S. Girish - Academia.edu (original) (raw)

Papers by S. Girish

Research paper thumbnail of A rare case of melanotic malignant trichoblastoma

Journal of cancer research and therapeutics

ABSTRACT Trichoblastoma is a rare benign trichogenic tumor with epithelial and mesenchymal compon... more ABSTRACT Trichoblastoma is a rare benign trichogenic tumor with epithelial and mesenchymal components resembling the germinal hair bulb and associated mesenchyme. [1] Melanotic/pigmented variant of malignant trichoblastoma (MMT) is a rarity and less reported in world literature. [2] We present a case of MMT in a 45-year-old female. There is a need to differentiate this tumor from other pigmented tumors due to its aggressive course and specific management. [1]

Research paper thumbnail of Sternomastoid rupture an index of antemortem hanging-An autopsy study of hundred cases

Research paper thumbnail of Improvement of learning outcome and its measurement using social learning intelligence

2014 International Conference on Interactive Collaborative Learning (ICL), 2014

Research paper thumbnail of Clinico-pathological profile of lung cancer in Uttarakhand

Lung India, 2009

Lung cancer stands one of the most common malignancies causing very high morbidity and mortality.... more Lung cancer stands one of the most common malignancies causing very high morbidity and mortality. An increase in the incidence of lung cancer has been observed in India. The aim of this study is to evaluate the clinico-pathological profile of lung cancer attended in a tertiary referral centre in India. A retrospective analysis was done over those patients who were histopathologically proved cases of primary lung carcinoma. The outpatient and inpatient of the department of Pulmonary Medicine in a tertiary medical college attended during the period from January 2008 to December 2009. A total of 266 cases were studied, and the male to female ratio was 6.6:1. The major age group involved was 41-60 years (52.63%) and the rest were below 40 years group (2.63%). The commonest clinical symptom was cough (68.42%).The most common radiological finding in the chest was a mass or space occupying lesion (55.26%). In most cases there was a history of smoking (81.2%). Commonest mode of diagnosis was made by imaging guided fine needle aspiration cytology in 170 patients (63.91%).The most common histological type of lung cancer was squamous cell carcinoma (35.34%). Majority of cases were diagnosed in the later stages of diseases (71.8%). It was found that squamous cell carcinoma was the most frequent histological type .History of smoking was found in majority of patients. Major patients were diagnosed at the later stages of disease (Stage 3B or 4).

Research paper thumbnail of The effect of ketoprofen in chronic periodontitis: A clinical double-blind study

Journal of Indian Society of Periodontology, 2011

The objective of this double-blind clinical trial was to evaluate the effects of the nonsteroidal... more The objective of this double-blind clinical trial was to evaluate the effects of the nonsteroidal anti-inflammatory drug (NSAID), ketoprofen, on patients with chronic periodontitis. Two similar local drug delivery preparations of a poloxamen gel containing 1.5% ketoprofen and a placebo were indigenously prepared for this purpose. Ten subjects aged 33-55 years with moderate to severe chronic periodontitis were recruited and were monitored for a period of 90 days. Three sites in each patient (total 30 sites) with a probing pocket depth of 5-8 mm were selected and divided randomly into three groups: 1) group A: scaling and rootplaning (SRP) + drug A; 2) group B: SRP + drug B; and 3) group C: SRP. Clinical parameters and blood smear (from intracrevicular blood) were assessed to determine the differential count and Arneth index. All parameters were assessed at baseline, 30 days and 90 days, respectively. Highly significant values were achieved for plaque index (P=0.00), and significant values were obtained for gingival index (P=0.044). Reduction in bleeding on probing was found to be highly significant. Probing depth and clinical attachment level showed no inter group variation. The results of this double-blind trial indicate that the combined effect of locally delivered ketoprofen with SRP was more effective in controlling periodontal disease than SRP alone.

