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    Rajendra Badwe

    PURPOSE Preventing metastases by using perioperative interventions has not been adequately explored. Local anesthesia blocks voltage-gated sodium channels and thereby prevents activation of prometastatic pathways. We conducted an... more
    PURPOSE Preventing metastases by using perioperative interventions has not been adequately explored. Local anesthesia blocks voltage-gated sodium channels and thereby prevents activation of prometastatic pathways. We conducted an open-label, multicenter randomized trial to test the impact of presurgical, peritumoral infiltration of local anesthesia on disease-free survival (DFS). METHODS Women with early breast cancer planned for upfront surgery without prior neoadjuvant treatment were randomly assigned to receive peritumoral injection of 0.5% lidocaine, 7-10 minutes before surgery (local anesthetics [LA] arm) or surgery without lidocaine (no LA arm). Random assignment was stratified by menopausal status, tumor size, and center. Participants received standard postoperative adjuvant treatment. Primary and secondary end points were DFS and overall survival (OS), respectively. RESULTS Excluding eligibility violations, 1,583 of 1,600 randomly assigned patients were included in this anal...
    Introduction: Several online prediction models that use known prognostic factors in breast cancer (BC) are routinely used to assist in decisions regarding overall survival (OS) benefit of adjuvant systemic therapy. PREDICT ver 2.2 (P2.2)... more
    Introduction: Several online prediction models that use known prognostic factors in breast cancer (BC) are routinely used to assist in decisions regarding overall survival (OS) benefit of adjuvant systemic therapy. PREDICT ver 2.2 (P2.2) is one such freely available online tool, which uses T size, LN positive, grade, age, hormone receptor (HR), HER2neu status and Ki67.We performed an external validation of P2.2 for overall survival in a retrospective cohort of patients with non-metastatic invasive breast cancer treated at a single tertiary care centre in India. Methodology: Women treated for operable BC (OBC) between 2008 and 2016 with non-metastatic, T1-T2 invasive, HER2neu receptor negative BC and with available 5-year OS data were selected for this study. Median predicted 5- year OS rates were used to calculate predicted events for the whole validation cohort and subgroups. Chi-squared test was used to evaluate the goodness- of-fit of the tool. Results: A total of 2780 eligible p...
    e24022 Background: Most of the care for adults with chronic/debilitating illnesses is provided by unpaid family members. There is little information on caregiver burden in older patients with cancer in India. Methods: This was an... more
    e24022 Background: Most of the care for adults with chronic/debilitating illnesses is provided by unpaid family members. There is little information on caregiver burden in older patients with cancer in India. Methods: This was an observational study conducted in the geriatric oncology clinic at the Tata Memorial Centre, a tertiary care oncology center in Mumbai, India. The Fronto Temporal Lobe Disorders (FTLDA) caregiver burden scale was administered to the caregiver who accompanied the patient to the geriatric clinic. The scale has 22 questions, each scored from 0 to 4. The points were added to give the total caregiver burden score. The severity of the caregiver burden was scored based on the standard key: 0-20 little or no burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, 61-88 severe burden. Descriptive statistics were used for demographic & clinical variables. The factors impacting the caregiver burden were analyzed using multiple linear regression analysis...
    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... 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 cohort—median 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.
    Background and ObjectivesThere are reports of outcomes of elective major cancer surgery during the COVID‐19 pandemic. We evaluated if reinforcement of hand hygiene, universal masking, and distancing as a part of pandemic precautions led... more
    Background and ObjectivesThere are reports of outcomes of elective major cancer surgery during the COVID‐19 pandemic. We evaluated if reinforcement of hand hygiene, universal masking, and distancing as a part of pandemic precautions led to a decrease in the incidence of surgical site infections (SSIs) in major oncologic resections.MethodsPropensity score matching using the nearest neighbor algorithm was performed on 3123 patients over seven covariates (age, comorbidities, surgery duration, prior treatment, disease stage, reconstruction, and surgical wound type) yielding 2614 matched (pre‐COVID 1612 and COVID 1002) patients. Conditional logistic regression was used to identify if SSI incidence was lower amongst patients operated during the pandemic.ResultsThere was a 4.2% (p = 0.006) decrease in SSI in patients operated during the pandemic. On multivariate regression, surgery during the COVID‐19 period (odds ratio [OR] = 0.77; 95% confidence interval [CI] = 0.61–0.98; p = 0.03), prio...
