Welcome to ReachMD.
This medical industry feature, titled “COSELA® Has Helped Improve My Patient Care in ES-SCLC” is sponsored by G1 Therapeutics.
This podcast is intended for US healthcare professionals only. Dr. Sujith Kalmadi, and is an oncologist and chief medical officer from Ironwood Cancer Center in Phoenix, Arizona, is a paid consultant on behalf of G1 Therapeutics. His statements in this podcast reflect his own clinical experience with patients he has treated with COSELA.
Before we dive in, let’s take a moment to review the indication and some safety information for COSELA.
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.
I'm Sujith Kalmadi. I run...I'm part of Ironwood Cancer Center. I've been there for about 12 years. I'm the Chief Medical Officer of this company. We're physician-owned, about 42 medical oncologists, 70 oncology-related physicians, the largest private practice in Phoenix, Arizona.
So, I usually tell my patients that using this proactively will reduce your myelosuppression-related side effects.
I'm now more confident going in and telling them that we can prevent some of your side effects, and the journey hopefully will be better from that standpoint.
So, we offer it to all our extensive-stage small cell lung cancer patients on frontline and second line.
I offer it to everybody who's going through that treatment because it's a tough disease. You don't see the complications until it's too late.
By the time you decide is this patient a gold standard or not, the complications could already have happened.
So, based on the data I have, I offer it to everybody.
I think that the mechanism of action is very unique. I like the fact that it works in all three cell lines. It's given proactively, so it reduces the neutropenic complications. Plus (it’s) the only drug on the market now for thrombocytopenia prevention in patients with cancer, so I think all of those led me to use it.
And I think in my own opinion, I'm able to get more patients onto second-line treatment, because they're spared the harsh side effects of the frontline. Their performance status is better maintained when they don't have anemia. Their fatigue is lower. So, that helps me to get them onto second line, which is where the real benefit is.
I think reduction, and I would say, postponement of treatment used to be a common occurrence, so that has reduced quite a bit. Reduction in doses used to be another thing which we have been able to prevent, and then the reduction in transfusions is obviously a welcome change.
So I think it's been a very welcome addition to my armamentarium. It has reduced my side effect management a little bit. Helps with the logistics of the practice where patients don't have to be rescheduled because there's a significant impact on the chair time when you re-change a patient from one week to the next, or one week to the next two days, the whole scheduling gets impacted, so logistically it's a big change, big welcome addition to the nurses so that they don't have to go through that.
So for me, the patient-related outcomes is very important.
Fatigue always is a concern because it can change a patient's expectations as to what they can do and not do, so improving their fatigue is very important.
Some of my patients are worried about low counts delaying their treatments and having to get their loved ones to bring them back and forth for the treatments and sometimes transfusions, so definitely myelosuppression-related count issues have impacted the quality of life for patients there.
So really, it's how the patient feels. That's really what helps me decide, should I be using this drug or not?
I do look at the patient-reported outcomes in the setting of a randomized trial. There you can compare meaningful numbers and make sure that, you know, what's the effect on the quality of life? What’s the effect on their relationships? Those kind of things.
It looks very safe, and in our practice, we have a unique practice where we have central lines on all our patients, usually a port, rarely a PICC line, so the infusion-related reaction such as phlebitis is- is a non-event for us in our own practice. The rest of the abnormalities are fairly easy to manage.
So, I usually tell my patients that, you know, using this proactively will reduce your, myelosuppression-related side effects.
And to my peers, I tell them we have a novel therapy which improves myelosuppression in extensive-stage small cell lung cancer with a very tolerable safety profile.
IMPORTANT SAFETY INFORMATION
- COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions, Including Phlebitis and Thrombophlebitis
- COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.
Acute Drug Hypersensitivity Reactions
- COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.
Interstitial Lung Disease/Pneumonitis
- Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.
- Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.
- Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
- Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
- Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
- Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
- The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.
- COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).
To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This information is not comprehensive. Please see full Prescribing Information at COSELA.com
This program was sponsored by G1 Therapeutics. If you missed any part of this discussion, visit ReachMD.com/IndustryFeature. This is ReachMD. Be Part of the Knowledge.