ABSTRACT
BACKGROUND: Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2â) metastatic breast cancer (MBC). OBJECTIVE: To assess whether clinical or demographic characteristics limit access to first-line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017 and April 2020. In addition, effectiveness will be described in an exploratory analysis. METHODS: Physicians from 12 centers participated in selecting demographic and clinical characteristics, treatment, and outcome data from women with HR + /HER2- MBC treated with or without CDK4/6i in addition to hormonal in the first-line setting, in a 3:1 proportion. Kaplan-Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). RESULTS: A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). Patients in the CDK 4/6i treatment group were younger (p = 0.0011), the biopsies of the metastatic site at the moment of the relapse were most commonly performed (p = 0.0454), and had multiple metastatic sites (p = 0.0025). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6-28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. CONCLUSIONS: Younger patients, biopsies of metastatic disease and with multiple metastatic sites were more frequently treated with CDK4/6i in our daily clinical practice.
ABSTRACT
PURPOSE: To assess the efficacy, safety, and quality-of-life outcomes of doxycycline 50 or 100 mg once daily in the prevention of skin toxicity in patients undergoing chemotherapy plus anti-EGFR therapy as first-line treatment of metastatic colorectal cancer (mCRC). METHODS: Phase II, multicenter, single-arm, exploratory study was conducted in 7 Spanish hospitals. The primary study outcome was the incidence of ≥ grade 2 skin toxicities during the 6-week skin treatment period. Quality of life was assessed with the Dermatology Life Quality Index (DLQI) questionnaire. Patients had to receive either doxycycline 50 mg once daily in a first stage with 10 patients, or, if more than three patients presented ≥ grade 2 skin toxicities, the next 30 patients had to receive 100 mg once daily. RESULTS: Thirty-four patients with RAS wild-type mCRC were enrolled in the study. Ten patients were first treated with doxycycline 50 mg once daily, and the following 24 were treated with doxycycline 100 mg once daily. A total of 60.0% (95% CI 29.6-90.0) and 20.8% (95% CI 4.6-37.0) of patients who received doxycycline 50 mg/day and 100 mg/day, respectively, had at least one ≥ grade 2 skin toxicity. Patients treated with doxycycline 100 mg once daily experienced less QoL deterioration. Only 1 patient reported a mild doxycycline-related gastrointestinal adverse event. CONCLUSION: Our results suggest that doxycycline doses as low as 100 mg once daily are efficacious and well tolerated for the prevention of skin toxicity in patients with mCRC who undergo treatment with chemotherapy plus EGFR-targeted therapies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03448731.
Subject(s)
Colonic Neoplasms , Colorectal Neoplasms , Rectal Neoplasms , Skin Diseases , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Colonic Neoplasms/drug therapy , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/pathology , Doxycycline/adverse effects , Humans , Quality of Life , Rectal Neoplasms/drug therapy , Skin Diseases/etiologyABSTRACT
No disponible
Subject(s)
Humans , Male , Middle Aged , Carcinoma, Neuroendocrine/surgery , Gallbladder Neoplasms/surgery , Tomography, X-Ray Computed , Mixed Tumor, Malignant/diagnosis , Cholecystitis/diagnosisSubject(s)
Carcinoma, Neuroendocrine/pathology , Gallbladder Neoplasms/pathology , Humans , Male , Middle AgedABSTRACT
Tumour thrombosis of the inferior cava vein is usually associated with primary renal cell cancer. To our knowledge, this is the first case reported of adrenal metastasis of breast cancer extending into the inferior vena cava. There are few references in the literature documenting this extension with positron emission tomography (PET) and enhanced computed tomography (CT). The authors focus on the role of combined PET-CT imaging in the accurate detection of malignant thrombus.
