High Body Fat Level Increases Breast Cancer Risk in Postmenopausal Women with Normal BMI

April 30th, 2019

There is an approximately 30% increased risk of breast cancer recurrence or death in those who are obese, compared to those with ideal body weight. Obesity is associated with alterations in Insulin/glucose homeostasis, adipokines, and sex hormones, which may all play a role in breast cancer outcomes.
BMI (Body Mass Index) does not discriminate between adiposity and muscle, and individuals deemed healthy based on a normal BMI may still be prone to cardiometabolic disorders due to high levels of visceral fat. It has been reported that approximately 18% of women with normal BMI had excess fat, detected on DEXA scan.
In a recently published article in JAMA Oncology involving 3460 postmenopausal women with normal BMI, there was a 56% increase in the risk of developing ER-positive breast cancer per 5-kg increase in trunk fat, despite a normal BMI. This study concluded that a normal BMI may not be an adequate proxy for the risk of breast cancer in postmenopausal women but high body fat levels and altered levels of circulating metabolic and inflammatory factors may be associated with a higher risk of invasive breast cancer.

FDA Approves TECENTRIQ® and ABRAXANE® Combination for Advanced Triple Negative Breast Cancer

April 10th, 2019

Triple Negative Breast Cancer (TNBC) is a heterogeneous, molecularly diverse group of breast cancers and are ER (Estrogen Receptor), PR (Progesterone Receptor) and HER2 (Human Epidermal Growth Factor Receptor-2) negative. Those with metastatic disease have one of the worst prognosis of all cancers with a median Overall Survival of 13 months.

TECENTRIQ® (Atezolizumab) an anti PD-L1 monoclonal antibody given along with ABRAXANE® (Nanoparticle Albumin-Bound – nab Paclitaxel) improved the Progression Free Survival (PFS) by 20%, when compared with ABRAXANE® alone. This benefit was even more significant among patients with PD-L1–positive tumors with PFS improvement of 38%. The combination of TECENTRIQ® plus ABRAXANE® could potentially change how we manage patients with Triple Negative Breast Cancer.

Increased Risk of Breast Cancer after Recent Childbirth

February 23rd, 2019

In a large International Premenopausal Breast Cancer study which included close to 900,000 women, compared with nulliparous women, parous women had an increased risk for breast cancer that peaked about 5 years after childbirth and then gradually decreased about 24 years after childbirth.The increase in breast cancer risk after childbirth may be due to proliferation of breast cells during pregnancy which could promote accelerated development of latent initiated tumor cells. Childbirth also brings about maternal changes beyond breast tissue including altered immune function and microbiota, increased stress, and accelerated aging processes. Health Care Professionals should take these factors into account when considering individual risk profiles for breast cancer in premenopausal women.

Radiotherapy plus ERBITUX® Inferior to Radiotherapy plus Cisplatin in HPV-Positive Oropharyngeal Squamous Cell Carcinoma

January 21st, 2019

The RTOG 1016 randomized, phase III trial has demonstrated that among  HPV-positive Oropharyngeal cancer patients, Radiotherapy plus ERBITUX® showed inferior Overall Survival and Progression Free Survival compared with Radiotherapy plus Cisplatin. Because of the substantial morbidity and lifelong toxicities such as dry mouth, difficulty swallowing, and loss of taste associated with Cisplatin chemotherapy and Radiotherapy, ERBITUX® (Cetuximab), an Epidermal Growth Factor Receptor (EGFR) targeted monoclonal antibody  is often considered an alternative to Cisplatin . Based on this first randomized clinical trial specifically designed for patients with HPV-positive Oropharyngeal cancer, Radiotherapy plus Cisplatin should be the standard of care for eligible patients with HPV-positive Oropharyngeal carcinoma.

IMFINZI® after Chemoradiotherapy Significantly Improves Overall Survival in Stage III NSCLC

November 8th, 2018

IMFINZI® (Durvalumab) is a selective, high-affinity, human IgG1 monoclonal antibody, that blocks the binding of Programmed Death Ligand 1 (PD-L1) to Programmed Death 1 (PD-1) receptor and CD80, thereby unleashing the T cells to recognize and kill tumor cells. Patients with stage III Non Small Cell Lung Cancer (NSCLC) are often treated with platinum-based doublet chemotherapy with concurrent radiation and have a median Progression Free Survival (PFS) of approximately 8 months and 5 year survival of only 15%. PACIFIC trial is a randomized, double-blind, international, phase III study in which IMFINZI® as consolidation therapy was compared with placebo, in patients with stage III, locally advanced, unresectable NSCLC, that had not progressed following platinum-based chemoradiotherapy.
At a median follow up of 25.2 months, the 24-month Overall Survival rate was 66.3% in the IMFINZI® group and 55.6% in the placebo group, suggesting a significantly prolonged Overall Survival with IMFINZI® when compared with placebo and a 32% reduction in the risk of death (HR for death=0.68; P=0.0025). The Overall Survival benefit with IMFINZI®, was observed across all the prespecified subgroups.
PACIFIC trial is the first study to demonstrate a survival advantage for unresectable Stage III NSCLC, supporting this regimen as the standard of care.

