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  • 1
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    Clinicopathological characteristics and prognosis in women with breast cancer affected by COVID 19.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e22517-e22517
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e22517-e22517
    Abstract: e22517 Background: there are few reported series n women with breast cancer (BC) and COVID-19, a better prognosis has been observed, with a lower rate of hospitalization and mortality than other neoplasms. Methods: We conducted a restrospective, non-experimental, observational, single center, study with a sample of 69 patients with BC who had presented COVID-19, in the period between March 2020 to August 2021. Clinicopathological characteristics of patients with BC were compared between severe and non-severe covid 19 groups, as well as hospitalized and non-hospitalized patients. An analysis of possible risk factors associated with severe disease and hospitalization was performed. Results: 69 cases were reported, median age 52y, mean BMI 25.2, ECOG 0-1: 97%. Smoking history in 24%, diabetes and hypertension were the most frequent comorbidities. The most frequent histology was ductal carcinoma in 80.6%, 73.8% showed ER + and 69.3% PR +, HER2 was overexpressed in 9.2%. The early stages predominated, I 22 (31.3%), II 25 (37.3%), III in 12 (17.9%) and IV in 6 (9%). The most frequents symptoms of COVID-19 were fatigue 70.1%, fever 65.7%, cough 59.7%, headache 56.7%, hyposmia 47.8%, dysgeusia 38.8%. A total of 53 (76.8%) mild cases, 14 (20.3) severe cases and 2 (2.9%) critical cases were registered. The 89.9% (62 patients) were treated as an outpatient basis, while 7 (10.1%) required hospitalization. Active treatment ( 〈 45 days) at the time of COVID-19 was hormonal therapy 36 (50.7%), chemotherapy 11 (16.4%), anti-HER2 in 3 (4.5%), immunotherapy in 1.5%, targeted treatment in 4 (6.0%), surgery in 7 (10.4%) and radiotherapy in 1 (1.5%) patient. When comparing the severe and non-severe groups, as well as hospitalized versus non-hospitalized, we observed no difference between the clinicopathological characteristics. Then, we serch for possible risk factors, in wich, surgery in a period of less than 3 months increases the risk of severity OR 1,297 (95% CI 1,112-1,514), the risk of hospitalization increased in the triple negative subgroup OR 1,143 (95% CI, 1,035- 1,262), surgery less than 3 months OR 1,116 (1,014-1,229) and chemotherapy less than 45 days OR 1,217 (95% CI, 1,024-1,447). Conclusions: In patients with BC, the prevalence of severe or critical COVID-19 was 23% and the hospitalizacion rate 10%. No patient died from this infection. The clinical and pathological characteristics of BC do not appear to increase the risk of severe COVID-19 or the rate of hospitalization. Surgery performed in a period of less than 3 months is marginally associated with an increased risk of severe disease. Chemotherapy, targeted therapy, and immunotherapy do not modify the risk of severe disease; however, higher Ki 67, triple negative subgroup, surgery and chemotherapy showed a slight increase in risk of hospitalization.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e22517
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 2
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    Correlation between five-year overall survival by PREDICT and 21 gene recurrence score (RS) in a Mexican private institution.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e12543-e12543
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e12543-e12543
    Abstract: e12543 Background: In México the 5-year overall survival of Early Breast Cancer (EBC) reaches to 82-97%. Oncotype Dx evaluates the expression of 21 genes associated with recurrence and classifies patients into risk groups. PREDICT (https://breast.predict.nhs.uk/tool) is an online tool which assesses 5 and 10 year overall survival in breast cancer patients who receive adjuvant chemotherapy, adjuvant hormonal therapy and trastuzumab therapy for HER2(+) patients. Methods: Retrospective review of medical records of early stage breast cancer patients with (HR+) and HER2 (-) treated at our institution. Clinicopathological characteristics and (RS) were collected. 