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1.
ESMO Open ; 7(1): 100311, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34920291

RESUMO

BACKGROUND: Gatipotuzumab is a humanized monoclonal antibody recognizing the carbohydrate-induced epitope of the tumor-associated mucin-1 (TA-MUC1). This study aimed to evaluate the efficacy and safety of switch maintenance therapy with gatipotuzumab in patients with TA-MUC1-positive recurrent ovarian, fallopian tube, or primary high-grade serous peritoneal cancer. PATIENTS AND METHODS: In this double-blind, randomized, placebo-controlled, phase II trial, patients with at least stable disease (SD) following chemotherapy were randomized 2:1 to receive intravenous gatipotuzumab (500 mg followed by 1700 mg 1 week later) or placebo every 3 weeks until tumor progression or unacceptable toxicity occurred. Stratification factors were the number of prior chemotherapy lines (2 versus 3-5), response versus SD after the most recent chemotherapy, and progression-free survival (PFS) <6 versus 6-12 months following the prior therapy. Primary endpoint was PFS according to modified immune-related RECIST 1.1 response criteria. Secondary endpoints were PFS at 6 months, safety, overall response rate, CA-125 progression, overall survival, quality of life, and pharmacokinetics. RESULTS: Overall, 216 patients were randomized to gatipotuzumab (n  = 151) or placebo (n  = 65). Median PFS with gatipotuzumab was 3.5 months as compared with 3.5 months with placebo (hazard ratio 0.96, 95% confidence interval 0.69-1.33, P  = 0.80). No advantage for gatipotuzumab over placebo was seen in the secondary efficacy endpoints or in any stratified subgroups. Gatipotuzumab was well tolerated, with mild to moderate infusion-related reactions being the most common adverse events. CONCLUSIONS: Gatipotuzumab switch maintenance therapy does not improve outcome in TA-MUC1-positive ovarian cancer patients. TRIAL REGISTRATION: ClinicalTrials.govNCT01899599; https://clinicaltrials.gov/ct2/show/NCT01899599.


Assuntos
Anticorpos Monoclonais Humanizados , Antineoplásicos Imunológicos , Mucina-1 , Neoplasias Ovarianas , Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos Imunológicos/uso terapêutico , Carcinoma Epitelial do Ovário/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Quimioterapia de Manutenção , Mucina-1/imunologia , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/patologia , Neoplasias Ovarianas/tratamento farmacológico , Qualidade de Vida
2.
Clin. transl. oncol. (Print) ; 23(5): 922-930, mayo 2021. tab, ilus
Artigo em Inglês | IBECS | ID: ibc-221232

RESUMO

Soft-tissue sarcomas constitute an uncommon and heterogeneous group of tumors of mesenchymal origin. Diagnosis, treatment, and management should be performed by an expert multidisciplinary team. MRI/CT of the primary tumor and biopsy is mandatory before any treatment. Wide surgical resection with tumor-free tissue margin is the mainstay for localized disease. Radiotherapy is indicated in large, deep, high-grade tumors, or after marginal resection not suitable for re-excision. Perioperative chemotherapy should be discussed for high-risk sarcomas of the extremities and trunk-wall. In the case of oligometastatic disease, patients should be considered for local therapies. First-line treatment with anthracyclines (or in combination with ifosfamide) is the treatment of choice. Other drugs have shown activity in second-line therapy and in specific histological subtypes but options are limited and thus, a clinical trial should always be discussed (AU)


Assuntos
Humanos , Neoplasias de Tecidos Moles/diagnóstico , Neoplasias de Tecidos Moles/terapia , Sarcoma/terapia , Sarcoma/diagnóstico , Tomografia Computadorizada por Raios X , Imageamento por Ressonância Magnética , Sociedades Médicas , Biópsia , Espanha
3.
Clin Transl Oncol ; 23(5): 922-930, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33405052

RESUMO

Soft-tissue sarcomas constitute an uncommon and heterogeneous group of tumors of mesenchymal origin. Diagnosis, treatment, and management should be performed by an expert multidisciplinary team. MRI/CT of the primary tumor and biopsy is mandatory before any treatment. Wide surgical resection with tumor-free tissue margin is the mainstay for localized disease. Radiotherapy is indicated in large, deep, high-grade tumors, or after marginal resection not suitable for re-excision. Perioperative chemotherapy should be discussed for high-risk sarcomas of the extremities and trunk-wall. In the case of oligometastatic disease, patients should be considered for local therapies. First-line treatment with anthracyclines (or in combination with ifosfamide) is the treatment of choice. Other drugs have shown activity in second-line therapy and in specific histological subtypes but options are limited and thus, a clinical trial should always be discussed.


