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  • 1
    In: Supportive Care in Cancer, Springer Science and Business Media LLC, Vol. 24, No. 4 ( 2016-4), p. 1595-1602
    Type of Medium: Online Resource
    ISSN: 0941-4355 , 1433-7339
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2016
    detail.hit.zdb_id: 1463166-0
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 27 ( 2015-09-20), p. 3065-3073
    Abstract: Advances in the treatment of childhood cancers have resulted in part from the development of national and international collaborative initiatives that have defined biologic determinants and generated risk-adapted therapies that maximize cure while minimizing acute and long-term effects. Currently, more than 80% of children with cancer who are treated with modern multidisciplinary treatments in developed countries are cured; however, of the approximately 160,000 children and adolescents who are diagnosed with cancer every year worldwide, 80% live in low- and middle-income countries (LMICs), where access to quality care is limited and chances of cure are low. In addition, the disease burden is not fully known because of the lack of population-based cancer registries in low-resource countries. Regional and ethnic variations in the incidence of the different childhood cancers suggest unique interactions between genetic and environmental factors that could provide opportunities for etiologic research. Regional collaborative initiatives have been developed in Central and South America and the Caribbean, Africa, the Middle East, Asia, and Oceania. These initiatives integrate regional capacity building, education of health care providers, implementation of intensity-graduated treatments, and establishment of research programs that are adjusted to local capacity and local needs. Together, the existing consortia and regional networks operating in LMICs have the potential to reach out to almost 60% of all children with cancer worldwide. In summary, childhood cancer burden has been shifted toward LMICs and, for that reason, global initiatives directed at pediatric cancer care and control are needed. Regional networks aiming to build capacity while incorporating research on epidemiology, health services, and outcomes should be supported.
    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: 2015
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 3_suppl ( 2021-01-20), p. 163-163
    Abstract: 163 Background: In RTOG 85-01, patients with locally advanced esophageal and gastroesophageal junction (GEJ) cancer treated with concurrent chemoradiotherapy (CRT) had a median overall survival (OS) of 14 months and 5-year OS of 27%. Improving outcomes in these patients is an unmet need. We investigated the addition of oral metronomic chemotherapy (OMC) following definitive CRT. Methods: A randomized integrated phase II/III clinical trial (CTRI/2015/09/006204) in patients with squamous cell carcinoma of the esophagus or the GEJ who had completed definitive radical CRT within the past 12 weeks, had an ECOG PS 0-2 and no clinical or radiologic evidence of progressive disease. Patients were stratified based on whether or not they had received induction chemotherapy followed by CRT, and then randomized 1:1 to receive OMC (celecoxib 200 mg twice daily and methotrexate 15 mg/m 2 weekly) for 12 months or observation. The primary efficacy endpoint for the phase II portion was progression free survival (PFS). The secondary endpoints were OS and toxicity. With a power of 70% and an alpha of 10%, we hypothesized a hazard ratio of 1.5, with a median follow-up of 6 months. The planned sample size for the phase II portion was 151 patients. The p-value for stopping the trial after the phase II part of the study was set at 0.2 for the PFS. Results: Between Jan 2016 and Dec 2019, we enrolled 151 patients, 75 to the OMC arm and 76 to observation. The median age was 57 years, 59% were male. The tumor originated in the upper thoracic esophagus in 79% patients, with median tumor length 6 cm. Induction chemotherapy was received by 14% of the patients. Concurrent CRT consisted of median 63 Gy in median 35 fractions; 91% patients received concurrent weekly paclitaxel and carboplatin with radiation. OMC was started at a median of 11 weeks (IQR, 9 to 12) from the start of CRT. Grade 3 or higher toxicities (regardless of relatedness to study intervention) were noted in 27 patients (17.9%), 18 in the OMC arm and 9 in the observation arm; P=0.071. The median time to disease progression or death was 23 months (95% CI, 7.9-38.1) in the OMC arm and not reached in the observation arm; HR, 1.33, 95% CI, 0.83-2.14; P=0.23. The 1-year PFS was 67% in both the arms; the 2-year PFS were 48% and 61% in the OMC and observation arms respectively. The median OS was 36 months (95% CI, 17.9-54) in the OMC arm and not reached in the observation arm; HR, 1.75; 95% CI, 1.02-2.99; P, 0.037. The 1-year OS was 74.7% in the OMC arm and 88% in the observation arm; the 2-year OS was 53.9% in the OMC arm and 75% in the observation arm. Conclusion: Adjuvant oral metronomic chemotherapy after radical CRT does not improve outcomes in patients with locally advanced esophageal or GEJ squamous cell carcinoma. Clinical trial information: CTRI/2015/09/006204.