    Background Young (≤40 years) breast cancers (YBC) are uncommon, inadequately represented in trials and have unique concerns and merit studying. Methods The YBC treated with a curative intent between 2015 and 2016 at our institute were... more
    Background Young (≤40 years) breast cancers (YBC) are uncommon, inadequately represented in trials and have unique concerns and merit studying. Methods The YBC treated with a curative intent between 2015 and 2016 at our institute were analysed. Results There were 1228 patients with a median age of 36 (12–40) years; 38 (3.1%) had Stage I, 455 (37.1%) - II, 692 (56.3%) –III, and remaining 43 (3.5%) Stage IV (oligo-metastatic) disease; 927 (75.5%) were node positive; 422 (34.4%) were Triple negatives (TNBC), 331 (27%) were HER-2 positive. There were 549 (48.2%) breast conservations and 591 (51.8%) mastectomies of which 62 (10.4%) underwent breast reconstruction. 1143 women received chemotherapy, 617 (53.9%) received as neoadjuvant and 142 (23.1%) had pathological complete response; 934 (81.9%) received adjuvant radiotherapy. At the median follow-up of 48 (0–131) months, 5-year overall and disease-free survival was 79.6% (76.8–82.5) and 59.1% (55.8–62.6). For stage I, II, III and IV, the 5-year overall-survival was 100%, 86.7% (82.8–90.6), 77.3% (73.4–81.2), 69.7% (52.5–86.9) and disease-free survival was 94% (85.9–100), 65.9% (60.3–71.5), 55% (50.5–59.5), and 29.6% (14–45.2) respectively. On multivariate analysis, TNBC and HER-2+ subgroups had poorer survival (p = 0.0035). 25 patients had BRCA mutations with a 5-year DFS of 65.1% (95% CI:43.6–86.6). Fertility preservation was administered in 104 (8.5%) patients; seven women conceived and 5 had live births. Significant postmenopausal symptoms were present in 153 (13%) patients. Conclusion More than half of the YBC in India were diagnosed at an advanced stage with aggressive features leading to suboptimal outcomes. Awareness via national registry and early diagnosis is highly warranted. Menopausal symptoms and fertility issues are prevalent and demand special focus.
    Background Pregnancy associated breast cancer (PABC) is a rare entity and defined as breast cancer diagnosed during pregnancy or one-year post-partum. There is sparse data especially from low and middle-income countries (LMIC) and merits... more
    Background Pregnancy associated breast cancer (PABC) is a rare entity and defined as breast cancer diagnosed during pregnancy or one-year post-partum. There is sparse data especially from low and middle-income countries (LMIC) and merits exploration. Methods The study (2013–2020) evaluated demographics, treatment patterns and outcomes of PABC. Results There were 104 patients, median age of 31 years; 43 (41%) had triple-negative disease, 31(29.8%) had hormone-receptor (HR) positive and HER2 negative, 14 (13.5%) had HER2-positive and HR negative and 16(15.4%) had triple positive disease. 101(97%) had IDC grade III tumors and 74% had delayed diagnosis. 72% presented with early stage (24, EBC) or locally advanced breast cancer (53, LABC) and received either neoadjuvant (n = 49) or adjuvant (n = 26) chemotherapy and surgery. Trastuzumab, tamoxifen, and radiotherapy were administered post-delivery. At a median follow up of 27 (IQR:19–35) months, the estimated 3-year event-free survival (EFS) for EBC and LABC was 82% (95% CI: 65.2–100) and 56% (95% CI: 42–75.6%) and for metastatic 24% (95% CI: 10.1%–58.5%) respectively. Of the 104 patients, 34 were diagnosed antepartum (AP) and 15 had termination, 2 had preterm and 16 had full-term deliveries(FTDs). Among postpartum cohort (n = 70), 2 had termination, 1 had preterm, 67 had FTDs. 83(including 17 from AP) children from both cohorts were experiencing normal milestones. Conclusion Data from the first Indian PABC registry showed that the majority had delayed diagnosis and aggressive features(TNBC, higher grade). Treatment was feasible in majority and stage matched outcomes were comparable to non-PABCs.
