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1.
Bull World Health Organ ; 101(9): 587-594, 2023 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-37638358

RESUMO

In health systems with little public funding and decentralized procurement processes, the pricing and quality of anti-cancer medicines directly affects access to effective anti-cancer therapy. Factors such as differential pricing, volume-dependent negotiation and reliance on low-priced generics without any evaluation of their quality can lead to supply and demand lags, high out-of-pocket expenditures for patients and poor treatment outcomes. While pooled procurement of medicines can help address some of these challenges, monitoring of the procurement process requires considerable administrative investment. Group negotiation to fix prices, issuing of uniform contracts with standardized terms and conditions, and procurement by individual hospitals also reduce costs and improve quality without significant investment. The National Cancer Grid, a network of more than 250 cancer centres in India, piloted pooled procurement to improve negotiability of high-value oncology and supportive care medicines. A total of 40 drugs were included in this pilot. The pooled demand for the drugs from 23 centres was equivalent to 15.6 billion Indian rupees (197 million United States dollars (US$)) based on maximum retail prices. The process included technical and financial evaluation followed by contracts between individual centres and the selected vendors. Savings of 13.2 billion Indian Rupees (US$ 166.7million) were made compared to the maximum retail prices. The savings ranged from 23% to 99% (median: 82%) and were more with generics than innovator and newly patented medicines. This study reveals the advantages of group negotiation in pooled procurement for high-value medicines, an approach that can be applied to other health systems.


Lorsque les systèmes de santé reçoivent peu de fonds publics et que leurs processus d'achat sont décentralisés, le prix et la qualité des médicaments contre le cancer ont un impact direct sur l'accès aux traitements efficaces contre la maladie. Des facteurs tels que l'application de prix différenciés, les négociations en fonction des volumes ainsi que la confiance placée dans des génériques bon marché dont la qualité n'a pas été évaluée peuvent entraîner des décalages entre l'offre et la demande, d'énormes dépenses non remboursables pour les patients et de piètres résultats thérapeutiques. Bien que les acquisitions groupées de médicaments puissent contribuer à résoudre certains de ces problèmes, le suivi du processus d'achat requiert un engagement considérable au niveau administratif. Les négociations collectives en vue de fixer les tarifs, l'établissement de contrats types assortis de conditions générales standardisées, mais aussi les achats effectués par des hôpitaux en particulier peuvent également faire baisser les coûts et améliorer la qualité sans nécessiter d'importants investissements. Le National Cancer Grid, un réseau réunissant plus de 250 centres d'oncologie en Inde, a testé un dispositif d'achat groupé visant à assurer une meilleure négociabilité pour des médicaments et soins de soutien essentiels contre le cancer. Au total, 40 substances ont été prises en compte dans ce projet pilote. La demande groupée en médicaments émise par 23 centres équivalait à 15,6 milliards de roupies indiennes (197 millions de dollars américains) d'après le prix maximal de vente au détail. Ce processus prévoyait une évaluation technique et financière, puis des contrats entre chaque centre et les distributeurs sélectionnés. Des économies de 13,2 milliards de roupies indiennes (166,7 millions de dollars américains) ont pu être réalisées par rapport au prix maximal de vente au détail. Ces économies étaient comprises entre 23 et 99% (médiane: 82%) et concernaient davantage les médicaments génériques que les marques et les médicaments récemment brevetés. La présente étude révèle les avantages que représentent les négociations collectives lors des achats groupés de médicaments essentiels, une approche applicable à d'autres systèmes de santé.