Assuntos
Sarcoma/diagnóstico , Sarcoma/terapia , Neoplasias de Tecidos Moles/diagnóstico , Neoplasias de Tecidos Moles/terapia , Antraciclinas/uso terapêutico , Antineoplásicos/uso terapêutico , Lista de Checagem , Quimioterapia Adjuvante/métodos , Dermatofibrossarcoma/terapia , Feminino , Fibromatose Agressiva/genética , Fibromatose Agressiva/terapia , Humanos , Imageamento por Ressonância Magnética , Masculino , Oncologia , Terapia Neoadjuvante/métodos , Radioterapia/métodos , Neoplasias Retroperitoneais/terapia , Sarcoma/diagnóstico por imagem , Sarcoma/patologia , Sociedades Médicas , Neoplasias de Tecidos Moles/diagnóstico por imagem , Neoplasias de Tecidos Moles/patologia , Tumores Fibrosos Solitários/tratamento farmacológico , Espanha , Tomografia Computadorizada por Raios X , Neoplasias Uterinas/terapia
6.
Ann Oncol ; 28(4): 711-717, 2017 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-28327917

RESUMO

The consensus statements regarding first-line therapies in women with ovarian cancer, reached at the Fifth Ovarian Cancer Consensus Conference held in Tokyo, Japan, in November 2015 are reported. Three topics were reviewed and the following statements are recommended: (i) Surgery: the subgroups that should be considered in first-line ovarian cancer clinical trials should be (a) patients undergoing primary debulking surgery and (b) patients receiving neo-adjuvant chemotherapy. The amount of residual disease following surgery should further stratify patients into those with absent gross residual disease and others. (ii) Control arms for chemotherapy: for advanced stage ovarian cancer the standard is intravenous 3-weekly carboplatin and paclitaxel. Acceptable alternatives, which should be stratified variables in trials when more than one regimen is offered, include weekly paclitaxel plus 3-weekly carboplatin, the addition of bevacizumab to 3-weekly carboplatin and paclitaxel, and intraperitoneal therapy. (iii) Trial Endpoints: overall survival is the preferred primary endpoint for first-line clinical trials with or without a maintenance component. Progression-free survival (PFS) is an alternative primary endpoint, but if PFS is chosen overall survival must be measured as a secondary endpoint and PFS must be supported by additional endpoints, including predefined patient reported outcomes and time to first or second subsequent therapy. For neoadjuvant therapy, additional 'window of opportunity' endpoints should be included.


Assuntos
Neoplasias Epiteliais e Glandulares/terapia , Neoplasias Ovarianas/terapia , Projetos de Pesquisa , Carcinoma Epitelial do Ovário , Feminino , Humanos
7.
Support Care Cancer ; 24(3): 1241-9, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26304156

RESUMO

BACKGROUND: A recent phase III trial compared the efficacy of cisplatin-topotecan (a topoisomerase I inhibitor) followed by carboplatin-paclitaxel (Arm 1) versus paclitaxel-carboplatin (Arm 2) in women with newly diagnosed stage IIB or greater ovarian cancer. There was a significantly lower response rate in the experimental arm compared to standard treatment, and less likelihood of normalized CA125 within the first 3 months. At 43 months follow-up, there were no significant group differences in progression-free survival. There were also significantly more side effects in the experimental arm. METHODS: The current study examined quality of life (QoL) endpoints using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the ovarian cancer module, QLQ-OV28, administered prior to randomization, at day 1 of treatment cycles 3, 5, and 7, at completion of the last cycle, and at 3 and 6 months following completion of chemotherapy. RESULTS: Global QoL, physical symptoms, fatigue, and role, emotional, cognitive and social function (all from the EORTC QLQ-C30) significantly improved in both treatment arms, with no significant between-arm differences. Between-group differences in pain, insomnia, and peripheral neuropathy reported while on treatment did not differ at follow-up. Nausea and vomiting improved more with standard treatment both during and after treatment. Body image significantly differed between the groups only at cycle 5 (more deterioration in Arm 2) but group differences disappeared at follow-up. A stratified analysis of global QoL by debulking surgery status found no greater effect indicating that overall improvements in QoL were unrelated to surgical recovery. CONCLUSIONS: There was no significant QoL advantage of cisplatin-topotecan. This finding, combined with no progression-free survival conferred by this combination, reaffirms carboplatin-paclitaxel as the standard of care for women with newly diagnosed ovarian cancer.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carboplatina/uso terapêutico , Cisplatino/uso terapêutico , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/psicologia , Paclitaxel/uso terapêutico , Qualidade de Vida/psicologia , Topotecan/uso terapêutico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Imagem Corporal/psicologia , Carboplatina/efeitos adversos , Cisplatino/efeitos adversos , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Inquéritos e Questionários , Topotecan/efeitos adversos
8.
Clin Transl Oncol ; 9(5): 308-16, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17525041