5-year overall survival was calculated with the PREDICT online tool. Both scores were compared and the correlation was estimated with Spearman’s Rho and global agreement with intraclass correlation coefficient (CCI), statistical software: STATA SE ver11.0 (StataCorp LLC Texas,USA). Results: From January 2008 to December 2018, 136 patients with EBC (IA-IIB), HR(+) HER2(-), N0-1 were included. The Median age at diagnosis was 55.03 years (30-80). Stage IA patients accounted for 68.38% of the population. Patients were classified into risks according to the original description of Oncotype. 72 patients (53%) were classified as low risk (LR), 49 (36%) at intermediate risk (IR) and 15 (11%) patients at high risk (HR). When reclassifying the risk categories using the cut-off values in TAILORx trial, the population distribution was modified, with a notable increase in the population in IR with 86 (63.2%) patients in this group, 28 patients in the LR group ( 20.5%) and 22 patients (16.1%) in HR. We decided to use TAILORx cut-off values for the aim of this work. Mean overall survival established by the 21 gene RS was 98% for the overall population. The mean overall survival calculated by PREDICT was 93%. Spearman’s correlation coefficient was 0.16 (Spearman’s Rho = 0.16 p = 0.065) with intraclass correlation coefficient (ICC) = 0.04 (IC 95% -0.15 – 0.22, p = 0.33). Conclusions: The results do not show a clear correlation between the tests. Lack of such correlation may be due to a low number of patients. In our population PREDICT couldn't replace the RS test for therapeutic decision making.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e12543
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Association of immune-related adverse events with immune-checkpoint inhibitors and treatment response in melanoma patients.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e21522-e21522
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e21522-e21522
    Abstract: e21522 Background: Immune-related adverse effects (irAE´s) of immune-checkpoint inhibitors (ICIs) have been linked with a better treatment response in melanoma patients, especially cutaneous toxicities. However, little is known regarding other irAE´s which is important as they can be used as clinical markers of an adequate therapeutical response. Methods: We conducted a retrospective study on patients who were diagnosed with melanoma and received treatment with ICI´s between January 2015 until December 2021, immune related adverse events and their relationship with overall survival in melanoma patients treated with ICIs was the main objective of this study. Results: 53 records of patients with advance melanoma treated with ICIs between january 2016 to december 2021, demographic characteristics were as follow: 64.2% were male, mean age at diagnoses was 60.3 years, 41.5% had smoking history and 15.1% were Jewish. At diagnosis 73.6% of patients had a good functional status (ECOG 0-1). The most common histological subtypes were epithelioid (34%), and nodular (22.6%). Lung metastases was the most common affected site (49.1%), followed by brain 43.4% and non-regional nodes 42.5%. BRAF mutations was determined in 81.1% of the biopsies and 36% of them being V600E mutation. ICI´s was the preferred first line treatment in 83% of cases, median number of administered cycles were 6 (range 1-54 cycles), 60.4% of patients received pembrolizumab, 37.7% nivolumab plus ipilimumab, 20.8% nivolumab monotherapy and 5.7% ipilimumab. Throughout the studied period IrAE´s were reported in 34% of patients with 66.7% of them being grade 1-2 and 33.3% grade 3-4. The most common IrAE’s: vitiligo 38.8%, hypothyroidism22% and 3.8% pneumonitis. Median PFS at 12 months and OS was significantly better in the group of patients with irAE´s: Patients who develop an irAE´s are 7 times more likely to be disease free at 12 months and 4.1 times more likely to have a longer OS regardless of severity and type of toxicity. The impact of developing irAEs is significantly important for PFS (HR: 11.9, CI 95%: 3.28-4.71) as median PFS was not yet reached in this group. Conclusions: Development of irAEs is associated with favorable outcomes to ICIs with patients being 7 times more likely to be 12-month disease free and 4.1 times more likely to have a longer OS. irAEs can be used as clinical markers of an adequate treatment response.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e21522
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 4
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    Prognostic factors for survival in patients with advanced gastric cancer treated with chemotherapy.
