paclitaxel
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Cáncer de mama metastásico tras fracaso de primera línea o cuando no procede antraciclina; adenocarcinoma pancreático metastásico de primera línea con gemcitabina; y cáncer de pulmón no microcítico de primera línea con carboplatino cuando no es candidato a cirugía o radioterapia curativa.
Contraindicaciones
Absolutas
- ANC basal <1.500/mm³; hipersensibilidad a nab-paclitaxel o a sus excipientes; lactancia.
Advertencias clínicas
- ABRAXANE/nab-paclitaxel no es intercambiable mg por mg con paclitaxel convencional ni con otras formulaciones. — DailyMed, set_id 135502ff-002c-4a29-ba93-60855cf44f31
- Vigila neutropenia, infección/sepsis, neuropatía periférica, neumonitis y extravasación. No reinicies un ciclo hasta ANC >1.500/mm³ y plaquetas >100.000/mm³. — DailyMed, set_id 135502ff-002c-4a29-ba93-60855cf44f31
Interacciones medicamentosas
- SeveraInhibidores o inductores de CYP2C8/CYP3A4
Mecanismo: Pueden aumentar la toxicidad o reducir la eficacia de nab-paclitaxel.
Recomendación: Evita combinaciones potentes si es posible o vigila estrechamente toxicidad y respuesta.
DailyMed, set_id 135502ff-002c-4a29-ba93-60855cf44f31
Embarazo y lactancia
Puede causar daño fetal. Realiza prueba de embarazo antes de iniciar. Las mujeres deben usar anticoncepción durante el tratamiento y durante 6 meses después; los hombres durante el tratamiento y durante 3 meses después. No amamantes. Puede afectar la fertilidad.
Bibliografía reciente (PubMed)
On the basis of phase 2 studies, trastuzumab deruxtecan was approved for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma who had previously received trastuzumab-based therapy. Ramucirumab plus paclitaxel is also a standard second-line treatment option regardless of HER2 status. We conducted an international, randomized, phase 3 trial comparing second-line trastuzumab deruxtecan at a dose of 6.4 mg per kilogram of body weight with ramucirumab plus paclitaxel in patients with HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma confirmed on tumor biopsy conducted after the patient had progression while receiving trastuzumab-based therapy. The primary end point was overall survival. Secondary end points included progression-free survival, confirmed objective response (complete or partial response lasting ≥4 weeks), disease control, duration of response, and safety. Among 494 patients who had undergone randomization, overall survival was significantly longer with trastuzumab deruxtecan than with ramucirumab plus paclitaxel (median, 14.7 vs. 11.4 months; hazard ratio for death, 0.70; 95% confidence interval, 0.55 to 0.90; P = 0.004). Significant results were also seen with regard to progression-free survival (hazard ratio for disease progression or death, 0.74; 95% CI, 0.59 to 0.92) and confirmed objective response (in 44.3% of the patients in the trastuzumab deruxtecan group vs. 29.1% of those in the ramucirumab-paclitaxel group). The incidence of drug-related adverse events of any grade was 93.0% with trastuzumab deruxtecan and 91.4% with ramucirumab plus paclitaxel; the incidence of drug-related adverse events of grade 3 or higher was 50.0% and 54.1%, respectively. Adjudicated drug-related interstitial lung disease or pneumonitis occurred in 13.9% of the patients who received trastuzumab deruxtecan (grade 1 or 2 in 33 patients and grade 3 in 1) a
Part 1 of the RUBY trial (NCT03981796) evaluated dostarlimab plus carboplatin-paclitaxel compared with placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (EC). At the first interim analysis, the trial met one of its dual primary endpoints with statistically significant progression-free survival benefits in the mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and overall populations. Overall survival (OS) results are reported from the second interim analysis. RUBY is a phase III, global, double-blind, randomized, placebo-controlled trial. Part 1 of RUBY enrolled eligible patients with primary advanced stage III or IV or first recurrent EC who were randomly assigned (1 : 1) to receive either dostarlimab (500 mg) or placebo, plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab (1000 mg) or placebo every 6 weeks for up to 3 years. OS was a dual primary endpoint. A total of 494 patients were randomized (245 in the dostarlimab arm; 249 in the placebo arm). In the overall population, with 51% maturity, RUBY met the dual primary endpoint for OS at this second interim analysis, with a statistically significant reduction in the risk of death [hazard ratio (HR) = 0.69, 95% confidence interval (CI) 0.54-0.89, P = 0.0020] in patients treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel alone. The risk of death was lower in the dMMR/MSI-H population (HR = 0.32, 95% CI 0.17-0.63, nominal P = 0.0002) and a trend in favor of dostarlimab was seen in the mismatch repair-proficient/microsatellite stable population (HR = 0.79, 95% CI 0.60-1.04, nominal P = 0.0493). The safety profile for dostarlimab plus carboplatin-paclitaxel was consistent with the first interim analysis. Dostarlimab in combination with carboplatin-paclitaxel demonstrated a statistically significant and clinically meaningful OS benefit in the overall population of patients with primary advan
Pancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with few treatment options. NAPOLI 3 aimed to compare the efficacy and safety of NALIRIFOX versus nab-paclitaxel and gemcitabine as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC). NAPOLI 3 was a randomised, open-label, phase 3 study conducted at 187 community and academic sites in 18 countries worldwide across Europe, North America, South America, Asia, and Australia. Patients with mPDAC and Eastern Cooperative Oncology Group performance status score 0 or 1 were randomly assigned (1:1) to receive NALIRIFOX (liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2, administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle or nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2, administered intravenously, on days 1, 8, and 15 of a 28-day cycle. Balanced block randomisation was stratified by geographical region, performance status, and liver metastases, managed through an interactive web response system. The primary endpoint was overall survival in the intention-to-treat population, evaluated when at least 543 events were observed across the two treatment groups. Safety was evaluated in all patients who received at least one dose of study treatment. This completed trial is registered with ClinicalTrials.gov, NCT04083235. Between Feb 19, 2020 and Aug 17, 2021, 770 patients were randomly assigned (NALIRIFOX, 383; nab-paclitaxel-gemcitabine, 387; median follow-up 16·1 months [IQR 13·4-19·1]). Median overall survival was 11·1 months (95% CI 10·0-12·1) with NALIRIFOX versus 9·2 months (8·3-10·6) with nab-paclitaxel-gemcitabine (hazard ratio 0·83; 95% CI 0·70-0·99; p=0·036). Grade 3 or higher treatment-emergent adverse events occurred in 322 (87%) of 370 patients receiving NALIRIFOX and 326 (86%) of 379 patients receiving nab-paclitaxel-gemcitabine; treatment-related deaths o
Relacorilant, a first-in-class selective glucocorticoid receptor antagonist, increases a tumour's sensitivity to chemotherapy by reducing cortisol signalling. This study aimed to show whether the addition of relacorilant to nab-paclitaxel improves progression-free and overall survival in females with platinum-resistant ovarian cancer. This randomised, controlled, open-label phase 3 trial (ROSELLA [GOG-3073/ENGOT-ov72]) was done at 117 hospitals and community oncology treatment centres in 14 countries across Australia, Europe, Latin America, North America, and South Korea. Patients had to be aged 18 years or older and had to have a confirmed diagnosis of platinum-resistant, epithelial (ie, high-grade serous, endometrioid, or carcinosarcoma with a ≥30% epithelial component) ovarian, primary peritoneal, or fallopian tube cancer; up to three previous lines of anticancer therapy and previous bevacizumab and disease progression or intolerance to the most recent therapy; measurable disease according to the Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1); an Eastern Cooperative Oncology Group performance status of 0 or 1; and adequate organ function. Patients were assigned (1:1) to relacorilant (150 mg orally the day before, of, and after nab-paclitaxel infusion) plus nab-paclitaxel (80 mg/m2 intravenously on days 1, 8, and 15 of each 28-day cycle) or nab-paclitaxel monotherapy (100 mg/m2 intravenously on the aforementioned schedule). The dual primary endpoints were progression-free survival assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours (version 1.1) and overall survival, and were assessed in all randomly assigned patients by intention to treat. The safety population included all randomly assigned patients who received at least one dose of the assigned treatment. This trial was registered at ClinicalTrials.gov, NCT05257408, and is ongoing. Between Jan 5, 2023, and April 8, 2024, 381 patients were randoml
Retifanlimab has activity in programmed death ligand 1-positive advanced squamous cell anal carcinoma (SCAC) that has progressed on platinum chemotherapy. We aimed to prospectively assess the benefit of adding retifanlimab to initial carboplatin-paclitaxel for this disease. This global, multicentre, double-blind, randomised, controlled, phase 3 trial was done at 70 centres in 12 countries across the EU, Australia, Japan, the UK, and the USA. Patients aged ≥18 years with inoperable locally recurrent or metastatic SCAC, an Eastern Cooperative Oncology Group performance status of 0 or 1, no previous systemic therapy, and well controlled HIV (ie, CD4+ count >200/μL and undetectable viral load) were eligible. Patients were randomly assigned (1:1) to retifanlimab (500 mg intravenous) or placebo every 4 weeks with standard carboplatin-paclitaxel for up to 1 year. Patients in the placebo group could cross over to retifanlimab monotherapy on confirmed disease progression. The primary endpoint was independently assessed progression-free survival (ie, time from date of randomisation to date of first documented progressive disease or death due to any cause) per Response Evaluation Criteria in Solid Tumours version 1.1. Efficacy was assessed by intention to treat. This trial is registered with ClinicalTrials.gov (NCT04472429) and EUDRA-CT (2020-000826-24) and is active but closed to enrolment. Between Nov 12, 2020, and July 3, 2023, 376 patients were assessed for eligibility and 308 were randomly assigned to retifanlimab plus carboplatin-paclitaxel (n=154) or placebo plus carboplatin-paclitaxel (n=154). 222 (72%) of 308 patients were female and 86 (28%) were male. Median progression-free survival was 9·3 months (95% CI 7·5-11·3) in the retifanlimab group and 7·4 months (7·1-7·7) in the placebo group (hazard ratio 0·63 [95% CI 0·47-0·84]; one-sided p=0·0006). Serious and grade 3 or worse adverse events were more frequent in the retifanlimab plus carboplatin-paclitaxel group compa