Research paper thumbnail of Effect of aggressive environments on composite properties

Journal of Applied Polymer Science, 1999

Research paper thumbnail of Random safety audits in the neonatal unit

Archives of Disease in Childhood - Fetal and Neonatal Edition, 2009

Random safety audits have been shown to be effective in improving standards of practice in high-r... more Random safety audits have been shown to be effective in improving standards of practice in high-risk industries. They are process audits rapidly performed during real-time clinical activity, with immediate feedback, allowing for immediate change of practice. Based on a concept described by the Vermont-Oxford Network, we aimed to introduce random safety audits to our unit to improve infection control and routine neonatal care. We designed simple data collection tables to audit 11 infection control and four routine care standards. Audits were undertaken during the weekly grand round. Immediate feedback was given. In 6 months we completed three cycles of 15 audits each. Complete results were available for 14 audits. The compliance with the infection control standards improved from a median of 70% (range 20%-100%) to 95% (range 66%-100%). The results of the routine care standards were more variable. We have shown that this innovative method of random safety audits is effective in quickly improving practice. We believe this to be due to the instant feedback, continued emphasis on infection control and good clinical practice, and improved teamwork.

Research paper thumbnail of Abstract A136: Nonclinical disposition, metabolism, and in vitro drug-drug interaction assessment of DM1, a component of trastuzumab emtansine (T-DM1)

Molecular Cancer Therapeutics, 2011

Research paper thumbnail of 5020 Pharmacokinetics (PK), safety, and efficacy of trastuzumab (T)-DM1, a HER2 antibody-drug conjugate (ADC), in patients with HER2+ metastatic breast cancer (MBC): phase I and phase II trial results

European Journal of Cancer Supplements, 2009

In this large study, safety and efficacy of Bev combined with taxane-based therapy was similar to... more In this large study, safety and efficacy of Bev combined with taxane-based therapy was similar to E2100 and AVADO results. Bev has minimal impact on the safety profile of CT. Hypertension >G3 was reported in 0.1% of pts (4% G3) and only 1 pt (<0.1%) had Bev-related cerebral haemorrhage. No new Bev-related safety signals were observed. Roche sponsored MO19391.

Research paper thumbnail of Abstract P5-18-11: Pharmacokinetics and exposure-efficacy relationship of trastuzumab emtansine in EMILIA, a phase 3 study of trastuzumab emtansine vs capecitabine and lapatinib in HER2-positive locally advanced or metastatic breast cancer

Research paper thumbnail of 2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer

European Journal of Cancer Supplements, 2007

Research paper thumbnail of Potential Mechanisms for Thrombocytopenia Development with Trastuzumab Emtansine (T-DM1)

Clinical Cancer Research, 2014

These experiments may impact patient care by increasing our understanding of mechanisms of trastu... more These experiments may impact patient care by increasing our understanding of mechanisms of trastuzumab emtansine (T-DM1)-induced thrombocytopenia. T-DM1

Research paper thumbnail of A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine

Journal of Clinical Oncology, 2012

To determine whether the antibody-drug conjugate trastuzumab emtansine (T-DM1), which combines hu... more To determine whether the antibody-drug conjugate trastuzumab emtansine (T-DM1), which combines human epidermal growth factor receptor 2 (HER2) -targeted delivery of the potent antimicrotubule agent DM1 with the antitumor activity of trastuzumab, is effective in patients with HER2-positive metastatic breast cancer (MBC) who have previously received all standard HER2-directed therapies. In this single-arm phase II study, T-DM1 3.6 mg/kg was administered intravenously every 3 weeks to patients with HER2-positive MBC who had prior treatment with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. The primary objectives were overall response rate (ORR) by independent review and safety. Among 110 pretreated patients (median, seven prior agents for MBC; median follow-up, 17.4 months), the ORR was 34.5% (95% CI, 26.1% to 43.9%), clinical benefit rate was 48.2% (95% CI, 38.8% to 57.9%), median progression-free survival (PFS) was 6.9 months (95% CI, 4.2 to 8.4 months), and median duration of response was 7.2 months (95% CI, 4.6 months to not estimable). In patients with confirmed HER2-positive tumors (n = 80 by retrospective central testing), the response rate was 41.3% (95% CI, 30.4% to 52.8%), and median PFS was 7.3 months (95% CI, 4.6 to 12.3 months). Most adverse events were grades 1 to 2; the most frequent grade ≥ 3 events were thrombocytopenia (9.1%), fatigue (4.5%), and cellulitis (3.6%). T-DM1 is well tolerated and has single-agent activity in patients with HER2-positive MBC who have previously received both approved HER2-directed therapies and multiple chemotherapy agents. T-DM1 may be an effective new treatment for this patient population.

