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Context: Trends in epidermal growth factor receptor (EGFR) mutation based on ethnicity assist the initial selection of targeted therapy regimen. Reported incidence of EGFR mutation in Indian NSCLC patients is variable, ranging from 22% to 51.8%.Aim and Settings and Design: This multicenter, noninterventional study evaluated the prevalence of EGFR mutation in Indian NSCLC patients, its association with patients’ demographics, and for the first time used a central laboratory for molecular testing.Subjects and Methods: Tissue samples from 252 NSCLC patients were tested at a Central Laboratory at Tata Memorial Hospital. Statistical Analysis Used: Patient demographics, baseline characteristics including smoking status from routine examination were recorded in a single visit. Chi-square or Fisher's exact test was used for association of EGFR mutation status with gender, age, smoking status, and histological subtypes.Results: The prevalence of EGFR mutation in Indian NSCLC patients was 23.4%. Among these, 55.9% patients had mutations in exon 19, 39% in exon 21, and 1.7% in exon 18. The incidence of EGFR mutation was higher in females than males (32.5% vs. 18.9%, respectively), and in 30.6% patients that had never smoked, 26.3% smokers, and 5.8% former smokers. The mean duration of transportation of tissue samples to the central laboratory was 48 h with an average turnaround time of 5 days for molecular testing.Conclusions: Molecular testing at a central laboratory is a feasible option in India. Prevalence of EGFR mutation in Indian NSCLC patients was similar across western and southern centers in India. A statistically significant association between EGFR mutation and gender as well as the smoking status of the patients was observed. Majority of the patients had in-frame deletions in exon 19.

Background Lung cancer is the leading cause of cancer-related deaths across the world. In this study, we present therapeutically relevant genetic alterations in lung adenocarcinoma of Indian origin. Materials and methods Forty-five primary lung adenocarcinoma tumors were sequenced for 676 amplicons using RainDance cancer panel at an average coverage of 1500 × (reads per million mapped reads). To validate the findings, 49 mutations across 23 genes were genotyped in an additional set of 363 primary lung adenocarcinoma tumors using mass spectrometry. NIH/3T3 cells over expressing mutant and wild-typeFGFR3 constructs were characterized for anchorage independent growth, constitutive activation, tumor formation and sensitivity to FGFR inhibitors usingin vitro and xenograft mouse models. Results We present the first spectrum of actionable alterations in lung adenocarcinoma tumors of Indian origin, and shows that mutations ofFGFR3 are present in 20 of 363 (5.5%) patients. TheseFGFR3 mutations are constitutively active and oncogenic when ectopically expressed in NIH/3T3 cells and using a xenograft model in NOD/SCID mice. Inhibition ofFGFR3 kinase activity inhibits transformation of NIH/3T3 overexpressingFGFR3 constructs and growth of tumors driven byFGFR3 in the xenograft models. The reduction in tumor size in the mouse is paralleled by a reduction in the amounts of phospho-ERK, validating thein vitro findings. Interestingly, theFGFR3 mutations are significantly higher in a proportion of younger patients and show a trend toward better overall survival, compared with patients lacking actionable alterations or those harboringKRAS mutations. Conclusion We present the first actionable mutation spectrum in Indian lung cancer genome. These findings implicateFGFR3 as a novel therapeutic in lung adenocarcinoma.

