NRG oncology trial of metformin for non-small cell lung cancer

Initial results of NRG-LU001 indicate that, although the diabetes agent metformin was well-tolerated by patients, the agent has not clearly improved progression-free survival (PFS) or overall survival (OS) for trial participants with locally advanced non-small cell lung cancer (NSCLC). These results are based on local center reported outcomes. Trial participants will continue to be followed for changes in their status. The initial report of these results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and the abstract was awarded a “Best of ASCO” designation.

“In previous pre-clinical studies, metformin enhanced the response of human non-small cell lung cancer (NSCLC) models to radiotherapy and chemotherapy,” stated Dr. Theodoros Tsakiridis, MD, PhD, of McMaster University and lead author of the NRG-LU001 abstract. “The pre-clinical data suggested a potential benefit for patients with lung cancer. For that, we pursued the NRG-LU001 trial to examine whether metformin could indeed improve outcomes in patients with stage III NSCLC treated with standard of care chemotherapy and radiotherapy.”

In NRG-LU001 patients were randomly assigned either to the control arm that received standard chemotherapy and radiotherapy alone or to the experimental arm that received chemotherapy, radiotherapy, and 2000mg of metformin per day during those treatments. This study was designed to detect a 15% improvement in 12-month PFS from 50% to 65% or, equivalently, a HR of 0.622. Following treatment, researchers tracked the participating patients for changes in survival outcomes, toxicities or side effects, time to local-regional progression (TTLRP), and time to distant metastasis (TTDM).

NRG-LU001 closed to accrual in December 2016 after completing accrual and randomization of the pre-planned number of 168 patients. There was no statistically significant difference in rates or grade of toxicity between the two arms, indicating that metformin was well-tolerated by patients. At the time of analysis, local centers reported 102 PFS events. The 1- and 2-year PFS rates were 60.4% (95% CI: 48.5, 70.4) and 40.1% (95% CI: 29.0, 51.0) in the control arm, and 51.3% (95% CI: 39.8, 61.7) and 34.5% (95% CI: 24.2, 45.1) in the experimental treatment arm with metformin. OS at 2 years was 65.4% (95% CI: 53.5, 75.0) in the control arm and 64.9% (95% CI:53.1, 74.5) in the experimental arm (HR=1.03 (95% CI: 0.64, 1.68). Deaths were due to lung cancer in 90% of the control arm and 71% of the experimental arm. These initial results of NRG-LU001 yielded no differences between treatment arms for TTLRP and TTDM.

“While finding no difference in the primary endpoint, between treatment arms was disappointing, we are heartened to observe better than expected PFS and OS rates in both arms of this study” said Dr. Heath Skinner, MD, PhD of the UPMC Hillman Cancer Center who was Co-Principal Investigator of the trial, along with Dr. Tsakiridis. “We plan to complete secondary analyses with a central clinical and radiological review of all cases, as well as biomarker studies involving the biospecimens collected during this trial.”

The results of NRG-LU001 demonstrate the value of continued investigation of NSCLC, one of the deadliest cancers worldwide, in multi-institutional settings such as NRG-Oncology.

This project was supported by National Cancer Institute (NCI) grants: U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), U24CA180803 (IROC).

###

Citation

Tsakiridis T*, Hu C, Skinner H*, Santana-Davila R, Lu B, Erasmus JJ, Doemer AJ, Videtic GMM, Coster J, Yang AX, Lee RY, Werner-Wasik M, Schaner PE, McCormack SE, Esparaz BT, McGarry RC, Bazan J, Struve T, Bradley JD. Initial reporting of NRG-LU001, randomized phase II trial of concurrent chemoradiotherapy (CRT) +/- metformin HCL in locally advanced Non-Small Cell Lung Cancer (NSCLC). Abstract presented at the annual meeting of the American Society of Clinical Oncology (ASCO). Chicago, IL.

*authors contributed equally to this work.

About NRG Oncology

NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.

https://www.eurekalert.org/pub_releases/2019-06/no-not053119.php

Biotech Investors: Mark Your Calendar For These June FDA Dates

The FDA approval machinery worked overtime in May, with several new labelings, original approvals and new molecule approvals coming through in the month.