En los sistemas sanitarios con escasa financiación pública y procesos de adquisición descentralizados, el sistema de fijación de precios y la calidad de los medicamentos contra el cáncer afectan directamente al acceso a una terapia eficaz contra dicha enfermedad. Factores como los diferentes sistemas de determinación de precios, la negociación en función del volumen y la dependencia de genéricos de bajo precio sin evaluación de su calidad pueden generar retrasos en la oferta y la demanda, elevados gastos para los pacientes y malos resultados en el tratamiento. Aunque la adquisición conjunta de medicamentos puede ayudar a abordar algunos de estos retos, el seguimiento del proceso de adquisición requiere una inversión administrativa considerable. La negociación colectiva a la hora de determinar los precios, la emisión de contratos unificados con términos y condiciones estandarizados y la adquisición por parte de algunos hospitales también reducen los costes y mejoran la calidad sin necesidad de realizar una gran inversión. La Red Nacional de Cáncer, una red que cuenta con más de 250 centros oncológicos en la India, puso a prueba la adquisición conjunta con el fin de mejorar la negociabilidad de medicamentos oncológicos y de tratamiento complementario que resultaban costosos. En esta prueba piloto se incluyó un total de 40 medicamentos. La demanda conjunta de medicamentos por parte de 23 centros fue equivalente a 15 600 millones de rupias indias (197 millones USD) según los precios minoristas máximos. El proceso incluyó una evaluación técnica y financiera, así como contratos entre centros independientes y proveedores seleccionados. Se logró un ahorro de 13 200 millones de rupias indias (166,7 millones USD) en comparación con los precios minoristas máximos. El ahorro osciló entre el 23 y el 99% (media: 82%) y fue más alto con los medicamentos genéricos que con los de marca y los recién patentados. Este estudio pone de manifiesto las ventajas de la negociación colectiva en lo que respecta a la adquisición conjunta de medicamentos costosos, un enfoque que se puede aplicar a otros sistemas sanitarios.


Assuntos
Neoplasias , Humanos , Neoplasias/tratamento farmacológico , Medicamentos Genéricos , Gastos em Saúde , Hospitais , Índia
2.
Indian J Urol ; 39(2): 148-155, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37304993

RESUMO

Introduction: There is a scarcity of population-based prostate cancer survival data in India. We assessed the population-based, overall survival of patients with prostate cancer from the Sangrur and Mansa cancer registries of the Punjab state, India. Methods: In the year 2013-2016, a total of 171 prostate cancer cases were registered in these two registries. Based on these registries, survival analysis was performed using the date of diagnosis as the starting date and the last follow-up date being December 31, 2021 or the date of death. Survival was calculated using STATA software. Relative survival was calculated using the Pohar Perme method. Results: Follow up was available for all the registered cases. Of the 171 cases, 41 (24%) were alive and 130 (76.0%) were dead. Of the prescribed treatments, 106 (62.7%) cases completed the treatment and 63 (37.3%) cases did not complete the treatment. Overall, 5-year age-standardized prostate cancer relative survival was 30.3%. Patients who completed the treatment had a 7.8 times higher 5-year relative survival (45.5%) compared to those who did not (5.8%). The difference between the two groups is statistically significant (hazard ratio 0.16, 95% confidence interval [0.10-0.27]). Conclusion: To improve survival, we need to raise awareness in the community and among primary physicians so that prostate cancer cases can reach the hospital early and should be treated effectively. The cancer center should develop the systems in their hospital so that there will be no hurdles to the patients in treatment completion. We found a low overall relative survival among patients of prostate cancer in these two registries. Patients who received treatment had a significantly higher survival.

