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1.
Psychooncology ; 2020 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-32979294

RESUMO

OBJECTIVE: Assess the feasibility of conducting a cluster randomized controlled trial (RCT) comparing technology-delivered mindfulness-based intervention (MBI) programs against a waitlist control arm targeting advanced cancer patients and their informal caregivers. METHODS: Two-arm cluster RCT within Kaiser Permanente Northern California. We recruited patients with metastatic solid malignancies or hematological cancers and their informal caregivers. Intervention-group participants chose to use either a commercially available mindfulness app (10-20 min/day) or a webinar-based mindfulness course for 6 weeks. The waitlist control group received usual care. We assessed feasibility measures and obtained participant-reported data on quality of life (QoL; primary outcome) and distress outcomes (secondary) pre- and postintervention. RESULTS: A hundred and three patients (median age 67 years; 70% female; 81% White) and 39 caregivers (median age 66 years; 79% female; 69% White) were enrolled. Nearly all participants chose the mindfulness app over the webinar-based program. Among the participants in the intervention arm who chose the mobile-app program and completed the postintervention (6-week) survey, 21 (68%) patients and 7 (47%) caregivers practiced mindfulness at least 50% of the days during the 6-week study period. Seventy-four percent of intervention participants were "very" or "extremely" satisfied with the mindfulness program. We observed improvements in anxiety, QoL, and mindfulness among patients in the intervention arm compared to those in the control group. CONCLUSIONS: We demonstrated the feasibility of conducting a cluster RCT of mHealth MBI for advanced cancer patients and their caregivers. Such remote interventions can be helpful particularly during the COVID-19 pandemic.

3.
J Am Geriatr Soc ; 67(7): 1489-1494, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31059140

RESUMO

OBJECTIVES: To describe the composition of the US provider workforce for adults with cancer older than 65 years and to determine whether there were differences in patients who received care from different providers (eg, nurse practitioners [NPs], physician assistants [PAs], and specialty physicians). DESIGN: Observational, cross-sectional study. SETTING: Adults within the 2013 Surveillance, Epidemiology, and End Results cancer registries linked to the Medicare claims database. PARTICIPANTS: Medicare beneficiaries who received ambulatory care for any solid or hematologic malignancies. MEASUREMENTS: International Classification of Diseases, Ninth Revision (ICD-9), diagnosis codes were used to identify Medicare patient claims for malignancies in older adults. Providers for those ambulatory claims were identified using taxonomy codes associated with their National Provider Identifier number. RESULTS: A total of 2.5 million malignancy claims were identified for 201, 237 patients, with 15, 227 providers linked to claims. NPs comprised the largest group (31.5%; n = 4,806), followed by hematology/oncology physicians (27.7%; n = 4,222), PAs (24.7%; n = 3767), medical oncologists (10.9%; n = 661), gynecological oncologists (2.6%; n = 403), and hematologists (2.4%; n = 368). Rural cancer patients were more likely to receive care from NPs (odds ratio [OR] = 1.84; 95% confidence interval [CI] = 1.65-2.05) or PAs (OR = 1.57; 95% CI = 1.40-1.77) than from physicians. Patients in the South were more likely to receive care from NPs (OR = 1.36; 95% CI = 1.24-1.49). CONCLUSIONS: A large proportion of older adults with cancer receive care from NPs and PAs, particularly those who reside in rural settings and in the southern United States. Workforce strategies need to integrate these provider groups to effectively respond to the rising need for cancer care within the older adult population.


Assuntos
Neoplasias/enfermagem , Profissionais de Enfermagem/provisão & distribução , Assistentes Médicos/provisão & distribução , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Masculino , Medicare , Programa de SEER , Estados Unidos
4.
Integr Cancer Ther ; 18: 1534735419850634, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31092044

