P. Sharmila Nirojini, N.K. Bhuvaneshwari, N. Dharsshini, S. Dhivya Bharathi, K. Velavan
Abstract Introduction 5-fluorouracil (5-FU) is a crucial agent in treating various types of cancer, particularly recurrent head and neck cancers (HNCs). According to prior studies, individuals who underwent therapeutic drug monitoring (TDM) based 5-FU dosage adjustments showed significantly higher response rates and experienced fewer adverse events compared with those who received the standard 5-FU administration. This study aims to enhance our understanding of the overall clinical outcomes in patients with recurrent HNCs who received 500 mg of 5-FU through a pharmacokinetic (PK) analysis. Objectives Our objectives are to conduct TDM in selected HNC patients and observe individual PK responses, efficacy, tolerability, and drug toxicity. Materials and Methods We enrolled a total of 12 patients with recurrent metastatic HNC, and all of them received a fixed dose of 500 mg with cisplatin in a 21-day cycle. During cycle II or III, we analyzed the blood concentrations and PK parameters of 5-FU using the liquid chromatography and mass spectrometry (LC–MS) technique. Notably, we calculated the Concentration maximum (Cmax), time at which the concentration reaches maxiumum (Tmax), Half life of the drug (T1/2), and area under the curve (AUC) for the 500-mg dose of 5-FU, as the PK data for this particular dose were unavailable, making our study uniquely valuable for assessing efficacy and toxicity. Results Within the study group, 83.33% obtained an average AUC range of 1,000 to 3,000 h/µg/mL. Out of this group, 41.66% showed a partial response, 33.33% experienced disease progression, and 25% remained stable during the therapy. One patient had an AUC below the expected value (832.21 h/µg/mL), while another had an overexposed AUC value (5726.87 h/µg/mL), resulting in a poor clinical outcome. After interpreting the results, suggestions for dosage adjustments were made to the clinician. Conclusion From our interventional study, it is evident that at a flat dose of 500 mg, PK-based individual dosage regimens play a superior role in managing advanced cancer patients with minimal toxicities. This PK analysis showed us clarity on the outcomes of 5-FU at a 500-mg dose.
{"title":"Therapeutic Drug Monitoring of 5-Fluorouracil in Head and Neck Cancer Patients: An Interventional Pilot Study","authors":"P. Sharmila Nirojini, N.K. Bhuvaneshwari, N. Dharsshini, S. Dhivya Bharathi, K. Velavan","doi":"10.1055/s-0043-1776294","DOIUrl":"https://doi.org/10.1055/s-0043-1776294","url":null,"abstract":"Abstract Introduction 5-fluorouracil (5-FU) is a crucial agent in treating various types of cancer, particularly recurrent head and neck cancers (HNCs). According to prior studies, individuals who underwent therapeutic drug monitoring (TDM) based 5-FU dosage adjustments showed significantly higher response rates and experienced fewer adverse events compared with those who received the standard 5-FU administration. This study aims to enhance our understanding of the overall clinical outcomes in patients with recurrent HNCs who received 500 mg of 5-FU through a pharmacokinetic (PK) analysis. Objectives Our objectives are to conduct TDM in selected HNC patients and observe individual PK responses, efficacy, tolerability, and drug toxicity. Materials and Methods We enrolled a total of 12 patients with recurrent metastatic HNC, and all of them received a fixed dose of 500 mg with cisplatin in a 21-day cycle. During cycle II or III, we analyzed the blood concentrations and PK parameters of 5-FU using the liquid chromatography and mass spectrometry (LC–MS) technique. Notably, we calculated the Concentration maximum (Cmax), time at which the concentration reaches maxiumum (Tmax), Half life of the drug (T1/2), and area under the curve (AUC) for the 500-mg dose of 5-FU, as the PK data for this particular dose were unavailable, making our study uniquely valuable for assessing efficacy and toxicity. Results Within the study group, 83.33% obtained an average AUC range of 1,000 to 3,000 h/µg/mL. Out of this group, 41.66% showed a partial response, 33.33% experienced disease progression, and 25% remained stable during the therapy. One patient had an AUC below the expected value (832.21 h/µg/mL), while another had an overexposed AUC value (5726.87 h/µg/mL), resulting in a poor clinical outcome. After interpreting the results, suggestions for dosage adjustments were made to the clinician. Conclusion From our interventional study, it is evident that at a flat dose of 500 mg, PK-based individual dosage regimens play a superior role in managing advanced cancer patients with minimal toxicities. This PK analysis showed us clarity on the outcomes of 5-FU at a 500-mg dose.