Usual starting dose of regorafenib? For a 75 yo pt?


Usual starting dose of regorafenib? For a 75 yo pt?

In general, what is the usual starting dose of regorafenib that you use?

What is the starting dose that you use for a 75-year-old patient?

Steven R Alberts, MD, MPH
Chair, Division of Medical Oncology
Professor of Oncology
Mayo Clinic
Rochester, Minnesota
Answer: 120 mg; 80 mg

I usually start regorafenib at a dose of 120 mg because many of my patients have experienced immediate problems when started at 160 mg. Hence, I am reluctant to start at 160 mg. It appears that patients tolerate regorafenib better on clinical trials than in general practice. This may be because of the selection of patients on the trials.

For a 75-year-old patient, I would start regorafenib at a dose of 80 mg. I’ve observed some fairly significant toxic effects of regorafenib in patients close to 80 years of age. If the patient tolerates treatment well at that dose, I would try to increase the dose to 120 mg.

Al B Benson III, MD
Professor of Medicine
Associate Director for
Clinical Investigations
Robert H Lurie Comprehensive
Cancer Center of
Northwestern University
Chicago, Illinois
Answer: 160 mg; Based on performance status

In general, I usually start regorafenib at a dose of 160 mg, but this depends on the performance status of the patient. If I were a bit concerned, I would reduce to a starting dose of 120 mg.

For a 75-year-old patient, the starting dose of regorafenib depends on the patient’s performance status.

Charles S Fuchs, MD, MPH
Director
Center for Gastrointestinal Cancer
Dana-Farber/Harvard Cancer Center
Professor of Medicine
Harvard Medical School
Boston, Massachusetts
Answer: 120 mg; 80 mg

I used to start regorafenib therapy at a dose of 160 mg. In the past few months, I have started at 120 mg, except for situations in which the patient was really young. For a few elderly patients, I have started at 80 mg/d before deciding on whether to dose escalate.

Many oncologists are struggling with the starting dose for regorafenib because of the learning curve to gain experience with it. Most oncologists did not have experience with regorafenib before it was approved by the FDA because most of the enrollment to the CORRECT trial was conducted in Europe.

Richard M Goldberg, MD
Professor of Medicine
Physician-in-Chief, OSUCCC -
James Cancer Hospital and
Richard J Solove Research Institute
Klotz Family Chair in Cancer Research
The Ohio State University
Columbus, Ohio
Answer: 120 mg; 120 mg

I usually start regorafenib therapy at a dose of 120 mg, but none of my patients tolerate the drug at this dose. Currently, my starting dose is still 120 mg, even for patients who are 75 years of age.

Axel Grothey, MD
Professor of Oncology
Department of Medical Oncology
Mayo Clinic
Rochester, Minnesota
Answer: 120 mg; 120 mg

In general, I usually start regorafenib therapy at a dose of 120 mg. With regorafenib, the toxic effects are experienced early, within the first cycle of the normal 3 weeks on, 1 week off treatment regimen. I follow up with my patients, if possible, by scheduling weekly visitations to the clinic. If not, we schedule at least one telephone contact with the patients once a week.

All patients are seen after 2 weeks of initiating regorafenib therapy for liver enzyme assessments. At this time I make a judgment call on whether to continue therapy or to escalate to a dose of 160 mg. Some patients do not experience any side effects at 120 mg/d. After escalating to 160 mg of regorafenib, I will reassess the situation after 2 weeks of treatment at this dose.

If the patient were 75 years old, I would start regorafenib at 120 mg. In fact, we presented some data at ASCO 2012 demonstrating that the patient’s age does not influence the dose intensity of regorafenib that could be received by patients (Van Cutsem E et al. Proc ASCO 2013;Abstract 3636).

Howard S Hochster, MD
Associate Director (Clinical Research)
Yale Cancer Center
Professor of Medicine
Yale School of Medicine
New Haven, Connecticut
Answer: 160 mg; Based on performance status

I usually try to start regorafenib at a dose of 160 mg, but most patients require dose reductions. For patients with a performance status of 2, I treat at a starting dose of 120 mg. In general, if I have any concerns about a patient, I start at 120 mg.

My choice of starting dose for a 75-year-old patient would depend primarily on the patient’s physiological age rather than the chronologic age.

Herbert I Hurwitz, MD
Associate Professor of Medicine
Division of Hematology/Oncology
Clinical Director, Phase I Program
Co-leader, GI Oncology Program
Duke University Medical Center
Durham, North Carolina
Answer: 120 mg; Not sure would use for 75 yo

I usually start treatment with regorafenib at 120 mg. If it’s tolerated, I escalate to a higher dose.

Regorafenib was tested in patients with a performance status (PS) of 0 to 1. Few 75-year-old patients fall into this category. So a 75-year-old patient enrolled on the study would have to have been an atypically fit patient. For this reason, I am uncertain that I would administer regorafenib to a 75-year-old patient with a PS higher than 1.

Wells A Messersmith, MD
Professor and Director
GI Medical Oncology Program
Co-Leader
Developmental Therapeutics Program
University of Colorado Cancer Center
Aurora, Colorado
Answer: 160 mg; 160 mg but use 80 mg 1st 5 days

In general, I start regorafenib therapy at a dose of 160 mg.

For elderly patients, I usually prescribe regorafenib at 160 mg. However, I tend to ask the patient to use half of this dose, at least for the first 5 to 7 days, in order to ensure that the patient does not develop any major side effects.