Aims: The study aimed to evaluate the safety and efficacy of afatinib in locally advanced or metastatic nonsmall cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations, in Indian subset of a Phase IIIB open-label study. Methods: A multicenter, open-label, Phase IIIB study was conducted to evaluate afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced/metastatic EGFRm + NSCLC across five countries (34 sites; China, Hong Kong, India, Singapore, and Taiwan). A total 541 patients were recruited, out of which 50 patients were from India. In this article, we have evaluated the safety and tolerability of afatinib in Indian subset of patients (n = 50). Treatment with afatinib was continued until lack of clinical benefit as determined by the investigator. Primary endpoint was safety in terms of patients with serious adverse events (SAEs). Secondary endpoints included number of patients with drug-related AEs, time to symptomatic progression (TTSP), and progression-free survival (PFS). Results: Forty-six out of 50 patients experienced at least one AE. As in the overall study, diarrhea was the most common drug-related AE in Indian patients. In majority (85%) of cases, severity of diarrhea was of grade 1 or 2. No new safety concern was identified in the study. Median TTSP and PFS were 13.43 months (95% confidence interval [CI]: 8.51, 18.33) and 10.08 months (95% CI: 7.32, 14.75), respectively, in Indian subset. Conclusions: Safety and tolerability of afatinib were consistent with overall study and previously reported data. Most of the AEs were manageable without any need of treatment discontinuation.

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Primary ureteral carcinoma is rare among all urogenital malignancies, with transitional cell carcinoma being the most common histology followed by squamous cell carcinoma. Adenocarcinoma is extremely rare. Herein, we report a case of primary mucin secreting adenocarcinoma of the right lower ureter in a 67-year-old male. Contrast-enhanced computed tomography (CECT) scan showed a large cystic mass occupying the whole abdomen along with a mass in the lower third of the right ureter mimicking as a giant renal mass. Ureteroscopy followed by laparotomy including right nephroureterectomy with bladder cuff excision was performed. On histopathological examination, the CECT scan-based suspected giant renal mass revealed to be xanthogranulomatous pyelonephritis of the kidney along with primary mucin secreting adenocarcinoma of the ureter.

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Ifosfamide-induced encephalopathy (IIE) is a rare adverse event and is usually transient and reversible. However, it may cause permanent neurological dysfunction and even death if not addressed early. The use of aprepitant and presence of acute kidney injury may precipitate IIE. In this report, a 55-year-old female presented with a 3-month history of abdominal mass and bleeding per vagina and was diagnosed as locally advanced high-grade uterine leiomyosarcoma. She underwent surgery followed by adjuvant radiotherapy and combination chemotherapy with doxorubicin plus ifosfamide regimen. During her third cycle chemotherapy, despite dose adjustment of ifosfamide according to patient's creatinine clearance, the patient became aphasic, disoriented, and landed in a stuporous state. After complete evaluation and ruling out other causes, she was diagnosed with IIE for which she was treated with methylene blue and thiamine. This patient showed dramatic response within 8 h of methylene blue administration and complete recovery within 24 h. Our report focuses on the risk factors for the development of IIE and the persistent risk despite ifosfamide dose adjustment according to creatinine clearance.

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Background: Fallopian tube specimens are studied either in conjunction with ovaries, uterus, and cervix or alone. However, there is less knowledge about the spectrum of histopathological changes in these specimens due to paucity of data. Aim: This study aims to describe the spectrum of histopathological changes with frequency observed in the resected fallopian tube specimens, especially to detect the malignant precursor lesions and malignancy rate. Materials and Methods: Four hundred and ninety-four patients of resected fallopian tubes either separately or along with other female genital tract organs were retrospectively reviewed for histopathological findings. Hematoxylin- and eosin-stained histopathology slides were retrieved and re-examined. The distal fimbriated end was longitudinally sectioned for examination of fimbrial epithelium. The “sectioning and extensively examining the fimbriated end” (SEE-FIM) sampling protocol was used. Results: Out of 494 resected specimens, 247 patients (50%) had some kind of fallopian tube pathology. Fibrosis was the most common lesion observed in 59 cases followed by hematosalpinx (33 cases). Primary neoplasm was seen in 3 (0.6%) of specimens and all were of serous adenocarcinoma histology. Whereas, secondary malignancies were seen in 2 cases (0.4%), with primary being ovary. Four cases of serous tubal intraepithelial carcinoma (STIC) (0.8%) were detected using SEE-FIM protocol. Conclusion: A thorough histopathological examination including SEE-FIM protocols should be followed for detection of various fallopian tube lesions, which will eventually help in appropriate patient workup and treatment. Early detection of precursor lesions such as STIC and prompt treatment intervention may help in the prevention of ovarian malignancies.

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Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a distressing side-effect of cancer chemotherapy which may lead to noncompliance with treatment or delay in treatment. Breakthrough nausea and vomiting is the current unmet need in the management in of CINV. Objectives: The present study was planned to determine the prevalence of breakthrough CINV in patients on highly emetogenic chemotherapy (HEC) and to evaluate the need for rescue medications in them. Materials and Methods: The present observational study was conducted on chemotherapy-naive patients, who were scheduled to receive HEC. The patients who received at least 2 cycles of HEC over a 1-year study period enrolled as a study sample. All patients were subjected to a questionnaire which consists of the demographic details, details of disease and prescribed chemotherapy, and probable risk factors for CINV. The severity of nausea vomiting was calculated using the Multinational Association of Supportive Care in Cancer antiemetic tool. The incidence of breakthrough nausea vomiting was assessed and accordingly the rescue medication was used. Results: A total of 100 patients received at least 2 cycles of HEC which consisted of breast carcinomas (n = 74), ovarian carcinoma (n = 13), lung carcinoma (n = 2), periampullary carcinoma (n = 3), sarcoma (n = 4), lymphoma (n = 3), and seminoma (n = 1). Anthracycline-cyclophosphamide combination for breast cancer was the most prescribed chemotherapy regimen. Forty-six patients developed breakthrough nausea/vomiting. Domperidone followed by olanzapine was the preferred rescue medications used. History of CINV in previous cycle and young age (<50 years) were the risk factors associated with breakthrough nausea vomiting in our study. Conclusion: Breakthrough nausea vomiting is a major challenge in patients receiving HEC regimen.

