Switch-maintenance avelumab immunotherapy following first-line chemotherapy for patients with advanced, unresectable or metastatic urothelial carcinoma: the first Japanese real-world evidence from a multicenter study

被引:18
作者
Miyake, Makito [1 ]
Shimizu, Takuto [1 ]
Oda, Yuki [2 ]
Tachibana, Akira [3 ]
Ohmori, Chihiro [4 ]
Itami, Yoshitaka [4 ]
Kiba, Keisuke [5 ]
Tomioka, Atsushi [6 ]
Yamamoto, Hiroaki [7 ]
Ohnishi, Kenta [8 ]
Nishimura, Nobutaka [9 ]
Hori, Shunta [11 ]
Morizawa, Yosuke [1 ]
Gotoh, Daisuke [1 ]
Nakai, Yasushi [1 ]
Torimoto, Kazumasa [1 ]
Fujii, Tomomi [10 ]
Tanaka, Nobumichi [11 ]
Fujimoto, Kiyohide [11 ]
机构
[1] Nara Med Univ, Dept Urol, 840 Shijo Cho, Kashihara, Nara 6348522, Japan
[2] Yamatotakada Municipal Hosp, Dept Urol, Nara, Japan
[3] Osaka Kaisei Hosp, Dept Urol, Osaka, Japan
[4] Nara Prefecture Gen Med Ctr, Dept Urol, Nara, Japan
[5] Kindai Univ, Dept Urol, Nara Hosp, Nara, Japan
[6] Saiseikai Chuwa Hosp, Dept Urol, Nara, Japan
[7] Gen Med Ctr, Dept Urol, Nara, Japan
[8] Hoshigaoka Med Ctr, Dept Urol, Osaka, Japan
[9] Okanami Gen Hosp, Dept Urol, Iga, Mie, Japan
[10] Nara Med Univ, Dept Prostate Brachytherapy, Nara, Japan
[11] Nara Med Univ, Dept Diagnost Pathol, Nara, Japan
关键词
(MeSH term): urinary bladder neoplasms; kidney pelvis; ureter; immunotherapy; avelumab; UNITED-STATES; BLADDER; CANCER; TUMORS;
D O I
10.1093/jjco/hyac186
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objective: To develop the first Japanese real-world evidence of switch-maintenance avelumab in advanced, unresectable or metastatic urothelial carcinoma (aUC). Methods: A multicenter-derived database registered 505 patients diagnosed with aUC between 2008 and 2021. Of these, 204 patients (40%) were selected and stratified according to the type of therapy used: maintenance avelumab group (27 [5.3%]), second-line (2 L) pembrolizumab group (103 [20%]) and 2 L cytotoxic chemotherapy group (74 [15%]). The progression-free survival and overall survival from the initiation of following therapy were compared. Tumor response was evaluated based on the Response Evaluation Criteria in Solid Tumors guideline v1.1 during the treatment period. A detailed analysis was performed in the maintenance avelumab group to investigate possible factors associated with response to avelumab therapy. Results: The maintenance avelumab group had a longer overall survival, not progression-free survival, compared with the other two treatment groups. The median treatment-free interval between the last dose of first-line (1 L) chemotherapy and the initiation of avelumab therapy was 6 weeks (range, 3-22). Disease control rate of maintenance avelumab therapy in patients with a treatment-free interval of <= 6 weeks was higher than that in patients with a treatment-free interval of >6 weeks (77 vs 40%, P = 0.029). The patients showing objective response to 1 L chemotherapy were less likely to experience tumor relapse (4 of 19) after the initiation of avelumab therapy compared with those showing stable disease (7 of 8). Conclusions: Objective response to 1 L chemotherapy and early induction of maintenance avelumab therapy may be associated with increased benefit from maintenance avelumab therapy.
引用
收藏
页码:253 / 262
页数:10
相关论文
共 30 条
[1]   Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma [J].
Bajorin, D. F. ;
Witjes, J. A. ;
Gschwend, J. E. ;
Schenker, M. ;
Valderrama, B. P. ;
Tomita, Y. ;
Bamias, A. ;
Lebret, T. ;
Shariat, S. F. ;
Park, S. H. ;
Ye, D. ;
Agerbaek, M. ;
Enting, D. ;
McDermott, R. ;
Gajate, P. ;
Peer, A. ;
Milowsky, M., I ;
Nosov, A. ;
Antonio Jr, J. N. ;
Tupikowski, K. ;
Toms, L. ;
Fischer, B. S. ;
Qureshi, A. ;
Collette, S. ;
Unsal-Kacmaz, K. ;
Broughton, E. ;
Zardavas, D. ;
Koon, H. B. ;
Galsky, M. D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (22) :2102-2114
[2]   Pembrolizumab (pembro) versus investigator's choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial. [J].