    American Society of Clinical Oncology (ASCO) ; 2016
    In:  Journal of Clinical Oncology Vol. 34, No. 4_suppl ( 2016-02-01), p. 142-142
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 4_suppl ( 2016-02-01), p. 142-142
    Abstract: 142 Background: A prognostic model in advanced gastric cancer that integrates the Her2 status,histopathological classifications and other patient’s or treatment-dependent parameters is lacking. The aim is to identify clinicopathological factors for overall survival in a cohort of patients with advanced gastric cancer. Methods: 526 consecutive patients with advanced adenocarcinoma of the distal esophagus, gastroesophageal junction or stomach were analyzed. All patients were treated with poly-chemotherapy ( ≥ 2 drugs) at 19 Spanish and one Chilean centers between 2012 and 2015. Characteristics of patients, tumors, therapies and pathological factors, were analyzed by a Cox proportional hazards model. Results: The median overall survival was 10.3 months [95% confidence interval (CI), 9.5-11.1], and the time to progression was 6.7 months (95% CI, 6.1-7.2). Independent prognostic factors associated with overall survival were: distal non-diffuse histopathological subtype (hazard ratio, (HR) 0.73), Her2 positive 3+ (HR 0.54), Her2 positive 2+ with FISH + (HR 0.68), surgery of metastases (HR 0.34), Eastern Cooperative Group performance status (ECOG PS) 2 (HR 2.5), ECOG PS 3 (HR 7.37), and only distant lymph node metastases (HR 0.63) (Table 1). Conclusions: We have identified clinicopathological prognostic factors that could be important to stratify advanced gastric cancer, with potential implications in research and treatment. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2016.34.4_suppl.142
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
    detail.hit.zdb_id: 2005181-5
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  • 5
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    Synthetic lethality interaction between aurora kinases and CHEK1 inhibitors in ovarian cancer.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. e17089-e17089
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e17089-e17089
    Abstract: e17089 Background: Ovarian cancer is characterized by frequent mutations at TP53. These tumors also harbor germline mutations at homologous recombination repair (HR) genes, so they rely on DNA-damage checkpoint proteins, like the Checkpoint kinase 1 (CHEK1) to induce G2 arrest. In our study, by using an in silico approach, we identified a synthetic lethality interaction between CHEK1 inhibitors and mitotic Aurora Kinase A and B (AURKA/B) inhibitors. Methods: Gene expression analyses were used for the identification of relevant biological functions. OVCAR3, OVCAR8, IGROV1 and SKOV3 were used for proliferation studies. Alisertib was tested as AURKA/B inhibitor and LY2603618 as CHEK1 inhibitor. Analyses of cell cycle and intracellular mediators were performed by flow cytometry and western-blot. Stem cell properties were evaluated with immunofluorescence. Results: Gene expression analyses followed by functional annotation identified cell cycle as a deregulated function. Identified druggable kinases within this function included AURKA/B, TTK kinase and CHEK1. CHEK1 and AURKA/B inhibitors showed a synergistic interaction in different cellular models. Combination of Alisertib and LY2603618 triggered apoptosis, reduced the stem cell population and increased the effect of taxanes and platinum compounds. AURKA and CHEK1 were amplified in 8.7% and 3.9% of ovarian cancers, respectively. Expression of these genes was linked with detrimental clinical outcome. Conclusions: Amplification of AURKA and CHEK1 was observed in more than 12% of ovarian tumors. Our data describes a synthetic lethality interaction between CHEK1 and AURKA/B inhibitors with potential translation to the clinic.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.e17089
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 6
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    Real-world clinical outcomes in patients receiving cyclin-dependent kinase 4/6 inhibitors (iCDK 4/6) for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer in Mexico.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e13053-e13053
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e13053-e13053
