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Dive into the research topics where Ashay Karpe is active.

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Featured researches published by Ashay Karpe.


ESMO Open | 2017

Phase III study of gefitinib or pemetrexed with carboplatin in EGFR-mutated advanced lung adenocarcinoma

Vijay Patil; Vanita Noronha; Amit Joshi; Anuradha Choughule; Atanu Bhattacharjee; Rajiv Kumar; Supriya Goud; Sucheta More; Anant Ramaswamy; Ashay Karpe; Nikhil Pande; Arun Chandrasekharan; Alok Goel; Vikas Talreja; Abhishek Mahajan; Amit Janu; Nilendu Purandare; Kumar Prabhash

Objective Oral tyrosine kinase inhibitor has been shown to prolong progression-free survival (PFS) in epidermal growthfactor receptor (EGFR) mutation positive adenocarcinoma; however, the comparator arm has not included the current standard adenocarcinoma regimen (pemetrexed carboplatin induction followed by maintenance pemetrexed) and patients from Indian subcontinent. Hence, this study was carried out in Indian patients to compare gefitinib with the above-mentioned chemotherapy regimen. Methods This was an open-labelled, randomised, parallel group study comparing gefitinib (250 mg orally daily) with pemetrexed (500 mg/m2) and carboplatin (area under the curve 5) doublet intravenous induction chemotherapy regimen followed by maintenance pemetrexed (500 mg/m2) in patients with EGFR-activating mutation-positive stage IIIB or stage IV adenocarcinoma lung in the first-line setting. The primary endpoint for the study was PFS. 260 patients were required to demonstrate a 50% improvement in PFS of gefitinib over chemotherapy, with 80% power and 5% type 1 error. With an expected 5% dropout rate, the sample size was 290 patients. Results The median PFS in gefitinib arm was 8.4 months (95% CI 6.3 to 10.5 months) compared with 5.6 months (95% CI 4.2 to 7.0 months) in pemetrexed–carboplatin arm (HR: 95% CI 0.513 to 0.851; p −0.001). The impact of gefitinib on PFS was seen across all subgroups.There was no statistically significant difference in overall survival between the two arms. Haematologicalgrade3–4toxicities likeanaemia,neutropaenia and thrombocytopaenia were common in the pemetrexed–carboplatin arm while grade3–4 acneiform rash and diarrhoeawere common in the gefitinib arm. Conclusion The study confirms the superiority of gefitinib in prolonging PFS against the most active chemotherapy regimen of pemetrexed–carboplatin followed by maintenance pemetrexed in EGFR-mutated lung adenocarcinoma. The median PFS in Indian patients in gefitinib arm is similar to that reported in east Asians and Caucasians.


Indian Journal of Cancer | 2015

Efficacy of second-line erlotinib in patients postprogression of first-line chemotherapy in head and neck cancers

Patil; Ashay Karpe; Noronha; Amit Joshi; Muddu; Atanu Bhattacharjee; Sachin Dhumal; Kumar Prabhash

BACKGROUND Oral tyrosine kinase inhibitor (gefitinib and erlotinib) have been used in the palliative treatment of head and neck cancers with limited success. In this report, we aim to quantify the symptomatic benefit, progression-free survival (PFS) and overall survival (OS) when erlotinib is given as second-line treatment in Head and neck cancers. METHODS This was a post-hoc retrospective analysis of a randomized study comparing metronomic chemotherapy with cisplatin. A patient who progressed on chemotherapy and had a PS0-2 were offered second-line chemotherapy. Patients who had received erlotinib (150 mg PO OD) as second line treatment were selected for this analysis. Erlotinib was discontinued in case of either progression of disease or if the patient had intolerable side effects. Patient were monitored 1-week after the start of erlotinib and subsequently at monthly intervals. The toxicity was recorded in accordance with CTCAE version 4.02 (NCI,USA) and the response were graded in accordance with RECIST version 1.1. All of these patients were followed-up till death. RESULTS Twenty-three patients were identified. The median age of these patients at the start of the second line was 47 years (interquartile range 40.5-51.75 years). The primary site of distribution was oral cavity primary in 17 patients (77.3%) and nonoral cavity primary in 05 (22.7%) patients. The immediate last chemotherapy regimen received was cisplatin in 9 patients (40.9%) and metronomic chemotherapy in 13 patients (59.1%). Symptomatic benefits post second-line erlotinib was seen in 18 patients (81.8%). The most common adverse events (any grade) seen were anemia in 20 patients (90.9%), rash in 10 patients (45.5%) and diarrhea in 7 patients (31.8%).The best radiological response documented were a partial response in 04 patients (19.2%). The median estimated PFS and OS were 110 days (95% confidence interval [CI]: 61-175 days) and 156 days (95% CI: 126-185 days) respectively. CONCLUSION Erlotinib single agent has promising activity in the second line and needs to be explored in future studies.


