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OUR CHEMOTHERAPY RESULTS IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC UROTHELIAL CANCER

Yıl 2025, Cilt: 7 Sayı: 3, 128 - 135, 26.12.2025
https://doi.org/10.55895/sshs.1728210

Öz

This study evaluated the impact of substituting cisplatin with carboplatin in the first-line treatment and using single-agent gemcitabine as maintenance therapy on progression-free survival (PFS) and overall survival (OS) in patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin. In addition, patients who received four cycles versus six cycles of cisplatin–gemcitabine or carboplatin–gemcitabine were compared. A total of 80 patients treated between January 2018 and January 2023 were retrospectively analyzed. Variables such as sex, age, tumor localization, sites of metastasis, number of chemotherapy cycles, and use of maintenance gemcitabine were evaluated. Kaplan-Meier method was used to compare survival and progression-free survival (PFS) between different clinical parameter groups, p-value <0.05 was considered statistically significant. The median OS was 23 months in female patients and 21 months in male patients. Median PFS was 46 months in males and 29 months in females, which was considered significant (p = 0.051). All patients received either cisplatin–gemcitabine or carboplatin–gemcitabine; among them, 24 patients received gemcitabine as maintenance therapy. The median PFS for the overall cohort was 6.7 months. In those who received gemcitabine maintenance, PFS was 46.7 months and considered statistically significant (p = 0.031), although no additional benefit was observed in OS. No OS difference was found
between patients receiving four versus six cycles of chemotherapy; however, PFS was 18 months in
patients who received four cycles compared with 59 months in those who received six cycles, which
was significantly longer (p = 0.026). Maintenance therapy with gemcitabine and completing six cycles
of chemotherapy may provide a favorable effect on PFS. These findings should be validated in larger, multicenter, prospective studies in advanced urothelial carcinoma.