RESUMO

PURPOSE: To assess feasibility and preliminary efficacy of a mobile/online-based (mHealth) mindfulness intervention for cancer patients and their caregivers to reduce distress and improve quality of life (QoL). MATERIAL AND METHODS: Two-arm randomized controlled trial within Kaiser Permanente Northern California targeting cancer patients who received chemotherapy and their informal caregivers. The intervention group received a commercially available mindfulness program for 8 weeks. The wait-list control group received usual care. We assessed feasibility using retention and adherence rates and obtained participant-reported data on distress, QoL, sleep, mindfulness, and posttraumatic growth before and immediately after the intervention. RESULTS: Ninety-seven patients (median age 59 years; female 69%; 65% whites) and 31 caregivers (median age 63 years; female 58%; 77% whites) were randomized. Among randomized participants, 74% of the patients and 84% of the caregivers completed the study. Among those in the intervention arm who initiated the mindfulness program, 65% practiced at least 50% of the days during the intervention period. We observed significantly greater improvement in QoL among patients in the intervention arm compared with controls. Caregivers in the intervention group experienced increased mindfulness compared with controls. Participants appreciated the convenience of the intervention and the mindfulness skills they obtained from the program. CONCLUSION: We demonstrated the feasibility of conducting a randomized trial of an mHealth mindfulness intervention for cancer patients and their informal caregivers. Results from fully powered efficacy trials would inform the potential for clinicians to use this scalable intervention to help improve QoL of those affected by cancer and their caregivers.


Assuntos
Cuidadores/psicologia , Atenção Plena/métodos , Neoplasias/psicologia , Adaptação Psicológica/fisiologia , Assistência à Saúde/métodos , Estudos de Viabilidade , Feminino , Humanos , Masculino , Meditação/psicologia , Pessoa de Meia-Idade , Qualidade de Vida/psicologia , Estresse Psicológico/psicologia , Estresse Psicológico/terapia , Inquéritos e Questionários , Telemedicina/métodos , Resultado do Tratamento
6.
J Pain Symptom Manage ; 57(3): 587-595, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30508637

RESUMO

CONTEXT: Patients with cancer commonly experience depression. If not addressed, depression can lead to reduced quality of life and survival. OBJECTIVE: Given the introduction of national initiatives to improve management of psychiatric symptoms among patients with cancer, we examined patterns of depression detection and treatment over time, and with respect to patient characteristics. METHODS: This cross-sectional study linked data from the Pathways Study, a prospective cohort study of women diagnosed with breast cancer at Kaiser Permanente Northern California between 2005 and 2013, with data from Kaiser Permanente Northern California's electronic medical record. Pathways participants eligible for this analysis had no known prior depression but reported depressive symptoms at baseline. We used modified Poisson regression to assess the association of cancer diagnosis year and other patient characteristics with receipt of a documented clinician response to depressive symptoms (depression diagnosis, mental health referral, or antidepressant prescription). RESULTS: Of the 725 women in our sample, 34% received a clinician response to depression. We observed no statistically significant association of breast cancer diagnosis year with clinician response. Characteristics associated with clinician response included Asian race (adjusted risk ratio, Asian vs. white: 0.44, 95% CI: 0.29-0.68) and depression severity (adjusted risk ratio, mild-moderate vs. severe depression: 1.45, 95% CI: 1.11-1.88). CONCLUSION: Most patients in our sample did not receive a clinician response to their study-reported depression, and rates of response do not appear to have improved over time. Asian women, and those with less severe depression, appeared to be at increased risk of having unmet mental health care needs.


Assuntos
Neoplasias da Mama/complicações , Depressão/diagnóstico , Transtorno Depressivo/diagnóstico , Adulto , Idoso , Neoplasias da Mama/psicologia , Estudos Transversais , Prestação Integrada de Cuidados de Saúde , Depressão/complicações , Depressão/terapia , Transtorno Depressivo/complicações , Transtorno Depressivo/terapia , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida
7.
J Clin Oncol ; : JCO2018788620, 2018 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-30204536

RESUMO

Purpose The US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable patient reporting of symptomatic adverse events in oncology clinical research. This study was designed to assess the feasibility and resource requirements associated with implementing PRO-CTCAE in a multicenter trial. Methods Patients with locally advanced rectal cancer enrolled in the National Cancer Institute-sponsored North Central Cancer Treatment Group (Alliance) Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision trial were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, via either the Web or an automated telephone system. If participants did not self-report within 3 days, a central coordinator called them to complete the items. Compliance was defined as the proportion of participants who completed PRO-CTCAE assessments at expected time points. Results The prespecified PRO-CTCAE analysis was conducted after the 500th patient completed the 6-month follow-up (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), across 165 sites. PRO-CTCAE was reported by participants at 4,491 of 4,882 expected preoperative time points (92.0% compliance), of which 3,771 (77.2%) were self-reported by participants and 720 (14.7%) were collected via central coordinator backup. Compliance at 6-month post-treatment follow-up was 333 of 468 (71.2%), with 122 (26.1%) via backup. Site research associates spent a median of 15 minutes on PRO-CTCAE work for each patient visit. Work by a central coordinator required a 50% time commitment. Conclusion Home-based reporting of PRO-CTCAE in a multicenter trial is feasible, with high patient compliance and low site administrative requirements. PRO-CTCAE data capture is improved through centralized backup calls.