    BACKGROUND Trend analysis in cancer quantifies the incidence rate and explains the trend and pattern. Breast and cervical cancers are the two most common cancers among Indian women which contributed 39.4 % to the total cancer in India for... more
    BACKGROUND Trend analysis in cancer quantifies the incidence rate and explains the trend and pattern. Breast and cervical cancers are the two most common cancers among Indian women which contributed 39.4 % to the total cancer in India for the year 2020. This study aimed to report the time trends in cancer incidence of breast and cervical cancer using Age-Period-Cohort (APC) model from five Population Based Cancer Registries (PBCRs) in India for the period of 1985-2014. METHOD Age-Period-Cohort model was fitted to five PBCRs of Bangalore, Chennai, Delhi, Bhopal and Barshi rural for breast and cervical cancer for 25-74 age-groups. The Estimated Annual Percent Change (EAPC) was calculated. Rate Ratio (RR) of cohort effects were estimated with a constraint of period slope to be zero (p = 0) since cohort has a stronger association with incidence than period. RESULT A significant increase was noted in breast cancer in all PBCRs (EAPC, Range: Delhi, 1.2 % to Bangalore, 2.7 %) while significant decrease in cervical cancer (EAPC, Range: Bangalore -2.5 % to Chennai, -4.6 %) from all the PBCRs including Barshi rural during the period. RR estimates for breast cancer showed increasing trend whereas cervical cancer showed decreasing trend in successive birth cohorts across all five PBCRs. CONCLUSION In both breast and cervical cancers, a significant age, cohort and period effect was noted in Bangalore, Chennai and Delhi. Despite period effect, the cohort effect was predominant and it may be attributed to the generational changes in risk factors among cancer breast and cervix.
    2011 Background: Despite survival benefits of guideline compliant cancer care, under treatment and over treatment are prevalent. Navya is an AI enabled online intervention that matches a patient’s medical record with NCCN and NCG... more
    2011 Background: Despite survival benefits of guideline compliant cancer care, under treatment and over treatment are prevalent. Navya is an AI enabled online intervention that matches a patient’s medical record with NCCN and NCG guidelines (National Cancer Grid, India) and layers live multidisciplinary expert review to recommend actionable treatment plans. It was developed to standardize care and mitigate morbidity and mortality, by delivering on-t ime, guideline based expert treatment plans. Methods: From July 2019 to January 2020, all patients who received a Navya treatment plan based on guidelines and live expert review were included. Intended treatment plans were prospectively collected from the patient. Compliance of intended plans with NCCN (including Resource Stratified Framework) or NCG was measured. Noncompliant intended plans were categorized as overtreatment or undertreatment. After delivery of Navya plan, prospective phone follow up assessed whether noncompliant intende...
    e12061 Background: Recent evidence suggest improved Disease Free Survival (DFS) and Overall Survival (OS) with IMC radiotherapy (RT) for inner / central quadrant breast cancers. Long term results of a prospective study using a novel... more
    e12061 Background: Recent evidence suggest improved Disease Free Survival (DFS) and Overall Survival (OS) with IMC radiotherapy (RT) for inner / central quadrant breast cancers. Long term results of a prospective study using a novel method of IMC RT with HDR catheter placed in the Internal Mammary Vessel are presented. Methods: In women with inner or central quadrant T3/4 or axillary node +ve breast cancer, IMC HDR brachytherapy was given along with standard surgery, external RT and systemic therapy as appropriate for the stage. Clinical outcomes in terms of DFS and OS (Kaplan Meier method), factors affecting DFS and OS (Cox proportional hazard model) and toxicity were assessed. Results: From 2001 to 2008, 506 breast cancer patients received IMC brachytherapy with single intraluminal flexible catheter to a dose of 34Gy/10#, treating an average length of 7.5 cm (range 4 – 12cm).This was followed by standard external RT to breast or chest wall and SCF to a dose of 45 – 50Gy/ 25# over 5 weeks. The median T s...