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134973477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Introduction Even in the absence of a pandemic, pediatric oncology patients have decreased immunological levels. This condition requires families to monitor their children's risk of infection on a frequent basis. The possibility of being exposed to coronavirus disease 2019 (COVID-19) in a hospital or community environment has created significant concern among cancer families. Objectives This study sought to ascertain the quality of life of parents who sought treatment for their children at a pediatric oncology clinic during the COVID-19 epidemic, as well as the factors that influenced it. Materials and Methods This cross-sectional study included 62 parents with children ages 0 to 19 who receive treatment for their children at the pediatric oncology clinic of an application and research center in Turkey's Western Black Sea area. “The Participant Information Form” and “The Scale of Quality of Life-Family Version (QOL-FV)” were used to collect data. The researchers used the face-to-face interview approach to obtain data. To investigate the differences in scale levels based on the descriptive characteristics of the parents, one-way analysis of variance, t-test, and post hoc (Tukey, least significant difference) analyses were used. Results The total mean score of the parents' QOL-FV was found to be 148.097 ± 25.843 (87–258). In the study, it was determined that financial difficulties, difficulties in accessing the hospital during the treatment process, and changes in daily activity/behavior had negative effects on parents' quality of life. Conclusion Most of the parents who participated in our study stated that their quality of life got worse with the pandemic. It was determined that the COVID-19 pandemic had effects on the quality of life of parents of pediatric oncology patients in various ways.
{"title":"Determination of the Quality of Life of Parents with Children Treated in the Pediatric Oncology Clinic during the COVID-19 Pandemic and Affecting Factors","authors":"Aysel Topan, Özlem Öztürk Şahin, Zeynep Aközlü, Dilek Bayram, Tülay Kuzlu Ayyıldız","doi":"10.1055/s-0043-1769589","DOIUrl":"https://doi.org/10.1055/s-0043-1769589","url":null,"abstract":"Abstract Introduction Even in the absence of a pandemic, pediatric oncology patients have decreased immunological levels. This condition requires families to monitor their children's risk of infection on a frequent basis. The possibility of being exposed to coronavirus disease 2019 (COVID-19) in a hospital or community environment has created significant concern among cancer families. Objectives This study sought to ascertain the quality of life of parents who sought treatment for their children at a pediatric oncology clinic during the COVID-19 epidemic, as well as the factors that influenced it. Materials and Methods This cross-sectional study included 62 parents with children ages 0 to 19 who receive treatment for their children at the pediatric oncology clinic of an application and research center in Turkey's Western Black Sea area. “The Participant Information Form” and “The Scale of Quality of Life-Family Version (QOL-FV)” were used to collect data. The researchers used the face-to-face interview approach to obtain data. To investigate the differences in scale levels based on the descriptive characteristics of the parents, one-way analysis of variance, t-test, and post hoc (Tukey, least significant difference) analyses were used. Results The total mean score of the parents' QOL-FV was found to be 148.097 ± 25.843 (87–258). In the study, it was determined that financial difficulties, difficulties in accessing the hospital during the treatment process, and changes in daily activity/behavior had negative effects on parents' quality of life. Conclusion Most of the parents who participated in our study stated that their quality of life got worse with the pandemic. It was determined that the COVID-19 pandemic had effects on the quality of life of parents of pediatric oncology patients in various ways.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134973476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rubi Gupta, Pariseema Dave, Bijal Patel, Remi Abdul Shukur
Abstract A synchronous solid and hematological malignancy is an uncommon condition in which a patient develops two or more primary cancers, one of which is a solid malignancy and the other one is a hematological malignancy, within 6 months of primary cancer diagnosis. The most common histology in solid malignancies is gastrointestinal adenocarcinoma, which coexists with the lymphoma subtype diffuse large B-cell lymphoma (DLBCL). Here, we report an extremely rare combination of serous carcinoma of the ovary synchronous with lymphoma of DLBCL subtype. A woman aged 52 years presented with an abdominal mass and abdominal pain for a short duration of 15 days. She was evaluated using clinical, radiological, and biochemical parameters. She was diagnosed with non-Hodgkin lymphoma by tru-cut biopsy from a bony lytic lesion and ovarian cancer by staging laparotomy. R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone) chemotherapy for lymphoma and staging laparotomy for persistent adnexal mass resulted in complete remission of both ovarian cancer and lymphoma. She received paclitaxel and carboplatin-based postoperative chemotherapy as an adjuvant for ovarian cancer.
