Category: Statistics

Indian J Cancer. 2021 Jul 16. doi: 10.4103/ijc.IJC_741_18. Online ahead of print.

ABSTRACT

BACKGROUND: Following a diagnosis of cancer, distress is a common reaction. For Iranian women with endometrial cancer, treatment and survivorship can result in disabling symptoms of depression, anxiety, social, and spiritual crises. The aim of this study was to determine whether a combination of education and support intervention as a comprehensive program focusing on education, coping, and support had better short- and long-term effects on anxiety of these patients.

METHODS: The current randomized clinical trial was performed on a sample of 140 women with endometrial cancer. A two-part instrument was used – a demographic information form and “Beck’s Anxiety” questionnaire. The intervention was an educational-supportive program in 3 weekly sessions in experimental group (N = 70), whereas control group (N = 70) received routine care. Descriptive statistics, Chi-square test, t-tests, and repeated measure analysis of variance were used to analyze data. P value less than 0.05 was considered as statistically significant.

RESULTS: The total scores of anxiety (mean± standard deviation) was significantly lower in the experimental group immediately after intervention (8.46 ± 5.17, P < 0.001), 1 month (7.78 ± 4.59, P < 0.001) and 2 months (7.55 ± 4.55, P < 0.001) after intervention to compare with before intervention (16.82 ± 10.19).

CONCLUSION: In this study, this program could decrease the anxiety in women with endometrial cancer.

PMID:34380854 | DOI:10.4103/ijc.IJC_741_18

Indian J Cancer. 2021 Jul 16. doi: 10.4103/ijc.IJC_765_19. Online ahead of print.

ABSTRACT

BACKGROUND: At present, the diagnosis and efficacy evaluation of acute leukemia (AL) are assessed by bone marrow aspiration, which is invasive and subject to sampling errors. Therefore, there is a pressing need to develop a noninvasive and accurate imaging method to evaluate bone marrow changes in patients with AL. This study aimed to compare the apparent diffusion coefficient (ADC) values obtained from fluid-attenuated inversion recovery diffusion-weighted imaging (FLAIR-DWI) and conventional DWI in the lumbar bone marrow of patients with AL and to investigate their performance for evaluating response to induction chemotherapy.

METHODS: A total of 28 patients with newly diagnosed AL and 25 patients with AL after induction chemotherapy underwent MRI scans at 1.5 Tesla using a conventional DWI and a FLAIR-DWI sequence on sagittal planes covering the lumbar bone marrow. Further, the ADC values from these two sequences, denoted as ADC_CON and ADC_FLAIR, were measured on multiple vertebrae. The percentage of leukemia cells in bone marrow was recorded, and bone marrow aspiration was performed on treated patients to determine complete remission (CR) and nonremission (NR).

RESULTS: ADC_FLAIR [(0.453 ± 0.103) × 10^-3 mm²/s] was significantly lower than ADC_CON [(0.486 ± 0.096) × 10^-3 mm²/s] in the 28 untreated patients (t = 3.051, P = 0.005). In the 25 treated patients, ADC_FLAIR and ADC_CON values [(0.566 ± 0.239) × 10^-3 mm²/s] and [(0.716 ± 0.235) × 10^-3 mm²/s], respectively, were higher compared with the untreated patients. The ADC_CON values showed a nonsignificant difference between the CR (n = 18) and NR (n = 7) groups (t = 1.409, P = 0.305). However, the ADC_FLAIR values exhibited statistically significant difference (t = 2.542, P = 0.018) between the two groups. In a receiver operator characteristic (ROC) analysis, the area under the curve (AUC) using ADC_FLAIR (0.770) was larger than that of ADC_CON (0.611) in distinguishing the CR and NR patients following the chemotherapy.

CONCLUSION: Although both ADC_CON and ADC_FLAIR are sensitive to tissue changes induced by chemotherapy, FLAIR-DWI outperformed conventional DWI in separating AL patients with CR from NR after chemotherapy. A possible mechanism is that FLAIR-DWI suppresses signals from free water, making the ADC measurement more sensitive to structural changes in the bone marrow.

PMID:34380856 | DOI:10.4103/ijc.IJC_765_19

Indian J Cancer. 2021 Jul 2. doi: 10.4103/ijc.IJC_538_19. Online ahead of print.

ABSTRACT

BACKGROUND: Cervical cancer is known to be the fourth most common cancer among women globally. In various factors, genetic factors have been considered as one major risk factor for cervical cancer. The research of genetic susceptibility to cervical cancer can be greatly helpful in studying the complex mechanism. This study was conducted to identify whether polymorphic variants of p73 G4C14-A4T14 and tumor protein p53 (p53) codon 72, either independently or jointly, might be associated with the risk of cervical cancer.