    Abstract: e13053 Background: Breast cancer was the second most common malignant tumor diagnosed in 2018 worldwide, and the main cause of cancer death in women. In Mexico is the leading cause of cancer deaths, the most common molecular subtypes is HR+/HER2- (63%). The addition of iCDK 4/6 can enhance the benefit seen with endocrine therapy (ET) alone. In this work we will describe the experience in a “real world” model, of two tertiary-level hospitals in Mexico, with the use of iCDK 4/6 in a period of 3 years. Methods: Retrospective review of medical records of all consecutive pts with histological diagnosis of metastatic breast cancer HR+/HER2- and iCDK 4/6 treatment at our Institutions from July 2016 to January 2019. Clinical and pathological variables at diagnosis were recorded. Progression free survival was estimated using Kaplan-Meier method and survival distributions were compared using the Log-rank test. To assess association variables and progression we use Chi square. Results: 65 pts were treated, all with iCDK 4/6 in combination with ET, either aromatase inhibitor or irreversible estrogen receptor antagonist. 62 with palbociclib and 3 with ribociclib; Median age was 53 y/o (IQR 42-63), ECOG 0-1 (92.3%), 80% was metastatic recurrent disease, 92% of these patients received endocrine adjuvant treatment. Median estrogen receptor percentage was 90 (IQR 61-92), progesterone 50 (9-83), KI67 20 (10-30). The metastatic sites were bone (64.6%), liver (41.5%), nodal (33.8%), lung (21.5%), CNS (3.1%) and others (18.5%). 26 pts (40%) received iCDK 4/6 in the first line, 21 (32.3%) in the second line, and 27% in subsequent lines. Any grade of toxicity was presented in 44 pts (67.7%), Most common toxicities were neutropenia (63%), fatigue (16.9%), anemia (9.2%), grade 3-4 toxicities were presented in 21.5% and 17 pts (26.2%) required any dose adjustment. At the cut-off date, 28 pts (43.1%) had disease progression, median time to progression for the 65 pts was 10 months (1-84). OR for first line treatment vs subsequent lines was 0.14 (0.04-0.47, 95%, p = 0.001). OR for pulmonary metastases were 4.21 (1.15-15.31, 95%, p = 0.03), for other sites of metastasis were NS. Conclusions: Our outcomes suggest that the PFS is better when iCDK 4/6 are used as a first line treatment. Pulmonary metastases are may associated with poorly outcomes. In low- and middle-income countries, efforts should be focused on early therapy with iCDK 4/6.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e13053
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 7
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    Neutrophil to lymphocyte ratio and lipi score prognostic value in patients with non-small cell lung cancer in a Mexican population.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e21593-e21593
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e21593-e21593
    Abstract: e21593 Background: Non-Small cell lung cancer (NSCLC) is the most common type of lung cancer and accounts for most of all cancer-related morbidity and deaths in the World. Recent Evidence shows that inflammatory response is associated with a poor prognostic in several cancers. Evaluating these markers is of great importance to classify patients of solid tumors including NSCLC. Inflammatory markers like, Glasgow Prognostic Score (GPS), Lung Immune prognostic index (LIPI) and C-Reactive Protein (CRP) have been associated with poor prognosis in patients treated with immune checkpoint inhibitors. Neutrophil to Lymphocyte Ratio (NLR) is a biomarker for the general immune response to various stress stimuli in peripheral blood. It can be easily determined, inexpensive and can correlate with poor outcomes. Methods: A review of medical records was performed including patients from January 2013 to December 2018. The clinical characteristics were described, analyzed and the NLR and the LIPI were calculated. Categorical variables were analyzed with Chi-square test and the correlation was analyzed with the Pearson correlation coefficient. Variables were included in the construction of survival models through Cox multivariate regression using statistical software: STATA SE ver11.0 (StataCorp LLC Texas,USA). Results: A total of 175 patients with complete medical record and pathology samples were included. Around half of patients were female. The mean age was 69 years ± 11 years. The most frequent histology was Adenocarcinoma in 87%, Epidermoid 10% and others 3%. The most frequent mutations were KRAS 25%, EGFR 22% and ALK 1%. PDL-1 〉 1% was determined in 20% of patients. Clinical stage IV was found in 58% of the cases followed by Clinical Stage I, II and III with 25%, 9%, 8% respectively. The NLR 〉 4 is associated with a worse prognosis in Stage I and II HR = 5.4 (95% CI 1.73 - 17.17, p = 0.004). LIPI 〉 2 had predictive capacity for progression in Stage IV HR = 8.2 (IC 95 % 2.39-23.4, p = 〈 0.001). Conclusions: NLR 〉 4 showed prognostic value for recurrence in early clinical stages. LIPI score 〉 2 resulted in higher risk for progression in metastatic stages. Determination of these indexes has the potential as a readily available prognostic indicator for patients.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e21593
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Prevalence of immunotherapy-related adverse events due to checkpoint inhibitors: First report in Mexico.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e14090-e14090
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e14090-e14090
