Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide.

A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph.

A novel EML4-NTRK3 fusion in lung adenocarcinoma with dramatic response to entrectinib.

In-frame fusions in NTRK genes, with intact kinase domain, have been reported to occur at higher frequencies in rare tumors like infantile fibrosarcoma, congenital mesoblastic nephroma, and secretory carcinoma, whereas they occur at very low frequencies in common malignancies like NSCLC and colon cancers (0.1%-1%). Despite the rare occurrence, these alterations have gained importance owing to approval of drugs like entrectinib and larotrectinib targeting the kinase domain of the gene.

Clinical and Epidemiological Profile of Elderly Hodgkin's Lymphoma in India.

Background Hodgkin's lymphoma (HL) is a curable malignancy that commonly involves the younger population. However, HL can rarely occur in the elderly population (≥60 years) and probably has different biology as compared to the younger counterparts. There was a paucity of data on the clinical and epidemiological profile of the elderly subset with HL in Indian patients who are misdiagnosed and empirically treated as tuberculosis.

Ramucirumab in Indian Patients with Advanced Gastric Cancer-Does Borderline Performance Status and Heavy Burden of Disease in Real World Practice Impact Clinical Benefit?

Vikas Ostwal  Ramucirumab is considered a standard of care as second-line therapy (CT2) in advanced gastric cancers (AGCs). The aim of this study was to assess practice patterns and outcomes with ramucirumab among Indian patients with AGCs.  A computerized clinical data entry form was formulated by the coordinating center's (Tata Memorial Hospital) medical oncologists and disseminated through personal contacts at academic conferences as well as via email for anonymized patient data entry.

All EGFR mutations are (not) created equal: focus on uncommon EGFR mutations.

Purpose: Most common EGFR mutations in NSCLC include del19 and exon 21 L858R. Approximately 10% of patients have uncommon EGFR mutations (indels, missense mutations involving G719, L861 and S768 codons, and exon 20 insertions) that do not respond to TKIs.

Methods: Of 490 EGFR mutated NSCLC samples, 60 cases harboring uncommon/compound EGFR mutations were reviewed retrospectively, and 44 were included for survival analysis.

Molecular Response Assessment with Immune Adaptive PERCIST in Lung Cancer Patients Treated with Nivolumab: Is It Better Than iRECIST?

 We compared the immune response evaluation criteria in solid tumors (iRECIST) with immune adaptive positron emission tomography response criteria in solid tumors (imPERCIST) in lung cancer patients treated with nivolumab.  Twenty lung cancer patients underwent fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) scan at baseline (PET-0), after four cycles (PET-1) and six to eight cycles (PET-2) of nivolumab were included. Kappa coefficient ( ) was derived to see the level of agreement in two response criteria.

EGFR detection by liquid biopsy: ripe for clinical usage.

With the International Association for the Study of Lung Cancer (IASLC) recommendations promoting liquid biopsy as a primary detection tool, a new era of research has begun. The authors aimed to study the concordance of plasma genotyping platforms against the tissue gold standard. 184 patients with non-small cell lung cancer underwent EGFR genotyping using Cobas, droplet digital polymerase chain reaction (ddPCR) and Therascreen assays from 2019-2020.

Are all ALK variants created equal? Clinicopathologic features and outcomes: a propensity-matched study.

Anaplastic lymphoma kinase (ALK) rearranged NSCLC comprises a molecularly distinct subgroup occurring in 10% cases. Various EML4-ALK and non EML4 variants are known to occur which can be detected only on NGS and show differential TKI responses. 113 ALK-IHC positive cases were subjected to a custom panel-based NGS for detection of ALK variants.

Adjuvant chemotherapy in uterine carcinosarcoma: Comparison of a doublet and a triplet chemotherapeutic regimen.

Background: Uterine carcinosarcoma (UCS) is a rare and aggressive malignancy, and there are no existing standard guidelines for adjuvant therapy. Doublet chemotherapy regimens are most favored in adjuvant setting; however, given the early chances of distant recurrences, does a triple-drug adjuvant chemotherapy improve disease-free survival (DFS), remains to be seen. Our aim of the study is to compare and review different adjuvant regimens used in UCS.

IHC versus FISH versus NGS to detect ALK gene rearrangement in NSCLC: all questions answered?

Aims: Anaplastic lymphoma kinase () rearranged non-small cell lung carcinoma (NSCLC) is a distinct molecular subtype and rapid approval of tyrosine kinase inhibitors (TKIs) has necessitated rapid and sensitive diagnostic modalities for the detection of this alteration. Gene rearrangements can be identified using many techniques including fluorescence in situ hybridisation (FISH), reverse transcriptase-PCR, next-generation sequencing (NGS) and immunohistochemistry (IHC) for fusion oncoprotein expression. We aimed to determine the concordance between IHC, FISH and NGS for biomarker detection, and determine differences in sensitivity, and survival outcomes.

EGFR and PDL1: A Match (Not) Made in Heaven-A Real-World Retrospective Analysis of PDL1 Expression in EGFR-Mutated NSCLC.

Introduction: EGFR (epidermal growth factor receptor) mutant NSCLC (non-small cell lung carcinoma) comprises 35-40% of cases in the Asian NSCLC cohort, compared to 15-20% in the rest of the world. Improved response rates have been observed in terms of PFS (progression-free survival) and ORR (overall response rate) when treated with EGFR TKIs (tyrosine kinase inhibitors). However, resistance eventually ensues regardless of the generation of TKI used.

