Carlos Vallejos
Research Subjects
Carlos Vallejos has a total of 457 co-authors. Here are the top co-authors by number of shared publications:
- Henry Leonidas Gomez
Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru
12 shared publications - Joseph Arturo Pinto
Centro de Investigación Básicas y traslacional, Auna Ideas, Lima, Peru
8 shared publications Alfredo Aguilar
Departamento de Medicina Oncológica, Oncosalud-AUNA, Lima 15036, Perú
3 shared publicationsE. J. Freireich
Department of Developmental Therapeutics, the University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston, Texas
3 shared publicationsGerald P. Bodey
University of Texas at Houston, M. D. Anderson Hospital and Tumor Institute, Houston, TX
3 shared publications- Gilberto Schwartsmann
Department of Internal Medicine, Faculty of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, Brazil
3 shared publications
Latest Publications
- Open Access
- 30 October 2022
- Published by Sociedad Peruana de Oncología Médica del Perú in ONKORESEARCH
- Vol. 1 (1) , 5-13
Características clínicas y desenlace en pacientes oncológicos afectados por el COVID- : estudio de un centro oncológico en el Perú
Objective: To describe the clinical features and outcomes of COVID-19 infection in cancer patients and evaluate the risk factors associated with severe disease. Materials and methods: An observational retrospective study was performed in Oncosalud-AUNA. We included patients with diagnosis of invasive cancer with a SARS-CoV-2 confirmed infection by RT-PCR assay. Univariate and multivariate binary logistic regression analysis were performed to evaluate the risk factors associated with severe desease. Results: A total of 36 patients were included. Median age was 61 years old; 36.1% males; 58.4% with ≥1 comorbidity. Breast cancer was the most frequent malignancy. 72% of patients were on anticáncer treatment. All patients were symptomatic. 16.7% were admitted to the ICU and 27.8% of patients died. The severity of disease was: mild, 27.8%; moderate, 33.3%; severe, 22.2%; and critical – ARDS, 16.7%. Patients with severe or critical disease were frequently ˃60 years old, male, in ECOG 2-3 and were receiving treatment with palliative intention. Conclusions: COVID-19 cancer patients were frequently overweight older adults with at least one comorbidity with active treatment and developed typical COVID-19 symptoms. Severe or critical COVID-19 occurred in more than one third of patients. Male patients and those ˃60 years old were at greater risk of developing severe or critical COVID-19.
- 30 October 2022
- Published by Sociedad Peruana de Oncología Médica del Perú in ONKORESEARCH
- Vol. 1 (1) , 5-13
Open AccessCaracterísticas clínicas y desenlace en pacientes oncológicos afectados por el COVID- : estudio de un centro oncológico en el Perú
Objective: To describe the clinical features and outcomes of COVID-19 infection in cancer patients and evaluate the risk factors associated with severe disease. Materials and methods: An observational retrospective study was performed in Oncosalud-AUNA. We included patients with diagnosis of invasive cancer with a SARS-CoV-2 confirmed infection by RT-PCR assay. Univariate and multivariate binary logistic regression analysis were performed to evaluate the risk factors associated with severe desease. Results: A total of 36 patients were included. Median age was 61 years old; 36.1% males; 58.4% with ≥1 comorbidity. Breast cancer was the most frequent malignancy. 72% of patients were on anticáncer treatment. All patients were symptomatic. 16.7% were admitted to the ICU and 27.8% of patients died. The severity of disease was: mild, 27.8%; moderate, 33.3%; severe, 22.2%; and critical – ARDS, 16.7%. Patients with severe or critical disease were frequently ˃60 years old, male, in ECOG 2-3 and were receiving treatment with palliative intention. Conclusions: COVID-19 cancer patients were frequently overweight older adults with at least one comorbidity with active treatment and developed typical COVID-19 symptoms. Severe or critical COVID-19 occurred in more than one third of patients. Male patients and those ˃60 years old were at greater risk of developing severe or critical COVID-19.