8.
Breast Cancer Res Treat ; 170(3): 593-603, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29623576

RESUMO

PURPOSE: Racial/ethnic differences in cancer symptom burden are well documented, but limited research has evaluated modifiable factors underlying these differences. Our objective was to examine the role of patient-provider interactions to help explain the relationship between race/ethnicity and cancer-specific physical well-being (PWB) among women with breast cancer. METHODS: The Pathways Study is a prospective cohort study of 4505 women diagnosed with breast cancer at Kaiser Permanente Northern California between 2006 and 2013. Our analysis included white, black, Hispanic, and Asian participants who completed baseline assessments of PWB, measured using the Functional Assessment of Cancer Therapy for Breast Cancer, and patient-provider interactions, measured by the Interpersonal Processes of Care Survey (IPC) (N = 4002). Using step-wise linear regression, we examined associations of race/ethnicity with PWB, and changes in associations when IPC domains were added. RESULTS: We observed racial/ethnic differences in PWB, with minorities reporting lower scores than whites (beta, black: - 1.79; beta, Hispanic: - 1.92; beta, Asian: - 1.68; p < 0.0001 for all comparisons). With the addition of health and demographic covariates to the model, associations between race/ethnicity and PWB score became attenuated for blacks and Asians (beta: - 0.63, p = 0.06; beta: - 0.68, p = 0.02, respectively) and, to a lesser extent, for Hispanic women (beta: - 1.06, p = 0.0003). Adjusting for IPC domains did not affect Hispanic-white differences (beta: - 1.08, p = 0.0002), and slightly attenuated black-white differences (beta: - 0.51, p = 0.14). Asian-white differences narrowed substantially (beta: - 0.31, p = 0.28). CONCLUSIONS: IPC domains, including those capturing perceived discrimination, respect, and clarity of communication, appeared to partly explain PWB differences for black and Asian women. Results highlight opportunities to improve providers' interactions with minority patients, and communication with minority patients about their supportive care needs.


Assuntos
Neoplasias da Mama/epidemiologia , Grupos de Populações Continentais , Grupos Étnicos , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/etnologia , Neoplasias da Mama/terapia , Assistência à Saúde , Gerenciamento Clínico , Feminino , Pessoal de Saúde , Humanos , Pessoa de Meia-Idade , Pacientes , Relações Médico-Paciente , Vigilância em Saúde Pública , Qualidade da Assistência à Saúde
10.
Cancer Chemother Pharmacol ; 80(6): 1161-1169, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29043412

RESUMO

PURPOSE: Etirinotecan pegol (EP) is a long-acting topoisomerase-I inhibitor designed to provide sustained exposure to SN-38 (active metabolite of irinotecan). This phase II study compared EP versus irinotecan as second-line treatment for KRAS-mutant, irinotecan-naïve, metastatic colorectal cancer (mCRC). METHODS: Patients were randomized to EP 145 mg/m2 or irinotecan 350 mg/m2 Q21d until disease progression/unacceptable toxicity. The primary endpoint was progression-free survival (PFS) with response determined by central radiologic review (RECIST version 1.1). RESULTS: The study was terminated before completing accrual due to evolving standards of care. Eighty-three patients were randomized. Median PFS was longer with EP versus irinotecan (4.0 versus 2.8 months, respectively; HR 0.65; 95% CI 0.40-1.04; P = 0.07). Six-month PFS rates were 32.8 and 15.4%, respectively. Median OS was 9.6 and 8.4 months in EP and irinotecan arms, respectively (HR 0.91; 95% CI 0.56-1.49). ORRs were 10 and 5%, respectively (P = 0.676); median DOR was significantly longer in EP arm (7.9 versus 1.4 months; P = 0.018). The most common grade-3/4 adverse events for EP and irinotecan were diarrhea (21 vs 20%), neutropenia (10 vs 22%), abdominal pain (14 vs 5%), nausea (14 vs 2%), and vomiting (12 vs 7%), respectively. CONCLUSION: EP is active and safe for second-line treatment of KRAS-mutant, irinotecan-naïve mCRC.


