From APhA: Nanaz Amini, PharmD, RPh, MS, on Diagnosing, Assessing, and Treating Melanoma

In March, Pharmacy Times^® interviewed Nanaz Amini, PharmD, RPh, MS, of the Angeles Clinic & Research Institute, regarding the diagnosis and treatment of melanoma, as well as T-VEC treatment and everything involved in its administration. The following are some key points she made, which have been edited and condensed.

BURDEN AND DISEASE CHARACTERISTICS OF MELANOMA

Melanoma is the second in line for life years lost for our patients who are in their 20s and 30s. It seems that the younger the patients are, the burden of loss is a lot more, obviously. And the prognosis when you have melanoma at a younger age is very grim. One person dies of melanoma every hour. They project that in just this year, there will be about 9700 patients diagnosed with melanoma.

Obviously, the staging of melanoma is stage 0, which is really nothing, and then stages I through IV. Patients who are in stage 1 usually have about a 5-year survival rate of 95%. It also depends on age. A patient could have a mole, which is stage I. It may be removed and there’s no reoccurrence, but it depends on if it’s ulcerated or not, and that can increase within 1 year. There are patients who are diagnosed—but not until they have like a stage III. So, that prognosis is very grim in the sense of going from stage III to stage IV. It may take not a lot of time. It also depends on the kind of melanoma they have.

DIAGNOSIS AND ASSESSMENT OF MELANOMA

[Many] patients go to dermatologists and they have just an annual checkup to see if they have moles, if they need to be removed, and then those are biopsied. However, sometimes assessment is as simple as when a patient feels a lump or something they think is a problem, and then they go to the doctor. So, it’s self-assessment. [Those] who are little more vigilant might go to a dermatologist and it’s assessed there.

Staging is basically done based on the thickness, the size of the tumor, whether the tumor is ulcerated or not ulcerated, and whether there’s nodal involvement and it’s metastasized. Usually that staging is done by the medical oncologist. But..., if there is a mole that’s removed...surgically or just by a biopsy in the dermatologist’s office and sent for pathology, that is the other method that’s used.

Regarding diagnostic tools that are used, as a whole, the first thing you’re going to do is assess a patient’s medical history to determine what drugs can be used. Also, you’ll see there are a lot of patients who come in and, long term, there’s a lot of family cancer in them. You might see that they have a sister, a brother, a mother, someone who has had a cancer or melanoma itself. So, that also helps. Basically, doctors realize that it runs in the family tree.

And then, in addition to that now—pretty much standard for not just for clinical trials, but just standard, especially in the field of melanoma—there’s genetic testing that’s done straight out the gate. We can now know if the patient is BRAF-positive or BRAF-negative. The original targeted therapy that was first approved, which was Zelboraf

(vemurafenib), was actually approved with an FDA-approved lab test. And that’s what has been the trend.

TREATMENT OF MELANOMA

Immunotherapy is first line. Yervoy (ipilimumab) is one. If you ... fail with Yervoy, Keytruda (pembrolizumab) or Opdivo (nivolumab) can be used. These therapies are wonderful in the sense that the adverse effects relative to what was standard of care, and the cytotoxic agents that were used previously are fewer. Infusion reactions are truly minimal, and I can say for the hundreds of patients that we’ve treated with just Keytruda, I have seen 1 patient who had a reaction. These therapies have been good for nurses, for the practice as a whole because infusion reactions [bring other patients’ infusions to a halt] because [staff must] manage that one patient.

Combination therapy, I would say, is going to become first line, as opposed to just immunotherapy, because you’re hitting a cancer from 2 different pathways. These days, if somebody has BRAF-positive disease, we will give them Tafinlar (dabrafenib) and Mekinist (trametinib), or Cotellic (cobimetinib) and Zelboraf (vemurafenib), with an immunotherapy tacked on.

The targeted therapy is basically targeting the proteins that are sitting on the cancer cells. It attacks and really reduces the size of the tumor, and then the immunotherapy that you’re giving as an infusion helps boost the immune system to fight the cancer. So, you’re working in 2 different pathways to come out with the same results. And the adverse effects, not that they don’t exist, but you’re going to get a much more durable response with combinatorial therapy down the line.

USE, PRODUCT STORAGE, DISPENSING, AND ADMINISTRATION OF T-VEC

In the final 3 segments of her interview, Dr. Amini discusses patient appropriateness and her protocol for administering T-VEC in melanoma patients. Additionally, she provides suggestions to health care professionals and patients alike for consideration before and after an injection. She further advises health care professionals on the proper storage and administration of T-VEC for appropriate patients with melanoma.

Finally, she highlights additional considerations that are important for both patients and health care professionals to acknowledge when handling and administering, or receiving, T-VEC treatment.