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1.
Cancer Med ; 2021 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-34786866

RESUMO

BACKGROUND: There is paucity of data regarding clinical characteristics, laboratory parameters and outcomes of coronavirus disease (COVID-19) in cancer versus non-cancer patients, particularly from India. MATERIALS AND METHODS: This was an observational, single-centre, retrospective analysis of patients with laboratory-confirmed COVID-19 hospitalised in our institution between 22 May 2020 and 1 December 2020. We compared baseline clinical characteristics, laboratory parameters and outcomes of COVID-19 (overall mortality, time to discharge) between cancer and non-cancer patients. RESULTS: A total of 200 COVID-19 infection episodes were analysed of which 109 (54.5%) were patients with cancer and 91 (45.5%) were patients without cancer. The median age was 43 (interquartile range [IQR]:32-57), 51 (IQR: 33-62) and 38 (IQR: 31.5-49.3) years; of whole cohort, cancer and non-cancer patients, respectively. Comparison of outcomes showed that oxygen requirement (31.2% [95% CI: 22.6-40.7] vs. 17.6% [95% CI: 10.4-26.9]; p = 0.03), median time to discharge (11 days [IQR: 6.75-16] vs. 6 days [IQR: 3-9.75]; p < 0.001) and mortality (10.0% [95% CI: 5.2-17.3] vs. 1.1% [95% CI: 0.03-5.9]; p = 0.017) were significantly higher in patients with cancer. In univariable analysis, factors associated with higher mortality in the whole cohort included diagnosis of cancer (10.1% vs. 1.1%; p = 0.027; odds ratio [OR]: 7.04), age ≥60 (17.4% vs. 2.6%; p = 0.001; OR: 7.38), oxygen requirement (22% vs. 0.6%; p < 0.001; OR: 29.01), chest infiltrates (19.2% vs. 1.4%; p < 0.001; OR: 22.65), baseline absolute lymphocyte count <1 × 109 /L (10.8% vs. 1.9%; p = 0.023; OR:5.1), C-reactive protein >1 mg% (12.8% vs. 0%; p = 0.027; OR: 24.69), serum procalcitonin >0.05 ng/ml (22.65% vs. 0%; p = 0.004; OR: 4.49) and interleukin-6 >6 pg/ml (10.8% vs. 1.3%; p = 0.036; OR: 3.08). In multivariable logistic regression, factors significantly associated with mortality were oxygen requirement (p = 0.005; OR: 13.11) and high baseline procalcitonin level (p = 0.014; OR: 37.6). CONCLUSION: Cancer patients with COVID-19 have higher mortality and require longer hospital stay. High procalcitonin levels and oxygen requirement during admission are other factors that affect outcomes adversely.

2.
Int J Cancer ; 2021 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-34751432

RESUMO

The real-world data on short-course of ICI use is sparse and merits exploration. A multi-centric observational study on the safety and efficacy of ICI in oncology patients between August 2014 to October 2020 involving 1011 patients across 13 centers in India. The median age was 59 (min 16- max 98) years with male preponderance (77.9%). The predominant cohort received short-course ICI therapy; the median number of cycles were 5 (95% CI 1 - 27) and median duration of therapy was 3 (95% CI 0.5 - 13) months. ICI were used commonly in second and third line setting in our study (66.4%, n=671). Objective response rate (ORR) (complete or partial response) was documented in 254 (25.1%) of the patients, 202 (20.0%) had stable disease and 374 (37.0%) had progressive disease. The clinical benefit rate was present in 456 (45.1%). Among the patients whom ICI was stopped (n=906), the most common reason for cessation of ICI was disease progression (616, 68.0%) followed by logistic reasons like financial constraints (234, 25.82%). With a median follow up of 14.1 (95%CI 12.9-15.3) months, there were 616 events of progression and 443 events of death and the median progression free survival and overall survival were 6.4 (95%CI 5.5-7.3) and 13.6 (95%CI 11.6-15.7) months respectively in the overall cohort. Among the immune related adverse events (irAEs), autoimmune pneumonitis (29, 3.8%) and thyroiditis (24, 2.4%) were common. Real-world multicentric Indian data predominantly with short-course ICI therapy, has comparable efficacy/safety to international literature with standard ICI therapy. This article is protected by copyright. All rights reserved.