RESUMO

National and international specialists have met with the aim of writing down the guidelines for the treatment of epithelial ovarian cancer (in the Spanish Castilian language). These guidelines are based on the International Consensus that was published in English in the Annals of Oncology in 2005. This condition is the leading cause of death from gynaecological cancer in western countries. Its low rate of survival, barely 30% at 5 years, is above all due to late diagnosis and inappropriate surgery, so emphasis is put on these aspects. After describing the methodology for early detection and a scheme of surgical diagnostic procedures in view of the staging of an ovarian mass, the following therapeutic strategies will be recommended: cytoreductive surgery together with platinum chemotherapy under normal conditions, and also in the case of relapse. Likewise, very recent models of treatment focused on molecular targets are presented, and a broad section on methodology of clinical assays. As for this, co-operation among groups is crucial in order to make the conclusions of these studies valid for the development of new therapies.


Assuntos
Neoplasias Ovarianas/terapia , Feminino , Humanos , Recidiva Local de Neoplasia
9.
Clin. transl. oncol. (Print) ; 9(5): 308-316, mayo 2007. ilus, tab
Artigo em Inglês | IBECS | ID: ibc-123311

RESUMO

National and international specialists have met with the aim of writing down the guidelines for the treatment of epithelial ovarian cancer (in the Spanish Castilian language). These guidelines are based on the International Consensus that was published in English in the Annals of Oncology in 2005. This condition is the leading cause of death from gynaecological cancer in western countries. Its low rate of survival, barely 30% at 5 years, is above all due to late diagnosis and inappropriate surgery, so emphasis is put on these aspects. After describing the methodology for early detection and a scheme of surgical diagnostic procedures in view of the staging of an ovarian mass, the following therapeutic strategies will be recommended: cytoreductive surgery together with platinum chemotherapy under normal conditions, and also in the case of relapse. Likewise, very recent models of treatment focused on molecular targets are presented, and a broad section on methodology of clinical assays. As for this, co-operation among groups is crucial in order to make the conclusions of these studies valid for the development of new therapies (AU)


Assuntos
Humanos , Feminino , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/terapia , Recidiva Local de Neoplasia/complicações , Sociedades Médicas/legislação & jurisprudência , Sociedades Médicas/normas , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/terapia
10.
Clin Transl Oncol ; 8(5): 375-8, 2006 May.
Artigo em Inglês | MEDLINE | ID: mdl-16760015

RESUMO

Cardiac metastases are more frequent than primary heart neoplasias. Nearly any malignant tumour may metastasize to the heart, but the most common are carcinomas rather than sarcomas. We report the case of a patient who presented with heart metastasis 6 years after resection of an uterine leiomyosarcoma. The patient died thirty months after surgical resection without evidence of cardiac recurrence. Although cardiac metastases from uterine leiomyosarcoma are exceptional, they should be suspected in the presence of suggestive symptoms, since they can be associated with long survival after surgical treatment.


Assuntos
Neoplasias Cardíacas/secundário , Leiomiossarcoma/secundário , Neoplasias Uterinas/patologia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia Combinada , Dacarbazina/administração & dosagem , Dacarbazina/análogos & derivados , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Erros de Diagnóstico , Docetaxel , Doxorrubicina/administração & dosagem , Evolução Fatal , Feminino , Neoplasias Cardíacas/cirurgia , Humanos , Histerectomia , Ifosfamida/administração & dosagem , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/secundário , Neoplasias Renais/cirurgia , Leiomioma/diagnóstico , Leiomiossarcoma/diagnóstico , Leiomiossarcoma/tratamento farmacológico , Leiomiossarcoma/cirurgia , Neoplasias Pulmonares/secundário , Neoplasias Pulmonares/cirurgia , Pessoa de Meia-Idade , Ovariectomia , Taxoides/administração & dosagem , Temozolomida , Cirurgia Torácica Vídeoassistida , Neoplasias Uterinas/diagnóstico , Neoplasias Uterinas/cirurgia , Gencitabina
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