The month saw the approval of two new molecular entities, or NMEs: Novartis AG NVS 0.22%‘s Piqray in combination with fulvestrant to treat postmenopausal women and men, with hormone HR-positive HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer and Pfizer Inc. PFE 0.88%‘s Vyndaqel and Vyndamax capsules for treating heart disease caused by transthyretin-mediated amyloidosis.

Novartis also won approval for Zolgensma, its novel gene therapy for spinal muscular atrophy Type 1.

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Here are the key PDUFA dates to watch for June.

Merck Seeks Approval For Expanded Indication For Antibiotic

• Company: Merck & Co., Inc. MRK 0.61%
• Type of Application: sNDA
• Candidate: Zerbaxa (ceftolozone and tazobactam)
• Indication: Treating adult patients with ventilated nosocomial (hospital-acquired) pneumonia
• Date: June 3

Zerbaxa is indicated for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain susceptible gram-negative microorganisms, and also for the treatment of adult patients with complicated intra-abdominal infections in combination with metronidazole.

In April, Merck released the results of a Phase 3 trial, showing non-inferiority of Zarbaxa to meropenem, the active comparator, in the primary and key secondary endpoints.

Xeris’ Glucagon Autoinjector For Low Blood Sugar

• Company: Xeris Pharmaceuticals Inc XERS 4.44%
• Type of Application: NDA
• Candidate: Gvoke HypoPen
• Indication: Treating severe hypoglycemia in people with diabetes
• Date: June 10

Gvoke HypoPen is Xeris’ lead product candidate – a ready-to-use, room-temperature stable liquid glucagon rescue pen auto injector. Glucagon is the standard-of-care for treating severe hypoglycemia.

“Compared to the current glucagon rescue option for people with diabetes who are at risk for severe hypoglycemia, the Xeris glucagon rescue pen would eliminate the need for reconstitution and dramatically simplify the preparation and administration process,” according to Xeris.

Can Merck Snatch Another Approval For Keytruda?

• Company: Merck
• Type of Application: sBLA
• Candidate: Keytruda
• Indication: First-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma, or HNSCC
• Date: June 10

The FDA accorded priority review status for the application, and Keytruda is being evaluated as a monotherapy, or in combination with platinum and 5-fluorouracil chemotherapy. The application is supported by the pivotal Phase 3 KEYNOTE-048 trial, in which Keytruda demonstrated a significant improvement in overall survival compared with the standard-of-care.

Merck’s Keytruda For Lung Cancer

• Company: Merck
• Type of Application: sBLA
• Candidate: Keytruda
• Indication: For treating patients with advanced small cell lung cancer, or SCLC, whose disease has progressed after two or more lines of prior therapy
• Date: June 17

The regulatory submission was based on data from the SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials.

Palatin’s Drug For Hypoactive Sexual Desire Disorder Awaits

• Company: AMAG Pharmaceuticals, Inc. AMAG 1.75% and Palatin Technologies, Inc. PTN 3.85%
• Type of Application: NDA
• Candidate: Vyleesi (bremelanotide)
• Indication: Treating premenopasal women with hypoactive sexual desire disorder, or HSDD
• Date: June 23

Vyleesi is a novel melanocortin 4 receptor agonist under evaluation for restoring a natural sexual desire in premenopausal women with HSDD. It’s administered as a subcutaneous injection under the skin using a single-use autoinjector pen. The drug developed by Palatin is being licensed to Amag.

The original PDUFA date of March 23 was pushed forward by three months to allow the regulatory agency to parse through additional Phase 1 data submitted by the company at FDA’s request.

Acer Seeks Approval For Drug To Treat Rare Genetic Disease of Connective Tissue

• Company: Acer Therapeutics Inc ACER 2.69%
• Type of Application: NDA
• Candidate: Edsivo
• Indication: Treatment of vascular Ehlers-Danlos syndrome, or vEDS, in patients with a confirmed type III collagen (COL3A1) mutation
• Date: June 25

Ehlers-Danlos Syndrome is a group of hereditary disorders of connective tissues, with vEDS being the most severe subtype, where patients suffer from life-threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. The drug has received Orphan Drug Designation in 2015 and the NDA has been granted priority review as well.