Background Relapse or progression in glioblastoma is common. Multiple options ranging from local treatment like re-surgery, re-radiation to systemic therapies like bevacizumab, CCNU, etc. are available. Patients with longer progression-free interval (> 2 years), smaller volume of disease and disease in non-eloquent areas are preferably selected for local therapies and while the others receive systemic therapy. There is limited data available on the pattern of care in relapsed gliomas hence we conducted an audit to address this deficiency. Methods A prospective database of all glioma patients has been maintained from June 2015 onwards at neuro-oncology DMG (Disease Management Group) at the Tata Memorial Hospital. We analysed the data of patients with relapsed gliomas treated from June 2015 to December 2017. Results The database had 854 patients of which 749 (87.7%) had disease progression. The treatment received by these 749 patients were best supportive care in 519 (69.3%), local therapy with or without systemic therapy in 85 (11.3%) and systemic therapy in 145 (19.4%) patients. Local therapy consisted of re-surgery (with or without re-radiation) in 63 patients and re-radiation (with or without systemic therapy) in 23 patients. The systemic therapies received were salvage temozolomide in 79 patients, bevacizumab (with or without an additional agent) in 41 patients and CCNU in 25 patients. The factors associated with administration of therapy at relapse were age (p = 0.009) and family income (0.041). The other factors tested were gender (p = 0.311) and performance status at relapse (p = 0.637). Conclusions This data highlights that a large number of patients with recurrent gliomas do not receive any treatment (69%), which is similar to the pattern of care reported from Australia. The pessimism associated with treatment of relapsed glioma is due to dismal prognosis at relapse with the current therapy available. Legal entity responsible for the study Tata Memorial Hospital. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background Advanced salivary gland neoplasm have variable natural history. The goal of systemic treatment is palliation however no clear evidence regarding when and to whom it needs to be administered.The objective of this study was to determine the molecular profile of malignant salivary gland tumors and to evaluate the impact of systemic therapy.This was a retrospective cohort study. Methods Head and Neck Medical Oncology outpatient department maintains a prospective chemotherapy database of patients planned for any form of systemic therapy. Adult patients (Age > or = 18 years) with (ECOG PS) 0-3 histologically proven salivary gland malignancy treated between January 2010- September 2018 at the host institute.Data regarding demographics, baseline characteristics, tumor details, staging details, treatment details, outcome details expression of ER, PR, AR and HER-2 Neu status was extracted.The procedure for performing IHC, interpreting, and quality assurance is already published.Molecular profilingSnapshot profiling was performed using Multiplex polymerase chain reaction (PCR) followed by multiplex base extension assay utilizing the SNaPshot TM methodology. It consists of a combination of real time PCR looking for 21 hotspot mutation sites in nine cancer genes: (EGFR, HER2, KRAS, NRAS,PIK3CA, BRAF, MEK1, PTEN,AKT1-). Results Out of the 69 evaluable patients, 55% (n = 38) had actionable target. Androgen Receptor (AR) expression was present in majority of patients (n = 23,34%), with it alone being expressed in 17% (n = 12) of patients, and along with other actionable targets in the other. 60 (87%) patients received systemic therapy either in form of chemotherapy (35,58.3%) or targeted therapy (25,41.7%). The strategy of observation in asymptomatic status lead to an median OS of 32.27 (3.03-NA) similar to patients receiving systemic therapy (p = 0.992). In patients with visceral crisis, the median OS was higher in patients receiving chemotherapy than targeted therapy (19.07 (14.20-23.8) versus 6.07 (2.23-NA), p Conclusions Actionable targets are seen in salivary gland tumors and treatment strategies should be based on these and symptomatic status. Legal entity responsible for the study Tata Memorial Hospital Mumbai. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background Management of brain metastasis is a complex multidisciplinary venture. Hence, we started a multidisciplinary brain metastasis clinic for opinion on difficult brain metastasis cases. This is the review of the impact of this clinic on the treatment decisions. Methods Brain metastasis clinic (BMC) was started in the month of April 2018 and meets once a week. Data of patients discussed between 27th April 2018 to 28th June 2019 were included for thisanalysis. Treatment decision made by clinicians (before sending the patient to the BMC were compared with the decisions made in BMC. The decisions were broken on a predefined proforma as intent of treatment (curative or palliative), modalities planned (surgery, radiation, chemotherapy), type of therapy planned (details of each therapy) in each modality were collected both pre and post BMC. In addition, compliance of the respective physicians to BMC decision was also calculated. SPSS version 20 was used for analysis. Descriptive statistics was performed. Results Ninety-nine patients were discussed in this time period. The median age was 51 (range 17-68) years. The gender distribution was 70 males (70.7%) and 29 females (29.3%). Lung was thepredominant site of malignancy (79, 79.8%). Thirty-one patients (31.3%) had EGFR TKI domain activating mutation while 17 (17.2%) had ALK rearrangement. The treatment plan was changed in 46 patients (46.5%). The intent of treatment was changed in 5 patients (5.3%). Change in treatment plan with respect to surgery in 9 patients (9.1%), radiation in 37 patients (37.4%), chemotherapy in 15 patients (15.2%), targeted therapy in 11 patients (22.9%) and intrathecal in 6 patients (6.1%) respectively. The compliance to the BMC decision in patients in whom it was changed was 84.8% (39, n = 46). Conclusions Multidisciplinary management of difficult brain metastasis cases in specialized clinics has significant impact on treatment decisions. Legal entity responsible for the study Tata Memorial Hospital, Mumbai. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