    e11552 Background: Paclitaxel is an integral component of chemotherapy for breast cancer but its benefit comes at the risk of peripheral neuropathy. There are experimental models of peripheral nerve injury in which progesterone is... more
    e11552 Background: Paclitaxel is an integral component of chemotherapy for breast cancer but its benefit comes at the risk of peripheral neuropathy. There are experimental models of peripheral nerve injury in which progesterone is protective, possibly through remyelination and other mechanisms. Methods: We evaluated the effect of menopausal status, as a surrogate for circulating progesterone levels, on the risk of developing paclitaxel induced peripheral neuropathy, in a retrospective audit of breast cancer patients. Patients who had received paclitaxel chemotherapy for breast cancer were characterized as having CIPN or not by clinical history/examination. Results: 256 women treated with paclitaxel at our institution were assessed for CIPN. Of these 133(52%) were premenopausal and 123(48%) postmenopausal at diagnosis. 22(8.6%) had preexisting diabetes mellitus. Of the 133 premenopausal women 97(72.9%) developed chemotherapy induced amenorrhea (CIA). The incidence of CIPN was 23.1% i...
    1108 Background: Post neoadjuvant chemotherapy (NACT) sentinel node biopsy (SNB) is not a standard of care due to the wide variability in false negative rate (FNR), varying from 5.7% to 33%. In operable breast cancer (OBC), FNR of less... more
    1108 Background: Post neoadjuvant chemotherapy (NACT) sentinel node biopsy (SNB) is not a standard of care due to the wide variability in false negative rate (FNR), varying from 5.7% to 33%. In operable breast cancer (OBC), FNR of less than 10% is acceptable. We attempted to find out the reliability of low axillary sampling(LAS), with dissection limited below the first intercostobrachial nerve, to correctly identify the node negative axilla in the post NACT clinically node negative (N0) patients. Methods: Women with large operable (LOBC) and locally advanced breast cancer (LABC), post-NACT clinically N0, underwent concomitant blue dye-colloid guided SNB and LAS. The identification rate, FNR, and negative predictive value (NPV) of both procedures were compared. Results: Post-NACT 209 eligible women underwent combined LAS and SNB procedure. At presentation, the tumors were large (median 5.0 cm) with 70% clinically palpable nodes. All patients received 4 cycles of neo-adjuvant anthracy...
    e22130Background: Understanding patients’ and caregivers’ preferences and attitudes about knowing the cancer diagnosis and prognosis (D&P) prevents demoralization of the patients. The Western medic...
    TPS1618 Background: Oral, esophageal and hypopharyngeal cancers are common and important public health problems in India. They are highly aggressive neoplasms and are associated with a poor prognosis especially because most patients are... more
    TPS1618 Background: Oral, esophageal and hypopharyngeal cancers are common and important public health problems in India. They are highly aggressive neoplasms and are associated with a poor prognosis especially because most patients are diagnosed at late stages of disease. Certain high risk factors like tobacco, betel and arecanut and alcohol use have been associated with the causation of these cancers. Screening may offer the opportunity to reduce the incidence of invasive lesions and also help in decreasing the mortality rates associated with these cancers. Methods: We are currently doing a large cluster randomized trial in Ratnagiri district, Maharashtra, India to ascertain whether screening of oral cancers with visual examination by trained health workers and hypopharyngeal and esophageal cancers with double contrast barium swallow (DCBS) will reduce mortality from these diseases. The population between 35 and 65 years of age who have used tobacco and/or alcohol for more than five years are eligible f...