3.
South Asian J Cancer ; 10(2): 102-106, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34604126

RESUMO

Objectives Peritoneal tuberculosis can mimic advanced abdominal malignancy. We describe clinical and laboratory characteristics in a series of female patients with peritoneal tuberculosis who were referred to a tertiary cancer center with a diagnosis of suspected advanced ovarian/primary peritoneal cancer. Materials and Methods Details of clinical features, laboratory results including serum tumor markers, radiological findings, and ascitic fluid evaluation were retrospectively collected from hospital records for patients diagnosed to have peritoneal tuberculosis and reported descriptively. Statistical Analysis Descriptive statistics was performed using SPSS Statistics for Windows software, version 20.0 (SPSS, Chicago, Illinois). Results Between January 2009 and December 2017, 120 patients of peritoneal tuberculosis with a median age 41 years (range, 15-79 years) were identified. Of these 112 (93.3%; 95% CI 88.9-97.8%) patients had ascites and 63 (52.5%; 95% CI 43.6-61.4%) had adnexal mass at presentation. Mean serum cancer antigen 125 (CA-125) level was 666.9 (range, 38-18,554) U/mL. Ascitic fluid was negative for malignant cells in all patients and lymphocyte rich exudate was seen in 103 (91.9%; 86.9-97.0%) patients. Ascitic fluid adenosine deaminase (ADA) level was more than 40 U/L in 107 (95.5%; 95% CI 91.7-99.4%). Ascitic fluid Ziel-Neelsen staining was positive in 4/62 (6.5%; 95% CI 0.3-12.6%) patients while ascitic fluid culture examination for mycobacterium tuberculosis was positive in 7/59 (11.9%; 95% CI 3.6-20.1%) patients. The diagnosis of tuberculosis was based on image-guided biopsy in 44 (36.7%) patients, surgical biopsy in 8 (6.7%) patients, and a combination of clinicoradiological and laboratory features in 68 (56.7%) patients. All patients received standard antitubercular treatment. Conclusions The study results suggest that peritoneal tuberculosis has clinical, radiological, and serological profile which may mimic advanced ovarian/primary peritoneal cancer. Peritoneal tuberculosis should be considered in the differential diagnosis of advanced abdominal malignancy.

4.
Breast ; 60: 147-154, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34624757

RESUMO

AIM: To evaluate pharmacokinetics, efficacy and safety of fixed-dose combination (FDC) of oral capecitabine + cyclophosphamide in metastatic breast cancer (MBC) patients progressing after anthracycline and/or taxane chemotherapy. METHODS: In this prospective, adaptive, phase-2/3, open-label study (CTRI/2014/12/005234), patients were randomized (1:1:1) to three FDC doses (doses/day: D1, capecitabine + cyclophosphamide 1400 mg + 60 mg; D2, 1800 mg + 80 mg; D3, 2200 mg + 100 mg) for 14 days, in 21-day cycles. In Part-I, multiple-dose pharmacokinetics and optimal dose(s) were evaluated with futility analysis. Group(s) with <3 responders based on best overall response rate (BOR, complete response [CR]+partial response [PR]), were discontinued. Efficacy (BOR, disease control rates [DCR; CR + PR + stable disease]) and safety of optimal dose(s) were evaluated in Part-II. RESULTS: Of 66 patients (n = 22/group) in Part-I, pharmacokinetics (D1 = 7/22, D2 = 9/22, D3 = 8/22) showed dose-proportionality for cyclophosphamide and greater than dose-proportionality for capecitabine. Modified intent-to-treat (mITT) analysis showed BOR of 7.14% (1/14) in D1 (discontinued), and 22.22% (4/18) each in D2 and D3, respectively. In Part-II, 50 additional patients were randomized in D2 and D3 (n = 144; total 72 [22 + 50] patients/group). mITT analysis in D2 (n = 54) and D3 (n = 58) showed BOR of 29.63% (16/54, 95%CI: 17.45-41.81%) and 22.41% (13/58, 95%CI: 11.68-33.15%), respectively. DCR in D2 and D3 were 87.04% (47/54, 95%CI: 78.08-96.00%) and 82.76% (48/58; 95%CI: 73.04-92.48%) after 3 and 57.41% (31/54; 95%CI: 52.41-79.50%) and 50.00% (29/58; 95%CI: 40.40-67.00%), after 6-cycles, respectively. Hand-foot syndrome (16.67%), vomiting (9.72%) in D2, and hand-foot syndrome (18.06%), asthenia (15.28%) in D3 were most-common adverse events. CONCLUSION: FDC of capecitabine + cyclophosphamide (1800 + 80 mg/day) showed high disease control rates and good safety profile in MBC patients.

