Diagnosis of Oral Cancers by Targeting VPAC Receptors: Preliminary Report.

INTRODUCTION: Oral cancer is a major health problem. The study of exfoliative cytology material helps in the differentiation of premalignant and malignant alterations of oral lesions. The objective of this study was to assess the feasibility of detecting oral cancer by targeting genomic VPAC (combined vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase-activating peptide) receptors expressed on malignant oral cancer cells. PATIENTS & METHODS: All patients with suspected oral cavity cancers/lesions formed the study group. The samples from the oral cavity lesion or suspicious area were collected with a cytology brush. The harvested material was examined for malignant cells by 1. the standard PAP stain and 2. targeting the VPAC receptors on the cell surface using a fluorescent microscope. Similarly, malignant cells were identified from cells shed in oral gargles. RESULTS: A total of 60 patients with oral lesions were included in the study. The histopathological diagnosis was squamous cell carcinoma in 30 of these. The VPAC receptor positivity both on the brush cytology staining as well oral gargle staining was more sensitive than the brush cytology PAP staining. The accuracy of the various techniques was as follows, brush cytology PAP staining at 86.67%, brush cytology VPAC staining at 91.67% and oral gargle VPAC staining at 95%. CONCLUSIONS: This preliminary study validates our belief that malignant cells in the saliva can be identified by targeting the VPAC receptors. The test is simple, easy, non-invasive and reliable in the detection of oral cancers.

Plasmablastic Lymphoma of the Endometrium: A Rare Site for Primary Presentation.

Global incidence of non-Hodgkin's lymphoma (NHL) is 3% of which 1% occurs in extranodal lymphoma. Plasmablastic lymphoma (PBL) is a rare and aggressive variant of diffuse large B-cell lymphoma (DLBCL). It is usually seen in human immunodeficiency virus (HIV) infected patients. PBL occurring in extranodal site, particularly female genital tract, is very rare, and only few case reports have been reported. Here, we report a unique rare case of uterine PBL in an HIV/Epstein-Barr virus-negative patient that was initially diagnosed as endometrioid carcinoma.

Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab.

BACKGROUND: BCD-021 is a bevacizumab biosimilar which was shown to be equivalent to reference bevacizumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to compare efficacy and safety of BCD-021 and reference bevacizumab in combination with paclitaxel and carboplatin in a first-line treatment of inoperable or advanced non-squamous non-small-cell lung cancer (NSCLC). METHODS: Patients with no previous treatment for advanced non-squamous NSCLC were randomly assigned 3:2 to BCD-021 or reference bevacizumab and were treated with bevacizumab + paclitaxel + carboplatin. Therapy continued for 6 cycles (every 3 weeks), until progression of the disease or unbearable toxicity. The primary study endpoint was the overall response rate. The study goal was to prove the equivalent efficacy of BCD-021 and reference bevacizumab. Equivalence margins for 95% CI for the difference in the overall response rates were set at [-18%; 18%], for 90% CI for the ratio of overall response rate were set at [67%; 150%]. RESULTS: In total 357 patients were enrolled in the study, 212 in the BCD-021 group and 145 in the reference bevacizumab group. The ORR was 34.63% in the BCD-022 group and 33.82% in the reference bevacizumab group. Limits of 95% CI for the difference in overall response rates between the groups were [-9.47%; 11.09%]. Limits of 90% CI for the ratio of overall response rate between the groups were [79.6%; 131.73%]. For both approaches CI lied within predetermined equivalence margins. Profile of adverse events (AEs) was similar between the groups (any AEs were reported in 86.89% of patients in BCD-021 group and 89.05% of patients in reference group). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding anti-drug antibody occurrence rate was found between BCD-022 (n=4; 1.96%) and comparator (n=5; 3.65%). Both drug products showed low occurrence rate and short life of anti-bevacizumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures. CONCLUSIONS: Thus, the results of this study demonstrated therapeutic equivalence of bevacizumab biosimilar BCD-021 and referent bevacizumab drug. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov (Study Number NCT01763645, date of registration 09/01/2013).

Submandibular gland extirpation during neck dissection, is it truly justified?

