Those with current evidence of leptomeningeal disease, known human immunodeficiency virus infection or active hepatitis B or C infection, or neuropathy, among others, were not eligible to participate.The primary end point of the trial was PFS, and key secondary end points included overall survival, objective response rate per IRC, disease control rate per IRC, central nervous system (CNS) ORR in those with CNS metastases at baseline per IRC, CNS PFS in patients with CNS metastases at baseline or a history of CNS metastases in the intent-to-treat population, and CNS OS in patients with CNS metastases at baseline or a history of CNS metastases.With regard to safety, the combination of tesetaxel plus reduced-dose capecitabine was found to have a manageable toxicity profile that proved to be consistent with data from previous trials examining the agents. 9,10 The goal of this prospective study was to analyze the feasibility of capecitabine therapy using a tailored-dose strategy in terms of dose intensity (DI), tolerability, and efficacy in elderly CC … 2 tablets Sinemet ® 12.5 mg/50 mg is equivalent to 1 tablet Sinemet ® Plus 25 mg/100 mg. For Sinemet … Grade 3 or higher treatment-emergent adverse effects (AEs) that were reported in 5% or more patients included neutropenia (71.2% with the combination and 8.3% with the monotherapy), diarrhea (13.4% vs 8.9%, respectively), hand-foot syndrome (6.8% vs 12.2%), febrile neutropenia (12.8% vs 1.2%), fatigue (8.6% vs 4.5%), hypokalemia (8.6% vs 2.7%), leukopenia (10.1% vs 0.9%), and anemia (8.0% vs 2.1%).In 1% or more of patients, some AEs with the combination and the monotherapy resulted in treatment discontinuation; these included neutropenia or febrile neutropenia (4.2% vs 1.5%, respectively), neuropathy (3.6% vs 0.3%), diarrhea (0.9% vs 1.5%), and hand-foot syndrome (0.6% vs 2.1%). This dose reduction was not associated with any increased risk of progression or resistance to treatment in fact there was slightly better controlled disease in those whose dose reduced by 25% in the oral capecitabine arm (the above dose) CYCLE FREQUENCY AND NUMBER OF CYCLES … Management of Capecitabine Toxicities in Breast Cancer May Be Better With Dose Reduction. Toxicities associated with capecitabine may be better managed by dose reductions and/or a week-on/week-off (WOWO) dosing schedule among patients aged 70 years or older with metastatic breast cancer. And, it’s off-patent and cheap.” Final OS data from the trial are anticipated to read out in 2022.“The clinically meaningful PFS improvement observed in CONTESSA, along with the once-every-3-week oral dosing and low rates of clinically significant hair loss and neuropathy, could make tesetaxel an important new treatment option for patients with metastatic breast cancer,” Andrew Seidman, MD, attending physician of Breast Medicine Service in the Department of Medicine and medical director of Bobst International Center at Memorial Sloan Kettering Cancer Center; a professor of medicine at Weill Cornell Medical College, and co-principal investigator of CONTESSA, added in the press release.Odonate Therapeutics will submit the results from the pivotal phase 3 trial for presentation at an upcoming medical meeting. Treatment discontinuation because of any toxicity was reported in more patients treated with the combination compared with the monotherapy, at 23.1% versus 11.9%, respectively.Additionally, grade 2 alopecia was reported in 8.0% of patients who received the combination versus 0.3% of patients who received capecitabine alone. November 1, 2016. Of those receiving that dose, 27% to 50% require a dose reduction due to toxicity.The starting dose and schedule for capecitabine at The Royal Marsden Hospital and NHS Foundation Trust is 2000 mg/mBecause capecitabine is metabolized by the liver and cleared renally, a switch to a WOWO schedule is being substituted in order to improve tolerance in the elderly. fluorouracil, the active moiety of capecitabine . DPD deficient patients are at a greater risk of severe capecitabine-related toxicities. Tesetaxel in combination with a reduced dose of capecitabine led to a significant improvement in progression-free survival (PFS) versus the approved dose of capecitabine …
The proportions are expressed in the form x/y where x and y are the strengths in milligrams of carbidopa and levodopa respectively. “This enabled them to stay on their dose for a longer time, despite their poor performance status and impaired kidney function, which is usually a contraindication for this drug.“Capecitabine toxicity can be managed by dose reduction and/or a switch to a WOWO schedule; both strategies enabled continued treatment in those deriving clinical benefit,” he concluded.Additionally, he added that the study’s findings revive the use of capecitabine for these patients with metastatic breast cancer.“In many respects, the major conferences are all about getting new drugwhich get us very excited for a while—and then we forget about them sooner or later after a few years.