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Background: There is limited real-world evidence on the treatment outcomes with Trastuzumab, specifically with biosimilars. This analysis aims to evaluate the safety and effectiveness of Trastuzumab in early and/or locally advanced breast cancer patients treated with neoadjuvant-adjuvant treatment in the real world setting and to compare biosimilar with reference trastuzumab. Materials and Methods: We retrospectively analyzed the data of patients with human epidermal growth factor receptor-2 (HER-2)-positive breast cancers, who were treated with trastuzumab-based standard therapies. The survival curves were generated using the Kaplan–Meier method. Event-free survival (EFS) was calculated. All patients were assessed for toxicity as per CTCAE version 4.0. The subgroup analysis was carried out to compare the effectiveness of biosimilar with reference trastuzumab. Results: A total of 88 patients were evaluated from 2008 to 2018. EFS at 1, 2, and 5-year was 89.5%, 78%, and 44.2%, respectively. The median EFS was 43 months. In subgroup analysis, the 1, 2-, and 3-year EFS rates were 86.7%, 86.7%, and 57.8%, respectively, for reference Trastuzumab (n = 29) as compared to 91%, 74.4%, and 56.9%, respectively, for Biosimilar Trastuzumab (n = 59). Similarly, median EFS was 43 months and not reached, respectively. There was no significant difference in EFS between the two groups (P = 0.991). A significant asymptomatic decrease in the left ventricular ejection fraction (LVEF) of ≥10% to below the lower limit of normal was noted in only two patients (2.3%). There was no significant difference observed in reduction of LVEF to below the lower limit of normal between the two groups (P = 0.514). The common grade 3/4 adverse events (AEs) observed such as vomiting, diarrhea, pancytopenia, and anemia were mostly due to chemotherapy. These AEs were comparable in both groups. Conclusions: The EFS in our study is consistent with the historical data. Safety and effectiveness of biosimilars were comparable to the reference transtuzumab.

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Background: Better planning of limited resources in oncology is possible with more real-world data of lung cancer, one of the most common causes of cancer related mortality in India and Globe. Aim: This study aimed to evaluate the clinical profile and treatment outcomes in patients with Stage IV adenocarcinoma of lung at our center. Materials and Methods: One hundred and eighty-two patients with Stage IV adenocarcinoma of lung were prospectively screened and analyzed, of which 107 patients who met the inclusion criteria were included in the final analysis. Patients with epidermal growth factor receptor (EGFR) and echinodermal microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) genomic alterations were treated with tyrosine kinase inhibitors and others were treated as per standard chemotherapy regimens. Response rates (RRs), progression-free survival (PFS), and overall survival (OS) were measured. Results: Median age of patients was 55.6 years (range, 26–82) with a male-to-female ratio of 1.23:1. Analyses for EGFR and EML4-ALK alterations were possible for 104 (96.3%) patients and were detected in 31.7% and 8.7% patients, respectively. The overall RR for the entire cohort was 51.4%, while median PFS and median OS were 6.9 and 13.7 months, respectively. Median PFS for the EGFR-mutated and ALK-rearranged group was 9.6 and 10.2 months, respectively, which was higher than non-EGFR non-ALK patients. Median OS for the whole cohort was 13.7 months, while median OS was not reached for EGFR and ALK altered groups. Conclusions: As patients with driver mutations like EGFR and ALK have better prognosis than those who do not, every patient diagnosed with advanced nonsmall cell lung cancer should be offered mutational analysis.

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Background: Primary tracheal cancers (PTC) are uncommon, and the treatment methods vary considerably. Aim: The aim of the present study was to explore the clinical features, management, and prognosis of PTC in an Indian context. Methods: Nineteen patients of PTC were retrieved from the medical records over a period from January 2013 to December 2019. The clinical profile, histological features, and treatment details were recorded and outcomes are analyzed in terms of progression-free survival (PFS) and overall survival (OS). Results: Histological distribution for the cases were squamous cell carcinoma (SCC) (n = 12), adenoid cystic carcinoma (ACC) (n = 6) and small cell carcinoma (n = 1). All the patients were symptomatic. SCC was located more (7 out of 12 cases; 58.33%) in the lower third of the trachea than ACC (2 out of 6 cases; 33.33%). At initial diagnosis, five patients had metastatic disease and all the cases were of SCC histology (4 cases treated with palliative chemotherapy and 1 case received best supportive care). Among nonmetastatic cases (n = 14), 4 patients (SCC: 2; ACC: 2) were considered for primary surgery and the rest were considered unresectable and treated with other modalities except one case of ACC who did not come for treatment after diagnosis. The median PFS for ACC patients was higher than SCC (32 months vs. 10 months; P = 0.013). The median OS for ACC was higher than SCC cases (34.5 months vs. 11.2 months; P = 0.009). Conclusions: SCC followed by ACC are the most common histology types for PTC. ACC has a better prognosis compared to SCC.

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