Πέμπτη, 2 Μαΐου 2019


"Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center of India": A commentary
Fatih Safa Erenay, Susan Horton

Indian Journal of Cancer 2019 56(2):99-100

Incidence, prevalence, and mortality associated with head and neck cancer in India: Protocol for a systematic review
Aayush Poddar, Ritchlynn Aranha, Madhav Madurantakam Royam, Kodiveri Muthukaliannan Gothandam, Ramesh Nachimuthu, Rama Jayaraj

Indian Journal of Cancer 2019 56(2):101-106

BACKGROUND: Head and neck cancer (HNC) is a heterogeneous tumor at various anatomic sites and one of the most common cancers in India. Published and existing reports and studies highlight an alarming increase in the incidence, prevalence, and mortality of HNC. Despite its high incidence, there is a dearth of more precise estimates of reliable epidemiological data pertaining to HNC in India. AIM: This protocol aims to conduct a full-scale systematic review and meta-analysis on the HNC epidemiology (incidence, prevalence, and mortality) in 29 states and 7 union territories of India. METHODS AND ANALYSIS: We will search for eligible published studies through PubMed, Scopus, Science Direct, MEDLINE, Web of Science, and Cochrane Review. Cancer registries such as (but not limited to) World Health Organization, International Agency for Research on Cancer, and the National Centre for Disease Informatics and Research-National Cancer Registry Program, which is maintained by the Indian Council of Medical Research, will be used for extracting relevant data using a standardized data collection form. The random-effects model of meta-analysis will be employed to aggregate the pooled estimates of relative ratios with 95% confidence intervals. Publication bias will be assessed using a funnel plot, and Egger's regression will be applied to test the symmetry of the funnel plot. DISCUSSION: This review will provide updated evidence of the current burden of HNC in India. This will guide future studies and cancer registry reports to provide holistically representative epidemiological data. SYSTEMATIC REVIEW REGISTRATION: In accordance with the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews and was assigned the registration number, CRD42017077482. 

Role of community health worker in a mobile health program for early detection of oral cancer
N Praveen Birur, Keerthi Gurushanth, Sanjana Patrick, Sumsum P Sunny, Shubhasini A Raghavan, Shubha Gurudath, Usha Hegde, Vidya Tiwari, Vipin Jain, Mohammed Imran, Pratima Rao, Moni Abraham Kuriakose

Indian Journal of Cancer 2019 56(2):107-113

Background: The global incidence of oral cancer occurs in low-resource settings. Community-based oral screening is a strategic step toward downstaging oral cancer by early diagnosis. The mobile health (mHealth) program is a technology-based platform, steered with the aim to assess the use of mHealth by community health workers (CHWs) in the identification of oral mucosal lesions. MATERIALS AND METHODS: mHealth is a mobile phone-based oral cancer-screening program in a workplace setting. The participants were screened by two CHWs, followed by an assessment by an oral medicine specialist. A mobile phone-based questionnaire that included the risk assessment was distributed among participants. On specialist recommendation an oral surgeon performed biopsy on participants. The diagnosis by onsite specialist that was confirmed by histopathology was considered as gold standard. All individuals received the standard treatment protocol. A remote oral medicine specialist reviewed the uploaded data in Open Medical Record System. Sensitivity, specificity, positive and negative predictive values were calculated. Inter-rater agreement was analyzed with Cohen's kappa coefficient (κ) test, and the diagnostic ability of CHWs, onsite specialist, and remote specialist was illustrated using receiver operating characteristic curve. RESULTS: CHWs identified oral lesions in 405 (11.8%) individuals; the onsite specialist identified oral lesions in 394 (11.4%) individuals; and the remote specialist diagnosed oral lesions in 444 (13%). The inter-rater agreement between the CHW and the onsite specialist showed almost perfect agreement with the κ score of 0.92, and a substantial agreement between CHW and remote specialist showed a score of 0.62. The sensitivity, specificity, positive and negative predictive values of CHWs in the identification of oral lesion were 84.7, 97.6, 84.8, and 97.7%, respectively. CONCLUSION: The trained CHWs can aid in identifying oral potentially malignant disorders and they can be utilized in oral cancer-screening program mHealth effectively. 