BACKGROUND: Cisplatin-based chemoradiation (CTRT) is the standard of care in locally advanced head and neck cancers. Limited treatment options are available in patients unfit for cisplatin. AIMS: This audit was carried out to study the toxicities, tolerance, and outcomes of carboplatin-based CTRT in patients who are not eligible for cisplatin. MATERIALS AND METHODS: A total of 63 locally advanced head and neck cancer patients treated between January 2011 and October 2015 were administered carboplatin-based CTRT. The dose of carboplatin was equivalent to area under the curve equivalent to 2 administered once a week for a maximum of 7 cycles. Toxicity was coded as per the CTCAE version 4.03. SPSS software version 16 was used for statistical analysis. STATISTICAL ANALYSIS: Descriptive statistics was performed. Progression-free survival (PFS) and overall survival (OS) were estimated by Kaplan–Meier survival analysis. Cox proportional hazard model was used for identifying factors affecting PFS and OS. RESULTS: The reasons for patients being unfit for cisplatin were low serum creatinine clearance in 41 (65.07%), sensorineural hearing loss in 18 (28.57%), uncontrolled medical comorbidities in 3 (4.76%), and old age in 1 patient (1.6%). 53 patients (84.1%) completed planned radiotherapy. The median number of chemotherapy cycles administered was 6. Grade 3–4 toxicities were seen in 32 patients (50.8%). The median OS and PFS were 28 months (95% confidence interval [CI]: 20.9–34.6 months) and 17 months (95% CI: 08.2–25.7 months), respectively. Age was the only factor significantly affecting OS and PFS. CONCLUSION: Carboplatin-based CTRT is well tolerated in patients unfit for cisplatin and seems to have superior outcomes than those reported in radical radiotherapy studies.

ROS1 rearrangement acts as a driver mutation in 1-2% of NSCLC. Crizotinib is approved in this situation both in treatment naive and pre-treated patients. Here we report our experience with crizotinib in patients with advanced NSCLC harbouring ROS1 rearrangement. Eleven patients were included in our study. More than half of our patients had associated comorbidities and one fourth of them had a compromised performance status. Out of 11 patients, 5 of them were exposed to crizotinib .The response rates among crizotinib treated patients was 80%. With a median follow up of 9 months, median PFS and OS were 5.4 months and 8.5 months respectively for the entire population. Analyzing the outcomes separately , median PFS and OS was not reached for those who received crizotinib compared to median PFS of 2.5 months and median OS of 4.2 months in those who were not exposed to crizotinib. The difference was statistically significant. Estimated 1 year OS was 80% for those who received crizotinib compared to 18% for who did not receive crizotinib. In conclusion, crizotinib is effective with acceptable side effect profile in patients with ROS1 rearranged NSCLC in our population.

