V. Parmar | Homi Bhabha National Institute (HBNI, BARC, MUMBAI) (original) (raw)

Papers by V. Parmar

Indian Journal of Surgical Oncology, 2021

The ACOSOG Z0011 study, heralded as a "practice changing" trial, suggested that women with T1-2 b... more The ACOSOG Z0011 study, heralded as a "practice changing" trial, suggested that women with T1-2 breast cancer with 1-2 SLN+, undergoing breast conservation therapy, need not be offered further ALND. However, whether these results are applicable to all women in the Indian setting, it remains debatable. A retrospective audit of all cN0 operated from 2013 to 2018 was conducted. We analyzed the percentage of additional LN positive (LN+) in the ALND group and compared it to the ACOZOG Z11 trial. Of the 2350 cN0 with EBC who underwent LAS, 687 (29%) had positive lymph nodes on final histopathology. Five hundred ninety-seven (86.9%) patients had 1-2 LN+, 40 (5.8%) patients had 3 LN+, and 50 (7.3%) had 4 or more nodes positive. Demographic features in the ACOSOG Z11 are different from those in our study, looking at ACOZOG Z11 versus our cohortmedian pT 1.7 cm versus 3 cm, 45% micrometastasis versus 99.16% macrometastasis, and 28-30% grade 3 tumors versus 73.7%. In our cohort 31.82% of the 1-2 LN positive had additional LN+ on ALND. Keeping in mind the difference in clinicopathological features between our cohort and that of ACOZOG Z0011 and that 31.82% of women had additional LN+ on ALND, it may not be appropriate to apply the results of the ACOSOG Z0011 trial directly to our general population. Possibly, only a select subset of patients who match the trial population of the ACOSOG Z11 could be offered observation of the axilla and validated nomograms can be used to identify high-risk patients.

Asian Pacific Journal of Cancer Prevention, 2021

Cancer has become the leading cause of death among non-communicable diseases in at least half of ... more Cancer has become the leading cause of death among non-communicable diseases in at least half of the countries worldwide. Cancer accounted for 233.5 million Disability Adjusted Life Years (DALYs) in 2017 Among all cancer related DALYs 97% was attributed to Years of Life Lost (YLL) and 3% was attributed to Years of Live with Disability (YLD) (Fitzmaurice et al., 2019). Of the 18.1 million cancers diagnosed globally in 2018, about 2.1 million were of breast cancer. Breast cancer is the leading type of cancer in 80% of the countries and the leading cause of cancer mortality in the majority of the countries (Bray et al., 2018).The incidence and mortality

Clinical Oncology, 2017

Aims: (1) To confirm the existence of a constant node in the axilla that drains the lymphatics of... more Aims: (1) To confirm the existence of a constant node in the axilla that drains the lymphatics of the upper limb. (2) To identify the percentage of cases in which the ARM node harbours metastasis in clinically/pathological N0, N1, N2 and N3 disease. Methods: 100 breast cancer patients between April 2012 and May 2013 were studied. Patients who had previous surgery or chemotherapy were excluded. All patients had an injection of radio-isotope (99mTc sulpher colloid) into the second and third web spaces of the hand after anaesthesia. Complete axillary dissection was done in all patients. A gamma probe was used to identify and remove the ARM node. Results: The ARM node was successfully identified in 92/100 cases. The location of the ARM node was found to be lateral to the subscapular pedicle and above the second ICB nerve, just below the axillary vein in about 90% of cases (83/92). Of the 92 patients in whom ARM was done and node was identified, it was pathologically involved with metastasis in 9 patients. 4/11 patients with N3 disease (36%), 4/22 (18%) patients with N2 disease and 1/23 (4.3%) (P ¼ 0.56) patients with N1 disease had metastasis in the ARM node. Conclusion: ARM node is identifiable in 92% of cases by isotope. Its location is constant in 90% of cases. There is a definite role of preservation of ARM node in clinically N0 and N1 cases and during SLNB. Even if there is no facility for SLNB, preservation of the area lateral to subscapular vessels, above the second IC nerve and below the axillary vein may preserve the ARM node and lymphatics.

Radiotherapy and Oncology, 2017

ESTRO 36 ________________________________________________________________________________________... more ESTRO 36 _______________________________________________________________________________________________ technique, showed an equivalent 1.5% rate of LR at a median 5-year follow-up time. Also age could play an important role in a multifactorial patient's selection; the recently published subgroup analysis of the Florence trial concerning patients aged 70 years or older, showed an IBTR rate at 5 years of 1.9%, and significantly better results in terms of acute skin toxicity, in favor of APBI arm. Therefore, tumor biology seems to play a crucial role on patient's selection; treatment decisions should always consider disease stage, comorbidities, and tumor biomarkers. Longer follow-up of recently presented studies with appropriately selected patients will be critical to define the rates of local control, survival, and long-term toxicity before APBI could be accepted as a standard alternative to conventional WBI. Outcome results from ongoing unpublished prospective trials (e. g. RAPID, IRMA, SHARE, NSABP B-39/RTOG 0413 trials) are awaited.

