(Urothelial Carcinoma) Is Gemcitabine Plus Eribulin Effective?
Medical Supporter — Мэдээллийн мэдэгдэл
Энэ нийтлэл нь олон улсын эмнэлгийн мэдээллийн эмхэтгэл бөгөөд эмнэлгийн зөвлөгөө биш; таны эмчийн оношлогоо, эмчилгээний төлөвлөгөөг орлохгүй. Энд буй мэдээлэл нь Японы томоохон эмнэлгийн байгууллагуудын нээлттэй эх сурвалжаас эмхэтгэсэн бөгөөд аливаа эмчилгээний тохиромж, үр дүн өвчтөн бүрээр өөр тул мэргэшсэн эмч тус бүрчлэн үнэлэх ёстой.
- September 10, 2019
- Reading time: 2 minutes
On August 7, 2019, Sarmad Sadeghi published in the Journal of Clinical Oncology the Phase 2 trial results: "Efficacy and safety of gemcitabine plus eribulin in platinum-ineligible patients with metastatic urothelial carcinoma."
Trial Design
This trial enrolled patients with platinum-ineligible metastatic urothelial carcinoma (defined as creatinine clearance <60 mL/min, or Grade 2 neurotoxicity or hearing impairment). Treatment was gemcitabine 1000 mg/m² + eribulin 1.4 mg/m² on Days 1 and 8 of each 21-day cycle. Primary endpoint: ORR. Secondary endpoints: PFS, OS.
Background: Gemcitabine plus carboplatin and immune checkpoint inhibitors are standard treatments for cisplatin-ineligible metastatic urothelial carcinoma. However, the FDA restricted the use of immune checkpoint inhibitors as first-line therapy in patients with low PD-L1 expression. This trial therefore evaluated gemcitabine plus eribulin in cisplatin-ineligible metastatic urothelial carcinoma.
Patient Characteristics
- Median age: 73 years (range 62–88)
- <70 years: 46% | ≥70 years: 54%
- Sex: Male 17% / Female 83%
- Race: White 92% / Hispanic 4% / Asian 4%
- Disease: Locally advanced 21% / Metastatic 79%
- ECOG performance status: 0 (46%) / 1 (46%) / 2 (8%)
- Baseline eGFR: ≥60 mL/min: 25% / <60 mL/min: 75%
Efficacy Results
- ORR (primary endpoint): 50% (complete response 4%, partial response 46%)
- Median OS: 11.9 months
- Median PFS: 5.3 months
Safety Profile
Most common adverse events: fatigue (83%), neutropenia (79%), anemia (63%), alopecia (50%), AST elevation (50%), constipation (42%), nausea (42%), thrombocytopenia (42%)
Most common Grade 3–4 adverse events: neutropenia (63%), anemia (29%), fatigue (29%)
Conclusions
Based on the Phase 2 trial results, Sarmad Sadeghi concluded that gemcitabine plus eribulin improved ORR, PFS, and OS in platinum-ineligible patients with metastatic urothelial carcinoma.
Source: Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). J Clin Oncol. 2019 Aug 7.
Tags: #UrothelialCarcinoma
- Clinical trial drug
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Японд эмчлүүлэхээр төлөвлөж байна уу? Мэдээлэл, тусламж хэрэгтэй юу?
Бид Японд эмчлүүлэхэд шаардлагатай мэдээллийг эмхэтгэх, Японы эмнэлгийн байгууллагуудтай холбогдох, хоёр дахь саналын зөвлөгөө зохион байгуулахад тусална.Анхны зөвлөгөө үнэгүй; зөвлөх таны дараагийн алхмыг тодорхой болгоход тусална.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5