South Asian Journal of Cancer | 2016

Metronomic palliative chemotherapy in maxillary sinus tumor

Vijay Patil; Vanita Noronh; Amit Joshi; Ashay Karpe; Vikas Talreja; Arun Chandrasekharan; Sachin Dhumal; Kumar Prabhash

Background: Metronomic chemotherapy consisting of methotrexate and celecoxib recently has shown promising results in multiple studies in head and neck cancers. However, these studies have not included patients with maxillary sinus primaries. Hence, the role of palliative metronomic chemotherapy in patients with maxillary sinus carcinoma that is not amenable to radical therapy is unknown. Methods: This was a retrospective analysis of carcinoma maxillary sinus patients who received palliative metronomic chemotherapy between August 2011 and August 2014. The demographic details, symptomatology, previous treatment details, indication for palliative chemotherapy, response to therapy, and overall survival (OS) details were extracted. SPSS version 16 was used for analysis. Descriptive statistics have been performed. Survival analysis was done by Kaplan-Meier method. Results: Five patients had received metronomic chemotherapy. The median age was 60 years (range 37-64 years). The proportion of patients surviving at 6 months, 12 months, and 18 months were 40%, 40%, and 20%, respectively. The estimated median OS was 126 days (95% confidence interval 0-299.9 days). The estimated median survival in patients with an event-free period after the last therapy of <6 months was 45 days, whereas it was 409 days in patients with an event-free period postlast therapy above 6 months (P = 0.063). Conclusion: Metronomic chemotherapy in carcinoma maxillary sinus holds promise. It has activity similar to that seen in head and neck cancers and needs to be evaluated further in a larger cohort of patients.


South Asian Journal of Cancer | 2018

Quality of life and quality-adjusted time without toxicity in palliatively treated head-and-neck cancer patients

Kumar Prabhash; Vijay Patil; Amit Joshi; Vanita Noronha; Atanu Bhattacharjee; Sachin Dhumal; Mv Chandrakanth; Ashay Karpe; Vikas Talreja; Arun Chandrasekharan; Siddharth Turkar; Nikhil Pande; Anant Ramaswamy

Background: Quality-adjusted time without toxicity (Q-TWiST) and quality of life (QOL) are indicators of benefit provided by different chemotherapy regimens. Methods: This was a prospective study, in which adult head-and-neck (H and N) cancer patients, treated with metronomic chemotherapy were enrolled. The Functional Assessment of Cancer Therapy-General H and N (FACT-G and H and N) version 4 pro formas were self-administered before the start of chemotherapy and then at 2, 4, and 6 months. FACT QOL and Q-TWiST analysis were then performed. Results: There was an improvement in the social well-being (P = 0.370), emotional well-being (P = 0.000), functional well-being (P = 0.000), H and N cancer subscale (P = 0.001), FACT H and N trial outcome index (P = 0.000), FACT G-total score (P = 0.000), and FACT H and N total score (P = 0.000) with palliative chemotherapy. The QTWiST value for a utility score of 0.25 for toxicity and relapse state was 145.93 days. Conclusion: Metronomic chemotherapy is associated with improvement in QOL and has a low duration of time spent in toxicity state.


Lung India | 2018

Efficacy of gefitinib in epidermal growth factor receptor-activating mutation-positive nonsmall cell lung cancer: Does exon 19 deletion differ from exon 21 mutation?