Background: There is no oncologic basis for the extirpation of the submandibular gland (SMG) in early oral squamous cell carcinomas (OSCC) unless the SMG is truly infiltrated by the tumor. The study aimed at assessing the true involvement of SMG in OSCC and to determine whether the gland extirpation in all cases is justified. Methods: This study prospectively evaluated the pathological involvement of SMG by OSCC in 281 patients, who were diagnosed with OSCC and underwent wide local excision of the primary tumor with simultaneous neck dissection. Results: Among 281 patients, 29 (10%) cases underwent bilateral neck dissection. A total of 310 SMG were evaluated. Involvement of SMG was seen in 5 (1.6%) cases. SMG metastases from Level Ib were seen in 3 (0.9%) of cases, whereas 0.6% showed direct SMG infiltration from the primary tumor. The advanced floor of mouth and lower alveolus cases had a higher tendency to infiltrate SMG. In none of the cases, bilateral or contralateral SMG was involved. Conclusion: The findings of this study show that the extirpation of SMG in all cases is truly irrational. Preserving the SMG is justified in early OSCC with no nodal metastasis. However, SMG preservation is case dependent and is an individual preference. Further studies are required to assess the locoregional control rate and salivary flow rate in postradiotherapy cases where SMG is preserved.

Concurrent Weekly Cisplatin and Simultaneous Integrated Boost-IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma-An Institutional Experience.

Introduction Concurrent chemoradiation with weekly cisplatin in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is widely practiced in India. Radiation with simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) has the advantage of executing IMRT in single phase with better dose distribution. Material and Methods 150 patients with LA-HNSCC treated between April 2015 and December 2019 were retrospectively evaluated. All patients received 70Gy in 33 to 35 fractions with SIB-IMRT and concurrent weekly cisplatin at a dose of 40 mg/m 2 . Treatment compliance and toxicities were assessed. Overall survival (OS) was evaluated using Kaplan-Meier estimates; univariate and multivariate analysis of prognostic factors were also evaluated. Results Median age was 58.5 years. Forty-five percent had primary oropharyngeal cancer. Sixty-two percent had T3 disease, 41% had N2 disease, and 51% had stage IV disease. All patients received 70Gy dose of RT. Median chemotherapy cycles were six, 84.7% received 200 mg/m 2 . Acute grade 2 xerostomia was seen in 79%, grade 3 neutropenia, mucositis and pharyngitis were seen in 11, 15, and 21%, respectively. Complete response was seen in 66.6%. At median follow-up of 21.4 months (3-71) OS was 60% and median OS was 33.2 months. Estimated 2 and 3 year OS was 56 and 48%. On univariate analysis, absence of node, N0-N1, stage III, cisplatin use, dose per fraction 2.12Gy ,and complete response showed good OS ( p <0.05). On multivariate analysis dose per fraction 2.12Gy and complete response showed good OS ( p <0.05). Conclusion Definitive chemoradiation with weekly cisplatin and SIB-IMRT in LA-HNSCC is well tolerated with good clinical outcomes.

Predictive factors for loco regional recurrence and distant metastasis following primary surgical treatment of cutaneous melanoma.

BACKGROUND: Cutaneous melanoma (CM) has a high propensity for regional and systemic spread. This is one of the largest series of CM reported from India. AIMS: To predict factors for loco regional recurrence (LRR) and distant metastasis in patients with CM primarily treated with surgery. STUDY DESIGN: Retrospective analysis of patient database at a tertiary care cancer center with evaluation of factors for LRR and distant metastasis for CM. MATERIALS AND METHODS: Data from 68 patients treated for CM between January 2006 and December 2010 were reviewed. Data recorded included age, sex, symptoms, investigations, treatment given, histopathology, recurrence and follow-up. Patient factors, tumor factors, pathologic variables, and adjuvant treatment were investigated as predictors' of LRR and distant metastasis. RESULTS: Mean age of patients was 54 years. Melanoma was more common in males (44). Tumor thickness > 4 mm was found in 43 patients. Lymph node involvement was found in 43 patients. Adjuvant radiotherapy was given in seven patients. At mean follow-up of 16.5 months, LRR was seen in 34 patients and distant metastasis in 28 patients. LRR and distant metastasis were more commonly found in females, age > 40 years, Clark's level IV and V, Breslow's depth > 4 mm, patients with lymph node involvement and extra-capsular spread. CONCLUSION: The age, sex, site, thickness of lesion, involvement of lymph node, and extra-capsular spread were important factors in predicting LRR and distant metastasis. Distant metastasis was also more commonly found in patients with LRR.