    Abstract: e14090 Background: Since 2010, immune checkpoint inhibitors (ICI) have been approved for the treatment of several neoplasms. Their immune-mediated toxicity profile, used as monotherapy (nivolumab [N], Ipilimumab [Ip] , pembrolizumab [P]) or in combination (Nivolumab/Ipilimumab [N/Ip] ) and their management is still being described, recently. Methods: A retrospective review of medical records, included all cancer patients treated, in our institution, with ICI from January 2014 to February 2018. Frequency, type and grade of immune related adverse events (irAE) by neoplasm, individual agent or combination were recorded. Time to first ir-AE (TTF-irAE) was estimated by Kaplan Meir Method and compared by Cox regression model. Results: 140 patients were evaluated, all in pretreated metastatic setting. Median age 65.8+/-11.8, men in 59.3%. The most frequent neoplasms treated with ICI were: lung (34%), melanoma (33%), genitourinary (17%), H & NC (6%), and GI (6%). Ip alone was indicated in 11.4% cases; N, 30%; P, 54.29%; N/Ip 4.29%. Median number of cycles per drug: Ip: 3 cycles, N/Ip: 4; N: 6; and P: 4 cycles. Toxicity (G1-4) was seen in Ip: 62.5%, N/Ip: 50%, N: 40.5%, P: 31.6%, p 〉 0.05. The most frequent irAE's were: dermatological 40%, gastrointestinal 18.3%, and endocrine 13.4%; other irAE´s were reported in: pulmonary 7.3%, ophthalmologic 6%, muscle-skeletal 6%, neurologic 2.4%, renal 1.2%, hematologic 1.2%. Severe toxicities (G3-4) were observed with N/Ip: 33.3%, P: 17.4%, Ip: 10%, N: 5.6%. TTF-ir-AE per drug: I: 1 st cycle (dermatitis, pruritus, colitis), N/Ip: 2 nd cycle (dermatitis, conjunctivitis), N: 3 rd cycle (dermatitis, thyroiditis, colitis, hepatitis), P: 1 st cycle (pruritus, neuritis, adrenalitis). Ipilimumab was an independent prognostic factor for developing severe ir-AE´s [OR = 12.8, p = 0.038], and any grade toxicity [OR = 1.9 (IC95% 0.92 - 4.1, p = 0.079)] . Conclusions: In this study, the dermatological, gastrointestinal and endocrine toxicities were the most frequent ir-AE´s, and they were observed in a low grade toxicity. The irAE´s profile is different among ICI or their combination and number of cycles administered. Ipilimumab alone or combined was associated to higher risk of severe irAEs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e14090
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Killer-cell Inmunoglobulin-like Receptor (KIR) genes as a predictor of response to the anti-HER therapy in solid tumors.
    American Society of Clinical Oncology (ASCO) ; 2016
    In:  Journal of Clinical Oncology Vol. 34, No. 15_suppl ( 2016-05-20), p. e13024-e13024
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 15_suppl ( 2016-05-20), p. e13024-e13024
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2016.34.15_suppl.e13024
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Dual effects of metformin on breast cancer proliferation in a randomized trial.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 519-519
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 519-519
    Abstract: 519 Background: Metformin lowers breast cancer risk in observational studies in diabetics, but evidence for its clinical activity is scanty. We studied the metformin antiproliferative effect in a pre-surgical study. Since the antidiabetic effect of metformin is heterogeneous according to obesity and insulin resistance (IR), we also determined whether its antiproliferative effect was modified by risk biomarkers. Methods: After tumor biopsy, we randomly allocated 200 non-diabetic women with breast cancer to either metformin, 850 mg/bid (n=100) or placebo (n=100) for 4 wks. The primary endpoint was the post-pretreatment change in Ki-67 between arms. We explored effect modifications by STEPP and tested biomarker thresholds that showed an interaction with treatment on Ki-67. Results: Overall, median (IQR) Ki-67 was 19 (14-31) at baseline and 21 (14-32) after 4 wks and 18 (12-29) at baseline and 20 (13-31) after 4 wks in the metformin and placebo arm, respectively with mean increase of 4.0% (95%CI, -5.6 to 14.4) on metformin versus placebo. Multivariate analyses showed an increase of Ki-67 after 4 wks placebo in the following subgroups: HOMA 〉 IR threshold, IGFBP3 〉 highest quartile, IGFBP1 〈 lowest quintile, IGFratio (IGF1/IGFBP3) 〈 median, CRP 〉 inflection point at STEPP analysis, HER2+ve tumors (versus –ve). Metformin blunted the increase of Ki-67 noted on placebo in these subgroups. Conclusions: Overall, metformin did not affect Ki-67 in most subjects with breast cancer. However, in exploratory analysis we identified subgroups of patients where metformin showed antiproliferative effect. Further studies to a personalized approach are warranted with selection of study populations. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.519
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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