{"title":"A Rare Occurrence of Solid Gynecological Malignancy Synchronous with Hematological Malignancy: Rare Case and Review of Literature","authors":"Rubi Gupta, Pariseema Dave, Bijal Patel, Remi Abdul Shukur","doi":"10.1055/s-0043-1775830","DOIUrl":"https://doi.org/10.1055/s-0043-1775830","url":null,"abstract":"Abstract A synchronous solid and hematological malignancy is an uncommon condition in which a patient develops two or more primary cancers, one of which is a solid malignancy and the other one is a hematological malignancy, within 6 months of primary cancer diagnosis. The most common histology in solid malignancies is gastrointestinal adenocarcinoma, which coexists with the lymphoma subtype diffuse large B-cell lymphoma (DLBCL). Here, we report an extremely rare combination of serous carcinoma of the ovary synchronous with lymphoma of DLBCL subtype. A woman aged 52 years presented with an abdominal mass and abdominal pain for a short duration of 15 days. She was evaluated using clinical, radiological, and biochemical parameters. She was diagnosed with non-Hodgkin lymphoma by tru-cut biopsy from a bony lytic lesion and ovarian cancer by staging laparotomy. R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone) chemotherapy for lymphoma and staging laparotomy for persistent adnexal mass resulted in complete remission of both ovarian cancer and lymphoma. She received paclitaxel and carboplatin-based postoperative chemotherapy as an adjuvant for ovarian cancer.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"79 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135689075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hematological malignancies, namely, leukemias and lymphomas comprise the major part of clinical practice for most centers that manage children with cancer.[1] Survival of children with common pediatric malignancies such as acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma, and Burkitt's lymphoma has improved by leaps and bounds over the last few decades. This can be largely attributed to superior diagnostic techniques and risk-stratified approaches that tailor the therapy for different patient subgroups. The pathology laboratory, by performing indispensable tests ranging from cytology and histomorphology to immunohistochemistry (IHC), flow cytometry, and molecular methods, has veritably paved the way for this success story.
{"title":"The Symbiotic Relationship between a Clinical Hematologist and Hematopathologist in the Management of Children with Cancer","authors":"Sidharth Totadri, Tulasi Geevar, Arun Kumar Arunachalam","doi":"10.1055/s-0043-1764367","DOIUrl":"https://doi.org/10.1055/s-0043-1764367","url":null,"abstract":"Hematological malignancies, namely, leukemias and lymphomas comprise the major part of clinical practice for most centers that manage children with cancer.[1] Survival of children with common pediatric malignancies such as acute lymphoblastic leukemia (ALL), Hodgkin's lymphoma, and Burkitt's lymphoma has improved by leaps and bounds over the last few decades. This can be largely attributed to superior diagnostic techniques and risk-stratified approaches that tailor the therapy for different patient subgroups. The pathology laboratory, by performing indispensable tests ranging from cytology and histomorphology to immunohistochemistry (IHC), flow cytometry, and molecular methods, has veritably paved the way for this success story.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136168604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The field of hematopathology is rapidly evolving. Along with advancements in the fields of flow cytometry and molecular diagnostics, the assessment of minimal residual disease (MRD) has progressively become a cornerstone in the clinical management of hematologic malignancies. The idea to have a special issue on hematopathology in the Indian Journal of Medical and Pediatric Oncology (IJMPO) was conceptualized by Dr. Padmaj S. Kulkarni (Editor-in-Chief at that time) and was further materialized under the current Editor-in-chief Dr. Seema Gulia. I feel honored to have been given an opportunity to be the Editor for this special issue in my field of interest and expertise.