Amit Joshi; Vijay Patil; Vanita Noronha; Anuradha Chougule; Atanu Bhattacharjee; Rajiv Kumar; Supriya Goud; Sucheta More; Anant Ramaswamy; Ashay Karpe; Nikhil Pande; Arun Chandrasekharan; Alok Goel; Vikas Talreja; Abhishek Mahajan; Amit Janu; Nilendu Purandare; Kumar Prabhash

Background: This study was designed to evaluate the differential effect of epidermal growth factor receptor (EGFR) mutation status (exon 19 vs. 21) on progression-free survival (PFS) and overall survival (OS) in treatment-naïve advanced EGFR mutation-positive nonsmall cell lung cancer (NSCLC) treated with gefitinib as first-line agent. Methods: This was a post hoc analysis of EGFR-mutated (exon 19 and 21) advanced-stage (Stage IIIB or IV), chemotherapy-naive NSCLC patients treated with gefitinib as first line in a phase 3 randomized study. Patients were treated with gefitinib 250 mg daily. Patients underwent axial imaging for response assessment on D42, D84, D126, and subsequently every 2 months till progression. Responding or stable patients were treated until progression or unacceptable toxicity. SPSS was used for statistical analysis. Kaplan–Meier method was used for survival estimation and log-rank test for comparison. Cox proportion hazard model was used for multivariate analysis. Results: One hundred and forty-one patients were eligible for analysis, of which 78 were males and 63 were females. A total of 127 patients (90.1%) were ECOG 0–1 while 14 patients (9.1%) were ECOG >1. Exon 21 mutation was present in 65 patients (46.1%) and exon 19 mutation in 76 patients (53.9%). One hundred and thirty-three of 141 patients were evaluable for response. Response rate of patients having exon 19 mutation was 72.9% (51 patients, n = 70) while it was 55.6% in patients having exon 21 mutation (35 patients, n = 63) (P = 0.046). Median PFS in exon 19-mutated patients was 9.3 months (95% confidence interval [CI] 6.832–11.768) compared to 7.8 months (95% CI 5.543–10.0) (P = 0.699) in exon 21-mutated patients. The median OS in exon 19-mutated patients was 19.8 months (95% CI 16.8–22.7), and it was 16.5 months (95% CI 10.9–22.1) in exon 21-mutated patients (P = 0.215). Conclusion: There were no differential outcomes in the Indian patients of advanced-stage NSCLC with exon 19 and 21 EGFR mutations treated with gefitinib.


Journal of Global Oncology | 2018

Outcomes in Treatment-Naïve Patients With Metastatic Extremity Osteosarcoma Treated With OGS-12, a Novel Non–High-Dose Methotrexate–Based, Dose-Dense Combination Chemotherapy, in a Tertiary Care Cancer Center

Jyoti Bajpai; Arun Chandrasekharan; Vijai Simha; Vikas Talreja; Ashay Karpe; Nikihil Pandey; Ashish Singh; Bharat Rekhi; Tushar Vora; Jaya Ghosh; Shripad Banavali; Sudeep Gupta

Purpose Metastatic osteosarcoma is largely treated with high-dose methotrexate (HDMTX)–based therapy, especially in the pediatric population. This mandates complex pharmacokinetic monitoring in a costly inpatient setting to mitigate unpredictable serious toxicities. Hence, a non-HDMTX–based regimen is worth exploring, especially in India and low- and middle-income countries. Materials and Methods All consecutive treatment-naïve patients with metastatic osteosarcoma were prospectively treated on the novel OGS-12 protocol consisting of sequential doublets of doxorubicin, cisplatin, and ifosfamide. Four cycles were administered as neoadjuvant therapy followed by planned curative intent surgery and metastasectomy when feasible, followed by four cycles of adjuvant chemotherapy. Baseline characteristics, histologic response, event-free survival (EFS), overall survival (OS), and toxicity data were prospectively collected. Results Three hundred seventeen patients were enrolled onto the OGS-12 protocol from 2011 to 2014, of whom 80 (25%) had metastatic disease; median age was 17 years. The majority of patients were nutritionally challenged with high-risk features. At presentation, 83% of patients (66 patients) had lung metastases. After neoadjuvant chemotherapy, 57% of patients were histologically good responders. Four-year EFS and OS rates were 24% and 27%, respectively, in the intent-to-treat population and 27% and 29%, respectively, in the per-protocol analysis. Significant grade 3 or 4 toxicities were febrile neutropenia (51%), thrombocytopenia (36%), and anemia (54%). Histologic response was an independent predictor for EFS and OS in patients who underwent surgery. Surgical intervention was found to be significant for survival in univariable analysis. Conclusion The novel, low-cost, non-HDMTX–based, dose-dense OGS-12 regimen has shown comparable outcomes to international standards in metastatic osteosarcomas and is worthy of wider clinical application. An aggressive multimodality approach may result in long-term survival in a select group of patients and, hence, is worth considering.