Optimization of sentinel lymph node identification techniques in the Indian setting: A randomized clinical trial
V Seenu, Suhani Suhani, Anurag Srivastava, Rajinder Parshad, Sandeep Mathur, Rakesh Kumar

Indian Journal of Cancer 2019 56(2):114-118

INTRODUCTION: The recommended technique of sentinel lymph node biopsy (SLNB) in breast cancer is a combination of blue dye and radiotracer. In the Indian scenario, SLNB is still not routinely practiced due to lack of nuclear medicine facilities and unavailability of isosulfan blue or patent blue violet (PBV). This study was conducted for optimizing SLN identification techniques by comparing the identification rate using PBV and methylene blue (MB) in combination with radiotracer. MATERIALS AND METHODS: Single-blinded two-arm parallel design randomized control trial was conducted at an apex teaching and research medical institute in India. Patients with axillary LN–negative breast cancer were included. Blue dye and radio tracer were injected preoperatively, and SLNB was performed using a combination technique. Frozen section was performed. Demographic, clinical, radiological, operative, and histopathological data were recorded. Descriptive statistics were used to represent patient characteristics. Baseline characteristics for entire cohort and between groups were compared using Student's t-test for quantitative variables and Chi-square test for qualitative variables. RESULTS: A total of 119 patients were randomized for mapping with MB and 118 patients with PBV between 2011 and 2015. SLN was identified in 116 patients with MB and 115 with PBV. SLN identification proportions were 97.4% (MB) and 96.6% (PBV). In patients undergoing axillary lymph node dissection, concordance with SLNB was 98.5% and 96.61% in MB and PBV, respectively. False-negative proportion for MB was 2.56% and 7.69% for PBV, respectively. The cost of MB is about INR 15 per ~10-mL vial. The cost of PBV is approximately ~$91 per ampoule (equivalent to approximately INR 8190). CONCLUSION: SLNB using MB can be recommended as the technique of choice in low-resource settings. 

FISH and HER2/neu equivocal immunohistochemistry in breast carcinoma
Geeta Vikram Patil Okaly, Dipti Panwar, Kavitha Bidadli Lingappa, Prasanna Kumari, Abhishek Anand, Prashantha Kumar, Manju Hosur Chikkalingaiah, Rekha Vijay Kumar

Indian Journal of Cancer 2019 56(2):119-123

AIM: The aim of this study was to validate the role of fluorescence in situ hybridization (FISH) in investigating HER2/neu gene amplification (human epidermal growth factor receptor 2) in patients with HER2/neu equivocal breast cancer diagnosed on immunohistochemistry (IHC). MATERIALS AND METHODS: This was a retrospective study conducted from January 2013 to October 2017. A total of 134 patients diagnosed with invasive breast carcinoma and HER2/neu equivocal status on IHC were analyzed. Also, the cases for the years 2016 and 2017 formed a subgroup that was analyzed further to study the impact of pre-analytical factors on IHC and FISH results. RESULTS: A total of 134 women with HER2/neu IHC equivocal breast cancer were included in the study with a median age of 50 years (range 25–81). HER2/neu amplification by FISH was noted in 72 (54%) cases, whereas it was non-amplified in 52 (39%) cases. Ten cases were reported as equivocal even on FISH (ASCO/CAP 2013 guidelines). Polysomy 17 was noted in 55 cases (41%), of which 26 patients were≤50 years and 29 patients were >50 years of age. Twenty (36%) of these 55 cases showed HER2/neu amplification, whereas 26 (48%) cases were non-amplified and 9 (16%) cases were reported as equivocal on FISH. Also, more than half of the polysomy cases were hormone receptor negative. CONCLUSION: IHC is a good screening tool for negative and positive results. Any patient targeted for trastuzumab therapy should undergo confirmation of HER2/neu equivocal status by FISH analysis. We also suggest that if a non-classical FISH pattern is seen, the test should be repeated with a non-centromeric chromosome 17 reference locus probe for better treatment planning. 