5.
Front Oncol ; 11: 710585, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34568037

RESUMO

Background: Treatment of malignant melanoma has undergone a paradigm shift with the advent of immune checkpoint inhibitors (ICI) and targeted therapies. However, access to ICI is limited in low-middle income countries (LMICs). Patients and Methods: Histologically confirmed malignant melanoma cases registered from 2013 to 2019 were analysed for pattern of care, safety, and efficacy of systemic therapies (ST). Results: There were 659 patients with a median age of 53 (range 44-63) years; 58.9% were males; 55.2% were mucosal melanomas. Most common primary sites were extremities (36.6%) and anorectum (31.4%). Nearly 10.8% of the metastatic cohort were BRAF mutated. Among 368 non-metastatic patients (172 prior treated, 185 de novo, and 11 unresectable), with a median follow-up of 26 months (0-83 months), median EFS and OS were 29.5 (95% CI: 22-40) and 33.3 (95% CI: 29.5-41.2) months, respectively. In the metastatic cohort, with a median follow up of 24 (0-85) months, the median EFS for BSC was 3.1 (95% CI 1.9-4.8) months versus 3.98 (95% CI 3.2-4.7) months with any ST (HR: 0.69, 95% CI: 0.52-0.92; P = 0.011). The median OS was 3.9 (95% CI 3.3-6.4) months for BSC alone versus 12.0 (95% CI 10.5-15.1) months in any ST (HR: 0.38, 95% CI: 0.28-0.50; P < 0.001). The disease control rate was 51.55%. Commonest grade 3-4 toxicity was anemia with chemotherapy (9.5%) and ICI (8.8%). In multivariate analysis, any ST received had a better prognostic impact in the metastatic cohort. Conclusions: Large real-world data reflects the treatment patterns adopted in LMIC for melanomas and poor access to expensive, standard of care therapies. Other systemic therapies provide meaningful clinical benefit and are worth exploring especially when the standard therapies are challenging to administer.

6.
Immunol Cell Biol ; 2021 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-34582592

RESUMO

Recent studies have highlighted multiple immune perturbations related to severe acute respiratory syndrome coronavirus 2 infection-associated respiratory disease [coronavirus disease 2019 (COVID-19)]. Some of them were associated with immunopathogenesis of severe COVID-19. However, reports on immunological indicators of severe COVID-19 in the early phase of infection in patients with comorbidities such as cancer are scarce. We prospectively studied about 200 immune response parameters, including a comprehensive immune-cell profile, inflammatory cytokines and other parameters, in 95 patients with COVID-19 (37 cancer patients without active disease and intensive chemo/immunotherapy, 58 patients without cancer) and 21 healthy donors. Of 95 patients, 41 had severe disease, and the remaining 54 were categorized as having a nonsevere disease. We evaluated the association of immune response parameters with severe COVID-19. By principal component analysis, three immune signatures defining characteristic immune responses in COVID-19 patients were found. Immune cell perturbations, in particular, decreased levels of circulating dendritic cells (DCs) along with reduced levels of CD4 T-cell subsets such as regulatory T cells (Tregs ), type 1 T helper (Th1) and Th9; additionally, relative expansion of effector natural killer (NK) cells were significantly associated with severe COVID-19. Compared with patients without cancer, the levels of terminal effector CD4 T cells, Tregs , Th9, effector NK cells, B cells, intermediate-type monocytes and myeloid DCs were significantly lower in cancer patients with mild and severe COVID-19. We concluded that severely depleted circulating myeloid DCs and helper T subsets in the initial phase of infection were strongly associated with severe COVID-19 independent of age, type of comorbidity and other parameters. Thus, our study describes the early immune response associated with severe COVID-19 in cancer patients without intensive chemo/immunotherapy.

7.
J Clin Oncol ; 39(33): 3682-3692, 2021 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-34506246

RESUMO

PURPOSE: Postoperative Adjuvant Radiation in Cervical Cancer (PARCER), a phase III randomized trial, compared late toxicity after image-guided intensity-modulated radiotherapy (IG-IMRT) with three-dimensional conformal radiation therapy (3D-CRT) in women with cervical cancer undergoing postoperative radiation. METHODS: Patients were randomly assigned to receive either IG-IMRT or 3D-CRT after stratification for the type of hysterectomy and use of concurrent chemotherapy. The primary end point was 3-year grade ≥ 2 late GI toxicity assessed using Common Toxicity Criteria for Adverse Events v 3.0 and estimated using time-to-event, intention-to-treat analysis, with a study level type I error of 0.05 and a nominal α of .047 after accounting for one interim analysis. Secondary end points included acute toxicity, health-related quality of life, and pelvic relapse-free, disease-free, and overall survival. RESULTS: Between 2011 and 2019, 300 patients were randomly assigned (IG-IMRT 151 and 3D-CRT 149). At a median follow-up of 46 (interquartile range, 20-72) months, the 3-year cumulative incidence of grade ≥ 2 late GI toxicity in the IG-IMRT and 3D-CRT arms were 21.1% versus 42.4% (hazard ratio [HR] 0.46; 95% CI, 0.29 to 0.73; P < .001). The cumulative incidence of grade ≥ 2 any late toxicity was 28.1% versus 48.9% (HR 0.50; 95% CI, 0.33 to 0.76; P < .001), respectively. Patients reported reduced diarrhea (P = .04), improved appetite (P = .008), and lesser bowel symptoms (P = .002) with IG-IMRT. However, no difference was observed in the time by treatment interaction. The 3-year pelvic relapse-free survival and disease-free survival in the IG-IMRT versus the 3D-CRT arm were 81.8% versus 84% (HR 1.17; 95% CI, 0.68 to 1.99; P = .55) and 76.9% versus 81.2% (HR 1.03; 95% CI, 0.62 to 1.71; P = .89), respectively. CONCLUSION: IG-IMRT results in reduced toxicity with no difference in disease outcomes.