血液病理学领域正在迅速发展。随着流式细胞术和分子诊断技术的进步，微小残留病(MRD)的评估已逐渐成为血液系统恶性肿瘤临床管理的基石。在《印度医学和儿科肿瘤学杂志》(IJMPO)上发表关于血液病理学的特刊的想法是由Padmaj S. Kulkarni博士(当时的主编)提出的，并在现任主编Seema Gulia博士的领导下进一步具体化。我很荣幸有机会在我感兴趣和专业的领域担任本期特刊的编辑。
{"title":"Editor's Note on Hematopathology Special Issue","authors":"Karthik Bommannan","doi":"10.1055/s-0043-1772237","DOIUrl":"https://doi.org/10.1055/s-0043-1772237","url":null,"abstract":"The field of hematopathology is rapidly evolving. Along with advancements in the fields of flow cytometry and molecular diagnostics, the assessment of minimal residual disease (MRD) has progressively become a cornerstone in the clinical management of hematologic malignancies. The idea to have a special issue on hematopathology in the Indian Journal of Medical and Pediatric Oncology (IJMPO) was conceptualized by Dr. Padmaj S. Kulkarni (Editor-in-Chief at that time) and was further materialized under the current Editor-in-chief Dr. Seema Gulia. I feel honored to have been given an opportunity to be the Editor for this special issue in my field of interest and expertise.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136168607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Acute lymphoblastic leukemias (ALLs) are hematological neoplasms characterized by clonal proliferation of lymphoid blasts, which can be B- or T-cell type. Flow cytometric immunophenotyping is an integral component in establishing blast lineage during the diagnostic workup of ALLs, aiding in appropriate therapy, prognostication, and monitoring of the disease. The current review focuses on the utility of flow cytometry in the workup of ALLs, including the usefulness of various antibodies and pitfalls in diagnosis.
{"title":"Flow Cytometry in the Diagnostic Laboratory Workup of Acute Lymphoblastic Leukemias","authors":"Praveen Sharma, Tharageswari Srinivasan, Nabhajit Mallik","doi":"10.1055/s-0043-1772204","DOIUrl":"https://doi.org/10.1055/s-0043-1772204","url":null,"abstract":"Abstract Acute lymphoblastic leukemias (ALLs) are hematological neoplasms characterized by clonal proliferation of lymphoid blasts, which can be B- or T-cell type. Flow cytometric immunophenotyping is an integral component in establishing blast lineage during the diagnostic workup of ALLs, aiding in appropriate therapy, prognostication, and monitoring of the disease. The current review focuses on the utility of flow cytometry in the workup of ALLs, including the usefulness of various antibodies and pitfalls in diagnosis.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136168606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Recent advances in the field of hemato-oncology have significantly improved outcomes for patients. However, these changes have also increased the complexity of investigations required at the time of diagnosis and during the follow-up of these patients. Close interaction and exchange of information between the pathologist and the clinician is important for sucessful management of patients. This article briefly discusses the advances in the field and the impact of these changes on the management of patients. A clinician's perspective of what is required from a hematopathologist while managing patients in the current era is presented. An attempt is made to classify the requirements as to what is expected in ideal as well as in resource-limited settings.
