Tag Archives: ASCO

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SHC’s Von Hoff honored for cancer advances

In association with its 50th anniversary, the American Society of Clinical Oncology (ASCO) has named Daniel D. Von Hoff, M.D., FACP, one of ASCO’s 50 Oncology Luminaries, celebrating 50 doctors who over the past half-century have significantly advanced cancer care.

Dr. Von Hoff is Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief and Distinguished Professor at Phoenix-based Translational Genomics Research Institute (TGen). He is an internationally recognized physician and scientist whose research during the past 30 years has contributed to the development of many anticancer agents that are routinely used in clinical practice. Among these drugs are fludarabine, mitoxantrone, paclitaxel, docetaxel, irinotecan, topotecan, nelarabine, gemcitabine, vismodegib, and nanoparticle paclitaxel.

ASCO was founded in 1964 by oncologists to improve the care of cancer patients. Profiles of the 50 Oncology Luminaries are being featured on the ASCO website, and their accomplishments will be celebrated at ASCO’s 50th annual meeting, May 30-June 3 in Chicago.

Although it is difficult to pick one highlight of his career, Dr. Von Hoff and his team played an instrumental role in the development of gemcitabine, the first drug to improve the survival of patients with stage IV pancreatic cancer. In 1997, they published the results of a clinical trial that showed that gemcitabine not only increased the rate of clinical benefit in patients with pancreatic cancer compared with fluorouracil (5-FU), but it also improved overall survival.

This work was followed by recognition of the activity of nab-paclitaxel plus gemcitabine against pancreatic cancer with the recent finding that that regimen also improved survival for patients with stage IV pancreatic cancer. On Sept. 6, 2013, the U.S. Food and Drug Administration (FDA) approved nab-paclitaxel as a frontline therapy for patients with advanced pancreatic cancer.

International clinical trials that led to the FDA’s approval were led by Dr. Von Hoff at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership of Scottsdale Healthcare and TGen, at Scottsdale Healthcare Shea Medical Center in Scottsdale, Ariz.

Dr. Von Hoff has also been instrumental in the concept of development of personalized therapy for patients with refractory cancer based on using molecular techniques to profile their cancers. This work included the initial clinical trials to determine what percentage of patients could benefit from that approach.

Dr. Von Hoff has spent the past 30 years of his career leading teams in phase I trials and the development of new therapies, first as the founding director of the Institute for Drug Development at the Cancer Therapy and Research Center in San Antonio, then as the director of the Cancer Center and Professor of Medicine at the University of Arizona. He also is Professor of Medicine at the Mayo Clinic and serves as Chief Scientific Officer for US Oncology.

When Dr. Von Hoff was awarded ASCO’s David A. Karnofsky Memorial Award in 2010, he took several minutes at the beginning of his lecture to memorialize all of the patients that he and his team had lost during phase I trials the previous year, mentioning several of them by name. The gesture reflected what Dr. Von Hoff named as the greatest accomplishment of his career: working hard to help as many people as he could.

“I have been extremely fortunate to have many great (and incredibly patient) teachers, mentors, and co-workers,” Dr. Von Hoff said. “Truly though I think the greatest teachers and mentors for me have been those I have been privileged to care for.”

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TGen-TD2-Scottsdale Healthcare study benefits patients

The Side-Out Foundation’s breast cancer pilot study, led by the Translational Genomics Research Institute (TGen), Translational Drug Development (TD2) and Scottsdale Healthcare, has shown that cancer patients do better when their treatment is guided by molecular profiling.

Specifically, 52 percent of patients with advanced breast cancer received clinical benefit – meaning their disease was controlled for a longer time – when their cancer was treated based on addressing the abnormal proteins in their tumor, according to the study conducted at the Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.

Each patient’s treatment was “personalized,” meaning that the therapy they received was based on their individual tumor biology.

“This study demonstrates the feasibility of personalized cancer treatment, and shows that this approach merits further investigation in future studies,” said Gayle Jameson, Nurse Practitioner at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and the study’s Principal Investigator.

“The success of this pilot study will lead to a larger study and hopefully greater clinical benefit for more patients with advanced breast cancer,” said Jameson, who presented the results of the study in June at the 2013 American Society of Clinical Oncology (ASCO) in Chicago.

Due to the overwhelmingly positive results, a new study incorporating additional technology for tumor analysis, Side-Out II, will open at the Virginia G. Piper Cancer Center Clinical Trials in the near future for patients with advanced breast cancer.

“The success of our pilot proof-of-concept study has established a firm launching pad for the upcoming Side-Out II study, which involves a more in-depth investigation of tumor biology with an expanded repertoire of tests to direct personalized treatment,” said Dr. Jasgit Sachdev, M.D., a breast cancer specialist and Associate Professor at the Virginia G. Piper Cancer Center Clinical Trials.

“By showing the significant advantages of molecular profiling, this pilot study has enabled us to move forward with a project that should strengthen the evidence for using this approach in routine clinical care.”

The recent pilot study built on previous studies by Scottsdale Healthcare and TGen that showed the value of guiding treatment based on molecular profiling, in which each patient’s tumor was analyzed for protein abnormalities that may “drive” the cancer’s growth. The results pointed investigators toward specific genetic changes that might be addressed by specific medications.