Research paper thumbnail of Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer

Journal of Clinical Oncology, 2010

Trastuzumab-DM1 (T-DM1) is an antibody-drug conjugate that uses trastuzumab to specifically deliv... more Trastuzumab-DM1 (T-DM1) is an antibody-drug conjugate that uses trastuzumab to specifically deliver the maytansinoid antimicrotubule agent DM1 to HER2-positive cells. This first-in-human study of T-DM1 evaluated safety, pharmacokinetics, and preliminary activity of T-DM1 in patients with advanced HER2-positive breast cancer.

Research paper thumbnail of Population Pharmacokinetics of Trastuzumab-DM1, a First-in-Class HER2 Antibody-Drug Conjugate Given Every 3 Weeks (q3w) and Weekly (qw) to Patients with HER2-Positive Metastatic Breast Cancer (MBC)

Research paper thumbnail of Abstract P3-14-22: Pharmacokinetics (PK) of Trastuzumab-DM1 (T-DM1) and Paclitaxel (T) in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing Regimen

Research paper thumbnail of Abstract P3-14-06: Pharmacokinetic (PK) Interaction Potential of Trastuzumab-DM1 (T-DM1) and Pertuzumab (P) in Pts with HER2-Positive, Locally Advanced or MBC: Results from a Phase 1b/2 Study

Research paper thumbnail of A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer

Research paper thumbnail of P1-12-13: Comparative Pharmacokinetics (PK) of Trastuzumab Emtansine (T-DM1) in Patients Who Have or Who Have Not Received Prior Treatment for Human Epidermal Growth Factor 2 (HER2)-Positive Metastatic Breast Cancer (MBC)

Research paper thumbnail of P1-12-07: Pharmacokinetics (PK) of Trastuzumab Emtansine and Paclitaxel or Docetaxel in Patients with HER2-Positive MBC Previously Treated with a Trastuzumab-Containing Regimen

Research paper thumbnail of A rare case of melanotic malignant trichoblastoma

Journal of cancer research and therapeutics

ABSTRACT Trichoblastoma is a rare benign trichogenic tumor with epithelial and mesenchymal compon... more ABSTRACT Trichoblastoma is a rare benign trichogenic tumor with epithelial and mesenchymal components resembling the germinal hair bulb and associated mesenchyme. [1] Melanotic/pigmented variant of malignant trichoblastoma (MMT) is a rarity and less reported in world literature. [2] We present a case of MMT in a 45-year-old female. There is a need to differentiate this tumor from other pigmented tumors due to its aggressive course and specific management. [1]

Research paper thumbnail of Sternomastoid rupture an index of antemortem hanging-An autopsy study of hundred cases

Research paper thumbnail of Improvement of learning outcome and its measurement using social learning intelligence

2014 International Conference on Interactive Collaborative Learning (ICL), 2014

Research paper thumbnail of Clinico-pathological profile of lung cancer in Uttarakhand

Lung India, 2009

Lung cancer stands one of the most common malignancies causing very high morbidity and mortality.... more Lung cancer stands one of the most common malignancies causing very high morbidity and mortality. An increase in the incidence of lung cancer has been observed in India. The aim of this study is to evaluate the clinico-pathological profile of lung cancer attended in a tertiary referral centre in India. A retrospective analysis was done over those patients who were histopathologically proved cases of primary lung carcinoma. The outpatient and inpatient of the department of Pulmonary Medicine in a tertiary medical college attended during the period from January 2008 to December 2009. A total of 266 cases were studied, and the male to female ratio was 6.6:1. The major age group involved was 41-60 years (52.63%) and the rest were below 40 years group (2.63%). The commonest clinical symptom was cough (68.42%).The most common radiological finding in the chest was a mass or space occupying lesion (55.26%). In most cases there was a history of smoking (81.2%). Commonest mode of diagnosis was made by imaging guided fine needle aspiration cytology in 170 patients (63.91%).The most common histological type of lung cancer was squamous cell carcinoma (35.34%). Majority of cases were diagnosed in the later stages of diseases (71.8%). It was found that squamous cell carcinoma was the most frequent histological type .History of smoking was found in majority of patients. Major patients were diagnosed at the later stages of disease (Stage 3B or 4).