METHODS: The genotypes of p73 G4C14-A4T14 and p53 codon 72 polymorphisms of peripheral blood DNA from 190 cervical cancer patients and 210 controls were investigated using polymerase chain reaction with confronting two-pair primers and polymerase chain reaction-restriction fragment length polymorphism, respectively.

RESULTS: The frequency of p73 G4C14-A4T14 AT/AT (P = 0.013) or p53 codon 72 GG (P = 0.026) genotype was associated with an increased risk of cervical cancer by comparing with the p73 G4C14-A4T14 GC/GC or p53 codon 72 CC genotype, respectively. In addition, the interaction between the p73 G4C14-A4T14 and p53 codon 72 polymorphisms increased the risk of cervical cancer in a multiply manner, with the odds ratio being 3.692 (95% confidence interval =2.106-6.473) for subjects carrying both p73 G4C14-A4T14 GC/AT+AT/AT and p53 codon 72 GG genotypes.

CONCLUSION: These results suggest that there is a statistical difference between p73 and p53 gene polymorphism and the risk of cervical cancer in Chinese women, and there is a potential gene-gene interaction in the incidence of cervical cancer.

PMID:34380847 | DOI:10.4103/ijc.IJC_538_19

Indian J Cancer. 2021 Jul 2. doi: 10.4103/ijc.IJC_666_19. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of the study is to investigate the factors affecting acute hematologic toxicity (HT) in the adjuvant radiotherapy (RT) of gynecologic cancers by machine learning.

METHODS: Between January 2015 and September 2018, 121 patients with endometrium and cervical cancer who underwent adjuvant RT with volumetric-modulated arc therapy (VMAT) were evaluated. The relationship between patient and treatment characteristics and acute HT was investigated using machine learning techniques, namely Logistic Regression, XGBoost, Artificial Neural Network, Random Forest, Naive Bayes, Support Vector Machine (SVM), and Gaussian Naive Bayes (GaussianNB) algorithms.

RESULTS: No HT was observed in 11 cases (9.1%) and at least one grade of HT was observed in 110 cases. There were 55 (45.5%) cases with ≤grade 2 HT (mild HT) and 66 (54.5%) cases with grade ≥3 HT (severe HT). None of the patients developed grade 5 HT. Of 24 variables that could affect acute HT, nine were determined as important variables. According to the results, the best machine learning technique for acute HT estimation was SVM (accuracy 70%, area under curve (AUC): 0.65, sensitivity 71.4%, specificity 66.6%). Parameters affecting hematologic toxicity were evaluated also by classical statistical methods and there was a statistically significant relationship between age, RT, and bone marrow (BM) maximum dose.

CONCLUSION: It is important to predict the patients who will develop acute HT in order to minimize the side effects of treatment. If these cases can be identified in advance, toxicity rates can be reduced by taking necessary precautions. These cases can be predicted with machine learning algorithms.

PMID:34380848 | DOI:10.4103/ijc.IJC_666_19

Indian J Cancer. 2021 Jun 21. doi: 10.4103/ijc.IJC_766_19. Online ahead of print.

ABSTRACT

BACKGROUND: Mutations in the RAS genes, HRAS, KRAS, and NRAS, are the most common modifications in many types of human tumors and are found in approximately 30% of all human cancers. These mutations are usually found in codons 12, 13, or 61.

METHODS: The aim of this study is to evaluate mutations in codons 59, 117, and 146 of KRAS and NRAS genes in addition to codons 12,13, and 61 of KRAS gene in lung cancer tissue specimens obtained with bronchoscopy. KRAS and NRAS mutation analyses with pyrosequencing were performed on DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue samples of 64 patients histopathologically diagnosed as lung cancer after bronchoscopic biopsy.

RESULTS: In all, 20 patients (31.2%) had mutations in KRAS gene (8/27 squamous cell carcinoma, 8/11 adenocarcinoma, 3/16 small cell carcinoma, and 1/1 pleomorphic carcinoma). The most common mutation in codon 12 was in c.35G>T (G12V). When the mutation rate of adenocarcinoma (72.7%) and squamous cell carcinoma (22.9%) patients was compared with each other, a statistically significant difference was observed (P = 0.008). There were no mutations in codons 59, 117, or 146 of KRAS and NRAS genes in patients with lung cancer.

CONCLUSION: In this study, we firstly examined mutations in codons 59, 117, and 146 of KRAS and NRAS genes in addition to codons 12, 13, and 61 of KRAS gene in Turkish lung cancer patients both in non-small cell lung cancer and small cell lung cancer. Although no mutation was detected in codons 59, 117, and 146 of KRAS and NRAS genes, the frequency of KRAS gene mutation was higher than the rate of mutation in both Asian and Western countries, and multicenter studies including more cases should be performed to further explore our results.