Indian Journal of Cancer | 2017

Development and validation of a predictive score, for identifying poor eastern cooperative oncology group performance status (performance status 3–4) advanced nonsmall cell lung cancer patients who are likely to benefit from tyrosine kinase inhibitors

Amit Joshi; Atanu Bhattacharjee; Vanita Noronha; V. Patil; Ashay Karpe; N Kadam; L Solanki; Kumar Prabhash

BACKGROUND One of the ten advanced lung cancer patients presents with poor eastern cooperative oncology group performance status (ECOG PS). There are no clear guidelines about management of these patients. The benefit of tyrosine kinase inhibitors (TKI) in this patient population remains questionable. Hence, in this study, we attempted to develop and validate a predictive score which would predict benefit from oral TKI. METHODS This was a prospective observational study done at Tata Memorial Hospital, India. Patients with nonsmall cell lung cancer with ECOG PS 3-4 were included in this study. All these patients had received oral TKI on compassionate grounds and were followed up till death. The overall survival (OS) was calculated from date of start of TKI to date of death. R software was used for development and validation of the predictive model. RESULTS The median survival duration of the discovery cohort and validation cohort were 170.5 and 115 days, respectively. The model predicted OS accurately, within ±2 months in 72.1% and within ±3 months in 81.7% of patients. CONCLUSION The current model can predict OS in poor PS patients treated with TKI within a satisfactory clinical range and can be used for decision-making of these patients.


Ecancermedicalscience | 2017

Impact of exon 19 versus exon 21 EGFR-activating mutation on outcomes with upfront pemetrexed–carboplatin chemotherapy

Vanita Noronha; Vijay Patil; Amit Joshi; Anuradha Chougule; Atanu Bhattacharjee; Rajiv Kumar; Sucheta More; Supriya Goud; Ashay Karpe; Anant Ramaswamy; Nikhil P; Arun Ch; rasekharan; Alok Goel; Vikas Talreja; Abhishek Mahajan; Amit Janu; Nilendu Pur; are; Kumar Prabhash

Background EGFR mutation subtype is a recognised factor impacting outcomes of patients receiving oral tyrosine kinase inhibitors (TKIs) in non-small-cell lung cancer (NSCLC). Evidence for the effect of this factor on outcomes in patients receiving pemetrexed is limited. Methods We completed a study comparing pemetrexed–platinum combination versus oral TKI in EGFR mutation-positive patients in lung cancer. We analysed the impact of EGFR mutation subtype, specifically, exon 19 and 21 on the PFS and OS of patients treated with pemetrexed (500 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) as first-line therapy. Patients underwent axial imaging for response assessment on D42, D84, D126 and subsequently every two months till progression. Patients post-progression were treated with gefitinib. Results Fifty-one patients (36%) had exon 21 mutation, while 92 patients (64%) had exon 19 mutation. Response rates in evaluable patients was 47.7% in exon 19 patients (41 patients, n = 86) and 42.9 % in exon 21 patients (18 patients, n = 42). There was a significant increase in median overall survival for patients with exon 19 mutations (24.5 months, 95% CI: 21.3–27.7 months ) over the exon 21-mutated patients (18.1 months, 95% Cl: 13.5–22.6 months, p = 0.002). This differential impact was due to second-line gefitinib having a differential outcome on these mutations. Conclusion Pemetrexed-based chemotherapy does not have a differential impact on exon 19- or exon 21-mutated patients. However, second-line treatment with gefitinib has a favourable response and outcome in exon 19-mutated patients.