Research paper thumbnail of The effect of ketoprofen in chronic periodontitis: A clinical double-blind study

Journal of Indian Society of Periodontology, 2011

The objective of this double-blind clinical trial was to evaluate the effects of the nonsteroidal... more The objective of this double-blind clinical trial was to evaluate the effects of the nonsteroidal anti-inflammatory drug (NSAID), ketoprofen, on patients with chronic periodontitis. Two similar local drug delivery preparations of a poloxamen gel containing 1.5% ketoprofen and a placebo were indigenously prepared for this purpose. Ten subjects aged 33-55 years with moderate to severe chronic periodontitis were recruited and were monitored for a period of 90 days. Three sites in each patient (total 30 sites) with a probing pocket depth of 5-8 mm were selected and divided randomly into three groups: 1) group A: scaling and rootplaning (SRP) + drug A; 2) group B: SRP + drug B; and 3) group C: SRP. Clinical parameters and blood smear (from intracrevicular blood) were assessed to determine the differential count and Arneth index. All parameters were assessed at baseline, 30 days and 90 days, respectively. Highly significant values were achieved for plaque index (P=0.00), and significant values were obtained for gingival index (P=0.044). Reduction in bleeding on probing was found to be highly significant. Probing depth and clinical attachment level showed no inter group variation. The results of this double-blind trial indicate that the combined effect of locally delivered ketoprofen with SRP was more effective in controlling periodontal disease than SRP alone.

Research paper thumbnail of Effect of aggressive environments on composite properties

Journal of Applied Polymer Science, 1999

Research paper thumbnail of Random safety audits in the neonatal unit

Archives of Disease in Childhood - Fetal and Neonatal Edition, 2009

Random safety audits have been shown to be effective in improving standards of practice in high-r... more Random safety audits have been shown to be effective in improving standards of practice in high-risk industries. They are process audits rapidly performed during real-time clinical activity, with immediate feedback, allowing for immediate change of practice. Based on a concept described by the Vermont-Oxford Network, we aimed to introduce random safety audits to our unit to improve infection control and routine neonatal care. We designed simple data collection tables to audit 11 infection control and four routine care standards. Audits were undertaken during the weekly grand round. Immediate feedback was given. In 6 months we completed three cycles of 15 audits each. Complete results were available for 14 audits. The compliance with the infection control standards improved from a median of 70% (range 20%-100%) to 95% (range 66%-100%). The results of the routine care standards were more variable. We have shown that this innovative method of random safety audits is effective in quickly improving practice. We believe this to be due to the instant feedback, continued emphasis on infection control and good clinical practice, and improved teamwork.

Research paper thumbnail of Abstract A136: Nonclinical disposition, metabolism, and in vitro drug-drug interaction assessment of DM1, a component of trastuzumab emtansine (T-DM1)

Molecular Cancer Therapeutics, 2011

Research paper thumbnail of 5020 Pharmacokinetics (PK), safety, and efficacy of trastuzumab (T)-DM1, a HER2 antibody-drug conjugate (ADC), in patients with HER2+ metastatic breast cancer (MBC): phase I and phase II trial results

European Journal of Cancer Supplements, 2009

In this large study, safety and efficacy of Bev combined with taxane-based therapy was similar to... more In this large study, safety and efficacy of Bev combined with taxane-based therapy was similar to E2100 and AVADO results. Bev has minimal impact on the safety profile of CT. Hypertension >G3 was reported in 0.1% of pts (4% G3) and only 1 pt (<0.1%) had Bev-related cerebral haemorrhage. No new Bev-related safety signals were observed. Roche sponsored MO19391.