3.
J Surg Oncol ; 125(3): 327-335, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34729779

RESUMO

BACKGROUND AND OBJECTIVES: There are reports of outcomes of elective major cancer surgery during the COVID-19 pandemic. We evaluated if reinforcement of hand hygiene, universal masking, and distancing as a part of pandemic precautions led to a decrease in the incidence of surgical site infections (SSIs) in major oncologic resections. METHODS: Propensity score matching using the nearest neighbor algorithm was performed on 3123 patients over seven covariates (age, comorbidities, surgery duration, prior treatment, disease stage, reconstruction, and surgical wound type) yielding 2614 matched (pre-COVID 1612 and COVID 1002) patients. Conditional logistic regression was used to identify if SSI incidence was lower amongst patients operated during the pandemic. RESULTS: There was a 4.2% (p = 0.006) decrease in SSI in patients operated during the pandemic. On multivariate regression, surgery during the COVID-19 period (odds ratio [OR] = 0.77; 95% confidence interval [CI] = 0.61-0.98; p = 0.03), prior chemoradiation (OR = 2.46; CI = 1.45-4.17; p < 0.001), duration of surgery >4 h (OR = 2.17; 95%CI = 1.55-3.05; p < 0.001) and clean contaminated wounds (OR = 2.50; 95% CI = 1.09-2.18; p = 0.012) were significantly associated with SSI. CONCLUSION: Increased compliance with hand hygiene, near-universal mask usage, and social distancing during the COVID-19 pandemic possibly led to a 23% decreased odds of SSI in major oncologic resections. Extending these low-cost interventions in the post-pandemic era can decrease morbidity associated with SSI in cancer surgery.


Assuntos
COVID-19/epidemiologia , Controle de Infecções , Neoplasias/cirurgia , Infecção da Ferida Cirúrgica/epidemiologia , Algoritmos , COVID-19/prevenção & controle , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Pontuação de Propensão , Estudos Retrospectivos , Fatores de Risco
4.
Natl Med J India ; 35(3): 142-146, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36461874

RESUMO

Background The Covid-19 pandemic and subsequent lockdown in India caused disruptions in cancer treatment due to the restriction on movement of patients. We aimed to maintain continuity in cancer treatment during the lockdown through teleconsultations. We tried to reach out to our patients using telephonic consultations by establishing a Teleconsult Centre facility run by a team of doctors and patient navigators. Methods We telephonically contacted all patients who had outpatient appointments from 23 March to 30 April 2020 at our centre through the Teleconsult Centre to understand their current circumstances, feasibility of follow-up, local resources and offered best possible alternatives to continue cancer treatment, if required. Results Of the 2686 patients scheduled for follow-up during this period, we could contact 1783 patients in 9 working days. Through teleconsultations, we could defer follow-ups of 1034 patients (57.99%, 95% confidence interval [CI] 55.6%-60.3%), thus reducing the need for patients to travel to the hospital. Change in systemic therapy was made in 75 patients (4.2%, 95% CI 3.3%-5.2%) as per the requirements and available resources. Symptoms suggestive of disease progression were picked up in 12 patients (0.67%, 95% CI 0.35%-1.17%), who were advised to meet local physicians. Conclusion Our study suggests that the majority of patients on follow-up can be managed with teleconsultation in times of crisis. Teleconsultation has the potential of being one of the standard methods of patient follow-up even during periods of normalcy.


Assuntos
COVID-19 , Neoplasias , Telemedicina , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Centros de Atenção Terciária , Pandemias , Controle de Doenças Transmissíveis , Índia/epidemiologia , Continuidade da Assistência ao Paciente , Neoplasias/epidemiologia , Neoplasias/terapia
5.
Lancet Oncol ; 22(8): e369-e376, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34216541

RESUMO

Low-income and middle-income countries (LMICs) have a disproportionately high burden of cancer and cancer mortality. The unique barriers to optimum cancer care in these regions necessitate context-specific research. The conduct of research in LMICs has several challenges, not least of which is a paucity of formal training in research methods. Building capacity by training early career researchers is essential to improve research output and cancer outcomes in LMICs. The International Collaboration for Research methods Development in Oncology (CReDO) workshop is an initiative by the Tata Memorial Centre and the National Cancer Grid of India to address gaps in research training and increase capacity in oncology research. Since 2015, there have been five CReDO workshops, which have trained more than 250 oncologists from India and other countries in clinical research methods and protocol development. Participants from all oncology and allied fields were represented at these workshops. Protocols developed included clinical trials, comparative effectiveness studies, health services research, and observational studies, and many of these protocols were particularly relevant to cancer management in LMICs. A follow-up of these participants in 2020 elicited an 88% response rate and showed that 42% of participants had made progress with their CReDO protocols, and 73% had initiated other research protocols and published papers. In this Policy Review, we describe the challenges to research in LMICs, as well as the evolution, structure, and impact of CReDO and other similar workshops on global oncology research.