The National medical journal of India

Targeted sentinel node biopsy has been extensively validated. It has been incorporated into stand... more Targeted sentinel node biopsy has been extensively validated. It has been incorporated into standard guidelines for axillary prediction in women with clinically node-negative operable breast cancer. However, the high cost of the gamma probe and the need for radiocolloid have limited its widespread acceptance in developing countries. We aimed to validate low axillary sampling as a reliable alternative method to sentinel node biopsy in a developing country. An anatomically guided low axillary sampling removes the lower level I axillary fat with lymph nodes and the method was validated by completing axillary clearance in all women. Three hundred fifty-five women with clinically node-negative operable breast cancer underwent validation of low axillary sampling, with lymph nodes identified in all of them. The median number of nodes identified in low axillary sampling was 5 with overall node-positivity of 32.1% (114 of 355). Ten of these 114 patients were wrongly identified as node-negati...

Cancer Research, 2013

BACKGROUND: The role of loco-regional treatment, in women with metastatic breast cancer (MBC) at ... more BACKGROUND: The role of loco-regional treatment, in women with metastatic breast cancer (MBC) at first presentation, is debatable. Preclinical evidence suggests that such treatment may facilitate growth of metastatic disease. On the other hand, many retrospective analyses in clinical cohorts have suggested favorable impact of loco-regional treatment in these patients. However, these results are likely to be influenced by selection bias. We conducted a prospective randomized controlled trial to assess the impact of loco-regional treatment on outcome in women with metastatic breast cancer at initial diagnosis. [NCT00193778] METHODS: Women with metastatic breast cancer at initial diagnosis and planned to be treated with anthracycline based chemotherapy (CT) were registered for the study. Those who had objective tumor response after 6 cycles of CT were randomized to one of the following arms: ‘LRT’ (loco-regional treatment) or ‘No-LRT’ (no loco-regional treatment). Patients were stratif...

European Journal of Cancer Supplements, 2008

The Breast, 2005

The local disease-free survival at 3 years was in favor of conservation (85% Vs 76%, p=0.03). The... more The local disease-free survival at 3 years was in favor of conservation (85% Vs 76%, p=0.03). The DFS at 5 years after conservation surgery Vs mastectomy was 60% Vs 30% (p<0.0001). The predictive factors for response to chemotherapy and prognostic factors for recurrence have been analyzed and will be presented at the meeting. Conclusion: Breast conservation therapy is technically feasible and safe in women with locally advanced breast cancer after sufficient down-staging with neo-adjuvant chemotherapy.

The Breast, 2005

Background: Recent results demonstrated strong evidence for the routine use of the invasion marke... more Background: Recent results demonstrated strong evidence for the routine use of the invasion markers urokinase-type plasminogen activator (uPA) and its inhibitor PAl-1 as prognostic factors in node-negative breast cancer. Lowrisk patients have an excellent 5-year overall survival (>95%) even without any adjuvant therapy. In contrast to risk estimation by St.Gallen criteria, the use of these invasion markers have shown to spare adjuvant chemotherapy for a substantial part of all node-negative breast cancer patients. In addition, patients with high uPA/PAI-1 seem to have enhanced benefit from adjuvant chemotherapy. The NNBC-3 Europe trial seeks to answer two questions: 1) Is risk assessment by invasion markers uPA/PAI-1 superior to that by clinico-pathological factors with regard to identification of low-risk patients? 2) Is adjuvant chemotherapy using an anthracycline-taxane containing sequence (FEC-Docetaxel) superior to standard FEC in high-risk patients? Methods: In the NNBC-3 Europe trial, participating centres opt to either perform risk estimation by traditional clinico-pathological factors or by invasion markers uPA/PAI-I. Low-risk patients will then be observed without adjuvant chemotherapy. High-risk patients are randomised to adjuvant chemotherapy (FEC-100 *6 versus FEC-100 *3 followed by Docetaxel-100 *3). All patients with steroid hormone receptor positive tumors receive adequate endocrine therapy. Results: Of the first 171 patients (16 centers) in the tumor-biological arm, 14 (8%) had grade 1 tumors, and 63(37%) had grade 3 tumors. Among grade 2 tumors, 55% (n=94), 38(40%) had low levels of uPA (med. 1,0ng/mg protein) and PAl-1 (med. 8,2ng/mg); 56 (60%) patients presented with elevated values: uPA (med. 3,2ng/mg) and PAl-1 (med. 21,3ng/mg). Grade 3 tumors showed uPA at 2,7ng/mg and PAl-1 at 20,5ng/mg (med.). Overall, 30% of patients were allocated to the low-risk group, with no adjuvant chemotherapy. Conclusion: Conducting an adjuvant chemotherapy trial based on uPA/PAI-1 determination is feasible in a multicentre setting. Applying the invasion markers uPA/PAI-1 for risk assessment, in the first study patients, almost 52 were assigned to the low-risk group. Thus, in this early phase of the study, patient distribution shows to be in line with the expected distribution. The study is planned to recruit 5700 patients. This study is performed in association with the EORTC Receptor and Biomarker Group and the German AGO Breast Group.