- Open Access
- 10 November 2020
- Published by Fundacion Instituto Hipolito Unanue in Diagnóstico
- Vol. 59 (2) , 77-85
Situación del Cáncer en el Perú
El cáncer es uno de los problemas de salud pública en muchos países o regiones del mundo. La incidencia, mortalidad y la prevalencia del cáncer, permiten cuantificar la magnitud de esta patología y orientan las políticas públicas en relación a la prevención y los servicios de salud. El elevado costo económico y social que representa la atención de estos pacientes, hace que la prevalencia, forma de evolución y pronóstico difieran de un país a otro. En el Perú, el cáncer representa la primera causa de muerte. Para el año 2018, según Globocan, se diagnosticaron más de 66 mil nuevos casos y se registraron más de 33 mil muertes por cáncer. Las tres patologías más frecuentes en las mujeres fueron cáncer de mama (19%), cérvix (11%) y cáncer de estómago (7%), en los hombres cáncer de próstata (25%), estómago (10%) y colorrectal (7%); y las principales causas de muerte fueron por cáncer de estómago (13.9%), pulmón (8.6%) y próstata (8.2%). La tasa de incidencia fue de 192.6 y la tasa de mortalidad de 92.9 por 100,000 personas, respectivamente; según la localización del tumor, la tasa de incidencia de cáncer de próstata fue de 47.8, mama 40.0, cérvix 23.2 y de estómago 16.1, y la tasa de mortalidad por cáncer de próstata fue de 15.6, estómago 12.8, mama 10.3 y de cérvix 10.2 por 100,000, respectivamente. La prevalencia estimada a un año fue de 42,849 casos, a tres años 104,007 y a 5 años 150,132 casos; las patologías más prevalentes en los hombres fueron cáncer de próstata, colorrectal y LNH, en las mujeres fueron cáncer de mama, cérvix y tiroides. La razón de mortalidad e incidencia, que permiten cuantificar la letalidad de la enfermedad en nuestro medio, siguen siendo altas en neoplasias como cáncer de hígado, páncreas, estómago y pulmón. La tasa de incidencia y mortalidad por cáncer siguen incrementándose en nuestra población en relación al reporte del período 2012; es posible que estos incrementos sean una consecuencia de los cambios de la estructura de edad de la población, adopción de estilos de vida sedentaria, dieta no saludable y entre otros factores.
- 10 November 2020
- Published by Fundacion Instituto Hipolito Unanue in Diagnóstico
- Vol. 59 (2) , 77-85
Open AccessSituación del Cáncer en el Perú
El cáncer es uno de los problemas de salud pública en muchos países o regiones del mundo. La incidencia, mortalidad y la prevalencia del cáncer, permiten cuantificar la magnitud de esta patología y orientan las políticas públicas en relación a la prevención y los servicios de salud. El elevado costo económico y social que representa la atención de estos pacientes, hace que la prevalencia, forma de evolución y pronóstico difieran de un país a otro. En el Perú, el cáncer representa la primera causa de muerte. Para el año 2018, según Globocan, se diagnosticaron más de 66 mil nuevos casos y se registraron más de 33 mil muertes por cáncer. Las tres patologías más frecuentes en las mujeres fueron cáncer de mama (19%), cérvix (11%) y cáncer de estómago (7%), en los hombres cáncer de próstata (25%), estómago (10%) y colorrectal (7%); y las principales causas de muerte fueron por cáncer de estómago (13.9%), pulmón (8.6%) y próstata (8.2%). La tasa de incidencia fue de 192.6 y la tasa de mortalidad de 92.9 por 100,000 personas, respectivamente; según la localización del tumor, la tasa de incidencia de cáncer de próstata fue de 47.8, mama 40.0, cérvix 23.2 y de estómago 16.1, y la tasa de mortalidad por cáncer de próstata fue de 15.6, estómago 12.8, mama 10.3 y de cérvix 10.2 por 100,000, respectivamente. La prevalencia estimada a un año fue de 42,849 casos, a tres años 104,007 y a 5 años 150,132 casos; las patologías más prevalentes en los hombres fueron cáncer de próstata, colorrectal y LNH, en las mujeres fueron cáncer de mama, cérvix y tiroides. La razón de mortalidad e incidencia, que permiten cuantificar la letalidad de la enfermedad en nuestro medio, siguen siendo altas en neoplasias como cáncer de hígado, páncreas, estómago y pulmón. La tasa de incidencia y mortalidad por cáncer siguen incrementándose en nuestra población en relación al reporte del período 2012; es posible que estos incrementos sean una consecuencia de los cambios de la estructura de edad de la población, adopción de estilos de vida sedentaria, dieta no saludable y entre otros factores.