Can Dupixent Get The Nod For Expanded Indication?

• Company: Sanofi SA SNY 1% and Regeneron Pharmaceuticals Inc REGN 2.03%
• Type of Application: sBLA
• Candidate: Dupixent
• Indication: Add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps, or CRSwNP
• Date: June 26

Dupixent has already been approved for eczema and as a maintenance therapy in combination with other medicines for asthma.

“Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages,” the company said.

Can Alexion’s Soliris Pass The Muster For NMOSD?

• Company: Alexion Pharmaceuticals, Inc. ALXN 5.65%
• Type of Application: sBLA
• Candidate: Soliris (eclizumab)
• Indication: for treating patients with neuromyelitis optica spectrum disorder, or NMOSD
• Date: June 28

The sNDA was supported by comprehensive data from the PREVENT study in patients with anti-AQP4 auto antibody-positive NMOSD, who represent three-quarters of all patients with NMOSD.

NMOSD is a rare, complement-mediated disorder of the central nervous system characterized by relapses. Each relapse results in stepwise accumulation of disability, including blindness and paralysis, and sometimes premature death. There is currently no FDA-approved therapy for the indication.

Retrophin Awaits FDA Nod For New Formulation Of Rare Kidney Disorder Drug

• Company: Retrophin Inc RTRX 0.05%
• Type of Application: NDA
• Candidate: new formulation of Thiola (tiopronin)
• Indication: Treatment of cystinuria
• Date: June 30

Dova’s Bleeding Disorder Drug On Course For Snagging Another Approval

• Company: Dova Pharmaceuticals Inc DOVA 1.56%
• Type of Application: sNDA
• Candidate: Doptelet (avatrombopag)
• Indication: Treatment for patients with chronic immune thrombocytopenia, or ITP, who have had an inadequate response to prior treatment
• Date: June 30

Allergan Seeks Label Expansion For Botox

• Company: Allergan plc AGN 0.46%
• Type of Application: sNDA
• Candidate: Botox
• Indication: Treatment of pediatric patients (two years of age and older) with upper and lower limb spasticity
• Date: Second quarter (exact date not given)

https://www.benzinga.com/general/biotech/19/05/13816006/attention-biotech-investors-mark-your-calendar-for-these-june-pdufa-dates

Janssen Shares Notable Prostate Cancer Data at ASCO

A little more than a year after winning regulatory approval for a non-metastatic prostate cancer treatment, Janssen Pharmaceuticals is aiming to gain approval for the same medication as a treatment for metastatic castration-sensitive prostate cancer (mCSPC).

In April, the Johnson & Johnson subsidiary announced it had submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking approval for Erleada (apalutamide) for the aforementioned treatment of mCSPC. The sNDA is based on findings from the Phase III TITAN study, presented at the American Society of Oncology meeting today. TITAN was designed to determine whether Erleada, a selective next-generation androgen receptor inhibitor, plus androgen deprivation therapy (ADT) improves radiographic progression-free survival (rPFS) and overall survival (OS) compared with placebo plus ADT in patients with mCSPC. ADT is the backbone of treatment for this condition but the addition of supporting medications, such as Erleada has certainly improved the outcomes of care. The data from Janssen’s TITAN study is certainly impressive. And what the data shows is impressive, Joaquin Casariego Garcia Luben, J&J’s medical affairs director for prostate cancer for Europe, the Middle East and Africa, told BioSpace in an exclusive interview.

During the presentation of the abstract, Janssen showed that treatment with Erleada significantly improved (rPFS) with a reduction in the risk of death by 52 percent. Additionally, in overall survival, the TITAN data showed Erleada and ADT significantly improved OS with a 33 percent reduction in risk of death. The dual primary endpoints of the study are rPFS and OS, both of which were hit. The data showed that the combination of Erleada and ADT significantly improved radiographic progression-free survival and overall survival. The secondary endpoint of prolonged time to cytotoxic chemotherapy in patients treated with Erleada plus ADT was also met, with a 61 percent risk reduction compared with placebo plus ADT, Janssen said. Overall, the data suggests that treatment with Erleada prolongs overall survival and delays disease progression in patients with mCSPC.

