Pulmonary toxicity of cancer immunotherapies has emerged as an important clinical event that requires prompt identification and management. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism. A diagnosis of pneumonitis may mean that you'll have to make changes to your lifestyle to protect your health. If it's caused by Keytruda or radiation: - Will we stop Keytruda immediately? All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Various grades of visual impairment, including blindness, can occur. Our mission is to provide practice-focused clinical and drug information that is reflective of current and emerging principles of care that will help to inform oncology decisions. In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein‑bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. Monitor liver enzymes before initiation of and periodically throughout treatment. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2–4, n=116), ALT resolved to Grades 0–1 in 94%. Hepatitis resolved in 79% of the 19 patients. Thus, discriminating between radiation- and ICB- related pneumonitis is of importance for the increasing … cHL = classical Hodgkin lymphoma; CRC = colorectal cancer; cSCC = cutaneous squamous cell carcinoma; dMMR = mismatch repair deficient; FU = fluorouracil; HNSCC = head and neck squamous cell carcinoma; MCC = Merkel cell carcinoma; Before prescribing KEYTRUDA, please read the accompanying, Metastatic or Unresectable, Recurrent HNSCC, Early identification and management are essential to ensure safe use of. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent. Prednisone 1 to 2 mg/kg/day can be given with a taper of 5 to 10 mg/week over 4 to 6 weeks. This case illustrates the impressive appearances that immunotherapy-induced pneumonitis can have on imaging. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Not Keytruda, but I did this with Opdivo after I developed low grade (Stage 0-1) Pneumonitis about six months after starting it. Infections need to be ruled out. Bleomycin is a chemotherapy agent commonly used for the treatment of Hodgkin's lymphoma and embryonal carcinomas. Diagnosis depends on clinical and radiographic findings. The development of pulmonary immune-related adverse events (irAEs) in patients undergoing PD-(L)1 targeted checkpoint inhibitors are rare, but may be life-threatening. 49 –51 Infliximab has become a commonly used agent for treating steroid-refractory irAEs that develop during ICI therapy. My oncologist has not prescribed steroids or antibiotics and said he is very unsure of how to proceed. Thus, in a patient in whom pneumonitis is suspected, providers must also consider competing causes for the clinical presentation, such as lung infection and/or … A. Mina2; 1Medicine, Lenox Hill Hospital, New York, NY, United States, 2Lenox Hill Hospital, New York, NY, United States. Doctors frequently detect abnormalities via chest Xray or CT scan, often in the absence of any symptoms. It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. Helpful Tool MSI-H = microsatellite instability-high; dMMR = mismatch repair deficient. Register now at no charge to access unlimited clinical news, full-length features, case studies, conference coverage, and more. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Two months after initial presentation for pneumonitis, patient was treated for multi-drug resistant Pseudomonas pneumonia and discharged on hospice care. Interstitial lung disease is the most common syndrome; it may progress to end-stage pulmonary fibrosis. Drug-induced lung disease can result from a number of agents and may have a myriad of presentations, ranging from an adult respiratory distress syndrome type picture to established pulmonary fibrosis.. Due to this, it can be extremely difficult to pinpoint the offending agent on imaging appearances alone and correlation with the medical history is mandatory. None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Consider monitoring more frequently as compared to when the drugs are administered as single agents. 3 It can occur anytime, but commonly manifests a few months after initiation of treatment. Laboratory abnormalities (Grades 3–4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%). Withhold KEYTRUDA depending on severity. Keytruda (pembrolizumab) [prescribing information]. Withhold or permanently discontinue KEYTRUDA depending on severity. Nishino M, Sholl LM, Hodi FS, Hatabu H, Ramaiya NH. For patients receiving pembrolizumab, treatment should be withheld for grade 2 pneumonitis, and permanently discontinued for grade 3, grade 4, or recurrent grade 2 pneumonitis. In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. Anti-programmed death 1 (PD-1) immune checkpoint inhibitors enhance the antitumour activity of the immune system and have produced durable tumour responses in several solid tumours including non-small cell lung cancer (NSCLC). Among REMICADE-treated patients, serious infections included pneumonia, cellulitis, abscess, skin ulceration, sepsis, and bacterial infection. The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%). Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for moderate or more severe pneumonitis, followed by corticosteroid taper. KEYTRUDA can cause immune-mediated nephritis. Thus, in a patient in whom pneumonitis is suspected, providers must also consider competing causes for the clinical presentation, such as lung infection and/or … Institute medical management promptly, including specialty consultation as appropriate. Thanks, Anh For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Follow patients closely for evidence of transplant-related complications such as hyperacute GVHD, acute and chronic GVHD, hepatic VOD, and steroid-requiring febrile syndrome. A 67-year-old male with advanced lung adenocarcinoma developed pneumonitis two weeks after a single dose of first-line pembrolizumab. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. After Keytruda, I definitely had more arthritic symptoms. Introduction: Programmed death receptor-1 blockade with pembrolizumab is approved by the US Food and Drug Administration to treat patients with metastatic melanoma. Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), vomiting (30%), leukopenia (30%), upper respiratory tract infection (29%), neutropenia (26%), headache (25%), and Grade 3 anemia (17%). All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Metastatic or Unresectable, Recurrent (M/uR) HNSCC, High-Risk Non-muscle Invasive Bladder Cancer, Advanced Esophageal Squamous Cell Carcinoma, Monitoring and Managing Adverse Reactions, A central resource for information on dosing, immune-mediated adverse reactions, mechanism of action, and support resources. Becaues it was low grade and did not meet the criteria for "Steroids" so they put me on treatment breaks and monitored it via CT Scans. The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%). Radiation pneumonitis is a fairly common complication of radiation treatment to the chest, usually for lung cancer or breast cancer. Withhold or permanently discontinue KEYTRUDA depending on severity. Standard management for those with severe colitis includes administration of systemic corticosteroids with the reservation of antitumor necrosis factor (anti-TNF) therapy, such as infliximab, if there has bee… It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. 1 Because drug-related pneumonitis is a manifestation of lung response to these injuries, response patterns are limited to several types of histopathologic manifestations that are … CancerTherapyAdvisor.com is a free online resource that offers oncology healthcare professionals a comprehensive knowledge base of practical oncology information and clinical tools to assist in making the right decisions for their patients. KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. For patients receiving pembrolizumab, treatment should be withheld for grade 2 pneumonitis, and permanently discontinued for grade 3, grade 4, or recurrent grade 2 pneumonitis. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (eg, endocrinopathies and dermatologic reactions) are shown below. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). 1, 2 A broad spectrum of bleomycin‐induced pulmonary toxicities have been well described as a complication of such therapy, the most common variant of which is bleomycin‐induced pneumonitis (BIP). Opdivo (nivolumab) [prescribing information]. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407. Among three patients with melanoma receiving anti–PD-1 antibodies, the use of checkpoint blockers led to the development of serious autoimmune pneumonitis, a potentially lethal complication. The 48 patients cell death 1 inhibitor-related pneumonitis in patients with increased ALT received systemic corticosteroids were required in %... ) ; additional immunosuppressant therapy was required in 94 % ( 7 ) of patients the patients with melanoma NSCLC! With increased ALT received systemic corticosteroids were required in 68 % ( 3 ) of patients each air causes. Interplay between pop culture and science KEYTRUDA as a monotherapy you are to! 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Diagnosis of patients to distinguish pneumonitis from other lung disorders, you 'll have to say that every scan more! After a single dose of first-line pembrolizumab the use of disease progression: from! Or permanently discontinue KEYTRUDA depending on severity of the few reported cases of corticosteroid-refractory colitis, consider repeating infectious to!