The present analysis reports the clinical, pathological, treatment profile and overall survival (OS) and disease-free survival (DFS) outcomes of consecutive breast cancer patients from three Indian centres, who underwent curative surgery as their first treatment. Among the 3453 patients, stage I, II, and III cases were 11.75%, 66.79%, and 21.64%, respectively while hormone receptor positive/HER2 negative, triple negative (TNBC) and hormone receptor any/HER2 positive cases were 55.2%, 24.2% and 20.6%, respectively. The five-year OS in the entire cohort, node-negative and node-positive patients were 94.1% (93.25–94.98), 96.17% (95.2–97.15) and 91.83% (90.36–93.31), respectively, and the corresponding DFS were 88.1% (86.96–89.31), 92.0% (90.64–93.39) and 83.93% (82.03–85.89), respectively. The five-year OS in hormone receptor positive/HER2 negative, TNBC and HER2 subgroups were 96.11% (95.12–97.1), 92.74% (90.73–94.8) and 90.62% (88.17–93.15), respectively, and the corresponding DFS were 91.59% (90.19–93.02), 85.46% (82.79–88.22) and 81.29% (78.11–84.61), respectively. This is the largest dataset of early breast cancer patients from India with survival outcome analysis and can therefore serve as a benchmark for future studies.

To assess the immunohistochemical expression of estrogen receptor (ER), progesterone receptor (PgR) and human epidermal growth factor receptor-2 (HER2) neu receptor in breast cancer and their associations with various clinicopathological characteristics. This is a retrospective analysis of women who presented with primary, unilateral breast cancer in the Department of Medical Oncology at Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India during the period from January 2008 to December 2011. Data were retrieved from the medical records of the hospital including both early and locally advanced cancer cases. ER, PgR and HER2neu expression in these patients was assessed and triple negative patients were identified. Associations of triple negative and non-triple negative groups with clinicopathological characteristics were also evaluated. A total of 1,284 women (mean age 52.1 years, 41.9% premenopausal) were included in the analysis. Hormone receptor positivity (ER and/or PgR) was seen in 63.4% patients, while 23.8% of tumors were triple negative. Only 23.0% were HER2 positive. Around 10.0% of tumors were both ER and HER2 positive. ER and PgR positivity was significantly associated with negative HER2 status (p-value<0.0001). Younger age, premenopausal status, higher tumor grade, lymph node negativity, advanced cancer stage, and type of tumor were strongly associated with triple negativity. Significantly, a smaller proportion of women had ductal carcinoma in situ in the triple negative group compared with the non-triple negative group (35.6% versus 60.8%, p-value<0.01). The present analysis is one of the largest studies from India. The majority of the Indian breast cancer patients seen in our hospital present with ER and PgR positive tumors. The triple negative patients tended to be younger, premenopausal, and were associated with higher tumor grades, negative lymph nodes status and lower frequency of ductal carcinoma in situ.

Background: Adenocarcinoma, a subgroup of non-small cell lung cancer, is the most frequent form occurring in the non-smokers. Mutation in tyrosine kinase domain of epidermal growth factor receptor (EGFR) has been a common feature observed in lung adenocarcinoma. The study was carried out to detect the prevalence of EGFR mutation in lung adenocarcinoma. Materials and Methods: EGFR mutation status in 166 lung adenocarcinoma patients was obtained retrospectively. Mutation tests were performed on paraffin embedded tissue blocks as a routine diagnostic procedure by polymerase chain reaction followed by direct nucleotide sequencing. Patient's demographics and other clinical details were obtained from the medical records. Results: EGFR mutation was detected in 43/166 (25.9%) patients. Gender wise mutation was observed as 18/55 (32.7%) in females and 25/111 (22.5%) in males. Overall, EGFR mutation was correlated with never smokers and distant metastasis ( P < 0.05), but not associated with the gender, disease stage and pleural effusion. Exon 19 deletions were significantly correlated with females, never smokers, pleural effusion and distant metastasis ( P < 0.05). However, point mutation on exon 21 did not show any statistical association with the above variables. Median overall survival was 22 months (95% confidence interval, 15.4-28.6). Female sex, EGFR mutation and absence of metastasis are associated with good prognosis. Conclusion: EGFR mutation in lung adenocarcinoma was higher in never smokers, females and patients with distant metastasis. However, it was not linked with tobacco smoking. The prevalence of EGFR mutation observed is in range with the previously published reports from the Asian countries.