The Breast, 2007

IHC), tumor stage II to IIIb (T2 > 2 cm, T3, T4b, N0−2, M0) non suitable for conservative surgery... more IHC), tumor stage II to IIIb (T2 > 2 cm, T3, T4b, N0−2, M0) non suitable for conservative surgery. Inflammatory or T4a tumors were excluded. The primary endpoint was to determine the median duration of treatment to optimal response defined as the interval of time required to achieve the maximal response by clinical exam. The ratio of clinical responses and the frequency of conservative surgery were secondary objectives. Results: Seventy patients have been recruited in four centers from June 2003 to September 2005. This report includes a preliminary efficacy analysis with the first 30 patients. Median age: 79.8 years (68−91), Stage T2 N0 (59.1%), ER[+] (95.4%). No severe adverse event was reported, and only minor muscle-esqueletal symptoms were noted. The median time to objective and to maximal response were 3.5 months (2.3−4.7) and 4.2 months (4.0−4.4) respectively. At the time of maximal response, the ORR was 80.0%; 53.3% obtaining a PR and 26.7% a CR. Conclusions: Letrozole shows a high activity and tolerability as neoadjuvant endocrine therapy in elderly patients with endocrine dependent criteria breast cancer. Mature results with the optimal duration of this approach will be helpful to increase local disease control. The poster will include a final efficacy analysis with 70 recruited patients.

International Journal of Surgery, 2006

Introduction: In absence of randomized evidence to support safety of conservative surgery (BCT) i... more Introduction: In absence of randomized evidence to support safety of conservative surgery (BCT) in locally advanced breast cancer (LABC), we analyzed a cohort of 664 women with LABC treated during

Indian Journal of Cancer, 2011

BACKGROUND: This study was undertaken to document the pattern of expression of estrogen (ER), pro... more BACKGROUND: This study was undertaken to document the pattern of expression of estrogen (ER), progesterone (PR) and human epidermal growth factor receptor-2 (HER2) and the usage of HER2-targeted therapy in a large tertiary care hospital in India in the year 2008. MATERIALS AND METHODS: The histopathology reports of all breast cancer patients registered in the hospital in 2008 were extracted from the electronic medical record system. All the cases were immunohistochemically evaluated for estrogen and progesterone receptor status (ER and PR), and c-erbB-2 protein (HER2) expression using standard immunoperoxidase method. The use of HER2-targeted therapies was evaluated by extracting relevant information from the database of the hospital pharmacy and case charts of patients enrolled in ongoing approved trials. RESULTS: A total of 2001 new patients of invasive breast cancers with available pathology reports were registered in the hospital in the year 2008. ER and/or PR expression was positive in tumors of 1025 (51.2%) patients. HER2 3+ expression by immunohistochemistry (IHC) was found in 335 (16.7%) and HER2 2+ in 163 (8.1%). The triple negative phenotype was found in 596 (29.8%) patients. An estimated 441 patients were eligible to receive HER2-targeted therapy based on their HER2 status. Of these 38 (8.6%) patients received some form of HER2-targeted therapy; 20 patients (4.5%) as part of ongoing clinical trials and 18 (4.1%) as part of routine care. CONCLUSIONS: The overwhelming majority of patients eligible for HER2-targeted therapy in our institution are unable to receive it because of financial constraints and limited access to health insurance. There is a higher fraction of patients with the triple negative phenotype compared to the Western population.

European Journal of Cancer, 2011

Diseases of the Esophagus, 2003

The right subclavian artery normally arises from the brachiocephalic artery. Anomalies in develop... more The right subclavian artery normally arises from the brachiocephalic artery. Anomalies in development may lead to peculiar problems during surgery. We report a patient with esophageal carcinoma who had an aberrant right subclavian artery, posing specific difficulties during a transhiatal esophagectomy, requiring conversion of the procedure into a transthoracic approach. The embryologic basis of this anomaly and the clinical significance are discussed.