Assuntos
Pesquisa sobre Serviços de Saúde , Oncologia/educação , Neoplasias , Fortalecimento Institucional , Países em Desenvolvimento , Educação , Humanos , Índia
6.
Indian J Med Res ; 154(2): 229-236, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34854430

RESUMO

Low- and middle-income countries (LMICs) have limited financial resources and proportionately smaller portions allocated for health budget. With competing health priorities, treatment of the diagnosed cases and establishment of treatment facilities are the main concerns in LMICs. Infectious diseases, reducing infant, child and maternal mortality may seem crucial as compared to early cancer detection. LMICs that are committed to providing comprehensive cancer care, will need to judiciously choose the screening tool depending on specifics of how the tool is expected to perform in the population and the cost-effectiveness with respect to the number of lives expected to be saved. Increasing awareness about breast health in general and common cancers and non communicable diseases (NCDs), in particular, may lead to symptomatic women approaching the healthcare facilities at an earlier stage. When the limited available resources are mobilized towards cancer screening, increasing awareness would lead to greater acceptability of the programme. The reach of the programme to achieve good population coverage, the establishment of the diagnostic referral linkages and the availability and accessibility of treatment facilities, will all decide the outcome of the screening programme.


Assuntos
Neoplasias da Mama , Países em Desenvolvimento , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Análise Custo-Benefício , Detecção Precoce de Câncer , Feminino , Humanos , Programas de Rastreamento
7.
Ann Surg ; 272(3): e249-e252, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32520743

RESUMO

BACKGROUND: Overburdened systems and concerns of adverse outcomes have resulted in deferred cancer surgeries with devastating consequences. In this COVID pandemic, the decision to continue elective cancer surgeries, and their subsequent outcomes, are sparsely reported from hotspots. METHODS: A prospective database of the Department of Surgical Oncology was analysed from March 23rd to April 30th, 2020. FINDINGS: Four hundred ninety-four elective surgeries were performed (377 untested and 117 tested for Covid 19 before surgery). Median age was 48 years with 13% (n = 64) above the age of 60 years. Sixty-eight percent patients were American Society of Anaesthesiology (ASA) grade I. As per surgical complexity grading, 71 (14·4%) cases were lower grade (I-III) and 423 (85.6%) were higher grade complex surgeries (IV - VI).Clavien-Dindo ≥ grade III complications were 5.6% (n = 28) and there were no postoperative deaths. Patients >60 years documented 9.3% major complications compared to 5.2% in <60 years (P = 0.169). The median hospital stay was 1 to 9 days across specialties.Postoperatively, 26 patients were tested for COVID 19 and 6 tested positive. They all had higher grade surgeries but none required escalated or intensive care treatment related to COVID infection. INTERPRETATION: A combination of scientific and administrative rationale contributed to favorable outcomes after major elective cancer surgeries. These results support the continuation of elective major cancer surgery in regions with Covid 19 trends similar to India.


Assuntos
COVID-19/epidemiologia , Procedimentos Cirúrgicos Eletivos , Neoplasias/cirurgia , Complicações Pós-Operatórias/epidemiologia , Adulto , Idoso , Estudos de Coortes , Bases de Dados Factuais , Feminino , Hospitalização , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/patologia , Avaliação de Resultados em Cuidados de Saúde , Seleção de Pacientes
8.
J Biol Chem ; 293(50): 19263-19276, 2018 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-30337371