Clinical and epidemiological study of EGFR mutations and EML4-ALK fusion genes among Indian patients with adenocarcinoma of the lung DC Doval,1 K Prabhash,2 S Patil,3 H Chaturvedi,4 C Goswami,5 AK Vaid,6 S Desai,2 S Dutt,7 VH Veldore,8 N Jambhekar,2 A Mehta,1 D Hazarika,8 S Azam,1 S Gawande,9 S Gupta10 1Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, 2Tata Memorial Hospital, Mumbai, 3Bangalore Institute of Oncology, HCG Group, Bengaluru, 4Max Super Speciality Hospital, New Delhi, 5B. P. Poddar Hospital, Kolkata, 6Medanta The Medicity, Gurgaon, 7Oncquest Laboratories Ltd., New Delhi, 8Triesta Reference Laboratory, HCG Group, Bengaluru, 9Pfizer India Ltd., Mumbai, 10Catalyst Clinical Services Pvt. Ltd., New Delhi, India Background: Mutation in the tyrosine kinase domain of epidermal growth factor receptor (EGFR) is a common feature observed in lung adenocarcinoma. A fusion gene between echinoderm microtubule-associated protein-like 4 (EML4) and the intracellular domain of anaplastic lymphoma kinase (ALK), named EML4-ALK, has been identified in a subset of non-small-cell lung cancer (NSCLC) tumors. The objective of this study was to determine the prevalence of EGFR mutations and EML4-ALK fusions in Indian patients with NSCLC (adenocarcinoma) as well as evaluate their clinical characteristics.Patients and methods: Patients with NSCLC, adenocarcinoma histology, whose tumors had been tested for EGFR mutational status, were considered for this study. ALK gene rearrangement was detected by fluorescence in situ hybridization using the Vysis ALK Break Apart Rearrangement Probe Kit. ALK mutation was tested in samples that were negative for EGFR mutation.Results: A total of 500 NSCLC adenocarcinoma patients were enrolled across six centers. There were 337 (67.4%) men and 163 (32.6%) women with a median age of 58 years. One hundred and sixty-four (32.8%) blocks were positive for EGFR mutations, whereas 336 (67.2%) were EGFR wild-type. Of the 336 EGFR-negative blocks, EML4-ALK fusion gene was present in 15 (4.5%) patients, whereas 321 (95.5%) tumors were EML4-ALK negative. The overall incidence of EML4-ALK fusion gene was 3% (15/500).Conclusion: The incidence of EGFR mutations (33%) in this Indian population is close to the reported incidence in Asian patients. EML4-ALK gene fusions are present in lung adenocarcinomas from Indian patients, and the 3% incidence of EML4-ALK gene fusion in EGFR mutation-negative cases is similar to what has been observed in other Western and Asian populations. The mutual exclusivity of EML4-ALK and EGFR mutations suggests implementation of biomarker testing for tumors harboring ALK rearrangements in order to identify patients that can benefit from newer targeted therapies. Keywords: NSCLC, Crizotinib, Vysis ALK Break Apart Rearrangement Probe Kit

The aim of this study was to evaluate the impact of intensity-modulated radiation therapy (IMRT) on the incidence and severity of chronic dysphagia in patients with head and neck cancer. 62 evaluable patients with head and neck cancer who were treated with IMRT with or without concurrent chemotherapy were analysed. The majority of the patients (77.4%) had advanced locoregional disease. 45 patients underwent definitive IMRT and 17 received post-operative IMRT. Concurrent chemotherapy was given to 29 of the 45 patients treated with definitive IMRT. The average prescribed dose to clinical target volume (CTV)1 was 66–70 Gy (definitive IMRT) and 56–62 Gy (post-operative IMRT); 60 Gy to CTV2; 54 Gy to CTV3; and 50–52 Gy to the supraclavicular area. At a median follow-up of 19 months, 2-year actuarial locoregional control and survival was 77% and 74%, respectively. At 6 months after IMRT, chronic dysphagia was Grade 0 in 77.1% of patients, Grade 1 in 10.5% and Grade 2 in 12.3%. Acute mucositis showed no correlation with long-term dysphagia. The percutaneous endoscopic gastrostomy or nasogastric tube was removed in all of the patients within 8 weeks of completion of treatment. Xerostomia was Grade 0 in 61.4% of patients, Grade 1 in 31.5% and Grade 2 in 7% of patients. In conclusion, IMRT conferred a major favourable impact on chronic dysphagia in patients with locally advanced head and neck cancers, with satisfactory locoregional control.

Clinical trials are the mainstay for bringing out newer and better drugs to serve the mankind. By virtue of participating in a clinical trial, a patient receives access to the newer drugs/therapies, but nothing is generally being offered to them once their participation in the study comes to an end. Though the issue of post-trial access to treatment by patients participating in a clinical trial is debatable, there is no compelling justification either for or against it. We examined a case study in order to evaluate the applicability of post-trial access to treatment for patients participating in clinical trials. The provision of post-trial access to treatment should also keep into consideration the compassionate use of drugs on humanitarian grounds, especially in cases of trial drugs that have offered significant benefit to the trial patients and whose termination would lead to deterioration in patient's overall condition. In the present era of personalized medicine, the incorporation of genetic testing into clinical practice further authenticates the rationale of compassionate use of drugs and post-trial access to treatment.