    Background: Hypoxia is defined as oxygen levels in tumor microenvironment of less than that in blood (90-100 mm Hg) and influences many aspects of tumour biology. During surgery tumour vasculature is cut off gradually leading to induction... more
    Background: Hypoxia is defined as oxygen levels in tumor microenvironment of less than that in blood (90-100 mm Hg) and influences many aspects of tumour biology. During surgery tumour vasculature is cut off gradually leading to induction of acute hypoxia.The present study aims to experimentally test the genotypic and phenotypic effects of surgically induced acute hypoxia in breast cancer tumor samples and cell lines. Methodology: Core biopsy samples were collected from breast tumors (N=8 patients) at three time points during their curative surgery: prior (pre), mid-way (intra) and at the end (post). The samples were subjected to RNA-Seq and a list of differentially expressed genes (DEG) was prepared. A set of 26 DEG (‘pre’ Vs ‘intra’ Vs ‘post’) obtained from RNA-Seq analysis and additional 17 genes involved in inflammation, EMT and hypoxia pathways were chosen for validation in tumor samples. These genes were validated using a customized qPCR Array (Qiagen). A gene was considered v...
    Introduction: Access to expert, evidence based clinical decision making is crucial in maximizing the outcome of women with breast cancer, but is a scarce resource, especially in developing countries. The Navya Expert System is a patented,... more
    Introduction: Access to expert, evidence based clinical decision making is crucial in maximizing the outcome of women with breast cancer, but is a scarce resource, especially in developing countries. The Navya Expert System is a patented, software based clinical decision support system that exhaustively searches and assimilates relevant medical literature and guidelines to make specific therapeutic recommendations for individual patients based on their clinical data. This study is a retrospective validation of Navya Expert System's output against tumor board decisions of a multidisciplinary group of expert breast cancer clinicians working in a tertiary care oncology center in India. Methods: Women with non-metastatic breast cancer who had already completed their loco-regional and systemic therapy based on the recommendations of the tumor board were included in the study. The protocol specified clinical and pathology data of these women were retrospectively abstracted from their ...
    Background: Sentinel lymph node biopsy is currently standard of care in node negative early breast cancer. There are various tracers for detecting sentinel lymph nodes in breast cancer. Sentinel lymph node biopsy (SLNB) using Technetium... more
    Background: Sentinel lymph node biopsy is currently standard of care in node negative early breast cancer. There are various tracers for detecting sentinel lymph nodes in breast cancer. Sentinel lymph node biopsy (SLNB) using Technetium tagged Sulphur colloid is a convenient and safe method to assess lymph node status. However, sulphur colloid is radioactive and its use needs gamma camera which is very costly and available in very few centers in India. Methylene blue dye is an economical alternative for sulphur colloid having identification rate similar to the isotope. However, it may react with hemoglobin forming meth-hemoglobin resulting in difficulty in pulse oximetry during operation and causes skin eruptions and necrosis. Hence, there is a need to identify a sensitive, inexpensive and safe dye for sentinel node biopsy. In this study we have investigated the effectiveness and safety of fluorescein in sentinel node biopsy in a cross-sectional analytical study compared to Methylen...
    The relevance of population-based cancer registries for planning and implementing cancer control programmes cannot be overemphasized. There are some urban registries in India but very few rural registries despite India being predominantly... more
    The relevance of population-based cancer registries for planning and implementing cancer control programmes cannot be overemphasized. There are some urban registries in India but very few rural registries despite India being predominantly rural. There are several obstacles to setting up a rural registry including lack of cancer awareness in the rural population and inaccessibility of modern medical facilities. The first rural cancer registry was set up in 1987 at Barshi (population 0.4 million) in western Maharashtra by adopting a methodology suitable for rural areas. The innovative methodology supplemented the usual registry methodology by regular interaction with the community to educate them on warning signals for cancer, raise cancer awareness and motivate suspected individuals to seek medical attention. Cancer detection clinics were held in villages. The reliability indices show that the registry is of an acceptable standard. The registry activity has increased cancer awareness...