RESUMO

Preoperative progesterone intervention has been shown to confer a survival benefit to breast cancer patients independently of their progesterone receptor (PR) status. This observation raises the question how progesterone affects the outcome of PR-negative cancer. Here, using microarray and RNA-Seq-based gene expression profiling and ChIP-Seq analyses of breast cancer cells, we observed that the serum- and glucocorticoid-regulated kinase gene (SGK1) and the tumor metastasis-suppressor gene N-Myc downstream regulated gene 1 (NDRG1) are up-regulated and that the microRNAs miR-29a and miR-101-1 targeting the 3'-UTR of SGK1 are down-regulated in response to progesterone. We further demonstrate a dual-phase transcriptional and post-transcriptional regulation of SGK1 in response to progesterone, leading to an up-regulation of NDRG1 that is mediated by a set of genes regulated by the transcription factor AP-1. We found that NDRG1, in turn, inactivates a set of kinases, impeding the invasion and migration of breast cancer cells. In summary, we propose a model for the mode of action of progesterone in breast cancer. This model helps decipher the molecular basis of observations in a randomized clinical trial of the effect of progesterone on breast cancer and has therefore the potential to improve the prognosis of breast cancer patients receiving preoperative progesterone treatment.


Assuntos
Neoplasias da Mama/patologia , Proteínas de Ciclo Celular/metabolismo , Proteínas Imediatamente Precoces/genética , Peptídeos e Proteínas de Sinalização Intracelular/metabolismo , Progesterona/farmacologia , Proteínas Serina-Treonina Quinases/genética , Receptores de Progesterona/metabolismo , Fator de Transcrição AP-1/metabolismo , Regulação para Cima/efeitos dos fármacos , Linhagem Celular Tumoral , Movimento Celular/efeitos dos fármacos , Receptores ErbB/metabolismo , Humanos , Proteínas Imediatamente Precoces/metabolismo , Sistema de Sinalização das MAP Quinases/efeitos dos fármacos , Invasividade Neoplásica , Proteínas Serina-Treonina Quinases/metabolismo
10.
Breast Cancer Res Treat ; 170(2): 431-438, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29564740

RESUMO

PURPOSE: We have reported a survival benefit of single injection of hydroxyprogesterone prior to surgery for primary tumour in patients with node-positive operable breast cancer. Hydroxyprogesterone was meant to recapitulate the luteal phase of menstrual cycle in these women. We wanted to understand the molecular basis of action of hydroxyprogesterone on primary breast tumours in a peri-operative setting. METHODS: We performed whole transcriptome sequencing (RNA-Seq) of primary breast tumour samples collected from patients before and after hydroxyprogesterone exposure and controls. Paired breast cancer samples were obtained from patients who were given hydroxyprogesterone before surgery and a group of patients who were subjected to only surgery. RESULTS: A test of significance between the two groups revealed 207 significantly altered genes, after correction for multiple hypothesis testing. We found significantly contrasting gene expression patterns in exposed versus unexposed groups; 142 genes were up-regulated post-surgery among exposed patients, and down-regulated post-surgery among unexposed patients. Significantly enriched pathways included genes that respond to progesterone, cellular stress, nonsense-mediated decay of proteins and negative regulation of inflammatory response. These results suggest that cellular stress is modulated by hydroxyprogesterone. Network analysis revealed that UBC, a mediator of stress response, to be a major node to which many of the significantly altered genes connect. CONCLUSIONS: Our study suggests that pre-operative exposure to progesterone favourably modulates the effect of surgical stress, and this might underlie its beneficial effect when administered prior to surgery.


Assuntos
Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Progesterona/metabolismo , Estresse Fisiológico , Neoplasias da Mama/genética , Neoplasias da Mama/cirurgia , Biologia Computacional/métodos , Feminino , Perfilação da Expressão Gênica , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Mastectomia , Anotação de Sequência Molecular , Estadiamento de Neoplasias , Período Pré-Operatório , Progesterona/genética , Reprodutibilidade dos Testes , Transdução de Sinais , Transcriptoma
13.
Lancet Oncol ; 15(6): e223-33, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24731888