8.
JCO Glob Oncol ; 7: 1286-1305, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34406802

RESUMO

PURPOSE: There are scarce data to aid in prognostication of the outcome of critically ill cancer patients with COVID-19. In this systematic review and meta-analysis, we investigated the mortality of critically ill cancer patients with COVID-19. METHODS: We searched online databases and manually searched for studies in English that reported on outcomes of adult cancer patients with COVID-19 admitted to an intensive care unit (ICU) or those with severe COVID-19 between December 2019 and October 2020. Risk of bias was assessed by the Modified Newcastle-Ottawa Scale. The primary outcome was all-cause mortality. We also determined the odds of death for cancer patients versus noncancer patients, as also outcomes by cancer subtypes, presence of recent anticancer therapy, and presence of one or more comorbidities. Random-effects modeling was used. RESULTS: In 28 studies (1,276 patients), pooled mortality in cancer patients with COVID-19 admitted to an ICU was 60.2% (95% CI, 53.6 to 6.7; I2 = 80.27%), with four studies (7,259 patients) showing higher odds of dying in cancer versus noncancer patients (odds ratio 1.924; 95% CI, 1.596 to 2.320). In four studies (106 patients) of patients with cancer and severe COVID-19, pooled mortality was 59.4% (95% CI, -39.4 to 77.5; I2 = 72.28%); in one study, presence of hematologic malignancy was associated with significantly higher mortality compared with nonhematologic cancers (odds ratio 1.878; 95% CI, 1.171 to 3.012). Risk of bias was low. CONCLUSION: Most studies were reported before the results of trials suggesting the benefit of dexamethasone and tocilizumab, potentially overestimating mortality. The observed mortality of 60% in cancer patients with COVID-19 admitted to the ICU is not prohibitively high, and admission to the ICU should be considered for selected patients (registered with PROSPERO, CRD42020207209).


Assuntos
COVID-19 , Neoplasias , Adulto , COVID-19/complicações , Hospitalização , Humanos , Unidades de Terapia Intensiva , Neoplasias/complicações , Neoplasias/mortalidade , Neoplasias/terapia , SARS-CoV-2
9.
Nucl Med Commun ; 42(12): 1382-1395, 2021 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-34406146

RESUMO

OBJECTIVES: Internal organ dosimetry is an important procedure to demonstrate the reliable application of 177Lu-trastuzumab radioimmunotherapy for human epidermal growth factor receptor-positive metastatic breast cancers. We are reporting the first human dosimetry study for 177Lu-trastuzumab. Another objective of our study was to calculate and compare the absorbed doses for normal organs and tumor lesions in patients before radioimmunotherapy with 177Lu-trastuzumab using two different imaging scenarios. METHODS: Eleven patients (48.27 ± 8.95 years) with a history of metastatic breast cancer were included in the study. Postadministration of 177Lu-trastuzumab (351.09 ± 23.89 MBq/2 mg), acquisition was performed using planar and hybrid imaging scenarios at 4, 24, 72 and 168 h. Single-photon emission computed tomography/computed tomography imaging was performed at 72 h postinjection. Acquired images were processed using Dosimetry Toolkit software for the estimation of normalized cumulated activity in organs and tumor lesions. OLINDA/EXM 2.0 software was used for absorbed dose calculation in both scenarios. RESULTS: Significant difference in normalized cumulated activity and the absorbed dose is noted between two imaging scenarios for the organs and tumor lesions (P < 0.05). Mean absorbed dose (mGy/MBq) estimated from heart, lungs, liver, spleen, kidney, adrenal, pancreas and colon using planar and hybrid scenarios were 0.81 ± 0.19 and 0.63 ± 0.17; 0.75 ± 0.13 and 0.32 ± 0.06; 1.26 ± 0.25 and 1.01 ± 0.17; 0.68 ± 0.22 and 0.53 ± 0.16; 0.91 ± 0.3 and 0.69 ± 0.24; 0.18 ± 0.04 and 0.11 ± 0.02; 0.25 ± 0.22 and 0.09 ± 0.02 and 0.75 ± 0.61 and 0.44 ± 0.28, respectively. CONCLUSIONS: On the basis of our dosimetric evaluation, we concluded that radioimmunotherapy with 177Lu-trastuzumab is well tolerated to be implemented in routine clinical practice against HER2 positive metastatic breast cancer. Liver is the main critical organ at risk. Hybrid scenario demonstrated significantly lower absorbed doses in organs and tumors compared to the multiplanar method.