Chemotherapy Research and Practice | 2017

Efficacy of Second-Line Pemetrexed-Carboplatin in EGFR-Activating Mutation-Positive NSCLC: Does Exon 19 Deletion Differ from Exon 21 Mutation?

Amit Joshi; Vanita Noronha; Vijay Patil; Anuradha Chougule; Atanu Bhattacharjee; Rajiv Kumar; Supriya Goud; Sucheta More; Anant Ramaswamy; Ashay Karpe; Nikhil Pande; Arun Chandrasekharan; Alok Goel; Vikas Talreja; Abhishek Mahajan; Amit Janu; Nilendu Purandare; Kumar Prabhash

Background It is unknown whether the outcomes of second-line pemetrexed-carboplatin chemotherapy administered after progression on gefitinib are dependent on type of EGFR mutation present at baseline. Method Adult non-small-cell lung cancer patients, with exon 19 deletion or exon 21 L858R mutation, who progressed on gefitinib and received pemetrexed-carboplatin chemotherapy were selected for this analysis. Result 55 patients received pemetrexed-carboplatin as second-line treatment. Response rates in evaluable patients were 39.3% in exon 19 patients (n = 28) and 33.3% in exon 21 patients (n = 15) (p = 0.752, Fishers exact 2-sided p value). The median PFS in exon 19 and 21 cohorts was 5.900 months (95% CI: 4.274–7.526) and 4.767 months (95% CI: 1.374–8.159), respectively. The median overall survival in exon 19 patients was (11.8 months, 95% CI: 9.916–13.684 months) significantly better than that seen in exon 21 mutation patients (6.2 months, 95% CI: 4.215–8.118 months, p = 0.024) on univariate analysis; however, on multivariate analysis, this association was not confirmed (HR = 0.361, 95% CI: 0.090–1.439, p = 0.149). Conclusion Exon 19 deletion has no impact on PFS and OS in EGFR-mutated patients treated with second-line pemetrexed-carboplatin.


Indian Journal of Cancer | 2016

Weekly cisplatin (30–40 mg/m2) as radiosensitizer: Is it high or moderate emetic agent?

Ashay Karpe; Vijay Patil; Amit Joshi; Vanita Noronha; Sudeep Gupta; Anant Ramaswamy; Arvind Sahu; Vipul Doshi; Tejpal Gupta; S Rath; S Banavali; Kumar Prabhash

PURPOSE The American Society of Clinical Oncology (ASCO) guideline recommends a high antiemetic prophylaxis for any dose of cisplatin. This hypothesis was tested by us in this analysis of solid tumor patients who received weekly cisplatin as a radiosensitizer in a dose range of 30-40 mg/m2. METHODS This was a retrospective analysis of 181 solid tumor patients who received weekly cisplatin (in the dose range of 30-40 mg/m2) as a radiosensitizer between July 2015 and August 2015. The antiemetic prophylaxis schedule provided was classified as optimal (if a high antiemetic prophylaxis was provided) or suboptimal (if a nonhigh antiemetic prophylaxis was provided). The incidence of acute, delayed and breakthrough vomiting after chemotherapy was noted. SPSS version 20 was used for analysis. Fishers exact test was used to determine the association between antiemetic schedule (suboptimal vs. optimal) and postchemotherapy emesis. RESULTS In the present study, of 181 patients, only 25 patients (13.8%) received optimal antiemetic prophylaxis while the remaining 156 (86.2%) received suboptimal prophylaxis. In the cohort of patients with suboptimal prophylaxis, dexamethasone was omitted in all patients (100%) while NK receptor antagonist was omitted in 76 patients (48.7%). The rate of vomiting was lower in patients receiving optimal prophylaxis as compared to that in patients receiving suboptimal prophylaxis (12% vs. 39.75%; P - 0.005). CONCLUSION Omission of dexamethasone followed by aprepitant was the main reason for suboptimal prophylaxis. High antiemetic prophylaxis in accordance with ASCO guidelines overall decreased the risk of emesis in patients receiving CTRT with weekly cisplatin in the dose range of 30-40 mg/m2.

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Vijay Patil

Tata Memorial Hospital

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Amit Joshi

Tata Memorial Hospital

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Alok Goel

Tata Memorial Hospital

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