log-rank test was used for univariate analysis, and multivariate analysis was done by Cox proportional hazard ratio method.

RESULTS: The 5-year overall survival (OS) of all patients was 47.2% and the 5-year disease-free survival (DFS) of operated patients was 41.5%. On univariate analysis, association with NF1 (P = 0.009), grade (P = 0.017), and margin status (P = 0.002) had a significant effect on DFS, whereas association with NF1 (P = 0.025), metastatic disease on presentation (P < 0.0001), palliative intent of treatment (P < 0.0001), grade (P = 0.049), and margin status (P = 0.036) had a significant effect on OS. On multivariate analysis for patients who were treated with curative-intent treatment, grade (P = 0.015), and margin status (P = 0.028) had a significant effect on DFS, whereas association with NF1 (P = 0.00026) and location of tumor (P = 0.040) had a significant effect on OS.

CONCLUSIONS: The presence of distant metastasis, palliative intent of treatment, association with NF1, location of the tumor in the head and neck, high tumor grade, and positive margin status were the risk factors associated with poor survival for the patients with MPNST. Wide local excision with negative resection margin is the highly recommended treatment.

PMID:33723140 | DOI:10.4103/jcrt.JCRT_854_19

Niger J Clin Pract. 2021 Mar;24(3):393-399. doi: 10.4103/njcp.njcp_280_18.

ABSTRACT

BACKGROUND: Self-efficacy is defined as the ability of an individual to perform an action successfully or her/his perception of being able to control events. The self-efficacy perception of diabetes management may affect well-being of the patient.

AIMS: This study aimed to examine the relationships between self-efficacy of diabetes management and well-being in patients with type 2 diabetes.

SUBJECTS AND METHODS: The study used a descriptive correlational design. Sample of the study included 200 patients with type 2 diabetes. Sociodemographic and disease-related questionnaire form “Self-Efficacy Scale for Diabetes Management” and “Well-Being Questionnaire” have been used as data collection tools. Multiple linear regression analysis was performed to explore the predictors of well-being in patients with type 2 diabetes.

RESULTS: Self-efficacy level, age, level of compliance with treatment, and state of doing exercise were found to be statistically significant predictors of well-being in type 2 diabetic patients. Self-efficacy level for diabetes management was found to be the strongest predictor of well-being in patients with type 2 diabetes.

CONCLUSION: Self-efficacy level of diabetes management is a factor that affects well-being in type 2 diabetes patients and it should be considered during interventions for improving the well-being of patients.

PMID:33723114 | DOI:10.4103/njcp.njcp_280_18