Based on the trial results, the independent data monitoring committee recommended unblinding the study in order to allow those patients on placebo and ADT to receive the combination of Erleada and ADT.

“Both endpoints go together, it really shows the strength of the efficacy of this treatment,” Casariego told BioSpace in a telephone interview from Spain, ahead of his journey to ASCO in Chicago. Casariego noted that an IDMC rarely recommends unblinding a study unless the data is exceptional. He said the IDMC’s decision was made due to the “magnitude” of the results.

Janssen’s sNDA is being reviewed by the FDA through its Real-Time Oncology Review program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application.

Casariego said Janssen’s goal, as well as the goal of other companies developing treatments for cancer, is to provide a treatment that can cheat death out of as many years as possible from patients.

“It’s about adding years to life, as well as life to years. This is the main challenge,” he said. “These results are promising to that. We are stealing years to death and we keep investing in research to do this.”

Prostate cancer is the second most common cancer in men worldwide, with about 164,000 expected diagnoses in the United States this year. Erleada was the first FDA-approved treatment for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). In the trial that won it the first approval, Erleada demonstrated a 72 percent reduction in risk of distant metastasis or death. Metastatic prostate cancer is cancer that has spread to another part of the body. mCSPC refers to prostate cancer that still responds to ADT. Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth. Patients with mCSPC tend to have a poor prognosis, with a median OS of less than five years, which underscores the need for new treatments, Luben said.

Now 49, Casariego said he is of an age where he will begin to receive regular prostate examinations. If a doctor discovers anything that could indicate cancer, he said he is glad to know that there are an increasing number of treatment options for this disease. Any treatment, he said, that can steal time from death, is a good thing for patients.

https://www.biospace.com/article/1-janssen-to-present-titan-prostate-cancer-study-data-at-asco/

Adding BP Med to Pancreatic Cancer Treatment May Simplify Tumor Removal

A medical and research team at Massachusetts General Hospital (MGH) Cancer Center published clinical trial results of a new treatment protocol for locally advanced pancreatic cancer (LAPC). The procedure combined intensive chemotherapy and radiation with the blood-pressure drug losartan. The research was published in the journal JAMA Oncology.

Locally advanced pancreatic cancer is a type that has grown into major blood vessels and as a result, can’t be removed safety via surgery (unresectable). The cancer has not yet metastasized outside the pancreas.

“Around 40% of pancreatic cancer patients have either locally advanced or borderline resectable disease, with historically poor rates of successful surgery,”Janet Murphy told The Harvard Gazette. Murphy is co-lead and corresponding author of the study, an instructor in medicine in the hematology/oncology division of Mass General’s Department of Medicine.

“To be able to successfully remove the primary tumor in 61% of patients sets a new benchmark and offers much hope,” she added. “To our knowledge, this is the first LAPC clinical trial that defined surgical success as its primary outcome.”

The new aspect of the procedure and the study is the addition of losartan, a drug for high blood pressure that is marketed as a generic form and under the brand name of Cozaar. Earlier studies by co-author Rakesh K. Jain, director of the Steele Laboratories for Tumor Biology at MGH and Andrew Werk Cook Professor of Radiation Oncology at Harvard Medical School, found that the drug improved chemotherapy delivery in animal models of breast, pancreatic and ovarian cancer. Its method of action for this is to relieve pressure in the tumor microenvironment that actually blocks drug delivery and decreases the oxygen supply, which is necessary for the tumor-killing activity of radiation therapy. Jain’s studies also indicated that cancer patients who were otherwise taking losartan or similar hypertension medications generally lived longer than others receiving the same types of cancer therapies.

In the current study, between August 2013 and July 2017, 49 MGH Cancer Center patients who had previously been untreated for LAPC received chemotherapy with a combination of fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) for four months. They also took daily doses of losartan.

They then underwent CT scans to determine if the blood vessels were still involved with the tumors. Those whose blood vessels were no longer entangled received a short course of proton-beam radiation therapy. Those whose tumors still involved blood vessels received more conventional radiation therapy. Both groups continued to receive capecitabine chemotherapy during this post-CT period.