- Open Access
- 22 January 2019
- Published by Ecancer Global Foundation in ecancermedicalscience
- Vol. 13, 897
Barriers in Latin America for the management of locally advanced breast cancer
Ecancermedicalscience is the peer-reviewed open access cancer journal founded by the European Institute of Oncology in Milan. We consider articles on all aspects of research relating to cancer, including molecular biology, genetics, pathophysiology, epide
- 22 January 2019
- Published by Ecancer Global Foundation in ecancermedicalscience
- Vol. 13, 897
Open AccessBarriers in Latin America for the management of locally advanced breast cancer
Ecancermedicalscience is the peer-reviewed open access cancer journal founded by the European Institute of Oncology in Milan. We consider articles on all aspects of research relating to cancer, including molecular biology, genetics, pathophysiology, epide
- 1 January 2017
- Published by Elsevier in Clinical Lung Cancer
- Vol. 18 (1) , e71-e79
Challenges in Facing the Lung Cancer Epidemic and Treating Advanced Disease in Latin America
- 1 January 2017
- Published by Elsevier in Clinical Lung Cancer
- Vol. 18 (1) , e71-e79
Challenges in Facing the Lung Cancer Epidemic and Treating Advanced Disease in Latin America
- 1 October 2016
- Published by Elsevier in The Lancet Infectious Diseases
- Vol. 16 (10) , 1154-1168
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study
- 1 October 2016
- Published by Elsevier in The Lancet Infectious Diseases
- Vol. 16 (10) , 1154-1168
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study
- Open Access
- 10 June 2016
- Published by Spandidos Publications in Molecular and Clinical Oncology
- Vol. 5 (2) , 241-245
Control of cervical cancer in Peru: Current barriers and challenges for the future
Cervical cancer is the leading malignant neoplasm in Peruvian women. This malignancy is a public health problem and several efforts were previously performed to develop cancer control plans. Geographical, cultural, structural, infrastructural and procedural barriers can limit the implementation of such strategies. Several previous studies have characterized human papilloma virus (HPV) epidemiology, where prevalence of high‑risk HPV in adult females is ~12% and the prevalence in cervical cancer is 90‑95%. The predominant barriers for the control of cervical cancer are lack of specialists in remote villages, education/cultural issues, loss of patients in follow‑up, lack of access to HPV testing and lack of compliance for HPV vaccination. A good strategy for the prevention and early detection of high‑risk HPV, pre‑malignant neoplasms and cervical cancer, identified by interventional studies, is the self‑sampling test, which assists with overcoming the cultural and geographic barriers. The current cancer control plan, termed ‘Plan Esperanza’, is performed with massive training of health professionals and social sensitization campaigns leading to filling the gaps regarding education and, in addition, it provides cancer care coverage for poorer individuals. In our experience at Oncosalud‑AUNA, with a cohort of ~750,000 affiliates using a pre‑paid system with annual screenings for cervical cancer for women, offered free-of-charge, a lower incidence of this malignancy (5.8/100,000) is now observed compared with the national incidence (32.7/100,000). As in other countries, the HPV vaccination can be a cost‑utility strategy to reduce the high burdens of cervical cancer in Peru, a rapid and cheap HPV molecular sub-typification is rapidly required.
- 10 June 2016
- Published by Spandidos Publications in Molecular and Clinical Oncology
- Vol. 5 (2) , 241-245
Open AccessControl of cervical cancer in Peru: Current barriers and challenges for the future
Cervical cancer is the leading malignant neoplasm in Peruvian women. This malignancy is a public health problem and several efforts were previously performed to develop cancer control plans. Geographical, cultural, structural, infrastructural and procedural barriers can limit the implementation of such strategies. Several previous studies have characterized human papilloma virus (HPV) epidemiology, where prevalence of high‑risk HPV in adult females is ~12% and the prevalence in cervical cancer is 90‑95%. The predominant barriers for the control of cervical cancer are lack of specialists in remote villages, education/cultural issues, loss of patients in follow‑up, lack of access to HPV testing and lack of compliance for HPV vaccination. A good strategy for the prevention and early detection of high‑risk HPV, pre‑malignant neoplasms and cervical cancer, identified by interventional studies, is the self‑sampling test, which assists with overcoming the cultural and geographic barriers. The current cancer control plan, termed ‘Plan Esperanza’, is performed with massive training of health professionals and social sensitization campaigns leading to filling the gaps regarding education and, in addition, it provides cancer care coverage for poorer individuals. In our experience at Oncosalud‑AUNA, with a cohort of ~750,000 affiliates using a pre‑paid system with annual screenings for cervical cancer for women, offered free-of-charge, a lower incidence of this malignancy (5.8/100,000) is now observed compared with the national incidence (32.7/100,000). As in other countries, the HPV vaccination can be a cost‑utility strategy to reduce the high burdens of cervical cancer in Peru, a rapid and cheap HPV molecular sub-typification is rapidly required.
