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Quality of life in patients submitted to neoadjuvant chemotherapy with cisplatin and gemcitabine followed by chemoradiation with cisplatin in invasive locally advanced cervical cancer

Grant number: 16/16568-4
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): November 01, 2016
Effective date (End): October 31, 2017
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Maria Del Pilar Estevez Diz
Grantee:Fernanda Nunes de Arruda
Home Institution: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (ICESP). Coordenadoria de Serviços de Saúde (CSS). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

The importance of cervical cancer's study can be comprehended as we evaluate the national magnitude: it is the third primary location of incidence and mortality due to cancer in women. In this context, multiples therapies have been developed on the past decade, trying to optimize survival. However it is not clear what is the impact of treatments on these women's quality of life. Aspects related to mental and social health as well as sexual life quality are essential on the choice of treatment. On the sphere of therapies, recent studies indicates that radiochemotherapy is equal or superior to surgical treatment, and others results evaluates positively the association of gemcitabine and cisplatin on the palliative context. Until this moment, neoadjuvant chemotherapy followed by exclusive chemoradiation was not evaluated on a prospective study. This strategy of treatment is involved on an institutional study, which is being developed on ICESP, called "Prospective, randomized, non-comparative, phase II study of treatment with induction chemotherapy based on cisplatin and gemcitabine followed by chemoradiation or definitive chemoradiation in invasive locally advanced cervical carcinomas"(LACC). Objective: The present study objectify to evaluate and compare two lines of treatment concerning the quality of life and sexual life of patients with invasive cervical carcinoma, which are (1) induction chemotherapy with cisplatin and gemcitabine, followed by chemoradiation, and (2) chemoradiation only. Methods: For this study, were eligible patients admitted at Instituto do Câncer do Estado de São Paulo (ICESP) and Instituto de Radiologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (INRAD - HC - FMUSP) with histological diagnosis of invasive locally advanced uterine cervical cancer, with IIB to IVA stages settled by International Federation of Gynecology and Obstetrics (FIGO) and candidates to treatment with definitive chemoradiation participants of "Prospective, randomized, non-comparative, phase II study of treatment with induction chemotherapy based on cisplatin and gemcitabine followed by chemoradiation or definitive chemoradiation in invasive locally advanced cervical carcinomas". There were selected for evaluation on the present study fifty patients. These patients were submitted to blood tests for biological markers of angiogenesis and proliferation. The inclusion's criteria comprehend the consent and filling out the questionnaires of life's quality, as well as the participation on the study mentioned above. The analysis of patients' life's quality have been done using the scale of the State of Global Health of the European Organization for Investigation and Treatment of Cancer (EORTC) QLQ-C30 and the module of cervical cancer by the same organization - EORTC QLQ-CX24. These questionnaires will be administered on the beginning and after 3, 6 and 12 months of treatment. The questionnaires' application have been done before the beginning of the two lines of treatment, and before the medical consult which precedes every cycle of chemotherapy and radiotherapy. With the evaluation, we expect to discover which are the complaint of major impact on patients' life and, starting from these discovers, elaborate new conducts or orientations. Thus, it is possible to evaluate which is the most efficient and less debilitating treatment to the patient.