Metastatik kastrasyona dirençli prostat kanseri olan hastalarda lutesyum-177 prostat spesifik membran antijen radyonüklid tedavisinin terapötik etkinliği ve güvenliği
Therapeutic efficacy and safety of lutetium-177 prostate-specific membrane antigen radioligand therapy in patients with metastatic castration-resistant prostate cancer
- Tez No: 861552
- Danışmanlar: PROF. DR. ERTAN ŞAHİN
- Tez Türü: Tıpta Uzmanlık
- Konular: Radyoloji ve Nükleer Tıp, Radiology and Nuclear Medicine
- Anahtar Kelimeler: 68Ga-PSMA, hematotoxicity, 177Lu-PSMA, PSA
- Yıl: 2024
- Dil: Türkçe
- Üniversite: Gaziantep Üniversitesi
- Enstitü: Tıp Fakültesi
- Ana Bilim Dalı: Nükleer Tıp Ana Bilim Dalı
- Bilim Dalı: Belirtilmemiş.
- Sayfa Sayısı: 88
Özet
Amaç: Metastatik kastrasyona dirençli prostat kanseri (MKDPK) olan hastalarda 177Lu prostat spesifik membran antijen (PSMA) radyonüklid tedavisinin terapötik etkinliğini ve güvenliğini araştırmak amaçlanmıştır. Gereç ve Yöntem: Ocak 2018- Ocak 2023 tarihleri arasında, Gaziantep Üniversitesi Şahinbey Eğitim ve Araştırma Hastanesi Nükleer Tıp Kliniğinde altı ile sekiz hafta ara ile en az dört kür 177Lu-PSMA tedavisi alan toplam 59 MKDPK'li hasta (ort yaş: 74 ± 8,57 yıl) çalışmaya dahil edilmiştir. Hastaların tedavi öncesinde, takiplerde ve dört kür 177Lu-PSMA tedavi sonrası serum total PSA, tam kan, rutin biyokimyasal tetkikleri, 68Ga-PSMA PET/BT görüntüleri ve ECOG performans skorları değerlendirilmiştir. Biyokimyasal yanıt değerlendirmesi amacıyla, hastalar tedavi sonrası PSA değerindeki değişimler baz alınarak hastalar“Prostate Cancer Working Group-3”(PCWG-3) kriterlerine göre sınıflandırılmıştır. Moleküler yanıtı değerlendirmek için yapılan 68Ga-PSMA PET/BT görüntüleri ise“PET Response Criteria in Solid Tumors”(PERCIST 1.0) kriterlerine göre sınıflandırılmıştır. Ayrıca klinik yanıt değerlendirmesi için hastaların tedavi öncesi ve tedavi sonrası ECOG performans skalası oluşturuldu. Tedavinin hematotoksisite, nefrotoksisite ve hepatotoksisite değerlendirilmesi“Common Terminology Criteria for Adverse Events 5.0”(CTCAE v 5.0) kriterlerine baz alınarak tam kan ve biyokimya sonuçlarına göre yapılmıştır. Analizler SPSS 22.0 programıyla gerçekleştirilmiş olup anlamlılık seviyesi için p
Özet (Çeviri)
Objective: The aim of the study was to investigate the therapeutic efficacy and safety of 177Lu prostate-specific membrane antigen (PSMA) radioligand therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Materials and Metods: Between January 2018 and January 2023, a total of 59 patients with metastatic castration-resistant prostate cancer (mCRPC), with an average age of 74 ± 8.57, who received at least four cycles of 177Lu-PSMA therapy with intervals of six to eight weeks, were included in the study at the Nuclear Medicine Clinic of Gaziantep University Sahinbey Training and Research Hospital. Patients' serum total PSA levels, complete blood count, routine biochemical tests, 68Ga-PSMA PET/CT images, and ECOG performance scores were evaluated before treatment, during follow-ups, and after four cycles of 177Lu-PSMA therapy. For the purpose of assessing biochemical response, patients were classified according to the“Prostate Cancer Working Group-3”(PCWG-3) criteria based on changes in PSA levels following treatment. The 68Ga-PSMA PET/CT images obtained for evaluating molecular response were classified according to the“PET Response Criteria in Solid Tumors”(PERCIST 1.0) criteria. In addition, clinical response assessment was conducted by establishing the ECOG performance scale for patients before and after treatment. The evaluation of hematotoxicity, nephrotoxicity, and hepatotoxicity of the treatment was performed based on the results of complete blood count and biochemical tests according to the“Common Terminology Criteria for Adverse Events 5.0”(CTCAE v 5.0) criteria.. The analyses were conducted using SPSS 22.0 software, and a significance level of p < 0.05 was selected. Results: In a study comprising 59 patients, the PSA value after two treatment courses for one patient and after four treatment courses for another patient could not be obtained. After four cycles of treatment in 57 patients, the following outcomes were observed: a decrease of 50% or more in PSA levels compared to pretreatment was observed in 52.6% (n=30) of patients, a decrease of less than 50% but more than 25%, or an increase of less than 25% was observed in 10.5% (n=6) of patients, and an increase of more than 25% was observed in 36.9% (n=21) of patients. In the study involving 59 patients, one patient's 68Ga-PSMA PET/CT images could not be obtained after four treatment courses. When evaluated according to the PERCIST 1.0 criteria, the 68Ga-PSMA PET/CT results after four treatment courses in 58 patients showed a complete response in 3.4% (n=2) of patients, a partial response in 56.9% (n=33) of patients, stable disease in 6.9% (n=4) of patients, and progressive disease in 32.8% (n=19) of patients. When comparing the ECOG performance scores before and after treatment for clinical response evaluation, no statistically significant difference was observed (p=0.059). Statistically significant differences were detected in the hemoglobin levels, total leukocyte count, and platelet levels before and after four cycles of treatment in patients (p=0.001). After four cycles of treatment, no grade (G) 3-4 increases in creatinine, AST, and ALT were detected in any of the patients. Conclusion: 177Lu-PSMA therapy is considered an effective and safe treatment method for patients with metastatic castration-resistant prostate cancer (mCRPC). 177Lu-PSMA therapy is considered to be reliable in terms of hematotoxicity, nephrotoxicity, and hepatotoxicity; however, reductions in platelet and hemoglobin levels are most commonly observed during treatment. In addition, appropriate patient selection, effective and safe dose administration, and close patient monitoring are crucial due to potential toxicity risks associated with repeated treatment cycles.
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