Bellmunt, Joaquim ;
Necchi, Andrea ;
De Wit, Ronald ;
Lee, Jae-Lyun ;
Fong, Lawrence ;
Vogelzang, Nicholas J. ;
Duran, Miguel A. Climent ;
Petrylak, Daniel P. ;
Choueiri, Toni K. ;
Gerritsen, Winald R. ;
Gurney, Howard ;
Quinn, David I. ;
Culine, Stephane ;
Sternberg, Cora N. ;
Xu, Jin Zhi ;
Moreno, Blanca Homet ;
Godwin, James Luke ;
Bajorin, Dean F. ;
Vaughn, David J. ;
Fradet, Yves .
JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (15)
[3]  
Benbow Jennifer H, 2022, Am Soc Clin Oncol Educ Book, V42, P1, DOI 10.1200/EDBK_350574
[4]   Induction of Peripheral Effector CD8 T-cell Proliferation by Combination of Paclitaxel, Carboplatin, and Bevacizumab in Non-small Cell Lung Cancer Patients [J].
de Goeje, Pauline L. ;
Poncin, Myrthe ;
Bezemer, Koen ;
Kaijen-Lambers, Margaretha E. H. ;
Groen, Harry J. M. ;
Smit, Egbert F. ;
Dingemans, Anne-Marie C. ;
Kunert, Andre ;
Hendriks, Rudi W. ;
Aerts, Joachim G. J. V. .
CLINICAL CANCER RESEARCH, 2019, 25 (07) :2219-2227
[5]   Treatment Sequencing Patterns in Patients with Metastatic Urothelial Cancer Treated in the Community Practice Setting in the United States: SPEAR-Bladder (Study informing treatment Pathway dEcision in bladder cAnceR) [J].
Doshi, Gurjyot K. ;
Bhanegaonkar, Abhijeet ;
Kearney, Mairead ;
Bharmal, Murtuza ;
Cislo, Paul ;
Kim, Ruth ;
Boyd, Marley ;
Aguilar, Kathleen M. ;
Phatak, Hemant .
CLINICOECONOMICS AND OUTCOMES RESEARCH, 2020, 12 :645-656
[6]   New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].
Eisenhauer, E. A. ;
Therasse, P. ;
Bogaerts, J. ;
Schwartz, L. H. ;
Sargent, D. ;
Ford, R. ;
Dancey, J. ;
Arbuck, S. ;
Gwyther, S. ;
Mooney, M. ;
Rubinstein, L. ;
Shankar, L. ;
Dodd, L. ;
Kaplan, R. ;
Lacombe, D. ;
Verweij, J. .
EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247
[7]   Cisplatin increases PD-L1 expression and optimizes immune check-point blockade in non-small cell lung cancer [J].
Fournel, Ludovic ;
Wu, Zherui ;
Stadler, Nicolas ;
Damotte, Diane ;
Lococo, Filippo ;
Boulle, Geoffroy ;
Segal-Bendirdjian, Evelyne ;
Bobbio, Antonio ;
Icard, Philippe ;
Tredaniel, Jean ;
Alifano, Marco ;
Forgez, Patricia .
CANCER LETTERS, 2019, 464 :5-14
[8]   Impact of radiotherapy to the primary tumor on the efficacy of pembrolizumab for patients with advanced urothelial cancer: A preliminary study [J].
Fukushima, Hiroshi ;
Kijima, Toshiki ;
Fukuda, Shohei ;
Moriyama, Shingo ;
Uehara, Sho ;
Yasuda, Yosuke ;
Tanaka, Hajime ;
Yoshida, Soichiro ;
Yokoyama, Minato ;
Matsuoka, Yoh ;
Saito, Kazutaka ;
Matsubara, Nobuaki ;
Numao, Noboru ;
Sakai, Yasuyuki ;
Yuasa, Takeshi ;
Masuda, Hitoshi ;
Yonese, Junji ;
Kageyama, Yukio ;
Fujii, Yasuhisa .
CANCER MEDICINE, 2020, 9 (22) :8355-8363
[9]  
Galluzzi L, 2020, J IMMUNOTHER CANCER, V8, DOI 10.1136/jitc-2019-000337
[10]   Avelumab first-line (1L) maintenance plus best supportive care (BSC) vs BSC alone with 1L chemotherapy (CTx) for advanced urothelial carcinoma (UC): Subgroup analyses from JAVELIN Bladder 100 [J].
Grivas, P. ;
Park, S. H. ;
Voog, E. ;
Caserta, C. ;
Perez Valderrama, B. ;
Gurney, H. ;
Kalofonos, H. ;
Radulovic, S. ;
Demey, W. ;
Ullen, A. ;
Loriot, Y. ;
Sridhar, S. S. ;
Tsuchiya, N. ;
Kopyltsov, E. ;
Gupta, S. ;
Huang, B. ;
Costa, N. ;
Blake-Haskins, J. A. ;
di Pietro, A. ;
Powles, T. B. .
ANNALS OF ONCOLOGY, 2020, 31 :S555-S556