    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: 2021
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e24023-e24023
    Abstract: e24023 Background: Clinical judgement alone is inadequate in accurately predicting chemotherapy toxicity in older adult cancer patients. Hurria and colleagues developed and validated, the CARG score (range, 0–17) as a convenient and reliable tool for predicting chemotherapy toxicity in older cancer patients in America, however, its applicability in Indian patients is unknown. Methods: An observational retrospective and prospective study between 2018 and 2020 was conducted in the Department of Medical Oncology at Tata Memorial Hospital, Mumbai, India. The study was approved by the institutional ethics committee (IEC-III; Project No. 900596) and registered in the Clinical Trials Registry of India (CTRI/2020/04/024675). Written informed consent was obtained in the prospective part of the study. Patients aged ≥ 60 years and planned for systemic therapy were evaluated in the geriatric oncology clinic and their CARG score was calculated. Patients were stratified into low (0-4), intermediate (5-9) and high risk (10-17) based on the CARG scores. The CARG score was provided to the treating physicians, along with the results of the geriatric assessment. Chemotherapy-related toxicities were captured from the electronic medical record and graded as per the NCI CTCAE, version 4.0. Results: We assessed 130 patients, with a median age 69 years (IQR, 60 to 84); 72% patients were males. The common malignancies included gastrointestinal (52%) and lung (30%). Approximately 78% patients received polychemotherapy and 53% received full dose chemotherapy. Based on the CARG score, 28 (22%) patients belonged to low risk, 80 (61%) to intermediate risk and 22 (17%) to the high risk category. The AU-ROC of the CARG score in predicting grade 3-5 toxicities was 0.61 (95% CI, 0.51-0.71). The sensitivity and specificity of the CARG score in predicting grade 3-5 toxicities were 60.8% and 78.6%. Grade 3-5 toxicities occurred in 6/28 patients (21%) in the low risk group, compared to 62/102 patients (61%) in the intermediate /high risk group, p = 0.0002. There was also a significant difference in the time to development of grade 3-5 toxicities, which occurred at a median of 2.5 cycles (IQR, 1-3.8) in the intermediate /high risk group and at a median of 6 cycles (IQR, 3.5-8) in the low risk group, p = 0.0011. Conclusions: In older Indian patients with cancer, the CARG score reliably stratifies patients into low risk and intermediate/high risk categories, predicting both the occurrence and the time to occurrence of grade 3-5 toxicities from chemotherapy. The CARG score may aid the oncologist in estimating the risk-benefit ratio of chemotherapy. An important limitation was that we provided the CARG score to the treating oncologists prior to the start of chemotherapy, which may have resulted in alterations in the chemotherapy regimen and dose and may have impacted the CARG risk prediction model. Clinical trial information: CTRI/2020/04/024675.