PURPOSE: The aim of this study was to report the median overall survival (OS) in epidermal growth factor receptor (EGFR) mutation-positive patients who were managed out of a clinical trial. METHODS: Nonsmall cell lung cancer patients harboring activating EGFR mutations who were either ineligible or refused participation in a clinical trial were selected for this analysis. The reason for not participating in trial, staging, treatment, and outcome details were obtained from a prospective lung cancer database. The Kaplan–Meier method was used to estimate OS. Log-rank test and Cox proportion hazard model were used for univariate and multivariate analysis, respectively. RESULTS: We included 225 patients in this analysis. The median age of the cohort was 56 years (range 29–85 years). A compromised Eastern Cooperative Oncology Group performance status (PS) of >2 was the major reason (83 patients, 36.9%) for ineligibility of patients in a clinical trial. The major reason provided by eligible patients for refusal to participate in a clinical trial was long distance of travel and inability to comply with the study-mandated follow-up visits (65 patients, 28.9%). The median OS in patients with PS 0–2 was 18.17 months (95% confidence interval [CI]: 15.6–20.8 months) and it was 12.1 months (95% CI: 9.0–15.2 months) in patients with PS 3–4 (hazard ratio - 0.579 [95% CI: 0.398–0.843] P = 0.004). CONCLUSION: EGFR positive patients who were ineligible for a clinical trial due to poor PS had lower survival; however, patients with good PS treated off-trial had similar OS to that reported in multiple clinical trials.

INTRODUCTION: The feasibility and success rate of repeat biopsy for epidermal growth factor receptor (EGFR) mutation-positive lung cancers that have progressed on tyrosine kinase inhibitors (TKIs) are varied and merits further assessment. MATERIALS AND METHODS: EGFR mutation-positive lung cancers were offered repeat biopsy upon progression on TKIs. Two groups of patients, first one on a clinical trial and second one from a database, were included for analysis. The feasibility to perform a repeat biopsy was analyzed in the first group. Success rate of biopsy and tissue adequacy for molecular testing was analyzed in both groups. Descriptive statistics were used for analyzing the demography, EGFR mutation type, tissue adequacy, and molecular profile at repeat biopsy. Kolmogorov–Smirnov test was used to assess normality of data. Two sample t-tests were used for comparison of proportions. RESULTS: The feasibility of undergoing repeat biopsy was 77% (95% confidence interval [CI] of 69.4%–83.5%) in the first group (114/148 patients). Feasibility was not analyzed in the second group of patients. Out of 196 patients who underwent a repeat biopsy, 154 patients (78.6%; 95% CI: 72.2%–84.1%) had tumor tissue adequate for performing molecular testing. 27/196 (13.8%) patients did not have any evidence of malignancy on repeat biopsy whereas 15/196 (7.6%) patients had scanty tissue on repeat biopsy prohibiting molecular testing. Six patients (3.06%; 95% CI: 1.1%–6.5%) had small cell transformation. T790M mutation was detected in 12 out of the 42 patients (28.6%; 95% CI: 15.7–44.6) in whom EGFR testing was performed on repeat biopsy specimen. CONCLUSION: Repeat biopsy was able to provide adequate tissue acquisition in only two-thirds of the patients. Liquid biopsy represents an important tool to bridge this gap.

