Efficacy and safety of pemetrexed maintenance chemotherapy for advanced non-small cell lung cancer in a real-world setting

被引：5

作者：

Li, Jianjie ^{[1
]}

Chi, Yujia ^{[1
]}

Cao, Guang ^{[1
]}

Zhao, Jun ^{[1
]}

An, Tongtong ^{[1
]}

Wu, Meina ^{[1
]}

Wang, Yuyan ^{[1
]}

Zhuo, Minglei ^{[1
]}

Yang, Xue ^{[1
]}

Jia, Bo ^{[1
]}

Chen, Hanxiao ^{[1
]}

Wang, Jingjing ^{[1
]}

Zhai, Xiaoyu ^{[1
]}

Wang, Ziping ^{[1
]}

机构：

[1] Peking Univ Canc Hosp & Inst, Dept Thorac Med Oncol, Minist Educ Beijing, Key Lab Carcinogenesis & Translat Res, 52 Fucheng Rd, Beijing 100142, Peoples R China

来源：

JOURNAL OF THORACIC DISEASE | 2021年 / 13卷 / 03期

关键词：

Pemetrexed; maintenance; non-small cell lung cancer (NSCLC); progression-free survival (PFS); adverse events; RANDOMIZED PHASE-III; THERAPY; BEVACIZUMAB; CARBOPLATIN; CISPLATIN; SURVIVAL; TRIAL; NSCLC;

D O I：

10.21037/jtd-21-337

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

Background: Pemetrexed maintenance therapy offers a survival benefit in patients with nonprogressive advanced nonsquamous non-small cell lung cancer (NSCLC) with good tolerability. This study was designed to analyze the efficacy and safety of pemetrexed maintenance chemotherapy in advanced nonsquamous NSCLC patients in a real-world setting. Methods: The response rate (RR) and adverse events in 71 nonsquamous NSCLC patients treated with pemetrexed-based chemotherapy were observed until disease progression or unacceptable toxicities. Measures of survival were analyzed during follow-up. Results: Of 69 efficacy-evaluable patients, the objective response rate (ORR) was 46.4% and the disease control rate (DCR) was 98.6%. ORR showed no significant difference between patients who received pemetrexed as first-line therapy and those who received pemetrexed as second-line or higher treatment. The median treatment cycle for all patients was 8. The median progression-free survival (PFS) was 9.5 months (m) and median overall survival (OS) was 30.5 m. The univariate and multivariate analyses showed that the number of chemotherapy cycles was an independent factor for PFS. The most common adverse reactions were grade 1 to 2 hematologic toxicities, gastrointestinal reactions, and liver enzyme abnormalities. Only 1 patient experienced a grade 3 gastrointestinal event. Conclusions: Pemetrexed maintenance chemotherapy can improve PFS in patients with advanced nonsquamous NSCLC with good tolerability. Keywords: Pemetrexed; maintenance; non-small cell lung cancer (NSCLC); progression-free survival (PFS); Background: Pemetrexed maintenance therapy offers a survival benefit in patients with nonprogressive advanced nonsquamous non-small cell lung cancer (NSCLC) with good tolerability. This study was designed to analyze the efficacy and safety of pemetrexed maintenance chemotherapy in advanced nonsquamous NSCLC patients in a real-world setting. Methods: The response rate (RR) and adverse events in 71 nonsquamous NSCLC patients treated with pemetrexed-based chemotherapy were observed until disease progression or unacceptable toxicities. Measures of survival were analyzed during follow-up. Results: Of 69 efficacy-evaluable patients, the objective response rate (ORR) was 46.4% and the disease control rate (DCR) was 98.6%. ORR showed no significant difference between patients who received pemetrexed as first-line therapy and those who received pemetrexed as second-line or higher treatment. The median treatment cycle for all patients was 8. The median progression-free survival (PFS) was 9.5 months (m) and median overall survival (OS) was 30.5 m. The univariate and multivariate analyses showed that the number of chemotherapy cycles was an independent factor for PFS. The most common adverse reactions were grade 1 to 2 hematologic toxicities, gastrointestinal reactions, and liver enzyme abnormalities. Only 1 patient experienced a grade 3 gastrointestinal event. Conclusions: Pemetrexed maintenance chemotherapy can improve PFS in patients with advanced nonsquamous NSCLC with good tolerability.

引用

页码：1813 / 1821

页数：9

共 17 条

[1] Chemotherapy in addition to supportive care improves survival in advanced non-small-cell lung cancer: A systematic review and meta-analysis of individual patient data from 16 randomized controlled trials - NSCLC meta-analyses collaborative group [J].

Burdett, S. ;

Stephens, R. ;

Stewart, L. ;

Tierney, J. ;

Auperin, A. ;

Le Chevalier, T. ;

Le Pechoux, C. ;

Pignon, J. P. ;

Arriagada, R. ;

Higgins, J. ;

Johnson, D. ;

van Meerbeeck, J. ;

Parmar, M. ;

Souhami, R. .

JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (28) :4617-4625

[2] Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study [J].

Ciuleanu, Tudor ;

Brodowicz, Thomas ;

Zielinski, Christoph ;

Kim, Joo Hang ;

Krzakowski, Maciej ;

Laack, Eckart ;

Wu, Yi-Long ;

Bover, Isabel ;

Begbie, Stephen ;

Tzekova, Valentina ;

Cucevic, Branka ;

Pereira, Jose Rodrigues ;

Yang, Sung Hyun ;

Madhavan, Jayaprakash ;

Sugarman, Katherine P. ;

Peterson, Patrick ;

John, William J. ;

Krejcy, Kurt ;

Belani, Chandra P. .