Research paper thumbnail of Abstract P5-18-11: Pharmacokinetics and exposure-efficacy relationship of trastuzumab emtansine in EMILIA, a phase 3 study of trastuzumab emtansine vs capecitabine and lapatinib in HER2-positive locally advanced or metastatic breast cancer

Research paper thumbnail of 2118 POSTER A phase I study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer

European Journal of Cancer Supplements, 2007

Research paper thumbnail of Potential Mechanisms for Thrombocytopenia Development with Trastuzumab Emtansine (T-DM1)

Clinical Cancer Research, 2014

These experiments may impact patient care by increasing our understanding of mechanisms of trastu... more These experiments may impact patient care by increasing our understanding of mechanisms of trastuzumab emtansine (T-DM1)-induced thrombocytopenia. T-DM1

Research paper thumbnail of A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine

Journal of Clinical Oncology, 2012

To determine whether the antibody-drug conjugate trastuzumab emtansine (T-DM1), which combines hu... more To determine whether the antibody-drug conjugate trastuzumab emtansine (T-DM1), which combines human epidermal growth factor receptor 2 (HER2) -targeted delivery of the potent antimicrotubule agent DM1 with the antitumor activity of trastuzumab, is effective in patients with HER2-positive metastatic breast cancer (MBC) who have previously received all standard HER2-directed therapies. In this single-arm phase II study, T-DM1 3.6 mg/kg was administered intravenously every 3 weeks to patients with HER2-positive MBC who had prior treatment with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. The primary objectives were overall response rate (ORR) by independent review and safety. Among 110 pretreated patients (median, seven prior agents for MBC; median follow-up, 17.4 months), the ORR was 34.5% (95% CI, 26.1% to 43.9%), clinical benefit rate was 48.2% (95% CI, 38.8% to 57.9%), median progression-free survival (PFS) was 6.9 months (95% CI, 4.2 to 8.4 months), and median duration of response was 7.2 months (95% CI, 4.6 months to not estimable). In patients with confirmed HER2-positive tumors (n = 80 by retrospective central testing), the response rate was 41.3% (95% CI, 30.4% to 52.8%), and median PFS was 7.3 months (95% CI, 4.6 to 12.3 months). Most adverse events were grades 1 to 2; the most frequent grade ≥ 3 events were thrombocytopenia (9.1%), fatigue (4.5%), and cellulitis (3.6%). T-DM1 is well tolerated and has single-agent activity in patients with HER2-positive MBC who have previously received both approved HER2-directed therapies and multiple chemotherapy agents. T-DM1 may be an effective new treatment for this patient population.

Research paper thumbnail of Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer

Journal of Clinical Oncology, 2010

Trastuzumab-DM1 (T-DM1) is an antibody-drug conjugate that uses trastuzumab to specifically deliv... more Trastuzumab-DM1 (T-DM1) is an antibody-drug conjugate that uses trastuzumab to specifically deliver the maytansinoid antimicrotubule agent DM1 to HER2-positive cells. This first-in-human study of T-DM1 evaluated safety, pharmacokinetics, and preliminary activity of T-DM1 in patients with advanced HER2-positive breast cancer.

Research paper thumbnail of Population Pharmacokinetics of Trastuzumab-DM1, a First-in-Class HER2 Antibody-Drug Conjugate Given Every 3 Weeks (q3w) and Weekly (qw) to Patients with HER2-Positive Metastatic Breast Cancer (MBC)

Research paper thumbnail of Abstract P3-14-22: Pharmacokinetics (PK) of Trastuzumab-DM1 (T-DM1) and Paclitaxel (T) in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with a Trastuzumab-Containing Regimen

Research paper thumbnail of Abstract P3-14-06: Pharmacokinetic (PK) Interaction Potential of Trastuzumab-DM1 (T-DM1) and Pertuzumab (P) in Pts with HER2-Positive, Locally Advanced or MBC: Results from a Phase 1b/2 Study

Research paper thumbnail of A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2+ breast cancer

Research paper thumbnail of P1-12-13: Comparative Pharmacokinetics (PK) of Trastuzumab Emtansine (T-DM1) in Patients Who Have or Who Have Not Received Prior Treatment for Human Epidermal Growth Factor 2 (HER2)-Positive Metastatic Breast Cancer (MBC)

Research paper thumbnail of P1-12-07: Pharmacokinetics (PK) of Trastuzumab Emtansine and Paclitaxel or Docetaxel in Patients with HER2-Positive MBC Previously Treated with a Trastuzumab-Containing Regimen