BACKGROUND: Metronomic chemotherapy has shown promising results in selected patients of head and neck cancer in a small randomized study. This retrospective analysis was done to see whether the efficacy of metronomic chemotherapy in an unselected cohort of head and neck cancer patients is similar to that reported in the randomized study and the influence of the site and subsite of head and neck cancer on survival. MATERIALS AND METHODS: This was a retrospective analysis of head and neck cancer patients who received palliative metronomic chemotherapy between January 2013 and February 2015. The data of these patients were collected from our palliative chemotherapy database maintained in medical oncology outpatient department. The overall survival (OS) was calculated in days from the date of start of chemotherapy to the date of death. Patients who had not expired at last follow-up were censored during estimation of OS by Kaplan–Meier method. Factors affecting OS were identified by COX regression analysis. RESULTS: Over the stipulated time period, 340 patients received palliative metronomic chemotherapy. The median age of these patients was 48 years (22–90 years). The sites of tumor origin were oral cavity in 281 patients (82.6%), oropharynx in 33 patients (9.7%), larynx in seven patients (2.1%), hypopharynx in 12 patients (3.5%), and maxilla in seven patients (2.1%). Previous treatment was received by 286 patients (84.1%). The median time to failure was 3.5 months (interquartile range 2.0–6.0 months). The overall median survival was 155 days (95% confidence interval 140.2–169.8 days). Failure within 6 months of previous treatment was the most important factor influencing OS. There was a trend toward lower OS in patients with oral cancers (139 days vs. 210 days). Among the various oral cancer subsites, oral tongue primary had a lower OS. CONCLUSION: Oral metronomic chemotherapy has promising results when used in a selected cohort of patients but has dismal results in patients who failed within 6 months of previous treatment.

Aims The role of whole brain radiotherapy (WBRT) in patients with brain metastases from non-small cell lung cancers (NSCLC) has been questioned. However, no reliable criteria exist to identify patients who do not benefit from WBRT. The objective of the current study was to develop a prognostic model to identify such patients whose survival matches that of the Quality of Life after Treatment for Brain Metastases (QUARTZ) study. Materials and methods Outcome data of patients with NSCLC with brain metastases undergoing WBRT enrolled in a prospective observational study in a tertiary cancer centre were used to develop a prognostic model. Baseline clinico-radiological factors were used for development of the model. The model was internally validated and calibration accuracy was checked for prediction of 70 day mortality. The generated prognostic model was presented as a nomogram. Results The median overall survival of 140 patients enrolled in the study was 166 days (95% confidence interval 108–242 days). The prognostic model identified gender, Karnofsky performance status and epidermal growth factor receptor activating mutation status as significant factors influencing overall survival. The model showed a modest discriminative ability with an optimism-corrected C-index of 0.64. However, model calibration error did reveal a moderate degree of calibration error. The high-risk subgroup identified by the model had a median overall survival of 67 days (95% confidence interval 56–101 days), which was similar to that observed in the QUARTZ trial. Conclusion This prognostic model derived from traditional clinico-radiological features had a modest ability to identify patients with poor prognosis who may not benefit from WBRT. However, the high-risk subgroup identified using this prognostic model had a survival similar to that observed for patients in the QUARTZ trial.

Aims Neoadjuvant chemotherapy (NACT) is the standard of care in non-small cell lung cancers (NSCLC) with locally advanced N2 disease. There is a scarcity of data for the pemetrexed–platinum regimen as NACT. Also, apart from N2 disease, the role of NACT in locally advanced NSCLCs for tumour downstaging is unclear. Materials and methods Non-metastatic adenocarcinomas of lung treated with pemetrexed–platinum-based NACT were analysed. The patients with locoregionally advanced N2 disease and those who were borderline candidates for upfront definitive treatment were planned for NACT after discussion in a multidisciplinary clinic. In total, four cycles of 3-weekly pemetrexed and platinum were delivered in the combined neoadjuvant and adjuvant setting. A response assessment was carried out using RECIST criteria. Progression-free (PFS) and overall survival were calculated using the Kaplan–Meier method. Results Of 114 patients, 96 evaluable patients received NACT with pemetrexed–platinum. The most common indication for NACT was N2 disease at baseline (46.8%). The objective response rate was 36.4% (95% confidence interval 22–52%), including two complete and 32 partial responses, whereas 12.5% of patients had progressive disease on NACT. The median PFS was 14 months (95% confidence interval 10.7–17.3) and the median overall survival was 22 months (95% confidence interval 15.6–28.4) at a median follow-up of 16 months. There was a significant improvement in the overall survival of patients undergoing definitive therapy versus no definitive therapy (median overall survival 25 months [95% confidence interval 19.6–30.4] versus 12 months [95% confidence interval 3.2–20.7], respectively; P = 0.015, hazard ratio 0.56 [95% confidence interval 0.3–0.9]). Among patients who could not undergo definitive chemoradiation upfront due to dosimetric constraints ( n = 34), 24 (70.6%) patients finally underwent definitive therapy after NACT. Conclusions Pemetrexed–platinum-based NACT seems to be an effective option and many borderline cases, where upfront definitive therapy is not feasible, may become amenable to the same after incorporation of NACT.

