Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0278488 (metastatic breast cancer)
 7,812 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A 47-year-old woman with metastatic breast cancer developed acute pancreatitis while receiving capecitabine. She had been receiving capecitabine 2000 mg/m2/day; however, when the dosage was increased to 2500 mg/m2/day (the maximum dosage approved by the Food and Drug Administration) she experienced abdominal pain and cramping. These symptoms were followed by nausea and vomiting, palmar-plantar erythrodysesthesia (hand-foot syndrome), and mucositis, resulting in admission to the hospital. Laboratory tests for liver function showed elevated levels of alkaline phosphatase and lactate dehydrogenase. The patient's lipase and amylase levels were also elevated, but an abdominal ultrasound was normal. After bowel rest and intravenous hydration, the patient's liver function tests and lipase and amylase levels returned to normal. Many chemotherapeutic agents have been documented to cause pancreatitis; however, we found no previously described reports of capecitabine-induced pancreatitis. Clinicians should be aware of this potential adverse effect, particularly in patients with preexisting risk factors for pancreatitis who are prescribed capecitabine.
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PMID:Capecitabine-induced pancreatitis. 1292 Dec 54

On May 24, 2019, the FDA granted regular approval to alpelisib in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Approval was based on the SOLAR-1 study, a randomized, double-blind, placebo-controlled trial of alpelisib plus fulvestrant versus placebo plus fulvestrant. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.1 in the cohort of trial participants whose tumors had a PIK3CA mutation. The estimated median PFS by investigator assessment in the alpelisib plus fulvestrant arm was 11.0 months (95% CI: 7.5, 14.5) compared with 5.7 months (95% CI: 3.7, 7.4) in the placebo plus fulvestrant arm (HR 0.65; 95% CI: 0.50, 0.85; two-sided p=0.001). The median overall survival (OS) was not yet reached for the alpelisib plus fulvestrant arm (95% CI: 28.1, NE) and was 26.9 months (95% CI: 21.9, NE) for the fulvestrant control arm. No PFS benefit was observed in trial participants whose tumors did not have a PIK3CA mutation (HR = 0.85; 95% CI: 0.58, 1.25).The most common adverse reactions, including laboratory abnormalities, on the alpelisib plus fulvestrant arm were increased glucose, increased creatinine, diarrhea, rash, decreased lymphocyte count, increased gamma glutamyl transferase, nausea, increased alanine aminotransferase, fatigue, decreased hemoglobin, increased lipase, decreased appetite, stomatitis, vomiting, decreased weight, decreased calcium, decreased glucose, prolonged activated partial thromboplastin time, and alopecia.
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PMID:FDA Approval Summary: Alpelisib plus fulvestrant for patients with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer. 3316 57