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  • 1
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e19119-e19119
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e19119-e19119
    Abstract: e19119 Background: Systemic combination chemotherapy is accepted as a standard of care for patients with advanced non-small cell lung cancer (NSCLC). Substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. Quality of life (QOL) analysis will help to customize chemotherapy to improve outcome in NSCLC patients. Methods: Using PUBMED database, a review of randomized controlled phase III trials of advanced NSCLC published in last 5 years reporting comparative safety and efficacy between chemotherapeutic regimens as end points was conducted. An evaluation of end points, difference in efficacy endpoints, QOL analysis, and final conclusion was conducted. Results: The search criteria identified 51 trials (33,481 patients). Out of these 51 clinical trials, 16 trials showed difference in efficacy (13 survival endpoint, 1 ORR (objective response rate), 2 survival without grade 3/4 toxicity) and 11 trials used validated QOL instruments and were included for review. Two trials; one comparing pemetrexed/cisplatin with gemcitabine/cisplatin, and other comparing cisplatin/weekly vinoralbine with cisplatin/vinoralbine on day 1 and 8; showed difference with QOL; though not statistically significant. The QOL reporting/analysis techniques were heterogeneous. Two trials used QOL as primary endpoint. Safety reporting included percentage adverse events with treatment arms. Conclusions: Based on our review, it seems critical to have QOL as an endpoint while evaluating newer combination chemotherapeutic regimens for NSCLC. Secondly, it is unlikely that a major difference exists in the global QOL associated with standard chemotherapy regimens for NSCLC. An effort to have uniform QOL assessment across trials evaluating newer combination regimens for NSCLC will help to customize treatment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 7043-7043
    Abstract: 7043 Background: Engraftment fever (EF) is a phenomenon observed in some patients undergoing autologous transplant (ASCT). We analyzed our data to evaluate the incidence and risk factors associated with EF. Methods: Seventy-nine patients underwent ASCT (53-Hodgkin’s and 26- Non Hodgkin’s) from August 2007 – January 2013. All except 5 received LACE (Lomustine, Ara-C, Cyclophosphamide and Etoposide) conditioning regimen. EF was defined as onset of fever with rising white cell count for which no infectious cause was ascertained. Patients of EF and non-EF groups were compared for the following variables to determine risk factors. These included histology, number of lines of chemotherapy regimens pre-transplant, complete remission (CR) at transplant, peripheral blood CD 34 count on day 1 of collection (PBCD34-D1), CD 34 cell dose collected and infused and number of days of stem cell collection. Results: The median age at transplant was 23.5 years with 57 males and 22 females. Time to neutrophil and platelet engraftment was 10 and 13 days respectively. EF was seen in 35 patients (44 %) at a median of 9 days. Short course of methylprednisolone (n=28) or hydrocortisone (n=3) was given to which all responded. On univariate analysis, PBCD34-D1 〉 50/uL (P = 0.037), CD 34 cell dose infused 〉 5.9x10 6 /kg (P=0.012),CD34 cell dose collected 〉 7.2 x 10 6 /kg (P=0.032) , those receiving ≤ 2 lines of chemotherapy regimens before transplant (P=0.04), those who had ≤ 2 days of stem cell collection (P=0.002) and patients in CR at transplant (P = 0.015) were associated with risk of developing EF. On multivariate analysis, patients in CR at transplant and those who had ≤ 2 days of collection had higher risk of EF. Conclusions: The incidence of EF is high. Patients with lesser days of stem collection and those in CR at transplant have significant risk of developing EF.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e21201-e21201
    Abstract: e21201 Background: Osimertinib is one of the favoured treatment options in EGFR mutated NSCLC and was established as a treatment option in last 2-3 years. However the treatment pattern post-osimertinib failure is not established. Hence we conducted this audit to study the pattern of treatment post-osimertinib failure in India. Methods: This was a retrospective multi-centric audit of adult (age ≥18 years) EGFR mutated NSCLC patients who were treated with osimertinib and had failed. The treatment pattern of these patients was noted. Descriptive statistics were performed. Median with range was estimated for continuous variables while the percentage with 95% CI were estimated for ordinal and nominal variables. Results: We had 25 patients who had failed on osimertinib. Oligo-progression versus widespread progression was seen in 5 (20%) and 20 (80%) patients respectively. The median