    Objectives The objective is to present the patterns of dual primary malignancies diagnosed at the Pathology Laboratory of Cancer Hospital with the support from hospital-based cancer registry (HBCR), Sangrur, Punjab, India for the years... more
    Objectives The objective is to present the patterns of dual primary malignancies diagnosed at the Pathology Laboratory of Cancer Hospital with the support from hospital-based cancer registry (HBCR), Sangrur, Punjab, India for the years 2018 and 2019. Methods HBCR abstracts data from electronic medical records. Trained cancer registry staff abstracts cases in standard pro forma. Dual primary was coded as per the International Agency for Research on Cancer rule and was rechecked by the pathologist. Statistical Analysis Data about multiple primary was entered and documented in an Excel sheet. Time interval was calculated by subtracting the date of diagnosis for second primary and first primary. Results A total of 6,933 cases were registered, 45 cases are dual primary (26 females, 19 males) of which 64.4% are synchronous and 35.6% metachronous cases. Seventy-nine percent received cancer-directed treatment for synchronous and 87% for metachronous. The most common sites of the primary tum...
    PURPOSE There are sparse data in patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer with brain metastases from real-world settings, especially where access to newer targeted therapies is limited. METHODS... more
    PURPOSE There are sparse data in patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer with brain metastases from real-world settings, especially where access to newer targeted therapies is limited. METHODS This was a single institution, retrospective cohort study of patients with HER2-positive breast cancer diagnosed between January 2013 and December 2017 to have brain metastases and treated with any HER2-targeted therapy. The main objectives were to estimate progression-free survival (PFS) and overall survival (OS) from the time of brain metastases. RESULTS A total of 102 patients with a median age of 52 (interquartile range, 45-57) years were included, of whom 63 (61.8%) had received one line and 14 (13.7%) had received two lines of HER2-targeted therapies before brain metastasis, 98 (96.1%) were symptomatic at presentation, 22 (25.3%) had solitary brain lesion, 22 (25.3%) had 2-5 lesions, and 43 (49.4%) had ≥ 5 lesions. Local treatment included sur...
    Rationale: Surgery results in rapid and progressively severe exposure of tumor tissue to hypoxia, up to the point of complete removal, but its effect on tumor gene expression is not well characterized. We document the molecular effects of... more
    Rationale: Surgery results in rapid and progressively severe exposure of tumor tissue to hypoxia, up to the point of complete removal, but its effect on tumor gene expression is not well characterized. We document the molecular effects of surgery on primary breast cancer tumor with a serial tissue sampling strategy, including an intra-operative sample. Methods: We included treatment naïve, non-metastatic breast cancer patients and sampled tumor and tumour adjacent normal tissue during surgery at three time points: beginning of surgery (Sample A), after half the tumor circumference had been devascularized (Sample B) and from completely resected tumor (Sample C). Patients were divided into two groups: discovery and validation. Tumor or adjacent normal samples from the discovery group underwent whole transcriptome paired-end sequencing (RNA-Seq) generating at least 50 million reads using next generation sequencing. Findings from discovery group were evaluated in a validation group usin...
    Introduction Paclitaxel can cause peripheral neuropathy in up to 60% of patients. Chemotherapy-induced peripheral neuropathy (CIPN) compromises quality of life and often leads to dose reduction or discontinuation of lifesaving... more
    Introduction Paclitaxel can cause peripheral neuropathy in up to 60% of patients. Chemotherapy-induced peripheral neuropathy (CIPN) compromises quality of life and often leads to dose reduction or discontinuation of lifesaving chemotherapy. Preclinical models have suggested the possible neuroprotective effect of progesterone through remyelination and other mechanisms. Objectives The aim of this study was to evaluate the incidence of CIPN for different menopausal status. Materials and Methods We evaluated the effect of menopausal status, as a surrogate for circulating progesterone levels, on the risk of developing paclitaxel-induced peripheral neuropathy, in an audit of breast cancer patients. Data on CIPN (by clinical history and examination) and other variables were collected from the case charts of patients who had received paclitaxel-based chemotherapy for breast cancer at our institution. Results Five hundred and fifty women were treated with either neoadjuvant or adjuvant pacli...