Clinical Oncology, 2012

Aim: To study the toxicity profile and response rates of weekly paclitaxel given as neoadjuvant c... more Aim: To study the toxicity profile and response rates of weekly paclitaxel given as neoadjuvant chemotherapy (NACT) in patients with locally advanced breast cancer. Materials and methods: The study was planned as a single arm, prospective phase II study. Twenty-six patients with locally advanced breast cancer were enrolled in the study from December 2006 to October 2007. These patients underwent NACT with weekly paclitaxel at 100 mg/m 2 for 8 consecutive weeks followed by surgery. This was followed by anthracycline-based chemotherapy for three to four cycles followed by radiation. The patients received standard adjuvant hormonal therapy. The patients were carefully monitored for side-effects using common toxicity criteria. The clinical and pathological response rates were documented. The response rates were descriptively stated. Results: The median age of the patients was 52 years (30e67 years) and the median tumour size was 7 cm (2.5e15 cm). Of the 208 planned weekly cycles, 207 could be given. The rates of grade 3e4 neutropenia, thrombocytopenia and neuropathy were 4, 12 and 4%, respectively. A complete clinical response was observed in 10 patients (38.5%) and a completed pathological response, defined as the absence of invasive cancer from the breast and axillary nodes, was seen in 11.5% of patients. Breast-conserving surgery was possible in 23% of patients. Conclusion: The regimen of weekly single agent paclitaxel is feasible in patients with locally advanced breast cancer with acceptable toxicity. It resulted in a pathological response rate that was comparable with other regimens in this group of advanced stage patients. Considering the efficacy and low toxicity of this regimen, it is worth exploring in larger studies.

Cancer Research, 2009

Introduction: Early detection of breast cancer is known to have a more favourable outcome. Curren... more Introduction: Early detection of breast cancer is known to have a more favourable outcome. Currently clinical breast examination and imaging modalities, primarily mammography are used for screening purposes. In India, more than 85% of the population is below the age of 50 years, wherein the sensitivity of mammography is at best 64%. Additional drawbacks of the procedure are physical discomfort and ionizing radiation dose to the patient. So newer techniques have been investigated which detect cancer induced neovascularity with digital thermal imaging. The purpose of this clinical study was to determine the efficacy of a software assisted thermal image analysis tool to distinguish between benign and malignant lesions of the breast.Methods: A prospective study was conducted in women who presented to the breast clinic with clinically or mammographically suspicious breast lesions. They also underwent thermal imaging of the breast. All mammographically suspicious lumps were subjected to h...

Radiotherapy and Oncology, 2018

ESTRO 37 S566 institutional studies can be challenging due to different Experience Level (EL). Th... more ESTRO 37 S566 institutional studies can be challenging due to different Experience Level (EL). The aim of this work was to preliminary evaluate the role of a re-planning phase in a multi-institutional study for achieving similar plan quality results and for further benchmarking. Material and Methods 45 prostate SBRT plans from 9 centers were included. EL was ranked as 1 for 'no experience", 2 for '<100 SBRT prostate cases planned" and 3 for '≥100 SBRT prostate cases planned". Each center was provided with 5 anonymized CTs with pre-delineated volumes and was asked to create SBRT plans according to pre-set dose constraints. Dose prescription was 7Gyx5fr. The DVH text file and the RP_DICOM of each plan were used to extract dosimetric parameters, modulation indexes, and dynamic parameters from IMRT/VMAT plans. Results were summarized in a Spearman-correlation matrix and deemed correlated for R>0.50; statistical significance was set at p=0.01. In a 2 nd phase, planners were asked to re-plan the 5 th patient, based on the median DVHs of all partecipants, for improving target homogeneity and

Breast Cancer, 2019

Background To compare the early cosmetic outcomes after whole breast radiotherapy (WBRT) and acce... more Background To compare the early cosmetic outcomes after whole breast radiotherapy (WBRT) and accelerated partial breast irradiation (APBI) by various cosmetic assessment methods. Materials/methods APBI was delivered using multiplane interstitial brachytherapy as per standard guidelines. Majority of women in WBRT cohort received hypo-fractionated external beam radiotherapy using bitangential portals and mega-voltage photons along with sequential boost to the tumor bed. Single cross-sectional assessment (18-36 months post-treatment completion) of the breast cosmesis was done by RO, SO and the patient using the modified Harvard scale and by photographic assessment using the BCCT.core software. The two cohorts were propensity score-matched using menopausal status, size of surgical cavity, size of tumor in greatest dimension, median number of lymph nodes dissected, treatment with adjuvant chemotherapy and treatment with hormonal therapy. Results A total of 64 APBI patients were matched with 99 WBRT patients of the entire cohort of 320. At a median follow-up of 25 months, cosmetic results were significantly better for APBI as compared to WBRT cohort by all methods of evaluation (excellent/good: RO:75% vs 38.4%, p = 0.0001; SO: 54.7% vs 37.4%, p = 0.009; patient: 87.5% vs 58.6%, p = 0.001 and BCCT: 73.4% vs 51.6%, p = 0.001). Individual parameters that were significantly better in APBI cohort included size and shape of breast as well as location and shape of NAC. Better results for individual BCCT parameters (pLBC, pBRE, pBAD) were also seen. Conclusions Overall cosmetic outcomes as well as individual subdomains are significantly better with APBI as compared to WBRT by all methods of assessment of cosmesis when matched for various factors.