Kaynakça

  • Bladder cancer: ESMO practice guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 25(Suppl 3).
  • Boustead, G. B., Fowler, S., Swamy, R., Kocklebergh, R., & Hounsome, L. (2014). Stage, grade, and pathological characteristics of bladder cancer in the UK: British Association of Urological Surgeons (BAUS) urological tumor registry. BJU International, 113(6), 924–930.
  • Cathomas, R., Lorch, A., Bruins, H. M., et al. (2021). The 2021 updated European Association of Urology guidelines on metastatic urothelial carcinoma. European Urology, 81, 95–103.
  • Chen, C. H., Dickman, K. G., Moriya, M., Zavadil, J., Sidorenko, V. S., Edwards, K. L., et al. (2012). Aristolochic acid-associated urothelial cancer in Taiwan. Proceedings of the National Academy of Sciences, 109(21), 8241–8246. Dash, A., Galsky, M. D., Vickers, A. J., et al. (2006). Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer, 107(3), 506–513.
  • De Santis, M., Bellmunt, J., Mead, G., et al. (2009). Randomized phase II/III trial assessing gemcitabine/carboplatinandmethotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: Phase II—results of EORTC study 30986. Journal of Clinical Oncology, 27(33), 5634–5639.
  • De Santis, M., Bellmunt, J., Mead, G., et al. (2012). Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. Journal of Clinical Oncology, 30, 191–199.
  • EAU Guidelines (2024): Strong recommendation for maintenance avelumab after 4–6 cycles of platinum-based chemotherapy in advanced or metastatic urothelial carcinoma. European Society for Medical Oncology. (2019, December 16). eUpdate: Bladder cancer treatment recommendations.
  • Flaig, T. W., Spiess, P. E., Agarwal, N., et al. (2018). NCCN guidelines insights: Bladder cancer, version 5.2018. Journal of the National Comprehensive Cancer Network, 16(9), 1041–1053.
  • Galsky, M. D., Hahn, N. M., Rosenberg, J., et al. (2011). Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. Journal of Clinical Oncology, 29(17), 2432–2438.
  • Grivas, P., Agarwal, N., Pal, S., et al. (2021). Avelumab first-line maintenance in locally advanced or metastatic urothelial carcinoma: Applying clinical trial findings to clinical practice. Cancer Treatment Reviews, 97, 102187.
  • Grivas, P., Monk, B. J., Petrylak, D., et al. (2019). Immune checkpoint inhibitors as switch or continuation maintenance therapy in solid tumors: Rationale and current state. Targeted Oncology, 14, 505–525.
  • Grivas, P., Plimack, E., Balar, A. V., et al. (2017). Pembrolizumab as first-line therapy in cisplatin-ineligible advanced urothelial cancer: Outcomes from KEYNOTE-052 in senior patients with poor performance status. Annals of Oncology, 28(Suppl 5), v301
  • Hsiao, P. J., Hsieh, P. F., Chang, C. H., Wu, H. C., Yang, C. R., & Huang, C. P. (2016). Higher risk of urothelial carcinoma in the upper urinary tract than in the urinary bladder in hemodialysis patients. Renal Failure, 38(5), 663–670.
  • Powles, T., Park, S. H., Caserta, C., Valderrama, B. P., Gurney, H., Ullén, A., ... & Grivas, P. (2023). Avelumab first-line maintenance for advanced urothelial carcinoma: results from the JAVELIN Bladder 100 trial after≥ 2 years of follow-up. Journal of Clinical Oncology, 41(19), 3486-3492.
  • Kim, T. J., Cho, K. S., & Koo, K. C. (2020). Current status and future perspectives of immunotherapy for locally advanced or metastatic urothelial carcinoma: A comprehensive review. Cancers, 12(192).
  • National Cancer Institute (2020). Cancer stat facts: Bladder cancer. Surveillance, Epidemiology, and End Results Program.
  • National Cancer Institute (2017). FDA approves immunotherapy drugs for patients with bladder cancer.
  • National Comprehensive Cancer Network. (2020). NCCN clinical practice guidelines in oncology: Bladder cancer (Version 5).
  • NCCN. (2023). Clinical practice guidelines in oncology: Bladder cancer (Version 3.2023).
  • Powles, T., Bellmunt, J., Comperat, E., et al. (2022). Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment, and follow-up. Annals of Oncology, 33, 244–258.
  • Rouprêt, M., Babjuk, M., Burger, M., Capoun, O., Cohen, D., Compérat, E. M., et al. (2021). European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. European Urology, 79(1), 62–79.
  • Siegel, R. L., Miller, K. D., Fuchs, H. E., & Jemal, A. (2022). Cancer statistics 2022. CA: A Cancer Journal for Clinicians, 72(1), 7–33. https://doi.org/10.3322/caac.21708
  • Sonpavde, G. P., Mariani, L., Lo Vullo, S., et al. (2018). Impact of the number of cycles of platinum-based first-line chemotherapy for advanced urothelial carcinoma. Journal of Urology, 200, 1207–1214.
  • Thomas, V. M., Grivas, P., & Agarwal, N. (2024). Gemcitabine with cisplatin and nivolumab: Redefining standard of care for first-line metastatic urothelial carcinoma? Med, 5(2), 109-111.
  • von der Maase, H., Sengelov, L., Roberts, J. T., et al. (2005). Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. Journal of Clinical Oncology, 23(21), 4602–4608.
  • Yang, M. H., Chen, K. K., Yen, C. C., Wang, W. S., Chang, Y. H., & Huang, W. J., et al. (2002). Unusually high incidence of upper urinary tract urothelial carcinoma in Taiwan. Urology, 59(5), 681–687.

LOKAL İLERİ VE METASTATİK ÜROTELYAL KANSERLİ HASTALARDA KEMOTERAPİ SONUÇLARIMIZ

Yıl 2025, Cilt: 7 Sayı: 3, 128 - 135, 26.12.2025
https://doi.org/10.55895/sshs.1728210