Assuntos
Antineoplásicos/uso terapêutico , Camptotecina/análogos & derivados , Neoplasias Colorretais/tratamento farmacológico , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Polietilenoglicóis/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Camptotecina/uso terapêutico , Neoplasias Colorretais/patologia , Intervalo Livre de Doença , Feminino , Humanos , Irinotecano , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica
11.
J Clin Oncol ; 35(31): 3538-3546, 2017 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-28862883

RESUMO

Purpose To evaluate the impact of the addition of bortezomib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on outcomes in previously untreated patients with non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). Patients and Methods After real-time determination of non-GCB DLBCL using the Hans immunohistochemistry algorithm, 206 patients were randomly assigned (1:1; stratified by International Prognostic Index [IPI] score) to six 21-day cycles of standard R-CHOP alone or R-CHOP plus bortezomib 1.3 mg/m2 intravenously on days 1 and 4 (VR-CHOP). The primary end point, progression-free survival (PFS), was evaluated in 183 patients with centrally confirmed non-GCB DLBCL who received one or more doses of study drug (91 R-CHOP, 92 VR-CHOP). Results After a median follow-up of 34 months, with 25% (R-CHOP) and 18% (VR-CHOP) of patients having had PFS events, the hazard ratio (HR) for PFS was 0.73 (90% CI, 0.43 to 1.24) with VR-CHOP ( P = .611). Two-year PFS rates were 77.6% with R-CHOP and 82.0% with VR-CHOP; they were 65.1% versus 72.4% in patients with high-intermediate/high IPI (HR, 0.67; 90% CI, 0.34 to 1.29), and 90.0% versus 88.9% (HR, 0.85; 90% CI, 0.35 to 2.10) in patients with low/low-intermediate IPI. Overall response rate with R-CHOP and VR-CHOP was 98% and 96%, respectively. The overall survival HR was 0.75 (90% CI, 0.38 to 1.45); 2-year survival rates were 88.4% and 93.0%, respectively. In the safety population (100 R-CHOP and 101 VR-CHOP patients), grade ≥ 3 adverse events included neutropenia (53% v 49%), thrombocytopenia (13% v 29%), anemia (7% v 15%), leukopenia (26% v 25%), and neuropathy (1% v 5%). Conclusion Outcomes for newly diagnosed, prospectively enrolled patients with non-GCB DLBCL were more favorable than expected with R-CHOP and were not significantly improved by adding bortezomib.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Murinos/administração & dosagem , Anticorpos Monoclonais Murinos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bortezomib/administração & dosagem , Bortezomib/efeitos adversos , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Intervalo Livre de Doença , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Feminino , Humanos , Linfoma Difuso de Grandes Células B/diagnóstico por imagem , Linfoma Difuso de Grandes Células B/patologia , Masculino , Pessoa de Meia-Idade , Prednisona/administração & dosagem , Prednisona/efeitos adversos , Rituximab , Vincristina/administração & dosagem , Vincristina/efeitos adversos , Adulto Jovem
12.
J Oncol Pract ; 9(6): e275-83, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24151327

RESUMO

PURPOSE: Oncology clinical trials (OCTs) are crucial in evaluating new cancer treatments, but only 2% to 3% of US adult patients with cancer enter OCTs. This study assessed barriers to participation in clinical trials among oncologists in a large integrated health care delivery system with an active clinical trials program. Although many studies have identified major physician barriers to enrollment, few have examined how these barriers affect actual trial accrual. METHODS: Using information from a mailed survey, we examined the effect of oncologists' attitudes, beliefs, experiences, sociodemographic factors, and practice characteristics on clinical trial accrual in the 2 years following the survey. We identified relationships between these variables and subsequent clinical trial accrual using correlations and mixed effects models. RESULTS: A construct combining questions that assessed oncologist attitudes, beliefs, and experiences substantially influenced OCT enrollment (r = .51; P < .0001). This construct included awareness of open clinical trials and specific eligible patients, as well as the practice of initiating a discussion about OCTs with most eligible patients. This broad concept of awareness had the greatest correlation with enrollment and mediated the effect on enrollment of other values and beliefs, such as welcoming a patient's initiation of a trial discussion and valuing the support of research nurses and coordinators. CONCLUSION: Even in a health care setting with an active clinical trials program, substantial research personnel, infrastructure support, and widespread access to trials among oncologists and patients, oncologists' participation remains quite variable. Oncologist values, beliefs, and awareness of clinical trials play an important role in OCT accrual.


