Tag: statistics

J Minim Access Surg. 2021 Apr-Jun;17(2):192-196. doi: 10.4103/jmas.JMAS_287_19.

ABSTRACT

BACKGROUND: We compared outcomes of en bloc stapler ligation of the renal hilum with separate Hem-o-lok polymer clip ligation of the renal vessels during laparoscopic nephrectomy (LN).

MATERIALS AND METHODS: Clinical data of patients who underwent LN for renal surgery from January 2009 to December 2015 were collected. Operation time, estimated blood loss, device malfunction rate, open conversion rate, complications and arteriovenous fistula (AVF) formation were evaluated.

RESULTS: En bloc stapler ligation and separate clip ligation were performed in 64 and 66 patients, respectively. The mean operative time was 106.8 ± 20.8 min (range: 70-165) in the en bloc stapler ligation group compared with 112.5 ± 24.1 min (range: 70-180) in the separate clip ligation group (P = 0.147). The mean estimated blood loss was 141.4 ± 124.1 ml (range: 25-600) in the en bloc stapler ligation group compared with 147.6 ± 112.4 ml (range: 25-450) in the separate clip ligation group (P = 0.767). The open conversion was required in 7/64 (10.9%) and 2/66 (3.0%) patients in the en bloc stapler ligation and separate clip ligation groups, respectively (P = 0.093). Stapler device malfunction occurred in 6 patients (9.3%). There were no statistically significant differences in overall complications (P = 0.726), minor (Grade 1-2) complications (P = 0.698) and major (Grade 3-5) complications (P = 0.716). No patient was diagnosed with AVF formation during overall median 33-month (interquartile range: 30, range: 24-96) follow-up.

CONCLUSIONS: En bloc stapler ligation of the renal hilum during nephrectomy is an effective and safe technique. Although there is no reported AVF formation with en bloc stapler ligation of the renal hilum, longer follow-up is necessary.

PMID:33723183 | DOI:10.4103/jmas.JMAS_287_19

Sci Data. 2021 Mar 15;8(1):86. doi: 10.1038/s41597-021-00874-2.

NO ABSTRACT

PMID:33723256 | DOI:10.1038/s41597-021-00874-2

J Minim Access Surg. 2021 Apr-Jun;17(2):147-152. doi: 10.4103/jmas.JMAS_294_19.

ABSTRACT

BACKGROUND AND OBJECTIVES: The objective was to assess the efficacy and safety in treating gastric stromal tumours by laparoscopy combined with gastroscopy positioning surgery.

METHODS: The randomised controlled trials (RCTs), which are about the efficacy and safety of laparoscopy combined with gastroscopy positioning surgery in treating gastric stromal tumours were searched from the PubMed (1998-1990-2018.6), Wanfang Data (1990-2018.6), China National Knowledge Infrastructure (1979-2018.6) and International Statistical Institute (1998-2018.6). The data were extracted from these trials, and the meta-analysis was made through from RevMan 5.3 software.

RESULTS: Six RCTs involving 451 patients were included in the study (227 patients in the laparoscopy combined with gastroscopy positioning group and 224 patients in laparoscopic surgery group). Compared with laparoscopic surgery group, this meta-analysis showed that laparoscopy combined with gastroscopy positioning group could shorten the post-operation hospital stay (P < 0.05) and reduce the intraoperative blood loss (P < 0.05). However, there was no significant difference in others between the two groups, such as operation time (P > 0.05), post-operative time of recovery of intestinal peristalsis (P > 0.05) and the total hospital stay (P > 0.05).

CONCLUSION: Compared with laparoscopic surgery group, the better total effect occurs in laparoscopy combined with gastroscopy positioning group for the treatment of gastric stromal tumours is better. Laparoscopy combined with gastroscopy positioning group for the gastric stromal tumours is acceptable.

PMID:33723177 | DOI:10.4103/jmas.JMAS_294_19

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):198-203. doi: 10.4103/jcrt.JCRT_569_18.

ABSTRACT

INTRODUCTION: Neutrophil gelatinase-associated lipocalin (NGAL) has been reported to be unregulated in many cancers and to suppress tumor suppressor genes like p53 leading to cell proliferation. Studies to report its relationship with carcinoma cervix (Ca Cx) are still scant.

MATERIALS AND METHODS: Serum NGAL levels were analyzed in 30 patients of histopathologically proven locally advanced Ca Cx at the time of diagnosis and 3 weeks after standard chemoradiation by enzyme-linked immunosorbent assay. These patients underwent either brachytherapy or supplementary external beam radiotherapy (EBRT) depending on the response of treatment. The results were analyzed statistically by applying Student’s paired t-test.

RESULTS: No statistically significant difference (P > 0.05) was observed in patients of Ca Cx before and after treatment or when compared stage wise, histopathological grade wise, or response wise. But the levels were found to increase when duration of treatment was ≥8 weeks (P = 0.040) and to decrease significantly when duration of treatment was <8 weeks (P = 0.0052). The NGAL levels also increased significantly after treatment in patients who received EBRT and supplementary radiotherapy (P = 0.019) while the pre- and post-treatment difference in NGAL levels was not statistically significant in patients who received EBRT + intracavitary brachytherapy (P > 0.05).

CONCLUSION: As the duration as well as modality of treatment is quite important in Ca Cx, shorter duration associated with better results and lower NGAL levels, NGAL might prove to be a useful biomarker although further studies are needed to support the claim.

PMID:33723155 | DOI:10.4103/jcrt.JCRT_569_18

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