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 OstwalBackground 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. Materials and Methods 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. The data was analyzed for clinical characteristics, response rates, and survival outcomes. Results A total of 26 physicians contributed data, resulting in 55 patients receiving ramucirumab and being available for analysis. Median age was 53 years (range: 26-78), 69.1% of patients had greater than two sites of disease, and baseline Eastern Cooperative Oncology Group's performance score (ECOG PS) ≥ 2 was seen in 61.8% of patients. Ramucirumab was used as monotherapy in 10.9% of patients, while the remaining 89.1% received ramucirumab combined with chemotherapy. Median event-free survival (EFS) and median overall survival (OS) with ramucirumab were3.53 months (95% CI: 2.5-4.57) and 5.7 months (95% CI: 2.39-9.0), respectively. Common class specific grade adverse events seen with ramucirumab included gastrointestinal (GI) hemorrhage (9.1% - all grades) and uncontrolled hypertension (Grade 3/4 - 3.6%). Conclusions Ramucirumab appears to have similar efficacy in Indian AGC patients when compared with real-world data from other countries in terms of median EFS, but OS appears inferior due to more patients having borderline ECOG PS and high metastatic disease burden. GI hemorrhages appear more common than published data, although not unequivocally related to ramucirumab.

CONCORDANCE: A real-world evidence study to evaluate the concordance of detecting epidermal growth factor receptor (EGFR) mutation by circulating tumor DNA* versus tissue biopsy in patients with metastatic non-small cell lung cancer.

Background: Molecular tissue testing in non-small cell lung cancer (NSCLC) is done for the assessment of epidermal growth factor receptor (EGFR) mutation. EGFR mutation status is the basis for deciding the targeted treatment option for patients with metastatic NSCLC. The nonavailability of tissue samples and contraindications for biopsy pose a significant challenge. Hence, circulating tumor DNA (ctDNA) by liquid biopsy can be a viable alternative for NSCLC patients. Methods: This study was conducted at 15 sites across India. EGFR mutation testing from plasma was done as part of the study at the central laboratory by the next-generation sequencing (NGS) method, and EGFR mutation test results from tissue samples (done as part of routine practice) were recorded for all the patients. Results: Out of the total patients enrolled (N = 245), the majority (64.5%, n = 158) were men. The median age of patients was 58.0 (range: 26-84) years. The concordance between plasma and tissue testing was found to be 82.9% (95% confidence interval [CI]: 77.55, 87.45). The sensitivity and specificity of NGS were 68.4% (95% CI: 56.92, 78.37) and 90.1% [95% CI: 84.36, 94.21), respectively. Plasma testing detected 1.2% (n = 3) and tissue sample testing detected 2.4% (n = 6) positive status of exon 20 T790M EGFR mutation. Out of the total number of patients enrolled, 25 were tissue positive and plasma negative, while 16 were plasma positive and tissue negative. Conclusions: "> This real-world study in Indian patients suggests that plasma testing for EGFR mutation analysis is a viable diagnostic option in newly diagnosed advanced/metastatic NSCLC patients. The noninvasive plasma procedure in patients without available/evaluable tumor sample may enable more patients to receive appropriate targeted therapies by providing clinicians with valuable insights into the patient's tumor mutation status. ClinicalTrials.gov Identifier: NCT03562819.

Punjabi version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-OES 18 and Quality of Life Questionnaire-OG25 modules for quality of life assessment.

CONTEXT: Health-related quality of life (HRQOL) assessment plays an important role in the decision-making process in oncology. AIMS: The aim of the study was to translate European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) OES18 and OG25 in Punjabi language for HRQOL assessment of patients diagnosed with esophagus and esophagogastric malignancies. SUBJECTS AND METHODS: The EORTC translation guidelines were duly followed to translate QLQ-OES18 and OG25 into Punjabi language. Each set of questionnaire was independently translated by two forward translators, followed by backward translation of the reconciled version by two independent translators. The final version was submitted to the EORTC Translation Team and served to the patients for the pilot testing. RESULTS: The questionnaire was administered to ten patients each of esophagus and esophagogastric malignancies who were evaluated and treated at our hospital. Every patient underwent an interview to check if any of the questions was difficult, uncomfortable, or upsetting to answer. Their concerns were recorded as per the template provided by the EORTC team and due changes done if required. CONCLUSIONS: The EORTC QLQ-OES18 and OG25 questionnaire has been translated to Punjabi language and subsequently approved for usage.

Multiple Myeloma Presenting as Thyroid Plasmacytoma.

Thyroid gland and thyroid cartilage infiltration in multiple myeloma (MM) are rare. Here, we discuss a patient who presented with hoarseness of voice and was found to have a hypodense lesion in right lobe of thyroid involving thyroid and cricoid cartilage. Fine-needle aspiration cytology with immunohistochemistry revealed extramedullary plasmacytoma of thyroid. MM was ruled out initially by serum protein electrophoresis, immunofixation, and bone marrow biopsy. Later, lytic lesions were found in multiple bones on radiation planning scan and he was finally diagnosed as case of MM with thyroid involvement. Treatment strategies of MM and thyroid plasmacytoma are also discussed briefly.