Assuntos
Atitude do Pessoal de Saúde , Ensaios Clínicos como Assunto/estatística & dados numéricos , Oncologia , Seleção de Pacientes , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Estudos Prospectivos , Inquéritos e Questionários
13.
Cancer Med ; 2(6): 881-8, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24403261

RESUMO

Recent discoveries promise increasingly to help oncologists individually tailor anticancer therapy to their patients' molecular tumor characteristics. One such promising molecular diagnostic is Kirsten ras (KRAS) tumor mutation testing for metastatic colorectal cancer (mCRC) patients. In the current study, we examined how and why physicians adopt KRAS testing and how they subsequently utilize the information when discussing treatment strategies with patients. We conducted 34 semi-structured in-person or telephone interviews with oncologists from seven different health plans. Each interview was audiotaped, transcribed, and coded using qualitative research methods. Information and salient themes relating to the research questions were summarized for each interview. All of the oncologists in this study reported using the KRAS test at the time of the interview. Most appeared to have adopted the test rapidly, within 6 months of the publication of National Clinical Guidelines. Oncologists chose to administer the test at various time points, although the majority ordered the test at the time their patient was diagnosed with mCRC. While oncologists expressed a range of opinions about the KRAS test, there was a general consensus that the test was useful and provided benefits to mCRC patients. The rapid adoption and enthusiasm for KRAS suggests that these types of tests may be filling an important informational need for oncologists when making treatment decisions. Future research should focus on the informational needs of patients around this test and whether patients feel informed or confident with their physicians' use of these tests to determine treatment access.


Assuntos
Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/genética , Proteínas Proto-Oncogênicas/genética , Proteínas ras/genética , Atitude do Pessoal de Saúde , Comunicação , Tomada de Decisões , Feminino , Testes Genéticos , Humanos , Masculino , Oncologia , Mutação , Relações Médico-Paciente , Médicos , Medicina de Precisão , Proteínas Proto-Oncogênicas p21(ras)
14.
Breast Cancer Res Treat ; 137(1): 247-60, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23139057

RESUMO

Chemotherapy regimens for early stage breast cancer have been tested by randomized clinical trials, and specified by evidence-based practice guidelines. However, little is known about the translation of trial results and guidelines to clinical practice. We extracted individual-level data on chemotherapy administration from the electronic medical records of Kaiser Permanente Northern California (KPNC), a pre-paid integrated healthcare system serving 29 % of the local population. We linked data to the California Cancer Registry, incorporating socio-demographic and tumor factors, and performed multivariable logistic regression analyses on the receipt of specific chemotherapy regimens. We identified 6,004 women diagnosed with Stage I-III breast cancer at KPNC during 2004-2007; 2,669 (44.5 %) received at least one chemotherapy infusion at KPNC within 12 months of diagnosis. Factors associated with receiving chemotherapy included <50 years of age [odds ratio (OR) 2.27, 95 % confidence interval (CI) 1.81-2.86], tumor >2 cm (OR 2.14, 95 % CI 1.75-2.61), involved lymph nodes (OR 11.3, 95 % CI 9.29-13.6), hormone receptor-negative (OR 6.94, 95 % CI 4.89-9.86), Her2/neu-positive (OR 2.71, 95 % CI 2.10-3.51), or high grade (OR 3.53, 95 % CI 2.77-4.49) tumors; comorbidities associated inversely with chemotherapy use [heart disease for anthracyclines (OR 0.24, 95 % CI 0.14-0.41), neuropathy for taxanes (OR 0.45, 95 % CI 0.22-0.89)]. Relative to high-socioeconomic status (SES) non-Hispanic Whites, we observed less anthracycline and taxane use by SES non-Hispanic Whites (OR 0.63, 95 % CI 0.49-0.82) and American Indians (OR 0.23, 95 % CI 0.06-0.93), and more anthracycline use by high-SES Asians/Pacific Islanders (OR 1.72, 95 % CI 1.02-2.90). In this equal-access healthcare system, chemotherapy use followed practice guidelines, but varied by race and socio-demographic factors. These findings may inform efforts to optimize quality in breast cancer care.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Lobular/tratamento farmacológico , Adulto , Idoso , Antraciclinas/uso terapêutico , Antineoplásicos/uso terapêutico , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , California/epidemiologia , Carcinoma Ductal de Mama/epidemiologia , Carcinoma Ductal de Mama/secundário , Carcinoma Lobular/epidemiologia , Carcinoma Lobular/secundário , Quimioterapia Adjuvante/estatística & dados numéricos , Registros Eletrônicos de Saúde , Feminino , Pessoal de Saúde , Humanos , Modelos Logísticos , Metástase Linfática , Pessoa de Meia-Idade , Análise Multivariada , Guias de Prática Clínica como Assunto , Taxoides/uso terapêutico , Carga Tumoral
15.
J Clin Oncol ; 29(2): 142-8, 2011 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-21135282