{"title":"What Does an Adult Hemato-Oncology Physician Expect from a Hematopathologist?","authors":"Fen Tity Saj, Prasanth Ganesan","doi":"10.1055/s-0043-1768567","DOIUrl":"https://doi.org/10.1055/s-0043-1768567","url":null,"abstract":"Recent advances in the field of hemato-oncology have significantly improved outcomes for patients. However, these changes have also increased the complexity of investigations required at the time of diagnosis and during the follow-up of these patients. Close interaction and exchange of information between the pathologist and the clinician is important for sucessful management of patients. This article briefly discusses the advances in the field and the impact of these changes on the management of patients. A clinician's perspective of what is required from a hematopathologist while managing patients in the current era is presented. An attempt is made to classify the requirements as to what is expected in ideal as well as in resource-limited settings.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"67 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136168605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Identification of underlying cytogenetic (CG) aberrancies plays a significant role in risk stratification of hematological malignancies. These abnormalities can be due to aberrancies that affect the number or structure of chromosomes. Numerical chromosomal abnormalities are called aneuploidies, which result from either gain or loss of whole chromosomes. Ploidy assessment by CG is a laborious and less sensitive technique. With the aid of fluorescent nucleic acid binding dyes, the total DNA content and different phases of the cell cycle specific to any population of interest can be deciphered and analyzed by flow cytometry (FCM). DNA index (DI), a parameter derived by FCM DNA analysis, is equivalent to conventional CG-based ploidy assessment. In this study, the technical aspects and implications of FCM DNA assessment among patients diagnosed with acute lymphoblastic leukemia and plasma cell myeloma are discussed.
{"title":"Flow Cytometric Ploidy Analysis in Acute Lymphoblastic Leukemia and Plasma Cell Myeloma","authors":"Karthik Bommannan","doi":"10.1055/s-0043-1776046","DOIUrl":"https://doi.org/10.1055/s-0043-1776046","url":null,"abstract":"Abstract Identification of underlying cytogenetic (CG) aberrancies plays a significant role in risk stratification of hematological malignancies. These abnormalities can be due to aberrancies that affect the number or structure of chromosomes. Numerical chromosomal abnormalities are called aneuploidies, which result from either gain or loss of whole chromosomes. Ploidy assessment by CG is a laborious and less sensitive technique. With the aid of fluorescent nucleic acid binding dyes, the total DNA content and different phases of the cell cycle specific to any population of interest can be deciphered and analyzed by flow cytometry (FCM). DNA index (DI), a parameter derived by FCM DNA analysis, is equivalent to conventional CG-based ploidy assessment. In this study, the technical aspects and implications of FCM DNA assessment among patients diagnosed with acute lymphoblastic leukemia and plasma cell myeloma are discussed.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136168603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Advances in the care of cancer patients are almost always due to clinical trials that demonstrate improved patient outcomes in terms of better survival or improved quality of life. Pharmaceutical companies invest a large amount of time, effort, and money in developing novel agents, but only a few of these end up actually changing patient care. Agents such as imatinib, osimertinib, trastuzumab, rituximab, and pembrolizumab, among others, are prime examples of this approach. A recent analysis found that the median cost of development of an anticancer drug was $648.0 million.[1]
{"title":"Local Clinical Trials: The Need of the Hour to Improve Global Cancer Care","authors":"Apar Kishor Ganti","doi":"10.1055/s-0043-1768568","DOIUrl":"https://doi.org/10.1055/s-0043-1768568","url":null,"abstract":"Advances in the care of cancer patients are almost always due to clinical trials that demonstrate improved patient outcomes in terms of better survival or improved quality of life. Pharmaceutical companies invest a large amount of time, effort, and money in developing novel agents, but only a few of these end up actually changing patient care. Agents such as imatinib, osimertinib, trastuzumab, rituximab, and pembrolizumab, among others, are prime examples of this approach. A recent analysis found that the median cost of development of an anticancer drug was $648.0 million.[1]","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135345252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Molecular analysis of biospecimens is the key to diagnostic and therapeutic decisions in clinical practice. However, there is a lack of consolidated guidelines for biospecimen collection, tissue handling, and storage in India. Therefore, this study aims to generate expert recommendations for the optimization of tissue handling and processing practices in India in the era of precision medicine. This study aimed to evaluate the clinical gaps related to tissue handling for molecular analysis and develop expert recommendations to mitigate preanalytical issues associated with biospecimen processing. These expert recommendations will help in increasing the diagnostic yield and accuracy of biomarker testing in clinical practice. A virtual advisory board meeting was convened with 19 experts, including pathologists, molecular biologists, medical oncologists, surgical oncologists, interventional radiologists, and a senior histology technician from 10 hospitals in India, along with an accreditation officer for testing and calibration of laboratory procedures. The scientific coordinators developed specific questions to address the salient issues associated with the preanalytic phase of tissue specimen preparation. The experts discussed each question until a complete set of recommendations was obtained. The expert panel provided recommendations for tissue collection, processing, fixation, and block preparation to ensure high-quality biospecimens. As per the expert panel recommendations, tissue sampling can be performed from any easily accessible site, regardless of the primary or metastatic locations. In addition, the cold ischemia time should be <1 hour, 10% neutral-buffered formalin should be used as the fixative, isopropyl alcohol should be used as the dehydrating agent, the volume of tissue to fixative ratio should be 1:10, and all the paraffin blocks should be archived in dry, pest-free conditions at room temperature. The experts suggested that the formalin used for fixation should be freshly prepared and its pH should be checked daily; moreover, the pH and date of formalin preparation should be mentioned on the containers. The experts highlighted the need to educate multidisciplinary teams on the optimization of tissue handling practices and emphasized that a pathologist should always check the tissue for adequate quality and quantity for biomarker testing. The existing routine clinical procedures for collecting and handling biospecimens adversely affect their quality. The expert recommendations for preanalytical quality control would ensure high-quality biospecimens for molecular analysis and precision medicine.