Indian Journal of Surgical Oncology, 2021

The ACOSOG Z0011 study, heralded as a "practice changing" trial, suggested that women with T1-2 b... more The ACOSOG Z0011 study, heralded as a "practice changing" trial, suggested that women with T1-2 breast cancer with 1-2 SLN+, undergoing breast conservation therapy, need not be offered further ALND. However, whether these results are applicable to all women in the Indian setting, it remains debatable. A retrospective audit of all cN0 operated from 2013 to 2018 was conducted. We analyzed the percentage of additional LN positive (LN+) in the ALND group and compared it to the ACOZOG Z11 trial. Of the 2350 cN0 with EBC who underwent LAS, 687 (29%) had positive lymph nodes on final histopathology. Five hundred ninety-seven (86.9%) patients had 1-2 LN+, 40 (5.8%) patients had 3 LN+, and 50 (7.3%) had 4 or more nodes positive. Demographic features in the ACOSOG Z11 are different from those in our study, looking at ACOZOG Z11 versus our cohortmedian pT 1.7 cm versus 3 cm, 45% micrometastasis versus 99.16% macrometastasis, and 28-30% grade 3 tumors versus 73.7%. In our cohort 31.82% of the 1-2 LN positive had additional LN+ on ALND. Keeping in mind the difference in clinicopathological features between our cohort and that of ACOZOG Z0011 and that 31.82% of women had additional LN+ on ALND, it may not be appropriate to apply the results of the ACOSOG Z0011 trial directly to our general population. Possibly, only a select subset of patients who match the trial population of the ACOSOG Z11 could be offered observation of the axilla and validated nomograms can be used to identify high-risk patients.

Asian Pacific Journal of Cancer Prevention, 2021

Cancer has become the leading cause of death among non-communicable diseases in at least half of ... more Cancer has become the leading cause of death among non-communicable diseases in at least half of the countries worldwide. Cancer accounted for 233.5 million Disability Adjusted Life Years (DALYs) in 2017 Among all cancer related DALYs 97% was attributed to Years of Life Lost (YLL) and 3% was attributed to Years of Live with Disability (YLD) (Fitzmaurice et al., 2019). Of the 18.1 million cancers diagnosed globally in 2018, about 2.1 million were of breast cancer. Breast cancer is the leading type of cancer in 80% of the countries and the leading cause of cancer mortality in the majority of the countries (Bray et al., 2018).The incidence and mortality

Clinical Oncology, 2017

Aims: (1) To confirm the existence of a constant node in the axilla that drains the lymphatics of... more Aims: (1) To confirm the existence of a constant node in the axilla that drains the lymphatics of the upper limb. (2) To identify the percentage of cases in which the ARM node harbours metastasis in clinically/pathological N0, N1, N2 and N3 disease. Methods: 100 breast cancer patients between April 2012 and May 2013 were studied. Patients who had previous surgery or chemotherapy were excluded. All patients had an injection of radio-isotope (99mTc sulpher colloid) into the second and third web spaces of the hand after anaesthesia. Complete axillary dissection was done in all patients. A gamma probe was used to identify and remove the ARM node. Results: The ARM node was successfully identified in 92/100 cases. The location of the ARM node was found to be lateral to the subscapular pedicle and above the second ICB nerve, just below the axillary vein in about 90% of cases (83/92). Of the 92 patients in whom ARM was done and node was identified, it was pathologically involved with metastasis in 9 patients. 4/11 patients with N3 disease (36%), 4/22 (18%) patients with N2 disease and 1/23 (4.3%) (P ¼ 0.56) patients with N1 disease had metastasis in the ARM node. Conclusion: ARM node is identifiable in 92% of cases by isotope. Its location is constant in 90% of cases. There is a definite role of preservation of ARM node in clinically N0 and N1 cases and during SLNB. Even if there is no facility for SLNB, preservation of the area lateral to subscapular vessels, above the second IC nerve and below the axillary vein may preserve the ARM node and lymphatics.

Radiotherapy and Oncology, 2017

ESTRO 36 ________________________________________________________________________________________... more ESTRO 36 _______________________________________________________________________________________________ technique, showed an equivalent 1.5% rate of LR at a median 5-year follow-up time. Also age could play an important role in a multifactorial patient's selection; the recently published subgroup analysis of the Florence trial concerning patients aged 70 years or older, showed an IBTR rate at 5 years of 1.9%, and significantly better results in terms of acute skin toxicity, in favor of APBI arm. Therefore, tumor biology seems to play a crucial role on patient's selection; treatment decisions should always consider disease stage, comorbidities, and tumor biomarkers. Longer follow-up of recently presented studies with appropriately selected patients will be critical to define the rates of local control, survival, and long-term toxicity before APBI could be accepted as a standard alternative to conventional WBI. Outcome results from ongoing unpublished prospective trials (e. g. RAPID, IRMA, SHARE, NSABP B-39/RTOG 0413 trials) are awaited.