age was years 56.5 year (Range-26-71) with 4/25 (16%) of patients were elderly (≥65 years). Male-to-female ratio was 18:7 (72% males, 28% females).The ECOG PS at failure were 0-1 in 12 patients (48%), 2 in 11 patients(44%) and 3-4 in 2 patients (8%) patients. The treatment offered were platinum doublet in 14 patients (56%) with variable combinations with TKIs in 5 patients (20%) and bevacizumab in 4 patients(16%). A repeat NGS for assessing the mechanism of resistance was done in patients revealed new mutations in 6 patients (24%) with EGFR Exon 20 T790M being most common in 3 patients (12%). Conclusions: We conclude that, in real-world practice, platinum-doublet formed the backbone of treatment post-osimertinib progression, with variable combinations, most commonly, along with TKIs or bevacizumab. No standard guidelines for the treatment of patients post-osimertinib progression are available with variable responses and tolerability. Larger and prospective studies are needed to identify the best options of therapies in such patients.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 6017-6017
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e12520-e12520
    Abstract: e12520 Background: The use of neoadjuvant chemotherapy(NACT) in head & neck cancers is not well defined. Very few publications on this topic deal with the epidemiology ,clinical & biochemical profile. These factors have an important say in deciding the choice of regimen. Methods: An prospective analysis of oral cavity cancer patients ,who were referred for NACT at our center, was done. The analysis focussed on the demographics, clinical & biochemical parameters of these patients at presentation . Results: From 2010-2012 , 528 patients of oral cavity cancers were referred for NACT from the multidisciplinary clinic. The median age of patients was 45 years (22-78 years) ; 10.4% were above the age of 60 years and 83.7% were males. Only 16.5% of patients were from the city in which the hospital was located. 69.1% were tobacco users, 53.8% were smokers , 37.5% were alcoholic & 81.5% had in addition other local tobacco containing chewable preparations. Only 2.65% denied any addictions. Amongst the symptoms pain, facical swelling,oral ulcer , oral bleeding, foul smell, trismus & weight loss were present in 41.9%, 72.5%, 57.6% , 72.5% , 77.1%, 41.4% & 49.4% respectively. The ECOG performance status were 0,1,2 in 8.3%, 84.7%, 2.7% patients respectively. The subsite of the disease were buccal mucosa,tongue, floor of mouth, alveolus, hard palate in 67.8%, 24.4% ,4.7% , 0.9% ,1.1% respectively. 65.3% & 16.7% patients were in T4a and T4b stage. N2b(42%) and N2c (31.4% )were the most common N stage seen. All patients had stage IV disease. Comorbidites like diabetes mellitus, hypertension and cardiac disease were seen in 22.3%, 18.9% & 13.3%. The median BMI was 21.45 Kg/m2 & 24.3% had BMI below 18.5 Kg/m2 (severly malnourished). The need for NACT was mainly due to extensive disease ,edema reaching upto zygoma and edema upto hyoid bone .The regimens administered were TPF in 6.6% and Taxane with Platinum in rest others. The major reasons for not selecting TPF were logistics (75%) & malnourished status (25%). Conclusions: Patients referred for NACT at our center had locally advanced disease,nearly all were addicts, one fourth had severe malnourishment & current standard TPF could be administered in only a few of them.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 5554-5554
    Abstract: 5554 Background: Etoposide (E), cyclophosphamide (C) and tamoxifen (T) have been used as single agents in relapsed epithelial ovarian cancer (EOC) patients. We tested a low dose, continuous, daily, oral metronomic regimen that combined these 3 agents. Methods: This single centre prospective study included patients of relapsed EOC with exposure to at least 2 prior lines of chemotherapy (CT) and at least partial as the best response to most recent regimen. Study regimen comprised daily oral administration of E (50 mg/m2) and C (50 mg/m2) for 21 of a 28 day cycle plus T (20 mg/m2, twice per day) continuously. The primary endpoint was serological (CA-125) progression-free survival (PFS) as per Rustin Criteria and secondary endpoints were radiological (RECIST) PFS, overall survival (OS), duration of response (DOR), response rates and toxicity. The data cut-off date was 15 Jan 2013. Results: 26 patients with a median age of 48 years were accrued, of whom 21 had received 2 prior lines of CT and 5 had received 3 lines. 25 patients who were evaluable for analysis received a median of 6 (1-19) cycles of metronomic regimen. The median delivered relative dose intensities of E, C and T were 0.71, 0.71 and 0.97 respectively. 13 (52%) patients needed dose reduction after a median of 3 (1-9) cycles. Most common grade 3 or 4 toxicities included anemia, neutropenia, febrile neutropenia, nausea, vomiting and diarrhea in 44%, 36%, 12%, 16%, 16% and 12% patients respectively. 