The New England journal of medicine · 2025
Bevacizumab and Erlotinib in Hereditary and Sporadic Papillary Kidney Cancer.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
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Srinivasan Ramaprasad, Gurram Sandeep, Singer Eric A, Sidana Abhinav, Al Harthy Munjid, Ball Mark W, Friend Julia C, Mac Lisa, Purcell Erin, Vocke Cathy D, Ricketts Christopher J, Kong Heidi H, Cowen Edward W, Malayeri Ashkan A, Shih Joanna H, Merino Maria J, Linehan W Marston
Аннотация
BACKGROUND: Hereditary leiomyomatosis and renal-cell cancer (HLRCC) is an inherited disorder characterized by germline pathogenic variants in the gene encoding fumarate hydratase and an increased risk of papillary renal-cell carcinoma. No effective therapy is known for patients with advanced HLRCC-associated papillary renal-cell carcinoma, and most patients die from progressive disease.
METHODS: In this open-label, phase 2 study, we evaluated the efficacy of bevacizumab (10 mg per kilogram of body weight every 2 weeks) and erlotinib (150 mg once daily) in patients with advanced HLRCC-associated or sporadic papillary renal-cell carcinoma. The primary end point was overall response; secondary end points included progression-free and overall survival.
RESULTS: A total of 43 patients with HLRCC-associated papillary renal-cell carcinoma and 40 patients with sporadic papillary renal-cell carcinoma were enrolled. A confirmed response occurred in 31 patients (72%; 95% confidence interval [CI], 57 to 83) with HLRCC-associated papillary renal-cell carcinoma; the median progression-free survival was 21.1 months (95% CI, 15.6 to 26.6), and the median overall survival was 44.6 months (95% CI, 32.7 to could not be estimated). A confirmed response occurred in 14 patients (35%; 95% CI, 22 to 51) with sporadic papillary renal-cell carcinoma, with a median progression-free survival of 8.9 months (95% CI, 5.5 to 18.3) and a median overall survival of 18.2 months (95% CI, 12.6 to 29.3). The most common treatment-related adverse events were acneiform rash (93%), diarrhea (89%), and proteinuria (78%). The most common treatment-related adverse events of grade 3 or higher were hypertension (34%) and proteinuria (17%).
CONCLUSIONS: The combination of bevacizumab and erlotinib showed antitumor activity in patients with HLRCC-associated or sporadic papillary renal-cell carcinoma. Toxic effects were those known to be associated with this combination. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT01130519.).
METHODS: In this open-label, phase 2 study, we evaluated the efficacy of bevacizumab (10 mg per kilogram of body weight every 2 weeks) and erlotinib (150 mg once daily) in patients with advanced HLRCC-associated or sporadic papillary renal-cell carcinoma. The primary end point was overall response; secondary end points included progression-free and overall survival.
RESULTS: A total of 43 patients with HLRCC-associated papillary renal-cell carcinoma and 40 patients with sporadic papillary renal-cell carcinoma were enrolled. A confirmed response occurred in 31 patients (72%; 95% confidence interval [CI], 57 to 83) with HLRCC-associated papillary renal-cell carcinoma; the median progression-free survival was 21.1 months (95% CI, 15.6 to 26.6), and the median overall survival was 44.6 months (95% CI, 32.7 to could not be estimated). A confirmed response occurred in 14 patients (35%; 95% CI, 22 to 51) with sporadic papillary renal-cell carcinoma, with a median progression-free survival of 8.9 months (95% CI, 5.5 to 18.3) and a median overall survival of 18.2 months (95% CI, 12.6 to 29.3). The most common treatment-related adverse events were acneiform rash (93%), diarrhea (89%), and proteinuria (78%). The most common treatment-related adverse events of grade 3 or higher were hypertension (34%) and proteinuria (17%).
CONCLUSIONS: The combination of bevacizumab and erlotinib showed antitumor activity in patients with HLRCC-associated or sporadic papillary renal-cell carcinoma. Toxic effects were those known to be associated with this combination. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT01130519.).
Предметные рубрики MeSH
AdultAgedFemaleHumansMaleMiddle AgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Renal CellErlotinib HydrochlorideKidney NeoplasmsLeiomyomatosisNeoplastic Syndromes, HereditaryProgression-Free SurvivalResponse Evaluation Criteria in Solid TumorsKaplan-Meier EstimateTreatment OutcomeAdministration, OralInfusions, IntravenousSkin NeoplasmsUterine Neoplasms