- Open Access
- 6 March 2016
- Published by Impact Journals, LLC in Oncotarget
- Vol. 7 (15) , 20282-20292
Repeated observation of immune gene sets enrichment in women with non-small cell lung cancer
Repeated observation of immune gene sets enrichment in women with non-small cell lung cancer
- 6 March 2016
- Published by Impact Journals, LLC in Oncotarget
- Vol. 7 (15) , 20282-20292
Open AccessRepeated observation of immune gene sets enrichment in women with non-small cell lung cancer
Repeated observation of immune gene sets enrichment in women with non-small cell lung cancer
- Open Access
- 19 December 2015
- Published by Wiley in International Journal of Cancer
- Vol. 138 (10) , 2428-2438
Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study
The control arm of the phase III VIVIANE (Human PapillomaVIrus: Vaccine Immunogenicity ANd Efficacy; NCT00294047) study in women >25 years was studied to assess risk of progression from cervical HPV infection to detectable cervical intraepithelial neoplasia (CIN). The risk of detecting CIN associated with the same HPV type as the reference infection was analysed using Kaplan–Meier and multivariable Cox models. Infections were categorised depending upon persistence as 6‐month persistent infection (6MPI) or infection of any duration. The 4‐year interim analysis included 2,838 women, of whom 1,073 (37.8%) experienced 2,615 infections of any duration and 708 (24.9%) experienced 1,130 6MPIs. Infection with oncogenic HPV types significantly increased the risk of detecting CIN grade 2 or greater (CIN2+) versus non‐oncogenic types. For 6MPI, the highest risk was associated with HPV‐33 (hazard ratio [HR]: 31.9 [8.3–122.2, p < 0.0001]). The next highest risk was with HPV‐16 (21.1 [6.3–70.0], p < 0.0001). Similar findings were seen for infections of any duration. Significant risk was also observed for HPV‐18, HPV‐31, and HPV‐45. Concomitant HPV infection or CIN grade 1 or greater associated with a different oncogenic HPV type increased risk. Most women (79.3%) with an HPV infection at baseline cleared detectable infections of any duration, and 69.9% cleared a 6MPI. The risk of progression of HPV infection to CIN2+ in women >25 years in this study was similar to that in women 15–25 years in PATRICIA.
- 19 December 2015
- Published by Wiley in International Journal of Cancer
- Vol. 138 (10) , 2428-2438
Open AccessProgression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study
The control arm of the phase III VIVIANE (Human PapillomaVIrus: Vaccine Immunogenicity ANd Efficacy; NCT00294047) study in women >25 years was studied to assess risk of progression from cervical HPV infection to detectable cervical intraepithelial neoplasia (CIN). The risk of detecting CIN associated with the same HPV type as the reference infection was analysed using Kaplan–Meier and multivariable Cox models. Infections were categorised depending upon persistence as 6‐month persistent infection (6MPI) or infection of any duration. The 4‐year interim analysis included 2,838 women, of whom 1,073 (37.8%) experienced 2,615 infections of any duration and 708 (24.9%) experienced 1,130 6MPIs. Infection with oncogenic HPV types significantly increased the risk of detecting CIN grade 2 or greater (CIN2+) versus non‐oncogenic types. For 6MPI, the highest risk was associated with HPV‐33 (hazard ratio [HR]: 31.9 [8.3–122.2, p < 0.0001]). The next highest risk was with HPV‐16 (21.1 [6.3–70.0], p < 0.0001). Similar findings were seen for infections of any duration. Significant risk was also observed for HPV‐18, HPV‐31, and HPV‐45. Concomitant HPV infection or CIN grade 1 or greater associated with a different oncogenic HPV type increased risk. Most women (79.3%) with an HPV infection at baseline cleared detectable infections of any duration, and 69.9% cleared a 6MPI. The risk of progression of HPV infection to CIN2+ in women >25 years in this study was similar to that in women 15–25 years in PATRICIA.