Survival and treatment outcomes of metaplastic breast carcinoma: Single tertiary care center experience in Pakistan
Zarka Samoon, Madiha Beg, Romana Idress, Adnan A Jabbar

Indian Journal of Cancer 2019 56(2):124-129

BACKGROUND: Metaplastic breast carcinoma (MBC) is a rare disease with incidence of less than 1%. MBC present with a larger tumor size, less number of nodes involved, mostly undifferentiated triple negative tumors. We aimed to determine progression-free and overall survival and reported hospital-based incidence of MBC. MATERIAL AND METHODS: A retrospective closed Cohort study elicited data of 42 patients with MBC from January 2008 to December 2013; followed till August 2016. Kaplan-Meier method was applied to compute overall and progression-free survival analysis. Cox Proportional hazard ratios were computed to assess associations between survival and independent variables. RESULTS: Hospital-based incidence of MBC was 1.92% (42/2187), 95% CI [1.41-2.56]. The median age at tumor diagnosis was 54 years (range, 25–81 years). Thirty-nine (92.9%) patients had Grade III tumor. The most common histopathology was squamous (69%). The median tumor size was 4.5 cm (range, 0.8–17 cm). Nineteen (45.2%) patients had nodal involvement at diagnosis. Four patients (9.5%) had metastatic disease at presentation. Hormone receptors were positive in 19 (45.2%) patients. Her-2 neu receptor was positive in 9 (19%) patients. Sixteen (38.1%) patients had triple negative disease. Neoadjuvant and adjuvant chemotherapy was received by 10 (31.25%) and 19 (45.2%) patients respectively. Both median progression-free and overall survival was 38 months. CONCLUSION: Five-year progression-free and overall survival was 79.5% and 76.3%, respectively. We report better survival outcomes when compared to series described earlier despite our patient population presenting mostly with high grade, large tumors, and half of them exhibiting nodal and hormonal involvement. 

Association of serum level of vitamin D and VDR polymorphism Fok1 with the risk or survival of pancreatic cancer in Egyptian population
Amal Ahmed Mohamed, Ahmed Moustafa Aref, Soha M Talima, Reham A A Elshimy, Shawkat S Gerges, Mohamed Meghed, Fawkia Eissa Zahran, Eman H EL-Adawy, Sherief Abd-Elsalam

Indian Journal of Cancer 2019 56(2):130-134

BACKGROUND AND AIMS: Pancreatic cancer (PC) is the fourth most common cause of death from cancer in Egypt. Few studies have been conducted to assess the relationship between vitamin D serum level and vitamin D receptor (VDR) polymorphisms with the survival of PC patients. This is the first study in Egypt to investigate the association of the status of vitamin D serum level and genotypic distribution of single nucleotide polymorphisms (SNP) Fok1 with the risk of developing PC and whether they could detect survival or not. PATIENTS AND METHODS: The study included a total of 47 PC cases that were histopathologically proven to have PC, and 37 controls that were attending at the same time for investigation but proved that they were all PC free. Pre-diagnostic concentrations of vitamin D and VDR polymorphism Fok1 were assessed from all participants in the study. RESULTS: There was a 1.5-fold increase in the serum level of vitamin D in PC patients when compared to non-PC subjects. Regarding VDR Fok1, polymorphism distribution in PC was CC (Wild Type) 26 (55.3%), CT 16 (34%), and TT 5 patients (10.7%). For the control group, CC was found in 24 (64.8%), CT in 12 (32.4%), and TT genotype was found only in one individual 1 (2.8%) with no statistically significant difference between the two studied groups (P 0.72). CONCLUSION: Low serum vitamin D or VDR-SNP is not a risk factor for PC in Egyptian patients. Recommendations to increase vitamin D concentrations in healthy persons for the prevention of cancer and improving overall survival should be carefully considered. 