Beyond molecular profiling, the pilot study also included mapping proteomic pathways within the tumor tissue so each patient could receive a highly targeted regimen designed to impede their cancer growth.

All of the patients in the recent study had advanced breast cancer that had progressed following multiple previous chemotherapy treatments. Of the 25 patients, 13 received clinical benefit as a result of molecular profiling. For all 25 patients, the therapy selected based on their tumor analysis was different than what they would have received in their next planned treatment, if they had not participated in the study.

The Virginia G. Piper Cancer Center at Scottsdale Healthcare was the lead site in the 2-½ year pilot study. In addition, patients in the study were treated at Virginia Cancer Specialists, US Oncology, in Fairfax, Vir.; and at Evergreen Hematology & Oncology in Spokane, Wash.

Translational Drug Development (TD2), a TGen company, managed the pilot clinical trial, and will also oversee the follow-on study, Side-Out II.

“This was an exciting study for TD2,” said Linda Vocila, BSN, RN, Director of Clinical Operations at TD2 and co-author of the study. “It demonstrates that close collaboration between physicians and scientists leads to greater clinical benefit for patients with cancer.”

Two labs analyzed tissue: the Center for Applied Proteomics and Molecular Medicine (CAPMM) at George Mason University in Manassas, Vir.; and Caris Life Sciences in Phoenix.

The Side-Out Foundation of Fairfax, Vir., sponsored the study.

To participate in a clinical trial at the Virginia G. Piper Cancer Center, please contact Patient Care Coordinator Joyce Schaffer at 480-323-1339 or joschaffer@shc.org.

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TGen, Scottsdale Healthcare study may help pancreatic cancer patients

A multi-center Phase III clinical trial demonstrates that Abraxane (nab-paclitaxel) plus gemcitabine is the first combination of cancer drugs to extend survival of late-stage pancreatic cancer patients compared to standard treatment.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study was led by physicians from Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

Their findings show that Abraxane plus gemcitabine was well tolerated and resulted in clinically meaningful outcomes compared to gemcitabine alone, the current standard of care. The study abstract was released today and the data will be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers annual meeting Jan. 25 in San Francisco.

“We are ecstatic that this clinical trial of Abraxane plus gemcitabine improves survival for patients with advanced stage IV pancreatic cancer,” said Dr. Daniel Von Hoff, international lead investigator for MPACT, chief scientific officer for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, and TGen’s Physician-In-Chief. “It once again demonstrates that laboratory science based medicine can make a difference for patients.”

MPACT is the largest phase III clinical trial completed in advanced pancreatic cancer with more than 800 patients. Findings from the study showed a 59 percent increase in one-year median survival rates from less than a quarter of the patients (22 percent) to more than a third (35 percent). The two-year survival rate for this cancer is negligible, less than 4 percent, but that more than doubles (9 percent) with the nab-paclitaxel/gemcitabine combination.

One of those patients was Lynne Jacoby, 48, of Phoenix, who works as a director of compliance for a healthcare company. Jacoby was given only weeks to live when her Stage 4 pancreatic adenocarcinoma, a tumor the size of a golf ball, was first diagnosed in April 2012 — nine months ago.

“If you had to live your life in a year, and that is all the time you have, wouldn’t you do everything you could to experience this time,” said Jacoby, who for nearly a year before her diagnosis had experienced night sweats, indigestion, stomach pains, neck and back pain, and an elevated white-blood count.

She began the treatment of Abraxane plus gemcitabine in May 2012 and continues on the medications, saying now that she “feels awesome, wonderful.” She is scheduled to remain on the drug combination through May 2013.

“Life is priceless. No amount of money can be placed on life. I know I would be gone already if it was not for Dr. Von Hoff,” said Jacoby, who also refers to him as “Dr. Von Hope.”

The study showed significant improvement among some of the sickest patients including those with increased metastases. Significantly there was no increase in life-threatening toxicity. Other drug combinations that have demonstrated benefit have been limited by increased toxicities.

“This is a major improvement in a cancer with the lowest survival rates among all cancer types,” said Dr. Ramesh Ramanathan, medical director of Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and principal investigator for the clinical trial in the United States. “Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and throughout the world. It is difficult to diagnose with a majority of the cases diagnosed at a late stage after the disease has already advanced.”

Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano sized shells of albumin, a protein that the tumor sees as food. The tumor uses various mechanisms to preferentially attract the albumin, which then acts like a “Trojan Horse” to release its package of chemotherapy inside the tumor. It is approved in the U.S. for metastatic breast cancer and non-small cell lung cancer.

The pancreas is a gland behind the stomach that secretes enzymes into the upper part of the small intestine to help digestion. It also produces hormones, including insulin, which helps regulate the metabolism of sugars.

The incidence of pancreatic cancer is increasing worldwide with an estimated 279,000 cases per year, including nearly 44,000 in the U.S. in 2012, and resulting in more than 37,000 American deaths last year.

Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at: 480-323-1339; toll free at 1-877-273-3713; or via email at clinicaltrials@shc.org.