    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: 2021
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 17_suppl ( 2022-06-10), p. LBA6016-LBA6016
    Abstract: LBA6016 Background: The regimens approved for the treatment of advanced head and neck squamous cell carcinoma (HNSCC) are accessible to only 1-3% of patients in low and middle-income countries due to cost. In our previous study, metronomic chemotherapy (MC) improved survival in this setting. Retrospective data suggest that a low dose of nivolumab may be efficacious. Hence, we aimed to assess whether the addition of low dose nivolumab to MC improved the overall survival. Methods: This was a randomised phase 3 superiority open-label study. Adult patients with relapsed -recurrent or newly diagnosed advanced HNSCC being treated with palliative intent with ECOG PS 0-1 were eligible. Patients were randomised 1:1 to MC consisting of methotrexate 15 mg/m2 PO weekly, celecoxib 200 mg PO daily and erlotinib 150 mg PO daily, or MC with intravenous nivolumab 20 mg flat dose once-every-3-weeks. Therapy was continued until disease progression or intolerable adverse events. Response assessment (RECIST version 1.1) was performed every 2 months. The primary endpoint was 1-year overall survival (OS) and this was a pre-specified interim analysis with the nominal p-value for efficacy being 0.006. Results: 151 patients were randomised, 75 in MC and 76 in the MC-I arm respectively. The addition of low dose nivolumab led to an improvement in the 1-year overall survival from 16.3% (95%CI 7.95-27.4) to 43.4% (95% CI 30.8-52.3) [Hazard ratio-0.545; 95%CI 0.362-0.82; P=0.00358]. The median overall survival in MC and MC-I arms was 6.7 months (95%CI 5.83 -8.07) and 10.1 months (95%CI 7.37-12.63) respectively (P=0.0052). The median progression-free survival in MC and MC-I arms was 4.57 months (95%CI 4.2 -5.3) and 6.57 months (95%CI 4.43-8.9) respectively (P=0.0021). Response rate in MC and MC-I arm were 49.3% (95% CI 37.8-60.8) and 65.2% (95%CI 53.4-75.4) respectively (P=0.085). The rate of grade 3 and above adverse events was 50% and 46.1% in MC and MC-I arm respectively (P=0.744). Conclusions: In this first-ever randomised study, the addition of low dose nivolumab led to improved overall survival and is an alternative standard of care for those who cannot access full dose nivolumab. Clinical trial information: CTRI/2020/11/028953.
    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: 2022
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 6073-6073
    Abstract: 6073 Background: Locally advanced head and neck cancer treated with radical chemoradiation have unsatisfactory outcomes. Oral metronomic chemotherapy improves outcomes in comparison to maximum tolerated dose chemotherapy in the palliative setting. There is also limited evidence that it may do so in an adjuvant setting. Hence this randomised study was conducted. Methods: Patients of HN cancer with primary in oropharynx, larynx or hypopharynx, with PS 0-2 post radical chemoradiation with documented complete response were 1:1 randomised to either observation or oral metronomic adjuvant chemotherapy (MAC) for 18 months. MAC consisted of weekly oral methotrexate (15 mg/m2) and celecoxib (200 mg PO BD). The primary endpoint was OS and the overall sample size was 1038. The study had 3 planned interim analyses for efficacy and futility. Results: 137 patients were recruited and an interim analysis was done. The 3 year PFS in the observation arm was 67.1% (95% CI 53.8-77.3) and the same in the MAC arm was 62.5%(95%CI 49.4-73.1). The corresponding hazard ratio was 1.402 (95% CI 0.7393-2.66, P-value = 0.3). The 3 year OS in the observation arm was 77.3% (95% CI 64.4-86) and the same in the MAC arm was 64.1% (95%CI 51-74.5). The corresponding hazard ratio was 1.588 (95% CI 0.8734-2.886, P-value = 0.1). Any grade mucositis was seen in 30 patients (45.5%) in the MAC arm and 20 patients (28.2%) in the observation arm (P-value = 0.05). The rate of grade 3 or above mucositis was 7.6%(n = 5) in the MAC arm and 1.4%(n = 1) in the observation arm (P-value = 0.106). Conclusions: Both arms had similar OS. Hence observation post complete response post radical chemoradiation remains the standard of care. Clinical trial information: CTRI/2016/09/007315.