- Open Access
- 1 June 2015
- Published by Wolters Kluwer Health in Obstetrical & Gynecological Survey
- Vol. 70 (6) , 392-393
Goserelin for Ovarian Protection During Breast-Cancer Adjuvant Chemotherapy
Premature ovarian failure is a devastating long-term toxic effect of chemotherapy for premenopausal women. The survival benefit of adjuvant chemotherapy in young women with operable hormone receptor–negative breast cancer is well known, but concern over becoming infertile may influence the choice of treatment for many women. A number of trials have investigated the combined use of a gonadotropin-releasing hormone (GnRH) agonist and adjuvant chemotherapy in an attempt to protect ovarian function in premenopausal women. Results of such studies were mixed, and there were few data on pregnancy outcomes. The aim of this randomized trial was to determine whether administration of the GnRH agonist goserelin with chemotherapy would reduce the rate of ovarian failure after adjuvant or neoadjuvant treatment of hormone-receptor–negative early-stage breast cancer. A total of 257 premenopausal women with operable hormone receptor–negative breast cancer were randomized to receive standard chemotherapy with goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy-alone group). The rate of ovarian failure at 2 years was the primary study end point. Ovarian failure was defined as the absence of menses for the preceding 6 months and follicle-stimulating hormone levels in the postmenopausal range at 2 years. Conditional logistic regression was used to compare rates. Secondary end points evaluated included pregnancy outcomes and disease-free and overall survival. Of the 257 patients, 218 were eligible and could be evaluated: 113 in the chemotherapy-alone group and 105 in the goserelin group. Complete primary end-point data were available for 135 of the 218 patients who could be evaluated. Among these, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group; the odds ratio was 0.30, with a 95% confidence interval of 0.09 to 0.97; 2-sided P = 0.04. To determine the effect of the missing primary end-point data on the main study findings, sensitivity analyses were performed. The results of these analyses showed that the missing data had no significant effect on the association between treatment and stratification variables (age and planned chemotherapy regimen). Among the 218 patients who could be evaluated, more women became pregnant in the goserelin group than in the chemotherapy-alone group (21% vs 11%, P = 0.03). Kaplan-Meier curves showed that more women in the goserelin group had improved disease-free survival (P = 0.04) and overall survival (P = 0.05). Consistent with the findings of previous randomized trials, these data suggest that administration of a GnRH agonist with chemotherapy protects ovarian function, reducing the risk of early menopause and improving prospects for fertility. Although missing primary-end-point data weaken interpretation of the findings, there is no evidence that the missing data influenced the relative comparison between randomized groups.
- 1 June 2015
- Published by Wolters Kluwer Health in Obstetrical & Gynecological Survey
- Vol. 70 (6) , 392-393
Open AccessGoserelin for Ovarian Protection During Breast-Cancer Adjuvant Chemotherapy
Premature ovarian failure is a devastating long-term toxic effect of chemotherapy for premenopausal women. The survival benefit of adjuvant chemotherapy in young women with operable hormone receptor–negative breast cancer is well known, but concern over becoming infertile may influence the choice of treatment for many women. A number of trials have investigated the combined use of a gonadotropin-releasing hormone (GnRH) agonist and adjuvant chemotherapy in an attempt to protect ovarian function in premenopausal women. Results of such studies were mixed, and there were few data on pregnancy outcomes. The aim of this randomized trial was to determine whether administration of the GnRH agonist goserelin with chemotherapy would reduce the rate of ovarian failure after adjuvant or neoadjuvant treatment of hormone-receptor–negative early-stage breast cancer. A total of 257 premenopausal women with operable hormone receptor–negative breast cancer were randomized to receive standard chemotherapy with goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy-alone group). The rate of ovarian failure at 2 years was the primary study end point. Ovarian failure was defined as the absence of menses for the preceding 6 months and follicle-stimulating hormone levels in the postmenopausal range at 2 years. Conditional logistic regression was used to compare rates. Secondary end points evaluated included pregnancy outcomes and disease-free and overall survival. Of the 257 patients, 218 were eligible and could be evaluated: 113 in the chemotherapy-alone group and 105 in the goserelin group. Complete primary end-point data were available for 135 of the 218 patients who could be evaluated. Among these, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group; the odds ratio was 0.30, with a 95% confidence interval of 0.09 to 0.97; 2-sided P = 0.04. To determine the effect of the missing primary end-point data on the main study findings, sensitivity analyses were performed. The results of these analyses showed that the missing data had no significant effect on the association between treatment and stratification variables (age and planned chemotherapy regimen). Among the 218 patients who could be evaluated, more women became pregnant in the goserelin group than in the chemotherapy-alone group (21% vs 11%, P = 0.03). Kaplan-Meier curves showed that more women in the goserelin group had improved disease-free survival (P = 0.04) and overall survival (P = 0.05). Consistent with the findings of previous randomized trials, these data suggest that administration of a GnRH agonist with chemotherapy protects ovarian function, reducing the risk of early menopause and improving prospects for fertility. Although missing primary-end-point data weaken interpretation of the findings, there is no evidence that the missing data influenced the relative comparison between randomized groups.