The National medical journal of India

Targeted sentinel node biopsy has been extensively validated. It has been incorporated into stand... more Targeted sentinel node biopsy has been extensively validated. It has been incorporated into standard guidelines for axillary prediction in women with clinically node-negative operable breast cancer. However, the high cost of the gamma probe and the need for radiocolloid have limited its widespread acceptance in developing countries. We aimed to validate low axillary sampling as a reliable alternative method to sentinel node biopsy in a developing country. An anatomically guided low axillary sampling removes the lower level I axillary fat with lymph nodes and the method was validated by completing axillary clearance in all women. Three hundred fifty-five women with clinically node-negative operable breast cancer underwent validation of low axillary sampling, with lymph nodes identified in all of them. The median number of nodes identified in low axillary sampling was 5 with overall node-positivity of 32.1% (114 of 355). Ten of these 114 patients were wrongly identified as node-negati...

Cancer Research, 2013

BACKGROUND: The role of loco-regional treatment, in women with metastatic breast cancer (MBC) at ... more BACKGROUND: The role of loco-regional treatment, in women with metastatic breast cancer (MBC) at first presentation, is debatable. Preclinical evidence suggests that such treatment may facilitate growth of metastatic disease. On the other hand, many retrospective analyses in clinical cohorts have suggested favorable impact of loco-regional treatment in these patients. However, these results are likely to be influenced by selection bias. We conducted a prospective randomized controlled trial to assess the impact of loco-regional treatment on outcome in women with metastatic breast cancer at initial diagnosis. [NCT00193778] METHODS: Women with metastatic breast cancer at initial diagnosis and planned to be treated with anthracycline based chemotherapy (CT) were registered for the study. Those who had objective tumor response after 6 cycles of CT were randomized to one of the following arms: ‘LRT’ (loco-regional treatment) or ‘No-LRT’ (no loco-regional treatment). Patients were stratif...

European Journal of Cancer Supplements, 2008

The Breast, 2005

The local disease-free survival at 3 years was in favor of conservation (85% Vs 76%, p=0.03). The... more The local disease-free survival at 3 years was in favor of conservation (85% Vs 76%, p=0.03). The DFS at 5 years after conservation surgery Vs mastectomy was 60% Vs 30% (p<0.0001). The predictive factors for response to chemotherapy and prognostic factors for recurrence have been analyzed and will be presented at the meeting. Conclusion: Breast conservation therapy is technically feasible and safe in women with locally advanced breast cancer after sufficient down-staging with neo-adjuvant chemotherapy.

The Breast, 2005

Background: Recent results demonstrated strong evidence for the routine use of the invasion marke... more Background: Recent results demonstrated strong evidence for the routine use of the invasion markers urokinase-type plasminogen activator (uPA) and its inhibitor PAl-1 as prognostic factors in node-negative breast cancer. Lowrisk patients have an excellent 5-year overall survival (>95%) even without any adjuvant therapy. In contrast to risk estimation by St.Gallen criteria, the use of these invasion markers have shown to spare adjuvant chemotherapy for a substantial part of all node-negative breast cancer patients. In addition, patients with high uPA/PAI-1 seem to have enhanced benefit from adjuvant chemotherapy. The NNBC-3 Europe trial seeks to answer two questions: 1) Is risk assessment by invasion markers uPA/PAI-1 superior to that by clinico-pathological factors with regard to identification of low-risk patients? 2) Is adjuvant chemotherapy using an anthracycline-taxane containing sequence (FEC-Docetaxel) superior to standard FEC in high-risk patients? Methods: In the NNBC-3 Europe trial, participating centres opt to either perform risk estimation by traditional clinico-pathological factors or by invasion markers uPA/PAI-I. Low-risk patients will then be observed without adjuvant chemotherapy. High-risk patients are randomised to adjuvant chemotherapy (FEC-100 *6 versus FEC-100 *3 followed by Docetaxel-100 *3). All patients with steroid hormone receptor positive tumors receive adequate endocrine therapy. Results: Of the first 171 patients (16 centers) in the tumor-biological arm, 14 (8%) had grade 1 tumors, and 63(37%) had grade 3 tumors. Among grade 2 tumors, 55% (n=94), 38(40%) had low levels of uPA (med. 1,0ng/mg protein) and PAl-1 (med. 8,2ng/mg); 56 (60%) patients presented with elevated values: uPA (med. 3,2ng/mg) and PAl-1 (med. 21,3ng/mg). Grade 3 tumors showed uPA at 2,7ng/mg and PAl-1 at 20,5ng/mg (med.). Overall, 30% of patients were allocated to the low-risk group, with no adjuvant chemotherapy. Conclusion: Conducting an adjuvant chemotherapy trial based on uPA/PAI-1 determination is feasible in a multicentre setting. Applying the invasion markers uPA/PAI-1 for risk assessment, in the first study patients, almost 52 were assigned to the low-risk group. Thus, in this early phase of the study, patient distribution shows to be in line with the expected distribution. The study is planned to recruit 5700 patients. This study is performed in association with the EORTC Receptor and Biomarker Group and the German AGO Breast Group.

