Over (yumurtalık) kanseri kadınlarda en sık görülen kanserlerden biridir. Platin bazlı kemoterapiler sonrası diğer kurtarma tedavilerinin yanıt oranı düşüktür.
Yeni bir molekül over kanseri olan ve daha önce kemoterapi görmüş nüks gelişen hastalar için bir seçenek oldu.
Mirvetuximab Soravtansine adlı molekül over kanserli hastalarda diğer kemoterapi seçeneklerine göre yanıt oranı, hastalıksız süre ve genel sağkalım yönünden avantajlı bulundu.
Mirvetuximab Soravtansine, damar yolu ile verilen, Folate receptor alpha inhibisyonu yapan bir antikor yapısında molekül.
Folate receptor alpha over kanserinde yaklaşık olarak %90 oranında kanser hücrelerinde artmış oranında bulunan bir reseptör. Bu reseptörün aşırı aktive olması kanserin metastazı ve saldırganlığını artırıyor.
Özelikle immün histokimyasal olarak yapılan incelemede yükse Folate receptor alpha ekspresyonu gösteren kanser hastalarında (%75 oranında pozitif boyanma) bu ilaç etkinliğinin standart kemoterapiye göre 3 kat daha iyi yanıtla ilişkili olduğu saptandı.
Kemoterapiye göre daha iyi tolere edilen ilacın göz toksisitesi ve pnömoni yapma riski mevcut.
Bu çalışma sonrası Amerika Birleşik Devletleri Gıda ve İlaç Dairesi (FDA) daha önce platin bazlı kemoterapi almış ve nüks gelişmiş Folate receptor alpha ekspresyonu yüksek hastalarda bu ilacın kullanımını onayladı.
Kaynak
Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer
By Matthew Stenger
Study Details
In the global open-label trial, 453 patients enrolled from sites in 21 countries beginning in February 2020 were randomly assigned to receive mirvetuximab soravtansine at 6 mg/kg every 3 weeks (n = 227) or investigator’s choice of chemotherapy (n = 226): either paclitaxel (n = 92), pegylated liposomal doxorubicin (n = 81), or topotecan (n = 53). All patients had previously received one to three lines of therapy and had high FRα tumor expression (≥ 75% of cells with ≥ 2+ staining intensity). The primary endpoint was investigator-assessed progression-free survival.
Progression-Free Survival and Other Outcomes
Median progression-free survival was 5.62 months (95% confidence interval [CI] = 4.34–5.95 months) in the mirvetuximab soravtansine group vs 3.98 months (95% CI = 2.86–4.47 months) in the chemotherapy group (P < .001).
Objective response was observed in 42.3% of patients in the mirvetuximab soravtansine group vs 15.9% of those in the chemotherapy group (odds ratio = 3.81, 95% CI = 2.44–5.94), with complete response in 5.3% vs 0%. Median response duration was 6.77 months (95% CI = 5.62–8.31 months) vs 4.47 months (95% CI = 4.17–5.82 months)
Median overall survival was 16.46 months (95% CI = 14.46–24.57 months) in the mirvetuximab soravtansine group vs 12.75 months (95% CI = 10.91–14.36 months) in the chemotherapy group (hazard ratio [HR] = 0.67, 95% CI = 0.50–0.89, P = .005).
KEY POINTS
Progression-free survival was significantly better with mirvetuximab soravtansine vs chemotherapy (median = 5.62 vs 3.98 months).
Median overall survival was significantly better with mirvetuximab soravtansine.
Adverse Events
Grade ≥ 3 adverse events occurred in 41.7% of patients in the mirvetuximab soravtansine group vs 54.1% of the chemotherapy group. The most common reported side effects included keratopathy (9.2%), blurred vision (7.8%), and dry eye (3.2%) in the mirvetuximab soravtansine group, and neutropenia (17.4%), anemia (10.1%), and fatigue (5.3%) in the chemotherapy group. Ocular adverse events of any grade occurred in 56.0% of those in the mirvetuximab soravtansine group.
Serious adverse events occurred in 23.9% vs 32.9% of patients. Adverse events led to treatment discontinuation in 9.2% of patients in the mirvetuximab soravtansine group, most commonly blurred vision and pneumonitis (3 patients each), and in 15.9% of the chemotherapy group, most commonly peripheral neuropathy (4 patients), thrombocytopenia (3 patients), and fatigue (3 patients). Fatal adverse events occurred in 2.3% vs 2.4% of patients; treatment-related death occurred in one patient in the mirvetuximab soravtansine group (due to neutropenic sepsis) and in one patient in the chemotherapy group (due to septic shock).
The investigators concluded, “Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with mirvetuximab soravtansine showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response.”
Dr. Moore, of the Stephenson Cancer Center Section of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, is the corresponding author for The New England Journal of Medicine article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