10.
Indian J Med Res ; 153(5&6): 585-590, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34414920

RESUMO

The ongoing SARS-CoV-2 pandemic has spread all over the world due to rapid person-to-person transmission. More information about viral load dynamics and replication is needed for clarity on duration of infectiousness of an individual, along with its implications on transmission. This is important to healthcare facilities and public health authorities in formulating guidance on the duration of isolation for patients and return to work criteria for healthcare workers. The duration of detection of viral RNA by molecular methods in the upper respiratory tract has ranged from 2 to 12 wk. Viral RNA detection by reverse transcription polymerase chain reaction (RT-PCR) does not necessarily mean that the individual is infectious to others, as the detected virus may not be replication competent. Infectious virus is generally not shed beyond 20 days of the onset of symptoms in most patients, including severely ill and immunocompromised, as indicated by failure to isolate replication-competent virus beyond this timeline in available studies. Further, detection of neutralizing antibodies in the serum, although associated with positive RT-PCR, is generally not associated with infectious virus shedding as indicated by negative viral cultures beyond this period. In this review, we analyze the current literature on the dynamics of viral load, culture, seroconversion and their implications on infectivity and the duration of isolation precautions for COVID-19 patients.


Assuntos
COVID-19 , RNA Viral , Humanos , Políticas , RNA Viral/genética , SARS-CoV-2 , Soroconversão , Carga Viral
11.
Ecancermedicalscience ; 15: 1252, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34267808

RESUMO

India accounts for almost a third of the global burden of oral cancer, a situation worsened by the inability to afford care. When available, aid is often insufficient, and costing is based on informal estimations. This study objectively determines direct healthcare costs of oral cancer in India. The study was performed from a healthcare provider's perspective using a validated bottom-up method. Care pathways were determined by prospectively observing the natural management of 100 oral cancer patients treated between October 2019 and March 2020. Specific costing categories were built across services, and apportioned values for each interaction was averaged. Costs of treatment and service utilisation were obtained using probabilistic sensitivity analyses. The unit cost of treating advanced stages (United States Dollar (USD) 2,717) was found to be 42% greater than early stages (USD1,568). There was an 11% reduction in unit costs with increases in socioeconomic status. Medical equipment accounted for 97.8% of capital costs, with the highest contributor being imaging services. Variable costs for surgery in advanced stages were 1.4 times higher than early stages. Compared to surgery alone, the average cost of treatment increased by 44.6% with adjuvant therapy. These results show that over the next decade, India will incur an economic burden of USD 3 billion towards the direct healthcare of oral cancer. Early detection and prevention strategies leading to 20% reduction in advanced stage disease could save USD 30 million annually. These results are critical to deliver a disease-driven and objective reform for oral cancer care.

12.
BMJ Open ; 11(7): e048513, 2021 07 29.
Artigo em Inglês | MEDLINE | ID: mdl-34326050

RESUMO

INTRODUCTION: The rising economic burden of cancer on healthcare system and patients in India has led to the increased demand for evidence in order to inform policy decisions such as drug price regulation, setting reimbursement package rates under publicly financed health insurance schemes and prioritising available resources to maximise value of investments in health. Economic evaluations are an integral component of this important evidence. Lack of existing evidence on healthcare costs and health-related quality of life (HRQOL) makes conducting economic evaluations a very challenging task. Therefore, it is imperative to develop a national database for health expenditure and HRQOL for cancer. METHODS AND ANALYSIS: The present study proposes to develop a National Cancer Database for Cost and Quality of Life (CaDCQoL) in India. The healthcare costs will be estimated using a patient perspective. A cross-sectional study will be conducted to assess the direct out-of-pocket expenditure (OOPE), indirect cost and HRQOL among cancer patients who will be recruited at seven leading cancer centres from six states in India. Mean OOPE and HRQOL scores will be estimated by cancer site, stage of disease and type of treatment. Economic impact of cancer care on household financial risk protection will be assessed by estimating prevalence of catastrophic health expenditures and impoverishment. The national database would serve as a unique open access data repository to derive estimates of cancer-related OOPE and HRQOL. These estimates would be useful in conducting future cost-effectiveness analyses of management strategies for value-based cancer care. ETHICS AND DISSEMINATION: Approval was granted by Institutional Ethics Committee vide letter no. PGI/IEC-03/2020-1565 of Post Graduate Institute of Medical Education and Research, Chandigarh, India. The study results will be published in peer-reviewed journals and presented to the policymakers at national level.


Assuntos
Neoplasias , Qualidade de Vida , Estudos Transversais , Gastos em Saúde , Humanos , Índia/epidemiologia , Seguro Saúde
13.
PLoS One ; 16(7): e0253722, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34292933

RESUMO

BACKGROUND: There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. METHODS: This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. RESULTS: The study included 101 female patients with median age of 57 (IQR 48-62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5-41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5-43.7) months, median PFS and OS were 5.98 (95%CI 4.96-7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3-4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25-0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20-0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008-0.206, p = 0.000) with OS. CONCLUSION: Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.