MicroRNA-31-3p Expression is a Predictive Biomarker of Anti-EGFR Efficacy in Patients with RAS Wild-type Metastatic Colorectal Cancer

October 9th, 2018

Advanced ColoRectal Cancer (CRC) is often incurable and standard chemotherapy when combined with anti EGFR (Epidermal Growth Factor Receptor) targeted monoclonal antibodies such as VECTIBIX® (Panitumumab) and ERBITUX® (Cetuximab) as well as anti VEGF agent AVASTIN® (Bevacizumab), have demonstrated improvement in Progression Free Survival (PFS) and Overall Survival (OS). The benefit with anti EGFR agents however is only demonstrable in patients with metastatic CRC, whose tumors do not harbor RAS mutations. It is now becoming clear that among these pan RAS wild type tumors, a predictive biomarker, MiR-31-3p expression in tumors, may further determine who would benefit from Anti-EGFR targeted therapy.
In a recently published study (Clin Cancer Res 2018), tumors with Low MiR-31-3p expression benefited from ERBITUX® combination compared to AVASTIN® for PFS (HR=0.74;P=0.05), OS (HR=0.61;P<0.01) and Objective Response Rate (P<0.01). There was however no difference in outcomes among High MiR-31-3p expressors between the two treatment groups. This study suggested that only low MiR-31-3p expressing tumors among the pan RAS wild type CRC patients benefit from Anti-EGFR targeted therapies.

American Cancer Society Updates Colorectal Cancer Screening Guideline for Average Risk Adults

September 17th, 2018

The ACS recently updated Colorectal Cancer Screening Guideline using prevailing evidence as well as microsimulation modeling analyses. The new guideline does not prioritize among screening test options. This is because test preferences vary among individuals and the guidelines development committee emphasized that screening rates could be improved by endorsing the full range of tests without preference. Adults born around 1990 have twice the risk of colon cancer and four times the risk of rectal cancer compared with adults born around 1950, who have the lowest risk. In the updated guideline, screening is recommended earlier, starting at age 45 years and may be performed  with either a high-sensitivity stool-based test or a structural (visual) exam, depending on patient preference and test availability.

First Line TECENTRIQ® plus Chemotherapy in Advanced Squamous NSCLC

July 30th, 2018

Non Small Cell Lung Cancer (NSCLC) accounts for approximately 85% of all lung cancers and 30% are Squamous Cell Carcinomas (SCC). Non Small Cell Lung Cancer patients with Squamous Cell histology have been a traditionally hard- to-treat, patient group, and less than 15% of patients with advanced Squamous NSCLC survive a year after diagnosis and less than 5% of patients survive for five years or longer. IMpower131 is a multicenter, open-label, phase III study, in which 1021 chemotherapy-naïve patients with stage IV Squamous NSCLC received TECENTRIQ® ((Atezolizumab)) along with Carboplatin, and Paclitaxel, TECENTRIQ® along with Carboplatin, and ABRAXANE® (nab-paclitaxel) or Carboplatin and ABRAXANE® (control group). The addition of  TECENTRIQ® to chemotherapy significantly improved median Progression Free Survival across all PD-L1 subgroups. This is the first phase III trial of an immunotherapy-based treatment regimen, to demonstrate a significant improvement in Progression Free Survival, in advanced Squamous NSCLC.

MRI Targeted Biopsy Superior to Standard TRUS Guided Biopsy for Prostate Cancer Diagnosis

June 12th, 2018

TransRectal UltraSound (TRUS) guided biopsy has been the standard of care for diagnosing prostate cancer in men with a clinical suspicion of prostate cancer. TRUS guided biopsy is a blind biopsy of the lateral and posterior peripheral zone of the prostate using a template, and 10 to 12 cores of prostate tissue is obtained. Even though this may result in a higher rate of prostate cancer detection, many detected are low grade tumors that do not benefit from treatment. The major limitation of this biopsy procedure is the risk of under-sampling a more significant tumor that is located in a region of the prostate not usually targeted with a template.
Multiparametric MRI (mp-MRI) combines anatomic imaging in the form of T2-weighted imaging, with functional imaging, and is being used to detect or rule out cancer in men who have persistent concern for prostate cancer. It can be used as a triage test to avoid a biopsy if the results were negative, and if positive could be used for targeting abnormal areas in the prostate during biopsy. In the PRECISION study, mp-MRI was superior to standard TRUS guided biopsy, and was able to identify a high proportion of men who would benefit from treatment, and minimizes the identification of men with clinically insignificant cancer, thereby preventing overtreatment. Utilizing mp-MRI, more than 25% of the participants in this study were able to avoid a biopsy.

FDA Approves AndexXa®, The First Antidote for Factor Xa Inhibitors

May 13th, 2018

The FDA on May 3, 2018 approved AndexXa&reg; (Andexanet Alfa), a recombinant coagulation Factor Xa, inactivated-zhzo), for patients treated with XARELTO&reg; (Rivaroxaban) and ELIQUIS&reg; (Apixaban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval of AndexXa&reg; was based on data from two Phase III ANNEXA studies (ANNEXA-A and ANNEXA-R) as well as interim data from the ongoing ANNEXA-4 study. AndexXa&reg; significantly reduced anti-Factor Xa activity of Factor Xa Inhibitors by over 90% compared with placebo, with reversal persisting for 1 to 2 hours after completion of the infusion. The availability of this antidote assures both patients and Health Care Providers to consider Factor Xa inhibitors with greater confidence.