After this stage, 34 of the 49 patients had improved to where they could have their cancers removed. Thirty of the 34 patients’ cancers were successfully removed eliminating all evidence of cancer. For three patients, a pathologic complete response was observed, meaning no tumor was observed anywhere.

Biomarker studies also saw significant decreases in the expression of TGF-ß, showing that losartan was having the desired effect. Time until recurrence as well as overall survival time was significantly longer than was previously observed in LAPC patients.

“Locally advanced pancreatic cancer has been generally considered an incurable disease, so these results mark a dramatic improvement with respect both to rates of conversion to surgical resectability and to long-term disease outcomes,” co-lead author Jennifer Wo, assistant professor of radiation oncology, told The Harvard Gazette. “Based on these results we have launched a new, multi-institutional clinical trial that will also include the immunotherapy drug nivolumab [Bristol-Myers Squibb’s Opdivo), since losartan treatment has also been shown to activate several immune-system pathways.”

https://www.biospace.com/article/mass-general-tests-new-approach-to-pancreatic-cancer/

Adaptive Biotech Plans $230 Million IPO to Advance Immune Sequencing Tech

Seattle-based Adaptive Biotechnologies announced plans for an initial public offering (IPO) to raise up to $230 million.

Founded in 2009 by brothers Chad and Harlan Robins, the company utilizes high-throughput gene sequencing with computer infrastructure that allows scientists to minutely analyze T-cell receptors (TCR). Prior to this breakthrough, it was possible to catalog about 30,000 unique TCRs out of 100 million. The new tech allows scientists to identify 10 to 15 million in a single individual.

“Our goal is to understand the adaptive immune system and translate it into new products with unprecedented scale, precision and speed,” Adaptive stated in its preliminary prospectus for the IPO. As such, it is focused on cancers, autoimmune and infectious diseases.

The company has 346 staffers and to date has raised more than $400 million in private funding. Its largest shareholders are Viking Global Entities, which holds 36%, and Matrix Capital Management with 16.4%. In 2018, the company had a net loss of $46.4 million on revenues of $55.6 million, and as of March 31 reported having $440 million in cash and cash equivalents. About two-thirds of the revenue derived from sequencing services. Its accumulated deficit as of March 2019 was $314 million.

In early 2018 Adaptive partnered with Microsoft to develop a blood test that could diagnose multiple diseases in a single assay. The idea was to utilize artificial intelligence to map the immune system’s response to foreign substances and toxins. In January 2019, the companies announced they were ready to roll and placed an open call for collaborators to help sequence immune data from 25,000 people with five diseases: type 1 diabetes, celiac disease, ovarian cancer, pancreatic cancer and Lyme disease.

In January 2019, Adaptive inked a deal with Genentech, a Roche company, to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for a number of cancers. This partnership combines Genentech’s cancer immunotherapy R&D with Adaptive’s T-cell receptor (TCR) discovery and immune profiling platform (TruTCR). Adaptive’s technology platform quickly identifies TCRs that may be the most effective at recognizing and targeting specific neoantigens, proteins created by tumor-specific mutations not observed in normal tissues. Genentech paid Adaptive $300 million up front for that deal.

The prospectus indicates the $440 million in cash and the proceeds from the IPO will fund the company’s activities for the next two years.

At the American Society of Clinical Oncology (ASCO) Annual Meeting being held this weekend, the company is presenting data from more than 15 studies for clonoSEQ and immunoSEQ.