RESUMO

The delivery of affordable and equitable cancer care is one of India's greatest public health challenges. Public expenditure on cancer in India remains below US$10 per person (compared with more than US$100 per person in high-income countries), and overall public expenditure on health care is still only slightly above 1% of gross domestic product. Out-of-pocket payments, which account for more than three-quarters of cancer expenditures in India, are one of the greatest threats to patients and families, and a cancer diagnosis is increasingly responsible for catastrophic expenditures that negatively affect not only the patient but also the welfare and education of several generations of their family. We explore the complex nature of cancer care systems across India, from state to government levels, and address the crucial issues of infrastructure, manpower shortages, and the pressing need to develop cross-state solutions to prevention and early detection of cancer, in addition to governance of the largely unregulated private sector and the cost of new technologies and drugs. We discuss the role of public insurance schemes, the need to develop new political mandates and authority to set priorities, the necessity to greatly improve the quality of care, and the drive to understand and deliver cost-effective cancer care programmes.


Assuntos
Atenção à Saúde/economia , Política de Saúde/economia , Necessidades e Demandas de Serviços de Saúde/economia , Neoplasias/economia , Humanos , Índia , Neoplasias/terapia , Fatores Socioeconômicos
14.
Lancet Oncol ; 15(6): e205-12, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24731885

RESUMO

Cancer can have profound social and economic consequences for people in India, often leading to family impoverishment and societal inequity. Reported age-adjusted incidence rates for cancer are still quite low in the demographically young country. Slightly more than 1 million new cases of cancer are diagnosed every year in a population of 1.2 billion. In age-adjusted terms this represents a combined male and female incidence of about a quarter of that recorded in western Europe. However, an estimated 600,000-700,000 deaths in India were caused by cancer in 2012. In age-standardised terms this figure is close to the mortality burden seen in high-income countries. Such figures are partly indicative of low rates of early-stage detection and poor treatment outcomes. Many cancer cases in India are associated with tobacco use, infections, and other avoidable causes. Social factors, especially inequalities, are major determinants of India's cancer burden, with poorer people more likely to die from cancer before the age of 70 years than those who are more affluent. In this first of three papers, we examine the complex epidemiology of cancer, the future burden, and the dominant sociopolitical themes relating to cancer in India.


Assuntos
Neoplasias/epidemiologia , Distribuição por Idade , Efeitos Psicossociais da Doença , Feminino , Humanos , Índia/epidemiologia , Masculino , Neoplasias/etiologia , Distribuição por Sexo , Fatores Socioeconômicos
15.
Lancet Oncol ; 15(6): e213-22, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24731887

RESUMO

Over the past 20 years, cancer research in India has grown in size and impact. Clinicians, scientists, and government and state policy makers in India have championed cancer research, from studies to achieve low-tech, large-scale health outcomes to some of the most advanced areas of fundamental cancer science. In this paper, we frame public policy discussions about cancer with use of an in-depth analysis of research publications from India. Cancer research in India is a complex environment that needs to balance public policy across many competing agendas. We identify major needs across these environments such as those for increased research capacity and training and protected time for clinical researchers; for more support from states and enhanced collaborative funding programmes from government; for development of national infrastructures across a range of domains (ie, clinical trials, tissue banking, registries, etc); and for a streamlined and rational regulatory environment. We also discuss improvements that should be made to translate research into improvements in cancer outcomes and public health.


Assuntos
Necessidades e Demandas de Serviços de Saúde , Neoplasias , Política Pública , Pesquisa , Humanos , Índia , Pesquisa/educação , Pesquisa/organização & administração , Pesquisa/tendências
16.
Jpn J Clin Oncol ; 44(5): 401-7, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24755545

RESUMO

During the last 20 years, India has emerged as a fast growing economy with changes in lifestyle-related behavior partially responsible for the increasing cancer burden. While cancer incidence rates are lower than many western countries some changes over recent decades have emerged. This paper examines the time trends in cancer-specific incidence from six population-based cancer registries in India and review articles published on cancer trends in the country. The results are examined in light of their implications to cancer prevention and cancer control.


