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Regan M.M.,Dana-Farber Cancer Institute | Francis P.A.,University of Melbourne | Francis P.A.,University of Newcastle | Pagani O.,Institute of Oncology of Southern Switzerland | And 15 more authors.
Journal of Clinical Oncology | Year: 2016

Purpose Risk of recurrence is the primary consideration in breast cancer adjuvant therapy recommendations. The TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive breast cancer, testing exemestane plus ovarian function suppression (OFS), tamoxifen plus OFS, and tamoxifen alone. We examined absolute treatment effect across a continuum of recurrence risk to individualize endocrine therapy decision making for premenopausal women with human epidermal growth factor receptor 2 (HER2) -negative disease. Patients and Methods The TEXT and SOFT hormone receptor-positive, HER2-negative analysis population included 4,891 women. The endpoint wasbreast cancer-free interval (BCFI), defined as time from random assignment to first occurrence of invasive locoregional, distant, or contralateral breast cancer. A continuous, composite measure of recurrence risk for each patient was determined from a Cox model incorporating age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. Subpopulation treatment effect pattern plot methodology revealed differential treatment effects on 5-year BCFI according to composite risk. Results SOFT patients who remained premenopausal after chemotherapy experienced absolute improvement of 5% or more in 5-year BCFI with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone, reaching 10% to 15% at intermediate to high composite risk; the benefit of tamoxifen plus OFS versus tamoxifen alone was apparent at the highest composite risk. The SOFT no-chemotherapy cohort-for whom composite risk was lowest on average-did well with all endocrine therapies. For TEXT patients, the benefit of exemestane plus OFS versus tamoxifen plus OFS in 5-year BCFI ranged from 5% to 15%; patients not receiving chemotherapy and with lowest composite risk did well with both treatments. Conclusion Premenopausal women with hormone receptor-positive, HER2-negative disease and high recurrence risk, as defined by clinicopathologic characteristics, may experience improvement of 10% to 15% in 5-year BCFI with exemestane plus OFS versus tamoxifen alone. An improvement of at least 5% may be achieved for women at intermediate risk, and improvement is minimal for those at lowest risk. © 2016 by American Society of Clinical Oncology.


Walter L.,Columbia University | Vidaurre T.,Instituto Nacional Of Enfermedades Neoplasticas | Poquioma E.,Instituto Nacional Of Enfermedades Neoplasticas | Olaechea C.,Instituto Nacional Of Enfermedades Neoplasticas | Marks M.A.,U.S. National Cancer Institute
Head and Neck | Year: 2014

Background Few studies have evaluated the trends in head and neck cancer in developing countries. The purpose of this study was to estimate trends in incidence of human papillomavirus-related (HPV-R) and HPV-unrelated (HPV-U) head and neck cancer in Lima, Peru, from 1987 to 2008. Methods Registry data from a single public cancer hospital were used to estimate age and sex-specific incidence rates. Annualized percent change was estimated using Poisson regression. Results The rate of total head and neck cancers, HPV-U, and HPV-R was 11.9, 10.9, and 0.8, respectively, per 100,000 person-years. Significant increases in HPV-U head and neck cancer were observed in men aged 30 to 44 (2.5%/year) and women 15 to 29 (4.2%/year), 30 to 44 (3.4%/year), and 60 to 74 (2.0%/year). Significant increases in HPV-R head and neck cancer were observed only among men aged 45 to 59 (9.6%/year). Conclusion Although increased exposure to tobacco, occupational carcinogens, and changing sexual behaviors could be influencing these trends, additional analyses to assess generalizability of these findings to other regions of Peru are needed. Copyright © 2013 Wiley Periodicals, Inc.


Duenas-Gonzalez A.,National Autonomous University of Mexico | Duenas-Gonzalez A.,Medical Center | Duenas-Gonzalez A.,Eli Lilly and Company | Duenas-Gonzalez A.,Post Graduate Institute of Medical Education and Research | And 95 more authors.
Journal of Clinical Oncology | Year: 2011

Purpose: To determine whether addition of gemcitabine to concurrent cisplatin chemoradiotherapy and as adjuvant chemotherapy with cisplatin improves progression-free survival (PFS) at 3 years compared with current standard of care in locally advanced cervical cancer. Patients and Methods: Eligible chemotherapy- and radiotherapy-naive patients with stage IIB to IVA disease and Karnofsky performance score ≥ 70 were randomly assigned to arm A (cisplatin 40 mg/m2 and gemcitabine 125 mg/m2 weekly for 6 weeks with concurrent external-beam radiotherapy [XRT] 50.4 Gy in 28 fractions, followed by brachytherapy [BCT] 30 to 35 Gy in 96 hours, and then two adjuvant 21-day cycles of cisplatin, 50 mg/m2 on day 1, plus gemcitabine, 1,000 mg/m2 on days 1 and 8) or to arm B (cisplatin and concurrent XRT followed by BCT only; dosing same as for arm A). Results: Between May 2002 and March 2004, 515 patients were enrolled (arm A, n = 259; arm B, n = 256). PFS at 3 years was significantly improved in arm A versus arm B (74.4% v 65.0%, respectively; P = .029), as were overall PFS (log-rank P = .0227; hazard ratio [HR], 0.68; 95% CI, 0.49 to 0.95), overall survival (log-rank P = .0224; HR, 0.68; 95% CI, 0.49 to 0.95), and time to progressive disease (log-rank P = .0012; HR, 0.54; 95% CI, 0.37 to 0.79). Grade 3 and 4 toxicities were more frequent in arm A than in arm B (86.5% v 46.3%, respectively; P < .001), including two deaths possibly related to treatment toxicity in arm A. Conclusion: Gemcitabine plus cisplatin chemoradiotherapy followed by BCT and adjuvant gemcitabine/cisplatin chemotherapy improved survival outcomes with increased but clinically manageable toxicity when compared with standard treatment. © 2011 by American Society of Clinical Oncology.

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