“At Adaptive, we are decoding the adaptive immune system to help diagnose and treat disease,” stated Chad Robins, co-founder and chief executive officer of Adaptive. “With our FDA-cleared NGS MRD Assay, clonoSEQ, we are enabling physicians in clinical practice to monitor and track a patient’s minimal residual disease (MRD) status to predict outcomes and guide treatment decisions. Additionally, our immunoSEQ research tool is helping to validate response to immunotherapies and assess toxicity. We remain committed to expanding the clinical applications of our immune medicine platform to reach greater numbers of patients.”

https://www.biospace.com/article/adaptive-biotechnologies-files-for-230-million-ipo/

Genocea Call Monday on Top 10 Featured Immuno-oncology Abstract

Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today announced that the Journal of Clinical Oncology^® (An American Society of Clinical Oncology Journal) has selected the company’s GEN-009 clinical results presentation at the 2019 ASCO Annual Meeting as a top 10 featured abstract in immuno-oncology. The full poster will be available on the Genocea website here concurrent with its presentation tomorrow:

ASCO 2019 POSTER SESSION: Developmental Immunotherapy and Tumor Immunobiology
Poster Board: #255 • Abstract 2611

	Title:		A phase 1/2a study of GEN-009, a neoantigen vaccine based on autologous peptide immune responses
	Presenters:		Roger B. Cohen, M.D., University of Pennsylvania Perelman School of Medicine and principal investigator in the trial, and Przemyslaw W. Twardowski, M.D., John Wayne Cancer Institute
	Date:		Saturday, June 1, 8:00 AM – 11:00 AM Central Time
	Location:		Hall A

Conference Call and Webcast – Monday, June 3^rd at 8:30 am ETGenocea will host a conference call and webcast to discuss the clinical results presented at ASCO at 8:30 am ET on Monday, June 3, 2019. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 9068006. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

https://www.globenewswire.com/news-release/2019/05/31/1861059/0/en/Genocea-s-GEN-009-Clinical-Results-Presentation-Selected-by-ASCO-s-Journal-of-Clinical-Oncology-as-a-Top-10-Featured-Immuno-oncology-Abstract.html

ASCO 2019: Delays lead to late-stage colorectal cancer diagnosis in young

The incidence of early onset colorectal cancer has increased nearly 50 percent in the last 30 years. A University of Colorado Cancer Center study presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago aimed to identify factors that may aid in earlier diagnosis and treatment of the disease.

“The rising incidence of colorectal cancer in young adults is concerning,” says Gurprataap Sandhu, MD, fellow at the CU Cancer Center. “In addition to trying to identify the cause of this increase, it is crucial to diagnose these patients at an earlier stage to improve clinical outcomes.”

The results of the study found that there was a high incidence of advanced stage cancer and prolonged rectal bleeding history before diagnosis in young-onset patients with colorectal cancer. More than half of the 173 patients presented with rectal bleeding before diagnosis. On average, 294 days passed between the first time the patient noticed rectal bleeding and the time they were diagnosed. By the time of diagnosis, 37.8 percent of the patients were Stage IV.

“Our results show that young adult patients present with a much higher rate of Stage IV colorectal cancer compared to patients who are older than years of age,” says Sandhu. “This is especially significant as Stage IV patients have a much worse prognosis and are typically incurable with a few exceptions.”

Traditionally colorectal cancer screening starts at 50 years of age. However, the American Cancer Society (ACS) dropped the recommended screening age for average risk patients to 45 in response to the increase of early onset diagnoses.

“The finding of prolonged bleeding prior to diagnosis was a surprising. It is possible that the bleeding was attributed to hemorrhoids initially, leading to potential delay in seeking medical attention and ultimately diagnostic workup,” says Sandhu. “Patients and primary care physicians should be made aware this finding in order to facilitate timely referral for colonoscopy which may lead to earlier diagnosis, less advanced disease at diagnosis, and improved outcomes.”

More about early onset colorectal cancer

Colorectal cancer diagnoses in young people (under 50 years old) have been increasing significantly in the last decades. The reasons behind this are unclear but theories include the rising obesity in children, a decrease in childhood physical activity, and changes in the microbiome due to exposure to antibiotics.

According to a survey conducted by the Colorectal Cancer Alliance;

• 82% of young cancer survivors were initially misdiagnosed
• 73% were diagnosed at a later stage
• 50% felt their symptoms were ignored
• 62% did not have a family history
• 67% saw at least two doctors before being diagnosed

If caught early, the average five-year survival rate for patients with colorectal cancer is 90 percent. This drops to 14 percent if diagnosed at later stages.

https://eurekalert.org/pub_releases/2019-05/uoca-a2d052919.php