BACKGROUND: Optimal management of recurrent high grade gliomas continues to be challenging, with Bevacizumab as one of the modalities increasingly used in the last few years. The current audit looks at the pattern of use and its results from a major tertiary care center in India. METHODS: Patients who received Bevacizumab as salvage treatment for recurrent high grade glioma between January 2015 to August 2016 were included for this analysis. The demographics, characteristics at recurrence, symptomatic response, adverse events, and survival were noted. SPSS version 16 was used for analysis. Descriptive statistics was performed and Kaplan Meier time to event estimation method was used for estimation of progression free survival and overall survival. Results: Twenty seven patients were selected for this analysis. The median age was 47 years and 23 patients were males (85.1%). The histopathology was grade IV glioma in 21 patients (77.7%) and grade 3 in 6 patients (22.3%). Bevacizumab was used as 2nd line treatment in 22 patients, 3rd line in 4 patients and 4th line in 1 patient. It was administered as single agent in 11 patients and with chemotherapy in rest of the patients (CCNU in 2 patients and irinotecan in rest). The median number of cycles administered were 6 (1-12). Twenty two patients were eligible for symptomatic response assessment and 15 patients (68.1%) had symptomatic benefit. The median progression free survival was 145 days (57-232) and median overall survival was 164 days (123-204) respectively. The toxicity was limited to febrile neutropenia in 1 patient, bleeding episode in 1 patient and dyslipidemia in 1 patient. There was no episode of intracranial bleed or hypertension noted. There was a trend towards decrease in steroid use with bevacizumab. Conclusions: In Indian context Bevacizumab is well tolerated. Bevacizumab was associated with symptomatic improvement in recurrent high grade glioma. The ability of this drug to improve survival still remains questionable.

INTRODUCTION: Sorafenib is an established upfront treatment option for metastatic RCC (mRCC). There is no published literature regarding its performance in Indian Patients. We present an analysis of Sorafenib use in our institute and attempt to validate the Heng criteria as a prognostic score in these patients. MATERIALS AND METHODS: Patients who received Sorafenib as first line treatment for advanced RCC from June 2012 to December 2015 were prognosticated by Heng criteria and retrospectively analysed for baseline demographics, toxicity, response and outcomes. RESULTS: 82 patients (65 males, 17 females) with a median age of 57 years were included for final analysis. Median ECOG PS was 1, 95.2 % of the patients had Stage IV disease and clear cell was the predominant histology (79.4%). 23.2%, 42.7% and 34.1% of patients were classified as low, intermediate and high risk by Heng's criteria, respectively. Dose reduction was required in 24.4% of patients, while 14.6% required permanent cessation of Sorafenib due to intolerable or recurrent side effects. Common adverse events included HFS (68.2%), mucositis (35.3%), fatigue (35.3%), rash (32.9%) and hypertension (25.6%). Response rate observed was 18.2%, while clinical benefit rate was 57.2% in the 57 patients where response was evaluable. Median progression free survival was 7.75 months (5.45-10.05) and median overall survival (OS) was 12.18 months (9.61 – 14.76). Median OS was 19.6, 16.1 and 10.3 months respectively for low, intermediate and high risk patients by Heng criteria and the criteria was statistically discriminatory for the 3 groups for OS (p=0.045, chi-square test). CONCLUSION: Sorafenib is a viable upfront treatment option for metastatic RCC in Indian patients with acceptable PFS, although a high incidence of HFS, mucositis and rash is observed. The Heng score has discriminatory value in mRCC with Sorafenib and can be considered for routine use in the clinic.