LANCET, 2009, 374 (9699) :1432-1440

[3] Randomized phase III trial comparing switch-maintenance pemetrexed with observation followed by pemetrexed at progression in advanced NSCLC [J].

Halvorsen, Tarje O. ;

Stokke, Kristin ;

Killingberg, Kristin T. ;

Raj, Sunil X. ;

Sorhaug, Sveinung ;

Brustugun, Odd Terje ;

Flotten, Oystein ;

Helbekkmo, Nina ;

Hornslien, Kjersti ;

Madebo, Tesfaye ;

Fluge, Sverre ;

Gronberg, Bjorn Henning .

ACTA ONCOLOGICA, 2020, 59 (09) :1051-1057

[4] Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy [J].

Hanna, N ;

Shepherd, FA ;

Fossella, FV ;

Pereira, JR ;

De Marinis, F ;

von Pawel, J ;

Gatzemeier, U ;

Tsao, TCY ;

Pless, M ;

Muller, T ;

Lim, HL ;

Desch, C ;

Szondy, K ;

Gervais, R ;

Shaharyar ;

Manegold, C ;

Paul, S ;

Paoletti, P ;

Einhorn, L ;

Bunn, PA .

JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (09) :1589-1597

[5] Maintenance therapy in NSCLC: why? To whom? Which agent? [J].

Novello, Silvia ;

Milella, Michele ;

Tiseo, Marcello ;

Banna, Giuseppe ;

Cortinovis, Diego ;

Di Maio, Massimo ;

Garassino, Marina ;

Maione, Paolo ;

Martelli, Olga ;

Vavala, Tiziana ;

Bria, Emilio .

JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH, 2011, 30

[6] PointBreak: A Randomized Phase III Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small-Cell Lung Cancer [J].

Patel, Jyoti D. ;

Socinski, Mark A. ;

Garon, Edward B. ;

Reynolds, Craig H. ;

Spigel, David R. ;

Olsen, Mark R. ;

Hermann, Robert C. ;

Jotte, Robert M. ;

Beck, Thaddeus ;

Richards, Donald A. ;

Guba, Susan C. ;

Liu, Jingyi ;

Frimodt-Moller, Bente ;

John, William J. ;

Obasaju, Coleman K. ;

Pennella, Eduardo J. ;

Bonomi, Philip ;

Govindan, Ramaswamy .

JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (34) :4349-U77

[7] Phase II Study of Pemetrexed and Carboplatin Plus Bevacizumab With Maintenance Pemetrexed and Bevacizumab As First-Line Therapy for Nonsquamous Non-Small-Cell Lung Cancer [J].

Patel, Jyoti D. ;

Hensing, Thomas A. ;

Rademaker, Alfred ;

Hart, Eric M. ;

Blum, Matthew G. ;

Milton, Daniel T. ;

Bonomi, Philip D. .

JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (20) :3284-3289

[8] PARAMOUNT: Final Overall Survival Results of the Phase III Study of Maintenance Pemetrexed Versus Placebo Immediately After Induction Treatment With Pemetrexed Plus Cisplatin for Advanced Nonsquamous Non-Small-Cell Lung Cancer [J].

Paz-Ares, Luis G. ;

de Marinis, Filippo ;

Dediu, Mircea ;

Thomas, Michael ;

Pujol, Jean-Louis ;

Bidoli, Paolo ;

Molinier, Olivier ;

Sahoo, Tarini Prasad ;

Laack, Eckart ;

Reck, Martin ;

Corral, Jesus ;

Melemed, Symantha ;

John, William ;

Chouaki, Nadia ;

Zimmermann, Annamaria H. ;

Visseren-Grul, Carla ;

Gridelli, Cesare .

JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (23) :2895-+

[9] Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer [J].

Peters, Solange ;

Camidge, D. Ross ;

Shaw, Alice T. ;

Gadgeel, Shirish ;

Ahn, Jin S. ;

Kim, Dong-Wan ;

Ou, Sai-Hong I. ;

Perol, Maurice ;

Dziadziuszko, Rafal ;

Rosell, Rafael ;

Zeaiter, Ali ;

Mitry, Emmanuel ;

Golding, Sophie ;

Balas, Bogdana ;

Noe, Johannes ;

Morcos, Peter N. ;

Mok, Tony .

NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (09) :829-838

[10] Pemetrexed, Bevacizumab, or the Combination As Maintenance Therapy for Advanced Nonsquamous Non-Small-Cell Lung Cancer: ECOG-ACRIN 5508 [J].

Ramalingam, Suresh S. ;

Dahlberg, Suzanne E. ;

Belani, Chandra P. ;

Saltzman, Joel N. ;

Pennell, Nathan A. ;

Nambudiri, Gopakumar S. ;

McCann, John C. ;

Winegarden, Jerome D. ;

Kassem, Mohammed A. ;

Mohamed, Mohamed K. ;

Rothman, Jan M. ;

Lyss, Alan P. ;

Horn, Leora ;

Stinchcombe, Thomas E. ;

Schiller, Joan H. .

JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (26) :2360-+

← 1 2 →