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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 6074-6074
    Abstract: 6074 Background: Nanosomal docetaxel lipid suspension (NDLS), a polysorbate-80 and ethanol free formulation, was developed to overcome the toxicity issues and to improve disease outcomes associated with conventional docetaxel. We evaluated the safety and efficacy of NDLS based TPF (NDLS, cisplatin and 5-fluorouracil [FU]) induction chemotherapy in patients with inoperable/unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). Methods: In this multicentric, single arm, open label, Phase IV clinical study, patients with inoperable/ unresectable LA HNSCC received induction chemotherapy with NDLS (75 mg/m 2 ; Day 1), cisplatin (75 mg/m 2 ; Day 1) and 5-FU (750 mg/m 2 /day for 5 days) based TPF regimen every 3 weeks (q3w) for 4 cycles followed by radiotherapy. The study outcomes were overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). Results: Fifty patients were enrolled in this study. Most of the patients belonged to the age group of 35-64 years (86%) and had a WHO performance status of 1 (66%). In the modified intent-to-treat (mITT) population ( n = 40), the ORR after NDLS based TPF induction chemotherapy was 42.5%, which increased to 60.0% after loco-regional therapy. In the per-protocol (PP) population ( n = 14), the ORR was 64.3%, which increased to 80.0% after loco-regional therapy (Table). At 2 years, the PFS and OS rates were 82.5% and 97.5%, respectively, in the mITT population and 85.7% and 100% respectively, in the PP population. The most common grade 3/4 adverse effects reported were neutropenia (10%), leukopenia (6%), febrile neutropenia (4%), asthenia (2%), diarrhea (2%), and thrombocytopenia (2%) respectively. Grade 3/4 infusion-related reactions, hyperglycemia or neuropathy were not reported. Conclusions: NDLS based induction chemotherapy was effective and well-tolerated in the treatment of inoperable LA HNSCC and showed high response rates. Clinical trial information: CTRI/2017/12/010938 .[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e21507-e21507
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2016
    In:  The Indian Journal of Pediatrics Vol. 83, No. 9 ( 2016-9), p. 1009-1012
    In: The Indian Journal of Pediatrics, Springer Science and Business Media LLC, Vol. 83, No. 9 ( 2016-9), p. 1009-1012
    Type of Medium: Online Resource
    ISSN: 0019-5456 , 0973-7693
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2016
    detail.hit.zdb_id: 2065273-2
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e18003-e18003
    Abstract: e18003 Background: As perEuropean Leukemia Net (ELN) guidelines Imatinib 400mg/day is the standard of care in CML-CP. Options for patients with suboptimal response and failure are dose hike or change to second line TKIs. In resource poor countries where second line TKIs are expensive, dose hike of Imatinib may be an alternative. Methods: We retrospectively analyzed all CML - CP patients requiring dose hike at our centre from 2003-2009. Mutational analysis could not be performed. The trigger for dose hike to 600mg was suboptimal response or failure as per ELN 2010 guidelines. Event free survival (EFS), transformation free survival (TFS), and overall survival (OS) were analysed. EFS was defined as time from dose escalation to transformation to BC/AP or lost to follow up or death due to any cause. OS was defined as time from dose escalation to death. TFS was defined as progression to BC/AP from dose hike. Cytogenetic response was evaluated. Statistical analysis is done using Graphpad Prism. Results: There were 76 patients with a median age of 35 years (range, 13-68) and M: F ratio of 1.8:1.Trigger for dose hike was failure in 56 patients (73%) and suboptimal response in 27%. In failure group, after dose hike, complete cytogenetic response (CCR) was achieved in 41/56 (73%), partial (PCR) 4/56(7%), minor 5/56(9%), nil cytogenetic response in 6/56(10%). In suboptimal group CCR were seen in15/20(75%). Five year EFS, TFS and OS in both the groups together were 64.3%, 91.9%, and 94.7% respectively. The five year EFS, TFS and OS in failure group were 63.4%, 93.3% and 95.1% respectively. Five year EFS, TFS and OS in suboptimal group were 62.8%, 88.5% and 94.4% respectively. There was no significant difference between suboptimal and failure groups (p values for EFS-0.8414, TFS- 0.446,OS-0.7368). 75% patients experienced manageble toxicities. Conclusions: Dose hike to 600mg is still one of the viable options in CML CP patients with suboptimal response or failure in resource limited countries with an acceptable toxicity profile.