{"title":"Optimization of Tissue Handling and Processing in the Era of Precision Medicine: A Practical Recommendation from a Multidisciplinary Panel of Indian Experts","authors":"Rajiv Kumar Kaushal, Santosh Menon, Omshree Shetty, Tanuja Shet, Sangeeta Desai, Anurag Mehta, Anuradha Choughule, Bivas Biswas, Divya Midha, Gurudutt Gupta, Jaya Ghosh, Jay Mehta, Kumar Prabhash, Sayed Mahmood Nadeem, S P. Somashekhar, Ujwala Joshi, Veena Ramaswamy, Veeraiah Koppula, Sudeep Gupta","doi":"10.1055/s-0043-1774752","DOIUrl":"https://doi.org/10.1055/s-0043-1774752","url":null,"abstract":"Abstract Molecular analysis of biospecimens is the key to diagnostic and therapeutic decisions in clinical practice. However, there is a lack of consolidated guidelines for biospecimen collection, tissue handling, and storage in India. Therefore, this study aims to generate expert recommendations for the optimization of tissue handling and processing practices in India in the era of precision medicine. This study aimed to evaluate the clinical gaps related to tissue handling for molecular analysis and develop expert recommendations to mitigate preanalytical issues associated with biospecimen processing. These expert recommendations will help in increasing the diagnostic yield and accuracy of biomarker testing in clinical practice. A virtual advisory board meeting was convened with 19 experts, including pathologists, molecular biologists, medical oncologists, surgical oncologists, interventional radiologists, and a senior histology technician from 10 hospitals in India, along with an accreditation officer for testing and calibration of laboratory procedures. The scientific coordinators developed specific questions to address the salient issues associated with the preanalytic phase of tissue specimen preparation. The experts discussed each question until a complete set of recommendations was obtained. The expert panel provided recommendations for tissue collection, processing, fixation, and block preparation to ensure high-quality biospecimens. As per the expert panel recommendations, tissue sampling can be performed from any easily accessible site, regardless of the primary or metastatic locations. In addition, the cold ischemia time should be <1 hour, 10% neutral-buffered formalin should be used as the fixative, isopropyl alcohol should be used as the dehydrating agent, the volume of tissue to fixative ratio should be 1:10, and all the paraffin blocks should be archived in dry, pest-free conditions at room temperature. The experts suggested that the formalin used for fixation should be freshly prepared and its pH should be checked daily; moreover, the pH and date of formalin preparation should be mentioned on the containers. The experts highlighted the need to educate multidisciplinary teams on the optimization of tissue handling practices and emphasized that a pathologist should always check the tissue for adequate quality and quantity for biomarker testing. The existing routine clinical procedures for collecting and handling biospecimens adversely affect their quality. The expert recommendations for preanalytical quality control would ensure high-quality biospecimens for molecular analysis and precision medicine.","PeriodicalId":13513,"journal":{"name":"Indian Journal of Medical and Paediatric Oncology","volume":"99 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135479050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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