Next generation sequencing for detection of alterations in NSCLC: is more better?

Aims: The emergence of sophisticated next generation sequencing (NGS) based technologies in routine molecular diagnostics has paved the way for robust and accurate detection of variants which may otherwise be missed on single gene testing. This study aims at highlighting the same premise in EGFR mutated non-small cell lung carcinoma (NSCLC).

Methods: 1350 cases of NSCLC were screened, of which 490 EGFR mutated cases were taken.

A Walk with Lu-177 PSMA: How Close we Have Reached from Bench to Bedside?

Metastatic castration-resistant prostate cancer (mCRPC) is a natural sequela in advanced prostate cancer following resistance to standard treatment regimes, where patients develop with rising PSA, bone pains, and high disease volume. Further palliative treatment is the need of the hour for ensuring disease control and quality of life. In recent times, many novel methods have been evolved for these patients.

Role of F-Flurodeoxyglucose Positron-Emission Tomography/Computed Tomography in the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients with Locally Advanced Triple-Negative Breast Cancer.

Background: Response evaluation in locally advanced breast cancer is done through different methods ranging from clinical examination to magnetic resonance imaging, however evaluation with positron-emission tomography/computed tomography (PET/CT) in now being incorporated for the response evaluation. The aim of the present study is to correlate response to neoadjuvant chemotherapy (NACT) with PET/CT scan.

Materials And Methods: The present study is a retrospective analysis of 30 locally advanced, triple-negative breast cancer patients.

Real world experience of treatment and outcome in ALK-rearranged metastatic nonsmall cell lung cancer: A multicenter study from India.

Background: Anaplastic lymphoma kinase (ALK) rearranged metastatic non-small cell lung cancer (NSCLC) comprises 5%-7% of all lung cancer and carries a good prognosis with available ALK-inhibitors. Majority of registration trials in ALK-inhibitors did not include Indian patients. Hence, this study was planned to analyze the outcome of Indian patients treated with ALK-inhibitors and associated challenges.

Efficacy and tolerability of nimotuzumab in combination with chemotherapy in recurrent and metastatic squamous cell carcinoma of head and neck at a cancer center in Northern India.

Introduction: Squamous cell carcinoma of head and neck (SCCHN) account for approximately 30-33% of all cancer and the median survival for recurrent and metastatic(R/M) SCCHN remains less than 1 year despite modern advances in therapy. Chemotherapy, usually single agent remains the backbone of therapy in these patients. EGFR antibodies are being used in (R/M) SCCHN.

Spark Plasma Sintering Effect on Thermoelectric Properties of Nanostructured Bismuth Telluride Synthesized by High Energy Ball Milling.

Thermoelectric properties of high energy ball milled nano structured bismuth telluride (Bi₂Te₃) have been reported. By high energy ball milling, alloyed bulk crystalline ingots crush into nanopowder and followed by spark plasma sintering (SPS), we have demonstrate high figure of merit (ZT) in bismuth telluride pellet samples. In this work systematic study carried out on three pellet samples of Bi₂Te₃, synthesized by high ball milling for the time period of 4 hours, 8 hours and 12 hours and followed by SPS at the same processing parameters.

Synthesis of Highly Transparent Indium Tin Oxide Thin Films Using Vacuum Evaporation Technique.

The synthesis of thin films of ITO (Indium Tin Oxide) is synthesized by thermal evaporation technique under high vacuum conditions and further annealing at different conditions of temperature. These films were further characterized by using SEM, XRD, AFM, photoluminescence spectroscopy and UV-Visible in order to understand the structural and optical properties associated with them. Parameters to synthesize uniform, homogeneous, single phase and highly transparent ITO thin films have been optimized.

Ki-67 labeling index as a predictor of response to neoadjuvant chemotherapy in breast cancer.

Aims: To investigate Ki-67 index with regard to its ability to predict achievement of pathologic complete response (pCR) to neoadjuvant chemotherapy (NACT) in breast cancer patient.

Material And Methods: It was a prospective observational study, conducted in Department of Medical Oncology, Rajiv Gandhi Cancer Institute & Research Center (RGCIRC), New Delhi from February 2014 to March 2016. A total of 134 patients with Stage II/III breast cancer who underwent NACT followed by surgery at our center were enrolled and analyzed.

Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study.

The present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and validation of analytical methods. The candidate standard for Insulin lispro was evaluated in a collaborative study to assign the vial content in order to serve it as NRS to support the Indian Pharmacopoeia (IP) monograph. The candidate standard was calibrated against the Ph.

Frequency of T790M mutations after progression on epidermal growth factor receptor tyrosine kinase inhibitor in metastatic non-small cell lung cancer in Indian patients: real-time data from tertiary cancer hospital.

Aim: The aim of this study is to determine the incidence of T790M mutations after progression on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) and median duration on TKI before progression on TKI.

Methods: Records of Rajiv Gandhi Cancer Institute and Research Centre, of patients who were diagnosed with metastatic adenocarcinoma of the lung and progressed on oral EGFR TKIs and underwent T790M mutation analysis in the last 6 months were retrospectively reviewed. The incidence of T790M positivity, sites of progression, and median duration of TKI treatment before progression was calculated.