    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: 2022
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e24024-e24024
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e24024-e24024
    Abstract: e24024 Background: The ‘G8’ and ‘VES13’ are quick and easy-to-use screening tools, developed and validated in Western patients for predicting abnormalities in the subsequent geriatric assessment (GA). These tools predict functional decline and survival in older patients with cancer, but their applicability in our older Indian patients with cancer is not known. We performed this study in an attempt to validate the use of these screening tools in our patient population. Methods: An observational study with a retrospective and prospective cohort of 308 patients, aged 60 years and above, presenting to the Geriatric Oncology clinic at Tata Memorial Hospital, Mumbai, between June 2018 - November 2020. Patients either planned for or recently started on systemic therapy were enrolled and underwent the G8 & VES13 screening tools followed by a GA. The primary objective was to determine the appropriateness of the use of G8/VES13 screening tools to detect an abnormal GA. Our secondary objectives were to determine the optimal G8 cut-off value (using the AU-ROC curves) in our patient population, correlation between abnormal G8/VES13 scores and OS and to assess the utility of combining the G8 and VES13 scores (i.e. abnormal score on either of the two screening tools) to predict for an abnormal GA and poorer OS. Results: The abnormal G8 cut-off score appropriate for our population was 12. This revised cut-off score was compared with the international standard (Abnormal G8 〈 / = 14). With abnormal G8 cut-offs at 〈 / = 14 the sensitivity, specificity & overall accuracy was 84%, 18% & 80% respectively; the corresponding values were 57%, 88% & 58% with cut-off 〈 12. An abnormal G8 ( 〈 / = 14) and VES13 score correlated with poor ECOG PS (PS 2/3, p = 0.0001 [G8], p = 0.00001 [VES13] ) and CARG high risk scores (p = 0.006 [G8], p = 0.005 [VES13] ) however it did not correlate with an abnormal GA (p = 0.736 [G8], p = 0.195 [VES13). The median OS in patients with abnormal ( 〈 / = 14) vs normal G8 scores was 13m vs 18m respectively (HR 0.777). Abnormal G8 cut-off scores 〈 12 correlated with a poor ECOG PS (p 〈 0.00001), CARG high risk scores (p = 0.006) and also with an abnormal GA (p 〈 0.001). The median OS in patients with abnormal ( 〈 12) vs normal G8 scores was 11m vs 17m (HR 1.658). Abnormal G8 ( 〈 12) + VES13 scores also correlated with abnormal GA (p 0.0001) and predicted for worse survival outcomes (Median OS 13m vs 17mHR 1.641). Abnormal VES13 scores also predicted for shorter survival (Median OS 10m vs 17m, HR 1.097). Conclusions: An abnormal G8 cut-off score 〈 12 is appropriate in our older Indian patients with cancer as compared to the internationally validated cut-off of 〈 / = 14. This revised G8 cut-off score ( 〈 12) predicts for the presence of non-oncological vulnerability, poorer OS and translated to a 35% reduction in the number of patients undergoing a full GA. Combined with VES13, the G8 can be used as a screening tool which may help in optimal resource utilization especially in busy Indian centers.
    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: 2021
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  • 8
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. e21000-e21000
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e21000-e21000
    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: 2014
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. 6000-6000
    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: 2018
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e24018-e24018
    Abstract: e24018 Background: The use of potentially inappropriate medication (PIM) and polypharmacy are highly prevalent in older cancer patients and are recognized as potential risk factors for adverse outcomes during cancer treatment. With geriatric cases increasing steadily in India, there is a need for comprehensive studies to identify a reliable screening tool for the assessment of PIMs. Methods: Retrospective analysis of patients ≥ 60 years who visited the Geriatric Oncology Clinic of the Tata Memorial Hospital, Mumbai, India between 2018-2021. Five tools (Beers-2015, STOPP and START-2014, PRISCUS-2010, FORTA-2018, and the EU (7)-PIM list-2015) were used to assess PIM. A standardized PIM value (SPV) was assigned for each patient for each scale which represented the ratio of the number of PIMs identified by a given scale to the total number of medications taken. The median SPV of all 5 scales for each patient was considered the reference standard. Agreement between each scale and the reference was carried out using Bland-Altman plots. The agreement was determined based on bias and the width of the limit of agreement. Association between categorical variables such as sex, comorbidities, and number of medications (above and below the median) and PIM use was determined using the chi-squared test. Results: 352 patients were included; median age - 70(range: 60-100) years, 287 (81.6%) were males. The bias and limit of agreement given by the Bland-Altman plot for each scale is shown in Table 1. The EU(7)-PIM list was found to have the least bias of 0.7% and the narrowest limits of agreement of 0.43 (-0.21 to 0.22). PIM use was observed to be significantly higher in patients with diabetes than without (83/281 versus 13/82, respectively, p = 0.013) and, patients prescribed with 〉 7 medications compared with ≤7 (137/281 versus 06/70, respectively, p 〈 0.001). Conclusions: The EU(7)-PIM list was found to have the least bias and thus considered the most reliable among all other scales in our study population. A high degree of discordance was observed between the tools, thus, we emphasize the need for future studies to identify the most reliable tool for the prediction of PIMs to aid clinical decision-making in geriatric practice.[Table: see text]
    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: 2021
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