19 (76%) patients had serological CR or PR with a median time to response (TTR) and DOR of 1.8 (0.83-2.96) and 7.0 (95% CI, 5.8-8.2) months respectively. 11 (45.8%) of the 24 evaluable patients achieved radiological CR or PR with median TTR and DOR of 3.7 (1.8-7.2) and 5.5 (95% CI, 3.9-7.2) months respectively. 17, 18 and 7 patients have respectively experienced serological progression, radiological progression and death at the time of analysis. The median serological PFS, radiological PFS and OS are 7.9 (95% CI 7.2-8.6), 7.97 (95% CI, 5.95-9.98) and 22.3 (95% CI, 17.4-27.3) months, respectively. Conclusions: The oral metronomic combination of E, C and T has substantial and durable activity in relapsed EOC and is worthy of further evaluation in a larger randomized study.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e17027-e17027
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e17027-e17027
    Abstract: e17027 Background: Neoadjuvant chemotherapy administration is associated with significant amount of morbidity and around 2-3% mortality in the Western world protocol settings. In developing countries where malnourishment is prevalent, the same data might not apply. Methods: This analysis was performed on a database of patients undergoing NACT for oral cancers at our center from 2010- 2012. The toxicity was graded according to CTCAE version 4.02 scale. Descriptive analysis, univariate and multivariate analysis were performed to determine factors affecting toxicity. Results: There were 528 patients, the median age was 45 years (22-78 years). The regimens administered were TPF in 35 patients (6.6%) and taxane with platinum in the rest. At least one cycle of chemotherapy was taken at our center by 94.8% (494). The median number of cycles were 2. The any grade toxicity after 1 st cycle of chemotherapy were vomiting, diarrhea, mucositis, fatigue, febrile neutropenia (FN), peripheral neuropathy, hyponatremia, hypokalemia, hperkalemia, transaminitis were in 41.3% (204), 43.9% (217), 44.3% (219), 47.2% (233), 7.2% (35), 3.0% (15), 33.8% (167), 14.4% (71), 4.9% (24) and 12.3% (61).Toxicity details of second cycle of chemotherapy were available for 390 patients. The any grade toxicity after 2 nd cycle of chemotherapy were vomiting, diarrhea, mucositis, fatigue, febrile neutropenia, peripheral neuropathy, hyponatremia, hypokalemia, hyperkalemia, transaminitis were in 28.6% (113), 37.3% (108), 31.3% (124), 39.3% (116), 3.1 % (12), 3.2% (13), 19.7 % (74), 7.4% (30), 3.1% (12) and 4.9% (19). For diarrhoea, female sex, nutrition (BMI below 18.5 KG/m2) and use of 3 drug regimen were predictive. For development of mucositis only nutrition was predictive. Use of 3 drug regimen and overnourishment were predictive of FN. Use of 3 drug regimen and use of docetaxel were predictive for hyponatremia. On multivariate analysis for diarrhoea only nutrition was predictive (p=0.017), for FN both drug regimen (p=0.003) and over nutrition (p=0.035) were predictive and for hyponatremia only use of 3 drug regimen was significant (p=0.017). Conclusions: 3 drug regimen, malnourishment and use of docetaxel are important predictors of acute toxicity associated with NACT in oral cancers.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e18862-e18862
    Abstract: e18862 Background: There are limited data available from India on the real-world use of checkpoint inhibitors. Hence we did this analysis across India to study the pattern of use and outcomes with checkpoint inhibitors. Methods: This was a retrospective multicentric protocol. Patients who received immunotherapy from January 2016 to October 2021 were included. The baseline demographic, previous treatment, response, date of progression, date of death and status were noted. SPSS version 20 was used for analysis. Descriptive statistics were performed. Kaplan Meier method was used for estimation of progression-free survival (PFS) and overall survival (OS). COX regression model was used to identify factors impacting OS. Results: We identified 308 patients in the study. The median age was 58.5 years (Interquartile range 51-66 years) and there was a male preponderance (249, 80.8%). The 3 commonest sites of use were head and neck cancer in 144 patients (46.8%), lung cancer in 81 (26.3%) and renal cell carcinoma in 31(10.1) patients. The ECOG PS was 0-1 in 215 (70%), 2 in 71 (23.1), 3-4 in 21(6.8%) and not documented in 1(0.3%) patient. The two most common checkpoint inhibitors used were nivolumab and pembrolizumab 255 (82.8%) and 37(12%) patients respectively. These were used in curative setting in 6 patients (1.9%) and palliative in rest all. 43(14%) patients received them as first-line in, 129 (41.9) as second-line and beyond the second line in 130 (42.2%) patients. The response rate was 24% (n = 74). The median PFS was 4.067 (95%CI 3.45-4.67) and the median OS was 10.0 months (95%CI 6.2-13.8). Among the factors tested for impact on OS the ECOG PS 0-1 ( HR-0.493 95%CI 0.324-0.749; P = 0.001), non head and neck site of the disease (HR-2.134 95%CI 1.164-3.911) and reception of immunotherapy in first line setting (HR -0.533 95%CI 0.295-0.963: P = 0.037) had an favorable impact on OS. Conclusions: Checkpoint inhibitors provide similar efficacy as those seen in pivotal studies in real-world settings.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 6085-6085