Öz

Bu çalışmada, sisplatin tedavisine uygun olmayan lokal ileri veya metastatik ürotelyal karsinomlu hastalarda birinci basamakta sisplatin yerine karboplatin kullanımı ve idame tedavide tek ajan gemsitabinin progresyonsuz sağkalım (PFS) ve genel sağkalım (OS) üzerine etkisi değerlendirildi.
Ayrıca, dört kür ile altı kür sisplatin-gemsitabin veya karboplatin-gemsitabin tedavisi alan hastalar karşılaştırıldı. Ocak 2018-Ocak 2023 tarihleri arasında tedavi edilen 80 hasta retrospektif olarak analiz edildi. Cinsiyet, yaş, tümör lokalizasyonu, metastaz bölgeleri, kemoterapi kür sayısı ve idame gemsitabin kullanımı gibi değişkenler değerlendirildi. Çeşitli klinik parametre grupları arasında sağ kalım ve PFS sürelerinin karşılaştırılmasında Kaplan Meier yöntemi kullanılmıştır. p<0.05 istatistiki olarak anlamlı kabul edilmiştir. Genel olarak kadın hastalarda ortalama sağkalım 23 ay iken erkek hastalarda 21 ay olarak hesaplandı. Erkek hastalarda PFS 46 ay iken kadınlarda 29 ay olarak hesapladı ve bu durum anlamlı olarak kabul edildi (p = 0,051). Tüm hastalara sisplatin-gemsitabin veya karboplatingemsitabin verildi; 80 hastanın dahil edildiği çalışmada 14 hasta idame dönemde gemsitabin aldı. Ortalama PFS 6,7 ay idi. Sadece gemsitabin ile idame tedavi alanlarda PFS 46,7 ay olup anlamlı olarak kabul edilirken(p=0.031) OS açısından ek katkı saptanmadı. Dört kür ile altı kür kemoterapi alanlar arasında OS farkı gözlenmezken, dört kür tedavi alanlarda PFS 18 ay iken altı kür tedavi alanlarda PFS 59 ay idi ve bu anlamlı olarak uzun olarak değerlendirildi (p =0,026). Gemsitabin ile idame tedavi ve kemoterapinin altı küre tamamlanması, PFS üzerinde olumlu etki sağlayabilir. Bu sonuçlar, ileri evre ürotelyal karsinomda daha geniş, çok merkezli ve prospektif çalışmalarla doğrulanmalıdır.