    Background There is limited access to 1 year of adjuvant trastuzumab in resource-constrained settings. Most randomized studies have failed to prove non-inferiority of shorter durations of adjuvant trastuzumab compared to 1 year However,... more
    Background There is limited access to 1 year of adjuvant trastuzumab in resource-constrained settings. Most randomized studies have failed to prove non-inferiority of shorter durations of adjuvant trastuzumab compared to 1 year However, shorter durations are often used when 1 year is not financially viable. We report the outcomes with 12 weeks of trastuzumab administered as part of curative-intent treatment. Methods This is a retrospective analysis of patients treated at Tata Memorial Centre, Mumbai, a tertiary care cancer center in India. Patients with human epidermal growth factor receptor (HER2)-positive early or locally advanced breast cancer who received 12 weeks of adjuvant or neoadjuvant trastuzumab with paclitaxel and four cycles of an anthracycline-based regimen in either sequence, through a patient assistance program between January 2011 and December 2012, were analyzed for disease-free survival (DFS), overall survival (OS), and toxicity. Results A total of 102 patients we...
    Background: The COVID-19 pandemic has disrupted healthcare systems leading to concerns about its impact on non-COVID disease conditions. The diagnosis and management of cancer is time-sensitive and is likely to be substantially affected... more
    Background: The COVID-19 pandemic has disrupted healthcare systems leading to concerns about its impact on non-COVID disease conditions. The diagnosis and management of cancer is time-sensitive and is likely to be substantially affected by these disruptions. We conducted a study to examine the impact of COVID-19 on cancer care in India. Methods: We conducted the study in member institutions of the National Cancer Grid of India to compare provision of oncology services during the months of March to May 2020 with corresponding months in 2019. We collected data related to cancer diagnosis and treatment, screening, research and educational activities. We calculated proportional reductions in 2020 compared to 2019. Findings: We collated data from 41 centres across India including public, private and charitable institutes, with a total annual patient load corresponding to 33.9% of India’s overall cancer burden. We found substantial reductions in almost all metrics studied. These included ...
    Background: Overburdened systems and concerns of adverse outcomes have resulted in deferred cancer surgeries with devastating consequences. In this COVID pandemic, the decision to continue elective cancer surgeries, and their subsequent... more
    Background: Overburdened systems and concerns of adverse outcomes have resulted in deferred cancer surgeries with devastating consequences. In this COVID pandemic, the decision to continue elective cancer surgeries, and their subsequent outcomes, are sparsely reported from hotspots. Methods: A prospective database of the Department of Surgical Oncology was analysed from March 23rd to April 30th, 2020. Findings: Four hundred ninety-four elective surgeries were performed (377 untested and 117 tested for Covid 19 before surgery). Median age was 48 years with 13% (n = 64) above the age of 60 years. Sixty-eight percent patients were American Society of Anaesthesiology (ASA) grade I. As per surgical complexity grading, 71 (14·4%) cases were lower grade (I-III) and 423 (85.6%) were higher grade complex surgeries (IV – VI). Clavien-Dindo ≥ grade III complications were 5.6% (n = 28) and there were no postoperative deaths. Patients >60 years documented 9.3% major complications compared to ...
    The European Organization for Research and Treatment of Cancer (EORTC) module QLQ-C30 and the breast cancer-specific module BR-23 have been validated worldwide to assess the quality of life (QOL) in women with breast cancer. No such study... more
    The European Organization for Research and Treatment of Cancer (EORTC) module QLQ-C30 and the breast cancer-specific module BR-23 have been validated worldwide to assess the quality of life (QOL) in women with breast cancer. No such study has been published on Indian women using EORTC questionnaires. QOL was assessed in relation to surgery, adjuvant chemotherapy, radiation therapy and hormone therapy in 299 Indian women with operable breast cancer (OBC) at the Breast Unit of Tata Memorial Hospital (TMH), Mumbai, from October 1998 to September 2001. The QLQ-C30 module was used to assess physical health, emotional, cognitive and social functioning, and the BR-23 module to assess breast cancer treatment-related symptoms. Assessment was done at 3 visits: visit 1 (after surgery); visit 2 (during adjuvant therapy) and visit 3 (on completion of adjuvant therapy). Of the 299 women at first visit, 274 (91.6%) completed the visit 2 questionnaire and 239 (80%) completed the visit 3 questionnai...
    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... 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...