The Breast, 2007

IHC), tumor stage II to IIIb (T2 > 2 cm, T3, T4b, N0−2, M0) non suitable for conservative surgery... more IHC), tumor stage II to IIIb (T2 > 2 cm, T3, T4b, N0−2, M0) non suitable for conservative surgery. Inflammatory or T4a tumors were excluded. The primary endpoint was to determine the median duration of treatment to optimal response defined as the interval of time required to achieve the maximal response by clinical exam. The ratio of clinical responses and the frequency of conservative surgery were secondary objectives. Results: Seventy patients have been recruited in four centers from June 2003 to September 2005. This report includes a preliminary efficacy analysis with the first 30 patients. Median age: 79.8 years (68−91), Stage T2 N0 (59.1%), ER[+] (95.4%). No severe adverse event was reported, and only minor muscle-esqueletal symptoms were noted. The median time to objective and to maximal response were 3.5 months (2.3−4.7) and 4.2 months (4.0−4.4) respectively. At the time of maximal response, the ORR was 80.0%; 53.3% obtaining a PR and 26.7% a CR. Conclusions: Letrozole shows a high activity and tolerability as neoadjuvant endocrine therapy in elderly patients with endocrine dependent criteria breast cancer. Mature results with the optimal duration of this approach will be helpful to increase local disease control. The poster will include a final efficacy analysis with 70 recruited patients.

International Journal of Surgery, 2006

Introduction: In absence of randomized evidence to support safety of conservative surgery (BCT) i... more Introduction: In absence of randomized evidence to support safety of conservative surgery (BCT) in locally advanced breast cancer (LABC), we analyzed a cohort of 664 women with LABC treated during

Indian Journal of Cancer, 2011

BACKGROUND: This study was undertaken to document the pattern of expression of estrogen (ER), pro... more BACKGROUND: This study was undertaken to document the pattern of expression of estrogen (ER), progesterone (PR) and human epidermal growth factor receptor-2 (HER2) and the usage of HER2-targeted therapy in a large tertiary care hospital in India in the year 2008. MATERIALS AND METHODS: The histopathology reports of all breast cancer patients registered in the hospital in 2008 were extracted from the electronic medical record system. All the cases were immunohistochemically evaluated for estrogen and progesterone receptor status (ER and PR), and c-erbB-2 protein (HER2) expression using standard immunoperoxidase method. The use of HER2-targeted therapies was evaluated by extracting relevant information from the database of the hospital pharmacy and case charts of patients enrolled in ongoing approved trials. RESULTS: A total of 2001 new patients of invasive breast cancers with available pathology reports were registered in the hospital in the year 2008. ER and/or PR expression was positive in tumors of 1025 (51.2%) patients. HER2 3+ expression by immunohistochemistry (IHC) was found in 335 (16.7%) and HER2 2+ in 163 (8.1%). The triple negative phenotype was found in 596 (29.8%) patients. An estimated 441 patients were eligible to receive HER2-targeted therapy based on their HER2 status. Of these 38 (8.6%) patients received some form of HER2-targeted therapy; 20 patients (4.5%) as part of ongoing clinical trials and 18 (4.1%) as part of routine care. CONCLUSIONS: The overwhelming majority of patients eligible for HER2-targeted therapy in our institution are unable to receive it because of financial constraints and limited access to health insurance. There is a higher fraction of patients with the triple negative phenotype compared to the Western population.

European Journal of Cancer, 2011

Diseases of the Esophagus, 2003

The right subclavian artery normally arises from the brachiocephalic artery. Anomalies in develop... more The right subclavian artery normally arises from the brachiocephalic artery. Anomalies in development may lead to peculiar problems during surgery. We report a patient with esophageal carcinoma who had an aberrant right subclavian artery, posing specific difficulties during a transhiatal esophagectomy, requiring conversion of the procedure into a transthoracic approach. The embryologic basis of this anomaly and the clinical significance are discussed.