Assuntos
Neoplasias/epidemiologia , Feminino , Humanos , Incidência , Índia/epidemiologia , Estilo de Vida , Masculino , Neoplasias/etiologia , Neoplasias/prevenção & controle
18.
Clin Orthop Relat Res ; 472(5): 1568-75, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24249538

RESUMO

BACKGROUND: Whether current postoperative surveillance regimes result in improved overall survival (OS) of patients with extremity sarcomas is unknown. QUESTIONS/PURPOSES: We hypothesized that a less intensive followup protocol would not be inferior to the conventional followup protocol in terms of OS. We (1) assessed OS of patients to determine if less intensive followup regimens led to worsened survival and asked (2) whether chest radiograph followup group was inferior to CT scan followup group in detecting pulmonary metastasis; and (3) whether less frequent (6-monthly) followup interval was inferior to more frequent (3-monthly) followup in detecting pulmonary metastasis and local recurrence. METHODS: A prospective randomized single-center noninferiority trial was conducted between January 2006 and June 2010. On the basis of 3-year survival of 60% with intensive, more frequent followup, 500 nonmetastatic patients were randomized to demonstrate noninferiority by a margin (delta) of 10% (hazard ratio [HR], 1.36). The primary end point was OS at 3 years. The secondary objective was to compare disease-free survival (DFS) (time to recurrence) at 3 years. At minimum followup of 30 months (median, 42 months; range, 30-81 months), 178 deaths were documented. RESULTS: Three-year OS and DFS for all patients was 67% and 52%, respectively. Three-year OS was 67% and 66% in chest radiography and CT groups, respectively (HR, 0.9; upper 90% confidence interval [CI], 1.13). DFS rate was 54% and 49% in chest radiography and CT groups, respectively (HR, 0.82; upper 90% CI, 0.97). Three-year OS was 64% and 69% in 6-monthly and 3-monthly groups, respectively (HR, 1.2; upper 90% CI, 1.47). DFS was 51% and 52% in 6-monthly and 3-monthly groups, respectively (HR, 1.01; upper 90% CI, 1.2). Almost 90% of local recurrences were identified by patients themselves. CONCLUSIONS: Inexpensive imaging detects the vast majority of recurrent disease in patients with sarcoma without deleterious effects on eventual outcomes. Patient education regarding self-examination will detect most instances of local recurrence although this was not directly assessed in this study. Although less frequent visits adequately detected metastasis and local recurrence, this trial could not conclusively demonstrate noninferiority in OS for a 6-monthly interval of followup visits against 3-monthly visits. LEVEL OF EVIDENCE: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.


Assuntos
Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Pulmonares/diagnóstico por imagem , Recidiva Local de Neoplasia/diagnóstico por imagem , Osteossarcoma/diagnóstico por imagem , Radiografia Torácica , Sarcoma/diagnóstico por imagem , Neoplasias de Tecidos Moles/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Adolescente , Adulto , Idoso , Neoplasias Ósseas/mortalidade , Neoplasias Ósseas/patologia , Neoplasias Ósseas/cirurgia , Criança , Pré-Escolar , Intervalo Livre de Doença , Extremidades , Feminino , Humanos , Índia , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/secundário , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/mortalidade , Osteossarcoma/mortalidade , Osteossarcoma/patologia , Osteossarcoma/cirurgia , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Estudos Prospectivos , Sarcoma/mortalidade , Sarcoma/secundário , Sarcoma/cirurgia , Neoplasias de Tecidos Moles/mortalidade , Neoplasias de Tecidos Moles/patologia , Neoplasias de Tecidos Moles/cirurgia , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
19.
South Asian J Cancer ; 13(3): 215-219, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39410988