    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
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  • 5
    In: Indian Journal of Medical and Paediatric Oncology, Georg Thieme Verlag KG, Vol. 38, No. 03 ( 2017-07), p. 282-286
    Abstract: Introduction: The Sokal and Hasford (Euro) scores were developed in the chemotherapy and interferon eras and are widely used as prognostic indicators in patients with chronic myeloid leukemia (CML). Recently, European Treatment and Outcome Study (EUTOS) scoring system was introduced. Data on risk stratification in pediatric CML population was lacking due to its rarity ( 〈 3%). Objective: To study the effectiveness in predicting the response and outcome with three prognostic scores in pediatric CML-chronic phase patients on front line Imatinib. Materials and Methods: We retrospectively analyzed the hospital records of newly diagnosed CML CP patients (aged ≤18 years) from 2006 to 2010 for their risk score, cytogenetic response at 18 months and event free survival (EFS) at the end of 4 years. Events include loss of hematological response, loss of cytological response, progression to accelerated/blast phase (AP/BC). All received free Imatinib under Gleevac international patient assistance program. Results: Data of 106 children was analyzed with median age of 13.5 (ranged 5-18 years) and male preponderance (M:F = 1.14:1). The distribution of children was 63%, 32% and 5% in Sokal low, intermediate and high risk respectively, 50%, 43% and 5% in Hasford/Euro low, intermediate and high risk respectively, 71% and 29% in EUTOS low and high risk respectively. The overall cumulative complete hematological response at the end of 3 month was 94%, and complete cytogenetic response at 12 months was 75%. The CCyR at 18 month was seen in 90%,74% and 83% among Sokal low, intermediate and high risk groups respectively, 83%, 86% and 83% among Hasford/Euro low, intermediate and high risk groups respectively, 84% and 86% EUTOS low and high risk groups respectively. The EFS at the end of 48 months was seen in 87%,79% and 83% among Sokal low, intermediate and high risk groups respectively, 83%, 86% and 83% among Hasford/Euro low, intermediate and high risk groups respectively, 86% and 80% EUTOS low and high risk groups respectively. Conclusion: None of the scoring systems predicted the response and outcome effectively in children with CML CP on front line Imatinib.
    Type of Medium: Online Resource
    ISSN: 0971-5851 , 0975-2129
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2017
    detail.hit.zdb_id: 2181724-8
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e21005-e21005
    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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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e14201-e14201
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e14201-e14201
    Abstract: e14201 Background: Inflammatory response exacerbates mechanisms linked to tumor growth and dissemination. As an index of systemic inflammatory marker, neutrophil lymphocyte ratio (NLR) may be a predictive biomarker of both prognosis and outcome in several malignancies. However very few reports have addressed the association of change in NLR and outcome in operable breast cancer. We evaluated preoperative NLR and postoperative NLR to assess which one would be predictive of disease outcome in triple negative breast cancer patients. Methods: This study included 67 stage I-III triple negative breast cancer patients diagnosed at HCG Cancer center, between 2013 to 2015. Those patients who underwent upfront surgery were included in the study. Patients who received neoadjuvant chemotherapy and those without adequate medical records were excluded. The NLR was calculated from the differential count by dividing neutrophil percentage with lymphocyte percentage. All preoperative NLRs were calculated from medical records, at the first visit. Postoperative NLR was obtained before first cycle chemotherapy. The NLR was divided into high if ratio is 〉 3 and low if it is ≤ 3. We evaluated prognostic value of NLR on 3 year DFS. Results: The median preoperative NLR was 2.52 (Range 0.77-8.6). The pre op NLR was high in 19 patients (28%) and low in 48 patients (72%). There was no significant difference between two groups in baseline characteristics. Among the preoperative High and low NLR groups, 3 year DFS is statistically significant. The median postoperative NLR was 2.23 (Range 0.89-8.1). The post operative NLR was high in 7 patients (11%) and low in 60 patients (89%). Among the postoperative High and low NLR groups, 3 year DFS is statistically not significant. The 12 (63%) patients in the high preoperative NLR patients were converted to of the low NLR after surgery. Conclusions: Preoperative NLR correlated with outcome in operable triple negative breast cancer than postoperative NLR. The NLR kinetics might be an index of response to the treatment which needs to be evaluated in prospective studies. Drawbacks of the study: single centre, retrospective study and small sample size.[Table: see text][Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e19533-e19533
    Abstract: e19533 Background: B Non Hodgkin Lymphoma (B-NHL) constitutes 90% of all NHLs. Surface CD20 is expressed in most of them. Standard of care worldwide for B NHLs currently is rituximab-based chemotherapy. In the present era, still rituximab-based chemotherapy is seldom used in India. We tried to analyze the proportion of eligible patients who received rituximab during their first line treatment and their outcome. Methods: We retrospectively analyzed all the cases of NHL patients registered at our center from 2001 to 2010. We defined “Refusal to treatment” as rejection of any therapeutic intervention, “abandonment” if treatment was initiated but not completed, “lost to follow up” as patients who have completed treatment, but missed the subsequent appointments. Results: A total of 1,351 cases of NHLs were registered during 2001-2010. B-NHLs constituted 90.6%. DLBCL accounted for 78.2% of all B-NHLs followed by follicular lymphoma (14.6%). Out of the 1,216 B-NHL patients registered, less than a third (377/1216 i.e 31%) were started on treatment, rest (69%) refused treatment. Four-fifths (79.3%) of the patients could complete at least 4 cycles of the intended chemotherapy, whereas 20.7% of them abandoned treatment in between. Rituximab-based chemotherapy could be initiated in only a quarter (94/377, 24.9%) of the eligible patients, out of which 68% (65/94) completed at least 4 cycles. Chemotherapy without rituximab was initiated in the remaining 75.1% of the patients, of which 78%(221/283) could complete at least 4 cycles. Among the 65 patients who completed at least 4 cycles of rituximab-based chemotherapy, 52% (34/65) were still alive without any evidence of disease as compared to 19% (42/221) of the patients who received chemotherapy without Rituximab at a median follow up of 17 months (range 1-125 months) p 〈 0.05. The proportion of patients who were lost to follow up with evidence of disease at their last visit in the clinic was 4%(3/65) vs. 39%(86/221), in the rituximab vs. non-rituximab-containing chemotherapy groups respectively. Conclusions: Only 7.7% (94/1216) of the eligible B-NHL patients were able to receive rituximab-based chemotherapy. A distinct survival advantage is noted in patients who received rituximab.