Background Addition of nimotuzumab to weekly cisplatin and radiation improves outcomes in head and neck cancer. HPV-negative oropharyngeal cancer has unsatisfactory treatment outcomes and is a candidate for escalation of treatment. Hence we wanted to determine whether the addition of nimotuzumab to cisplatin-radiation can improve outcomes in these subsets of poor-risk tumors. Methods This was a subgroup analysis of a phase 3 randomized study. In this study locally advanced head and neck cancer patients undergoing definitive chemoradiation were randomly allocated to weekly cisplatin (30 mg/m2 IV )- radiation (66-70 Gy) {CRT arm} or nimotuzumab (200 mg weekly) -weekly cisplatin (30 mg/m2)-radiation (66-70 Gy) {NCRT arm}. The data for HPV-negative oropharyngeal cancer was extracted from the database of this study for the current analysis. HPV testing was done with p16 IHC staining and reported according to the CAP criteria. The outcomes assessed were progression-free survival (PFS), disease-free survival (DFS), locoregional control (LRC), and overall survival (OS). Interaction test was performed between the study arms and HPV status prior to doing any HPV-specific analysis for each of the studied outcomes. Kaplan Meier estimates for 2-year OS with 95% CI is provided. The hazard ratio was calculated using Cox regression analysis. Results We had 187-HPV negative oropharyngeal cancers, 91-CRT arm and 96 in NCRT arm. The interaction test was significant for PFS (p = 0.000), locoregional control (p = 0.007) and overall survival (p = 0.002) but not for DFS (p = 0.072). The 2-year PFS was 31.5% (95%CI 21.5-42) in CRT arm versus 57.2% (95%CI 45.8-67.1) in NCRT arm (HR -0.54;95%CI 0.36-0.79, p = 0.002). While the 2-year LRC was 41.4 % (95%CI 29.8-52.6) in CRT arm versus in 60.4% (95%CI 48.7-70.2) in NCRT arm (HR -0.61;95%CI 0.4-0.94, p = 0.024). The addition of nimotuzumab also led to an improvement in OS from 39.0% (95%CI 28.4-49.6) to 57.6% (95%CI 46.3-67.4) (HR-0.63, 95%CI 0.43-0.92, p = 0.018). Conclusions The addition of nimotuzumab to weekly cisplatin-radiation improves outcomes inclusive of OS in HPV-negative oropharyngeal cancers. Clinical trial identification CTRI/2014/09/004980. Legal entity responsible for the study The authors. Funding Biocon Ltd, TRAC. Disclosure K. Prabhash: Research grant / Funding (institution): Dr. Reddy’s Laboratories Inc; Research grant / Funding (institution): Fresenius Kabi India Pvt Ltd; Research grant / Funding (institution): Alkem Laboratories; Research grant / Funding (institution): Natco Pharma Ltd; Research grant / Funding (institution): BDR Pharmaceutics Intl Pvt Ltd; Research grant / Funding (institution): Roche Holding AG. V. Noronha: Research grant / Funding (institution): Dr. Reddy’s Laboratories Inc; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Sanofi Aventis. All other authors have declared no conflicts of interest.

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 (30–67 years) and the median tumour size was 7 cm (2.5–15 cm). Of the 208 planned weekly cycles, 207 could be given. The rates of grade 3–4 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.