Assuntos
Aminopiridinas/administração & dosagem , Neoplasias da Mama , Piperazinas/administração & dosagem , Purinas/administração & dosagem , Piridinas/administração & dosagem , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo , Idoso , Aminopiridinas/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/metabolismo , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Bases de Dados Factuais , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Piperazinas/efeitos adversos , Purinas/efeitos adversos , Piridinas/efeitos adversos , Estudos Retrospectivos , Taxa de Sobrevida
14.
Adv Radiat Oncol ; 6(6): 100725, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34075350

RESUMO

Purpose: To report real-world compliance to radiation in gynecologic cancers during the complete lockdown phase of COVID-19 pandemic. Methods and Materials: From March 23, 2020, until June 30, 2020, complete lockdown was imposed in India. During this period there was restructuring of cancer care and radiation oncology department due to operational policies prevalent in the institution, and the care for gynecological cancer was based on the evolving international recommendations. Institutional review board approval was obtained to audit patterns of care during the complete lockdown phase. Descriptive variables were used to report on patient characteristics, compliance, delays, toxicity, and observed deviations in recommended care. Results: During the lockdown period spanning 100 days, treatment of 270 and telephonic follow-up of 1103 patients with gynecological cancer was undertaken. Of 270 new patients, due to travel restrictions, 90 patients were referred to the facilities in vicinity of their residence. Of the remaining 180 patients, 138 were planned for complete treatment at our institution and 42 were referred to our center for brachytherapy. Of 138 patients, only 106 (76%) completed the planned external radiation. Twenty-four (26%) patients completed full course of concurrent chemotherapy, 11 (12%) received chemotherapy dose reduction, and 57 (62%) received no concurrent chemotherapy. Treatment delay of up to 3 weeks was noted in 8.6% patients due to COVID-19 infection. No grade 4 to 5 acute sequelae were observed. No excess adverse effects were observed in high-risk population. Low rate of symptom burden was observed among 1103 patients on telephonic follow-up. With 100 (9.6%) patients reporting symptoms, among these, 54% (54 of 100) had complete resolution of symptoms within 4 weeks of teleconsultation, and 10% had disease progression. Conclusions: Low compliance with planned treatment was observed for radiation and concurrent chemotherapy due to lockdown and fear of contracting COVID-19 and will likely lead to increased risk of cancer-related mortality. Rapid restructuring of care is needed to prevent the same as COVID-19 pandemic further evolves.

15.
JCO Glob Oncol ; 7: 849-861, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34101484

RESUMO

PURPOSE: There are deficient data on prevalence of germline mutations in breast cancer susceptibility genes 1 and 2 (BRCA1/BRCA2) in Indian patients with ovarian cancer who are not selected by clinical features. METHODS: This prospective, cross-sectional, noninterventional study in nine Indian centers included patients with newly diagnosed or relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer. The primary objective was to assess the prevalence of BRCA1/BRCA2 mutations, and the secondary objective was to correlate BRCA1/BRCA2 status with clinicopathologic characteristics. Mutation testing was performed by a standard next-generation sequencing assay. RESULTS: Between March 2018 and December 2018, 239 patients with a median age of 53.0 (range, 23.0-86.0 years) years were included, of whom 203 (84.9%) had newly diagnosed disease, 36 (15.1%) had family history of ovarian or breast cancer, and 159 (66.5%) had serous subtype of epithelial ovarian cancer. Germline pathogenic or likely pathogenic mutations in BRCA1 and BRCA2 were detected in 37 (15.5%; 95% CI, 11.1 to 20.7) and 14 (5.9%; 95% CI, 3.2 to 9.6) patients, respectively, whereas variants of uncertain significance in these genes were seen in four (1.7%; 95% CI, 0.5 to 4.2) and six (2.5%; 95% CI, 0.9 to 5.4) patients, respectively. The prevalence of pathogenic or likely pathogenic BRCA mutations in patients with serous versus nonserous tumors, with versus without relevant family history, and ≤ 50 years versus > 50 years, were 40 of 159 (25.2%; 95% CI, 18.6 to 32.6) versus 11 of 80 (13.8%; 95% CI, 7.1 to 23.3; P = .0636), 20 of 36 (55.6%; 95% CI, 38.1 to 72.1) versus 41 of 203 (20.2%; 95% CI, 14.9 to 26.4; P < .0001), and 20 of 90 (22.2%; 95% CI, 14.1 to 32.2) versus 31 of 149 (20.8%; 95% CI, 14.6 to 28.2; P = .7956), respectively. CONCLUSION: There is a high prevalence of pathogenic or likely pathogenic germline BRCA mutations in Indian patients with ovarian cancer.