    Abstract: 6085 Background: A variety of regimens have been used for induction chemotherapy in locally advanced head & neck cancers. Cisplatin & 5 FU drug combination is inferior to the combination of taxane & these 2 drugs. However, often in clinical practice at our center giving TPF is difficult in view of logistics & tolerance issues. In such scenarios we prefer to use 2 drug combination of platinum & taxane. However no study has addressed whether when the 2 drug combination includes taxane, is it still inferior to the 3 drug combination and which the taxane of choice is. Methods: This is a retrospective analysis of prospectively collected data of patients undergoing induction chemotherapy in oral cavity cancers from 2010-2012. We chose for analysis those patients who had a baseline scan and a follow-up scan done within 2 weeks of completion of the second cycle of induction chemotherapy. Response was scored in accordance with RECIST 1.1. Data was analyzed using SPSS, version 16. Chi- square analysis was done to compare response rates between regimens. Results: Two hundred & forty five patients were indentified. The median age was 45 years (24-70 years), 208 (84.9%) were male patients & in 154 patients (62.9%) had primary in buccal mucosa. The regimen received were TPF 22 (9%), TP (Docetaxel + cisplatin) 97 (39.6%), PP (paclitaxel+cisplatin) 89 (36.3%), TC (Docetaxel+ carboplatin) 16 (6.5%) & PC (paclitaxel + carboplatin) 21 (8.6%).The overall response rates (RR) were CR, PR,SD & PD in 4 (1.6%), 56 (22.9%), 145 (59.2%) & 40 (16.3%). On comparison, 3 drug regimen (TPF) had 50% RR as against 22% RR with 2 drug regimen (p=0.004). On comparison for taxane, docetaxel containing regimens had 30.3% RR as against 17.2% RR with paclitaxel containing regimens (p=0.018). There was no statistically significant difference in RR between patients receiving carboplatin or cisplatin. Conclusions: TPF had better RR than a 2 drug taxane-containing regimen and docetaxel leads to a better RR than paclitaxel for induction chemotherapy in locally advanced oral cavity cancers.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 10
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e20678-e20678
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e20678-e20678
    Abstract: e20678 Background: Identifying the parameters associated with increased complications would help to formulate a cost-effective and rational therapy in patients with chemotherapy induced febrile neutropenia. Methods: We prospectively collected data from January 2007-December 2011 of consecutive episodes of neutropenic fever at our centre. Clinical features, laboratory characteristics and MASCC score were analysed to identify patients at higher risk for developing complications. Complications were defined as either of the following event: failure of first line antibiotics, organ failure, delay in next cycle of chemotherapy, inpatient admission and death. Results: Three hundred and eighty-eight febrile neutropenia (FN) episodes in 373 patients were included, 256 episodes of FN in hematolymphoid malignancies and 132 episodes of FN in solid tumours. The median age was 31 years (11-76 years). Two hundred and forty-four (65.4%) patients were male. One hundred forty-nine patients (39.94%) had FN during previous cycles, while primary GCSF prophylaxis was used for 205 (52.84%) cases. The median haemoglobin, nadir neutrophil count & median number of days with severe neutropenia ( 〈 1X10 9 /L) were 7.9 gm/dl, 0.04X10 9 /L and 4 days respectively. A clinical focus of infection was present in 174 (44.8%) episodes, with gastrointestinal being the commonest in 70episodes (40.23%). High risk MASCC score ( 〈 21) was present in 156 episodes (40%). Complications were seen in 133(34%) instances. On Univariate analysis, age, type of malignancy, prophylactic growth factor use, clinical focus of infection, day of FN, MASCC score, nadir Hb and platelet count were significantly associated with complications. All predictive factors except age and nadir Hb could independently predict complication on multivariate analysis. Conclusions: Clinical and laboratory parameters in addition to MASCC score could help in identifying patients with FN who require hospitalisation and more intensive management strategies.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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