Background And Aim: The percentage of elderly people with head and neck cancers (HNC) is on the rise. This makes HNC in this group of patients an important issue for healthcare providers. The present study was planned to analyze the patterns of care given to the geriatric patients and to identify the factors influencing the decision making process. Materials And Methods: Data of all the elderly patients (≥65 years) registered in the year 2012, with histologically proven HNC (all sites, stages, histopathological types, except lymphoma, sarcoma and cervical metastasis of unknown origin) receiving treatment (definitive/palliative) were collected. Results: A total of 270 patients were included in this study. The median age was 72 years (range: 65–101), with predominant male population (70%, n = 190). Oral cavity squamous cell carcinoma (SCC) was the most common cancer (57%, n = 154). Eastern Co-Operative Oncology Group performance status (PS) of 0–2 was seen in 91% of the patients. Co-morbidities were present in 139 (51.5%) patients. 50% ( n = 134) of the patients received palliative intent treatment, 45% ( n = 123) definitive treatment, whereas in 5% ( n = 13) the intent was not mentioned. Age, a clinical stage and PS significantly influenced the decision making on the intent of treatment. 208 (77%) patients completed their treatment irrespective of the intent. Age was the only factor influencing treatment completion irrespective of the intent. Conclusion: Geriatric HNC patients frequently present with advanced disease, having multiple co-morbidities. Hence, a multidisciplinary team management of these patients is essential, also taking into account of the social and financial support available to these patients.

Context: Indian febrile neutropenia (FN) data are limited, especially in adult solid tumor patients. AIMS: The aim was to study patterns of presentation, source of infection, management and outcome and to evaluate the factors which may correlate with outcome. Materials And Methods: A retrospective analysis of prospective data of FN patients at a tertiary care oncology teaching hospital in India between 2007 and 2012. A standardized form was filled for each patient. Patient management was at the discretion of the treating physician. Multinational Association for Supportive Care in Cancer (MASCC) score was retrospectively calculated. Failure of therapy was defined as death, organ failure, shifting from outpatient to inpatient or requirement of intensive care support. SPSS version 16 was used for analysis. Results: A total of 388 FN episodes were included: 256 in hematolymphoid and 132 in solid tumor patients. 156 episodes were high-risk by MASCC score. Focus of infection was clinical in 45% and radiologic in 16%. Blood cultures were positive in 18% cases, most commonly Gram-negative organisms (72%). 93% patients were treated with an antibiotic combination of third-generation cephalosporin/beta-lactamase inhibitor, with aminoglycoside or fluoroquinolone. Antibiotic sensitivity to ceftriaxone was low at 38% while sensitivity to cefoperazone/sulbactam and piperacillin/tazobactam ranged between 50% and 55% and for carbapenems 75%. Failure of therapy occurred in 156 episodes, most commonly due to the need for second line antibiotics. Mortality was 5.5%. On univariate analysis, MASCC score, age, type of malignancy, prophylactic growth factors, presence of focus of infection, hemoglobin and nadir platelet count correlated with FN complications. Conclusion: Gram-negative bacteremia continues to be the predominant cause of FN in our setup.

Background: There is deficit of data from India on elderly patients with cancer. Comprehensive geriatric assessment may lead to a better decision making capacity in this population. However, routine implementation of such assessment is resource consuming. Aim: The aim of this study was to determine the patterns of care in elderly patients treated at a tertiary rural cancer center in India. Materials And Methods: All patients with age 70 or above with solid tumors without any definitive treatment prior to the registration at our center and registered between 01/01/2010 and 31/12/2011 were selected for this study. The baseline demographic pattern and the pattern of care of treatment were analyzed. SPSS version 16 (IBM Inc, Armonk, New York, U.S.) was used for analysis. Descriptive data are provided. Results: A total of 761 patients were evaluable subject to the aforementioned inclusion criteria. The median age of this cohort was 75 years (70-95 years). The most frequent primary sites of malignancies in 451 males were head neck (32.4%), lung (23.3%) and gastrointestinal (23.3%). In 310 females, the most common sites were head neck (31.6%), gynecological (18.4%) and gastrointestinal (24.5%). 228 (30%) of the patients had localized disease, 376 (49.4%) had loco-regionally advanced disease and 145 (19.1%) had distant metastases at presentation. 334 (46.32%) of patients were treated with curative intent. On logistic regression analysis the factors that predicted use of curative intent treatment were age