Analysis of clinicopathological and immunohistochemical parameters and correlation of outcomes in gastrointestinal stromal tumors
Vaibhav Kumar Varshney, Rakesh Kumar Gupta, Sundeep Singh Saluja, Ila Tyagi, Pramod Kumar Mishra, Vineeta V Batra

Indian Journal of Cancer 2019 56(2):135-143

INTRODUCTION: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. We analyzed the clinicopathological features, resectability, immunohistochemical markers, and various factors predictive of disease recurrence and survival. MATERIALS AND METHODS: Retrospective analysis of prospectively maintained database of GIST patients managed from 2005 to 2016 was done. Size, site, malignant potential, nuclear pleomorphism, histopathological variety, immunohistochemical markers, type of surgery, and adjuvant imatinib therapy were analyzed. RESULTS: Ninety-two patients with GIST were analyzed. Immunohistochemistry showed positivity for c-kit (82.4%), DOG1 (75%), and PDGFR-α (79%). Among 16 patients with c-kit-negative tumors, 10 patients were positive for DOG1, PDGFR-α, or both. The most common primary site was stomach (44, 47.8%) followed by small bowel (17, 18.5%) and duodenum (14, 15.2%). Of 92 patients, 80 (87%) underwent R0 resection with organ sparing resection in 56 (70%) patients. Seventeen (21.3%) patients showed recurrence at a median follow-up of 6 years. Median and 5-year overall survival (OS) was 36 months (12–120) and 75%, respectively, and 5-year RFS was 81.8%. On univariate analysis, size, mitotic activity, malignant potential, and nuclear pleomorphism were predictors of recurrence. However, on multivariate analysis, only nuclear pleomorphism was significant. CONCLUSIONS: GISTs had a wide spectrum of presentation, and immunohistopathological features with organ sparing resection were conceivable in maximum. Nuclear pleomorphism may be considered as an important variable to predict recurrence in addition to malignant potential of tumors. 

MCQs for "Analysis of clinicopathological and immunohistochemical parameters and correlation of outcomes in gastrointestinal stromal tumors"
HS Darling, S Jayalakshmi, Pradeep Jaiswal

Indian Journal of Cancer 2019 56(2):144-145

Financial audit of wastage of anticancer drugs: Pilot study from a tertiary care center in India
Veena Reshma D'Souza, Princy Louis Palatty, Thomas George, Mohammed Adnan, Suresh Rao, Manjeshwar Shrinath Baliga

Indian Journal of Cancer 2019 56(2):146-150

PURPOSE: Drug wastage is a major concern in oncology where costs of antineoplastic drugs are exorbitant, and the disposal of toxic drugs increases the chances of occupational hazards to healthcare and sanitary workers and environmental pollution at the site of disposal. The principal objective of this study was to ascertain the extent of drug wastage and calculate its financial costs. MATERIALS AND METHODS: This was a prospective pilot study conducted to ascertain the quantity of drug wastage in a tertiary care hospital. This pilot study was conducted in day care and inpatient facilities in February 2016. The prescription of cytotoxic drugs, recommended dose, the quantity used, and remainder (waste) left were recorded from the nurses and pharmacy files of the hospital. Cost evaluation of the actual use and the waste was undertaken and an audit was conducted to understand in which anticancer drug the maximum wastage was generated. RESULTS: The results of this study indicated that 6.1% of the total amount of reconstituted drugs was wasted. The highest drug wastage was observed in trastuzumab (29.55%), followed by etoposide (20.4%), dacarbazine (17.14%), daunorubicin (16.67%), and carboplatin (11.29%). Cost analysis showed that the total cost of the drug issued during the study period was Rs. 1,294,975 and the cost of drug wastage amounted to Rs. 143,820 (11.1%). CONCLUSION: To the best of authors' knowledge, this is the first study from India and the results indicate that the financial impact of anticancer drug wastage was substantial. Attempts should be directed at minimizing the wastage and cost savings without risking patients' treatment regimen and administering effective dose schedule. 

Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos

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