    Background:The relationship between timing of surgery during menstrual cycle and survival in women with operable breast cancer (OBC) has been a subject of much debate. A meta-analysis of 37 retrospective studies revealed a modest survival... more
    Background:The relationship between timing of surgery during menstrual cycle and survival in women with operable breast cancer (OBC) has been a subject of much debate. A meta-analysis of 37 retrospective studies revealed a modest survival benefit of 15%±8(2P=0.003) for those operated during progestogenic phase, whereas three prospective studies did not show any difference. Another meta-analysis of effect of circulating progesterone at the time of surgery showed a 53%±4(2P<0.001) improvement in survival when progesterone levels were high. The effect was confined to women with tumours that harboured lymph node metastasis(LN mets). We tested the effect of pharmacological induction of a progestogenic environment at the time of surgery on survival in women with OBC in a randomized controlled trial.Methods: One thousand women with OBC stratified by menopausal status and tumour size were randomly assigned to standard treatment (control) or an additional injection of depot preparation of...
    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... 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...
    Sentinel node biopsy (SNB) was initially conceived as excision of the first station axillary lymph node(s) (LN) identified by radioactive and/or blue dye uptake. The definition was subsequently enlarged to also include palpable lymph... more
    Sentinel node biopsy (SNB) was initially conceived as excision of the first station axillary lymph node(s) (LN) identified by radioactive and/or blue dye uptake. The definition was subsequently enlarged to also include palpable lymph nodes in the vicinity of sentinel node(s) (SN). We reasoned that the excision of this combination of nodes might be best achieved by sampling the lower axilla. Each patient underwent low axillary sampling (LAS) and identification of SN in the excised specimen followed by complete axillary lymph node dissection (ALND). LAS was defined as excision of all fibrofatty tissue overlying the second digitation of serratus anterior below the intercostobrachial nerve and was carried out following a pre-operative injection of radioactive colloid and an intra-operative injection of blue dye. Blue and/or hot nodes (B&/HN) in the dissected tissue and remaining axilla, along with any palpable nodes within the sampled tissue, were defined as SN. The primary endpoint of the study was to compare false negative rates (FNR) of SN with that of LAS in predicting axillary LN status (NCT00128362). The study was performed between March 2004 and December 2011 in 478 women with clinically node negative axilla. On histopathological evaluation the median tumor size was 2.5 cm and axillary nodal metastases were found in 34.1% of patients. The FNR of SNB (12.7%, 95% CI 8.1-19.4) and LAS (10.5%, 95% CI 6.6-16.2) were not significantly different (p = 0.56). The FNR of B&/HN alone, without palpable nodes, (29.0%, 95% CI 22.5-36.6) was significantly inferior to those of SNB (p = 0.0007) and LAS (p = 0.0003). LAS is as accurate as SNB in predicting axillary LN status in women with clinically node negative operable breast cancer. Confining SNB procedure to excision of B&/HN, significantly increases the risk of leaving behind metastatic lymph nodes in the axilla. LAS is an effective and low cost procedure that minimizes axillary surgery and can be implemented widely. Registry Name: Clinicaltrials.gov. NCT00128362.
    The role of radical lymphadenectomy in esophageal cancer is controversial. While standard two-field lymph node dissection (2FLND) is considered the standard of care, the role of prophylactic radical three-field lymph note dissection... more
    The role of radical lymphadenectomy in esophageal cancer is controversial. While standard two-field lymph node dissection (2FLND) is considered the standard of care, the role of prophylactic radical three-field lymph note dissection (3FLND) is debatable. We conducted a large randomized trial comparing oncological outcomes between 2FLND and 3FLND for operable esophageal cancer. Here, we report the perioperative complications in the trial. Patients with operable esophageal squamous cell/adenocarcinoma between 18-75 years of age with no clinicoradiological supracarinal lymph node metastases were eligible. Patients were randomly allocated intraoperatively with allocation concealment (stratified by histology, T, N stage, level of growth, and neoadjuvant treatment) to 2FLND or 3FLND. Patients randomized to 2FLND underwent removal of all infracarinal mediastinal and D2 abdominal lymph nodes; patients randomized to 3FLND in addition had bilateral supracarinal mediastinal and lower cervical ...

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