Assuntos
Neoplasias das Tubas Uterinas , Neoplasias Ovarianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Proteína BRCA1/genética , Proteína BRCA2/genética , Estudos Transversais , Neoplasias das Tubas Uterinas/epidemiologia , Neoplasias das Tubas Uterinas/genética , Feminino , Humanos , Índia/epidemiologia , Pessoa de Meia-Idade , Mutação , Neoplasias Ovarianas/epidemiologia , Neoplasias Ovarianas/genética , Prevalência , Estudos Prospectivos , Adulto Jovem
16.
Int J Radiat Oncol Biol Phys ; 111(3): 826-834, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34146636

RESUMO

PURPOSE: A prospective phase 2 study was conducted to evaluate the feasibility and safety of single-application multifractionated (SA-MF), high-dose-rate (HDR), image guided adaptive brachytherapy (IGABT) for cervical cancer. METHODS AND MATERIALS: Patients (N = 41) with International Federation of Gynaecology and Obstetrics 2009 stage IIB-IVA disease recruited between 2017 and 2019 underwent SA-MF. After completion of external beam radiation therapy of 50 Gy in 25 fractions, patients received magnetic resonance IGABT. The IGABT protocol consisted of a single brachytherapy (BT) application and treatment with 3 fractions of HDR (9 Gy on day 1; 2 fractions of 7 Gy with a minimum 6-hour gap on day 2) after achieving planning aims of the high-risk clinical target volume (HRCTV) receiving >84 Gy EQD2 and 2 cm3 of the bladder and rectum/sigmoid receiving ≤85 Gy and <71 Gy, respectively. Interfraction variation was addressed by performing computed tomography planning and coregistration using a mutual information-based coordinate system on day 2 before the second fraction. Organ at risk contouring was done on computed tomography, and doses were re-evaluated and reoptimized if required. RESULTS: Thirty-eight patients were treated as per the protocol. All patients underwent Intracavitary + Interstitial BT with needles (median, 4; range, 3-11). The mean ± standard deviation HRCTV volume was 41 ± 21 cm3 and HRCTV D90 dose was 87.2 ± 3.6Gy. The 0.1 cm3 and 2 cm3 to bladder, rectum, and sigmoid were -103.2 ± 10.6 Gy and -84.6 ± 6.8 Gy, 82.2 ± 9.5 Gy and -68.3 ± 5.7 Gy, and 83.5 ± 9.8 Gy and -69.5 ± 5.9 Gy, respectively. Six patients required reoptimization before the second fraction to meet planning aims. Mean overall treatment time was 47 ± 6 days. With a median follow up of 22 months (range, 2-37), 2-year local control and disease-free and overall survival were 90.1%, 85%, and 94.5%, respectively. So far 1 patient with grade II and 2 patients with grade III rectal toxicities have been reported. CONCLUSION: Magnetic resonance IGABT with SA-MF BT was feasible in 95% of patients. The dosimetric parameters and clinical results achieved so far look promising.

17.
BMJ Open ; 11(6): e047376, 2021 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-34187825

RESUMO

IMPORTANCE: The Cancer Aging Research Group (CARG) toxicity score is used to assess toxicity risk in geriatric patients receiving chemotherapy. OBJECTIVE: The primary aim was to validate the CARG score in geriatric patients treated with curative intent chemotherapy in predicting grade 3-5 toxicities. DESIGN: This was a longitudinal prospective observational study. SETTING: Tata Memorial Hospital, Mumbai, India, a tertiary cancer care referral centre. PARTICIPANTS: Patients, aged ≥65 years, with gastrointestinal, breast or gynaecological stage I-III cancers being planned for curative intent chemotherapy. A total of 270 patients were required for accrual in the study. EXPOSURES: Total risk score ranged from 0 (lowest toxicity risk) to 19 (highest toxicity risk). MAIN OUTCOMES AND MEASURES: The primary endpoint of the study was to evaluate whether the CARG risk score predicted for grade 3-5 toxicities. RESULTS: The study cohort of 270 patients had a mean age of 69 (65-83) years, with the most common cancers being gastrointestinal (79%). Fifty-two per cent of patients had atleast one grade 3-5 toxicity. The risk of toxicity was increased with an increasing risk score (42% low risk, 51% medium risk and 79% high risk; p<0.001). There was no association between either Eastern Cooperative Oncology Group (ECOG) performance status (p=0.69) or age-adjusted Charlson Comorbidity Index (p=0.79) risk categories and grade 3-5 chemotherapy toxicities. CONCLUSIONS AND RELEVANCE: This study validates the CARG risk score in predicting for grade 3-5 toxicities in geriatric oncology patients receiving curative intent chemotherapy and can be considered as the standard of care before planning chemotherapy in every elderly patient. TRIAL REGISTRATION NUMBER: CTRI/2016/10/007357; Results.