- Top Cited PapersOpen Access
- 5 March 2015
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 372 (10) , 923-932
Goserelin for Ovarian Protection during Breast-Cancer Adjuvant Chemotherapy
Ovarian failure is a common toxic effect of chemotherapy. Studies of the use of gonadotropin-releasing hormone (GnRH) agonists to protect ovarian function have shown mixed results and lack data on pregnancy outcomes. We randomly assigned 257 premenopausal women with operable hormone-receptor–negative breast cancer to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy-alone group). The primary study end point was the rate of ovarian failure at 2 years, with ovarian failure defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone (FSH) in the postmenopausal range. Rates were compared with the use of conditional logistic regression. Secondary end points included pregnancy outcomes and disease-free and overall survival. At baseline, 218 patients were eligible and could be evaluated. Among 135 with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group (odds ratio, 0.30; 95% confidence interval [CI], 0.09 to 0.97; two-sided P=0.04). Owing to missing primary end-point data, sensitivity analyses were performed, and the results were consistent with the main findings. Missing data did not differ according to treatment group or according to the stratification factors of age and planned chemotherapy regimen. Among the 218 patients who could be evaluated, pregnancy occurred in more women in the goserelin group than in the chemotherapy-alone group (21% vs. 11%, P=0.03); women in the goserelin group also had improved disease-free survival (P=0.04) and overall survival (P=0.05). Although missing data weaken interpretation of the findings, administration of goserelin with chemotherapy appeared to protect against ovarian failure, reducing the risk of early menopause and improving prospects for fertility. (Funded by the National Cancer Institute and others; POEMS/S0230 ClinicalTrials.gov number, NCT00068601.)
- 5 March 2015
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 372 (10) , 923-932
Top Cited PapersOpen AccessGoserelin for Ovarian Protection during Breast-Cancer Adjuvant Chemotherapy
Ovarian failure is a common toxic effect of chemotherapy. Studies of the use of gonadotropin-releasing hormone (GnRH) agonists to protect ovarian function have shown mixed results and lack data on pregnancy outcomes. We randomly assigned 257 premenopausal women with operable hormone-receptor–negative breast cancer to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy-alone group). The primary study end point was the rate of ovarian failure at 2 years, with ovarian failure defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone (FSH) in the postmenopausal range. Rates were compared with the use of conditional logistic regression. Secondary end points included pregnancy outcomes and disease-free and overall survival. At baseline, 218 patients were eligible and could be evaluated. Among 135 with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group (odds ratio, 0.30; 95% confidence interval [CI], 0.09 to 0.97; two-sided P=0.04). Owing to missing primary end-point data, sensitivity analyses were performed, and the results were consistent with the main findings. Missing data did not differ according to treatment group or according to the stratification factors of age and planned chemotherapy regimen. Among the 218 patients who could be evaluated, pregnancy occurred in more women in the goserelin group than in the chemotherapy-alone group (21% vs. 11%, P=0.03); women in the goserelin group also had improved disease-free survival (P=0.04) and overall survival (P=0.05). Although missing data weaken interpretation of the findings, administration of goserelin with chemotherapy appeared to protect against ovarian failure, reducing the risk of early menopause and improving prospects for fertility. (Funded by the National Cancer Institute and others; POEMS/S0230 ClinicalTrials.gov number, NCT00068601.)