RESUMO

PURPOSE: This open-label, prospective, multicenter single-arm phase II study combined bevacizumab (BV) with radiation therapy (RT) and temozolomide (TMZ) for the treatment of newly diagnosed glioblastoma (GBM). The objectives were to determine the efficacy of this treatment combination and the associated toxicity. PATIENTS AND METHODS: Seventy patients with newly diagnosed GBM were enrolled between August 2006 and November 2008. Patients received standard RT starting within 3 to 6 weeks after surgery with concurrent administration of daily TMZ and biweekly BV. After completion of RT, patients resumed TMZ for 5 days every 4 weeks and continued biweekly BV. MGMT promoter methylation was assessed on patient tumor tissue. A University of California, Los Angeles/Kaiser Permanente Los Angeles (KPLA) control cohort of newly diagnosed patients treated with first-line RT and TMZ who had mostly received BV at recurrence was derived for comparison. RESULTS: The overall survival (OS) and progression-free survival (PFS) were 19.6 and 13.6 months, respectively, compared to 21.1 and 7.6 months in the University of California, Los Angeles/KPLA control cohort, and 14.6 and 6.9 months in the European Organisation for Research and Treatment of Cancer-National Cancer Institute of Canada cohort. Correlation of MGMT promoter methylation and improved OS and PFS was retained in the study group. Comparative subset analysis showed that poor prognosis patients (recursive partitioning analysis class V/VI) may derive an early benefit from the use of first-line BV. Toxicity attributable to RT/TMZ was similar, and additional toxicities were consistent with those reported in other BV trials. CONCLUSION: Patients treated with BV and TMZ during and after RT showed improved PFS without improved OS compared to the University of California, Los Angeles/KPLA control group. Additional studies are warranted to determine if BV administered first-line improves survival compared to BV at recurrence.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Encefálicas/tratamento farmacológico , Neoplasias Encefálicas/radioterapia , Glioblastoma/tratamento farmacológico , Glioblastoma/radioterapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados , Antineoplásicos Alquilantes/administração & dosagem , Antineoplásicos Alquilantes/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bevacizumab , Neoplasias Encefálicas/irrigação sanguínea , Terapia Combinada , Dacarbazina/administração & dosagem , Dacarbazina/efeitos adversos , Dacarbazina/análogos & derivados , Feminino , Glioblastoma/irrigação sanguínea , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Temozolomida
16.
J Thorac Oncol ; 4(11): 1389-96, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19701107

RESUMO

INTRODUCTION: We aimed to evaluate the safety and efficacy of canfosfamide in combination with carboplatin and paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer. METHODS: This was a phase 1-2a, multicenter, dose-ranging trial that enrolled patients with stage IIIB or IV non-small cell lung cancer with measurable disease. Patients received canfosfamide in doses ranging from 400 to 1000 mg/m2 intravenously (IV) with carboplatin at area under the curve 6 IV and paclitaxel at 200 mg/m2 IV day 1 every 3 weeks. The primary end point was objective response rate, and the secondary endpoints were safety and progression-free survival. RESULTS: One hundred twenty-nine patients were treated with canfosfamide at dose levels of 400 (n = 3), 500 (n = 51), 750 (n = 54), and 1000 mg/m2 (n = 21). Objective tumor responses by RECIST were observed in 40 patients [34% (95% confidence interval [CI], 26-44)], the median progression-free survival was 4.3 months (95% CI, 3.7-5.2) and the median survival 9.9 months (95% CI, 7.7-11.9). The percent of patients alive at 1 year was 43.1%. The overall safety profile of the combination was acceptable and consistent with the profiles of the individual agents. In an exploratory analysis, patients receiving the optional maintenance canfosfamide therapy had a prolonged median survival of 16.8 months compared with those eligible for but not receiving maintenance therapy at 8.8 months (hazard ratio = 0.38, p < 0.001). CONCLUSIONS: The combination of canfosfamide with carboplatin and paclitaxel chemotherapy is well tolerated and active. Maintenance canfosfamide may further improve outcomes. This regimen is worthy of additional study.


Assuntos
Antineoplásicos/administração & dosagem , Carboplatina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Glutationa/análogos & derivados , Neoplasias Pulmonares/tratamento farmacológico , Paclitaxel/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/patologia , Citotoxinas , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Seguimentos , Glutationa/administração & dosagem , Humanos , Injeções Intravenosas , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Resultado do Tratamento
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