RESUMO

Nita S. Nair Chemotherapeutic agents used in the treatment of breast cancer (BC) adversely impact growing ovarian follicles and can induce permanent premature ovarian failure or reduce ovarian reserve in younger women. As treatments result in improved survival of BC patients, young survivors face quality of life (QOL) issues, including treatment-related infertility. We conducted a survey to evaluate awareness among patients regarding the impact of cancer-directed therapy on fertility and available options of fertility preservation (FP). We interviewed 350 women with BC under 40 years of age at the start of treatment, of which 321 (91.70%) were in varying stages of follow-up, 8 women (2.30%) were scheduled to start treatment, and 21 (6.00%) women were under treatment. All received chemotherapy or hormone therapy with or without ovarian suppression. Of the 350 women who responded to the survey, 321 (91.70%) women were on follow-up, 8 (2.30%) women were due to start treatment, and 21 (6%) women were on treatment. The median age at diagnosis was 35 years, with 12.9% of women aged less than 30 years, 15 (4.28%) were unmarried, 31 (8.85%) were nulliparous, and 98 (28%) had one child. Overall, 271 (77.42%) women were aware (at the start of treatment) of impact of therapy on fertility, but only 48/271(17.71%) women were aware of the options of FP. In this cohort, 94/350 (26.85%) women felt FP was a priority, 64/350 (18.28%) women perceived their family as incomplete, and 17/64 (26.56%) women were willing to consider invasive reproductive assistance (IRA). Reasons for refusal for IRA included cost, risk of relapse, and delay of treatment. There was an association between being unmarried ( p = 0.00), having an incomplete family (0.00), considering more children ( p = 0.00) and willingness to consider IRA. FP is a priority for women treated for BC and an important QOL domain that needs to be addressed at the start of treatment We found a high level of awareness of impact of cancer-directed therapy to fertility in this cohort, but low awareness and acceptance for options for FP.

20.
South Asian J Cancer ; 13(2): 85-89, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38919667

RESUMO

Nita S. NairBackground Radiotherapy (RT) is an important modality in the management of breast cancers (BC). Large randomized trials have suggested that prophylactic regional nodal irradiation inclusive of internal mammary lymph nodes (IMLN) reduces BC-related mortality. However, the adoption of IMLN-RT has been variable due to relative benefits and toxicity concerns. Methods A survey was emailed to radiation oncologists (ROs) across the country wherein they were asked about their practice regarding IMLN-RT in BC. Results We received 128 responses, which included radiation oncologists across both private institutions (PIs) and government institutions (GIs). Fifty-six (43.8%) routinely offer prophylactic(p) IMLN-RT and an additional 15 (11.71%) suggested they would have offered it in the absence of logistic constraints. Almost all, 121 (94.5%) radiate the IMLN in case of radiologically positive lymph nodes (LNs). Fifty-six ROs (43.8%) offered prophylactic IMLN-RT in node-negative disease. Among those who did not offer IMLN-RT, most (84.72%) felt the clinical evidence was equivocal. Of the 56 who offered pIMLN-RT, 34/56 (60.71%) offered to locally advanced tumors, 20/56 (35.71%) offered to all inner and central tumors (ICQT), 29/56 (51.78%) to > 4 axillary LN-positive and 9/56 (16.07%) to any axillary LN-positive. The majority, i.e., 36/56 (64.28%) radiated upper three intercostal spaces, 9 (16.07%) radiated upper five intercostal spaces, and 6 (10.9%) decided based on tumor location, while 5 (9%) irradiated one space below the involved space. Overall, simulation-based planning was undertaken in 99% of PIs as opposed to 89% of GIs ( p = 0.03). The majority of ROs, i.e., 92 (72.4%) preferred IMRT to IMLN-RT. In addition, the surgical approach to IMLN was practiced by surgeons at 18 (14%) centers, of which 13 (72.22%) operated the IMLN when radiologically evident. The IMLN dissection was preferentially performed for second and third intercostal spaces as suggested in 10 (55.55%) responses, while 8 (44.44%) performed thoracoscopic dissection of the IMLN chain. The distribution of prophylactic, definitive IMLN-RT, and IMLN dissection did not differ significantly between GI and PI ( p = NS). Conclusion pIMLN-RT is still not the standard protocol in most centers citing equivocal evidence in the literature. Logistics, though different in GIs and PIs, did not impact the decision of pIMLN-RT. Further efforts would be required to standardize practice in IMLN across India.

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