Clinical Oncology, 2012

Aim: To study the toxicity profile and response rates of weekly paclitaxel given as neoadjuvant c... more Aim: To study the toxicity profile and response rates of weekly paclitaxel given as neoadjuvant chemotherapy (NACT) in patients with locally advanced breast cancer. Materials and methods: The study was planned as a single arm, prospective phase II study. Twenty-six patients with locally advanced breast cancer were enrolled in the study from December 2006 to October 2007. These patients underwent NACT with weekly paclitaxel at 100 mg/m 2 for 8 consecutive weeks followed by surgery. This was followed by anthracycline-based chemotherapy for three to four cycles followed by radiation. The patients received standard adjuvant hormonal therapy. The patients were carefully monitored for side-effects using common toxicity criteria. The clinical and pathological response rates were documented. The response rates were descriptively stated. Results: The median age of the patients was 52 years (30e67 years) and the median tumour size was 7 cm (2.5e15 cm). Of the 208 planned weekly cycles, 207 could be given. The rates of grade 3e4 neutropenia, thrombocytopenia and neuropathy were 4, 12 and 4%, respectively. A complete clinical response was observed in 10 patients (38.5%) and a completed pathological response, defined as the absence of invasive cancer from the breast and axillary nodes, was seen in 11.5% of patients. Breast-conserving surgery was possible in 23% of patients. Conclusion: The regimen of weekly single agent paclitaxel is feasible in patients with locally advanced breast cancer with acceptable toxicity. It resulted in a pathological response rate that was comparable with other regimens in this group of advanced stage patients. Considering the efficacy and low toxicity of this regimen, it is worth exploring in larger studies.

Cancer Research, 2009

Introduction: Early detection of breast cancer is known to have a more favourable outcome. Curren... more Introduction: Early detection of breast cancer is known to have a more favourable outcome. Currently clinical breast examination and imaging modalities, primarily mammography are used for screening purposes. In India, more than 85% of the population is below the age of 50 years, wherein the sensitivity of mammography is at best 64%. Additional drawbacks of the procedure are physical discomfort and ionizing radiation dose to the patient. So newer techniques have been investigated which detect cancer induced neovascularity with digital thermal imaging. The purpose of this clinical study was to determine the efficacy of a software assisted thermal image analysis tool to distinguish between benign and malignant lesions of the breast.Methods: A prospective study was conducted in women who presented to the breast clinic with clinically or mammographically suspicious breast lesions. They also underwent thermal imaging of the breast. All mammographically suspicious lumps were subjected to h...

Radiotherapy and Oncology, 2018

ESTRO 37 S566 institutional studies can be challenging due to different Experience Level (EL). Th... more ESTRO 37 S566 institutional studies can be challenging due to different Experience Level (EL). The aim of this work was to preliminary evaluate the role of a re-planning phase in a multi-institutional study for achieving similar plan quality results and for further benchmarking. Material and Methods 45 prostate SBRT plans from 9 centers were included. EL was ranked as 1 for 'no experience", 2 for '<100 SBRT prostate cases planned" and 3 for '≥100 SBRT prostate cases planned". Each center was provided with 5 anonymized CTs with pre-delineated volumes and was asked to create SBRT plans according to pre-set dose constraints. Dose prescription was 7Gyx5fr. The DVH text file and the RP_DICOM of each plan were used to extract dosimetric parameters, modulation indexes, and dynamic parameters from IMRT/VMAT plans. Results were summarized in a Spearman-correlation matrix and deemed correlated for R>0.50; statistical significance was set at p=0.01. In a 2 nd phase, planners were asked to re-plan the 5 th patient, based on the median DVHs of all partecipants, for improving target homogeneity and

Breast Cancer, 2019

Background To compare the early cosmetic outcomes after whole breast radiotherapy (WBRT) and acce... more Background To compare the early cosmetic outcomes after whole breast radiotherapy (WBRT) and accelerated partial breast irradiation (APBI) by various cosmetic assessment methods. Materials/methods APBI was delivered using multiplane interstitial brachytherapy as per standard guidelines. Majority of women in WBRT cohort received hypo-fractionated external beam radiotherapy using bitangential portals and mega-voltage photons along with sequential boost to the tumor bed. Single cross-sectional assessment (18-36 months post-treatment completion) of the breast cosmesis was done by RO, SO and the patient using the modified Harvard scale and by photographic assessment using the BCCT.core software. The two cohorts were propensity score-matched using menopausal status, size of surgical cavity, size of tumor in greatest dimension, median number of lymph nodes dissected, treatment with adjuvant chemotherapy and treatment with hormonal therapy. Results A total of 64 APBI patients were matched with 99 WBRT patients of the entire cohort of 320. At a median follow-up of 25 months, cosmetic results were significantly better for APBI as compared to WBRT cohort by all methods of evaluation (excellent/good: RO:75% vs 38.4%, p = 0.0001; SO: 54.7% vs 37.4%, p = 0.009; patient: 87.5% vs 58.6%, p = 0.001 and BCCT: 73.4% vs 51.6%, p = 0.001). Individual parameters that were significantly better in APBI cohort included size and shape of breast as well as location and shape of NAC. Better results for individual BCCT parameters (pLBC, pBRE, pBAD) were also seen. Conclusions Overall cosmetic outcomes as well as individual subdomains are significantly better with APBI as compared to WBRT by all methods of assessment of cosmesis when matched for various factors.