PMID:34380837 | DOI:10.4103/ijc.IJC_766_19

Indian J Cancer. 2021 Jun 24. doi: 10.4103/ijc.IJC_1059_19. Online ahead of print.

ABSTRACT

BACKGROUND: A comprehensive histopathology report of colorectal carcinoma surgery is important in cancer staging and planning adjuvant treatment. Our aim was to review histopathology reports of operated specimens of colorectal carcinoma in our institution between 2013 and 2015 to assess different histological parameters, including lymph node yield, and to evaluate compliance to minimum data sets.

METHODS: After approval by the institutional review board (IRB), we analyzed 1230 histopathology reports of colorectal carcinoma between 2013 and 2015. Various gross and microscopic findings (along with age, sex) were noted, for example, specimen type, tumor site, resection margins including circumferential resection margin (CRM), lymphovascular invasion, perineural invasion, pTNM stage, lymph node yield, etc.

RESULTS: Out of 1230 patients, 826 (67.15%) were men and 404 (32.85%) were women. The overall mean age was 52 (range: 18 – 90) years. There were 787 surgeries for rectal cancers. All reports commented on the type of specimen, tumor size (mean = 4.38 cm), proximal, and distal margins. Lymphovascular invasion (LVI) and the pT stage were mentioned in 98.06% and 99.84%, respectively. The overall mean lymph node yield was 18.38 (median = 15, range = 0-130 lymph nodes). A statistically significant difference in lymph node yield was detected between rectal and colonic cancer patients (14.79 and 27.26); post neoadjuvant therapy (NACT) cases, and NACT naive cases (13.51 and 25.11); and high tumor stage and low tumor stage disease (20.60 and 15.22). Not commenting on extramural vascular emboli, tumor budding, and CRM in non-rectal cancer cases were the lacunae.

CONCLUSION: Our compliance with minimal data sets is satisfactory. The overall mean lymph node yield was 18.38 (median = 15). Extramural vascular emboli, tumor budding need to be captured.

PMID:34380840 | DOI:10.4103/ijc.IJC_1059_19

Indian J Dermatol Venereol Leprol. 2021 Jul 29:1-7. doi: 10.25259/IJDVL_11_2020. Online ahead of print.

ABSTRACT

BACKGROUND: Topical corticosteroid (TCS) abuse is rampant and results in steroid addiction labeled as topical steroid-dependent or damaged face (TSDF). Indian market is replete with triple combination creams containing TCS sold as over-the-counter products at low cost, luring people to use them without prescription. The resultant damage if detected late is irreversible and difficult to treat. Dermoscopy can help in the early identification of features of TSDF at a preclinical stage resulting in better prognosis. However, the literature on the same is limited.

AIMS: This study is undertaken to characterize dermoscopic features of TSDF and to correlate them with potency and duration of application of the TCS.

METHODS: One hundred and thirty-two patients aged 18 years or above, with clinical symptoms and signs suggestive of TSDF and with history of application of TCS on the face for a period of more than one month, were enrolled in the study. Their demographic details, clinical features, and dermoscopy findings were recorded using a predesigned structured format. Comparison of dermoscopic findings with clinical examination, gender, potency of TCS, and duration of TCS use was done using Chi-square test, Fisher’s exact test, and one-tailed Z-test.

RESULTS: Mean age of the patients was 31.7 ± 8.1 years. Male to female ratio was 2:9. Sixty-nine (52.3%) patients abused TCS for more than one year. Clinical findings noted in the patients were erythema (81.1%), hyperpigmentation (80.3%), and hypertrichosis (68.2%). The most common dermoscopy findings seen were brown globules (96.2%), red diffuse areas (92.4%), vessels (87.1%), white structureless areas (86.4%), and hypertrichosis (80.3%). Red diffuse areas, vessels, brown globules, white structureless areas, and white hair were observed in a statistically higher proportion of cases dermoscopically. Y-shaped vessels and brown globules were seen in significantly higher number of patients, using TCS for more than three months and in those continuing it beyond six months, polygonal vessels were predominant.

LIMITATIONS: Lack of histopathological correlation is the limitation of our study. Furthermore, brown globules seen in 96.2% patients of TSDF on dermoscopy may have been over-estimated and not always signify TSDF; instead, it could represent melasma for which patient applied TCS.

CONCLUSION: Dermoscopy in TSDF can help dermatologists in a multitude of ways from confirming the diagnosis to differentiating from other causes of red face and predicting the approximate duration of TCS abuse.