Assuntos
Antineoplásicos , Neoplasias , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica , Humanos , Índia , Neoplasias/tratamento farmacológico , Estudos Prospectivos , Medição de Risco
18.
Int J Clin Pract ; 75(8): e14311, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33932309

RESUMO

It is unclear if the use of a molecular transport medium (MTM) containing guanidine isothiocyanate (GITC) would be advantageous over the CDC recommended, commonly used viral transport medium (VTM). We retested 70 SARS-CoV2 cases by RT-PCR in varying stages of follow-up using MTM and VTM in parallel and found discrepant results of RNase P, E and N genes. Majority (81%) patients tested positive with MTM as compared with VTM (27.1%). Even patients who were sampled 3 weeks after diagnosis demonstrated a significant discrepancy in the positivity rates between MTM vs VTM raising concerns about the clinical utility of VTM.


Assuntos
COVID-19 , SARS-CoV-2 , Teste para COVID-19 , Técnicas de Laboratório Clínico , Humanos , RNA Viral
19.
Pediatr Blood Cancer ; 68(9): e29081, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33991401

RESUMO

BACKGROUND: Outcome and toxicity data in adolescent-adult Ewing sarcoma (AA-ES) patients are sparse and merits exploration. METHODS: Histopathologically confirmed, nonmetastatic AA-ES patients, who received standard institutional combination chemotherapy regimen (Ewing's family of tumors-2001 [EFT-2001]) comprising of ifosfamide plus etoposide and vincristine, doxorubicin plus cyclophosphamide, lasting a total of 12 months between 2013 and 2018, were analyzed for treatment-related toxicities, event-free survival (EFS), and overall survival (OS). RESULTS: There were 235 patients (primary safety cohort [PSC]) with median age of 23 (15-61) years; 159 (67.7%) were males, 155 (65.9%) had skeletal primary and 114 (48.5%) had extremity tumors. One hundred ninety-six (83.4%) were treatment naïve (primary efficacy cohort [PEC]) and of these 119 (60.7%) had surgery. In PEC, at a median follow-up of 36.4 (interquartile range [IQR] 20-55) months, estimated 3-year EFS and OS were 67.3% (95% CI 60.3-75.1%) and 91.1% (95% CI 86.7-95.7%), respectively. Of these, 158 (80.6%) complying with intended treatment, at a median follow-up of 39 (IQR 26-57) months had an estimated 3-year EFS of 68.2% (95% CI 60.3-76.1%). In multivariable analysis, good prognostic factors included longer symptom(s) duration (HR 0.93, 95% CI 0.86-0.994), ≥99% necrosis (HR 0.30, 95% CI 0.11-0.77), and treatment completion (HR 0.32, 95% CI 0.14-0.74). Among PSC, grade 3-4 toxicities were febrile neutropenia (119, 50.6%), anemia (130, 55.3%), peripheral neuropathy (37, 15.7%), with three (1.3%) chemo-toxic deaths. CONCLUSIONS: The outcomes of AA nonmetastatic ES patients treated with EFT-2001 regimen were comparable to those reported by others, with acceptable toxicity. This regimen can be considered a standard of care in AA-ES.

20.
BMJ Open ; 11(5): e042943, 2021 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-33958335

RESUMO

OBJECTIVE: To understand the outcome of hospitalised patients from Mumbai City, which had the highest number of COVID-19 cases in India. DESIGN: Observational study with follow-up. SETTING: Data extraction from medical records of patients with COVID-19 admitted to Nair Hospital & TN Medical College, Mumbai, India. PARTICIPANTS: 689 patients with COVID-19 were admitted in the hospital from 26 March 2020 to 11 May 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: In-hospital mortality; joint effect of comorbidity and age on the risk of dying. RESULTS: A total of 689 patients (median age 44 years) admitted with RT-PCR-confirmed COVID-19 were included in the study. Of these, 77.36% of patients were discharged alive while 22.64% died. 11.61% required some kind of oxygen support while 2.8% of patients required intensive care unit admissions. Older age (HR 2.88, 95% CI 2.09 to 3.98), presence of comorbidities (HR 2.56, 95% CI 1.84 to 3.55), history of hypertension (HR 3.19, 95% CI 1.67 to 6.08), and presence of symptoms at the time of admission (HR 3.21, 95% CI 1.41 to 7.26) were associated with increased risk of in-hospital mortality. Treatment with a combination of azithromycin with hydroxychloroquine, antiviral or steroid compared with no treatment did not alter the disease course and in-hospital mortality. The combined effect of old age and presence of comorbid conditions was more pronounced in women than men. CONCLUSIONS: In-hospital patients were younger, less symptomatic with lesser need of ventilators and oxygen support as compared with many western countries. TRIAL REGISTRATION: Not applicable (observational study, not a clinical trial).


Assuntos
COVID-19 , Adulto , Idoso , Comorbidade , Feminino , Mortalidade Hospitalar , Hospitalização , Humanos , Hidroxicloroquina , Índia/epidemiologia , Masculino , SARS-CoV-2
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