    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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  • 9
    Online Resource
    Online Resource
    Georg Thieme Verlag KG ; 2016
    In:  South Asian Journal of Cancer Vol. 05, No. 04 ( 2016-10), p. 194-195
    In: South Asian Journal of Cancer, Georg Thieme Verlag KG, Vol. 05, No. 04 ( 2016-10), p. 194-195
    Abstract: Background: The outcome of localized Ewing′s sarcoma has improved with multi-disciplinary approach. Survivals of Ewing′s sarcoma from the Asian countries differed between centers. Methods: We retrospectively analyzed the records of newly diagnosed localized Ewing′s sarcoma patients from 2002 to 2012. The patients were analyzed in three groups; Group 1(2002-2004) who received non-ifosfomide based regimens, Group 2(2005-2008) who received VDC/IE for 12 cycles, and Group 3(2009-2012), who received VDC/IE for 17 cycles. The groups were compared for their baseline characteristics, treatment protocol and outcome. Results: Seventy three patients were included in the study. The median age of presentation was 15 years, with slight male predominance. Axial primary was seen in 62%. The median RFS of the three groups was 26.4, 31.4 and 36.8 months respectively (P = 0.0018). The median OS was 27.9, 35 and 43 months respectively (P = 0.0007). At a median follow-up of 35 months, the 3 year RFS and OS for the three treatment groups were 17%, 31%, 60% and 35%, 45% and 70% respectively. Larger tumor size, axial primary, high LDH were associated with poorer survival. Radiotherapy was associated with inferior local control and survival. Conclusions: We found that the survival of our ESFT patients improved over time with intensified multiagent chemotherapy and with lesser time to local therapy. But the results were still inferior to those reported in literature. We had majority of patients presenting in axial site and radiotherapy as the predominant mode of local control. The outcome may further improve with surgery as local control procedure.
    Type of Medium: Online Resource
    ISSN: 2278-330X , 2278-4306
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2016
    detail.hit.zdb_id: 2719571-5
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  • 10
    In: South Asian Journal of Cancer, Georg Thieme Verlag KG, Vol. 03, No. 04 ( 2014-10), p. 203-205
    Abstract: Introduction: Childhood chronic myeloid leukemia (CML) accounts for less than 3% of all childhood leukemias, hence, data on imatinib (IM) in adult CML patients has been largely extrapolated to children. We have analyzed our data to add to the existing literature. Aims: Primary objective is to assess the progression-free survival (PFS). Secondary objective are cytogenetic response, overall survival (OS), and toxicities. Settings and Design: This is a retrospective analysis from the case records from a single institution. Materials and Methods: Institutional ethics committee approval was obtained. All the children diagnosed CML in chronic phase (CML-CP) aged less than 18 years registered between 2000 and 2009 were enrolled. All the patients were started on IM at 260 mg/m 2 . Statistical Analysis: Kaplan-Meier curves were used to calculate the PFS and OS. Results: There were 64 children with median age of 13 years (range, 1-18) with male predominance (male:female (M: F) - 1.85:1). Sixty-one patients (95.4%) achieved complete hematological response (CHR) at median of 8 weeks. Thirty-seven (57.8%) patients had evaluation of cytogenetic response and were subjects for outcome analysis. The median time to best cytogenetic response evaluation was 13 months (range, 4-52). Twenty-nine patients (78.3%) achieved complete cytogenetic response (CCyR). At a median follow-up of 36 months (range 5-75), 21 (56.8%) remained progression free and 35 (94.5%) are alive. Adverse events were tolerable. Conclusions: PFS at a median follow-up of 36 months is 56.8% and OS 94.5%.
    Type of Medium: Online Resource
    ISSN: 2278-330X , 2278-4306
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2014
    detail.hit.zdb_id: 2719571-5
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