PMID:34379967 | DOI:10.25259/IJDVL_11_2020

Indian J Dermatol Venereol Leprol. 2021 Aug 5:1-8. doi: 10.25259/IJDVL_976_18. Online ahead of print.

ABSTRACT

BACKGROUND: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses.

AIMS AND OBJECTIVES: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo.

METHODS: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases.

RESULTS: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline.

LIMITATIONS: Small sample size and a short follow-up period of our study were major limitations.

CONCLUSION: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

PMID:34379946 | DOI:10.25259/IJDVL_976_18

Fa Yi Xue Za Zhi. 2021 Jun;37(3):351-357. doi: 10.12116/j.issn.1004-5619.2021.410204.

ABSTRACT

Objective To study the correlation between the abdominal wall subcutaneous fat thickness and heart weight, so as to provide reference for prediction methods of normal range of heart weight that is suitable for autopsy in China. Methods The forensic pathology autopsy cases accepted by Center for Medicolegal Expertise of Sun Yat-sen University from 1998 to 2017 were collected. Then the exclusion criteria were determined, and according to them the total case group was selected, and the 6 disease groups and the normal group were further selected from the total case group. The rank sum test was used to compare the heart weight of the normal group and the disease groups to determine the influence of diseases on heart weight. Then the Spearman rank correlation analysis of abdominal wall subcutaneous fat thickness and heart weight in different genders and different ages in the total case group and the normal group was conducted to get the correlation coefficient （r_s）. Results In the total case group, correlation between abdominal wall subcutaneous fat thickness and heart weight was shown in males of all ages （P<0.05）; while in females, the correlation had no statistical significance （P>0.05） in 15-<20 age and 50-<60 age, but was statistically significant （P<0.05） in other age groups. For the males in the normal group, r_s was respectively 0.411, 0.541 and 0.683 in the 15-<40 age, the 40-<60 age, and the ≥60 age. For the females, r_s was respectively 0.249 and 0.317 in the 15-<40 age and the 40-<60 age. The correlation in the ≥60 age had no statistical significance（P>0.05）. Conclusion In the general population and the normal population, abdominal wall subcutaneous fat thickness is correlated with the heart weight of males. It is of significance to include the abdominal wall subcutaneous fat thickness in the prediction of normal range of heart weight for males in China.

PMID:34379904 | DOI:10.12116/j.issn.1004-5619.2021.410204

N Engl J Med. 2021 Aug 11. doi: 10.1056/NEJMoa2109908. Online ahead of print.

ABSTRACT

BACKGROUND: Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a new syndrome associated with the ChAdOx1 nCoV-19 adenoviral vector vaccine against severe acute respiratory syndrome coronavirus 2. Data are lacking on the clinical features of and the prognostic criteria for this disorder.

METHODS: We conducted a prospective cohort study involving patients with suspected VITT who presented to hospitals in the United Kingdom between March 22 and June 6, 2021. Data were collected with the use of an anonymized electronic form, and cases were identified as definite or probable VITT according to prespecified criteria. Baseline characteristics and clinicopathological features of the patients, risk factors, treatment, and markers of poor prognosis were determined.

RESULTS: Among 294 patients who were evaluated, we identified 170 definite and 50 probable cases of VITT. All the patients had received the first dose of ChAdOx1 nCoV-19 vaccine and presented 5 to 48 days (median, 14) after vaccination. The age range was 18 to 79 years (median, 48), with no sex preponderance and no identifiable medical risk factors. Overall mortality was 22%. The odds of death increased by a factor of 2.7 (95% confidence interval [CI], 1.4 to 5.2) among patients with cerebral venous sinus thrombosis, by a factor of 1.7 (95% CI, 1.3 to 2.3) for every 50% decrease in the baseline platelet count, by a factor of 1.2 (95% CI, 1.0 to 1.3) for every increase of 10,000 fibrinogen-equivalent units in the baseline d-dimer level, and by a factor of 1.7 (95% CI, 1.1 to 2.5) for every 50% decrease in the baseline fibrinogen level. Multivariate analysis identified the baseline platelet count and the presence of intracranial hemorrhage as being independently associated with death; the observed mortality was 73% among patients with platelet counts below 30,000 per cubic millimeter and intracranial hemorrhage.

CONCLUSIONS: The high mortality associated with VITT was highest among patients with a low platelet count and intracranial hemorrhage. Treatment remains uncertain, but identification of prognostic markers may help guide effective management. (Funded by the Oxford University Hospitals NHS Foundation Trust.).

PMID:34379914 | DOI:10.1056/NEJMoa2109908