Kaynakça

  • Bladder cancer: ESMO practice guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 25(Suppl 3).
  • Boustead, G. B., Fowler, S., Swamy, R., Kocklebergh, R., & Hounsome, L. (2014). Stage, grade, and pathological characteristics of bladder cancer in the UK: British Association of Urological Surgeons (BAUS) urological tumor registry. BJU International, 113(6), 924–930.
  • Cathomas, R., Lorch, A., Bruins, H. M., et al. (2021). The 2021 updated European Association of Urology guidelines on metastatic urothelial carcinoma. European Urology, 81, 95–103.
  • Chen, C. H., Dickman, K. G., Moriya, M., Zavadil, J., Sidorenko, V. S., Edwards, K. L., et al. (2012). Aristolochic acid-associated urothelial cancer in Taiwan. Proceedings of the National Academy of Sciences, 109(21), 8241–8246. Dash, A., Galsky, M. D., Vickers, A. J., et al. (2006). Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer, 107(3), 506–513.
  • De Santis, M., Bellmunt, J., Mead, G., et al. (2009). Randomized phase II/III trial assessing gemcitabine/carboplatinandmethotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: Phase II—results of EORTC study 30986. Journal of Clinical Oncology, 27(33), 5634–5639.
  • De Santis, M., Bellmunt, J., Mead, G., et al. (2012). Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. Journal of Clinical Oncology, 30, 191–199.
  • EAU Guidelines (2024): Strong recommendation for maintenance avelumab after 4–6 cycles of platinum-based chemotherapy in advanced or metastatic urothelial carcinoma. European Society for Medical Oncology. (2019, December 16). eUpdate: Bladder cancer treatment recommendations.
  • Flaig, T. W., Spiess, P. E., Agarwal, N., et al. (2018). NCCN guidelines insights: Bladder cancer, version 5.2018. Journal of the National Comprehensive Cancer Network, 16(9), 1041–1053.
  • Galsky, M. D., Hahn, N. M., Rosenberg, J., et al. (2011). Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. Journal of Clinical Oncology, 29(17), 2432–2438.
  • Grivas, P., Agarwal, N., Pal, S., et al. (2021). Avelumab first-line maintenance in locally advanced or metastatic urothelial carcinoma: Applying clinical trial findings to clinical practice. Cancer Treatment Reviews, 97, 102187.
  • Grivas, P., Monk, B. J., Petrylak, D., et al. (2019). Immune checkpoint inhibitors as switch or continuation maintenance therapy in solid tumors: Rationale and current state. Targeted Oncology, 14, 505–525.
  • Grivas, P., Plimack, E., Balar, A. V., et al. (2017). Pembrolizumab as first-line therapy in cisplatin-ineligible advanced urothelial cancer: Outcomes from KEYNOTE-052 in senior patients with poor performance status. Annals of Oncology, 28(Suppl 5), v301
  • Hsiao, P. J., Hsieh, P. F., Chang, C. H., Wu, H. C., Yang, C. R., & Huang, C. P. (2016). Higher risk of urothelial carcinoma in the upper urinary tract than in the urinary bladder in hemodialysis patients. Renal Failure, 38(5), 663–670.
  • Powles, T., Park, S. H., Caserta, C., Valderrama, B. P., Gurney, H., Ullén, A., ... & Grivas, P. (2023). Avelumab first-line maintenance for advanced urothelial carcinoma: results from the JAVELIN Bladder 100 trial after≥ 2 years of follow-up. Journal of Clinical Oncology, 41(19), 3486-3492.
  • Kim, T. J., Cho, K. S., & Koo, K. C. (2020). Current status and future perspectives of immunotherapy for locally advanced or metastatic urothelial carcinoma: A comprehensive review. Cancers, 12(192).
  • National Cancer Institute (2020). Cancer stat facts: Bladder cancer. Surveillance, Epidemiology, and End Results Program.
  • National Cancer Institute (2017). FDA approves immunotherapy drugs for patients with bladder cancer.
  • National Comprehensive Cancer Network. (2020). NCCN clinical practice guidelines in oncology: Bladder cancer (Version 5).
  • NCCN. (2023). Clinical practice guidelines in oncology: Bladder cancer (Version 3.2023).
  • Powles, T., Bellmunt, J., Comperat, E., et al. (2022). Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment, and follow-up. Annals of Oncology, 33, 244–258.
  • Rouprêt, M., Babjuk, M., Burger, M., Capoun, O., Cohen, D., Compérat, E. M., et al. (2021). European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. European Urology, 79(1), 62–79.
  • Siegel, R. L., Miller, K. D., Fuchs, H. E., & Jemal, A. (2022). Cancer statistics 2022. CA: A Cancer Journal for Clinicians, 72(1), 7–33. https://doi.org/10.3322/caac.21708
  • Sonpavde, G. P., Mariani, L., Lo Vullo, S., et al. (2018). Impact of the number of cycles of platinum-based first-line chemotherapy for advanced urothelial carcinoma. Journal of Urology, 200, 1207–1214.
  • Thomas, V. M., Grivas, P., & Agarwal, N. (2024). Gemcitabine with cisplatin and nivolumab: Redefining standard of care for first-line metastatic urothelial carcinoma? Med, 5(2), 109-111.
  • von der Maase, H., Sengelov, L., Roberts, J. T., et al. (2005). Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. Journal of Clinical Oncology, 23(21), 4602–4608.
  • Yang, M. H., Chen, K. K., Yen, C. C., Wang, W. S., Chang, Y. H., & Huang, W. J., et al. (2002). Unusually high incidence of upper urinary tract urothelial carcinoma in Taiwan. Urology, 59(5), 681–687.
Toplam 26 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Klinik Onkoloji
Bölüm Araştırma Makalesi
Yazarlar

Esra Şazimet Kars 0000-0001-9414-0909

Fatma Esra Erdem Palaz 0000-0002-2387-7943

Vehbi Erçolak Bu kişi benim 0000-0003-1014-1694

Gönderilme Tarihi 27 Haziran 2025
Kabul Tarihi 15 Eylül 2025
Yayımlanma Tarihi 26 Aralık 2025
Yayımlandığı Sayı Yıl 2025 Cilt: 7 Sayı: 3

Kaynak Göster

APA Kars, E. Ş., Erdem Palaz, F. E., & Erçolak, V. (2025). OUR CHEMOTHERAPY RESULTS IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC UROTHELIAL CANCER. Sabuncuoglu Serefeddin Health Sciences, 7(3), 128-135. https://doi.org/10.55895/sshs.1728210

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